在国际化布局上，继今年上半年恩杂卢胺片与达格列净二甲双胍缓释片获得美国FDA暂时批准后，宣泰 医药产品梯队不断拓展：今年10月，枸橼酸托法替布缓释片（11mg）获得美国FDA正式批准，西格列 汀二甲双胍缓释片获得美国FDA暂时批准。 在国内市场，宣泰医药同样取得了积极进展。西格列汀二甲双胍缓释片50/500mg新规格获得国家药品 监督管理局（NMPA）批准，进一步丰富了公司在糖尿病领域的产品组合，增强了针对不同临床需求的 覆盖能力。此外，奥帕利片成功中选第十一批全国药品集中采购，西格列汀二甲双胍缓释片（II）原价 续约纳入国家医保目录，将进一步推动相关产品的市场推广、提升销售规模，对公司的长期经营发展具 有积极影响。 宣泰医药表示，此次公布激励计划，一方面向市场传递公司对未来长远发展的信心，另一方面能调动核 心员工的积极性，吸引、保留和激励优秀管理者、核心技术骨干员工，支持公司战略实现和长期可持续 发展，充分释放公司整体经营活力。（厉平） 12月25日晚间，宣泰医药(688247)公告《2025年限制性股票激励计划（草案）》，拟采用第二类限制性 股票的方式，向激励对象授予不超过623.00万股，约占公司股本总 ...

Core Insights - The company reported a revenue of 331 million yuan and a net profit of 63.46 million yuan for the first three quarters of 2025, with a quarterly revenue of 112 million yuan and a net profit of 17.88 million yuan in Q3 [1] - The company is accelerating product commercialization and expanding its global market presence, with its product Olaparib tablets expected to be selected in the recent national centralized drug procurement [1] - The company received FDA approval for its product Tocilizumab sustained-release tablets in October, marking a significant milestone in its product portfolio [1] Product Development - The company made breakthroughs in the diabetes sector, with the approval of new specifications for Sitagliptin Metformin sustained-release tablets by the National Medical Products Administration in September [2] - The product Sitagliptin Metformin sustained-release tablets also received temporary approval from the FDA in October, enhancing the company's international presence in diabetes treatment [2] - The company has established a solid foundation for entering the U.S. market with two products receiving temporary FDA approval in the first half of the year [2] High-end Generic Drugs - The company follows a "first generic, high activity" strategy, achieving global first-generic breakthroughs for several products, including Posaconazole enteric-coated tablets and Macitentan tablets [3] - The company has also received approvals for high-activity formulations such as Olaparib tablets and Exemestane tablets, establishing market barriers [3] - The company's self-developed modified new drug project XT-0043 has shown excellent safety and efficacy in Phase II clinical trials [3] Future Outlook - The company plans to continue driving innovation and steadily advancing its international layout strategy, focusing on enhancing its high-end generic and modified new drug pipeline [3] - The company aims to improve its production quality system and service capabilities while strengthening international cooperation to commercialize more products globally [3]

Core Insights - The company reported a revenue of 331 million yuan and a net profit of 63.46 million yuan for the first nine months of 2025, with a quarterly revenue of 112 million yuan and a net profit of 17.88 million yuan in Q3 [1] Group 1: Product Development and Market Expansion - The company achieved significant progress in its internationalization strategy, with the FDA approving its 11 mg formulation of tofacitinib citrate in October [1] - The diabetes pipeline saw breakthroughs, with the approval of a new specification for sitagliptin and metformin extended-release tablets by the National Medical Products Administration (NMPA) in September, enhancing the product matrix [2] - The company’s products are now available in multiple countries, including China, the USA, Australia, Canada, and Southeast Asia, creating a diversified global sales structure [2] Group 2: Regulatory Approvals and Quality Certifications - The company’s solid dosage form workshop received GMP certification from the European Medicines Agency (EMA) in July, maintaining a "zero-defect" record in inspections by major global regulatory agencies [3] - The company was awarded the highest information disclosure rating of "A" by the Shanghai Stock Exchange for the 2024-2025 information disclosure evaluation, reflecting its commitment to investor relations and transparency [3] Group 3: Strategic Commitments - The controlling shareholder, Shanghai Lianhe Investment Co., Ltd., voluntarily committed not to reduce its shareholding for two years starting from August 25, 2025, indicating confidence in the company's long-term development strategy [3]