Kelun-Biotech to Present Multiple Study Results at ESMO 2026
Kelun-Biotech to Present Multiple Study Results at ESMO 2026 |
| [13-October-2026] |
CHENGDU, China, Oct. 13, 2026 /PRNewswire/ -- The 2026 European Society for Medical Oncology (ESMO) Congress will be held in Madrid, Spain, from October 23 to 27. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) will present results from multiple clinical studies at the congress, including data from its trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870)(佳泰莱®) and another ADC.
Among them, multiple research findings for sac-TMT have been selected for oral presentations, including the Phase III OptiTROP-Lung04 and OptiTROP-Lung06 studies, which have both been selected for the "Non-Small Cell Lung Cancer (NSCLC), Metastatic" session and will be presented in the same time slot as proffered paper reports. In addition, data from the global pivotal Phase III TroFuse-005 trial led by MSD[1] will be presented for the first time in the ESMO Presidential Symposium. The abstract titles of the above studies as well as other studies from Kelun-Biotech have been published on the official ESMO website. Details are as follows:
About sac-TMT(佳泰莱®) Sac-TMT, a core product of the Company, is a novel TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors and genitourinary tumors, among others. Sac-TMT is developed with a unique, bifunctional linker that maximizes payload delivery to tumor cells both through its irreversible connection with the anti-TROP2 monoclonal antibody sacituzumab and its pH-sensitive cleavage from a belotecan-derivative topoisomerase I inhibitor payload (KL610023) in the lysosome, with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023 induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells. In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan). To date, four indications for sac-TMT have been approved and marketed in China for: 1) unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting); 2) epidermal growth factor receptor (EGFR) mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-tyrosine kinase inhibitor (TKI) therapy and platinum-based chemotherapy; 3) EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy; 4) unresectable or metastatic hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) (Immunohistochemistry (IHC) 0, IHC 1+ or IHC 2+/In Situ Hybridization (ISH)-) BC who have received prior endocrine therapy and at least one line of chemotherapy in advanced setting. The first two indications above have been included in China's National Reimbursement Drug List (NRDL). This inclusion is expected to bring clinically meaningful benefits to a greater number of patients with BC and NSCLC. Additionally, sac-TMT has been granted six Breakthrough Therapy Designations by the NMPA. Sac-TMT is the world's first TROP2 ADC drug approved for marketing in lung cancer. Two new indication applications have been accepted for review by the NMPA: 1) sac-TMT in combination with pembrolizumab as first‑line treatment for locally advanced or metastatic NSCLC who have programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1% and are EGFR-negative and ALK-negative; 2) sac‑TMT as first‑line treatment for patients with recurrent or metastatic TNBC who have a PD‑L1 combined positive score (CPS) <10 or have recurred after prior programmed cell death protein 1 (PD-1)/PD‑L1 inhibitor therapy in the early stage, both of the above two applications have been included in the priority review and approval process. As of today, the Company has initiated 9 registrational clinical studies in China. MSD has initiated 18 ongoing global Phase III clinical studies of sac-TMT as a monotherapy or in combination with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD. About SKB500 SKB500 is a B7-H3-targeted ADC independently developed by the company using its OptiDCTM platform technology, featuring a site-specific cleavable linker and a potent topoisomerase I inhibitor. In the Phase I clinical study, SKB500 demonstrated robust efficacy and manageable safety profiles across multiple advanced solid tumors. Currently, two Phase II studies of SKB500 in extensive-stage small cell lung cancer (ES-SCLC) and advanced esophageal squamous cell carcinoma (ESCC),etc. are ongoing in China. About Kelun-Biotech Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical, which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Kelun-Biotech focuses on major disease areas such as solid tumors, autoimmune, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects with 8 indications have been approved for marketing, 2 projects with 3 indications are in the NDA stage and more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world's leading proprietary ADC and novel DC platforms, OptiDCTM, and has 2 ADC projects with 5 indications approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit: https://en.kelun-biotech.com/.
SOURCE Kelun-Biotech | ||||||||||||||||||||||||||
Company Codes: HongKong:6990 | ||||||||||||||||||||||||||
View original content to download multimedia:
