With the continuous development of the biomedical field, the demand for related technol-ogies is also increasing. New biomedical technology is an emerging technology that acts at cell and molec-ular level and provides the necessary guarantee to support the development of biomedical research. More research is needed to explore the benefits and risks of this new experimental treatment method. China's new biomedical technology has recorded great achievements supported by the relevant policies. Yet it still faces problems including vague definition and lack of risk supervision. This paper introduces the definition of new biomedical technology in different fields, and taking the new biomedical technologies in the field of biomedicine as the object, it analyzes the development of the currently existing market and management status in China. It then discusses the risks associated with such biotechnology and puts forward personal suggestions for a suitable supervision system.

1.全国人民代表大会. 中华人民共和国生物安全法[EB/OL]. (2020-10-17) [2022-07-15]. http://www.npc.gov.cn/npc/c30834/202010/bb3bee5122854893a69acf4005a66059.shtml.

2.全国科学技术名词审定委员会事务中心.术语在线[EB/OL]. (2022-03-02) [2022-07-15]. https://www.termonline.cn/search?k=%E7%94%9F%E7%89%A9%E6%8A%80%E6%9C%AF&r=1647913891593.

3.科技部中国生物技术发展中心. 医药生物技术中长期发展战略研究报告2005~2020[R/OL]. (2014-07-16) [2022-07-15]. http://168.160.159.162/Upload/201407/16/ 201407161129085225.doc.

4.科学技术部. 科技部关于印发《“十三五”生物技术创新专项规划》的通知(国科发社〔2017〕103号) [EB/OL]. (2017-05-10) [2022-07-15]. http://www.most.gov.cn/tztg/201705/W020170510451953592712.pdf.

5.国家卫生健康委员会. 关于生物医学新技术临床应用管理条例(征求意见稿)公开征求意见的公告[EB/OL]. (2019-02-26) [2022-07-15]. http://www.nhc.gov.cn/wjw/yjzj/201902/0f24ddc242c24212abc42aa8b539584d/files/d48c71da4554416eba77863bddfa01b1.docx.

6.德勤. 引领市场，制胜未来——中国细胞和基因疗法市场分析[R/OL]. (2020-05-20) [2022-07-15]. https://www2.deloitte.com/content/dam/Deloitte/cn/Documents/strategy/deloitte-cn-strategy-and-operation-china-cgt-white-paper-zh-200520.pdf.

7.卫生部. 卫生部关于印发《医疗技术临床应用管理办法》的通知(卫医政发〔2009〕18号)[EB/OL]. (2009-03-16) [2022-07-15]. http://www.nhc.gov.cn/wjw/gfxwj/201304/28193228059c47388ea9f26af746234d.shtml.

8.何萍, 程涛, 郝莎. 干细胞临床研究的现状及展望[J]. 中国医药生物技术, 2020, 15(3): 290-294. [He P, Cheng T, Hao S. Current status and prospect of clinical research on stem cells[J]. Chinese Medicinal Biotechnolo-gy, 2020, 15(3): 290-294.] DOI: 10.3969/j.issn.1673-713X.2020. 03.011.

9.医政医管局. 国家限制类技术临床应用管理规范(2022 年版)[EB/OL]. (2022-04-20) [2022-07-15]. http://www.nhc.gov.cn/yzygj/s7657/202204/2efe9f8ca13f499c8e1f70844fe96144.shtml.

10.Pausch P, Al-Shayeb B, Bisom-Rapp E, et al. CRISPR-CasΦ from huge phages is a hypercompact ge-nome editor[J]. Science, 2020, 369(6501): 333-337. DOI: 10.1126/science.abb1400.

11.国务院. 中华人民共和国人类遗传资源管理条例[EB/OL]. (2010-05-28) [2022-07-15]. http://www.gov.cn/zhengce/2020-12/27/content_5574163.htm.

12.医政医管局. 生物医学新技术临床应用管理条例(征求意见稿)[R/OL]. (2019-02-26) [2022-07-15]. http://www.nhc.gov.cn/yzygj/s7659/201902/0f24ddc242c24212abc42aa8b539584d/files/d48c71da4554416eba77863bddfa01b1.docx.

13.国务院. 国务院办公厅关于全面加强药品监管能力建设的实施意见(国办发〔2021〕16号)[EB/OL].  (2021-05-10) [2022-07-15]. http://www.gov.cn/zhengce/content/2021-05/10/content_5605628.htm.

14.邱志超, 李卓霏, 石宏. 基因编辑技术及其在疾病治疗中的研究进展和应用前景[J]. 昆明理工大学学报, 2021, 46(5): 100-109. [Qiu ZC, Li ZF, Shi H. Research progress and application prospects of gene editing technology in disease treatment[J]. Journal of Kunming University of Science and Technology, 2021, 46(5): 100-109.] DOI: 10.16112/j.cnki.53-1223/n.2021.05.252.

15.张强, 顾明亮. 基因编辑技术及其临床应用[J]. 生命的化学, 2022, 42(1): 41-55. [Zhang Q, Gu ML. Gene editing technology and its clinical application[J]. Chemistry of Life, 2022, 42(1): 41-55.] DOI: 10.13488/j.smhx.20210674.

16.Lu Y, Xue JX, Deng T, et al. Safety and feasibility of CRISPR-edited T cells in patients with refractory non-small-cell lung cancer[J]. Nat Med, 2020, 26(5): 732-740. DOI: 10.1038/s41591-020-0840-5.

17.Xu L, Wang J, Liu YL, et al. CRISPR-Edited stem cells in a patient with HIV and acute lymphocytic leu-kemia[J]. N Engl J Med, 2019, 381(13): 1240-1247. DOI: 10.1056/NEJMoa1817426.

18.Ling SK, Yang SQ, Hu XD, et al. Lentiviral delivery of co-packaged Cas9 mRNA and a Vegfa-targeting guide RNA prevents wet age-related macular degeneration in mice[J]. Nat Biomed Eng, 2021, 5(2): 144-156. DOI: 10.1038/s41551-020-00656-y.

19.国家卫生健康委员会. 涉及人的生物医学研究伦理审查办法[EB/OL]. (2016-10-12) [2022-07-15]. http://www.nhc.gov.cn/wjw/c100022/202201/985ed1b0b9374dbbaf8f324139fe1efd.shtml.

20.国家发展和改革委员会, 中华人民共和国商务部. 外商投资准入特别管理措施(负面清单)(2021年版)[R/OL]. (2021-12-27) [2022-07-15]. http://www.gov.cn/zhengce/zhengceku/2021-12/28/5664886/files/5b1aecc9c9704b05b7a930eb6fd74e29.pdf.

21.科学技术部. 人类遗传资源管理条例实施细则(征求意见稿)[EB/OL]. (2022-03-22) [2022-07-15]. http://www.most.gov.cn/tztg/202203/W020220322405 257162084.docx.

22.林玲, 张新庆. 基因编辑婴儿的伦理、法律和社会蕴含[J]. 科技导报, 2019, 37(6): 13-18. [Lin L, Zhang XQ. Ethical, legal and social implications of germline gene editing babies[J]. Science & Technology Review, 2019, 37(6): 13-18.] DOI: 10.3981/j.issn.1000-7857. 2019.06.002.

23.胡新平, 石佳友. 我国人类生殖系基因组编辑治理框架的问题及其完善[J]. 经贸法律评论, 2022, (1): 19-37. [Hu XP, Shi JY. Problems and improvement of genome editing of germline system regulatory framework in Chi-na[J]. Business and Economic Law Review, 2022, (1): 19-37.] https://kns.cnki.net/kcms/detail/detail.aspx?dbcode=CJFD&dbname=CJFDLAST2022&filename=JMFV202201003&uniplatform=NZKPT&v=kmdqVvWrM_NBEQ4W6PCUFVBQpacIylso1W6i_6wZoExt44CG7gJur_mk8Cq7Ws1T.

24.丘祥兴, 沈铭贤, 胡庆灃. 干细胞研究伦理[J]. 生命科学, 2012, 24(11): 1308-1317. [Qiu XX, Shen MX, Hu QF. Ethics on stem cell research[J]. Chinese Bulletin of Life Sciences, 2012, 24(11): 1308-1317.] DOI: 10.13376/j.cbls/2012.11.016.

25.国务院. 国务院关于印发生物产业发展规划的通知(国发〔2012〕65号) [EB/OL]. (2013-01-06) [2022-07-15]. http://www.gov.cn/zwgk/2013-01/06/content_2305639.htm?c=3.