Kelun-Biotech Announces Fourth Indication for Sacituzumab Tirumotecan (sac-TMT) Approved by NMPA in HR+/HER2- Breast Cancer

About this update from Sichuan Kelun-biotech Biopharmaceutical Co., Ltd. Class H

[{"type":"text","content":"CHENGDU, China, Feb. 6, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) announced that a new indication application for its TROP2-directed ADC sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) (佳泰莱®) has been approved by the National Medical Products Administration (NMPA) of China for treatment of adult patients with unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer (BC) who have received prior endocrine therapy (ET) and at least one line of chemotherapy in advanced setting. This approval for HR+/HER2- BC after at least one prior line of chemotherapy marks the fourth indication for sac-TMT approved for marketing in China.","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":"The approval is based on the positive results from the Phase III OptiTROP-Breast02 study which was selected as a Late-Breaking Abstract (LBA) and presented as an oral report at the 2025 European Society for Medical Oncology (ESMO) Congress.","length":240,"tagName":"p"},{"type":"text","content":"The OptiTROP-Breast02 study evaluated the efficacy and safety of sac-TMT monotherapy compared to investigator's choice of chemotherapy in patients with unresectable or metastatic HR+/HER2- BC. Of the patients enrolled in this Phase III study, 95.7% had visceral metastases, 75.9% had liver metastases; 52.9% were HER2-zero (IHC 0), while 47.1% were HER2-low (IHC 1+ or IHC 2+/ISH-). All patients had received prior CDK4/6 inhibitor and taxane therapy; 56.6% had...

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