登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码：000788 证券简称：北大医药 公告编号：2025-074 北大医药股份有限公司 关于获得《药品注册证书》的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假记载、误导性陈述或重大遗 漏。 审批主要结论：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，发给药品注册证书。 近日，北大医药股份有限公司（以下简称"公司"）收到国家药品监督管理局核准签发的《药品注册证 书》。现将相关情况公告如下： 一、药品基本情况 1、药品通用名称：阿普米司特片 英文名/拉丁名：Apremilast Tablets 剂型：片剂 规格：10mg 注册分类：化学药品4类 药品批准文号：国药准字H20255527 上市许可持有人：北大医药股份有限公司 药品生产企业：北大医药股份有限公司 2、药品通用名称：阿普米司特片 英文名/拉丁名：Apremilast Tablets 剂型：片剂 规格：30mg 注册分类：化学药品4类 药品批准文号：国药准字H20255528 上市许可持有人：北大医药股份有限公司 药品生产企业 ...

格隆汇9月25日丨北大医药(000788.SZ)公布，收到国家药品监督管理局核准签发的《药品注册证书》， 药品通用名称：阿普米司特片。阿普米司特是一种特异性靶向磷酸二酯酶-4（PDE4）的小分子抑制 剂，通过调节细胞内炎症信号通路，有效抑制促炎因子释放并增加抗炎因子生成，从而精准控制炎症反 应。阿普米司特片用于治疗符合接受光疗或系统治疗指征的中度至重度斑块状银屑病的成人患者，具有 起效快、疗效明确、安全性高等特点，已被《中国银屑病诊疗指南（2023版）》列为系统药物治疗的一 线选择。 ...

人民财讯9月25日电，北大医药（000788）9月25日公告，公司收到国家药监局核准签发的阿普米司特片 的药品注册证书。阿普米司特片用于治疗符合接受光疗或系统治疗指征的中度至重度斑块状银屑病的成 人患者。 ...

阿普米司特是一种特异性靶向磷酸二酯酶-4(PDE4)的小分子抑制剂，通过调节细胞内炎症信号通路，有 效抑制促炎因子释放并增加抗炎因子生成，从而精准控制炎症反应。阿普米司特片用于治疗符合接受光 疗或系统治疗指征的中度至重度斑块状银屑病的成人患者，具有起效快、疗效明确、安全性高等特点。 智通财经APP讯，北大医药(000788.SZ)公告，公司收到国家药品监督管理局核准签发的《药品注册证 书》，本次取得药品注册证书的药品为阿普米司特片两种规格(10mg与30mg)。 ...

阿普米司特是一种特异性靶向磷酸二酯酶-4(PDE4)的小分子抑制剂，通过调节细胞内炎症信号通路，有 效抑制促炎因子释放并增加抗炎因子生成，从而精准控制炎症反应。阿普米司特片用于治疗符合接受光 疗或系统治疗指征的中度至重度斑块状银屑病的成人患者，具有起效快、疗效明确、安全性高等特点。 北大医药（000788）(000788.SZ)公告，公司收到国家药品监督管理局核准签发的《药品注册证书》， 本次取得药品注册证书的药品为阿普米司特片两种规格(10mg与30mg)。 ...

格隆汇9月25日丨北大医药(000788.SZ)公布，收到国家药品监督管理局核准签发的《药品注册证书》， 药品通用名称：阿普米司特片。阿普米司特是一种特异性靶向磷酸二酯酶-4（PDE4）的小分子抑制 剂，通过调节细胞内炎症信号通路，有效抑制促炎因子释放并增加抗炎因子生成，从而精准控制炎症反 应。阿普米司特片用于治疗符合接受光疗或系统治疗指征的中度至重度斑块状银屑病的成人患者，具有 起效快、疗效明确、安全性高等特点，已被《中国银屑病诊疗指南（2023版）》列为系统药物治疗的一 线选择。 ...

Core Viewpoint - The article discusses the results of drug production supervision inspections conducted by the Jiangxi Provincial Drug Supervision Administration from January to June 2025, highlighting compliance and non-compliance among various pharmaceutical companies [2][3][4]. Summary by Category Inspection Results - A total of 23 pharmaceutical companies were inspected during the first half of 2025, with most companies found to be compliant with the Good Manufacturing Practice (GMP) standards [2][3]. - Specific companies such as Jiangxi Ma Kang Pharmaceutical Co., Ltd. and Jiangxi Chengzhi Yongfeng Pharmaceutical Co., Ltd. were noted for their compliance in producing various drug forms including eye drops and traditional Chinese medicine [2][3]. Compliance Details - Companies like Jiangxi Qinfeng Pharmaceutical Co., Ltd. and Jiangxi Yichuan Pharmaceutical Technology Co., Ltd. were recognized for their adherence to GMP during inspections, covering a range of products from small volume injections to tablets [3][4]. - The inspections included checks on production lines for specific drugs, ensuring that companies met the required safety and quality standards [2][3]. Non-Compliance Issues - Some companies faced issues during inspections, although the article primarily focuses on those that complied with regulations [2][3]. - The inspections aimed to ensure that all pharmaceutical products manufactured in the province meet the necessary legal and quality standards [2][3][4].

Core Viewpoint - The rising public awareness of autoimmune diseases, particularly ankylosing spondylitis, has led to increased interest in the pharmaceutical company Ganzhou Hemei Pharmaceutical Co., Ltd. as it seeks to go public with its core drug Mufemilast targeting psoriasis and ankylosing spondylitis [1][6]. Company Overview - Ganzhou Hemei Pharmaceutical is preparing for an IPO under the Hong Kong Stock Exchange's 18A biotechnology rules, focusing on high investment and potential returns typical of biopharmaceutical companies [2]. - The company has not yet generated revenue and relies heavily on government subsidies and continuous financing to sustain operations [2][11]. Product Pipeline - The company has seven clinical-stage small molecule candidates aimed at addressing unmet medical needs in autoimmune diseases and oncology [2]. - Mufemilast is a dual-action PDE4 inhibitor that has entered the NDA priority review process, targeting multiple indications including psoriasis and ankylosing spondylitis [2][3]. Market Potential - The market for psoriasis drugs in China has seen rapid growth, with a compound annual growth rate (CAGR) of 30.4% from 2019 to 2023, reaching a market size of 13.9 billion yuan in 2023, projected to soar to 89.4 billion yuan by 2032 [3]. - The autoimmune disease drug market in China has expanded from $2.5 billion in 2019 to $4 billion in 2023, with expectations to reach $26.3 billion by 2032, reflecting a CAGR of 23.3% [6]. Competitive Landscape - The competitive environment for Mufemilast is intense, with existing competitors having undergone significant price reductions due to national procurement policies, with price drops exceeding 93% for some products [5]. - There are currently five approved small molecule targeted therapies for psoriasis in China, with 37 more in clinical development, indicating a crowded market for Mufemilast [5][8]. Financial Status - The company reported significant losses of 156 million yuan in 2023 and 123 million yuan in 2024, with minimal other income [11]. - The company has undergone multiple rounds of financing since 2021, raising over 500 million yuan to support its operations, with a post-investment valuation of 3.9 billion yuan [11]. Leadership - The founder and chairman, Zhang Hesheng, has over 20 years of experience in biopharmaceuticals and holds a significant voting power in the company [12].