YIFAN PHARMACEUTICAL(SZ:002019) Xin Lang Cai Jing·2025-09-29 08:11Core 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]