Core Points - Beijing Fuyuan Pharmaceutical Co., Ltd. has received the approval notice for the listing application of the chemical raw material drug Clobetasol [1][3] - The drug is indicated for the topical treatment of mild to moderate atopic dermatitis in patients aged 2 years and older [2] Summary by Sections Drug Basic Information - The company has obtained the "Chemical Raw Material Drug Listing Application Approval Notice" from the National Medical Products Administration for Clobetasol [1] Other Drug Information - The technical review application for Clobetasol was accepted by the National Medical Products Administration in July 2024, and the approval notice has now been issued [1] Impact on the Company - The approval of Clobetasol will enrich the company's product line and promote sustainable, stable, and healthy development [3] - The sales performance of the drug may be influenced by national policies and market environment changes, indicating a degree of uncertainty [3]

Core Viewpoint - Fuyuan Pharmaceutical has received approval from the National Medical Products Administration for the marketing application of the raw material drug Cliborin [2] Group 1 - The approval includes the issuance of the "Chemical Raw Material Drug Marketing Application Approval Notice" [2]

Core Viewpoint - Fuyuan Pharmaceutical (601089.SH) has received approval from the National Medical Products Administration for the raw material drug Clobetasol, which is intended for local treatment of mild to moderate atopic dermatitis in patients aged 2 and above [1] Group 1 - The approval of Clobetasol will enrich the company's product line [1] - This development is expected to promote the company's sustainable, stable, and healthy growth [1]

证券代码：601089 证券简称：福元医药 公告编号：临 2025-067 北京福元医药股份有限公司 | 药品名称 | 通用名称：克立硼罗 | | --- | --- | | | 英文名/拉丁名：Crisaborole | | 通知书编号 | 2025YS00932 | | 登记号 | Y20240000682 | | 有效期 | 24个月 | | 包装规格 | 1.0kg/袋，1袋/桶；2.0kg/袋，1袋/桶；5.0kg/袋， | | | 1袋/桶；10.0kg/袋，1袋/桶。 | | 申请事项 | 境内生产化学原料药上市申请 | | 审批结论 | 根据《中华人民共和国药品管理法》及有关规 | | | 定，经审查，本品符合药品注册的有关要求， | | | 批准注册。质量标准、标签及生产工艺照所附 | | | 执行。 | | 生产企业 | 名称：北京福元医药股份有限公司 | | | 地址：河北省沧州市临港经济技术开发区华佗 | | | 路5号 | 一、药品基本情况 通知书有效期 至2030年10月21日 关于获得化学原料药上市申请批准通知书的公告 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 ...

Core Viewpoint - Fuyuan Pharmaceutical (601089) has received approval from the National Medical Products Administration for the marketing authorization of Clobetasol Propionate raw material, which is intended for the topical treatment of mild to moderate atopic dermatitis in patients aged 2 years and older [1] Company Summary - Fuyuan Pharmaceutical announced on October 24 that it has obtained the marketing authorization for Clobetasol Propionate, a significant development for the company [1] - The approval allows the company to expand its product offerings in the dermatological treatment market, specifically targeting atopic dermatitis [1] Industry Summary - The approval of Clobetasol Propionate aligns with the growing demand for effective treatments for atopic dermatitis, a common skin condition affecting a significant portion of the population [1] - The market for dermatological products is expected to see increased competition and innovation as companies seek to address various skin conditions [1]

Core Viewpoint - The approval of the raw material drug Clobetasol by the National Medical Products Administration (NMPA) enhances the company's product line, although sales may face uncertainties due to policy and market factors [1] Group 1: Regulatory Approval - The company received the approval notice for Clobetasol raw material drug with registration number Y20240000682, valid until October 21, 2030 [1] - The technical review application for this raw material drug was accepted in July 2024, currently showing status "A" on the CDE raw and auxiliary materials registration information platform [1] Group 2: Product Indication - Clobetasol is indicated for local external treatment of mild to moderate atopic dermatitis in patients aged 2 years and older [1] Group 3: Market Considerations - The approval will enrich the company's product line, but drug sales are subject to uncertainties influenced by policies and market conditions [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for the raw material drug Clobetasol, which is intended for the local treatment of mild to moderate atopic dermatitis in patients aged 2 years and older [1] Group 1 - The approval of Clobetasol will enrich the company's product line [1] - This development is expected to promote the company's sustainable, stable, and healthy growth [1]

公司本次取得克立硼罗原料药《化学原料药上市申请批准通知书》，将进一步丰富公司产品线，促进公 司持续、稳定、健康地发展。 智通财经APP讯，福元医药(601089.SH)发布公告，近日，公司收到国家药品监督管理局核准签发的克 立硼罗原料药《化学原料药上市申请批准通知书》。克立硼罗适用于2岁及以上轻度至中度特应性皮炎 患者的局部外用治疗。 ...

Core Viewpoint - Beijing Fuyuan Pharmaceutical Co., Ltd. announced that its wholly-owned subsidiary, Zhejiang Aisheng Pharmaceutical Co., Ltd., has received a drug registration certificate from the National Medical Products Administration for Dydrogesterone Tablets, which will enhance the company's product line and market competitiveness [1][4]. Drug Registration Certificate Details - The drug registration certificate for Dydrogesterone Tablets (10mg) was issued by the National Medical Products Administration, indicating that the drug has passed the consistency evaluation as per national policies [1]. Drug Information - Dydrogesterone is an orally absorbable synthetic progestogen, originally developed by Solvay Pharmaceuticals and approved for market in Portugal in July 1961. It was approved for sale in China in December 2002 for treating endogenous progesterone deficiency and supporting luteal function in assisted reproductive technology [1][2]. R&D Investment - As of the announcement date, Zhejiang Aisheng has invested a total of RMB 5.3716 million (approximately 0.537 million) in the research and development of this drug [2]. Market Status of Similar Drugs - According to data from Minai Network, the sales revenue of Dydrogesterone Tablets in China's three major terminal markets is approximately RMB 2.57 billion (approximately 25.70 million), with public hospitals accounting for RMB 2.20 billion (approximately 22.01 million), community health centers and township hospitals for RMB 61 million (approximately 0.61 million), and retail pharmacies and online pharmacies for RMB 308 million (approximately 3.08 million) [3].

Group 1 - The core point of the article is that Fuyuan Pharmaceutical announced the approval of its subsidiary Zhejiang Aisheng Pharmaceutical's drug, Dydrogesterone Tablets (10mg), by the National Medical Products Administration [2][3] Group 2 - The drug has received a production license, indicating a significant milestone for the company [2] - This approval may enhance the company's product portfolio and market presence in the pharmaceutical industry [2]