By Fineline Cube 
Haihe Biopharma Co., Ltd. has filed a market application with Japan’s Ministry of Health, Labour and Welfare (MHLW) for risovalisib (CYH33), a PI3Kα inhibitor targeting ovarian clear cell carcinoma (OCCC) patients with PIK3CA gene mutations whose disease has progressed or recurred after prior chemotherapy.
Drug Mechanism and Background
Risovalisib is a highly selective phosphatidylinositol 3-kinase α (PI3Kα) inhibitor independently developed by Haihe Biopharma. It received orphan drug designation from Japan’s MHLW in June 2025 and holds global intellectual property rights.
Clinical Trial Results
The multinational, multicenter, open-label, single-arm Phase 2 trial (CYH33-G201) evaluated risovalisib’s efficacy and safety in patients with OCCC and PIK3CA mutations. Results demonstrated significant antitumor activity, supporting the drug’s potential as a new precision treatment option for OCCC.
Future Outlook
With its promising trial data and orphan drug status, risovalisib represents a significant advancement in the treatment of OCCC and highlights Haihe Biopharma’s commitment to innovative oncology solutions.-Fineline Info & Tech