Core Points - Yifan Pharmaceutical's subsidiary Sichuan Defeng Pharmaceutical has received a drug registration acceptance notice from the National Medical Products Administration for the production of Sodium Sapropterin Dihydrochloride Powder [1][2] - The drug is intended for patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin (BH4) responsive phenylketonuria (PKU) and is applicable for adults and children over one month old [1][2] - The company has invested approximately 4.22 million yuan in the research and development of this project [4] Drug Registration Details - Acceptance Number: CYHS2503557 - Drug Name: Sodium Sapropterin Dihydrochloride Powder - Application Type: Domestic production drug registration license - Specification: 100mg (calculated as C9H15N5O3·2HCl) - Drug Registration Category: Class 3 chemical drug - Applicant: Sichuan Defeng Pharmaceutical [1][2] Market Context - As of the report date, Yifan Pharmaceutical is the only company in China to apply for the registration of Sodium Sapropterin Dihydrochloride Powder, with only one other company, Annora Pharma Private Limited, having submitted a registration for a different category [2] - There are currently no Sodium Sapropterin Dihydrochloride Powder products available on the domestic market [2] - According to IQVIA, the global sales for Sodium Sapropterin Dihydrochloride Powder are projected to be approximately 100 million USD in 2024 [3]

Core Viewpoint - Yifan Pharmaceutical announced that its wholly-owned subsidiary, Sichuan Defeng Pharmaceutical Co., Ltd., has received the acceptance notice for the domestic production registration application of Salbutamol Sulfate Powder from the National Medical Products Administration [2] Group 1 - The acceptance notice indicates a significant step towards the commercialization of Salbutamol Sulfate Powder, which may enhance the company's product portfolio [2] - The approval process reflects the regulatory compliance and potential market entry for the new pharmaceutical product [2]

Group 1 - Yinglian Co., Ltd. expects a net profit increase of 1531.13% to 1672.97% year-on-year for the first three quarters of 2025, with projected revenue of 1.63 billion to 1.65 billion yuan, a growth of 9.49% to 10.83% [1] - Meixin Sheng plans to reduce its shareholding by no more than 1% through centralized bidding and block trading [1] - Huayin Technology signed two sales contracts totaling 402 million yuan, with one contract for special functional materials and another for research project materials [3] Group 2 - Shen Highways reported a total toll revenue of 114 million yuan for August [5] - Dash Smart signed a contract worth 113 million yuan for a smart hospital project [7] - Tianbang Food received an administrative regulatory measure decision from the China Securities Regulatory Commission for failing to disclose information in a timely manner [8] Group 3 - Fashilong plans to invest 250 million yuan to establish a wholly-owned subsidiary focused on AI applications and cloud computing [10] - Junpu Intelligent received a government subsidy of 20 million yuan, accounting for 243.97% of its audited net profit for 2024 [11] - Longyun Co. plans to apply for a bank credit limit of 32 million yuan [12] Group 4 - Yifan Pharmaceutical's subsidiary received acceptance for a drug registration application for a medication used to lower phenylalanine levels in patients [12] - Rundu Co. received a drug registration certificate for a hypertension medication [13] - Huahai Qingke elected a new employee director and appointed a new vice president [17] Group 5 - Wanyi Technology received a government subsidy of 173,000 yuan [19] - Haizheng Pharmaceutical's tacrolimus capsules passed the consistency evaluation for generic drugs [20] - Pulaike's new veterinary vaccine received registration certification [22] Group 6 - Boguang New Materials signed a major sales contract estimated at 4.3 billion to 5 billion yuan for nickel powder products [41] - Electric Soul Network announced plans for shareholders to reduce their holdings by up to 1.63% [42] - Jin Haitong's shareholders plan to reduce their holdings by up to 3% [44]

格隆汇9月29日丨亿帆医药(002019.SZ)公布，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》。盐酸沙丙蝶呤散剂 适用于降低四氢生物蝶呤（BH4）反应性苯丙酮尿症（PKU）所致的高苯丙氨酸血症（HPA）患者血中 苯丙氨酸（Phe）水平，可用于成人及1月龄以上儿童。 ...

亿帆医药（002019）(002019.SZ)发布公告，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》。 盐酸沙丙蝶呤散剂适用于降低四氢生物蝶呤(BH4)反应性苯丙酮尿症(PKU)所致的高苯丙氨酸血症(HPA) 患者血中苯丙氨酸(Phe)水平，可用于成人及1月龄以上儿童。公司于2025年9月向药监局递交境内生产 药品注册上市许可申请，并于2025年9月获得受理。 ...

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].