China’s National Medical Products Administration (NMPA) granted approval and priority review actions for two oncology programs this week, signaling continued regulatory openness to domestically developed cancer drugs. Innovent Biologics received NMPA approval for Tabosun (ipilimumab IBI‑310) in combination with sintilimab as neoadjuvant therapy for MSI‑high/mismatch repair deficient colon cancer. Separately, Hutchmed’s NDA for fanregratinib (HMPL‑453), an FGFR‑targeted therapy for intrahepatic cholangiocarcinoma, was accepted and given priority review based on a single‑arm phase II registration study in China. Both decisions reflect the regulator’s willingness to fast‑track high‑unmet‑need oncology agents and to accept streamlined datasets for niche indications. The moves accelerate commercialization pathways for domestic biotechs and could intensify competition in China’s oncology market while shaping international partnering and regulatory strategies.
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