Sichuan Huiyu Pharmaceutical Co., Ltd. (688553.SH) announced that its wholly-owned subsidiary, Sichuan Huiyu Haiyue Pharmaceutical Technology Co., Ltd. ("Huiyu Haiyue"), received the "Acceptance Notice" issued by the National Medical Products Administration (NMPA) on November 21, 2025. The clinical trial application for HYP-6589 tablets (R&D code: HY-0006) in combination with osimertinib for the treatment of advanced non-small cell lung cancer (NSCLC) with target-driven gene positivity has been accepted.

HYP-6589 tablets, developed by Huiyu Haiyue, are a highly selective SOS1 small-molecule inhibitor classified as a Class 1 innovative chemical drug. According to the NMPA's "Classification and Application Requirements for Chemical Drug Registration" (No. 44, 2020), HYP-6589 is a structurally novel compound with pharmacological activity. The company has already obtained approval and is conducting clinical research in China for HYP-6589 as a monotherapy for advanced solid tumors. This new application seeks to expand its use in combination with osimertinib for advanced NSCLC with target-driven gene positivity.

As of the announcement date, no similar products have been approved for marketing domestically or internationally.