Group 1: Industry Developments - Shanghai has initiated the online listing for the first batch of traditional Chinese medicine centralized procurement expansion, with the application period from August 12 to August 29, 2025 [1] - The Shanghai Market Supervision Administration reported a significant decline in the illegal rate of medical advertisements over the past five years, dropping from 3.89% in 2020 to 1.57% in 2024, a decrease of approximately 60% [2] - The first FDA-approved treatment for non-cystic fibrosis bronchiectasis (NCFB), Brinsupri, has been announced by Insmed, marking a significant milestone in the treatment options available for this condition [3] - The National Medical Products Administration has received a market application for the intraocular injection of Bevacizumab, indicating progress in ophthalmic drug development [4] - Heng Rui Medicine has received approval for clinical trials of its innovative drug SHR-A2102 for the treatment of recurrent/metastatic head and neck squamous cell carcinoma [5] Group 2: Capital Market Activities - Inokang Medical Technology has started the listing guidance process with Huatai Securities, indicating its intention to go public [6] - Rejuvenation Bio announced a capital increase of 100 million yuan for its subsidiary, Shun Jing Biomedical Technology, with a share price set at 25 yuan per registered capital [7] - Innovation Medical holds a 40% stake in Bole Brain Machine, which focuses on core technology research and product design in the medical rehabilitation field [8] Group 3: Vaccine and Pharmaceutical Developments - Zhifei Biological has completed the first nationwide vaccination for its quadrivalent influenza vaccine, showcasing advancements in vaccine distribution [9] - Zhonghui Bio's quadrivalent influenza vaccine has passed the preliminary review for inclusion in the national commercial health insurance innovative drug directory [10] - BeiGene anticipates that its drug Sotukimab will receive its first global approval by the end of 2026, with multiple clinical trials underway [11] Group 4: Regulatory and Market Challenges - The re-registration application for Green Valley Pharmaceutical's mannitol sodium capsules has not been approved, posing challenges for this controversial Alzheimer's drug [12] - There have been reports of supply shortages and rising prices for the mannitol sodium capsules, indicating market pressures and patient access issues [13] - Zhaoyan New Drug's former vice chairman plans to reduce his holdings by up to 352,450 shares, reflecting personal financial needs [14]

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]

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 ...

恒瑞医药(1276.HK)涨4.11%，报78.45港元，暂成交3.8亿港元，最新市值5207亿港元。恒瑞医药公告，近日，江苏恒瑞医药股份有限公司收到国家药品监督 管理局下发的《受理通知书》，公司海曲泊帕乙醇胺片的药品上市许可申请获国家药监局受理，适应症为：适用于既往对糖皮质激素、免疫球蛋白等治疗反 应不佳的持续性及慢性原发免疫性血小板减少症(ITP)成人及≥6岁的儿童患者。 中金发研报指，国家医保局发布基本医疗保险、生育保险和工伤保险药品目录以及商保创新药目录调整初步形式审查公告，534个药品通过初步形式审查， 预期当局启动双目录机制，可为医保形成清晰分工，基本医保目录覆盖临床必需的基础药品，而商保创新目录则重点纳入未被医保覆盖、但具有重大临床价 值的高价值药品。该行建议关注恒瑞医药等股票。(格隆汇) ...

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]

消息面上，恒瑞医药发布公告，近日，公司收到国家药品监督管理局下发的《受理通知书》，公司海曲 泊帕乙醇胺片的药品上市许可申请获国家药监局受理，适应症为：适用于既往对糖皮质激素、免疫球蛋 白等治疗反应不佳的持续性及慢性原发免疫性血小板减少症(ITP)成人及≥6岁的儿童患者。 2025年3月，海曲泊帕乙醇胺片Ⅲ期临床试验(HR-TPO-ITP-Ⅲ-PED)达到了方案预设的主要研究终点。 该研究是一项在儿童和青少年原发免疫性血小板减少症患者中评价海曲泊帕乙醇胺片的有效性和安全性 的多中心、随机、双盲及开放性的Ⅲ期研究，由首都医科大学附属北京儿童医院王天有教授担任主要研 究者，共入组100例6岁及以上儿童和青少年原发免疫性血小板减少症患者。试验组在主要终点上显著优 于对照组，且长期治疗的安全性、有效性良好。 智通财经APP获悉，恒瑞医药(01276)涨超3%，截至发稿，涨3.19%，报77.75港元，成交额1.46亿港元。 ...

Core Viewpoint - Jiangsu Hengrui Medicine Co., Ltd. has received acceptance from the National Medical Products Administration for the marketing authorization application of its drug, HAIQUPOLPA Ethanolamine Tablets, aimed at treating adults and children aged 6 and above with persistent and chronic primary immune thrombocytopenia (ITP) who have had inadequate responses to previous treatments [1][2]. Drug Basic Information - Drug Name: HAIQUPOLPA Ethanolamine Tablets - Dosage Form: Tablets - Acceptance Number: CXHS2500092, CXHS2500093, CXHS2500094 - Application Stage: Marketing - Indication: For adults and children aged ≥6 years with persistent and chronic primary immune thrombocytopenia (ITP) who have had inadequate responses to corticosteroids and immunoglobulins [1][2]. Clinical Trial Information - The Phase III clinical trial (HR-TPO-ITP-III-PED) for HAIQUPOLPA Ethanolamine Tablets achieved its primary endpoint in March 2025. The study evaluated the efficacy and safety of the drug in children and adolescents with primary immune thrombocytopenia, involving 100 participants aged 6 and above. The treatment group showed significant improvement over the control group, with good long-term safety and efficacy [1][2]. Approved Indications - HAIQUPOLPA Ethanolamine Tablets have already been approved for two indications: 1. Treatment of chronic primary immune thrombocytopenia in adults with inadequate response to corticosteroids and immunoglobulins (approved in June 2021). 2. Treatment of severe aplastic anemia in adults with poor response to immunosuppressive therapy [2]. Disease Context - ITP is an acquired autoimmune bleeding disorder characterized by skin and mucosal bleeding, with severe cases leading to internal bleeding and even intracranial hemorrhage. It is the most common bleeding disorder in children and adolescents, with an annual incidence rate of 1.6-5.3 per 100,000 for primary ITP in children aged 1 month to 18 years. Approximately 80% of cases resolve within 12 months, but about 20% persist for over a year, indicating a significant clinical treatment demand [2][3]. Market Context - HAIQUPOLPA Ethanolamine Tablets are a non-peptide thrombopoietin receptor (TPO-R) agonist that promotes platelet production. Similar products available internationally include Eltrombopag, Avatrombopag, and Lusutrombopag. The global sales of these similar products are approximately $2.59 billion. In China, Eltrombopag was approved in 2017, Avatrombopag in 2020, and Lusutrombopag in 2023 [3][4].

Core Viewpoint - Heng Rui Medicine's subsidiary Suzhou Shengdiya Biopharmaceutical Co., Ltd. and Shanghai Shengdi Medicine Co., Ltd. have had their injectable drugs SHR-A1811 and Adalimumab included in the National Medical Products Administration's list of proposed breakthrough therapies, marking the ninth inclusion for SHR-A1811 [1] Group 1 - The injectable SHR-A1811 targets HER2-expressing tumor cells, inducing apoptosis through a mechanism involving toxin release in lysosomes [1] - Adalimumab 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 [1]

Core Viewpoint - Heng Rui Medicine has received acceptance from the National Medical Products Administration for its drug application of Haequparib Ethanolamine Tablets, aimed at treating patients with chronic immune thrombocytopenia (ITP) who have had poor responses to previous treatments [1] Group 1 - The drug Haequparib Ethanolamine Tablets is an oral non-peptide thrombopoietin receptor (TPO-R) agonist that promotes platelet production by activating the STAT and MAPK signaling pathways [1] - The drug has already been approved for two indications prior to this application [1] - The target patient population includes adults and children aged 6 years and older with persistent and chronic primary immune thrombocytopenia [1]

Core Viewpoint - E Fund Healthcare Industry Mixed A Fund (110023) has shown significant performance with a recent net value of 4.5530 CNY, despite a slight decline of 1.73% [1] Performance Summary - The fund's one-month return is 12.81%, ranking 628 out of 4566 in its category [1] - Over the past six months, the fund has achieved a return of 48.74%, ranking 108 out of 4413 [1] - Year-to-date, the fund's return stands at 49.47%, with a ranking of 158 out of 4375 [1] Holdings Summary - The top ten stock holdings of E Fund Healthcare Industry Mixed A account for a total of 58.14%, with the following key positions: - Heng Rui Medicine: 7.39% - Rejing Biology: 7.00% - Xinlitai: 6.73% - BeiGene-U: 6.47% - Haizhi Science: 6.00% - Nocren Health-U: 5.21% - Yipinhong: 5.08% - Kelun Pharmaceutical: 5.07% - Shutaishen: 5.05% - Baili Tianheng: 4.14% [1] Fund Details - E Fund Healthcare Industry Mixed A was established on January 28, 2011, and as of June 30, 2025, it has a total scale of 3.944 billion CNY [1] - The fund manager is Yang Zhenshao, who holds a PhD in Science and has experience as an investment manager, industry researcher, and assistant fund manager at E Fund [1]