海和药物创新药申报海外上市许可

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]