Kelun-Biotech Announces Breakthrough Therapy Designation Granted for Sacituzumab Tirumotecan (Sac-TMT) in Combination With Tagitanlimab in China for Certain Types of Non-Small Cell Lung Cancer

, /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") today announced that its TROP2-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) (佳泰莱^®) in combination with the PD-L1 monoclonal antibody tagitanlimab (科泰莱^®) was granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without actionable genomic alterations. Breakthrough Therapy Designation is granted for treatment options that demonstrate significant clinical advantages over currently available treatments and is aimed at expediting the research, development and marketing of innovative treatment options that address clinically urgent medical needs. This designation is based on the efficacy and safety data from the non-squamous cohort of the Phase II OptiTROP-Lung01 study.

This marks the fifth Breakthrough Therapy Designation granted to sac-TMT by the NMPA. Sac-TMT has previously received this designation for:

• Locally advanced or metastatic triple-negative breast cancer (TNBC) in July 2022;
• EGFR-mutant, locally advanced or metastatic NSCLC after progression on EGFR-TKI therapy in January 2023;
• Locally advanced or metastatic hormone-receptor positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer (BC) in patients who have previously received at least two lines of systemic chemotherapy in June 2023；
• First-line treatment of unresectable locally advanced, recurrent or metastatic PD-L1 negative TNBC in March 2024.

Results from a Phase 2 OptiTROP-Lung01 study of sac-TMT in combination with tagitanlimab in first-line advanced or metastatic non-squamous NSCLC patients were presented in a poster session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting^[1].

Dr. Michael Ge, CEO of Kelun-Biotech said, "This designation by the NMPA highlights the importance of developing novel therapeutic options for diverse NSCLC subtypes. Sac-TMT in combination with tagitanlimab demonstrated clinically meaningful outcomes in key endpoints for patients with non-squamous NSCLC without actionable genomic alterations as a first-line treatment. We are excited about the therapeutic potential of TROP2 ADC- immunotherapy combinations, and we look forward to working with regulatory authorities in China to bring this combination therapy to patients in need as soon as possible."

About sac-TMT (佳泰莱^®)
Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, BC, gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor 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 KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, 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 (includes Mainland China, Hong Kong, Macao, and Taiwan).

To date, two indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) and EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. Sac-TMT became the first domestic ADC with global intellectual property rights to be fully approved for marketing. It is also the world's first TROP2 ADC to be approved for marketing in a lung cancer indication. In addition, two new indication applications for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy and with unresectable locally advanced, metastatic HR+/HER2- BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting were accepted by the CDE, and were included in the priority review and approval process. As of today, the Company has initiated 8 registrational clinical studies in China. MSD has initiated 14 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab2 or other agents for several types of cancer. These studies are sponsored and led by MSD.

About Tagitanlimab (科泰莱^®)
Tagitanlimab is the first PD-L1 mAb globally to receive authorization for the first-line treatment of NPC. Previously, the NMPA has approved the marketing in China of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of patients with R/M NPC and monotherapy for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy, respectively.

About Kelun-Biotech
Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization 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 in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 3 projects have been approved for marketing, 1 project is in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world's leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/.

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SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.