Group 1: Regulatory Developments - The National Healthcare Security Administration (NHSA) is soliciting public opinions on the "Guidelines for Real-World Comprehensive Value Assessment of Drugs" to establish a unified national evaluation system [1] - Huadong Medicine's subsidiary received FDA approval for clinical trials of DR10624, a novel drug targeting metabolic-associated fatty liver disease [1] - Fosun Pharma's subsidiary has had its drug registration application for erythromycin lactobionate injection accepted by the National Medical Products Administration [2] - Stone Pharmaceutical's new drug for hypertension has received FDA approval for clinical trials in the U.S. [3] - Zhi Mei Ru Kang's siRNA therapy for ALS has entered Phase 2 clinical trials [4] Group 2: Market and Corporate Developments - Cap Bio's major shareholders have increased their stake from 31.52% to 33.05% following capital changes and share buybacks [5] - Bluestar Medical's product is expected to be selected for national centralized procurement of drug-coated balloons, which could enhance its market presence [7] - NVIDIA and Eli Lilly have announced a $1 billion collaboration to establish an AI innovation lab focused on drug discovery and development [8] - Dr. Wang Qiang has transitioned from Xiansheng Pharmaceutical to Ganli Pharmaceutical as Senior Vice President and Chief Strategy Officer [9] Group 3: Quality Control and Safety - China Resources Double Crane has addressed recent quality issues with sodium bicarbonate injection products, clarifying that non-compliance was due to packaging issues during transport [10]

Core Viewpoint - Gan & Lee Pharmaceuticals has received marketing authorization from the European Commission for its insulin glargine injection (brand name: Ondibta?), which is intended for the treatment of diabetes in adults, adolescents, and children aged 2 years and older [1][3]. Group 1: Product Information - The insulin glargine injection is a long-acting insulin that requires subcutaneous injection once daily, providing a stable blood concentration and effective glucose control for 24 hours [1][4]. - The product is available in a pre-filled pen format with a concentration of 100 units/ml in a 3ml vial [4]. Group 2: Market Context - According to the International Diabetes Federation, there are approximately 588.7 million diabetes patients aged 20-79 globally, with 65.6 million in Europe, representing 11.1% of the global patient population [2]. - The total medical expenditure due to diabetes is estimated at $193 billion globally, with an average annual expenditure of $2,951 per patient [2]. - Sanofi is currently the main supplier of insulin glargine in Europe, with projected global sales of €2.855 billion (approximately $2.989 billion) for 2024, including €819 million (approximately $857 million) in Europe [2]. Group 3: Financial Investment - As of September 30, 2025, Gan & Lee Pharmaceuticals has invested a total of ¥936 million in research and development for the insulin glargine project [3].

北京商报讯（记者 丁宁）1月14日晚间，甘李药业（603087）发布公告称，公司及其欧洲全资子公司甘 李药业欧洲有限责任公司于近日收到欧盟委员会（European Commission） 通知，公司产品甘精胰岛素 注射液 （商品名：Ondibta） 获得在欧盟、 冰岛、列支敦士登和挪威的上市许可，适用于治疗成人、青 少年和2岁及以上儿童糖尿病。 ...

Core Viewpoint - Ganli Pharmaceutical has received marketing authorization from the European Commission for its insulin product, Ondibta®, which is intended for the treatment of diabetes in adults, adolescents, and children aged 2 years and older [1] Group 1 - Ganli Pharmaceutical and its wholly-owned subsidiary in Europe have been granted approval for Ondibta® in the EU, Iceland, Liechtenstein, and Norway [1] - Ondibta® is a long-acting insulin that requires subcutaneous injection once daily, providing a stable blood glucose control for 24 hours [1] - The product is characterized by its long duration of action, stable blood concentration without peaks, and smooth glucose control [1]

格隆汇1月14日丨甘李药业(603087.SH)公布，公司及其欧洲全资子公司甘李药业欧洲有限责任公司 （Gan & Lee Pharmaceuticals Europe GmbH，以下简称"甘李欧洲"）于近日收到欧盟委员会（European Commission，简称EC）通知，公司产品甘精胰岛素注射液（商品名：Ondibta®）获得在欧盟、冰岛、 列支敦士登和挪威的上市许可，适用于治疗成人、青少年和2 岁及以上儿童糖尿病。 甘精胰岛素为基础长效胰岛素，每天皮下注射一次，降糖作用时间持续24小时。其具有作用时间长、血 药浓度平稳无峰和平稳控糖的特点。 ...

甘精胰岛素为基础长效胰岛素，每天皮下注射一次，降糖作用时间持续24小时。其具有作用时间长、血 药浓度平稳无峰和平稳控糖的特点。 格隆汇1月14日丨甘李药业(603087.SH)公布，公司及其欧洲全资子公司甘李药业欧洲有限责任公司 （Gan & Lee Pharmaceuticals Europe GmbH，以下简称"甘李欧洲"）于近日收到欧盟委员会（European Commission，简称EC）通知，公司产品甘精胰岛素注射液（商品名：Ondibta®）获得在欧盟、冰岛、 列支敦士登和挪威的上市许可，适用于治疗成人、青少年和2 岁及以上儿童糖尿病。 ...

证券代码：603087 证券简称：甘李药业 公告编号：2026-004 甘李药业股份有限公司 关于甘精胰岛素注射液获得欧盟委员会上市许可的 公告 的糖尿病患者达 6560 万人，约占全球患者规模的 11.1%；因糖尿病导致的总医 疗支出为 1.93 千亿美元（全球总支出为 1.015 万亿美元），患者人均糖尿病相关 年度支出金额为 2,951 美元；在欧洲地区 20-79 岁的成年人口中，糖尿病的发病 率为 9.8%。 甘李药业股份有限公司（以下简称"公司"、"甘李药业"）及其欧洲全资 子公司甘李药业欧洲有限责任公司（Gan & Lee Pharmaceuticals Europe GmbH， 以下简称"甘李欧洲"）于近日收到欧盟委员会（European Commission，简称 EC）通知，公司产品甘精胰岛素注射液（商品名：Ondibta®）获得在欧盟、冰岛、 列支敦士登和挪威的上市许可，适用于治疗成人、青少年和 2 岁及以上儿童糖尿 病。现将相关情况公告如下： 一、药物基本情况 二、药物其他相关情况 甘精胰岛素为基础长效胰岛素，每天皮下注射一次，降糖作用时间持续 24 小时。其具有作用时间长、血药浓度平 ...

Core Viewpoint - The company and its wholly-owned subsidiary in Europe have received marketing authorization from the European Commission for its insulin injection product, Ondibta®, which is intended for diabetes treatment [1] Group 1: Product Development and Approval - The product Ondibta® has been granted marketing authorization in the EU, Iceland, Liechtenstein, and Norway [1] - The company has invested a total of 936 million yuan in research and development for this project as of September 30, 2025 [1] Group 2: Market Considerations - The expansion progress and sales scale of the product in the aforementioned regions are subject to uncertainties due to market demand, policies, exchange rates, and competition [1]

Core Viewpoint - The company has received marketing authorization for its long-acting insulin product, Ondibta®, in the EU and select European countries, which is expected to enhance its international market presence [1] Group 1: Product Approval - The company's European subsidiary has been granted marketing authorization by the European Commission for Ondibta®, a long-acting insulin injection [1] - Ondibta® is indicated for the treatment of diabetes in adults, adolescents, and children aged 2 years and older [1] - The product provides a stable blood concentration and maintains blood sugar control for up to 24 hours [1] Group 2: Market Expansion - The approval is a significant step for the company in expanding its international market footprint [1] - Future sales of the product may be influenced by market demand, regulatory environment, currency fluctuations, and competition [1]

Core Viewpoint - 甘李药业 has shown positive stock performance and financial growth, indicating a strong position in the biopharmaceutical industry, particularly in the production of insulin analogs and related products [1][2]. Financial Performance - As of September 30, 2025, 甘李药业 achieved a revenue of 30.47 billion yuan, representing a year-on-year growth of 35.73% [2]. - The net profit attributable to shareholders for the same period was 8.18 billion yuan, reflecting a year-on-year increase of 61.32% [2]. - The company has distributed a total of 16.12 billion yuan in dividends since its A-share listing, with 10.18 billion yuan distributed over the past three years [3]. Stock Market Activity - On January 14, 甘李药业's stock price increased by 2.01%, reaching 71.51 yuan per share, with a trading volume of 2.42 billion yuan and a turnover rate of 0.61% [1]. - The stock has risen by 5.05% year-to-date, with a 0.03% increase over the last five trading days, a 6.64% increase over the last 20 days, and a 2.79% increase over the last 60 days [1]. Shareholder Information - The number of shareholders as of September 30, 2025, was 94,700, an increase of 22.53% from the previous period [2]. - The average number of circulating shares per shareholder was 5,889, a decrease of 17.81% from the previous period [2]. - Major shareholders include Hong Kong Central Clearing Limited, which holds 8.0042 million shares, an increase of 494,300 shares from the previous period [3].