Investment Rating - The report maintains a "Market Weight" rating for the pharmaceutical and biotechnology industry, indicating that the industry is expected to perform within ±10% of the market index over the next six months [6][29]. Core Insights - The SW pharmaceutical and biotechnology industry underperformed the Shanghai and Shenzhen 300 index, with a gain of 1.36% from September 5 to September 18, 2025, lagging behind the index by approximately 1.66 percentage points [5][13]. - Most sub-sectors within the industry recorded positive returns during the same period, with the medical research outsourcing and medical equipment sectors leading with increases of 8.17% and 5.83%, respectively, while the chemical preparations sector saw a decline of 0.96% [5][14]. - Approximately 48% of stocks in the industry achieved positive returns, with notable performers including Zhendemedical, which had a weekly increase of 62.30% [15][18]. Summary by Sections 1. Market Review - The SW pharmaceutical and biotechnology industry underperformed the Shanghai and Shenzhen 300 index, gaining 1.36% from September 5 to September 18, 2025, which is 1.66 percentage points lower than the index [5][13]. - Most sub-sectors recorded positive returns, with medical research outsourcing and medical equipment sectors leading [5][14]. - About 48% of stocks in the industry recorded positive returns, with Zhendemedical showing the highest weekly increase [15][18]. - The overall industry valuation remained stable, with a PE ratio of approximately 56.10 times as of September 18, 2025, which is 4.26 times relative to the Shanghai and Shenzhen 300 index [19][29]. 2. Industry News - The report highlights the upcoming release of the 11th batch of national drug procurement rules, with discussions held on various aspects of the procurement process [6][27]. - The National Health Commission issued a notification regarding the 2025 version of medical quality control indicators, emphasizing the importance of a scientific and standardized quality control system [23][26]. 3. Company Announcements - Changchun High-tech announced a collaboration with Denmark's ALK-Abelló A/S for the development and commercialization of specific immunotherapy products in China [28]. 4. Weekly Industry Outlook - The report suggests maintaining a focus on investment opportunities in innovative drugs and sectors with expected business development catalysts, particularly in medical devices and pharmaceutical commerce [29][30].

Investment Rating - The report maintains a "Market Weight" rating for the pharmaceutical and biotechnology industry, indicating that the industry is expected to perform within ±10% of the market index over the next six months [36]. Core Insights - The SW pharmaceutical and biotechnology industry underperformed the CSI 300 index, with a gain of 1.36% from September 5 to September 18, 2025, lagging behind the index by approximately 1.66 percentage points [11]. - Most sub-sectors within the industry recorded positive returns during the same period, with the medical research outsourcing and medical equipment sectors leading with increases of 8.17% and 5.83%, respectively [12]. - Approximately 48% of stocks in the industry achieved positive returns, while 52% experienced negative returns during the reporting period [13]. - The overall industry valuation remained stable, with a PE (TTM) ratio of about 56.10 times as of September 18, 2025, and a relative PE to the CSI 300 of 4.26 times [17][27]. Summary by Sections Market Review - The SW pharmaceutical and biotechnology industry underperformed the CSI 300 index, with a 1.36% increase compared to the index's performance [11]. - Most sub-sectors recorded positive returns, particularly in medical research outsourcing and medical equipment [12]. - About 48% of stocks in the industry had positive returns, with notable performers and underperformers identified [13]. Industry News - The report highlights the upcoming release of the 11th batch of national drug procurement rules, with discussions on various aspects of the procurement process [25]. - The National Health Commission issued a notification regarding the 2025 version of medical quality control indicators, emphasizing the importance of a scientific and standardized quality control system [21][24]. Company Announcements - Changchun High-tech announced a collaboration with Denmark's ALK-Abelló A/S for the development and commercialization of specific immunotherapy products in China [26]. Industry Outlook - The report suggests focusing on investment opportunities in innovative drugs and sectors with expected business development catalysts, including medical devices and pharmaceutical commerce [27][28]. - Specific companies to watch include Mindray Medical, Yifeng Pharmacy, and Aier Eye Hospital, among others, due to their strong market positions and growth potential [29].

Policy Developments - The 2025 Pharmaceutical Digital Development Conference was held in Beijing on September 17-18, focusing on the modernization of drug regulation through information technology and digital collaboration [1] Drug and Device Approvals - Hengrui Medicine's SHR-1501 has been included in the list of proposed breakthrough therapy varieties by the National Medical Products Administration, aimed at treating non-muscle invasive bladder cancer [2] - Kehua Bio's ferritin assay kit received a medical device registration certificate, valid from September 17, 2025, to September 16, 2030, for the quantitative measurement of ferritin in human serum and plasma [3] - Shanghai Pharmaceuticals' Nicorandil tablets passed the consistency evaluation for generic drugs, with approximately 5.5352 million yuan invested in R&D [4] Capital Market - Roche announced a definitive agreement to acquire biopharmaceutical company 89bio for up to nearly $3.5 billion, focusing on innovative therapies for liver and heart metabolic diseases [5] Industry Events - The first national group standard for "Non-Clinical Safety Technical Guidelines for Oligonucleotide Drugs" was released during the 9th China (Tianjin) Nucleic Acid Drug Conference [6] Research and Development - Chinese researchers developed a new generation of brain-machine interface electrodes, marking a shift towards dynamic and intelligent detection in bioelectronic interfaces [7] - A new blood testing tool, "HPV-DeepSeek," can identify HPV-related head and neck cancers up to 10 years before symptoms appear, potentially improving patient outcomes [9] Corporate Governance - The independent director of Buchang Pharma, Cheng Hua, resigned due to personal reasons, leading to a temporary reduction in the number of independent directors on the board [10] Strategic Collaborations - Siemens Healthineers and Stryker announced a strategic partnership to develop a new robotic system for neurovascular interventions [8]

Core Viewpoint - Heng Rui Medicine's subsidiary, Guangdong Heng Rui Medicine Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of SHR-1139 injection for ulcerative colitis treatment [1] Group 1 - SHR-1139 injection is a self-developed biological product by Heng Rui Medicine, expected to enhance treatment for ulcerative colitis by inhibiting inflammatory responses and maintaining epithelial barrier mechanisms [1]

Core Viewpoint - Heng Rui Medicine announced the approval of clinical trials for SHR-3045 injection, a self-developed biological product aimed at treating rheumatoid arthritis by inhibiting immune cell function and reducing inflammation [1] Group 1 - The company received the clinical trial approval notice from the National Medical Products Administration for SHR-3045 injection [1] - SHR-3045 is expected to improve clinical symptoms in the treatment of rheumatoid arthritis [1] - The clinical trials are set to commence in the near future [1]

格隆汇9月18日｜渤海证券研报指出，恒瑞医药为我国制药龙头企业，坚持科技创新和国际化双轮驱 动，拥有110多款商业化药物，包括23款新分子实体创新药和4款其他创新药。公司股权结构稳定，员工 持股计划激发创新活力，在研管线不断丰富，技术平台多维度广泛开拓，研发投入继续加大，2024年营 收净利创新高。公司2025-2027年预计获批上市创新药及适应症约47项，涵盖肿瘤、自免、减重等多个 领域。公司BD进程不断加快，与MNC加强合作，历次BD合作中首付款和里程碑金额稳步提升，2025 年已实现与默沙东、默克、GSK多家MNC的BD合作，同时再次采用NewCo模式实现对外授权。公司从 前期follow-on到单个创新药获批上市到如今多种类创新药全面储备，以平台化保障公司长期创新药商业 化进程，促进营收放量。首次覆盖给予"买入"评级。 ...

Core Viewpoint - Heng Rui Medicine (01276) announced that its subsidiary, Guangdong Heng Rui Medicine Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of SHR-1139 injection, which is expected to begin soon [1] Group 1: Product Development - SHR-1139 injection is a self-developed biological product aimed at treating ulcerative colitis, expected to enhance treatment by inhibiting inflammatory responses and maintaining epithelial barriers [1] - Currently, there are no similar drugs approved for marketing domestically or internationally [1] Group 2: Financial Investment - The cumulative research and development investment for the SHR-1139 injection project has reached approximately 71.28 million yuan [1]

北京商报讯(记者王寅浩实习记者宋雨盈)9月18日，恒瑞医药（600276）发布公告称，公司子公司上海 恒瑞医药有限公司的注射用SHR—1501被国家药品监督管理局药品审评中心纳入拟突破性治疗品种公示 名单，公示期7日。 公告显示，SHR—1501为恒瑞医药自主研发并具有知识产权的白细胞介素—15(IL—15)融合蛋白，可以 刺激体内T细胞、B细胞和NK细胞增殖，发挥调动机体免疫系统清除体内异物(如肿瘤)的作用，其与 BCG联用可明显增强膀胱内的免疫反应，达到协同抗肿瘤的效果。 ...

Core Viewpoint - Heng Rui Medicine's subsidiary Shanghai Heng Rui Medicine Co., Ltd. has announced that its injectable SHR-1501 has been included in the list of proposed breakthrough therapeutic varieties by the National Medical Products Administration's Drug Review Center, with a public announcement period of 7 days [1] Group 1: Product Information - SHR-1501 is a self-developed interleukin-15 (IL-15) fusion protein with intellectual property rights, designed to stimulate the proliferation of T cells, B cells, and NK cells in the body [1] - The product enhances the immune response in the bladder when used in conjunction with BCG, achieving a synergistic anti-tumor effect [1] - Unlike IL-2, IL-15 does not stimulate the proliferation of regulatory T cells or induce T cell apoptosis [1] Group 2: Market Context - The foreign counterpart of SHR-1501, Nogapendekin Alfa Inbakicept (marketed as Anktiva), has already been approved for sale in the United States [1] - Currently, there are no approved products targeting the same pathway in the domestic market [1] Group 3: Financial Investment - The cumulative research and development investment for injectable SHR-1501 has reached approximately 102.18 million yuan [1]

Core Viewpoint - Heng Rui Medicine's subsidiary, Shanghai Heng Rui Medicine Co., Ltd., has announced that its injectable SHR-1501 has been included in the list of proposed breakthrough therapeutic varieties by the National Medical Products Administration's Drug Review Center, with a public announcement period of 7 days [1] Group 1 - SHR-1501 is a proprietary interleukin-15 (IL-15) fusion protein developed by the company [1] - The drug stimulates the proliferation of T cells, B cells, and NK cells in the body, enhancing the immune system's ability to eliminate foreign substances such as tumors [1] - When used in conjunction with BCG, SHR-1501 significantly enhances the immune response within the bladder, achieving a synergistic anti-tumor effect [1]