On July 15, 2026 Taiho Pharmaceutical Co., Ltd. (hereinafter "Taiho") reported that the PI3Kα inhibitor, HAIZEXIN tablets 10mg (generic name: risovalisib mesilate hydrate), has been listed on the National Health Insurance (NHI) reimbursement price list. The launch of this new product in Japan is scheduled for July 28, 2026.
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In March 2026, Haihe Biopharma K. K., a fully owned affiliate of Haihe Biopharma Co., Ltd. (hereinafter "Haihe"), obtained approval to manufacture and market HAIZEXIN in Japan for the treatment of a patient with ovarian clear cell carcinoma (hereinafter "OCCC") harboring PIK3CA gene mutations that has progressed after chemotherapy. Taiho will be responsible for sales and medical information activities for HAIZEXIN in Japan pursuant to an exclusive license agreement with Haihe, entered into in October 2025, for the development, manufacture, and commercialization of HAIZEXIN.
HAIZEXIN is a small-molecule PI3Kα inhibitor developed by Haihe. HAIZEXIN binds to the ATP-binding site of PI3Kα and inhibits its kinase activity, thereby inhibiting the phosphorylation of AKT, a downstream molecule in the PI3K signaling pathway¹, which is believed to result in antitumor effects.
Taiho and Haihe together will work with healthcare professionals to serve patients with OCCC by providing HAIZEXIN as a new treatment option.
Summary of Product Information in Japan
Brand name HAIZEXIN tablets 10mg
Generic name Risovalisib mesilate hydrate
Indications Ovarian clear cell carcinoma (OCCC) harboring PIK3CA gene mutations that has progressed after chemotherapy
Dosage and administration Normally, for adults, oral administration in fasting condition of 40mg of risovalisib once daily. Dosage should be reduced based on the patient’s condition.
Date of manufacturing and marketing approval March 23, 2026
Date listed in NHI reimbursement price listing July 15, 2026
Scheduled launch date in Japan July 28, 2026
NHI reimbursement price JPY 7,313.40 / tablet
Packaging PTP Packaging: 28 tablets (14 tablets x 2)
Manufacturer and distributor Haihe Biopharma K. K.
Distributor Taiho Pharmaceutical Co., Ltd.
About Ovarian Clear Cell Carcinoma with PIK3CA Gene Mutations
Ovarian cancer is one of the leading causes of cancer-related death in women, with approximately 320,000 new cases diagnosed worldwide in 2022, making it the third most common gynecologic cancer.2 In Japan, the number of registered ovarian cancer cases was reported to be 16,590 in 2023.3 OCCC is a histological subtype of epithelial ovarian cancer and accounts for approximately 21.9% of ovarian cancers in Japan.4 OCCC has a high prevalence of PIK3CA gene mutations, which are observed in approximately 30% to 40% of cases5,6; based on this prevalence, the annual number of patients with OCCC harboring PIK3CA gene mutations is estimated to be approximately 650 to 950. OCCC is a rare cancer with limited treatment options, and there remains a need to develop new therapies.
(Press release, Taiho, JUL 15, 2026, View Source [SID1234669206])