Group 1 - Company subsidiary Suzhou Shengdiya Biopharmaceutical Co., Ltd., Shanghai Hengrui Medicine Co., Ltd., and Shanghai Shengdi Medicine Co., Ltd. received approval from the National Medical Products Administration for clinical trials of SHR-A2102 and Adebeli monoclonal antibody injection [1] - SHR-A2102 is a targeted antibody-drug conjugate (ADC) developed by the company, targeting Nectin-4, with a payload of topoisomerase I inhibitor (TOP1i) [1] - Nectin-4 is highly expressed in tumors, correlating with tumor progression and poor prognosis; currently, there is one similar product approved globally, Enfortumab vedotin, with projected global sales of approximately $1.949 billion in 2024 [1] Group 2 - Adebeli monoclonal antibody injection is a humanized anti-PD-L1 monoclonal antibody that reactivates the immune system's anti-tumor activity by blocking the PD-1/PD-L1 pathway [2] - Adebeli monoclonal antibody injection (brand name: Ailili) was approved for use in first-line treatment of extensive-stage small cell lung cancer in March 2023; similar products include Atezolizumab, Avelumab, and Durvalumab, with combined projected global sales of approximately $9.648 billion in 2024 [2] - The cumulative R&D investment for Adebeli monoclonal antibody injection is approximately 901.3 million yuan [2]

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-115 江苏恒瑞医药股份有限公司 关于获得药物临床试验批准通知书的公告 药品名称 注射用 SHR-A2102 阿得贝利单抗注射液 剂型 注射剂 申请事项 临床试验 受理号 CXSL2500403 CXSL2500402 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 5 月 20 日受理的注射用 SHR-A2102、阿得贝利单抗注射 液符合药品注册的有关要求，同意开展临床试验。具体为：注射 用 SHR-A2102 联合阿得贝利单抗注射液联合或不联合其它抗肿瘤 治疗在复发/转移性头颈鳞癌受试者的多中心、开放Ⅰb/Ⅱ期临 床研究。 一、药品的基本情况 有 1 款同类产品获批上市，为 Enfortumab vedotin（商品名：Padcev），经查 询 EvaluatePharma 数据库，2024 年该产品全球销售额约为 19.49 亿美元。截至 目前，注射用 SHR-A2102 相关项目累计研发投入约 20,547 万元。 阿得贝利单抗注射液是公司自主研发的人源化抗 PD-L1 单克隆抗体，能通过 特异性结合 P ...

Core Viewpoint - Heng Rui Medicine (600276) announced on August 13 that its subsidiaries, Suzhou Shengdiya Biopharmaceutical, Shanghai Heng Rui Medicine, and Shanghai Shengdi Medicine, received approval from the National Medical Products Administration for the clinical trial of SHR-A2102 and Adebeli monoclonal antibody injection, which will commence shortly [1] Group 1 - The approval includes the clinical trial notification for SHR-A2102 and Adebeli monoclonal antibody injection [1] - The clinical trials are expected to begin in the near future [1]

每经AI快讯，8月13日，恒瑞医药（600276）(600276.SH)公告称，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、上海盛迪医药有限公司收到国家药监局核准签发关于注射用SHR-A2102、 阿得贝利单抗注射液的《药物临床试验批准通知书》，将于近期开展临床试验。注射用SHR-A2102为公 司自主研发的靶向Nectin-4的抗体药物偶联物(ADC)，阿得贝利单抗注射液是公司自主研发的人源化抗 PD-L1单克隆抗体。 ...

Core Viewpoint - Heng Rui Medicine announced that its subsidiaries Suzhou Shengdiya Biopharmaceutical Co., Ltd., Shanghai Heng Rui Medicine Co., Ltd., and Shanghai Shengdi Medicine Co., Ltd. have received approval from the National Medical Products Administration for clinical trials of SHR-A2102 and Adebeli monoclonal antibody injection [1] Group 1 - SHR-A2102 is a targeted antibody-drug conjugate (ADC) developed independently by the company, targeting Nectin-4 [1] - Adebeli monoclonal antibody injection is a humanized anti-PD-L1 monoclonal antibody developed by the company [1] - The clinical trials for these drugs will commence shortly [1]

Group 1 - Heng Rui Medicine (1276.HK) shares increased by 4.11%, reaching HKD 78.45, with a trading volume of HKD 380 million and a market capitalization of HKD 520.7 billion [1] - The company received a "Notice of Acceptance" from the National Medical Products Administration for its drug application of Haqubopar Ethanolamine Tablets, which is indicated for adults and children aged 6 and above with persistent and chronic primary immune thrombocytopenia (ITP) who have had poor responses to previous treatments [1] - CICC's research report indicates that the National Healthcare Security Administration has released a preliminary review announcement for the adjustment of the drug catalog for basic medical insurance, maternity insurance, and work-related injury insurance, with 534 drugs passing the preliminary review [1] Group 2 - The expected implementation of a dual catalog mechanism by authorities will provide clear delineation for medical insurance, with the basic medical insurance catalog covering essential clinical drugs, while the commercial insurance innovation catalog will focus on high-value drugs not covered by medical insurance but with significant clinical value [1] - CICC recommends paying attention to stocks like Heng Rui Medicine in light of these developments [1]

Core Insights - Heng Rui Medicine has received clinical trial approval for two drugs, SHR-2173 and HRS-9821, from the National Medical Products Administration, indicating progress in its innovative drug development pipeline [1][2] Group 1: Drug Development - SHR-2173 is a self-developed biological product targeting abnormally activated immune cells, aimed at treating primary membranous nephropathy, with a total R&D investment of approximately 64.07 million yuan [1] - HRS-9821 is a small molecule PDE3/PDE4 inhibitor intended for the maintenance treatment of chronic obstructive pulmonary disease (COPD), with a total R&D investment of about 38.43 million yuan [1] - The global market for similar products includes Ensifentrine, which is expected to generate sales of approximately 42 million dollars in 2024 [1] Group 2: Company Strategy and Market Position - Heng Rui Medicine has been focusing on innovative R&D, having obtained approvals for 23 first-class innovative drugs and 4 second-class new drugs in China, with over 90 self-innovated products currently in clinical development [2] - The company has expanded its research into various therapeutic areas, including metabolism, cardiovascular diseases, immunology, respiratory diseases, and neuroscience [2] - Heng Rui Medicine's recent listing on the Hong Kong Stock Exchange marks a significant step in its internationalization strategy, enhancing its global brand influence and attracting foreign investment [3]

Core Viewpoint - The recent approvals of domestic gout drugs indicate a revitalization of the relatively overlooked gout treatment market, highlighting the potential for innovation in this area due to unmet clinical needs and minimal investment from multinational corporations (MNCs) [1][2][21]. Industry Overview - The global prevalence of gout is rising, yet MNCs have been conservative in their investments in this field, unlike the diabetes sector, which has seen multiple successful drug launches [3][4]. - The market for gout medications is projected to reach approximately $3.3 billion by 2024, significantly smaller than the diabetes drug market, which is expected to exceed $100 billion [3][4]. Clinical Demand - There is a pressing clinical need for effective gout treatments, as many patients experience poor adherence to existing therapies, with over half stopping medication within six months of achieving target uric acid levels [3][4]. - Current treatments have significant safety concerns, leading to a high demand for new therapies that can address these issues [5][6][9]. Recent Developments - The approval of Fuxin Qibai monoclonal antibody marks a significant milestone as the first domestically developed IL-1β inhibitor for acute gouty arthritis, offering a long-acting treatment option [11][12]. - Fuxin Qibai has demonstrated rapid pain relief and a significant reduction in the risk of recurrence, with no serious adverse events reported [12][13]. Market Dynamics - The domestic market for gout treatments is characterized by a lack of MNC involvement, creating opportunities for local companies to establish a foothold and innovate [14][21]. - Several domestic pipelines are advancing, focusing on safety and efficacy, with multiple candidates in late-stage clinical trials [16][20]. Competitive Landscape - The URAT1 inhibitor segment is particularly competitive, with numerous domestic candidates showing promising safety profiles and efficacy [16][18]. - Companies like Hengrui and Yipin Hong are making significant progress with their URAT1 inhibitors, with Hengrui's SHR4640 showing superior results in clinical trials compared to existing treatments [18][20]. Future Outlook - The domestic gout treatment market is expected to grow as companies leverage unmet clinical needs and safety concerns of existing therapies to introduce innovative solutions [21]. - The increasing prevalence of hyperuricemia and gout in China, with an estimated 26 million gout patients, presents a substantial market opportunity for domestic pharmaceutical companies [21].

Core Insights - The National Healthcare Security Administration (NHSA) announced the preliminary review results for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance drug catalog, revealing 534 drugs passed the review, with 121 drugs included in the commercial insurance innovative drug catalog [1][2] Group 1: Drug Catalog Adjustments - The 2025 adjustments mark the first implementation of a "dual-track system," focusing on basic insurance for essential drugs while providing supplementary coverage for "exclusive new drugs" or "rare disease medications" through the commercial insurance innovative drug catalog [1][2] - A total of 718 submissions were received for the basic insurance catalog, with 534 approved, while 141 submissions were made for the commercial insurance catalog, with 121 approved [1][2] - The number of drug names excluded from the catalog increased from 249 in 2024 to 310 [1] Group 2: CAR-T Therapies - CAR-T therapies, which are personalized cancer treatments, have gained attention due to their high costs, with prices exceeding 1 million yuan per injection for several products [1][2] - The commercial insurance catalog will include CAR-T therapies in upgraded coverage plans in various regions, with Shanghai's "Huibao" covering up to 500,000 yuan for patients [2] - Over the past three years, more than 80 lymphoma patients have received treatment through this channel, with total reimbursements exceeding 40 million yuan [2] Group 3: Drug Composition and Approval Process - The approved drugs are predominantly Western medicines, with over 98% representation, and only two traditional Chinese medicines included [3] - Notable cancer drugs include those from major pharmaceutical companies, alongside innovative domestic products like gene therapy for hemophilia B and PD-1 monoclonal antibodies [3] - Passing the preliminary review does not guarantee inclusion in the final catalog, as further expert evaluations and price negotiations are required [3][4] Group 4: Submission Conditions - Unique drugs meeting specific criteria can apply for both the commercial insurance innovative drug catalog and the basic catalog simultaneously [4]

Core Viewpoint - Heng Rui Medicine (01276) has seen a stock price increase of over 3%, currently at HKD 77.75, with a trading volume of HKD 146 million, following the acceptance of its drug application by the National Medical Products Administration (NMPA) [1] Group 1: Company Developments - Heng Rui Medicine has received the "Acceptance Notification" from the NMPA for its drug application of Haequbopag Ethanolamine Tablets, which is indicated for adults and children aged 6 and above with persistent and chronic primary immune thrombocytopenia (ITP) who have had poor responses to previous treatments [1] - The Phase III clinical trial (HR-TPO-ITP-III-PED) for Haequbopag Ethanolamine Tablets achieved its primary research endpoint as planned in March 2025, demonstrating significant efficacy and safety in children and adolescents with primary immune thrombocytopenia [1] - The study was a multicenter, randomized, double-blind, and open-label Phase III trial, led by Professor Wang Tianyou from Beijing Children's Hospital, involving 100 participants aged 6 and above [1]