Core Viewpoint - The announcement highlights that the company has received approval for its innovative oral diabetes medication, marking a significant milestone in the pharmaceutical industry in China [1] Group 1 - The company, Shandong Shengdi Pharmaceutical Co., Ltd., a subsidiary of Heng Rui Medicine, has received notification from the National Medical Products Administration [1] - The approved product is Henggeli Jining Regaglitin Metformin Sustained-Release Tablets (HR20031), which is the first self-developed oral hypoglycemic combination drug in China [1] - This product represents a significant advancement in diabetes treatment options available in the Chinese market [1]

Core Viewpoint - Heng Rui Medicine's subsidiary, Shandong Shengdi Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the launch of its oral hypoglycemic drug, HR20031, which is the first self-developed fixed-dose combination of three oral hypoglycemic agents in China [1] Company Summary - The approved product, HR20031, is a combination of empagliflozin, linagliptin, and metformin extended-release tablets [1] - It is indicated for adult patients with type 2 diabetes who have inadequate blood sugar control with metformin hydrochloride, in conjunction with diet and exercise [1] - This marks a significant milestone as there are currently no similar products approved for sale in the domestic market [1]

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]