Investment Rating - The report does not explicitly state an investment rating for the industry [2] Core Insights - The pharmaceutical and biotechnology sector experienced a decline of 2.48% from October 13 to October 17, underperforming the broader market index, the CSI 300, which fell by 2.22% [3][8] - There is a sustained enthusiasm for business development (BD) transactions in innovative drugs, with several companies entering agreements with international pharmaceutical firms [3][12] - The ESMO conference held from October 17 to 21 showcased positive advancements in multiple studies, particularly in immunotherapy and antibody-drug conjugates (ADCs), highlighting the potential of domestic biotech companies [3][11] Market Weekly Review - The pharmaceutical and biotechnology sector saw a weekly decline of 2.48%, with offline pharmacies and traditional Chinese medicine showing slight gains of 0.59% and 0.38%, respectively [8] - Medical research outsourcing, medical devices, and other biological products faced significant declines, with drops of 6.46%, 5.37%, and 3.6% respectively [8][9] - Notable stock performances included Asia-Pacific Pharmaceutical with a rise of 36.7%, while Betta Pharmaceuticals saw a decline of 17.0% [11] Industry News and Key Company Announcements Important Industry Events - On October 18, Kangfang Biologics presented data on a PD-1/VEGF dual antibody in non-small cell lung cancer at the ESMO conference, showing significant improvement in progression-free survival (PFS) [11] - On October 16, Hansa Biopharma announced a licensing agreement with Roche for the global exclusive rights to develop and commercialize HS-20110, with an upfront payment of $80 million [12] - On October 16, Prigen Biologics entered a collaboration with Gilead's Kite Pharma, receiving an upfront payment of $120 million [12][13] Company Announcements - Huayuan Biologics reported a slight decrease in total revenue for the third quarter, amounting to 936 million yuan, a 0.2% year-on-year decline [14] - Shanghai Pharmaceuticals received FDA approval for Doxycycline capsules, with projected sales of approximately $130 million in the U.S. for 2024 [14][16]

中证报中证网讯（记者 李梦扬）10月14日晚间，上海医药公告，公司下属常州制药厂有限公司（简 称"常州制药厂"）收到美国食品药品监督管理局（简称"美国FDA"）的通知，其关于多西环素胶囊的简 略新药申请（"ANDA"，即美国仿制药申请）已获得批准。 上海医药称，截至公告日，公司针对该药品已投入研发费用约1083.33万元。本次常州制药厂关于多西 环素胶囊的ANDA获得美国FDA批准，对公司进一步拓展海外市场具有积极意义，并积累宝贵经验。 转自：中国证券报·中证网 ...

药械审批 欣安立适带状疱疹疫苗获批扩龄 葛兰素史克宣布，中国国家药品监督管理局（NMPA）已批准欣安立适（葛兰素史克重组带状疱疹疫 苗）用于18岁及以上因已知疾病或治疗（如自体造血干细胞移植）造成免疫缺陷或免疫抑制从而导致带 状疱疹发病风险增加的成人预防带状疱疹。 21点评：带状疱疹因水痘-带状疱疹病毒（VZV）再激活而引起，该病毒与导致水痘的病毒相同。中国 每年约有600万带状疱疹病例。除年龄增长外，免疫缺陷或免疫抑制等因素也会增加带状疱疹的发病风 险，而目前NMPA尚无其他获批用于该人群的带状疱疹疫苗。 这里是《21健讯Daily》，欢迎与21世纪经济报道新健康团队共同关注医药健康行业最新事件！ 政策动向 贵州推进医疗机构制剂不良反应监测 近日，贵州省药监局在贵阳组织召开医疗机构制剂不良反应监测暨监管工作推进会。会议指出，贵州省 医疗机构在制剂不良反应监测方面仍存在认识不足、主体责任落实不到位等问题，相关医疗机构应尽快 系统开展制剂不良反应监测工作，监测数据收集情况将作为贵州省医疗机构制剂调剂申请的重要依据之 一。 辽宁定点医药机构医保门诊结算明年将实施分级管理 根据相关报道，辽宁正在推进定点医药机构医保 ...

Monetary Policy and Economic Outlook - The People's Bank of China announced a buyout reverse repurchase operation of 600 billion yuan, set to take place on October 15, 2025, with a term of 6 months [2][4] - The International Monetary Fund (IMF) slightly raised its global economic growth forecast for 2025 to 3.2%, an increase of 0.2 percentage points from its July prediction [5] Automotive Industry - In the first nine months of 2025, China's production and sales of new energy vehicles both exceeded 10 million units, with a year-on-year growth rate of over 30% [5] - In August 2025, China's new energy vehicle sales reached 1.395 million units, a year-on-year increase of 26.82%, with a penetration rate of 48.8% [8] Robotics and Automation - China ranks first globally in the stock of industrial robots, with over 2 million units expected to be in operation by 2024 [7] - The development of humanoid robots is advancing, with breakthroughs in key technologies, promoting their application in various industries [7] Battery Industry - In September 2025, China's production of power batteries reached 151.2 GWh, a year-on-year increase of 35.4% [8] - Cumulative production of power batteries from January to September 2025 was 1,121.9 GWh, reflecting a year-on-year growth of 51.4% [8] Smart Technology and AI - Shanghai's economic and information technology committee released an action plan to enhance the scale of intelligent computing terminals, aiming to develop AI solutions across various industries [9] - The domestic computing power industry is gradually forming, driven by increased demand and advancements in technology [9] Public Offerings and Market Trends - Several companies, including Xinda Co. and Shenghe Resources, reported significant increases in net profits for the first three quarters of 2025, with growth rates ranging from approximately 2807.87% to 782.96% [11] - Equity ETFs saw a substantial inflow of over 560 billion yuan in just two trading days following the National Day holiday [13][14]

（文章来源：证券日报） 证券日报网讯 10月14日晚间，上海医药发布公告称，近日，公司下属常州制药厂有限公司收到美国食 品药品监督管理局（以下简称"美国FDA"）的通知，其关于多西环素胶囊的简略新药申请（"ANDA"， 即美国仿制药申请）已获得批准。 ...

Core Viewpoint - Shanghai Pharmaceuticals has received FDA approval for its abbreviated new drug application (ANDA) for doxycycline capsules, indicating a significant milestone for the company in the U.S. market [1] Company Summary - Shanghai Pharmaceuticals' subsidiary, Changzhou Pharmaceutical Factory, is the entity that received the FDA notification regarding the approval [1] - The approved doxycycline capsules contain two types of microcapsules: 30mg immediate-release and 10mg delayed-release, targeting inflammatory lesions in adult patients with rosacea [1]

多西环素胶囊(40mg)，内含两种类型的多西环素微丸(30mg速释微丸和10mg迟释微丸),主要用于成人患 者的玫瑰痤疮(红斑痤疮)的炎症性病变(丘疹和脓疱)。原研由GALDERMA LABORATORIES LP研发， 于2006年在美国上市。2024年09月，常州制药厂就该药品向美国FDA提出ANDA申请，并于近日获得批 准上市。截至本公告日，公司针对该药品已投入研发费用约人民币1,083.33万元。 上海医药（601607）(02607)发布公告，近日，上海医药集团股份有限公司(以下简称"上海医药"或"公 司")下属常州制药厂有限公司(以下简称"常州制药厂")收到美国食品药品监督管理局(以下简称"美国 FDA")的通知，其关于多西环素胶囊(基本情况详阅正文，以下简称"该药品")的简略新药申请 ("ANDA"，即美国仿制药申请)已获得批准。 ...

多西环素胶囊(40mg)，内含两种类型的多西环素微丸(30mg 速释微丸和 10mg 迟释微丸),主要用于成人 患者的玫瑰痤疮(红斑痤疮)的炎症性病变(丘疹和脓疱)。原研由 GALDERMA LABORATORIES LP 研 发，于 2006 年在美国上市。2024 年 09 月，常州制药厂就该药品向美国 FDA 提出 ANDA 申请，并于 近日获得批准上市。截至本公告日，公司针对该药品已投入研发费用约人民币 1,083.33 万元。 智通财经APP讯，上海医药(02607)发布公告，近日，上海医药集团股份有限公司(以下简称"上海医 药"或"公司")下属常州制药厂有限公司(以下简称"常州制药厂") 收到美国食品药品监督管理局(以下简 称"美国 FDA")的通知，其关于多西环素胶囊(基本情况详阅正文，以下简称"该药品")的简略新药申请 ("ANDA"，即美国仿制药申请)已获得批准。 ...

Core Viewpoint - Shanghai Pharmaceuticals has received approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for Doxycycline Capsules, which is significant for expanding its overseas market presence and gaining valuable experience [1] Group 1: Product Information - Doxycycline Capsules (40mg) contain two types of microcapsules: 30mg immediate-release and 10mg delayed-release, primarily used for treating inflammatory lesions of rosacea in adult patients [1] - The original drug was developed by Galderma Laboratories and was launched in the U.S. in 2006 [1] Group 2: Regulatory Approval - The ANDA application for Doxycycline was submitted to the U.S. FDA in September 2024 and has recently been approved for market entry [1] - The company has invested approximately RMB 10.83 million in research and development for this drug as of the announcement date [1] Group 3: Strategic Implications - The approval of Doxycycline Capsules is expected to positively impact the company's efforts to expand into international markets [1] - This achievement is seen as a way to accumulate valuable experience for future endeavors in the pharmaceutical industry [1]

Core Insights - Shanghai Pharmaceuticals' subsidiary, Changzhou Pharmaceutical Factory, has received FDA approval for its abbreviated new drug application (ANDA) for Doxycycline Capsules (40mg), which is primarily used for treating inflammatory lesions of rosacea in adult patients [1] - The same subsidiary has also obtained a drug registration certificate from the Malaysian National Pharmaceutical Regulatory Agency (NPRA) for Rivaroxaban Tablets, allowing it to be marketed in Malaysia [1] Company Developments - The approval of Doxycycline Capsules by the FDA marks a significant milestone for Shanghai Pharmaceuticals, enhancing its product portfolio in the dermatological segment [1] - The registration of Rivaroxaban Tablets in Malaysia indicates the company's expansion into international markets, potentially increasing its revenue streams [1] Industry Impact - The approval of generic drugs like Doxycycline and Rivaroxaban reflects the ongoing trend in the pharmaceutical industry towards increasing access to essential medications through generics [1] - The successful registration of these products may position Shanghai Pharmaceuticals favorably within the competitive landscape of the pharmaceutical industry, particularly in the Asian markets [1]