智通财经APP讯，基石药业-B(02616)发布公告，舒格利单抗的新适应症申请已获英国药品和医疗保健用 品管理局(MHRA)批准单药用于治疗肿瘤细胞PD-L1表达≥1%、无表皮生长因数受体(EGFR)敏感突变或 ALK、ROS1基因组变异、在含铂放化疗(CRT)后未出现疾病进展的、不可切除的III期小细胞肺癌 (NSCLC)成人患者。 基石药业首席医学官史青梅博士表示："此次MHRA对舒格利单抗III期NSCLC新适应症的批准是国际监 管机构对其临床价值的进一步肯定，将有力助推该产品的全球商业潜力释放。同时，我们也为基石药业 临床开发和注册团队高效的执行力、宝贵的全球注册经验以及成功适应欧洲与英国成熟监管体系的能力 而深感自豪。目前，舒格利单抗联合化疗用于IV期NSCLC已获《欧洲肿瘤内科学会(ESMO)非驱动基因 阳性转移性非小细胞肺癌动态临床指南》最高等级【I, A】的一线治疗推荐，我们期待其III期NSCLC新 适应症在不久的将来也能获得该权威指南推荐。此外，基石药业还将推进舒格利单抗用于胃癌(GC)、 食管鳞癌(ESCC)等新适应症的注册申报。" 基石药业首席执行官、研发总裁及执行董事杨建新博士表示： ...

盐酸普萘洛尔主要用于(i)作为二级预防，降低心肌梗死死亡率;(ii)高血压;(iii)劳力型心绞痛;及(iv)控制室 上性快速心律失常及室性心律失常。 石四药集团(02005)发布公告，本集团的盐酸普萘洛尔已获中国国家药品监督管理局批准登记成为在上 市制剂使用的原料药。 ...

Core Viewpoint - China National Pharmaceutical Group Co., Ltd. announced the approval of fumaric acid volnorelaxin tablets by the National Medical Products Administration, marking a significant step in the company's integrated layout of raw materials and formulations [1] Group 1: Product Approval and Specifications - The approved specifications for the drug are 10mg and 20mg, primarily used for treating reflux esophagitis and eradicating Helicobacter pylori in conjunction with antibiotics [1] - The total investment in the raw material and formulation project for this drug amounts to approximately 12.32 million RMB [1] Group 2: Market Potential and Sales Forecast - According to data from Minet, the estimated sales revenue for this drug in China's three major terminal markets is approximately 774 million RMB in 2024, with sales of about 778 million RMB in the first three quarters of 2025 [1] - Currently, a total of 40 production enterprises, including Tianfang Pharmaceutical, have obtained approval for this drug [1] Group 3: Strategic Implications - The approval is expected to enrich the company's product line and enhance its business layout [1] - Future sales performance may be influenced by uncertainties related to national policies and market conditions [1]

Core Viewpoint - China National Pharmaceutical Group Co., Ltd. announced that its wholly-owned subsidiary, Tianfang Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the registration of Dabigatran Etexilate Capsules, which will enhance the company's product line and development experience in generic drugs [1] Group 1: Product Approval and Specifications - The approved drug includes two specifications: 110mg and 150mg [1] - The drug is primarily used for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, as well as for the treatment and prevention of deep vein thrombosis and pulmonary embolism [1] Group 2: Financial and Market Impact - The drug registration application was accepted in May 2024, with a total investment of approximately 28 million RMB [1] - According to data from Minet, the estimated sales revenue for the drug in China's three major terminal markets in 2024 is approximately 571 million RMB [1] Group 3: Competitive Landscape and Future Outlook - Currently, there are 14 manufacturers, including Tianfang Pharmaceutical, that have obtained approval for this drug in China [1] - The company indicated that future sales may be influenced by national policies and market conditions, which could lead to performance that does not meet expectations [1]

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之內容概不負責，對其準確 性或完整性亦不發表任何聲明，並明確表示，概不會就因本公告全部或任何部份內容而產生 或因倚賴該等內容而引致之任何損失承擔任何責任。 自願公告 產品開發的最新進展 石四藥集團有限公司（「本公司」，連同其附屬公司，「本集團」）董事局（「董事局」）欣然公告， 本集團已取得中國國家藥品監督管理局有關鹽酸普羅帕酮注射液（20ml∶70mg）的藥品生產註 冊批件，屬於化學藥品第3類，視同通過一致性評價，是國內企業第三家獲批。 鹽酸普羅帕酮注射液主要用於需治療的室上性心動過速，如房室交界性心動過速，WPW 綜合 症合併室上性心動過速或陣發性心房顫動，及需治療或致命的室性心動過速。 本公告為本公司自願發佈，目的是使股東及潛在投資者瞭解本集團最新業務發展情況。 承董事局命 執行董事兼公司秘書 周興揚 香港，二零二六年一月三十日 於本公告日期，董事局成員包括執行董事曲繼廣先生、蘇學軍先生、孟國先生、周興揚先生及 曲婉蓉女士，非執行董事劉文軍先生，以及獨立非執行董事王亦兵先生、周國偉先生及姜廣策 先生。 ...

Core Viewpoint - Haizheng Pharmaceutical's wholly-owned subsidiary, Haizheng Hangzhou, has received FDA approval for the abbreviated new drug application of injectable micafungin, allowing production and sales in the U.S. [1] Group 1: Product Details - The approved drug is available in two specifications: 50mg and 100mg, and is indicated for the treatment and prevention of various candidiasis infections [1] - The global sales forecast for 2024 is approximately $208 million, with the U.S. market contributing about $67.57 million [1] - For the period from January to September 2025, global sales are projected to be around $143 million, with U.S. sales estimated at $46.23 million [1] Group 2: Investment and Financials - The company has invested approximately 17.94 million yuan in this project [1]

复星医药(600196.SH)发布公告，近日，公司控股子公司锦州奥鸿药业有限责任公司就重酒石酸去甲肾 上腺素注射液(以下简称"该药品")的药品注册申请获国家药品监督管理局批准。本次获批适应症为用于 急性低血压状态的血压恢复;也可用于心跳骤停的辅助治疗和心跳骤停复苏后的血压维持;对血容量不足 导致的休克，本品作为急救时补充血容量的辅助治疗，以使血压回升，暂时维持脑与冠状动脉灌注，直 到补充血容量治疗发生作用。 ...

Group 1 - The core point of the article is that Aimeike Technology Development Co., Ltd. has received approval from the National Medical Products Administration for the injection of type A botulinum toxin produced by Huons BioPharma Co., Ltd., marking a significant milestone in the company's strategic layout [1] - The approved product, with a specification of 100U per bottle, has a registration certificate valid until January 4, 2031, which will enable the company to provide more comprehensive solutions to its customers [1] - The import and sales of the product are subject to uncertainties due to domestic and international regulations, market conditions, and exchange rate fluctuations, which may affect the execution of the distribution agreement [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for the registration of Betamethasone Sodium Phosphate Injection, which is expected to enhance its product line and competitiveness [1] Group 1: Product Approval - The approved drug is Betamethasone Sodium Phosphate Injection, with a specification of 1ml: 4mg (calculated as C₂₂H₂₉FO₅) [1] - The registration classification of the drug is categorized as Class 3 chemical drugs [1] Group 2: Market Impact - The drug is primarily used for the treatment of diseases related to glucocorticoids, and the original drug has been marketed in multiple countries [1] - The approval is seen as beneficial for the company in terms of expanding its product offerings and improving its competitive position in the market [1] Group 3: Uncertainties - The research, production, and sales of the drug are subject to uncertainties influenced by policies and market factors [1]

Core Viewpoint - The approval of the drug Eivocase tablets by the National Medical Products Administration is expected to enhance the company's product portfolio and market competitiveness, although future sales remain uncertain [1] Group 1: Regulatory Approvals - The subsidiary Hangzhou Qianyuan Baoling Pharmaceutical Co., Ltd. received the drug registration certificate for Eivocase tablets [1] - The subsidiary Jiangsu Jiayi Pharmaceutical Co., Ltd. received the approval notice for the listing application of Eivocase as a chemical raw material drug [1] Group 2: Product Indication and Market Impact - Eivocase tablets are indicated for the treatment of secondary hyperparathyroidism in patients on maintenance dialysis and are classified as a Category B product in the national medical insurance catalog [1] - The approval of this drug is anticipated to enrich the company's product structure and enhance its market competitiveness [1]