Core Points - The Medical Health R Index (480016) closed at 7852.45 points, up 1.04%, with a trading volume of 22.052 billion yuan and a turnover rate of 0.74% [1] - Among the index constituents, 40 stocks rose while 9 fell, with WuXi AppTec leading the gainers at 4.27% and Pian Zai Huang leading the decliners at 0.91% [1] Index Constituents Summary - The top ten constituents of the Medical Health R Index include: - WuXi AppTec (603259) with a weight of 14.37%, latest price at 102.04, and a market cap of 304.463 billion yuan [1] - Hengrui Medicine (600276) with a weight of 11.45%, latest price at 66.00, and a market cap of 438.055 billion yuan [1] - Mindray Medical (300760) with a weight of 8.07%, latest price at 223.57, and a market cap of 271.066 billion yuan [1] - United Imaging Healthcare (688271) with a weight of 4.32%, latest price at 143.03, and a market cap of 117.879 billion yuan [1] - Pian Zai Huang (600436) with a weight of 3.59%, latest price at 185.38, and a market cap of 111.843 billion yuan [1] - Aier Eye Hospital (300015) with a weight of 3.21%, latest price at 12.33, and a market cap of 114.982 billion yuan [1] - Kelun Pharmaceutical (002422) with a weight of 2.54%, latest price at 36.05, and a market cap of 57.610 billion yuan [1] - Changchun High & New Technology (000661) with a weight of 2.35%, latest price at 120.28, and a market cap of 49.067 billion yuan [1] - Fosun Pharma (600196) with a weight of 2.28%, latest price at 29.28, and a market cap of 78.190 billion yuan [1] - Sinopharm (002001) with a weight of 2.22%, latest price at 23.27, and a market cap of 71.519 billion yuan [1] Capital Flow Analysis - The net inflow of main funds into the Medical Health R Index constituents totaled 634 million yuan, while retail funds saw a net outflow of 105 million yuan [1] - Detailed capital flow for key stocks includes: - WuXi AppTec with a net inflow of 353.9 million yuan from main funds [2] - Sinopharm with a net inflow of 90.036 million yuan from main funds [2] - Hengrui Medicine with a net inflow of 76.418 million yuan from main funds [2] - Other stocks like Changchun High & New Technology and Fosun Pharma also experienced varying levels of net inflow and outflow [2]

10月17日，据国家药品监督管理局（NMPA）官网最新公示，科伦药业旗下科伦博泰申报的1类新药注射用博度曲妥珠单抗在国内获批上市；与此同时，科 伦药业按化药注册分类4类申报的罗替高汀贴片也获批上市，且视同通过一致性评价，一举拿下国内首仿。 | 截图 | | --- | 来源：NMPA 注射用博度曲妥珠单抗是科伦博泰自主研发的HER2 ADC单抗，适用于既往接受过一种及以上抗HER2药物治疗的不可切除或转移性HER2阳性成人乳腺癌患 者。该药于2017年首次在国内申报临床，2018年启动首个临床试验。2023年5月，科伦博泰提交的首个上市申请（针对既往经二线及以上抗HER2治疗失败的 HER2阳性不可切除局部晚期、复发或转移性乳腺癌）获CDE受理，目前仍在审评中；本次获批适应症为该药第二项上市申请，于2025年1月获CDE受理。 截图来源：摩熵医药全球药物研发数据库 | 截图来源：摩熵医药中国药品审评数据库 | | --- | 目前，全球已获批的5款原研HER2 ADC均在国内获批。ADC药物是科伦药业重点布局方向，据摩熵医药数据库显示，旗下已有芦康沙妥珠单抗、博度曲妥 珠单抗2款新药获批上市。此外，科伦药业（ ...

Market Overview - The chemical pharmaceutical sector increased by 0.32% on October 20, with Fuxiang Pharmaceutical leading the gains [1] - The Shanghai Composite Index closed at 3863.89, up 0.63%, while the Shenzhen Component Index closed at 12813.21, up 0.98% [1] Top Gainers - Fuxiang Pharmaceutical (300497) closed at 10.48, up 5.43% with a trading volume of 302,100 shares and a transaction value of 316 million [1] - Changshan Pharmaceutical (300255) closed at 50.98, up 4.60% with a trading volume of 280,800 shares [1] - Kelong Pharmaceutical (002422) closed at 36.47, up 4.56% with a trading volume of 188,600 shares and a transaction value of 681 million [1] Top Losers - Anglikang (002940) closed at 41.66, down 7.05% with a trading volume of 214,800 shares [2] - Asia-Pacific Pharmaceutical (002370) closed at 7.35, down 5.16% with a trading volume of 1,918,400 shares [2] - Yifan Pharmaceutical (002019) closed at 13.11, down 4.45% with a trading volume of 271,200 shares and a transaction value of 358 million [2] Fund Flow Analysis - The chemical pharmaceutical sector experienced a net outflow of 623 million from institutional investors, while retail investors saw a net inflow of 672 million [2] - The top stock with the highest net inflow from institutional investors was Xingqi Eye Medicine (300573) with 206 million [3] - Kelong Pharmaceutical (002422) had a net inflow of 99.67 million from institutional investors [3]

Core Viewpoint - The report by Zhiyan Consulting highlights the growth and future trends in China's chemical pharmaceutical industry, indicating a steady increase in production and market dynamics from 2025 to 2031 [1]. Industry Summary - According to the National Bureau of Statistics, the production of chemical pharmaceutical raw materials in China reached 263,000 tons in August 2025, with a cumulative production of 2,477,000 tons from January to August 2025, reflecting a growth of 3.1% [1]. - The report provides insights into the supply and demand situation in the chemical pharmaceutical industry, projecting future trends and market conditions [1]. Company Summary - Listed companies in the report include Heng Rui Medicine, East China Medicine, Lizhu Group, Baiyunshan, North China Pharmaceutical, Haizheng Pharmaceutical, Fosun Pharmaceutical, Kelun Pharmaceutical, Enhua Pharmaceutical, and Xianju Pharmaceutical, indicating a diverse range of players in the market [1]. - The report emphasizes the importance of industry research and consulting services in aiding investment decisions, showcasing Zhiyan Consulting's expertise in providing comprehensive industry solutions [1].

科伦药业公告，公司控股子公司科伦博泰在2025年欧洲肿瘤内科学会(ESMO)大会上公布了多项临床研 究成果。芦康沙妥珠单抗(sac-TMT)在治疗EGFR突变非小细胞肺癌(NSCLC)的随机、多中心3期 OptiTROP-Lung04研究中，中位无进展生存期(PFS)为8.3个月，较化疗组显著改善，疾病进展或死亡风 险降低51%。在治疗局部晚期或转移性激素受体阳性且HER2阴性(HER2+/HER2-)乳腺癌的随机、多中 心3期OptiTROP-Breast02研究中，芦康沙妥珠单抗(sac-TMT)较化疗组显著延长中位PFS至8.3个月，客 观缓解率提高至41.5%。博度曲妥珠单抗对比恩美曲妥珠单抗(T-DM1)治疗HER2+转移性BC的随机3期 研究中，中位PFS显著延长至11.1个月，客观缓解率高达76.9%。 ...

Core Viewpoint - The company announced that its subsidiary, Sichuan Kelun-Botai Biopharmaceutical Co., Ltd., presented multiple clinical research results at the 2025 European Society for Medical Oncology (ESMO) conference held in Berlin from October 17 to 21 [1] Group 1 - The clinical research results include data on targeted antibody-drug conjugates (ADCs) such as sac-TMT (Jiatailai), targeting trophoblast cell surface antigen 2 (TROP2) [1] - The company also presented data on A166 (Shutailai), a HER2-targeted ADC [1] - Additionally, results related to Claudin18.2 (CLDN18.2) ADC SKB315 were shared [1]

Core Insights - The company announced that its subsidiary, Sichuan Kelun-Botai Biopharmaceutical Co., Ltd., presented multiple clinical research results at the 2025 European Society for Medical Oncology (ESMO) conference held in Berlin from October 17 to 21 [1] Group 1 - The clinical research results included data on targeted antibody-drug conjugates (ADCs) such as sac-TMT (Jiatailai®), targeting trophoblast cell surface antigen 2 (TROP2) [1] - The results also covered data on A166 (Shutailai®), a HER2-targeted ADC [1] - Additionally, data on SKB315, a Claudin18.2 (CLDN18.2) ADC, was presented [1]

Core Viewpoint - The announcement by Kelun Pharmaceutical regarding the presentation of multiple clinical research results at the 2025 European Society for Medical Oncology (ESMO) conference highlights the company's advancements in targeted antibody-drug conjugates (ADCs) [1] Group 1: Clinical Research Results - Kelun Pharmaceutical's subsidiary, Sichuan Kelun Biotech Co., Ltd., presented data on several ADCs, including sac-TMT targeting TROP2, A166 targeting HER2, and SKB315 targeting Claudin18.2 [1]

市场监管总局、国家药监局调研组在京开展《医疗器械管理法》立法调研 10月17日消息，市场监管总局副局长束为和国家药监局副局长徐景和率调研组10月15日在京就《医疗器 械管理法》草案开展立法调研。调研组一行先后走访瓦里安医疗设备（中国）有限公司、心诺普医疗技 术（北京）有限公司，了解医疗器械研发、生产、经营、使用等情况，并召开立法座谈会，听取北京市 药监局、北京市市场监管综合执法总队等监管部门、企业和医疗机构的意见建议，就进一步完善医疗器 械监管法律制度体系、强化全生命周期质量安全监管、促进产业高质量发展和高水平安全进行了深入交 流。调研组指出，医疗器械关系人民群众的生命健康，关系公共安全和国家安全。医疗器械管理立法要 坚持科学立法、民主立法、依法立法的要求，坚持问题导向，坚持国际视野，坚持改革创新，进一步提 高立法质量，推动法律实施。 药械审批 政策动向 华东医药全资子公司收到药品注册证书 10月17日，华东医药(000963.SZ)公告称，全资子公司中美华东收到国家药品监督管理局核准签发的 《药品注册证书》，由中美华东申报的瑞玛比嗪注射液的上市许可申请获得批准。该药物是一种注射用 外源性荧光示踪剂，需与Me ...

Policy Developments - The State Administration for Market Regulation and the National Medical Products Administration conducted legislative research on the draft Medical Device Management Law, emphasizing the importance of scientific, democratic, and legal legislation to enhance the quality of laws and promote implementation [1] Drug and Device Approvals - East China Pharmaceutical's subsidiary received a drug registration certificate for Remabizine injection, which is used in conjunction with MediBeacon's device to assess patients' glomerular filtration rate [2] - Kelun Pharmaceutical's subsidiary obtained approval for its ADC product, Botuzumab, for treating HER2-positive breast cancer, showing significant improvement in progression-free survival compared to T-DM1 [3] Financial Reports - WoHua Pharmaceutical reported a net profit increase of 179.34% year-on-year for the first three quarters, with revenue of 625 million yuan [4] - Pianzihuang's third-quarter net profit decreased by 28.82%, with revenue down 26.28% year-on-year, attributed to reduced sales in the pharmaceutical manufacturing sector [5] Capital Market Activities - Weigao Blood Products is planning to acquire 100% of Shandong Weigao Puri Pharmaceutical Packaging Co., leading to a stock suspension for up to 10 trading days [7] - Hansoh Pharmaceutical entered a licensing agreement with Roche, potentially earning up to $1.45 billion in milestone payments for the development of HS-20110, a targeted ADC for colorectal cancer [8] Industry Developments - Sanofi announced the launch of its insulin raw material project in Beijing, with a total investment of 1 billion euros, expected to be completed by 2032 [12]