Yifan Pharmaceutical announced that the wholly-owned subsidiary Suzhou Yifan Pharmaceutical Co., Ltd. received the “Notice of Acceptance” issued by the State Drug Administration for the registration and marketing of drugs produced domestically for oral phenylbutyrate on July 16, 2025. This drug is mainly suitable for long-term treatment of patients with urea cycle disorder that cannot be controlled by limiting protein intake and/or simply supplementing with amino acids. The company submitted an application for registration and marketing license for domestically produced drugs on June 23, 2025, and was accepted on July 16, 2025. As of the disclosure date of this report, only 1 domestic company listed the oral glyceryl phylbutyrate, which is Immedica Pharma AB. Currently, in addition to the company, 2 other companies are reviewing applications in accordance with the chemical drug registration classification category 4 application and the chemical drug registration classification category 5.2 application, respectively. According to IQVIA data, global sales of glyceryl phylbutyrate for oral use in 2024 were approximately US$71.05 million. The company invested about 6.9023 million yuan in research and development projects for oral administration of glyceryl phenylbutyrate and its APIs.

Yifan Pharmaceutical announced that the wholly-owned subsidiary Suzhou Yifan Pharmaceutical Co., Ltd. received the “Notice of Acceptance” issued by the State Drug Administration for the registration and marketing of drugs produced domestically for oral phenylbutyrate on July 16, 2025. This drug is mainly suitable for long-term treatment of patients with urea cycle disorder that cannot be controlled by limiting protein intake and/or simply supplementing with amino acids. The company submitted an application for registration and marketing license for domestically produced drugs on June 23, 2025, and was accepted on July 16, 2025. As of the disclosure date of this report, only 1 domestic company listed the oral glyceryl phylbutyrate, which is Immedica Pharma AB. Currently, in addition to the company, 2 other companies are reviewing applications in accordance with the chemical drug registration classification category 4 application and the chemical drug registration classification category 5.2 application, respectively. According to IQVIA data, global sales of glyceryl phylbutyrate for oral use in 2024 were approximately US$71.05 million. The company invested about 6.9023 million yuan in research and development projects for oral administration of glyceryl phenylbutyrate and its APIs.