2026年1月15日，公司甘精胰岛素注射液获得欧盟委员会的上市许可（详情请参考公告：2026-004）。 目前，产品正处于获批后的上市前准备阶段，公司正在全力推进包括市场准入、渠道布局、物流准备等 在内的系列商业化工作，尚未开始商业销售。 公司高度重视全球市场，欧盟是我们重要的战略目标市 场之一。此次获批是公司践行国际化战略的关键一步，未来公司将严格按照上市规则对商业化进展履行 持续信息披露义务。 格隆汇2月5日丨甘李药业(603087.SH)在投资者互动平台表示，在欧美市场，公司和山德士于2018年签 订商业和供货协议。协议约定，在三款生物类似药（甘精、门冬、赖脯）获得批准后，山德士将进行药 品在美国、欧洲及其他特定区域的商业运作，由公司负责药物开发（包括临床研究）及供货等事宜。截 至目前，公司与山德士的合作仍在持续稳步推进。 ...

格隆汇2月5日丨甘李药业(603087.SH)在投资者互动平台表示，在欧美市场，公司和山德士于2018年签 订商业和供货协议。协议约定，在三款生物类似药（甘精、门冬、赖脯）获得批准后，山德士将进行药 品在美国、欧洲及其他特定区域的商业运作，由公司负责药物开发（包括临床研究）及供货等事宜。截 至目前，公司与山德士的合作仍在持续稳步推进。 2026年1月15日，公司甘精胰岛素注射液获得欧盟委员会的上市许可（详情请参考公告：2026-004）。 目前，产品正处于获批后的上市前准备阶段，公司正在全力推进包括市场准入、渠道布局、物流准备等 在内的系列商业化工作，尚未开始商业销售。 公司高度重视全球市场，欧盟是我们重要的战略目标市 场之一。此次获批是公司践行国际化战略的关键一步，未来公司将严格按照上市规则对商业化进展履行 持续信息披露义务。 登录新浪财经APP 搜索【信披】查看更多考评等级 ...

Group 1 - The company Dongyangguang Pharmaceutical has received approval from the National Medical Products Administration of China for its SGLT-2 inhibitor, Ologliptin capsules, which are intended for improving blood glucose control in adults with type 2 diabetes [1] - The approval is based on two Phase III clinical trials that demonstrated statistically significant reductions in HbA1c levels after 24 weeks of treatment, along with improvements in fasting blood glucose and postprandial blood glucose [1] - The product also showed additional metabolic benefits, including weight loss and blood pressure reduction, aligning with the current trend of comprehensive management of diabetes focusing on blood glucose, weight, and blood pressure [1] Group 2 - Diabetes is now the third most serious chronic non-communicable disease globally, with a prevalence rate of 13.79% among adults in China, translating to approximately 148 million patients [2] - The company has a comprehensive product line in diabetes treatment, including five insulin products that have been approved and are consistent in effectiveness, safety, and quality with original formulations [2] - The new product approval will enhance the company's diabetes product portfolio, and the company plans to leverage its established production system and marketing network for rapid commercialization while exploring further clinical applications for diabetes complications [2]

Group 1 - The company Dongyangguang Pharmaceutical has received approval from the National Medical Products Administration of China for its innovative drug, Ologliptin capsules, which are designed to improve blood sugar control in adults with type 2 diabetes [1] - The approval is based on two Phase III clinical trials that demonstrated statistically significant reductions in HbA1c levels after 24 weeks of treatment, along with improvements in fasting blood glucose and postprandial blood glucose [1] - The product also offers additional metabolic benefits such as weight loss and blood pressure reduction, aligning with the current trend of comprehensive management of diabetes focusing on blood sugar, weight, and blood pressure [1] Group 2 - Diabetes has become the third most serious chronic non-communicable disease globally, with a prevalence rate of 13.79% among adults in China, translating to approximately 148 million patients [2] - The company has a comprehensive product line in the diabetes treatment field, including five insulin products that have been approved and are consistent in efficacy, safety, and quality with original formulations [2] - The approval of the new product will enhance the company's diabetes product portfolio, and it plans to leverage its established production system and marketing network for rapid commercialization while exploring further clinical applications for diabetes complications [2]

Group 1 - Dongyangguang Pharmaceutical (06887.HK) announced that its self-developed SGLT-2 inhibitor, Oloklignet capsules (brand name: Dongzean, specifications: 20mg, 50mg), received approval from the National Medical Products Administration of China for marketing, aimed at improving blood glucose control in adult patients with type 2 diabetes, either as monotherapy or in combination with metformin [1] - The registration approval was based on two multicenter, randomized, double-blind, placebo-controlled Phase III clinical studies, which showed statistically significant reductions in HbA1c levels after 24 weeks of treatment, along with significant improvements in fasting blood glucose and postprandial blood glucose [1] - The product also demonstrated additional metabolic benefits, including weight loss and blood pressure reduction, aligning with the current trend of comprehensive management of diabetes focusing on blood glucose, weight, and blood pressure [1] Group 2 - Diabetes has become the third most serious chronic non-communicable disease globally, following cancer and cardiovascular diseases, with the International Diabetes Federation reporting a diabetes prevalence rate of 13.79% among adults (ages 20-79) in China, translating to approximately 148 million patients, the highest in the world [2] - Over 90% of these cases are type 2 diabetes, with a poor medication adherence rate and an effective blood glucose control rate of only 50.1% [2] - The company has a comprehensive product line in the diabetes treatment field, having developed five insulin products that have been approved for marketing, all of which are consistent in efficacy, safety, and quality with original formulations and have been included in the national drug centralized procurement [2] - The approval of the new product will further enrich the company's diabetes product line, leveraging its established production system and marketing network for rapid commercialization, while also exploring clinical applications in diabetes complications to expand the range of indications [2]

香 港 交 易 及 結 算 所 有 限 公 司 及 香 港 聯 合 交 易 所 有 限 公 司 對 本 公 告 的 內 容 概 不 負 責，對其準確性或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部 或任何部分內容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。 SUNSHINE LAKE PHARMA CO., LTD. 廣 東 東 陽 光 藥 業 股 份 有 限 公 司 （在中華人民共和國註冊成立之股份有限公司） （股份代號：6887） 自願性公告 – 1 – 目前，糖尿病已成為全球範圍內繼腫瘤、心腦血管病之後，第三位嚴重危害人類 健康的慢性非傳染性疾病。國際糖尿病聯盟(IDF)第11版《糖尿病地圖》數據顯示， 中 國 成 人（ 20 – 79 歲 ）糖 尿 病 患 病 率 達 13.79 % ， 患 者 數 量 達 1.48 億 ， 位 居 全 球 首 位 。 其 中 2 型 糖 尿 病 佔 比 超 90 % ， 患 者 臨 床 用 藥 依 從 性 普 遍 不 佳 ， 血 糖 有 效 控 制 率僅有50.1 %。 本集團長期深耕糖尿病治療領域，擁有全面的產品規劃，佈局了完整的產品線。 本集團 ...

Core Viewpoint - The Shandong Provincial Government has introduced a new implementation plan aimed at enhancing the regulatory framework for pharmaceuticals and medical devices, focusing on innovation, efficiency, and collaborative support for the industry [1]. Group 1: Focus on Innovation and Support - The new implementation plan positions regulatory authorities as "innovation partners," providing proactive support during the early stages of product development for innovative drugs and devices. This includes assigning dedicated personnel for face-to-face guidance, aiming to reduce common issues and compliance risks in the R&D and registration processes [3]. - A notable example of this initiative is the expedited approval and production of Gan Li Pharmaceutical's insulin injection, which exceeded expectations [3]. Group 2: Focus on Review Efficiency and Process Optimization - The reform emphasizes a systematic restructuring of the review and approval processes, incorporating digital transformation. It aims to achieve full online processing for drug and medical device registrations, ensuring that all steps from application to certification are managed digitally, thereby minimizing the need for physical presence [4]. - The regulatory body will publicly commit to specific processing timelines for high-frequency matters, enhancing predictability for enterprises regarding the review process [4]. Group 3: Focus on Systematic Collaboration and Ecosystem Support - The plan aims to create a supportive ecosystem for the rapid development of innovative drugs and devices by ensuring smooth connections across various stages, including R&D, clinical trials, and market access. This includes optimizing the registration of clinical trial institutions and enhancing regulatory support for these entities [5]. - The regulatory authority will also strengthen collaboration with other departments, such as health and insurance, to address common challenges faced by innovative products in funding, clinical promotion, and insurance access [5].

Core Insights - The recent price reductions of GLP-1 drugs, particularly Novo Nordisk's semaglutide (brand name: Ozempic) and Eli Lilly's dual-target drug tirzepatide (brand name: Mounjaro), have garnered significant attention due to their popularity as weight loss medications [1] Pricing Adjustments - Novo Nordisk's semaglutide injection prices have been significantly reduced, with the 2.27mg/mL×3mL specification dropping from 1893.67 yuan to 987.48 yuan, and the 3.2mg/mL×3mL specification from 2463 yuan to 1284.36 yuan, representing nearly a 50% decrease [2] - The price of Mounjaro has also been adjusted, with various specifications seeing reductions of approximately 80%, such as the 10mg specification dropping from 1758 yuan to 324.12 yuan [3] Cost Savings for Patients - Prior to the price reduction, patients using Mounjaro for weight loss would incur costs exceeding 13,000 yuan over 16 weeks, but post-reduction, this cost has decreased to around 2,500 yuan, resulting in savings of over 10,000 yuan [3] E-commerce Price Trends - E-commerce platforms are also reflecting price reductions, with Mounjaro priced at 439 yuan for the 10mg specification on Meituan's platform, attributed to official subsidies [4][6] Future Market Dynamics - The anticipated expiration of Novo Nordisk's patent for semaglutide in 2026 is expected to lead to an influx of generic drugs and increased competition, potentially driving prices lower [8] - The production costs of GLP-1 drugs may align with those of insulin, suggesting that future pricing could be competitive, although the final pricing will depend on various market factors [9]

Group 1: WuXi AppTec - WuXi AppTec expects a net profit of approximately RMB 19.15 billion for the year 2025, representing a year-on-year growth of about 102.6% [1] - The company anticipates total revenue of around RMB 45.46 billion for 2025, reflecting a year-on-year increase of approximately 15.8%, with a 21.4% growth in revenue from continuing operations [1] - Basic earnings per share are projected to be around RMB 6.70, which is an increase of approximately 104.3% compared to the previous year [1] Group 2: Rongchang Biologics - Rongchang Biologics has signed an exclusive licensing agreement with AbbVie for RC148, granting AbbVie exclusive rights for development, production, and commercialization outside Greater China [2] - The agreement includes an upfront payment of USD 650 million and potential milestone payments up to USD 4.95 billion, along with double-digit royalties on net sales outside Greater China [2] - This licensing deal is expected to accelerate the global development and commercialization of RC148, enhancing the company's brand value and international influence [2] Group 3: National Medical Insurance Administration - The sixth batch of centralized procurement for high-value medical consumables has been conducted, with 202 out of 496 products winning bids, ensuring a diverse supply of mainstream products [3][4] - The procurement process emphasizes principles such as maintaining clinical stability, ensuring quality, and preventing price undercutting, with a focus on grouping products based on clinical demand [4] - The procurement includes drug-coated balloons and urological intervention consumables, with all 42 products from 32 companies in the drug-coated balloon category winning bids [3][4] Group 4: New Drug Listings and Market Expansion - As of January 11, over 11,000 designated medical institutions have equipped new drugs added to the medical insurance directory for 2025, including 105 negotiated drugs and 19 commercial insurance innovative drugs [5][6] - Among the 105 new negotiated drugs, 88 have available institution information, with significant coverage across provinces, indicating a strong distribution network [6] - The approval of insulin glargine injection by the European Commission marks a significant entry for Gan Li Pharmaceutical into the European market [7] Group 5: WuXi Biologics - WuXi Biologics' subsidiary, WuXi HeLian, has made a conditional cash offer to acquire all issued shares of Dongyao Pharmaceutical at HKD 4 per share, representing a premium of approximately 99% over the last undisturbed closing price [8] - The total consideration for the acquisition could reach approximately HKD 3.1047 billion, with the offer contingent on obtaining at least 60% of the voting rights [8] - This acquisition aims to expand production capacity and enhance the project and client portfolio in the ADC CDMO sector [8] Group 6: Sanofi Biologics - Sanofi Biologics expects a net profit for 2025 to be between RMB 152 million and RMB 190 million, indicating a year-on-year growth of 204.42% to 280.53% [9] - The projected net profit excluding non-recurring gains is expected to be between RMB 149 million and RMB 186 million, reflecting a significant increase compared to the previous year [9] - The growth is attributed to the company's strategic focus on expanding production capacity and increasing market demand for peptide raw materials [9]

Group 1 - The company, Ganli Pharmaceutical Co., Ltd., has received approval from the Ethiopian Food and Drug Authority for the registration of its insulin glargine injection and pre-filled pen, indicating a significant step in its market expansion in Ethiopia [1][2] - The approved drug, BasalinTM, is indicated for diabetes treatment and is available in two forms: injection and pre-filled pen, both with a concentration of 100 units/ml in a 3ml vial [1] - The insulin glargine is a long-acting insulin that requires daily subcutaneous injection, providing a stable blood glucose level for up to 24 hours [1] Group 2 - Ethiopia has a population of approximately 130 million, with a projected diabetes patient population of around 2.3 million among individuals aged 20-79, representing a prevalence rate of 3.6% [2] - The average annual expenditure on diabetes-related healthcare per patient in Ethiopia is estimated at $96.2 [2] - Sanofi is currently the main supplier of insulin glargine in Ethiopia, with global sales of its insulin products projected to reach €2.855 billion (approximately $2.989 billion) in 2024 [2] Group 3 - As of September 30, 2025, the company has invested a total of 936 million RMB in research and development for the insulin glargine project [3]