On October 16, 2025, Taiho Pharmaceutical Co., Ltd. (hereinafter "Taiho") and Haihe Biopharma Co., Ltd. (hereinafter "Haihe") announced today that the two companies have entered into an exclusive license agreement regarding the development, manufacturing and commercialization of the PI3Kα (phosphatidylinositol 3-kinase alpha) inhibitor risovalisib (international nonproprietary name; development code: CYH33). Risovalisib is currently being submitted for manufacturing and marketing approval in Japan as a treatment for ovarian clear cell carcinoma by Haihe Biopharma K.K., a fully owned affiliate of Haihe.
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Under the license agreement, Taiho will obtain exclusive rights in Japan to develop, manufacture and commercialize risovalisib, and Haihe will receive an upfront payment, development and sales milestone payments, and royalties based on sales revenue from Taiho.
Risovalisib is a novel, selective PI3Kα inhibitor developed by Haihe. In Japan, Haihe Biopharma K.K. submitted a New Drug Application in August 2025 for the anticipated indication of "advanced or recurrent ovarian clear cell carcinoma harboring PIK3CA gene mutations that has progressed after chemotherapy." Risovalisib was granted orphan drug designation by the Ministry of Health, Labour and Welfare in June 2025 in Japan.
"We are pleased to announce that we will be entering into this partnership with Haihe, with whom we have already built a strong collaborative relationship. Through risovalisib, a new treatment option for patients with ovarian clear cell carcinoma, we will continue to work together with Haihe to further contribute to patients and healthcare professionals," stated Masayuki Kobayashi, President and Representative Director of Taiho.
"We are pleased to announce that we are entering into a partnership with Taiho, one of the leading oncology companies in Japan, regarding the PI3Kα inhibitor risovalisib. We hope our collaboration will be able to provide a promising treatment option for patients with ovarian clear cell carcinoma and other PI3Kα-associated diseases," stated Dr. Jian Ding from Haihe, Academician of the Chinese Academy of Engineering.
(Press release, Taiho, OCT 16, 2025, View Source [SID1234669244])