Haihe Pharmaceutical’s Resorliside has been approved for marketing in Japan

On March 23, 2026, Haihe Pharmaceuticals reported that its independently developed selective PI3Kα inhibitor. Resorliside mesylate tablets have been approved for marketing in Japan for the treatment of ovarian clear cell carcinoma (OCCC) that has progressed after chemotherapy and carries the PIK3CA gene mutation.

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Resorlisel is the world’s first monotherapy targeted therapy for OCCC that has progressed after chemotherapy, and it is also the world’s first selective PI3Kα inhibitor approved in Japan.Resorlisel possesses a novel chemical structure. This approval is based on a single-arm, open-label, international multicenter pivotal phase II clinical trial (NCT05043922), conducted at 39 centers in China and Japan. The study population included patients with ovarian clear cell carcinoma who had progressed after chemotherapy and carried the PIK3CA gene mutation. The primary endpoint was objective response rate (ORR) assessed by a blinded independent review committee (BIRC). The medication was administered orally at a dose of 40 mg once daily on an empty stomach. Among 84 patients (45.2% in China, 54.8% in Japan) with evaluable efficacy…Resorlisel has demonstrated clinically significant antitumor activity. Its overall safety profile is manageable and well-tolerated. Common adverse reactions include hyperglycemia and rash, which are generally consistent with the safety profile of other approved PI3Kα inhibitors and can be effectively managed and reversed with symptomatic treatment or dose adjustment.

(Press release, Shanghai HaiHe Pharmaceutical, MAR 23, 2026, View Source;utm_source=official [SID1234669250])