In Vitro Diagnostic Industry in China 9819931096, 9789819931095

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In Vitro Diagnostic Industry in China Haibo Song Lizhong Dai Editors Second Edition

123

In Vitro Diagnostic Industry in China

Haibo Song  •  Lizhong Dai Editors

In Vitro Diagnostic Industry in China Second Edition

Editors Haibo Song China Association of In Vitro Diagnostics Shanghai, China

Lizhong Dai Sansure Biotechnology Co., Ltd Changsha, China

ISBN 978-981-99-3109-5    ISBN 978-981-99-3110-1 (eBook) https://doi.org/10.1007/978-981-99-3110-1 © Shanghai Scientific and Technical Publishers 2021, 2023 Jointly published with Shanghai Scientific and Technical Publishers The print edition is not for sale in China (Mainland). Customers from China (Mainland) please order the print book from: Shanghai Scientific and Technical Publishers. This work is subject to copyright. All rights are solely and exclusively licensed by the Publisher, whether the whole or part of the material is concerned, specifically the rights of reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publishers, the authors, and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publishers nor the authors or the editors give a warranty, expressed or implied, with respect to the material contained herein or for any errors or omissions that may have been made. The publishers remain neutral with regard to jurisdictional claims in published maps and institutional affiliations. This Springer imprint is published by the registered company Springer Nature Singapore Pte Ltd. The registered company address is: 152 Beach Road, #21-01/04 Gateway East, Singapore 189721, Singapore Paper in this product is recyclable.

Preface

In recent years, China’s in vitro diagnostic (IVD) industry has developed rapidly and has grown into a considerable industrial cluster. At present, China’s IVD industry has a complete range of categories, numerous R&D and production enterprises, a comprehensive distribution of distribution enterprises, an increasingly perfect upstream, middle and downstream industrial chain, and constantly improved product quality, making it the fastest growing medical device segment. At present, in vitro diagnostic products and technologies in China are developing towards integration, informatization, high-throughput, speediness, portability, and intelligence. The continuous emergence, updating, and iteration of some new technologies and new products such as mass spectrometry detection technology and gene editing technology make the development prospect of in  vitro diagnostic industry very broad. This book is the second edition of In Vitro Diagnostic Industry in China. The book is divided into 12 parts and 38 chapters, which comprehensively and systematically introduce the achievements and the latest development trends of the innovation and development of China’s IVD industry in recent years. The contents include the 2021 China IVD industry report, the academic, technological development, market situation and research and development of related products in various subdivisions such as immunodiagnosis, clinical chemical diagnosis, molecular diagnosis, blood and humoral diagnosis, microbial diagnosis, instant detection, mass spectrometry analysis, pathological diagnosis, etc., the development report of China’s IVD reagent raw materials, the development, investment and financing, acquisition and merger of China’s IVD listed enterprises, etc. The updated contents of this book are China’s IVD industry report, immunodiagnosis, clinical chemical diagnosis, molecular diagnosis, blood and humoral diagnosis, microbial diagnosis, real-time detection, China’s IVD listed enterprise development, investment and financing, mergers and acquisitions, etc. New contents added include the development and application of molecular diagnostic products of COVID-19, flight mass spectrometry, tandem mass spectrometry, tumor markers, ELISA immune reagents, autoimmune diagnosis, concomitant diagnosis, fecal and intestinal microecology detection, pathological diagnosis, in vitro diagnostic reagent raw materials, in vitro diagnostic reagent reference materials and quality control materials, which make the book more innovative and richer. This book is characterized by a more comprehensive

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Preface

and systematic reflection of the new trends and new progress in the development of China’s IVD industry, highlighting the hot technologies and innovative products in the industry, such as the novel coronavirus molecular diagnostic technology, instruments and reagents, COVID-19 nucleic acid emergency detection laboratory (gas membrane laboratory, shelter laboratory, mobile detection vehicle), and mass spectrometry detection technology. This book was jointly written by well-known entrepreneurs, experts, professors, and elites in China’s IVD industry, organized by the Medical Laboratory Science Industry Branch of the National Health Industry Enterprise Management Association, the Experimental Medicine Branch of the National Health Industry Enterprise Management Association, the IVD Branch of the China Medical Device Industry Association, and the Blue Book Editorial Department of China’s IVD Industry Development. The editing and publishing of the second edition of China’s IVD Industry will enable the world to have a more comprehensive and in-depth understanding of China’s IVD products and technologies, promote international exchanges in the IVD industry, grasp new developments in the industry, constantly improve the level of prevention, diagnosis, and treatment of clinical diseases, and serve the health of all mankind. Shanghai, China Hunan, China  November 22, 2022

Declaration  Lizhong Dai is an employee of Sansure Biotech Inc.

Haibo Song Lizhong Dai

Contents

Part I 2021 China In Vitro Diagnostics Industry Development Report 1

Status and Progress���������������������������������������������������������������������������������������� 3 Haibo Song, Yaoyi Zhu, Linda Zhang, Qi Chen, and Wenting Xiao

2

Opportunities and Challenges�������������������������������������������������������������������� 69 Yaoyi Zhu, Linda Zhang, Qi Chen, and Wenting Xiao

Part II Immunoassay 3

Chemiluminescence Analyzers and Reagents�������������������������������������������� 81 Shuang Li, Ting Peng, Ming Wang, and Yujie Cao

4

Automatic Enzyme Immunoassay Instrument and Related Instruments ���������������������������������������������������������������������������� 87 Yunqi Li, Rongbang Xia, Tao Zhao, Pengfei Lai, Nan Sun, Weijing Yi, and Wei Hu

5

Autoimmune Diagnostics���������������������������������������������������������������������������� 99 Haifeng Jin, Yanchun Guo, Tianshi Wang, Qiuping Yu, Xuexin Deng, and Mu Wang

6

Tumor Markers������������������������������������������������������������������������������������������ 135 Zhiyu Cai, Ye Sheng, Li Zhu, Jianer Yao, and Wei Deng

7

ELISA Immunological Reagents�������������������������������������������������������������� 151 Chao Chen, Yuming Ji, Jianfang Liu, Haifeng Shi, and Wan he Ding

Part III Clinical Chemistry 8

 Instruments and Reagents for Biochemical Analysis����������������������������� 161 Zuojun Zou, Yanshang Ma, Dalei Li, Nengke Pan, and Yuanli Li

9

Electrolyte Technologies���������������������������������������������������������������������������� 187 Jiandong Wang, Xiaolong Wang, Hui Xu, Dali Dai, Lili Chen, Wenguang Tan, Meichen Jiang, and Min Yang

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Contents

10 Analysis  of Blood Gas�������������������������������������������������������������������������������� 199 Lili Chen, Wenguang Tan, Min Yang, Ziyan Luo, Jiandong Wang, Xiaolong Wang, Hui Xu, and Dali Dai 11 Clinical Chemistry Laboratory Automation ������������������������������������������ 207 Wei Qin, Jianmei Zhang, Ye Sheng, Jianer Yao, Yan Yang, Hongyun Zhao, and Zengli Yang Part IV Molecular Diagnosis 12 Molecular  Diagnosis of Novel Coronavirus �������������������������������������������� 219 Lizhong Dai, Zhongping Deng, Jia Liu, Xiaomei Ren, Kang Wu, Deyong Tan, Hongjian Zhang, Yong Deng, Yingjuan Ai, Bozhi Ji, Yaping Xie, Jack Shao, and Qiang Li 13 Molecular  Diagnostic Analyzers and Reagents �������������������������������������� 241 Jack Shao, Qiang Li, Jie Zhang, Zhongping Deng, and Xiaomei Ren Part V POCT 14 Review �������������������������������������������������������������������������������������������������������� 261 Yaping Zhao, Xiaofang Wang, Jiaqi Zou, Li Tian, and Shan Guo 15 The POCT Market������������������������������������������������������������������������������������ 267 Yaping Zhao, Xiaofang Wang, Jiaqi Zou, Li Tian, and Shan Guo 16 Major  Manufacturers in China���������������������������������������������������������������� 277 Yaping Zhao, Xiaofang Wang, Jiaqi Zou, Li Tian, and Shan Guo Part VI Diagnosis of Blood and Body Fluids 17 Blood  Coagulation Analyzer and Reagents �������������������������������������������� 285 Zuojun Zou, Yanshang Ma, Qifan Tian, Hai Wang, Chonghui Ding, and Jiahong Zhang 18 Blood  Typing Instruments and Reagents������������������������������������������������ 311 Pengfei Lai, Nan Sun, Tao Zhao, Rongbang Xia, Yunqi Li, Yanshang Ma, Xiaoyan Yang, and Boping Dong 19 Urine������������������������������������������������������������������������������������������������������������ 325 Jun Jiang, Chuanjun Su, Kun Wang, and Yongqing Zhou 20 Stool  and Intestinal Microbiota Examination ���������������������������������������� 341 Tingting Wang, Xianglong Li, and Qinghua Liao 21 Semen���������������������������������������������������������������������������������������������������������� 361 Yufeng Cui, Bin Hu, Chenyue Dou, Yanyan Kang, Yongliang Ni, and Qifeng Nie 22 Vaginal Secretions ������������������������������������������������������������������������������������ 371 Yongliang Ni, Qifeng Nie, Shang Gao, and Zhengxu Kang

Contents

ix

23 Hematology Analyzers and Reagents ������������������������������������������������������ 381 Guangna Ma, Gengwen Chen, Jialin Lin, Lingyu Bai, Biao Wu, Yong Tang, Yang Yang, and Kang Yu Part VII Microbiology and Companion Diagnostic 24 Instruments  and Reagents for Microbial Culture Identification���������� 403 Yehuan Zheng, Juan Fang, Xiaoli Cui, Xiangyu Wang, Mengmeng Lv, Guangyu Fu, Bingbing Zeng, Wei Xiong, and Yifeng Sun 25 Companion Diagnostics ���������������������������������������������������������������������������� 419 Chengbo Fu, Yan Jiang, Yile Sun, and Yuqing Tang Part VIII Mass Spectrometry 26 Matrix-Assisted  Laser Desorption Ionization Time-of-Flight Mass Spectrometry������������������������������������������������������������������������������������ 445 Zengli Yang, Keya Cai, Gaoling Zhao, Meili Liu, and Zhimin Lin 27 Tandem Mass Spectrometry���������������������������������������������������������������������� 457 Quan Ji, Zhimin Lin, Sixing Chen, and Zengli Yang Part IX Pathological Diagnosis 28 Overview  of Pathological Diagnosis �������������������������������������������������������� 477 Xiaojun Zhou 29 Conventional Pathology���������������������������������������������������������������������������� 485 Xiaolu Wang and Xiaojun Zhou 30 Cytopathology�������������������������������������������������������������������������������������������� 489 Xuedong Fu and Yinghao Yu 31 Immunohistochemistry������������������������������������������������������������������������������ 495 Qinghai Yang, Qixin Lin, and Yun Shi 32 Molecular Pathology���������������������������������������������������������������������������������� 505 Chun Meng Part X Development Report of IVD Reagent Raw Materials 33 Classification  and Status of IVD Reagent Raw Materials��������������������� 523 Guangyu Yang, Hongsen Jin, Shuai Han, Huisheng Zhang, and Peng Cui 34 Development  Bottlenecks and Favorable Factors of IVD Reagent Raw Materials�������������������������������������������������������������������������������������������� 527 Guangyu Yang, Hongsen Jin, Shuai Han, Huisheng Zhang, and Peng Cui

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Contents

Part XI Reference Standards and Controls for In Vitro Diagnostic Reagents 35 Development  and Application Status of National Reference Materials for in Vitro Diagnostic Reagents �������������������������������������������� 537 Jian Zhang, Junli Zu, and Gongcheng Liu 36 Research  and Development, Production, and Application Status of Quality Controls for in Vitro Diagnostic Reagents ���������������� 547 Junli Zu, Jian Zhang, and Gongcheng Liu Part XII In Vitro Diagnosis of Listed Enterprises Development and Investment, Financing, Acquisition and Merger Status in China 37 Performance  of Listed Companies in 2021���������������������������������������������� 559 Xunzhi Su, Lei Wang, and Jianmeng Cao 38 Investment,  Financing, and Merger of Listed Companies in 2021 �������������������������������������������������������������������������������������������������������� 575 Xunzhi Su, Lei Wang, and Jianmeng Cao Appendix: List of Selected Chinese IVD Manufacturers ������������������������������ 579

About the Editors

Haibo Song  successively served as the Deputy Director of Anhui Provincial Center for Clinical Laboratories and as a senior technician. He is now Vice Chairman of National Association of Health Industry and Enterprises Management, Chairman of China Association of In Vitro Diagnostics, Vice Chairman of the Labeling Immunoassay Professional Committee of China Association for Instrumental Analysis, Vice Chairman and Secretary General of Professional Committee of Experimental Medicine, Standing committee member of the National Medical Clinical Laboratory and the Standardization Technical Committee of the In Vitro Diagnostic System, Associate Dean of Shanghai Academy of Experimental Medicine, and founder of CACLP. Lizhong  Dai  is a renowned molecular biologist, who obtained a PhD from Princeton University after graduated from Peking University and served as a postdoctoral fellow at the Massachusetts Institute of Technology. He is a famous leader of in vitro diagnostics in China and recipient of the State Council government special allowance for experts. He is Executive Director of China Medical Equipment Association, Vice President of Medical Laboratory Industry Branch of National Health Industry Enterprise Management Association, Vice Chairman of Hunan Federation of Industry and Commerce, Vice President of Hunan Preventive Medicine Association, Vice President of Hunan Pharmaceutical Industry Association, Vice President of Hunan Medical Device Association, and Chairman of Shengxiang Biotechnology Co., Ltd.

xi

Part I 2021 China In Vitro Diagnostics Industry Development Report

1

Status and Progress Haibo Song, Yaoyi Zhu, Linda Zhang, Qi Chen, and Wenting Xiao

In 2021, China’s in vitro diagnostics (IVD) industry had significant progress and development in all aspects. China Association of In Vitro Diagnostics and In Vitro Diagnostics Society of China Association for Medical Devices Industry jointly prepared the 2021 China In Vitro Diagnostics Industry Development Report.

1.1 IVD Market in China 1.1.1 Market Size of Domestic Enterprises and the Statistics of Listed Companies and Enterprises Listed on the National Equities Exchange and Quotations (NEEQ) By summarizing domestic and foreign information about China’s IVD market, based on the ex-factory price of manufacturers and the first-hand wholesale price of foreign-funded enterprises, and excluding the data of nonindustrial scope, it is

H. Song China Association of In Vitro Diagnostics, Shanghai, China e-mail: [email protected] Y. Zhu IVD Branch of China Association of Medical Devices Industry, Beijing, China L. Zhang (*) · Q. Chen · W. Xiao Fosun Diagnostics (Shanghai) Co., Ltd., Shanghai, China e-mail: [email protected]; [email protected]; [email protected] © Shanghai Scientific and Technical Publishers 2023 H. Song, L. Dai (eds.), In Vitro Diagnostic Industry in China, https://doi.org/10.1007/978-981-99-3110-1_1

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H. Song et al.

estimated that the size of China’s IVD market will exceed RMB 130 billion in 2021 with a growth rate of about 15%. The proportion of imported products is higher than 50%. Moreover, the data of 87 listed diagnostics companies and companies listed on the NEEQ in the first half of 2021 and the data of 94 listed diagnostics companies and companies listed on the NEEQ in the whole year of 2021 are summarized as follows: In the first half of 2021, the total revenue of 87 listed companies was 74.65 billion CNY with a year-on-year growth of 54.79%; the attributable net profit was 17.92 billion CNY with a year-on-year growth of 82.06%. In 2021, the total revenue of 94 listed companies was 163.486 billion CNY with a year-on-year growth of 33.72%; the attributable net profit was 35.52 billion CNY with a year-on-year growth of 39.42%. See Tables 1.1, 1.2, 1.3, and 1.4 for data. Tables 1.5, 1.6, 1.7, and 1.8 show the market value changes of A-share listed companies in recent 3 years, the list of newly listed companies, IPO queuing companies and delisted companies in 2021.

Orient Gene

Dian Diagnostics

KingMed

1

2

3

Mindray

5

Hotgen

DA AN GENE

KeHua Biology

Yes!Star

Sansure Biotech

Wantai BioPharm

Maccura

7

8

9

10

11

12

13

Biotechnology

BGI Genomics

6

Biomedical

Runda Medical

4

Diagnostics

Amount

Rankings

Operating revenue

196,037

196,397

202,832

232,270

239,997

348,272

359,972

364,621

396,165

433,331

545,545

579,121

638,198

Huakang Biotech

Medical

Gongdong

HOB

Bioperfectus

Technology

NanoMicro

Wantai BioPharm

Biotechnology

Bioeasy

HybriBio

Tellgen

Biotechnologies

Strong

Biomedicine

Easy Diagnosis

Orient Gene

Hotgen

Growth rate %

68.87%

70.76%

87.11%

Bioperfectus

Biotechnology

Maccura

Wondfo Biotech

Biomedicine

Easy Diagnosis

Wantai BioPharm

111.64%

97.46%

Dian Diagnostics

Kingmed

BGI Genomics

Sansure Biotech

Bio-­Medical

Mindray

Hotgen

DA AN GENE

Orient Gene

132.78%

151.16%

156.88%

157.93%

204.49%

216.55%

670.63%

3904.13%

Amount

50,203

53,168

55,567

57,956

72,151

72,709

105,923

108,602

112,089

134,690

145,262

159,788

339,425

Attributable net profit

HOB

KeHua Biology

Technology

NanoMicro

Biomedicine

Easy Diagnosis

BioPharm

Wantai

HybriBio

Novogene

Biotechnology

Bioeasy

Leadman

Biotechnologies

Strong

Orient Gene

Tellgen

Hotgen

Growth rate %

136.32%

148.64%

172.79%

189.53%

195.92%

203.15%

208.32%

316.45%

327.68%

547.62%

547.82%

968.67%

74261.79%

Table 1.1  Rankings of critical data of listed diagnostics companies in the first half of 2021 (10 thousand CNY)

Dian Diagnostics

Sino Biological

Sansure Biotech

Orient Gene

DA AN GENE

Technology

NanoMicro

Autobio

Snibe

BGI Genomics

Diagnostics

KingMed

GenScript

Wantai BioPharm

Bio-­Medical

Mindray

208.29

235.08

236.00

276.60

281.53

319.40

322.80

346.52

363.42

518.52

724.96

1344.59

4629.35

Amount (100 million CNY)

Market value (2021.12.31) Growth rate %

Tellgen

Technology

Lifotronic

Orient Gene

Runda Medical

Biotechnology

Medicalsystem

−0.20%

9.53%

13.55%

19.95%

30.23%

53.87%

54.60%

77.02%

78.41%

131.78%

197.90%

230.21%

249.25%

(continued)

Wantai BioPharm

IVD Medical

Leadman

Biomedicine

Easy Diagnosis

Huakang Biotech

Hotgen

GenScript

Medical

Gongdong

1  Status and Progress 5

Wondfo Biotech

Autobio

GenScript

HybriBio

Snibe

Thalys

IVD Medical

Easy Diagnosis

14

15

16

17

18

19

20

21

Bioperfectus

Medicalsystem

23

24

Strong

26

Novogene

Berry Genomics

Alltest Biotech

27

28

29

Biotechnologies

Liferiver Biotech

25

Biotechnology

Sinocare

22

Biomedicine

Amount

Rankings

Operating revenue

Table 1.1 (continued)

63,557

73,361

80,173

80,781

90,690

112,135

113,056

113,085

114,134

118,679

119,779

122,571

129,863

160,698

167,758

185,622

Biotechnology

Maccura

Novogene

Technology

Lifotronic

GenScript

Autobio

Leadman

Diagnostics

Amoy

Yes!Star

LBP

Runda Medical

Thalys Medical

Diagnostics

Chemclin

Diagnostics

KingMed

Getein Biotech

DA AN GENE

KeHua Biology

Growth rate %

34.97%

37.02%

37.31%

37.97%

39.13%

39.39%

40.96%

44.96%

46.65%

47.25%

55.23%

56.51%

57.01%

58.02%

63.31%

64.35%

Diagnostics

Amoy

Yes!Star

Sinocare

Biotechnology

Medicalsystem

Biotechnology

Bioeasy

Getein Biotech

Medical

Gongdong

Runda Medical

biotechnologies

Strong

Alltest Biotech

Liferiver Biotech

HybriBio

Autobio

Snibe

Sino Biological

KeHua Biology

Amount

11,132

11,191

11,901

13,305

16,331

17,086

17,706

20,699

22,118

32,610

38,679

39,102

41,268

42,861

44,265

47,905

Attributable net profit

LBP

Bioperfectus

Technology

AVE Science &

Huakang Biotech

Succeeder

Biotechnology

Maccura

Getein Biotech

Righton Gene

Runda medical

Diagnostics

KingMed

Medical

Gongdong

DA AN GENE

IVD Medical

Biosino

Yes!Star

Diagnostics

Chemclin

Growth rate %

56.09%

63.19%

63.29%

66.45%

66.59%

71.36%

78.08%

81.64%

86.10%

90.55%

97.74%

105.25%

106.07%

114.92%

117.48%

124.65%

Runda Medical

Bioperfectus

Bohui Innovation

Biotechnology

Medicalsystem

HybriBio

Technology

Lifotronic

Liferiver Biotech

Biotechnology

Bioeasy

biotechnologies

Strong

YHLO Biotech

Gongdong Medical

Biotechnology

Maccura

Novogene

Amoy Diagnostics

Sinocare

Wondfo Biotech

77.72

80.60

80.95

81.62

86.73

97.11

100.55

115.69

116.74

139.93

161.36

162.43

165.28

167.42

168.92

175.22

Amount (100 million CNY)

Market value (2021.12.31) Growth rate %

Biotechnologies

Strong

Succeeder

Getein Biotech

LBP

Bohui Innovation

Sinocare

Improve Medical

Thalys Medical

diagnostics

KingMed

Biomedical

Mindray

DA AN GENE

Yes!Star

KeHua Biology

Diagnostics

Amoy

Dian Diagnostics

HybriBio

−20.79%

−20.25%

−18.10%

−17.61%

−17.14%

−16.53%

−13.30%

−12.64%

−11.92%

−10.61%

−6.42%

−5.17%

−3.77%

−3.54%

−2.07%

−1.96%

6 H. Song et al.

Getein Biotech

Gongdong

31

32

Kindstar

34

Improve Medical

Amoy Diagnostics

Lifotronic

36

37

38

Bioeasy

40

Leadman

Chemclin

42

43

LBP

Biosino

44

45

Diagnostics

Tellgen

41

Biotechnology

Bohui Innovation

39

Technology

Dirui

35

Globalgene

YHLO Biotech

33

Medical

Sino Biological

30

17,467

21,238

23,693

24,552

30,329

33,049

34,869

35,608

39,895

41,624

Globalgene

Kindstar

Improve Medical

Liferiver Biotech

Succeeder

Wondfo Biotech

Sinocare

IVD Medical

Snibe

YHLO Biotech

Sino Biological

Bohui Innovation

Dian Diagnostics

43,820

41,762

Alltest Biotech

Biomedical

Mindray

Biomedical

Mindray

Technology

AVE Science &

Biosino

54,801

57,604

60,029

63,470

2.02%

3.59%

10.79%

11.59%

15.53%

16.30%

20.95%

26.35%

27.84%

28.18%

28.77%

29.46%

30.48%

30.76%

31.85%

32.94%

technology

AVE science &

Leadman

Righton Gene

Berry Genomics

Succeeder

HOB

LBP

Technology

NanoMicro

Diagnostics

Chemclin

Tellgen

IVD Medical

Novogene

Technology

Lifotronic

YHLO Biotech

Improve Medical

Dirui

1262

1356

2493

3123

4172

4508

5088

6506

7002

7481

7889

8158

8242.52

8856.16

8980.38

10991.92

Improve Medical

YHLO Biotech

Snibe

Liferiver Biotech

Sansure Biotech

Bohui Innovation

Dirui

Alltest Biotech

Technology

Lifotronic

GenScript

Wondfo Biotech

Sino Biological

Biomedical

Mindray

Diagnostics

Amoy

Dian Diagnostics

Autobio

Succeeder Improve Medical

HOB

−9.90%

−14.74%

Righton Gene

−12.05%

IVD Medical −9.59%

Leadman

−1.10% −9.00%

Dirui

Globalgene

Kindstar

Tellgen

Alltest Biotech

Berry Genomics

Diagnostics

Chemclin

Hotgen

Getein Biotech

KeHua Biology

Biomedicine

Easy Diagnosis

1.65%

3.57%

18.47%

19.43%

23.76%

32.26%

35.99%

37.77%

45.02%

50.63%

32.93

36.44

39.73

40.42

43.57

43.90

49.44

51.70

51.97

66.31

68.79

71.86

72.24

72.98

76.32

77.61

Diagnostics

Chemclin

Liferiver Biotech

Biotechnology

Bioeasy

YHLO Biotech

Novogene

Sino Biological

Technology

NanoMicro

Autobio

Berry Genomics

Sansure Biotech

Wondfo Biotech

Biotechnology

Maccura

Snibe

BGI Genomics

Bioperfectus

Dirui

(continued)

–

–

–

–

–

–

–

−50.70%

−49.03%

−48.22%

−42.68%

−37.43%

−36.37%

−29.35%

−28.51%

−23.55%

1  Status and Progress 7

NanoMicro

46

Succeeder

AVE Science &

49

50

Huakang Biotech

1217

9731

11,069

13,602

14,754

16,562

55.60%

BGI Genomics

Dirui

Sansure Biotech

Righton Gene

Biotechnology

Medicalsystem

Berry Genomics

Growth rate %

GenScript

−9.82%

1,776,536

Globalgene

Kindstar

Bohui Innovation

−3.41%

−11.24%

Huakang Biotech

Biosino

Thalys Medical

0.03%

0.21%

1.82%

Amount

−150,170

−63,785

−1613

−205

184

326

Attributable net profit

81.61%

Globalgene

Kindstar

Berry Genomics

Thalys Medical

Biotechnology

Medicalsystem

BGI Genomics

Sinocare

Growth rate %

−1528.62%

−73.41%

−57.66%

−41.12%

−34.24%

−24.89%

Huakang Biotech

Biosino

Technology

AVE Science &

Yes!Star

LBP

Thalys Medical

0.99

2.46

18.91

26.81

28.44

29.50

Amount (100 million CNY)

Market value (2021.12.31) Growth rate %

Biosino

Technology

AVE Science &

HOB

Righton Gene

Globalgene

Kindstar

Alltest Biotech

–

–

–

–

–

–

Note 1: The following table includes listed companies related to IVD on the main board, SME board, GEM and Hong Kong stocks Note 2: Mindray’s revenue adopts the revenue of the “in vitro diagnostics” product line in its financial statement, and the profit is calculated by multiplying the proportion of IVD product line in total revenue by the total profit, the same below

Summary 7,269,445

51

Righton Gene

48

Technology

HOB

47

Technology

Amount

Rankings

Operating revenue

Table 1.1 (continued)

8 H. Song et al.

Kangmei Biotech Libo Medicine Sunshine Medical

Tzone Biotechnology Surexam Bio-Tech

Baio Technology GenePharma King Diagnostic

Newscen Bio-Pharmaceutical

10 11 12

13

15 16 17

18

14

9

Jiacheng Biotechnology Xincheng Biological

Operating revenue Amount Huizhikang Darui Biotechnology J.H. Bio-Tech Venture Bio-tech Iprocom Xinle Medical Wiz Biotech

8

Rankings 1 2 3 4 5 6 7

4463

5029 4773 4519

5508

5523

7082 7078 5646

7618

8066

25,142 17,428 14,043 11,623 10,478 10,065 10,027

Xinle Medical

Sunshine Medical Baio Technology Yonghe-Sun Biotechnology Dahui Biotechnology Surexam Bio-Tech Clinisciences Huizhikang Libo Medicine

Iprocom

Growth rate % Venture Bio-tech Wiz Biotech Zhongsheng Jinyu Promed Tianqi Medical KeyGen BioTech MultiSciences Biotech GenePharma

29.94%

Zhongsheng Jinyu Tzone Biotechnology MultiSciences Biotech GenePharma

Oticon

36.65% 35.73% 30.37% 30.13%

Surexam Bio-Tech

Keyu Biological King Diagnostic Babio Biotechnology

Jiacheng Biotechnology Iprocom

36.70%

55.83% 50.79% 50.70%

56.74%

74.65%

1187.09% 608.66% 243.02% 201.65% 131.11% 104.36% 96.28%

Attributable net profit Amount Venture Bio-tech Wiz Biotech Huizhikang J.H. Bio-Tech Libo Medicine Darui Biotechnology Xincheng Biological

Table 1.2  Rankings of critical data of NEEQ companies in the first half of 2021 (10 thousand CNY)

206

405 354 238

494

521

703 568 534

730

1019

2911 2726 2345 1746 1402 1090 1020

Jiacheng Biotechnology

Tzone Biotechnology Dahui Biotechnology Iprocom

Baio Technology

King Diagnostic

Yonghe-Sun Biotechnology Kangmei Biotech Libo Medicine Promed

GenePharma

Growth rate % Surexam Bio-Tech Venture Bio-tech Wiz Biotech Darui Biotechnology MultiSciences Biotech Huizhikang Zhongsheng Jinyu

(continued)

22.38%

51.89% 38.89% 24.65%

60.69%

66.80%

104.77% 95.00% 68.93%

105.83%

132.83%

4607.17% 1085.38% 812.52% 252.50% 222.72% 196.24% 194.95%

1  Status and Progress 9

Zhongsheng Jinyu

Mokobio Life Science MultiSciences Biotech Haiyuan Medical

Oticon

Zhongzhi Biotechnologies Dahui Biotechnology Promed

24

25

28

29

31

30

27

26

23

Huamei Bio Yonghe-Sun Biotechnology KeyGen BioTech

Operating revenue Amount Keyu Biological Babio Biotechnology

21 22

Rankings 19 20

Table 1.2 (continued)

1279

1530

1538

1633

1846

1911

1986

2159

2534

3004 2648

4432 3404

Mokobio Life Science

Tzone Biotechnology Xincheng Biological J.H. Bio-Tech

Zhongzhi Biotechnologies King Diagnostic

Darui Biotechnology Huamei Bio

Oticon

Growth rate % Keyu biological Jiacheng Biotechnology Kangmei Biotech Haiyuan Medical

1.35%

2.18%

4.74%

5.35%

5.46%

6.40%

10.81%

14.34%

14.48%

21.24% 18.40%

27.34% 21.28%

Mokobio Life Science Zhongzhi Biotechnologies

Promed

Nymphavn Biotechnology Yasen Industrial

Clinisciences

Haiyuan Medical

Yonghe-Sun Biotechnology Marr Bio

Xinle Medical Kangmei Biotech

Attributable net profit Amount Dahui Biotechnology Sunshine Medical

Marr Bio Zhongzhi Biotechnologies Mokobio Life Science Sunshine Medical Xincheng Biological Babio Biotechnology KeyGen BioTech Xinle Medical

−14 −47 −57 −111 −120 −262 −306

Keyu Biological

Yasen Industrial Oticon

Growth rate % J.H. Bio-Tech Haiyuan Medical

11

21

67 44

107 73

−85.70%

−81.90%

−76.57%

−39.50%

−28.16%

−22.56%

−21.23%

−14.36%

−5.57%

14.98% 7.13%

18.62% 15.50%

10 H. Song et al.

Clinisciences

Marr Bio

Yasen Industrial

Nymphavn Biotechnology 195,941

33

34

35

36

Summary

Tianqi Medical

32

0

196

490

574

667

34.85%

Babio Biotechnology Yasen Industrial

Nymphavn Biotechnology Newscen BioPharmaceutical Marr Bio Newscen Bio-Pharmaceutical Huamei Bio KeyGen BioTech

−38.77%

−53.64% 15,271

Baio Technology

−11.94%

−44.18%

Tianqi Medical

0.00%

−910

−640

−631

−572

−392

157.16%

Tianqi Medical

Newscen Bio-Pharmaceutical Huamei Bio

Clinisciences

Nymphavn Biotechnology

−3260.10%

−259.76%

−241.09%

−151.18%

−112.23%

1  Status and Progress 11

Runda Medical

Mindray

4

5

BGI Genomics

Wantai

7

8

Sansure Biotech

KeHua Biology

Maccura

11

12

13

14

Yes!Star

10

Autobio

Biotechnology

Hotgen

9

BioPharm

DA AN GENE

6

Biomedical

Orient Gene

Diagnostics

KingMed

3

2

Dian

1

Diagnostics

Amount

Rankings

Operating revenue

376,592

398,065

426,801

451,454

493,069

536,920

575,033

676,614

766,426

844,863

886,011

1,016,917

1,194,322

1,308,261

Diagnostics

KingMed

Instrument

Hexin

Acrobiosystems

Bioperfectus

Alltest Biotech

Biotechnologies

Strong

HybriBio

Biotest Biotech

Technology

NanoMicro

Biotechnology

Bioeasy

BioPharm

Wantai

Biomedicine

Easy Diagnosis

Orient Gene

Hotgen

Growth rate %

44.88%

48.66%

56.30%

63.19%

64.98%

88.58%

97.34%

110.09%

117.74%

131.20%

144.25%

195.05%

211.43%

945.54%

Biotechnology

Maccura

Autobio

Snibe

Diagnostics

Dian

Bioperfectus

Biomedicine

Easy Diagnosis

BGI Genomics

BioPharm

Wantai

Hotgen

Diagnostics

KingMed

Sansure Biotech

Biomedical

Mindray

DA AN GENE

Orient Gene

Amount

95,660

97,366

97,370

116,288

119,321

141,322

146,154

202,147

218,576

221,964

224,270

267,492

361,819

492,019

Attributable net profit

Biotech

Huakang

Laboratory

Clinical

Labway

Biotest Biotech

Yes!Star

HybriBio

Leadman

Technology

NanoMicro

Orient Gene

BioPharm

Wantai

Biomedicine

Easy Diagnosis

Biotechnologies

Strong

Biotechnology

Bioeasy

Novogene

Hotgen

Growth rate %

Table 1.3  Rankings of critical data of listed diagnostics companies in 2021 (10 thousand CNY)

Diagnostics

Dian

Sino Biological

84.68%

63.71%

Sansure Biotech

Orient Gene

DA AN GENE

Technology

NanoMicro

Autobio

Snibe

BGI Genomics

Vazyme

Diagnostics

KingMed

GenScript

BioPharm

Wantai

Biomedical

Mindray

91.57%

100.56%

134.97%

143.97%

158.75%

193.33%

198.59%

201.37%

261.29%

261.38%

515.74%

1850.41%

Market value (2021.12.31)

208.29

235.08

236

276.6

281.53

319.4

322.8

346.52

363.42

424.01

518.52

724.96

1344.59

4629.35

Amount (100 million CNY)

HybriBio

Tellgen

Technology

Lifotronic

Orient Gene

Runda Medical

Biotechnology

Medicalsystem

BioPharm

Wantai

IVD Medical

Leadman

Biomedicine

Easy Diagnosis

Biotech

Huakang

Hotgen

GenScript

Medical

Gongdong

Growth rate %

−1.96%

−0.20%

9.53%

13.55%

19.95%

30.23%

53.87%

54.60%

77.02%

78.41%

131.78%

197.90%

230.21%

249.25%

12 H. Song et al.

GenScript

Bioperfectus

Easy Diagnosis

16

17

18

Thalys Medical

Snibe

Sinocare

Medicalsystem

21

22

23

24

Alltest Biotech

Vazyme

Novogene

Biotest Biotech

27

28

29

Biotech

Liferiver

26

25

HybriBio

20

Biotechnology

IVD Medical

19

Biomedicine

Wondfo Biotech

15

181,808

186,640

186,863

187,343

201,883

225,153

236,131

254,542

259,955

267,302

273,067

282,983

283,904

327,081

336,104

Getein Biotech

Novogene

Runda Medical

Diagnostics

Amoy

Autobio

Biomedical

Mindray

Univ Bio

GenScript

Assure Tech

Tellgen

Technology

Lifotronic

HOB

DA AN GENE

Laboratory

Labway Clinical

Medical

Gongdong

24.78%

25.26%

25.33%

25.90%

26.45%

27.12%

30.69%

30.76%

32.47%

33.70%

40.50%

43.20%

43.49%

43.62%

43.95%

Biotechnology

Bioeasy

Diagnostics

Amoy

Medical

Gongdong

Runda Medical

Getein Biotech

Biotechnologies

Strong

Wondfo Biotech

Vazyme

Sino Biological

KeHua Biology

Assure Tech

Biotech

Liferiver

Alltest Biotech

Biotest Biotech

HybriBio

23,651

23,957

31,099

38,023

39,899

40,565

63,443

67,829

72,001

72,102

73,853

75,852

76,569

83,359

85,216

Biomedical

Mindray

Autobio

Getein Biotech

Technology

Lifotronic

Diagnostics

Amoy

Tellgen

Medical

Gongdong

Succeeder

Univ Bio

Diagnostics

Dian

Bioperfectus

Diagnostics

KingMed

DA AN GENE

Acrobiosystems

HOB

27.11%

30.20%

30.93%

32.23%

32.86%

33.62%

Univ Bio

Technology

Lifotronic

Biotech

Liferiver

Assure Tech

Biotechnology

Bioeasy

Biotechnologies

Strong

laboratory

YHLO Biotech Labway Clinical

40.73%

Medical

Gongdong

Biotechnology

Maccura

Novogene

Diagnostics

Amoy

Acrobiosystems

Sinocare

Wondfo Biotech

37.68%

42.15%

44.83%

45.59%

47.03%

47.74%

50.34%

52.24%

89.27

97.11

100.55

109.50

115.69

116.74

139.10

139.93

161.36

162.43

165.28

167.42

168.90

168.92

175.22

−20.79%

−20.25%

−18.10%

−17.61%

−17.14%

−16.53%

−13.30%

−12.64%

−11.92%

−10.61%

−6.42%

−5.17%

−3.77%

−3.54%

−2.07%

(continued)

Biotechnologies

Strong

Succeeder

Getein Biotech

LBP

Innovation

Bohui

Sinocare

Medical

Improve

Thalys Medical

Diagnostics

KingMed

Biomedical

Mindray

DA AN GENE

Yes!Star

KeHua Biology

Diagnostics

Amoy

Diagnostics

Dian

1  Status and Progress 13

Berry Genomics

Getein Biotech

Gongdong

33

34

35

Sino Biological

Kindstar

38

39

45

44

43

Improve

Tellgen

Innovation

Bohui

Technology

Lifotronic

Medical

Dirui

42

Diagnostics

Amoy

41

40

Univ Bio

37

Globalgene

YHLO Biotech

36

Medical

Assure Tech

Biotechnologies

Strong

32

31

Labway Clinical

30

Laboratory

Amount

Rankings

Operating revenue

Table 1.3 (continued)

65,459

71,475

77,811

79,983

90,580

91,703

93,067

96,527

110,967

117,790

119,425

140,170

142,218

158,928

159,938

177,833

Biotechnology

Maccura

Succeeder

IVD Medical

Diagnostics

Chemclin

Snibe

Technology

AVE Science &

LBP

Sinocare

YHLO Biotech

Biotech

Huakang

Vazyme

Wondfo Biotech

Leadman

Yes!Star

Thalys Medical

Diagnostics

Dian

Growth rate %

7.47%

7.88%

12.46%

12.57%

15.97%

16.91%

16.93%

17.17%

17.91%

18.94%

19.44%

19.57%

19.63%

20.06%

22.30%

22.85%

LBP

HOB

Succeeder

Sinocare

Univ Bio

Diagnostics

Chemclin

Tellgen

Acrobiosystems

IVD Medical

Biotechnology

Medicalsystem

Technology

NanoMicro

Technology

Lifotronic

Laboratory

Clinical

Labway

YHLO Biotech

Dirui

Novogene

7978

8619

9737

10,757

10,873

14,276

16,108

17,421

17,454

17,949

18,809

19,035

20,384

20,475

20,995

22,499

Attributable net profit Amount

Vazyme

Sansure Biotech

LBP

YHLO Biotech

Wondfo Biotech

Snibe

Technology

AVE Science &

KeHua Biology

IVD Medical

Alltest Biotech

Instrument

Hexin

Assure Tech

Runda Medical

Biotechnology

Maccura

Diagnostics

Chemclin

Righton Gene

Growth rate %

−17.46%

−14.29%

Dirui

Globalgene

Kindstar

Tellgen

Alltest Biotech −5.86%

Berry Genomics −2.75%

Diagnostics

Chemclin

Hotgen

Getein Biotech

Biotest Biotech

KeHua Biology

Biomedicine

Easy Diagnosis

Runda Medical

Bioperfectus

Innovation

Bohui

Biotechnology

Medicalsystem

HybriBio

0.04%

3.68%

3.90%

6.76%

9.97%

12.73%

13.13%

13.80%

15.23%

20.49%

21.99%

22.26%

Market value (2021.12.31)

49.44

51.7

51.97

66.31

68.79

71.86

72.24

72.98

74.56

76.32

77.61

77.72

80.6

80.95

81.62

86.73

Amount (100 million CNY)

−37.43%

−36.37%

−29.35%

−28.51%

−23.55%

Diagnostics

Chemclin

Biotech

Liferiver

Biotechnology

Bioeasy

YHLO Biotech

Novogene

Sino Biological

Technology

NanoMicro

Autobio

–

–

–

–

–

–

–

−50.70%

Berry Genomics −49.03%

Sansure Biotech −48.22%

Wondfo Biotech −42.68%

Biotechnology

Maccura

Snibe

BGI Genomics

Bioperfectus

Dirui

Growth rate %

14 H. Song et al.

Biosino

HOB

Righton Gene

Succeeder

AVE Science &

53

54

55

56

57

Biotech

Huakang

Summary 15,916,033

58

Acrobiosystems

52

Technology

LBP

Technology

NanoMicro

Instrument

Hexin

51

50

49

Chemclin

48

Diagnostics

Leadman

Biotechnology

Bioeasy

47

46

2613

21,067

23,992

29,095

31,771

34,823

38,499

43,899

44,635

46,424

47,077

56,406

59,754

34.03%

Sino Biological

BGI Genomics

Medical

Improve

Berry Genomics

Sansure Biotech

Dirui

Innovation

Bohui

Biotechnology

Medicalsystem

Biotech

Liferiver

Righton Gene

KeHua Biology

Globalgene

Kindstar

Biosino

Bohui

−12.99%

−39.53%

−19.42%

Berry Genomics

−7.67%

3,525,841

GenScript

Globalgene

Kindstar

Innovation

Thalys Medical

Biotech

Huakang

Biosino

Yes!Star

Medical

Improve

Leadman

Technology

AVE Science &

Righton Gene

Instrument

Hexin

−5.22%

−3.35%

−3.24%

−2.19%

−1.62%

2.11%

2.71%

4.41%

7.06%

−222,634

−145,443

−32,218

−11,082

−4951

−422

−114

333

1857

2242

3128

4733

7857

40.41%

Innovation

Bohui

Thalys Medical

Berry Genomics

Biosino

Medical

Improve

GenScript

Globalgene

Kindstar

Sinocare

Biotechnology

Medicalsystem

Sino Biological

BGI Genomics

Dirui

Biotech

Liferiver

−4393.4%

−186.00%

−152.60%

−141.94%

−88.57%

−69.74%

−49.32%

−42.44%

−40.07%

−36.15%

−30.08%

−21.39%

−18.61%

Biotech

Huakang

Biosino

&Technology

AVE Science

Yes!Star

LBP

Thalys Medical

Medical

Improve

Succeeder

HOB

Righton Gene

Instrument

Hexin

IVD Medical

Leadman

0.99

2.46

18.91

26.81

28.44

29.5

32.93

36.44

39.73

40.42

41.96

43.57

43.9

Univ Bio

Acrobiosystems

Laboratory

LabwayClinical

Assure Tech

Vazyme

Instrument

Hexin

Biotest Biotech

Biosino

Technology

AVE Science &

HOB

Righton Gene

Globalgene

Kindstar

Alltest Biotech

–

–

–

–

–

–

–

–

–

–

–

–

–

1  Status and Progress 15

11,726

11,457

Venture Bio-tech

Jiacheng Biotechnology Xincheng Biological

Kangmei Biotech Libo Medicine Sunshine Medical

Tzone Biotechnology

Surexam Bio-Tech

King Diagnostic Baio Technology

GenePharma KeyGen BioTech

7

8

10 11 12

13

14

15 16

17 18

9

Xinle Medical

6

10,218 10,039

11,168 10,550

15,702 15,625 12,102

16,208

18,340

19,319

23,419

37,181 31,216 27,645 23,908

Darui Biotechnology J.H. Bio-Tech Wiz Biotech Iprocom

2 3 4 5

55,646

Operating revenue Amount Huizhikang

Rankings 1

Yonghe-Sun Biotechnology Sunshine Medical Dahui Biotechnology Haiyuan Medical Libo Medicine

Baio Technology Iprocom Jiacheng Biotechnology Xinle Medical

Promed

Wiz Biotech KeyGen BioTech Zhongsheng Jinyu Zhongzhi Biotechnologies Nymphavn Biotechnology MultiSciences Biotech GenePharma

Growth rate % Venture Bio-tech

19.69% 18.66%

30.68% 24.20%

32.82%

34.24%

35.35% 34.30% 34.25%

35.53%

36.02%

38.40%

46.54%

375.47% 90.56% 84.75% 48.05%

560.68%

Table 1.4  Rankings of critical data of NEEQ companies in 2021 (10 thousand CNY)

Tzone Biotechnology Zhongsheng Jinyu

KeyGen BioTech GenePharma

Jiacheng Biotechnology Oticon

Babio Biotechnology Keyu Biological Xinle Medical

Surexam Bio-Tech

King Diagnostic

Iprocom

Xincheng Biological

Huizhikang Venture Bio-tech J.H. Bio-Tech Libo Medicine

Attributable net profit Amount Wiz Biotech

330 317

638 364

914

Yasen Industrial Xinle Medical

Zhongzhi Biotechnologies Iprocom Xincheng Biological

Libo Medicine

1140

1402 1354 1155

Yonghe-Sun Biotechnology Surexam Bio-Tech King Diagnostic Dahui Biotechnology

Mokobio Life Science Promed

Kangmei Biotech

Growth rate % MultiSciences Biotech Venture Bio-tech Wiz Biotech GenePharma Zhongsheng Jinyu

1779

1814

2762

2779

4801 3950 3453 3119

6813

3.61% 0.63%

4.72% 3.69%

7.21%

22.63%

46.24% 43.86% 26.15%

50.06%

68.61%

76.91%

102.84%

7284.55% 341.44% 269.19% 160.47%

33290.59%

16 H. Song et al.

MultiSciences Biotech Zhongsheng Jinyu Oticon

Dahui Biotechnology Promed

Marr Bio Clinisciences

Tianqi Medical Yasen Industrial Nymphavn Biotechnology 432,568

27

30 31

32 33

34 35 36

Summary

28 29

26

25

24

22 23

Keyu Biological Babio Biotechnology Yonghe-Sun Biotechnology Huamei Bio Newscen Bio-Pharmaceutical Zhongzhi Biotechnologies Mokobio Life Science Haiyuan Medical

19 20 21

1190 392 1

1795 1254

3127 2359

3862 3155

3866

4565

4876

5073

5988 5694

9665 7713 6521

Yasen Industrial Marr Bio Newscen Bio-Pharmaceutical 23.35%

Huamei Bio Mokobio Life Science Tianqi Medical Babio Biotechnology

J.H. Bio-Tech Kangmei Biotech

Tzone Biotechnology Oticon

Clinisciences

Xincheng Biological

Darui Biotechnology King Diagnostic

Huizhikang Keyu Biological Surexam Bio-Tech

Haiyuan Medical Huamei Bio Darui Biotechnology Baio Technology Newscen Bio-Pharmaceutical 26,096

−6.59% −7.92% −36.83% −37.18% −41.18% −44.51% −46.73%

Yonghe-Sun Biotechnology Promed

Nymphavn Biotechnology Clinisciences

Kangmei Biotech Mokobio Life Science

MultiSciences Biotech Dahui Biotechnology Marr Bio

Yasen Industrial Zhongzhi Biotechnologies Sunshine Medical Tianqi Medical

1.72% −6.26%

2.48%

3.11%

6.82%

8.08%

10.33% 10.24%

16.41% 16.07% 11.81%

Marr Bio Tzone Biotechnology Babio Biotechnology KeyGen BioTech Huamei Bio Darui Biotechnology Haiyuan Medical

−110 −137 −144

−201 −221 −247 −556

−1516 −2896 −5089

−813 −1096

Sunshine Medical Nymphavn Biotechnology Tianqi Medical Clinisciences Newscen Bio-Pharmaceutical −28.59%

J.H. Bio-Tech

29 −43

−186

Huizhikang Keyu Biological Jiacheng Biotechnology Ocon Baio Technology

214 187 38

−234.49% −323.88% −2460.94%

−221.07% −230.02%

−124.55% −190.79%

−76.44% −116.24%

−63.77%

−46.38%

−46.07%

−42.54%

−25.14% −42.50%

0.24% −17.15% −20.81%

1  Status and Progress 17

KeHua Biology

DA AN GENE

Easy Diagnosis

002022

002030

002932

Leadman

Sinocare

Bohui Innovation

Dirui

Strong

300289

300298

300318

300396

300406

Tellgen

BGI Genomics

Amoy Diagnostics 2017/8/2

Mindray

300642

300676

300685

300760

301047

Bioeasy

300942

Sino Biological

Biotechnology

Snibe

300832

Biomedical

HybriBio

2021/8/16

2021/2/9

2020/5/12

2018/10/16

2017/7/14

2017/4/12

2017/4/12

Wondfo Biotech

2015/6/30

2015/5/28

GEM

GEM

GEM

GEM

GEM

GEM

GEM

GEM

GEM

GEM

GEM

GEM

2014/10/30

2015/4/22

GEM

2014/9/10

GEM

2012/5/23

GEM

GEM

GEM

SME board

SME board

SME board

GEM

300639

Biotechnology

Maccura

Biotechnology

Medicalsystem

FY2019

1590.61

77.31

289.83

37.97

31.91

116.26

108.25

54.28

75.42

43.31

40.23

68.4

32.72

127.5

19.02

30.7

105.9

58.07

Securities category Q1

2012/3/19

2012/2/16

2011/7/19

2009/12/25

2018/7/10

2004/8/9

2004/7/21

Listing date

300482

300463

300439

Dian Diagnostics

300244

Biotechnologies

Improve Medical

300030

Biomedicine

Company name

Code

1974.28

2246.6

96.29

257.06

230.74 77.58

36.99

42.24

168.24

144

49.05

81.34

43.86

33.08

77.34

23.12

153.87

16.89

25.21

80.78

48.95

Q3

37.32

31.85

131.66

144.27

50.43

76.47

48.17

33.92

67.72

26.78

107.59

17.63

27.59

87.08

52.24

Q2

Table 1.5  Market value changes of listed companies in recent 3 years

2211.34

98.36

274.87

37.39

53.13

177.41

150.41

46.93

81.59

46.73

33.41

84.74

24.51

137.31

22.02

24.11

91.7

60.1

Q4

FY2020

3182.27

99.23

301.72

39.44

59.32

265.89

155.01

49.13

85.84

55.39

38.81

83.90

24.21

145.51

34.79

27.57

138.20

82.76

Q1

709.42

3717.31

170.85

623.64

47.15

110.09

356.72

324.34

62.34

115.46

74.19

51.55

181.59

29.72

218.86

29.88

42.55

239.25

92.44

Q2

687.01

4231.68

169.85

575.80

51.20

106.62

284.86

295.10

64.62

115.92

74.60

129.09

226.17

32.88

245.95

43.69

51.04

307.04

93.32

Q3

544.55

5178.84

173.56

514.37

52.08

88.46

305.71

259.61

62.67

147.37

64.67

97.7

202.38

24.8

212.69

37.98

43.5

300.86

79.31

Q4

124.75

545.00

5669.38

189.42

534.90

61.76

93.89

347.58

264.72

83.19

120.10

66.14

66.66

210.58

28.25

241.98

34.28

75.28

294.11

89.64

Q1

FY2021

120.57

482.61

5835.93

230.77

490.90

78.15

97.01

287.91

234.37

73.92

116.21

57.50

65.92

177.06

25.89

237.64

36.62

67.33

298.09

92.16

Q2

260.43

113.48

384.37

4686.71

178.04

362.29

59.99

93.43

191.35

160.53

68.17

96.54

48.80

66.67

132.94

26.78

183.33

30.00

42.78

260.54

67.88

Q3

235.08

115.69

346.52

4629.35

167.42

363.42

51.97

86.73

175.22

162.43

81.62

116.74

49.44

80.95

168.92

43.90

208.29

32.93

77.61

281.53

76.32

Q4

18 H. Song et al.

Getein Biotech

KingMed

603387

603882

Gongdong

605369

Lifotronic

688389

Bioperfectus

Orient Gene

Succeeder

688399

688298

688338

Technology

2019/9/30

Hotgen

688068

2020/8/6

2020/2/5

2019/12/5

2019/11/4

2017/7/5

Berry Genomics

2020/9/16

2020/4/29

2017/9/8

2017/7/17

2016/10/31

2016/9/1

2015/6/30

2021/12/28

2021/10/18

2021/9/13

000710

Medical

Wantai BioPharm

603392

Diagnostics

Autobio

Thalys Medical

Runda Medical

603108

603658

Univ Bio

603716

Acrobiosystems

301166

Laboratory

Labway Clinical

301080

301060

Innovation Board

Technology

Science and

Innovation Board

Technology

Science and

Innovation Board

Technology

Science and

Innovation Board

Technology

Science and

Innovation Board

Technology

Science and

A-share

Shenzhen

Shanghai A-share

Shanghai A-share

Shanghai A-share

Shanghai A-share

Shanghai A-share

Shanghai A-share

Shanghai A-share

GEM

GEM

GEM

147.8

132.24

66.7

49.79

271.7

68.33

125.53

159.02

67.29

35.28

287.36

61.6

44.27

110.03

256.46

61.04

39.35

378.92

59.11

33.94

69.33

29.19

129.79

234.53

60.02

34.65

404.8

57.61

87.95

42.90

77.86

28.29

130.04

257.81

82.89

31.43

502.07

57.88

183.96

162.96

138.42

42.92

212.08

716.10

409.91

104.75

29.85

700.12

77.26

60.71

192.70

152.05

116.43

30.76

193.30

453.96

469.36

95.42

31.32

695.29

77.78

45.69

243.6

112.75

88.66

24.25

134.96

873.83

588.7

89.11

33.77

654.73

64.79

42.59

220.21

104.96

108.93

140.25

105.21

1336.10

667.41

90.57

28.64

551.01

69.49

45.38

261.12

98.83

129.45

117.55

106.52

1573.33

739.11

81.79

29.77

444.22

65.08

36.19

36.44

276.60

80.60

97.11

72.24

68.79

161.36

1344.59

518.52

72.98

29.50

322.80

77.72

89.27

168.90

139.10

(continued)

187.81

66.82

82.16

72.37

76.15

113.88

1347.54

475.23

66.79

23.27

312.34

59.33

72.98

1  Status and Progress 19

LBP

Sansure Biotech

HOB

Liferiver Biotech

Alltest Biotech

Chemclin

688393

688289

688656

688371

688606

688468

Novogene

Righton Gene

YHLO Biotech

688315

688217

688575

Diagnostics

Company name

Code

Table 1.5 (continued)

2021/5/17

2021/5/17

2021/4/13

2021/4/9

2021/3/25

2021/1/18

2021/1/13

2020/8/28

2020/8/20

Listing date

FY2019

Innovation Board

Technology

Science and

Innovation Board

Technology

Science and

Innovation Board

Technology

Science and

Innovation Board

Technology

Science and

Innovation Board

Technology

Science and

Innovation Board

Technology

Science and

Innovation Board

Technology

Science and

Innovation Board

Technology

Science and

Innovation Board

Technology

Science and

Securities category Q1

Q2

Q3

Q4

FY2020 Q1

Q2

443.16

39.96

Q3

455.8

34.52

Q4

172.69

86.17

109.07

143.75

49.53

397.44

35.37

Q1

FY2021

179.82

46.35

195.30

89.46

80.32

126.46

46.90

397.80

36.66

Q2

118.46

35.41

207.52

66.08

55.84

92.14

33.04

223.12

27.61

Q3

Q4

139.93

40.42

165.28

71.86

66.31

100.55

39.73

236.00

28.44

20 H. Song et al.

Hexin Instrument

Vazyme

Assure Tech

688622

688105

688075

2021/11/18

2021/11/16

2021/9/13

2021/9/8

2021/6/23

2021/6/16

Innovation Board

Technology

Science and

Innovation Board

Technology

Science and

Innovation Board

Technology

Science and

Innovation Board

Technology

Science and

Innovation Board

Technology

Science and

Innovation Board

Technology

Science and

21.35

48.35

61.25

317.96

18.88

109.50

424.01

41.96

74.56

319.40

18.91

Note: 1. By the end of 2019, the total market value of 27 listed companies in the IVD industry was 471 billion CNY; by the end of 2020, the total market value of 33 listed companies in the IVD industry was 1183.6 billion CNY; by the end of 2021, the total market value of 52 listed companies in the IVD industry was 1201.6 billion CNY 2. By the end of 2019, the average P/E ratio of 27 listed companies in the IVD industry was 44.01 times; by the end of 2020, the average P/E ratio of 33 listed companies in the IVD industry was 65.09 times; by the end of 2021, the average P/E ratio of 52 listed companies in the IVD industry was 45.51 times

Biotest Biotech

Technology

NanoMicro

Technology

AVE Science &

688767

688690

688067

1  Status and Progress 21

22

H. Song et al.

Table 1.6  Newly listed enterprises in diagnostics industry in 2021 Sector name GEM GEM GEM GEM GEM Science and Technology Innovation Board Science and Technology Innovation Board Science and Technology Innovation Board Science and Technology Innovation Board Science and Technology Innovation Board Science and Technology Innovation Board Science and Technology Innovation Board Science and Technology Innovation Board Science and Technology Innovation Board Science and Technology Innovation Board Science and Technology Innovation Board Science and Technology Innovation Board Science and Technology Innovation Board

Code 300942 301047 301060 301080 301166 688656

Company name Bioeasy Biotechnology Sino Biological Labway Clinical Laboratory Acrobiosystems Univ Bio HOB

Listing date 2021/2/9 2021/8/16 2021/9/13 2021/10/18 2021/12/28 2021/1/13

688371

Liferiver Biotech

2021/1/18

688606

Alltest Biotech

2021/3/25

688468

Chemclin Diagnostics

2021/4/9

688315

Novogene

2021/4/13

688217

Righton Gene

2021/5/17

688575

YHLO Biotech

2021/5/17

688067

AVE Science & Technology

2021/6/16

688690

NanoMicro Technology

2021/6/23

688767

Biotest Biotech

2021/9/8

688622

Hexin Instrument

2021/9/13

688105

Vazyme

2021/11/16

688075

Assure Tech

2021/11/18

1  Status and Progress

23

Table 1.7  IPO Queuing Companies in Diagnostics Industry in 2021 Filing enterprise Main board of Shanghai Stock Exchange Cowealth Medical GEM Orienter InTec Fapon Biotech VivaChek Zeesan Biotech Quaero Life Science and Technology Innovation Board MGI Rendu Biotechnology Innovita Hong Kong Stock Exchange Adicon Bioer Technology

Sponsor

Audit status

Haitong Securities

Approved

Sinolink Securities CITIC Securities Huatai Securities CITIC Securities CITIC Securities CITIC Securities

Inquired Inquired Inquired Inquired Accepted Accepted

CITIC Securities Sinolink Securities CITIC Securities

Submit registration Submit registration Inquired

Morgan Stanley CICC

Submitted Submitted

Table 1.8  Delisted enterprises in the IVD industry in 2021 835236

Icubio

2016/1/6

NEEQ

Compulsory withdrawal

1.1.2 Investment and Financing Events of Domestic IVD Enterprises in 2021 (Table 1.9)

TargetingOne

January 9

January 11

January 14

January 18

January 26

February 8

February 10

2

3

4

5

6

7

8

Accunome

Monad

Adicon

Inscinstech

Holosensor Medical

NuProbe

Invested company Calibra

S/no. Time 1 January 8

Round A2

Strategic investment Round A

Round Pre-A

Round Pre-A

Round A

Round B

Round Round B

Nearly 100 million CNY

200 million CNY

Tens of millions of CNY 88 million USD

Over 100 million CNY

42 million USD

150 million CNY

Financing amount Hundreds of millions of CNY

Overall solutions for molecular and protein research in life science and R&D of raw enzyme Automatic and universal molecular diagnosis platform with molecular diagnosis, infectious diseases and severe diseases as the core

Medical diagnostic test service

Genomics and molecular diagnostics of ultra-sensitive tumor sequencing Panel test and Infertility Genetic Detection With microfluidics as the core technology, it provides a new generation of products of liquid biopsy for tumors and rapid test for infectious pathogenic microorganisms High-end intelligent protein purifier

Business It is a high-tech enterprise under Dian Diagnostics that focuses on the R&D, clinical transformation and application of the new generation of multi-omics biomarker mass spectrometry Digital PCR system

Table 1.9  Summary of investment and financing events of domestic IVD enterprises in 2021

Luxin Venture Capital and ABclonal jointly led the investment, followed by Wuxi Jintou Sinovation Ventures

Baidu Venture led the investment, followed by Kunshan Kechuang Fund, SND Ventures, and Purple Cow Startups Dynamic Balance Investment Management OrbiMed Asia

Lilly Asia Ventures led the investment, followed by China Growth Capital, GL Ventures, as well as the old shareholders Qingdao Yufeng, Chongyuan Huichen BioTrack Capital and Yonghua Capital

Investor GL Ventures led the investment, followed by GL Capital Group and Green Pine Capital Partners

24 H. Song et al.

February 22

February 23

February 24

February 24

February 24

February 28

March 29 March 29

April 2

9

10

11

12

13

14

15 16

17

Sanmed Biotech

Dawei Bio Histomed

Celula

Calibra

Wuxi Diagnostics AnchorDx

RainSure

PushKang Biotechnology

Round B

Round Pre-A Round B

Round B+

Round B

Round C

Round B

Round B1

Round C

Undisclosed 100 million CNY - level 300 million CNY

Tens of millions of CNY

150 million CNY

Tens of millions of CNY 150million USD 40 million USD

Hundreds of millions of CNY

Automatic digital PCR Medical diagnosis and pathological test services Platform of liquid biopsy for tumors for early screening of serious malignant tumors such as lung cancer, intestinal cancer, breast cancer and liver cancer

NGS products of early screening and early diagnosis for cancers It focuses on the R&D, clinical transformation and application of the new generation of multi-omics biomarker mass spectrometry Small flow cytometry and digital PCR, noninvasive prenatal screening

Medical diagnostic test service

By using centrifugal microfluidic technology, combined with the original micro whole blood separation function and reagent freeze-­drying technology, it studies and develops coagulation (i.e. thrombosis and hemostasis), chemiluminescence immunoassay, biochemical and other diagnostic test reagent chips and new supporting POCT detection systems suitable for the national conditions, focusing on the coagulation market Digital PCR supporting IVD kit

CMG SDIC Capital

(continued)

Peikun Fund led the investment, followed by Xiamen Silicon Valley Torch Fund Qingkong Jinxin Capital, Maccura Feitu Venture Investment, etc.

OrbiMed Asia, Yaoming Huiying Investment Fund GL Ventures led the investment, followed by GL Capital Group and Green Pine Capital Partners

Qingke Asset Management led the investment, followed by Kaitai Capital Shiyu Capital, etc.

GL Ventures and Fu Rong Capital jointly led the investment, followed by Couplet Health Industry Fund

1  Status and Progress 25

April 8

April 8

April 19

May 10

May 10

May 10

June 1

June 3

19

20

21

22

23

24

25

26

S/no. Time 18 April 7

Table 1.9 (continued)

Accunome

Genskey

Willingmed

ET Healthcare

Reliable Med

Giant Med Diagnostics Demeter

YingSheng Biology

Invested company HRTJ

Round A3

Round C+

Round Pre-A

A new round

Round A+

Round A

Round Pre-A

Undisclosed

Round Round A

Hundreds of millions of CNY Hundreds of millions of CNY Tens of millions of CNY

20 million CNY Tens of millions of CNY Tens of millions of CNY More than 100 million USD

Undisclosed

Financing amount Tens of millions of CNY

Automatic and universal molecular diagnosis platform with molecular diagnosis, infectious diseases and severe diseases as the core

Medical diagnostic test service

Clinical mass spectrometry and chromatography Liquid chromatography tandem mass spectrometry products The biosensor Test-On-A-Probe (TOP) includes different detection technologies on a single probe to make the analysis of proteins, antibodies, nucleic acids, small molecules and cells Infectious precision medical products and services provider

Business It focuses on the allergen-­specificIgE antibody detection system based on microfluidics and protein coating Based on metabonomics and genomics, it has built a domestic leading gene test platform and mass spectrometry platform, covering birth defect screening, disease prevention, human health services and other fields Medical diagnostic test service

China Merchants Health

E-town International Investment, Songrui Phase I, Royal Capital, Biolink Capital, Delta Capital CPE Fund

Sequoia Capital China and GL Ventures led the investment

3H Health led the investment

Fortune Venture Capital

Northern Light Venture Capital

Investor River Head Capital led the investment, followed by TigerYeah Capital Alibaba Health

26 H. Song et al.

June 7

June 8

June 10

June 11

June 15

June 18

June 25

June 29

27

28

29

30

31

32

33

34

Round B

Round Pre-B

Kindstar Globalgene

Aivd Biotech

Gaugene

Tongshu Gene

Reigncom Biotech

140 million USD

Pre-IPO

Round A

Tens of millions of CNY Nearly 100 million CNY

Hundreds of millions of CNY 500 million CNY

200 million CNY

Nearly 100 million CNY 400 million CNY

Round A+

Round C

Round A

Health Biotech Round B+

Conlight Medical Qitan Technology

It has the dual capabilities of LDT+IVD, and provides gene test services with NGS micro library building as the core barrier, and a big data transformation research center based on tumor genomics specimen bank Flow fluorescent platform and multi-index combined determination It provides a one-stop ODM service solution from upstream raw materials to reagents Medical diagnostic test service

Clinical mass spectrometry

Clinical chromatography and mass spectrometry

Independent R&D, manufacturing and application of nanopore gene sequencer and supporting reagent consumables

Medical diagnostic test service

(continued)

Shenzhen HTI led the investment, followed by Shenzhen Nanling Equity Investment Fund Carmignac, etc.

Qiming Venture Partners

CDH VGC and GL Ventures jointly led the investment, followed by BioTrack Capital, Huagai Capital and River Head Capital Qiming Venture Partners led the investment, followed by BioVenture, C&D Emerging Investment and the long-term shareholder Sino-Ocean Capital Matrix Partners China led the investment, followed by Sinovation Ventures GL Capital Group, GCS Capital and Oceanpine Capital jointly led the investment

Ehong Impact Capital

1  Status and Progress 27

July 19

July 20

July 22

July 29

September 2

36

37

38

39

40

S/no. Time 35 July 16

Table 1.9 (continued)

Round C

Berry Oncology Round B1

Nearly 700 million CNY

Tens of millions of CNY

750 million CNY

200 million CNY

Nearly 100 million CNY

Strategic investment

Strategic investment

Financing amount Approx. 100 million USD

Round Round B

Healthcare Bio Round B+

Gene+

Hugo Biotech

RealMind Biotech

Invested company Wellgrow Technology

Gene tests focusing on the whole course of cancer

Analysis platform of fluorescence in situ hybridization (FISH)

Small chemoluminescence, automatic chemiluminescence POCT, microdropletcontrolled POCT and other platforms focusing on cardiac biomarkers, inflammation monitoring, reproductive function, growth and development, stomach function, brain damage, etc. A team that focuses on cell-free mNGS transformation clinical study and has the ability to self-develop algorithms Products such as large Panel gene detection and early screening for tumors

Business New high-­throughput flow fluorescence detection platform with independent intellectual property rights of magnetic fluorescence-­encoded microsphere technology and flow fluorescence detection platform

LYFE Capital led the investment, followed by the long-term shareholder Sinovation Ventures CCB International led the investment, followed by Fortune Capital, Jinmao Capital and GGV Capital Chuchang Investment and Luojia Capital led the investment, followed by Hubei Provincial High Technology Industry Investment China Merchants Capital led the investment

Investor China Pioneer Foundation & Capitals led the investment, followed by Cowin Asset Management, BioVenture VC, Beijing Life Science Park Venture Capital and the long-term shareholder Vinno Capital Ocean State Investment led the investment, followed by the original shareholders BGI Co-win and Portfolio

28 H. Song et al.

September 3

September 3

September 6

September 8

September 8

September 15

September 18

41

42

43

44

45

46

47

Round A+

Angel round

Round B+

Precision Scientific

GeneMind

Round B+

Round B

Shuwen Round B Bio-­Technology

Oncocare Life

Thistory Bio-Medical RH Genetech

Bioeast Biotech Round A

150 million CNY

410 million CNY

120 million CNY Nearly 100 million CNY

Tens of millions of CNY

Undisclosed

100 million CNY

It focuses on the R&D and manufacturing of upstream molecular diagnostic tool platforms based on gene sequencers, and has continuously innovated and accumulated a lot of intellectual property rights in underlying technologies such as instrument hardware, biochemical reagents, sequencing chips, software algorithms, etc Companion diagnostics provides full support based on multi-omics and data mining for the full cycle of new drug development

The fourth-­generation gene sequencing, nanopore virus detection and other equipment related to biomacromolecule detection Cancer gene methylation detection products Innovative products of tumor screening and in the field of maternal, infant and reproductive health

It has two series of products, namely bioactive materials and chemical synthetic materials (mainly including immunomagnetic beads used for chemiluminescence) IVD thrombus and hemostasis track

(continued)

Kington Capital and GTJA Investment jointly led the investment, followed by Qichen Investment andGrand Mount Capital

Oriza Seed led the investment, followed by Addor Capital Guolian Investment led the investment, followed by Stream V, Anyuan Investment Fund and Kaichuang Fund Sansure Biotech, Cowin Asset Management, Sino European Allied Capital

Leaguer

China Growth Capital led the investment, followed by BioVenture, Cowin Venture Capital and Portfolio Shenzhen Capital Group Co., Ltd.

1  Status and Progress 29

Matridx

September 26

September 26

September 27

October 8

October 15

49

50

51

52

54

Creative Biosciences

ChosenMed

Sniper

Promed

Invested company Sophonix

S/no. Time 48 September 22

Table 1.9 (continued)

Round D

Round C1

Round B

Undisclosed

Undisclosed

Round Undisclosed

560 million CNY

Hundreds of millions of CNY

200 million CNY

Hundreds of millions of CNY Nearly 100 million CNY

Financing amount Over 100 million CNY

Detect methylation canyon markers through an independently developed unique algorithm, and apply ctDNA methylation detection technology to early cancer screening Noninvasive early screening for intestinal cancer

IVD maternal and child health and coagulation diagnosis, maternal and child POCT and integrated photochemical signal transduction and transmission system and microfluidic chips Automatic digital PCR instrument

Business Chemiluminescence POCT supplier, focusing on brain damage, central nervous system diseases, cytokine storm and other detection fields Pathogen metagenome mNGS automatic detection products

Alibaba led the investment, followed by the old shareholders IDG Capital and China Renaissance

HM Capital led the investment, followed by Apricot Capital and Huangpu Biomedical Fund Yijing Investment, High-tech Health Care and Jingming Capital led the investment

Huatai Zijin and Alibaba led the investment, followed by Proxima Ventures and Qianhai FOF Qingke Asset Management

Investor ETP funds, CITIC Fund, Huajin Capital

30 H. Song et al.

October 18

October 18

October 21

October 22

October 25

October 25

October 28

55

56

57

58

59

60

61

Holosensor Medical

CoHealth

BiOligo Biotech

Qlife

Pinnacles Medical Technology

Willingmed

ATG Biotechnology

Undisclosed

Round A

Strategic investment Round A

Tens of millions of CNY

Tens of millions of CNY

Hundreds of millions of CNY 300 million CNY

300 million CNY

Round A

Round A+

Development technology and large-scale conversion and production of high-end molecular raw enzyme 100 million CNY

Angel round

It mainly has various DNA primers and fluorescence-­labeled probes required for in vitro diagnosis, connectors & sealers & amplicon primers & targeted capture probes used for NGS library building, various RNA synthesis products, large size DNA&RNA synthesis, etc. Mobile digital medical detection system and its supporting consumables, intelligently manufactured biochip Microfluidic chips, focusing on rapid test of tumors, infections, chronic diseases and other fields

Macrogenome high-throughput sequencing (mNGS) technology for rapid detection of complex infections It quickly builds an IVD platform company with the Build-Buy-­Collaborate model, and will continue to focus on building an efficient smart laboratory, and provide core products for a broader smart laboratory ecosystem Clinical mass spectrometry devices

mRNA synthetic raw material enzyme

(continued)

Puhua Capital and Chengdu Technology Transfer led the investment CDIB Capital Group led the investment

Centurium Capital, Cowin Asset Management Carlyle led the investment, followed by CICC and BioVenture

Lilly Asia Ventures (LAV) led the investment, and the new investors included Qingsong Investment Management and Vertex Ventures

Runda Medical and Gongshu SDIC jointly invested

Dynamic Balance Investment Management

1  Status and Progress 31

Asbios

November 2

November 2

November 3

November 8

November 8

November 9

November 10

63

64

65

66

67

68

69

Nearly 100 million USD

Round B Singleron Biotechnologies

100 million CNY

130 million CNY Nearly 100 million CNY Over 100 million CNY

Millions of CNY

Financing amount Tens of millions of USD

Over 100 million CNY

Round B

Round A

Round A+

Round A

Angel round

Round Strategic investment

Round B

Weimi Bio-Tech

Gloriousmed

Biocomma

Dynamic Biosystems Oebiotech

Invested company Axbio

S/no. Time 62 October 31

Table 1.9 (continued)

Two high-end platforms: neural autoimmunity and flow fluorescence. The products mainly focus on pathogenic microorganism detection, inflammation detection, etc. It focuses on high-throughput single-cell multi-omics platform products

Gene test of tumors of the urinary system

Molecular detection technology based on macrogenomic pathogenic microorganism detection (mNGS) Full-chain single-cell multi-omics technology Multi-omics detection services and molecular diagnostic products Adsorption & separation materials and filter materials

Business The fourth-­generation gene sequencer

Lake Bleu Capital led the investment, followed by Firstmed, MSA Capital, as well as the existing shareholders Sherpa Healthcare Partners, Lilly Asia Ventures, ARCH Venture Partners, CDG Capital, CDH Investments, SuperString Capital, 3w Global Investment, SBCVC, etc.

GL Ventures and HM Capital jointly led the investment Sinopharm Capital led the investment Shenzhen Capital led the investment, followed by SBCVC, BioVenture and Shenzhen HTI The government funds, industrial companies and old shareholders participated. CICC Qide Fund led the investment, followed by Med-Fine Capital, Chuangyu Investment and Jiahong Medical

Investor 5Y Capital, Kaitai Capital, MSA Capital and Yuanhe Puhua jointly invested Undisclosed

32 H. Song et al.

November 10

November 11

November 24

November 25

November 25

November 27

November 29

November 30

70

71

72

73

74

75

76

77

Round D

Undisclosed

Ustar

Hzymes Biotech Willingmed

NeoImmune

Round E+

Round A+

Round C

Round Pre-A

Vision Medicals Round D

Evergauge

Yuce Biological Round C+

Landing Med

Over 300 million CNY

800 million CNY 100 million CNY

30 million CNY

Tens of millions of CNY 300 million CNY

320 million CNY Nearly 100 million CNY

It has mNGS whole process high-throughput automation solution, focusing on the field of infectious precision molecular diagnosis Molecular POCT

Infectious precision medicine, aiming at clinical departments such as ICU, infection, respiration, paediatrics, and neurology to build an AI diagnosis system for infectious diseases based on genomics, radiomics, and EMR Key technologies for high-­throughput reading and writing of T and B lymphocyte receptor repertoire and their applications in clinical detection and therapy Special enzyme creation platform

Overall solution platform for tumor immune diagnosis and treatment. Focusing on the two research platforms, namely tumor genome and tumor microenvironment, the company builds a platform for the development and sales of clinical detection products for tumors and CRO service for pharmaceutical enterprises Capillary electrophoresis and CE-MS

AI tumor diagnosis cloud

(continued)

CPE Fund led the investment

GL Capital Group led the investment Shanghai Alliance led the investment exclusively

Ruijiang Kangsheng Fund

Haining Changhong Medical Industry Investment Partnership Boyu Capital led the investment

Alibaba Health led the investment, followed by Ether Investment Shenzhen Suizi Finance Management invested exclusively

1  Status and Progress 33

ABclonal

December 13

December 20

December 20

December 22

79

80

81

82

Vacure

ChosenMed

Lychix Bio

Invested company Bio Guoke

S/no. Time 78 November 30

Table 1.9 (continued)

Round A

Round C2

Round B

Round D

Round Round A+

Tens of millions of CNY

Hundreds of millions of CNY

150 million CNY

Financing amount Tens of millions of CNY 1.2 billion CNY

Based on the core technology platform μ-MPF, the company has built a number of application platforms, including an ultra-sensitive biomolecular detection platform, a multiple magnetic fluorescence-­encoded microsphere platform for multi-index combined determination, and a high-throughput single-cell parallel control platform for cell multi-omics. It covers tumor detection products in the whole industry chain, focusing on the guidance of targeted drugs for solid tumors, the prediction of the efficacy of tumor immunotherapy, especially the products regarding specific detection of nonsmall cell lung cancer and blood system tumors, etc. Microfluidic POCT

Business Based on population genome research and focusing on the field of birth defects Antibody, molecular enzyme reagent, CRO antibody discovery

Henan Jinggang Advanced Manufacturing Equity Investment Fund led the investment

Yijing Investment led the investment

Investor Maccura and Chengdu Huiling Changxi Fund Sequoia China, Luxin Venture Capital and China Merchant Bank International Capital jointly led the investment Legend Capital, HighLight Capital and CMG SDIC Capital jointly invested

34 H. Song et al.

1  Status and Progress

35

1.2 Industry Development Questionnaire The Medical Laboratory Society of the National Association of Health Industry and Enterprise Management cooperates with the In Vitro Diagnostics Society of the China Association for Medical Devices Industry to conduct a questionnaire, and invited the IVD Special Committee of the Shanghai Medical Instrument Trade Association, as well as the In Vitro Diagnostics and Precision Medical Investment and Industry Alliance, to hand out a questionnaire to the members of the industry associations. More than 400 valid questionnaires were connected in this industry development survey. The survey results are summarized and analyzed as follows:

1.2.1 The Growth in 2021 According to the Feedback from the Enterprises Is as Follows (Fig. 1.1) Fig. 1.1  Review of the growth in 2021 according to the feedback from the enterprises

The growth in 2021 Uncertain 2% 5%20% 25%

0