Yifan Pharmaceutical: Wholly-owned subsidiary receives drug registration acceptance notice.

Yifan Pharmaceuticals announced that its wholly-owned subsidiary, Suzhou Yifan Pharmaceutical Co., Ltd., received the "Acceptance Notice" for the registration and listing approval of orally administered glycerol phenylbutyrate domestically produced drugs issued by the National Medical Products Administration on July 16, 2025. This drug is mainly used for the long-term treatment of patients with urea cycle disorders who cannot be controlled by restricting protein intake and/or simply supplementing amino acids. The company submitted the application for domestic production drug registration and listing approval on June 23, 2025, and received acceptance on July 16, 2025. As of the date of this report disclosure, there is only one enterprise listed domestically for orally administered glycerol phenylbutyrate, Immedica Pharma AB. Currently, apart from the company, there are two other enterprises undergoing evaluation for chemical drug registration categories 4 and 5.2, respectively. According to IQVIA data, global sales of orally administered glycerol phenylbutyrate in 2024 were approximately $71.05 million. The company's research and development investment in orally administered glycerol phenylbutyrate and its raw materials project is approximately 6.9023 million yuan.