2024 年3月，新华制药向国家药品监督管理局CDE递交醋酸泼尼松龙境内生产化学原料药上市申请注册 申报资料并获受理，2025年11月获得《化学原料药上市申请批准通知书》，审评结论为批准注册。本品 主要用于过敏性与自身免疫性炎症疾病。现多用于活动性风湿、类风湿性关节炎、红斑狼疮、严重支气 管哮喘、肾病综合症、血小板减少性紫癜、粒细胞减少症、各种肾上腺皮质功能不足症、严重皮炎、急 性白血病等，也用于某些感染的综合治疗。根据有关统计数据，2024 年中国公立医疗机构醋酸泼尼松 龙相关制剂销售额约人民币1亿元。 山东新华制药（000756）股份(00719)发布公告，近日，公司收到国家药品监督管理局核准签发的醋酸 泼尼松龙《化学原料药上市申请批准通知书》。 ...

Core Viewpoint - The approval of fumaric acid volnorasone as a chemical raw material drug by the National Medical Products Administration enhances the company's product line and overall competitiveness in the pharmaceutical market [1][2]. Group 1: Product Approval - The company received the approval notice for fumaric acid volnorasone, with the notification number 2025YS00988 [1]. - The application for the domestic production of fumaric acid volnorasone was submitted in March 2024 and was accepted by the National Medical Products Administration [1]. - The approval for production was granted in November 2025, confirming the product's evaluation conclusion as approved [1]. Group 2: Market Potential - Fumaric acid volnorasone is primarily used for gastroesophageal reflux disease and is classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2025) [1]. - The estimated sales revenue for fumaric acid volnorasone-related formulations in Chinese public medical institutions is approximately RMB 825 million in 2024 [1]. Group 3: Competitive Advantage - The approval of this product will further enrich the company's product line, thereby enhancing its comprehensive competitiveness in the pharmaceutical industry [2].

Group 1 - The company has received approval from the National Medical Products Administration for the marketing application of Gatifloxacin, a chemical raw material drug [1][2] - Gatifloxacin is a broad-spectrum antibacterial agent effective against various bacteria, including Gram-positive and Gram-negative bacteria, and is the main raw material for the company's Gatifloxacin eye drops [2] - The approval is valid until October 21, 2030, and the company is required to continue accumulating research data on nitrosamine impurities and improve control strategies as necessary [2] Group 2 - The approved Gatifloxacin raw material is primarily intended to meet the production needs of the company's Gatifloxacin eye drops, and it is not expected to have a significant impact on the company's recent operations [3]

Core Viewpoint - Haizheng Pharmaceutical's subsidiary has received approval for the marketing of Minocycline Hydrochloride raw material from the National Medical Products Administration, indicating a significant advancement in the company's product portfolio and potential revenue growth [1] Group 1: Regulatory Approval - Haizheng Pharmaceutical's wholly-owned subsidiary, Haizheng Pharmaceutical Nantong Co., Ltd., has been granted the marketing approval for Minocycline Hydrochloride raw material by the National Medical Products Administration [1] Group 2: Sales Projections - The global sales volume for Minocycline Hydrochloride is projected to be approximately 35,648.65 kilograms in 2024, with domestic sales expected to reach around 7,914.5 kilograms [1] - For the first quarter of 2025, the global sales volume is estimated at about 8,572.46 kilograms, while domestic sales are anticipated to be approximately 2,092.66 kilograms [1] Group 3: Investment in Development - The company has invested approximately 19.21 million RMB in the development project for this pharmaceutical product [1]

Core Viewpoint - Rundu Co., Ltd. has received approval from the National Medical Products Administration for the marketing application of glucosamine sulfate sodium chloride compound, which is intended for the treatment of primary and secondary osteoarthritis, enhancing the company's product portfolio and market competitiveness, positively impacting future operational performance [1] Company Summary - The approved drug will enrich the company's product categories, which is beneficial for improving market competitiveness [1] - The approval is expected to have a positive effect on the company's future operating performance [1] Industry Summary - The market sales of the newly approved drug may be influenced by various uncertain factors, including policy environment and market changes [1]

Core Viewpoint - The approval of the chemical raw material drug Fumaric Acid Vonoprazan by the National Medical Products Administration will enhance the company's product portfolio and market competitiveness, although it is not expected to have a significant short-term impact on performance [1] Company Summary - Jiuzhou Pharmaceutical's wholly-owned subsidiary, Zhejiang Jiuzhou Pharmaceutical Technology Co., Ltd., has received the approval notice for Fumaric Acid Vonoprazan [1] - The drug is primarily used for the treatment of acid-related diseases [1] - The company has invested approximately 7.36 million yuan in research and development for this drug [1] - In 2023, the sales revenue of Fumaric Acid Vonoprazan tablets in Chinese public medical institutions exceeded 600 million yuan [1] Industry Summary - The approval of Fumaric Acid Vonoprazan is expected to enrich the company's product structure, thereby enhancing its competitiveness in the pharmaceutical industry [1]