By Fineline Cube 
China‑based Haihe Biopharma Co., Ltd. (the “Licensor”) announced today that it has entered into an exclusive license agreement with Taiho Pharmaceutical Co., Ltd. (the “Licensee”) for the development, manufacture, and commercialization of the phosphatidylinositol 3‑kinase alpha (PI3Kα) inhibitor risovalisib (development code: CYH33) in the Japanese market.
Key Deal Highlights
- Exclusive Rights – Taiho Pharmaceutical obtains sole rights to develop, manufacture, and sell risovalisib tablets in Japan.
- Financial Terms – Haihe will receive an upfront payment, milestone‑based development and sales payments, and ongoing royalties on net sales within the licensed territory.
- Strategic Continuity – This is the second collaboration between Haihe and Taiho, following their joint venture on glumetinib.
About Risovalisib
| Feature | Detail |
|---|---|
| Class | Novel, highly potent, PI3Kα‑selective inhibitor |
| Intellectual Property | Global independent IP owned by Haihe Biopharma |
| Clinical Focus | PIK3CA‑gene‑mutation‑positive ovarian clear cell carcinoma (OCCC) that has progressed or recurred after chemotherapy |
| Regulatory Status | NDA submitted to Japan (August 2025); Orphan Drug designation by MHLW (June 2025) |
Implications for the Japanese Oncology Market
- Unmet Need – OCCC is a rare, aggressive subtype of ovarian cancer with limited treatment options.
- Orphan Designation – The MHLW orphan status may accelerate review, provide market exclusivity, and enable price‑support mechanisms.
- Strategic Value – Taiho’s established oncology portfolio and distribution network will fast‑track risovalisib’s clinical development and market entry.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech