ZHONG LUN 中倫律師事務所 特殊的普通合伙 Limited Liability Partnership 北京市中伦律师事务所 关于甘李药业股份有限公司 2025年第一次临时股东大会的 法律意见书 二〇二五年十一月 · 深圳· 广州· 武汉· 成都· 重庆·青岛·杭州· 南京· 海口·东京·香港·伦敦· 纽约· 洛杉矶· 旧金山 北京 · 阿拉木图 22-24/F & 27-3 北京市中伦律师事务所 关于甘李药业股份有限公司 2025年第一次临时股东大会的 法律意见书 致:甘李药业股份有限公司 根据《中华人民共和国公司法》(以下简称"《公司法》")、《中华人民共 和国证券法》(以下简称"《证券法》")、中国证券监督管理委员会发布的《上 市公司股东会规则》(以下简称"《股东会规则》")的规定,北京市中伦律师 事务所(以下简称"本所")接受甘李药业股份有限公司(以下简称"公司") 的委托,指派本所律师出席公司 2025年第一次临时股东大会(以下简称"本次 股东大会"),对本次股东大会的相关事项进行见证并出具法律意见。 为出具本法律意见书,本所律师审查了公司提供的相关文件,该等文件包括 但不限于: 1.现行有 ...

证券代码：603087 证券简称：甘李药业 公告编号：2025-078 甘李药业股份有限公司 2025年第一次临时股东大会决议公告 (三)出席会议的普通股股东和恢复表决权的优先股股东及其持有股份情况： | 1、出席会议的股东和代理人人数 | 631 | | --- | --- | | 2、出席会议的股东所持有表决权的股份总数（股） | 261,261,375 | | 3、出席会议的股东所持有表决权股份数占公司有表决权股 | | | 份总数的比例（%） | 43.7400 | (四)表决方式是否符合《公司法》及《公司章程》的规定，大会主持情况等。 本次股东大会由公司董事会召集，会议召集与召开程序符合《中华人民共和 国公司法》及本公司章程的相关规定，合法有效。依据本公司章程的规定，本次 会议由公司董事长陈伟先生主持。 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。 重要内容提示： 本次会议是否有否决议案：无 一、 会议召开和出席情况 (一)股东大会召开的时间：2025 年 11 月 17 日 (二)股东大会召开的地点：北京市通州区 ...

Core Viewpoint - The Medical Health Index (980016) closed at 6572.66 points, down 0.65%, with a trading volume of 23.397 billion yuan and a turnover rate of 0.87% on November 14 [1] Group 1: Index Performance - Among the index constituents, 16 stocks rose while 33 stocks fell, with Ganli Pharmaceutical leading the gainers at a 2.0% increase and Yirui Technology leading the decliners at a 3.74% decrease [1] - The top ten constituents of the Medical Health Index include major companies such as WuXi AppTec, Hengrui Medicine, and Mindray Medical, with respective weights of 13.66%, 11.00%, and 7.57% [1] Group 2: Market Capitalization and Stock Prices - The total market capitalization of the top ten constituents ranges from 553.09 billion yuan for Kelun Pharmaceutical to 4603.55 billion yuan for Rihai Shenzhou, with stock prices varying from 12.25 yuan to 298.80 yuan [1] - The performance of the top ten stocks shows a mix of slight declines, with WuXi AppTec down 1.49% and Hengrui Medicine down 1.04% [1] Group 3: Capital Flow - The Medical Health Index constituents experienced a net outflow of 472 million yuan from major funds, while retail investors saw a net inflow of 388 million yuan [1] - Detailed capital flow data indicates that Ganli Pharmaceutical had a net inflow of 62.98 million yuan from major funds, despite a net outflow from retail investors [2]

Core Viewpoint - Ganli Pharmaceutical's insulin product has received a positive opinion from the European Medicines Agency (EMA), marking a significant step for Chinese biopharmaceuticals in the international market [1] Group 1: Company Developments - Ganli Pharmaceutical's insulin injection, Lantus® SoloStar® biosimilar, is recommended for approval by the EMA for treating diabetes in adults, adolescents, and children aged 2 and above [1] - This is the first time a Chinese-developed insulin has received positive recognition from a European regulatory body, indicating a major milestone for the company's internationalization strategy [1] - The positive opinion from the EMA is seen as a "golden passport" for entering international markets, enhancing the company's credibility and paving the way for future product launches in Europe [1][2] Group 2: Market Context - The European diabetes patient population aged 20 to 79 has surpassed 65.6 million, with related medical expenditures nearing $200 billion, highlighting a strong demand for effective and cost-efficient treatment options [2] - Currently, the European insulin market is dominated by Sanofi, with projected sales of €819 million in 2024, indicating a significant opportunity for Ganli Pharmaceutical to alter the market landscape [2] Group 3: Financial Performance - In the first three quarters of 2025, Ganli Pharmaceutical reported domestic formulation revenue of 2.624 billion yuan, a year-on-year increase of 45.6%, reflecting a robust recovery in the domestic market [2] - The company's international business also showed strong performance, with overseas sales revenue reaching 353 million yuan, up 45.5% year-on-year, indicating a growing order scale [2] - The company has achieved a 32.6% growth rate in agreement volume for six insulin products in the upcoming national procurement in 2024, laying a solid foundation for performance recovery [2]

Market Overview - The biopharmaceutical sector increased by 0.3% on November 14, with Jindike leading the gains [1] - The Shanghai Composite Index closed at 3990.49, down by 0.97%, while the Shenzhen Component Index closed at 13216.03, down by 1.93% [1] Stock Performance - Jindike (688670) closed at 28.03, up by 19.99% with a trading volume of 105,500 shares and a transaction value of 270 million [1] - Hualan Ting (301207) closed at 25.38, up by 7.22% with a trading volume of 336,800 shares [1] - Other notable performers include: - Saikai Pharmaceutical (300485) at 13.35, up by 4.54% [1] - Olin Bio (616889) at 24.81, up by 4.29% [1] - Wowo Bio (300357) at 33.65, up by 3.03% [1] Capital Flow - The biopharmaceutical sector experienced a net outflow of 59.84 million from institutional investors, while retail investors saw a net inflow of 23.85 million [2][3] - Key stocks with significant capital flow include: - Ganli Pharmaceutical (603087) with a net inflow of 62.98 million from institutional investors [3] - Jindike (688670) with a net inflow of 40.32 million from institutional investors [3] - Hualan Ting (301207) with a net inflow of 27.99 million from institutional investors [3]

Core Insights - The healthcare innovation sector is showing positive momentum, with the China Securities Medicine and Medical Device Innovation Index (931484) rising by 0.31% as of November 14, 2025, and several key stocks, including Sanofi and Ganli Pharmaceutical, experiencing significant gains [1] Group 1: Market Performance - The China Securities Medicine and Medical Device Innovation Index has seen a 0.31% increase, with notable stock performances: Sanofi up 4.64%, Ganli Pharmaceutical up 3.28%, and Jiutian Pharmaceutical up 1.83% [1] - The Medical Innovation ETF (516820) has also risen by 0.26%, marking its third consecutive increase [1] Group 2: Clinical Developments - AstraZeneca announced successful Phase III clinical trials for Baxdrostat, which significantly reduced 24-hour average systolic blood pressure in patients with resistant hypertension over 12 weeks, indicating a new treatment pathway for hypertension [1] Group 3: Industry Trends - According to Dongfang Caifu Securities, the pharmaceutical industry showed improvement in Q3 2025, with the medical device sector experiencing a turning point, achieving positive year-on-year revenue growth and a notable narrowing of net profit declines [1] - The CXO sector performed exceptionally well in the first three quarters of 2025, with medical R&D outsourcing revenue increasing by 12.2% and net profit rising by 56.8%, particularly in ADC CDMO and peptide CDMO fields [2] - The index reflects the performance of 30 profitable and growth-oriented companies in the pharmaceutical and medical device sectors, with the top ten stocks accounting for 64.12% of the index [2]

Core Viewpoint - Gan & Lee Pharmaceuticals has received a positive opinion from the European Medicines Agency (EMA) for its insulin glargine injection (brand name: Ondibta), recommending it as a biosimilar to Lantus SoloStar for diabetes treatment in adults, adolescents, and children aged 2 and above [2]. Drug Basic Information - Drug Name: Ondibta - Generic Name: Insulin Glargine - Indication: Diabetes - Dosage Form: Injection - Specification: 3ml: 100 units/ml (pre-filled pen) - Applicant: Gan & Lee Pharmaceuticals Europe GmbH [3]. Market Context - According to the International Diabetes Federation (IDF), there are approximately 588.7 million diabetes patients aged 20-79 globally in 2024, with Europe accounting for 65.6 million, representing 11.1% of the global patient population [3]. - The total medical expenditure due to diabetes is estimated at $193 billion globally, with an average annual expenditure of $2,951 per patient [3]. - The diabetes prevalence among the adult population in Europe is 9.8% [3]. Competitive Landscape - As of the announcement date, Sanofi is 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 [3][4]. - Gan & Lee Pharmaceuticals has invested a total of 936 million RMB in research and development for the insulin glargine project as of September 30, 2025 [4].

甘李药业(603087.SH)发布公告，公司及其欧洲全资子公司甘李药业欧洲有限责任公司 (Gan&LeePharmaceuticalsEuropeGmbH，以下简称"甘李欧洲")于近日收到欧洲药品管理局 (EuropeanMedicinesAgency， EMA)的通知，甘精胰岛素注射液(商品名：Ondibta)获得EMA人用药品委 员会(Committee for Medicinal Products for Human Use，CHMP)积极意见。CHMP 建议欧盟委员会 (EuropeanCommission，EC)批准甘精胰岛素注射液(商品名： Ondibta)作为 Lantus SoloStar 的生物类似药 上市，用于治疗成人、青少年和2岁及以上儿童的糖尿病。CHMP的建议将进入EC审查阶段，以获得 Ondibta在欧盟、冰岛、列支敦士登和挪威的上市许可，最终决定预计将于明年初做出。 甘李药业(603087.SH)发布公告，公司及其欧洲全资子公司甘李药业欧洲有限责任... ...

现将相关情况公告如下： 一、药物基本情况 证券代码：603087 证券简称：甘李药业 公告编号：2025-077 甘李药业股份有限公司 关于甘精胰岛素注射液（Ondibta ®）上市许可申请 （MAA）获得欧盟 CHMP 积极意见的公告 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。 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"）于近日收到欧洲药品管理局（European Medicines Agency， EMA）的通知，甘精胰岛素注射液（商品名：Ondibta®）获得 EMA 人用药品委 员会（Committee for Medicinal Products for Human Use，CHMP）积极意见。CHMP 建议欧盟委员会（European Commission，EC）批准甘精胰岛素注射液（商品名： Ondibta®）作为 Lantus SoloStar 的生物类 ...

智通财经APP讯，甘李药业(603087.SH)发布公告，公司及其欧洲全资子公司甘李药业欧洲有限责任公 司(Gan&LeePharmaceuticalsEuropeGmbH，以下简称"甘李欧洲")于近日收到欧洲药品管理局 (EuropeanMedicinesAgency， EMA)的通知，甘精胰岛素注射液(商品名：Ondibta®)获得EMA人用药品 委员会(Committee for Medicinal Products for Human Use，CHMP)积极意见。CHMP 建议欧盟委员会 (EuropeanCommission，EC)批准甘精胰岛素注射液(商品名： Ondibta®)作为 Lantus SoloStar 的生物类似 药上市，用于治疗成人、青少年和2岁及以上儿童的糖尿病。CHMP的建议将进入EC审查阶段，以获得 Ondibta®在欧盟、冰岛、列支敦士登和挪威的上市许可，最终决定预计将于明年初做出。 ...