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The sNDA for Sacituzumab Tirumotecan (sac-TMT) in Combination with Pembrolizumab as First‑Line Treatment for PD-L1-positive NSCLC Accepted for Review by NMPA
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company") announced that the sNDA (the "Application") for the Company's TROP2 ADC sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) (佳泰莱®) was accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. The application is for sac-TMT in combination with MSD's[1] anti-PD-1 monoclonal antibody pembrolizumab (KEYTRUDA®[2]) as first‑line treatment
About this update from Sichuan Kelun-biotech Biopharmaceutical Co., Ltd. Class H
[{"type":"text","content":"CHENGDU, China, May 8, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company") announced that the sNDA (the "Application") for the Company's TROP2 ADC sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) (佳泰莱®) was accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. The application is for sac-TMT in combination with MSD's[1] anti-PD-1 monoclonal antibody pembrolizumab (KEYTRUDA®[2]) as first‑line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have PD-L1 tumor proportion score (TPS) ≥1% and are EGFR-negative and ALK-negative. This acceptance is based on the positive results from the OptiTROP-Lung05 registrational Phase III study, and the application is the fifth indication application for sac-TMT that has been accepted by the NMPA.","length":974,"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/_akv3_ewNbQa30z0D5iFYg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTIwNA--/https://media.zenfs.com/en/prnewswire.com/5455aad5e4ea0b08ff580f6c7e429747","width":400,"height":116},"resize_sm":{"url":"https://s.yimg.com/ny/api/res/1.2/gkJw00lWJvUPRM0jwFSYnQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTY0MDtoPTE4Ng--/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":"The OptiTROP-Lung05 is a randomized, open-label, multicenter, Phase III clinical study that evaluates the efficacy and safety profile of sac-TMT in combination with pembrolizumab versus pembrolizumab monotherapy as first-line treatment for PD-L1-positive locally advanced or metastatic NSCLC. At a pre-specified interim analysis, the s...
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