#China #Chengdu #Kelun-Biotech #Tagitanlimab #Sac-TMT

Kelun-Biotech Announces Major Milestone in Cancer Treatment

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. has made a significant advance in the fight against non-small cell lung cancer (NSCLC) by receiving Breakthrough Therapy Designation from China's National Medical Products Administration (NMPA). This designation specifically applies to the company's novel therapy, sacituzumab tirumotecan (commonly referred to as Sac-TMT), when used in combination with the PD-L1 monoclonal antibody tagitanlimab. Notably, this treatment is targeted toward patients with locally advanced or metastatic non-squamous NSCLC that does not have actionable genomic alterations.

The Breakthrough Therapy Designation is granted uniquely for treatments that showcase substantial potential advantages over existing therapies, thereby accelerating their research and marketing processes. This decision is founded on the compelling data from the Phase II OptiTROP-Lung01 study, which highlighted the effectiveness and safety of sac-TMT combined with tagitanlimab.

This milestone marks the fifth time that sac-TMT has received Breakthrough Therapy Designation in China. Its previous designations include treatments for various conditions, such as triple-negative breast cancer and specific lung cancer cases. With these achievements, sac-TMT continues to demonstrate its versatility and potential in addressing critical cancer treatment challenges.

Dr. Michael Ge, CEO of Kelun-Biotech, expressed optimism about the designation, stating, “This recognition by the NMPA underscores the urgent need for innovative therapy options targeting diverse NSCLC subtypes.” He emphasized that the combination of sac-TMT and tagitanlimab has provided promising results, meeting vital endpoints for patients suffering from non-squamous NSCLC without actionable genetic mutations, positioning it as a viable first-line treatment option.

Results from the Phase 2 OptiTROP-Lung01 study were highlighted during the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, illustrating the therapy’s clinical efficacy.

About Sacituzumab Tirumotecan (Sac-TMT)

Sac-TMT is a pioneering human TROP2 antibody-drug conjugate (ADC) that exhibits a dual mechanism by specifically targeting TROP2 on the surface of cancer cells. It employs a novel linker to deliver a potent topoisomerase I inhibitor known as KL610023 directly to tumor cells, inducing DNA damage that can lead to cell-cycle arrest and ultimately apoptosis. This mechanism also enables a bystander effect, allowing adjacent tumor cells to be affected as well.

Since its inception, Sac-TMT has become notable as the first domestic ADC fully approved for marketing in China, and it has set precedence as the first TROP2 ADC authorized for lung cancer treatment globally. Currently, it has been approved for treating patients with certain forms of breast cancer and advanced NSCLC, showcasing its significant application potential in oncology.

Tagitanlimab's Role

Complementing Sac-TMT’s innovative approach is tagitanlimab, which is recognized for its role in the treatment of nasopharyngeal carcinoma (NPC). The pairing of sac-TMT with tagitanlimab represents a novel venture into combination therapy for NSCLC, enhancing the efficacy of cancer treatment regimens by targeting PD-L1 alongside TROP2.

The Vision of Kelun-Biotech

Kelun-Biotech aims to position itself as a leader in the biopharmaceutical sector, addressing critical medical needs across various disease states. They have a comprehensive pipeline of innovative drug projects, with recent advancements in ADC technology being at the forefront of their development efforts. With over 30 ongoing projects, including multiple registrational studies and collaborations with global entities like MSD, Kelun-Biotech is dedicated to transformative healthcare solutions.

As the company progresses, it anticipates that the expedited approval process for combination therapies like sac-TMT and tagitanlimab will significantly impact patient outcomes in China and beyond. The commitment to addressing unmet medical needs in oncology is at the heart of Kelun-Biotech’s mission as it moves forward.