格隆汇12月24日丨恒瑞医药(01276.HK)公告，近日，江苏恒瑞医药股份有限公司子公司苏州盛迪亚生物 医药有限公司、上海恒瑞医药有限公司收到国家药品监督管理局核准签发关于注射用SHR-A2102的《药 物临床试验批准通知书》，将于近期开展临床试验。 药物名称：注射用SHR-A2102 剂型：注射剂 申请事项：临床试验 受理号：CXSL2500879、CXSL2500881 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，2025年10月13日和14日受理的注 射用SHR-A2102临床试验申请符合药品注册的有关要求，同意本品开展两项临床试验。分别为：本品联 合注射用维迪西妥单抗在晚期实体瘤中开展临床试验；本品联合阿得贝利单抗或其他PD-(L)1药物联合 或不联合其他抗肿瘤治疗在局部晚期或转移性食管癌受试者中的安全性、耐受性及有效性的多中心、开 放ⅠB/Ⅱ期临床研究。 ...

Core Viewpoint - Heng Rui Medicine's subsidiary has received approval from the National Medical Products Administration for clinical trials of SHR-A2102, a targeted antibody-drug conjugate aimed at treating advanced solid tumors and esophageal cancer [1] Group 1: Clinical Trials - The company will conduct two clinical trials for SHR-A2102, one in combination with Vedolizumab for advanced solid tumors and another with Atezolizumab or other PD-(L)1 drugs for locally advanced or metastatic esophageal cancer [1] - The trials will assess the safety, tolerability, and efficacy of SHR-A2102 in a multicenter, open-label Phase I/II study [1] Group 2: Product Details - SHR-A2102 is an antibody-drug conjugate (ADC) targeting Nectin-4, with its active payload being a topoisomerase I inhibitor (TOP1i) [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of its drug SHR-A2102, indicating progress in its oncology pipeline and potential market entry for a new targeted therapy [1] Group 1: Clinical Trials - The company’s subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., and Shanghai Heng Rui Medicine Co., Ltd. have been authorized to conduct two clinical trials for SHR-A2102 [1] - The first trial will evaluate SHR-A2102 in combination with Vedolizumab for advanced solid tumors [1] - The second trial will assess SHR-A2102 in combination with Atezolizumab or other PD-(L)1 inhibitors for locally advanced or metastatic esophageal cancer in a multicenter, open-label Phase IB/II study [1] Group 2: Product Details - SHR-A2102 is a targeted antibody-drug conjugate (ADC) that targets Nectin-4, with an effective payload of topoisomerase I inhibitor (TOP1i) [1] - Currently, there is one similar product, Enfortumab vedotin (brand name: Padcev), which has been approved and is projected to generate global sales of approximately $1.949 billion in 2024 [1] Group 3: Investment and Development - The total investment in the SHR-A2102 development project has reached approximately 248.22 million yuan [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of SHR-A2102, indicating progress in its drug development pipeline [1] Group 1: Drug Information - Drug Name: SHR-A2102 [1] - Dosage Form: Injectable [1] - Application Type: Clinical trial [1] Group 2: Approval Details - Acceptance Numbers: CXSL2500879, CXSL2500881 [1] - Approval Conclusion: The clinical trial applications for SHR-A2102, submitted on October 13 and 14, 2025, meet the requirements for drug registration and are approved for two clinical trials [1] Group 3: Clinical Trials - The first trial will investigate the combination of SHR-A2102 with Vedolizumab in patients with advanced solid tumors [1] - The second trial will assess the safety, tolerability, and efficacy of SHR-A2102 combined with Atezolizumab or other PD-(L)1 inhibitors, with or without other anti-tumor treatments, in patients with locally advanced or metastatic esophageal cancer [1]

Core Viewpoint - Heng Rui Medicine (600276.SH) announced that its subsidiaries, Suzhou Shengdiya Biopharmaceutical Co., Ltd. and Shanghai Heng Rui Medicine Co., Ltd., have received approval from the National Medical Products Administration for the clinical trial of SHR-A2102, which will commence shortly [1] Group 1: Clinical Trial Approval - The clinical trial application for SHR-A2102 was accepted on October 13 and 14, 2025, and meets the requirements for drug registration [1] - Two clinical trials will be conducted: one involving SHR-A2102 in combination with Vedolizumab for advanced solid tumors, and the other involving SHR-A2102 in combination with Atezolizumab or other PD-(L)1 inhibitors for locally advanced or metastatic esophageal cancer [1]

Investment Rating - The report maintains a "Buy" rating for the company [4][6]. Core Insights - The company achieved a revenue of 23.188 billion yuan in the first three quarters of 2025, representing a year-on-year increase of 14.85%. The net profit attributable to the parent company was 5.751 billion yuan, up 24.50%, and the net profit after deducting non-recurring gains and losses was 5.589 billion yuan, an increase of 21.08% [1][4][6]. Summary by Sections Internationalization and Partnerships - In Q3 2025, the company secured three overseas licensing agreements, including a collaboration with GSK to develop up to 12 innovative drugs, receiving an upfront payment of 500 million USD, with potential total payments of approximately 12 billion USD [2]. - The company also entered into a New-Co transaction with Braveheart Bio for HRS-1893, receiving an upfront payment of 65 million USD and potential milestone payments of up to 1.013 billion USD [2]. - Additionally, the company licensed part of its international market rights for a drug to Glenmark, receiving an upfront payment of 18 million USD and potential milestone payments of up to 1.093 billion USD [2]. Innovation and R&D - The company increased its R&D expenditure to 4.945 billion yuan in the first three quarters of 2025. New products were approved for market, including EZH2 inhibitors and a new oral hypoglycemic combination [3]. - The company has over 100 self-developed innovative products in clinical development and more than 400 clinical trials ongoing domestically and internationally [3]. - At the 2025 ESMO annual meeting, the company presented 46 research results in the oncology field, with significant findings published in The Lancet [3]. Financial Forecast - The company is projected to achieve net profits of 8.803 billion yuan, 10.277 billion yuan, and 12.151 billion yuan for 2025, 2026, and 2027, respectively, with year-on-year growth rates of 38.9%, 16.8%, and 18.2% [4][10].

Core Viewpoint - HengRui Medicine has signed a licensing agreement with Glenmark Specialty for the innovative drug SHR-A1811, expanding its market reach and enhancing its global presence in cancer treatment [1][3]. Group 1: Licensing Agreement Details - The agreement allows Glenmark Specialty to license SHR-A1811, an antibody-drug conjugate targeting HER2, which is designed to induce apoptosis in tumor cells [1]. - Glenmark Specialty will pay an upfront fee of $18 million to HengRui, with potential milestone payments related to registration and sales reaching up to $1.093 billion [2]. Group 2: Clinical Development and Approvals - SHR-A1811 has received approval for use in adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 mutations, marking it as the first Chinese-developed ADC for this indication [1]. - Multiple clinical studies are ongoing, with SHR-A1811 receiving orphan drug designation from the FDA for use in gastric cancer and related conditions, and a new indication for breast cancer under priority review by the National Medical Products Administration [2]. Group 3: Strategic Implications - The agreement is expected to broaden the overseas market for SHR-A1811, providing high-quality treatment options for global patients and enhancing HengRui's innovative brand and international performance [3]. - The company aims to strengthen international cooperation while maintaining a focus on independent research and development, facilitating rapid transformation of research outcomes into marketable products [3].

Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology industry [1] Core Insights - The upcoming World Conference on Lung Cancer (WCLC) is expected to showcase significant advancements in innovative drugs, generating new business development expectations [1] - The A-share pharmaceutical index has increased by 3% this week and 25% year-to-date, outperforming the CSI 300 by 0.7% and 18.2% respectively [4][9] - The report highlights the strong performance of the pharmaceutical sector, particularly in innovative drugs, research services, and CXO [10][11] Industry Trends - The WCLC will take place from September 6 to September 9, 2025, in Barcelona, featuring over 1,500 presentations, with a significant number from Chinese researchers [17][18] - Chinese innovation is prominently represented, with over 400 submissions, indicating a shift towards the commercialization of innovative drugs [18][19] Stock Performance - Notable stock performances include a 69% increase for Sainuo Medical and a 94% increase for Paig Biological in the H-share market [4][9] - The report provides a detailed overview of stock performance, highlighting both top gainers and losers in the pharmaceutical sector [9][13] Recommendations - The report suggests a focus on specific sub-sectors, ranking them as follows: innovative drugs > research services > CXO > traditional Chinese medicine > medical devices > pharmacies [10] - Specific stock recommendations include companies like Bory Pharmaceutical, Singlera Genomics, and Innovent Biologics based on various therapeutic angles [11][12]

Group 1 - Ruikang Pharmaceutical's executive Li Zhe has had his detention changed to a notice of investigation, indicating a shift in the investigation phase [1] - The change from detention to a notice of investigation suggests a reduced level of coercion, highlighting the importance of internal control and compliance systems in listed companies [1] Group 2 - Zhixiang Jintai has initiated a Phase III clinical trial for GR1802 injection for allergic rhinitis, following communication with the National Medical Products Administration [2] - GR1802 is slightly behind in clinical progress compared to two other approved drugs targeting the same indication, but successful commercialization could lead to competition with Dupilumab [2] Group 3 - Rongchang Biopharmaceutical's innovative drug RC18 (Taitaxip) for primary Sjögren's syndrome has met its primary endpoint in Phase III clinical trials, marking a potential first in the global market for this indication [3] - If approved, this drug could provide a breakthrough treatment for millions of patients in China and strengthen Rongchang's position in the autoimmune field [3] Group 4 - Hengrui Medicine's SHR-A2102, a targeted antibody-drug conjugate (ADC) for Nectin-4, has received approval for clinical trials in combination with Atezolizumab for recurrent/metastatic head and neck squamous cell carcinoma [4] - There is currently only one similar product on the market, Padcev, which is projected to generate $1.949 billion in sales in 2024, indicating significant market potential for this target [4] Group 5 - BeiGene has launched the first domestic Phase III clinical trial for subcutaneous Tislelizumab, a PD-1 inhibitor, for use in combination with chemotherapy for locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma [5] - The subcutaneous formulation is becoming a competitive area for PD-1/PD-L1 inhibitors, with three other subcutaneous PD-1/L1 products already approved globally [5]

Investment Rating - The industry investment rating is "stronger than the market" (预计6个月内，行业指数表现强于市场表现5%以上) [35] Core Viewpoints - The report emphasizes the importance of multi-party collaboration in supporting the development of innovative drugs and medical devices, highlighting the integration of data, policy, and funding as essential elements for growth [4] - The report notes that recent measures from the Financial Supervisory Administration and the Medical Insurance Bureau aim to promote the development of commercial health insurance, which will provide additional support for the innovation and development of drugs and medical devices [4] Summary by Sections Industry Insights - The Medical Insurance Bureau's recent meetings have established a comprehensive support system for innovative drugs and medical devices, involving various stakeholders such as research institutions, enterprises, medical institutions, financial companies, and government departments [4] - The Financial Supervisory Administration has released measures to enhance the quality of commercial health insurance, which will further support the biopharmaceutical industry's innovation [4] Investment Strategy - The report suggests focusing on innovative pharmaceutical companies with rich pipelines, such as 恒瑞医药 (Hengrui Medicine), 百济神州 (BeiGene), and 中国生物制药 (China Biologic Products) [6] - It also highlights companies with significant single-product potential and those leading in advanced technology platforms, recommending关注 (focus on) companies like 凯莱英 (Kailaiying) and 药明康德 (WuXi AppTec) [6] Market Performance - The pharmaceutical sector experienced a decline of 0.84% last week, ranking last among 28 industries, while the Shanghai and Shenzhen 300 Index rose by 1.23% [9][21] - The report indicates that the pharmaceutical sector's valuation is currently at 30.91 times (TTM), with a premium of 37.32% compared to the overall A-shares excluding financials [27]