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个别及连带责任。 近日，津药药业股份有限公司（以下简称"公司"）子公司津药和平（天津）制药有限公司（以下简 称"津药和平"） 注射用甲泼尼龙琥珀酸钠（以下简称"该药品"）获得巴拿马共和国卫生部注册证书 （标志着可以生产并在巴拿马共和国市场销售该产品），现将相关信息公告如下： 一、药品的基本情况 1.药品名称：注射用甲泼尼龙琥珀酸钠 2.剂型：注射用冻干粉针剂 3.规格：500mg 4.持有人：津药和平（天津）制药有限公司 5.批准文号：210124 三、对上市公司影响及风险提示 津药和平注射用甲泼尼龙琥珀酸钠获得巴拿马共和国卫生部注册证书，将为制剂业务拓展巴拿马市场带 来新机遇，也将进一步推动公司国际化战略布局。由于该药品在国外市场销售的时间、市场规模、后续 拓展进度具有不确定性，加之药品出口业务容易受到国外市场环境变化、汇率波动等因素影响，敬请广 大投资者理性投资，注意防范投资风险。 特此公告。 津药药业股份有限公司 董事会 2025年11月18日 6.发证机构：巴拿马共和国卫生部 二、药 ...

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]

Core Viewpoint - The company is actively promoting its innovative drug, Anladiwei, for the treatment of influenza, with positive clinical trial results and plans for international market expansion [2][4]. Financial Performance - As of October 24, 2025, the company's stock closed at 17.96 yuan, down 2.55%, with a turnover rate of 5.9%, trading volume of 449,200 shares, and a transaction amount of 811 million yuan [1]. Product Development - Anladiwei is the world's first targeted drug for the PB2 subunit of the influenza A virus, showing rapid and effective treatment capabilities with low resistance [2]. - The drug has completed Phase III clinical trials, demonstrating significant efficacy against various influenza virus strains, including H1 and H3 subtypes [4]. Market Strategy - The company has established a commercialization partnership for Anladiwei in Macau and is exploring further international market opportunities [3][4]. - The company is monitoring disease dynamics and is prepared to enhance production and sales efforts [4]. Investor Engagement - The company has clarified that there are no current financing plans and emphasized adherence to disclosure obligations [2]. - The company is open to suggestions regarding marketing strategies to increase awareness of Anladiwei's efficacy [2]. Market Activity - On October 24, there was a net outflow of 132 million yuan from major funds, while retail investors saw a net inflow of 14 million yuan [5].

Core Viewpoint - The company is focusing on international market opportunities for its pharmaceuticals, specifically through a collaboration with Sinovac Biotech for the commercialization of Anglatavir tablets in Macau, which aims to enhance its brand presence overseas and support its international expansion efforts [1] Group 1 - The company has established a commercial partnership with Sinovac Biotech for Anglatavir tablets in Macau [1] - This collaboration is intended to create a brand radiating effect in international markets [1] - The company plans to explore further international market opportunities and accelerate its globalization efforts [1] Group 2 - The company is closely monitoring disease dynamics and is committed to effective drug production and sales [1]

Core Viewpoint - Tonghua Dongbao has received the drug registration certificate for insulin aspart injection from the Indonesian Food and Drug Authority, allowing the company to sell this product in Indonesia, which enhances its international market presence and competitiveness [1] Group 1: Product Information - Insulin aspart injection is a rapid-acting insulin analog that takes effect within 10-20 minutes after subcutaneous injection and lasts for 3-5 hours, primarily used to control postprandial blood sugar [1] - Insulin aspart is typically administered immediately before meals and can also be given right after meals if necessary, often in combination with long-acting insulin for comprehensive blood sugar management [1] Group 2: Strategic Implications - The approval of insulin aspart injection by the Indonesian authority signifies that Tonghua Dongbao is now permitted to market this product in Indonesia, which is beneficial for expanding the company's international product line [1] - This development is expected to enhance the company's brand image, facilitate the expansion of international business, accelerate its presence in emerging markets, and improve its competitiveness in the global market [1]

Core Viewpoint - The company and its subsidiaries have recently obtained drug marketing approvals in Denmark, Germany, Uzbekistan, and Bangladesh for several injectable medications, which will aid in expanding the product line and enhancing brand image in international markets [1] Group 1: Drug Approvals - The company has received marketing approvals for injectable paclitaxel, injectable cyclophosphamide, paclitaxel injection, injectable zoledronic acid solution, and injectable azacitidine [1] - These drugs have been registered in multiple countries, indicating a successful expansion strategy [1] Group 2: Market Preparation - The company has conducted preliminary preparations for the market launch of these products [1] - Future performance remains uncertain due to market competition and other influencing factors [1]

Core Viewpoint - The company has received marketing authorization for injectable bivalirudin from the Therapeutic Goods Administration (TGA) of Australia, indicating its capability to sell the product in Australia, which is expected to positively impact the company's overseas market expansion and performance [1][2]. Group 1: Product Information - Product Name: Injectable Bivalirudin [1] - Dosage Form: Injection [1] - Specification: 250mg [1] - Indication: Used as an anticoagulant for patients with high-risk acute coronary syndrome (ACS) undergoing early invasive treatment and those receiving percutaneous coronary intervention (PCI) [1]. Group 2: Regulatory Approvals and Milestones - In January 2019, the company received a drug registration certificate from the National Medical Products Administration (NMPA) for injectable bivalirudin [2]. - In May 2019, the company obtained a GMP certificate from the Hainan Provincial Drug Administration for the active pharmaceutical ingredient [2]. - In June 2019, the company successfully challenged the patent of the original holder of injectable bivalirudin [2]. - In October 2019, the ANDA for injectable bivalirudin received final approval from the FDA, leading to its market launch in the U.S. in 2020 [2]. - In December 2022, injectable bivalirudin passed the consistency evaluation for generic drug quality and efficacy by the NMPA [2]. - In February 2024, the product received registration approval from the Saudi Food and Drug Authority (SFDA) [2]. Group 3: Company Strategy and Product Portfolio - The company has extensive experience in the research, registration, production, and marketing of chemically synthesized peptide drugs, having developed multiple products including injectable thymosin alpha-1 and various other therapeutic drugs [3]. - The internationalization strategy aims to obtain drug approvals and market sales in developed countries such as the U.S. and EU to increase revenue and profit [3].

Core Insights - Shanghai Fosun Pharmaceutical Group Co., Ltd. reported Q1 2025 revenue of 9.42 billion yuan and a net profit of 765 million yuan, with operating cash flow of 1.056 billion yuan [1] Group 1: Financial Performance - The company achieved a revenue of 9.42 billion yuan in Q1 2025 [1] - The net profit attributable to shareholders was 765 million yuan [1] - Operating cash flow for the quarter was 1.056 billion yuan [1] Group 2: Product Development and Approvals - The company has several innovative drug products progressing towards market launch, expected to enter a "growth phase" in 2025 [1] - In January 2025, the registration application for the innovative small molecule CDK4/6 inhibitor, Fovetisil Capsules, was accepted by the National Medical Products Administration [1] - In February 2025, the innovative drug Vantorel (Tianapano Tablets) was approved for treating CKD adult dialysis patients in China [1] - In March 2025, the listing application for the new drug Dihydrosuifinib Capsules was accepted by the National Medical Products Administration [1] - In March 2025, the innovative anti-HER2 monoclonal antibody HLX22 received orphan drug designation from the FDA for gastric cancer treatment [1] Group 3: International Expansion - The innovative anti-PD-1 monoclonal antibody, Surulitinib, has been approved in over 30 countries, including China, Europe, and Southeast Asia, benefiting more than 100,000 patients [2] - The subsidiary, Fosun Pharma, signed a licensing agreement with Dr. Reddy's, granting exclusive commercialization rights for the biosimilar HLX15 in the U.S. and 42 European countries [2] Group 4: Share Buyback - In Q1 2025, the company initiated a new round of share buybacks, purchasing 1.61 million A-shares for approximately 39.99 million yuan [2] - The company also repurchased 1.66 million H-shares for about 22.91 million Hong Kong dollars [2]