Core Points - Shanghai Haihe Pharmaceutical Co., Ltd. has entered into an exclusive licensing agreement with Japan's Daikyo Pharmaceutical Co., Ltd. for the development, production, and commercialization of the PI3Kα inhibitor, CYH33, in Japan [1] - This collaboration follows a previous agreement between Haihe Pharmaceutical and Daikyo Pharmaceutical regarding the MET inhibitor, Gomitil, which has successfully been approved for sale in both China and Japan [1] - The agreement will provide Haihe Pharmaceutical with an upfront payment, milestone payments based on development and sales, and royalties based on sales in Japan [1] Group 1 - The partnership highlights Daikyo Pharmaceutical's recognition of Haihe Pharmaceutical's research capabilities [2] - The collaboration reflects Haihe Pharmaceutical's strategy of "Chinese innovation, global layout," supported by the capital investment from Huayi Family [2] - Huayi Family's investment has facilitated Haihe Pharmaceutical's research and global expansion, enhancing the stability and speed of its innovative drug's international journey [2]

Core Viewpoint - Shanghai Haihe Pharmaceutical Research and Development Co., Ltd. has officially applied for the new drug marketing authorization for its innovative drug PI3Kα inhibitor, Risoletin (development code: CYH33), to the Japanese Ministry of Health, Labour and Welfare (MHLW) [1] Group 1: Drug Development and Approval - The application is for the treatment of ovarian clear cell carcinoma (OCCC) with PIK3CA gene mutations in patients who have progressed or relapsed after chemotherapy [1] - Risoletin has previously received orphan drug designation from the MHLW [1] - The application is based on efficacy and safety data from the CYH33-G201 pivotal Phase II study, which is a multi-country, multi-center, open-label clinical trial [1] Group 2: Clinical Research and Efficacy - The global principal investigator for the study is Professor Wu Xiaohua from Fudan University Shanghai Cancer Center [1] - CYH33 is a novel, highly active selective inhibitor of phosphoinositide 3-kinase alpha (PI3Kα) with global intellectual property rights [1] - Preclinical studies indicate that CYH33 effectively and specifically inhibits PI3Kα kinase activity and demonstrates strong anti-tumor effects on tumor models with PIK3CA mutations [1] Group 3: Safety and Tolerability - Preliminary data from clinical trials suggest that CYH33 has good safety and tolerability, with controllable toxicity [2] - CYH33 is effective in treating various advanced solid tumors with PIK3CA mutations, including breast cancer, ovarian cancer, and endometrial cancer [2] - Ongoing clinical studies are evaluating CYH33 as a monotherapy or in combination with other anti-tumor drugs to assess its safety and efficacy in a broader range of advanced cancer patients [2]