近日，北京福元医药股份有限公司（以下简称"公司"）收到了国家药品监督管理局（以下简称"国家药 监局"）颁发的兰索拉唑肠溶胶囊（规格：15mg；30mg）（以下简称"该药品"）《药品注册证书》（证 书编号：2025S02336、2025S02337），批准该药品生产。现将相关情况公告如下： 一、药品注册证书主要内容 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、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性承担法律责任。 ■ 二、药品相关信息 由Takeda研制的兰索拉唑肠溶胶囊，最早于1990年12月31日获法国批准上市，1996年12月6日，经国家 药品监督管理局批准，兰索拉唑肠溶胶囊在国内上市，用于胃溃疡、十二指肠溃疡、反流性食管炎、 卓-艾综合征（Zollinger-Ellison症候群）、吻合口溃疡。 公司于2024年4月25日获得申报受理通知书，并于近日获得国家药监局批准。根据国家相关政策规定， 本次获得《药品注册证书》，为视同通过一致性评价。 截至本公告日，公司针对该药品累计研发投入为人民币583.23万元(未经审计)。 2025年8月1日 三、同类药品的市场状况 米内网数 ...

Group 1 - The core point of the article is that Fuyuan Pharmaceutical has received the drug registration certificate for Lansoprazole enteric-coated capsules from the National Medical Products Administration, allowing the company to commence production of the drug [2] Group 2 - The approved specifications for the drug are 15mg and 30mg [2] - This approval represents a significant milestone for the company in expanding its product offerings in the pharmaceutical market [2] - The announcement was made on the evening of July 31 [2]

2024年1至12月份，福元医药的营业收入构成为：药品制剂占比93.12%，医疗器械占比6.46%，其他业 务占比0.36%，其他占比0.06%。 福元医药（SH 601089，收盘价：24.13元）7月31日晚间发布公告称，近日，北京福元医药股份有限公 司收到了国家药品监督管理局颁发的兰索拉唑肠溶胶囊《药品注册证书》，批准该药品生产。 （文章来源：每日经济新闻） ...

Core Viewpoint - Fuyuan Pharmaceutical (601089.SH) has received the drug registration certificate from the National Medical Products Administration for Lansoprazole enteric-coated capsules, indicating approval for production [1] Company Summary - The approved Lansoprazole enteric-coated capsules are available in two specifications: 15mg and 30mg [1] - Lansoprazole was developed by Takeda and was first approved for sale in France on December 31, 1990 [1] - The drug was approved for domestic sale in China on December 6, 1996, and is indicated for conditions such as gastric ulcers, duodenal ulcers, gastroesophageal reflux disease, Zollinger-Ellison syndrome, and anastomotic ulcers [1] Industry Summary - The approval of Lansoprazole enteric-coated capsules reflects ongoing regulatory support for pharmaceutical products aimed at treating gastrointestinal disorders [1]

Core Viewpoint - The company has received the drug registration certificate for Lansoprazole enteric-coated capsules, which will enhance its product line and market competitiveness [1] Group 1 - The National Medical Products Administration has issued a drug registration certificate for Lansoprazole enteric-coated capsules in 15mg and 30mg specifications [1] - The drug is considered to have passed the consistency evaluation, indicating its quality and efficacy [1] - The total R&D investment for this drug by the company amounts to RMB 5.8323 million [1]