PRNewsWire
30 May 2026, 03:29 UTC · 3h ago
Source · https://www.prnewswire.com/news-releases/kelun-biotech-presents-pivotal-phase-ii-data-for-lunbotinib-fumarate-a400ep0031-in-ret-fusion-positive-nsclc-at-2026-asco-302786202.html
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China's NMPA has accepted the New Drug Application (NDA) for lunbotinib fumarate to treat RET fusion-positive NSCLC. — Acceptance of an NDA is a critical regulatory milestone that brings the company closer to commercialization and revenue generation in the Chinese market.
+0.70Pivotal Phase II data showed objective response rates (ORR) of 81.3% in treatment-naïve and 87.1% in pre-treated patients. — High efficacy rates in both patient groups suggest a strong competitive profile for the drug, increasing the likelihood of regulatory approval.
+0.60Lunbotinib fumarate demonstrated a 92.5% disease control rate in patients with baseline central nervous system (CNS) metastases. — Strong intracranial efficacy is a key differentiator in lung cancer treatments and expands the addressable patient population.
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The drug is currently in Phase II clinical trials in the US, UK, Europe, and UAE via a partnership with Ellipses Pharma. — International expansion increases the potential total addressable market beyond China, though it remains in the higher-risk trial stage.
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The company presented positive pivotal Phase II data for lunbotinib fumarate and had its New Drug Application accepted by the NMPA.
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