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。 ...

甘李药业（603087）(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。 ...

财经频道更多独家策划、专家专栏，免费查阅>>责任编辑：钟离 格隆汇11月13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。 ...

格隆汇11月13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 Commission，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。 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 & 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 ...