#China #Chengdu #Kelun-Biotech #NMPA #sacituzumab tirumotecan

Kelun-Biotech's Promising Developments in Lung Cancer Treatment

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., a notable name in the realm of innovative biopharmaceuticals, has recently announced a key milestone in its ongoing efforts to combat lung cancer. The company's supplemental New Drug Application (sNDA) for its flagship product, sacituzumab tirumotecan (sac-TMT), combined with pembrolizumab (known as KEYTRUDA), has been accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China.

This application is pivotal as it pertains to the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that tests positive for PD-L1. Specifically, the target group includes those with a tumor proportion score (TPS) of 1% or higher, who are also negative for both EGFR and ALK mutations. This acceptance is reflective of the encouraging outcomes from the OptiTROP-Lung05 Phase III study, reinforcing the potential of this combination therapy in enhancing patient survival rates.

In the OptiTROP-Lung05 study, which was a randomized, open-label clinical trial, the efficacy of sac-TMT alongside pembrolizumab was carefully assessed against pembrolizumab as a standalone treatment. An interim analysis revealed that the dual therapy not only achieved the primary endpoint of progression-free survival (PFS) but also hinted at a favorable trend in overall survival (OS). The notable aspect of this trial is its distinction as the first Phase III study to successfully meet its primary endpoint using a combination of immunotherapy and antibody-drug conjugate (ADC) in first-line treatment for NSCLC.

Dr. Michael Ge, CEO of Kelun-Biotech, expressed enthusiasm over this acceptance. He stated, “This marks a significant achievement in improving current treatment strategies for lung cancer. The combination therapy has not only shown promising PFS outcomes but also indicates a potential advantage in overall survival.” This progress is expected to pave the way for more comprehensive treatment options for lung cancer patients, emphasizing the urgent need for advancements in this area.

In the past, sac-TMT received Breakthrough Therapy Designation from NMPA, illustrating its importance as a treatment modality. Following the acceptance into the priority review pathway on April 9, 2026, this application is among the fifth indication submissions for sac-TMT that have been recognized by NMPA, potentially accelerating the approval timeline significantly.

About Sacituzumab Tirumotecan (sac-TMT)
Sac-TMT represents a new frontier in targeted cancer therapy as a TROP2 ADC. It employs a unique linker that enhances the delivery of its payload to tumor cells to maximize efficacy. Designed to selectively target TROP2, this ADC works by binding to the tumor cell surface, thereby facilitating the internalization and subsequent release of a topoisomerase I inhibitor, which is essential for inducing cytotoxicity in cancerous cells and influencing tumor growth dynamics.

Historical context shows that Kelun-Biotech has previously gained regulatory approval for four indications of sac-TMT within China for various forms of advanced solid tumors, demonstrating the drug's versatility in treating challenging malignancies. The successful inclusion of these indications in China's National Reimbursement Drug List indicates a commitment to making innovative treatments financially accessible to a broader patient population, further enhancing the company's impact on public health.

Future Directions
As it stands, Kelun-Biotech is actively pursuing global collaborations to expand the reach of sac-TMT, having partnered with MSD (Merck & Co.) for its development, commercialization, and distribution beyond Greater China. This collaboration is part of Kelun's larger strategy to utilize its proprietary platforms to address unmet medical needs not just in China but globally.

In summary, the acceptance of the sNDA for sac-TMT in combination with pembrolizumab is an exciting development in the ongoing battle against NSCLC, indicative of the rigorous research and innovative spirit cultivated at Kelun-Biotech. With a growing pipeline and expanding global collaboration efforts, the company appears well-positioned to lead the charge in next-generation cancer therapeutics.