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Kelun-Biotech Announces Breakthrough Therapy Designation Granted in China for Sacituzumab Tirumotecan (sac-TMT) in Combination with Immunotherapy Pembrolizumab for First-Line Treatment of PD-L1-Positive NSCLC
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company," 6990.HK) today announced that its TROP2-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) (佳泰莱®) in combination with MSD's anti-PD-1 monoclonal antibody pembrolizumab (KEYTRUDA®[1]) was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the first-line treatm
About this update from Sichuan Kelun-biotech Biopharmaceutical Co., Ltd. Class H
[{"type":"text","content":"CHENGDU, China, Jan. 5, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company," 6990.HK) today announced that its TROP2-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) (佳泰莱®) in combination with MSD's anti-PD-1 monoclonal antibody pembrolizumab (KEYTRUDA®[1]) was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the first-line treatment of 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.","length":757,"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":"BTD is granted for treatment regimens that provide effective treatment or prevention for conditions with no currently available therapy, or that demonstrate significant clinical advantages over currently available treatments. For drugs included in the breakthrough therapy process, if relevant conditions are met, applications for conditional approval and priority review and approval can be submitted when applying for marketing authorization.","length":444,"tagName":"p"},{"type":"text","content":"Previously, the company announced that results from the Phase III clinical trial of OptiTROP-Lung05, evaluating sac-TMT in combination with pembrolizumab as first-line treatment for PD-L1-positive NSCLC, demonstrated a statistically significant and clinically meanin...
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