Japan’s Ministry of Health approved Haihe Biopharma and Taiho Oncology’s risovalisib for PIK3CA-mutant advanced or recurrent ovarian clear cell carcinoma, pairing it with companion diagnostic clearance for AmoyDx’s AmoyDx PIK3CA Mutation Detection Kit. The approval expands biomarker-defined treatment options in Japan and ties eligibility to tumor tissue real-time PCR testing for PIK3CA mutations. The kit will be used to identify patients eligible for risovalisib, marketed as Haizexin in Japan. Haihe’s deal structure—exclusive rights for Taiho in Japan—puts both drug and test squarely into the same regulatory pathway, a key operational consideration for commercialization and patient access. For biotech operators, the decision is another marker of how regulators are increasingly bundling precision therapeutics with companion diagnostics to streamline clinical adoption and reduce off-label use.