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Kelun-Biotech Presents Pivotal Phase II Data for Lunbotinib Fumarate (A400/EP0031) in RET Fusion-Positive NSCLC at 2026 ASCO

On Friday, May 29, 2026, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. announced that China's National Medical Products Administration accepted its New Drug Application for lunbotinib fumarate to treat RET fusion-positive NSCLC.
Professor Qing Zhou from Guangdong Provincial People's Hospital presented pivotal Phase II data at the 2026 American Society of Clinical Oncology Annual Meeting in Chicago, where he noted the drug's progression "from the first presentation of Phase I data at ASCO 2023 to today."
The Independent Review Committee reported a confirmed objective response rate of 81.3% in treatment-naïve patients and 87.1% in pre-treated patients, demonstrating robust clinical activity regardless of therapy line.
Among 40 patients with central nervous system metastases, the disease control rate reached 92.5%, while treatment-related adverse events were predominantly Grade 1–2 with a 1.2% permanent discontinuation rate.
Kelun-Biotech, which has more than 30 ongoing innovative drug projects, granted United Kingdom-based Ellipses Pharma Limited exclusive development and commercialization rights for the agent outside Greater China.

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Kelun-Biotech Presents Pivotal Phase II Data for Lunbotinib Fumarate (A400/EP0031) in RET Fusion-Positive NSCLC at 2026 ASCO

CHENGDU, China, May 29, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company", 6990.HK) announced that at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago, USA, results from the pivotal Phase II study of…

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