Core Viewpoint - Yifan Pharmaceutical (002019.SZ) announced that its wholly-owned subsidiary, Sichuan Defeng Pharmaceutical Co., Ltd., has received the acceptance notice for the domestic production drug registration application for Sodium Sapropterin Dihydrochloride Granules from the National Medical Products Administration (NMPA) [1] Group 1 - The drug Sodium Sapropterin Dihydrochloride Granules is intended to lower phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) caused by tetrahydrobiopterin (BH4) responsive phenylketonuria (PKU) [1] - The medication is applicable for adults and children over one month old [1] - The company submitted the drug registration application to the NMPA in September 2025 and received acceptance in the same month [1]

Core Viewpoint - Yifan Pharmaceutical (002019) has received a production registration acceptance notice from the National Medical Products Administration for its hydrochloride sapropterin dispersible tablets, marking a significant step in the development of a treatment for phenylketonuria (PKU) [1] Company Summary - Yifan Pharmaceutical's wholly-owned subsidiary, Sichuan Defeng Pharmaceutical Co., Ltd., has been granted the acceptance notice for the registration of hydrochloride sapropterin dispersible tablets [1] - The product is intended to lower blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) caused by tetrahydrobiopterin (BH4) responsive phenylketonuria (PKU) and is suitable for adults and children over one month old [1] - As of the report date, Yifan Pharmaceutical is the only company in China to apply for the market registration of hydrochloride sapropterin dispersible tablets, with only one other company, Annora Pharma Private Limited, having submitted a similar application [1] Industry Summary - There are currently no hydrochloride sapropterin dispersible tablets available on the market in China, indicating a potential market opportunity for Yifan Pharmaceutical as the first applicant for this generic drug [1] - The registration application is classified under chemical drug registration category 3, positioning the company as a pioneer in this segment within the domestic market [1]

关于全资子公司收到药品注册受理通知书的公告 亿帆医药股份有限公司 证券代码：002019 证券简称：亿帆医药 公告编号：2025-060 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。 亿帆医药股份有限公司（以下简称"公司"）全资子公司四川德峰药业有限 公司于近日收到国家药品监督管理局（以下简称"药监局"）签发的盐酸沙丙蝶 呤散剂境内生产药品注册上市许可申请《受理通知书》。现将相关情况公告如下： 一、申请注册药品的基本情况 受理号：CYHS2503557 药品名称：盐酸沙丙蝶呤散剂 申请事项：境内生产药品注册上市许可 规格：100mg（按C9H15N5O3·2HCl 计） 药品注册分类：化学药品3类 申请人：四川德峰药业有限公司 二、产品的相关情况 截至本报告披露日，除本公司外，国内盐酸沙丙蝶呤散剂上市申报仅 1 家企 业，为 Annora Pharma Private Limited（注册分类为化药 5.2 类）。目前国内无盐 酸沙丙蝶呤散剂上市。公司按照化学药品注册分类 3 类申请上市许可，为国内首 个仿制药申报。 根据 IQVIA 数据显示，盐酸沙丙蝶呤 ...

Core Viewpoint - The company has received a production registration application acceptance notice for a new drug, indicating a significant step in its product development pipeline [1] Group 1: Company Developments - The company's wholly-owned subsidiary, Sichuan Defeng Pharmaceutical Co., Ltd., has received the acceptance notice from the National Medical Products Administration for the registration of a new drug, Sodium Sapropterin Dihydrochloride [1] - This drug is intended for patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin (BH4) responsive phenylketonuria (PKU), applicable for adults and children over one month old [1] - The company submitted the application in September 2025 and has become the first domestic company to apply for this generic drug, with only one overseas company having submitted a similar application [1] Group 2: Market Potential - The global sales forecast for the drug is approximately $100 million in 2024 [1] - The company has invested around 4.22 million yuan in research and development for this drug [1] - There is uncertainty regarding the subsequent approval and sales of the drug [1]

Core Viewpoint - The article discusses the announcement by President Trump regarding a new round of high tariffs on various imported products, particularly focusing on the pharmaceutical industry, which will see a 100% tariff on patented and branded drugs starting October 1, 2023, significantly higher than the previous 15% agreement with Europe [1][2]. Group 1: Tariff Details and Market Reaction - The new tariffs include a 50% tariff on kitchen cabinets and bathroom sinks, a 30% tariff on imported furniture, and a 100% tariff on patented and branded drugs, with exemptions for companies that have manufacturing facilities "under construction" in the U.S. [1][2] - Following the announcement, the innovation drug index and various biotech ETFs saw declines of over 1%, with specific companies like Huahai Pharmaceutical and Baiyue Shenzhou experiencing stock price drops [2][3]. Group 2: Company Responses and Strategies - Many domestic pharmaceutical companies are assessing the impact of the new tariffs, with some indicating that their production capabilities in the U.S. may mitigate the effects. For instance, Huahai Pharmaceutical is evaluating whether its facilities meet the criteria for exemption [4][5]. - Major U.S. pharmaceutical companies like Johnson & Johnson and Eli Lilly have already invested significantly in expanding their domestic production capabilities, with Johnson & Johnson planning to invest approximately $20 billion in North Carolina and Eli Lilly announcing a $270 billion investment for new factories [3][4]. Group 3: Expert Opinions and Future Outlook - Industry experts suggest that the 100% tariff is politically motivated and may not significantly impact domestic innovative drug companies, as many already have manufacturing in the U.S. and the majority of their sales are through partnerships with multinational corporations [6][7]. - The anticipated implementation of a global drug pricing model by the U.S. government could further influence drug pricing and market dynamics, but experts believe that the overall impact on the domestic pharmaceutical industry will be limited [6][7].

Core Viewpoint - The U.S. will impose a 100% tariff on patented and branded drugs starting October 1, which may impact pharmaceutical companies' operations and supply chains in the U.S. market [1] Company Response - Yifan Pharmaceutical has been monitoring U.S. tariff policies and is optimizing the supply chain and cost strategies for its innovative drug F-627 [1] - The company plans to shift the production and shipping of F-627 to the U.S. to mitigate the impact of tariffs, with the potential for local dispatch as early as next year [1] - Yifan Pharmaceutical asserts that the tariff policy will not have a significant adverse effect on the sales of F-627 in the U.S. market [1]

证券日报网讯亿帆医药（002019）9月24日在互动平台回答投资者提问时表示，截至2025年9月19日公司 股东人数为46838户。 ...

Core Viewpoint - The company is focusing on developing synthetic biological products and has made significant investments in its production capabilities, indicating a strategic shift towards in-house manufacturing and innovation [2]. Group 1: Investment and Production - The company has invested 1 billion yuan in building a new factory in Qidong City, which suggests a potential decision to move away from collaboration with Xinfu [2]. - The company aims to provide natural, green, and sustainable innovative products across various markets, including healthcare, human and animal nutrition, and pharmaceuticals [2]. Group 2: Collaboration and Future Plans - There are questions regarding the future of existing collaborations on products such as Ectoin, Farnesol, and Fucoidan, particularly whether these partnerships will end after their current terms [2].

Group 1 - The company Yifan Pharmaceutical (002019.SZ) is expected to disclose its Q3 financial report on October 31, 2023, as per the schedule set by the Shenzhen Stock Exchange [2] - The company has indicated that the preparation for the Q3 report by the Shenzhen Stock Exchange has not yet begun [2]

Group 1 - The core point of the article is that Yifan Pharmaceutical (002019.SZ) has successfully launched its product Yilishu in the United States [1] Group 2 - The company has announced this achievement on its investor interaction platform [1]