证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-165 批准的适应症：本品配合饮食控制和运动，用于经盐酸二甲双胍治疗血糖控 制不佳的成人 2 型糖尿病患者改善血糖控制。 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 近日，江苏恒瑞医药股份有限公司（以下简称"公司"）子公司山东盛迪医 药有限公司收到国家药品监督管理局（以下简称"国家药监局"）的通知，批准 公司恒格列净瑞格列汀二甲双胍缓释片（Ⅰ）、（Ⅱ）（HR20031 片）上市，该 产品是中国首个自主研发的口服降糖三药联合固定复方制剂，现将相关情况公告 如下： 一、药品的基本情况 药品名称：恒格列净瑞格列汀二甲双胍缓释片（Ⅰ）、（Ⅱ） 剂型：片剂 规格：5/50/750mg、10/100/1000mg 注册分类：化学药品 2.3 类 受理号：CXHS2300099、CXHS2300100 处方药/非处方药：处方药 江苏恒瑞医药股份有限公司 关于获得药品注册批准的公告 [1]. IDF Diabetes Atlas 11th edition. https:/ ...

Core Viewpoint - Heng Rui Medicine (600276) has received approval from the National Medical Products Administration for its subsidiary Shandong Shengdi Medicine to launch HR20031 tablets, a fixed-dose combination of three oral hypoglycemic agents, marking a significant advancement in diabetes treatment in China [1] Product Details - HR20031 tablets are the first self-developed oral hypoglycemic combination product in China, available in specifications of 5/50/750mg and 10/100/1000mg [1] - The product is classified as a chemical drug category 2.3 and is a prescription medication [1] - It is indicated for adults with type 2 diabetes who have inadequate blood sugar control despite treatment with metformin, in conjunction with diet and exercise [1] Mechanism and Market Position - The product utilizes three different mechanisms to lower blood sugar, simplifying the medication regimen and potentially improving patient adherence [1] - There are currently no similar products approved in China, while the international equivalent is TRIJARDY XR [1] R&D Investment - The cumulative research and development investment for HR20031 tablets has reached approximately 189.24 million yuan [1] Production and Sales Uncertainty - The company has indicated that there are uncertainties associated with the production and sales of the drug, advising investors to be cautious [1]

Core Insights - The announcement highlights that the subsidiary Shandong Shengdi Pharmaceutical has received approval from the National Medical Products Administration for the launch of a new oral diabetes medication, HR20031, which is the first self-developed fixed-dose combination of three antidiabetic drugs in China [1] Company Summary - The approved product, HR20031, is a combination of empagliflozin, linagliptin, and metformin, aimed at improving blood sugar control in adult patients with type 2 diabetes who have inadequate glycemic control with metformin alone [1] - The product is available in two specifications: 5/50/750 mg and 10/100/1000 mg [1] - The total research and development investment for this product has reached approximately 189 million yuan [1] Industry Summary - Currently, there are no similar products approved for market in China, indicating a unique position for the company in the diabetes treatment market [1]

Core Insights - The Hang Seng Healthcare Index has shown a positive trend, with notable increases in constituent stocks such as Kangnate Optical and WuXi AppTec, indicating a robust performance in the healthcare sector [2][8] - The upcoming launch of the Hang Seng Biotechnology Index futures on November 28 is expected to provide hedging and incremental tools for the H-share biotech sector [7] - The 11th round of national centralized procurement (VBP) bidding is scheduled for October 27, introducing uncertainty regarding pricing and product selection [8] Market Performance - As of October 24, 2025, the Hang Seng Healthcare ETF has risen by 0.46%, with a recent price of 0.66 yuan and a 3-month cumulative increase of 2.02% [2][11] - The Hong Kong Stock Connect Innovative Drug Selection Index has increased by 0.19%, with significant gains in stocks like Rongchang Bio and Sanofi [4] - The Medical 50 ETF has also seen a rise of 0.16%, with a recent price of 0.62 yuan and a 3-month cumulative increase of 4.36% [7][13] Liquidity and Trading Activity - The Hang Seng Healthcare ETF recorded a turnover rate of 10.25% with a trading volume of 703 million yuan, indicating active market participation [2][12] - The Hong Kong Innovative Drug Selection ETF had a turnover rate of 12.51% and a trading volume of 61.91 million yuan, reflecting a vibrant trading environment [5] - The Medical 50 ETF had a turnover rate of 0.61% with a trading volume of 1.0073 million yuan, showing lower liquidity compared to the other ETFs [7] Company Performance - Sanofi's Q3 performance was impressive, with a revenue of 1.116 billion yuan, a year-on-year increase of 18.8%, and a net profit of 399 million yuan, up 71.15% [8] - The focus on "outbound + BD" strategies is expected to drive growth in the innovative drug sector, with a concentration of BD events typically occurring in Q4 [9][10] ETF Overview - The Hang Seng Healthcare ETF has a total size of 6.777 billion yuan, ranking in the top third among comparable funds [11] - The Hong Kong Innovative Drug Selection ETF closely tracks the performance of the Hang Seng Hong Kong Stock Connect Innovative Drug Selection Index, focusing on leading innovative drug companies [12] - The Medical 50 ETF tracks the CSI Medical 50 Index, representing the top 50 companies in the pharmaceutical and healthcare sector [13]

Core Viewpoint - Antibody-drug conjugates (ADCs) targeting TROP-2 show promise in treating advanced or metastatic solid tumors, demonstrating good anti-tumor activity and manageable safety profiles [2][4][8]. Group 1: TROP-2 and ADC Development - TROP-2 is a member of the epithelial cell adhesion molecule family, frequently overexpressed in various epithelial cancers while showing low or undetectable levels in normal tissues, making it a suitable target for ADCs [1]. - The development of several ADCs targeting TROP-2 has been prompted by its role in cancer cell proliferation, invasion, metastasis, and self-renewal, often associated with aggressive disease and poor prognosis [1]. Group 2: SHR-A1921 Clinical Study - The study published in Cancer Cell reports on the first-in-human phase 1 trial of SHR-A1921, an ADC developed by Heng Rui Medicine, targeting TROP-2 in patients with advanced or metastatic solid tumors [2][3]. - SHR-A1921 consists of a humanized TROP-2 IgG1 monoclonal antibody, a cleavable GGFG peptide linker, and a DNA topoisomerase I inhibitor, designed to enhance stability and minimize premature release of the cytotoxic payload [3]. Group 3: Safety and Efficacy Results - In the trial, 132 patients (33.8%) experienced grade ≥3 treatment-related adverse events, with oral mucositis being the most common, affecting 57 patients (14.6%) [4]. - The overall objective response rate was 24.8%, with response rates in specific cancer types ranging from 18.2% to 43.1%, indicating variable efficacy across different cohorts [4]. - No significant correlation was found between TROP-2 expression levels and treatment outcomes, suggesting that other factors may influence efficacy [4]. Group 4: Optimal Dosage and Future Directions - SHR-A1921 demonstrated the best efficacy and safety balance at a dose of 3.0 mg/kg administered every three weeks, making it a candidate for further clinical trials [7][8].

Core Viewpoint - The Hong Kong innovative drug concept stocks have shown strong performance, with several companies experiencing significant gains in their stock prices [1] Group 1: Stock Performance - WuXi AppTec (药明合联) increased by 6% [1] - WuXi Biologics (药明生物) and 3SBio (三生制药) both rose by over 3% [1] - Other companies such as Innovent Biologics (信达生物), Genscript Biotech (巨子生物), and Hengrui Medicine (恒瑞医药) saw increases of over 2% [1]

Policy Developments - Liaoning Province will implement direct payment of maternity allowances to employees starting November 1, 2025, enhancing convenience and satisfaction for the public [1] Drug and Device Approvals - Hengrui Medicine's subsidiary received clinical trial approval for injection of Rukang Qutuzumab, aimed at treating advanced non-small cell lung cancer [2] - Jibeier received approval for the market application of the chemical raw material drug, Gatifloxacin, which is expected to support its production needs [3] Financial Reports - Ping An Good Doctor reported a 13.6% increase in revenue to 3.725 billion, with a net profit of 216 million, up 45.7% year-on-year [4] - Te Yi Pharmaceutical achieved a 985% increase in net profit, reporting 65.22 million in the first three quarters, with significant growth in traditional Chinese medicine sales [5] - Lijun Pharmaceutical reported a revenue of 9.116 billion, a slight increase of 0.38%, with a net profit of 1.754 billion, up 4.86% [6] Capital Market - In Shanghai's Baoshan District, 17 key biopharmaceutical projects were signed, with total investments exceeding 2 billion, aimed at enhancing the local biopharmaceutical industry [7][8] Industry Developments - Baiyang Pharmaceutical signed a cooperation agreement with Peking University International Hospital to establish a radiosurgery treatment center, enhancing access to high-quality medical resources [10] - Qiang Brain Technology established a new company in Chengdu focusing on AI-related businesses, including medical devices and internet data services [11] Regulatory Actions - The Shanghai Stock Exchange issued a regulatory warning to Zhejiang Dongya Pharmaceutical for discrepancies in the use of raised funds, highlighting the responsibility of the company's former board secretary [12]

Core Viewpoint - Heng Rui Medicine announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of SHR-A1811, a drug for HER2-positive breast cancer treatment [1] Group 1: Clinical Trial Approval - The approval allows for a clinical trial comparing SHR-A1811 with a combination of docetaxel, carboplatin, trastuzumab, and pertuzumab for neoadjuvant treatment of early or locally advanced HER2-positive breast cancer [1] Group 2: Mechanism of Action - SHR-A1811 works by binding to HER2-expressing tumor cells and inducing apoptosis through a mechanism involving the release of toxins within the tumor cells' lysosomes [1]

Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of injectable SHRA1811, a drug targeting HER2-positive breast cancer [1][2]. Group 1: Clinical Trial Approval - The clinical trial application for injectable SHRA1811 was accepted on July 31, 2025, and meets the requirements for drug registration, allowing the initiation of clinical trials [1]. - The trial will be a randomized, open-label, multi-center Phase III study comparing SHRA1811 with Docetaxel + Carboplatin + Trastuzumab + Pertuzumab for neoadjuvant treatment of early or locally advanced HER2-positive breast cancer [1]. Group 2: Product Mechanism and Market Context - Injectable SHRA1811 binds to HER2-expressing tumor cells, inducing apoptosis through the release of toxins in the lysosomes of tumor cells, which enhances anti-tumor efficacy [2]. - Similar products currently available in the market include Roche's Ado-trastuzumab emtansine and AstraZeneca's Fam-trastuzumab deruxtecan, both of which are already marketed in China [2]. - The global sales of similar products are projected to reach approximately $6.557 billion in 2024, with a cumulative R&D investment of about 141.475 million yuan for injectable SHRA1811 [2].

Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of injectable Rikan Trastuzumab, marking a significant step in the development of new cancer therapies [1][2]. Group 1: Clinical Trial Approval - The clinical trial application for injectable Rikan Trastuzumab (SHR-A1811) was approved, allowing for a Phase III study comparing it to a combination of Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab for the treatment of early or locally advanced HER2-positive breast cancer [1][2]. - The approval was based on compliance with the requirements for drug registration as per the Drug Administration Law of the People's Republic of China [1]. Group 2: Product Mechanism and Market Context - Injectable Rikan Trastuzumab works by binding to HER2-expressing tumor cells, inducing apoptosis through the release of toxins within the cells [2]. - Similar products already on the market include Roche's Ado-trastuzumab emtansine and AstraZeneca's Fam-trastuzumab deruxtecan, both of which have been approved in China [2]. - The global sales of similar products are projected to reach approximately $6.557 billion in 2024, indicating a robust market for HER2-targeted therapies [2]. - The cumulative R&D investment for injectable Rikan Trastuzumab has reached approximately 141.475 million yuan [2].