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Kelun-Biotech's New Drug Application for Its Novel Next-generation Selective RET Inhibitor A400/EP0031 Accepted for Review by the NMPA for the Treatment of RET-fusion positive NSCLC
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") announced that a new drug application (NDA) for the Company's small molecule rearranged during transfection (RET) kinase inhibitor A400 (also known as EP0031) was accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the treatment of adult patients with RET-fusion positive locally advanced, or metastatic non-small cell lung cancer (NSCLC). This acceptance fo
About this update from Sichuan Kelun-biotech Biopharmaceutical Co., Ltd. Class H
[{"type":"text","content":"CHENGDU, China, Sept. 23, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") announced that a new drug application (NDA) for the Company's small molecule rearranged during transfection (RET) kinase inhibitor A400 (also known as EP0031) was accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the treatment of adult patients with RET-fusion positive locally advanced, or metastatic non-small cell lung cancer (NSCLC). This acceptance for review is based on the positive results from the two pivotal Phase 2 cohorts of the KL400-I/II-01 study for both 1L and 2L+ advanced RET-fusion positive NSCLC.","length":762,"tagName":"p"},{"type":"image","alt":"(PRNewsfoto/四川科倫博泰生物醫藥股份有限公司)","displaySize":"","headline":null,"caption":"(PRNewsfoto/四川科倫博泰生物醫藥股份有限公司)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":116,"url":"https://media.zenfs.com/en/prnewswire.com/5455aad5e4ea0b08ff580f6c7e429747"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/vx69Ffpvj_nbbyPMBYckiw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTIwNDtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/5455aad5e4ea0b08ff580f6c7e429747","width":400,"height":116}},"href":"https://mma.prnewswire.com/media/2650617/logo_kelun_Biotech_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"Cohort 1 and 2, the Phase 2 stage of the KL400-I/II-01 study, evaluate the efficacy and safety of A400/EP0031 90mg orally once daily (QD) for the treatment of patients with pre-treated and treatment-naïve RET-fusion positive locally advanced, or metastatic NSCLC, respectively. Primary efficacy endpoints of the two pivotal cohorts were reached, where A400/EP0031 demonstrated favorable efficacy in pretreated and treatment-naïve NSCLC including patients with prior immunotherapy or brain metastases. A400/EP0031 also demonstrated an encouraging, manageable tolerability and safety profile.","length":635,"tagName":"p"},{"type":"text","content":"Dr. Michael Ge, CEO of Kelun-Biotech said, "We are pleased t...
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