CHENGDU, China, October 11, 2025 /PRNewswire/ — Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) announced that the Company’s trophoblast cell surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC), sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870), has been approved for marketing by the National Medical Products Administration (NMPA) for its third indication, the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) mutant-positive non-squamous cell lung cancer (NSCLC) who have progressed following treatment with EGFR tyrosine kinase inhibitor (TKI) therapy.
Sac-TMT is the first and only ADC in the world to demonstrate an overall survival (OS) benefit compared to platinum-based doublet chemotherapy and to be approved for advanced NSCLC that has progressed after only TKI treatment (second line). Currently, sac-TMT monotherapy is the only approved treatment regimen for advanced EGFR-mutant NSCLC following progression from TKI therapy or TKI therapy and platinum-based chemotherapy (used sequentially or in combination), providing full coverage in the TKI-resistant population.
In a prespecified interim analysis of OS, compared to current standard of care platinum-based dual chemotherapy, sac-TMT monotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) and OS, and significantly prolonged the survival outcomes of these patients. More importantly, it remains the only non-platinum-based dual chemotherapy monotherapy regimen approved for NSCLC after progression following TKI treatment.
The approval is based on a randomized, open-label, multicenter phase III study (OptiTROP-Lung04) that was selected as a late-breaking abstract (LBA) at the 2025 European Society for Medical Oncology (ESMO) Congress and will be presented as an oral report. In the session of the Presidential Symposium (Presentation # LBA5). The OptiTROP-Lung04 study is evaluating the efficacy and safety profile of sac-TMT monotherapy at 5 mg/kg every two weeks (q2w) intravenous injection compared to pemetrexed plus platinum chemotherapy for the treatment of patients with locally advanced or metastatic EGFR-mutant non-squamous NSCLC who have failed after treatment with EGFR-ITK. This is the first global phase III trial in a Chinese population demonstrating significant improvement in OS with an ADC compared to platinum-based dual chemotherapy in EGFR mutant NSCLC following TKI resistance. Sac-TMT demonstrated statistically significant and clinically meaningful improvement in OS and PFS.
In March 2025, sac-TMT was approved for EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression of EGFR-TKI treatment and platinum-based chemotherapy. Compared to the current standard of care of docetaxel, sac-TMT monotherapy significantly prolongs PFS and OS for these patients. Additionally, patient recruitment for a phase III registration study in China of sac-TMT combined with osimertinib as first-line treatment for locally advanced or metastatic non-squamous EGFR mutant NSCLC has been completed.
Dr. Michael Ge, CEO of Kelun-Biotech, said: “We are delighted to announce the approval of the third indication of our lead product, sac-TMT, marking another major milestone in the treatment of lung cancer. EGFR mutations are the most common oncogenic driver in lung cancer, accounting for approximately 40–50% of non-squamous NSCLC cases in China. patients, but resistance inevitably develops, leaving few effective treatment options. The approval of this new indication highlights the broad coverage of sac-TMT in TKI-treated NSCLC, providing more precise and effective treatment with proven survival benefit for a broader patient population. Looking ahead, we are advancing the clinical development of sac-TMT in combination with osimertinib for first-line EGFR mutant NSCLC. »
About NSCLC
Lung cancer is the leading malignancy in China. According to statistics from the National Cancer Center, approximately 1.06 million[1] new cases of lung cancer are diagnosed each year in the country. The pathological classification of lung cancer mainly includes non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), with NSCLC being the most common pathological type, accounting for approximately 80% to 85% of all lung cancer patients. According to the 2025 Guidelines of the Chinese Society of Clinical Oncology (CSCO) for the Diagnosis and Treatment of Non-Small Cell Lung Cancer and the Guidelines of the Chinese Medical Association for the Clinical Diagnosis and Treatment of Lung Cancer (2025 Edition), EGFR-TKI treatment is the first-line treatment for advanced NSCLC with EGFR mutations.[2],[3]. Following resistance to EGFR-TKIs, platinum-based dual chemotherapy remains the main standard treatment regimen. Current treatment options demonstrate suboptimal effectiveness, particularly in prolonging overall survival, leaving significant unmet clinical needs where there is an urgent need for new drugs to improve patient survival outcomes.
About Sac-TMT
Sac-TMT, a lead product of the Company, is a novel human TROP2 ADC to which the Company holds exclusive intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a topoisomerase I inhibitor derived from belotecan with a drug-to-antibody ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant humanized anti-TROP2 monoclonal antibodies, which are then endocytosed by tumor cells and release the KL610023 payload intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage in tumor cells, leading to cell cycle arrest and apoptosis. Additionally, it also releases KL610023 into the tumor microenvironment. Since KL610023 is membrane permeable, it may enable a bystander effect, or in other words kill adjacent tumor cells.
In May 2022, the Company licensed exclusive rights to MSD (the trading name of Merck & Co., Inc., Rahway, NJ, USA) to develop, use, manufacture and market the TMT-bag in all territories outside of Greater China (including Mainland China, Hong Kong, Macau and Taiwan).
To date, three indications of sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received at least two prior systemic treatments (at least one of them for advanced or metastatic setting), locally advanced non-squamous NSCLC or metastatic with mutation positive after progression on treatment with EGFR-TKI and platinum-based chemotherapy and locally advanced or metastatic non-squamous NSCLC positive with mutant EGFR which progressed after treatment with EGFR-TKI. Sac-TMT is the first TROP2 ADC drug approved for marketing in lung cancer globally. Additionally, the new indication application for sac-TMT for the treatment of adult patients with unresectable locally advanced, metastatic hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) BC who have previously received endocrine and other systemic therapy in an advanced or metastatic setting was accepted by the Center for Evaluation of NMPA drugs and was included in priority review and approval. process.
To date, the Company has launched 9 registrational clinical studies in China. MSD has initiated 14 ongoing global phase 3 clinical studies of sac-TMT as monotherapy or with pembrolizumab[4] or other anticancer agents for several types of cancer. These studies are sponsored and led by MSD.
About Kelun Biotech
Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, marketing and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory and metabolic diseases, and building a global drug development and industrialization platform to address unmet medical needs in China and the rest of the world. The Company is committed to becoming a leading global company in the field of innovative medicines. At present, the Company has more than 30 key innovative drug projects in progress, among which 3 projects have been approved for marketing, 2 projects are in the NDA stage and more than 10 projects are in the clinical stage. The company has created one of the world’s leading proprietary ADC and novel DC platforms, OptiDC™, and has 1 ADC project approved for commercialization, 1 ADC project at NDA stage, and several ADC and novel DC assets in clinical or preclinical research. For more information, please visit https://kelun-biotech.com/.
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SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
