What's Happening?
Kelun-Biotech, a subsidiary of Kelun Pharmaceutical, has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China for its Investigational New Drug (IND) application for SKB118. SKB118 is a PD-1
x VEGF bispecific antibody designed for the treatment of advanced solid tumors. This approval allows Kelun-Biotech to proceed with clinical trials in China, marking a significant step in the global development of SKB118. The company has been collaborating with Crescent Biopharma, which granted Kelun-Biotech exclusive rights to research, develop, manufacture, and commercialize SKB118 in Greater China. Crescent Biopharma has also received regulatory clearance from the U.S. FDA for the IND application, enabling the initiation of a global Phase I/II clinical trial for SKB118.
Why It's Important?
The approval of SKB118's IND application in China is crucial for Kelun-Biotech's strategy to expand its presence in the oncology market. SKB118's dual mechanism of action, targeting both PD-1 and VEGF, offers a promising approach to cancer treatment by enhancing T cell activity and inhibiting tumor growth. This development could lead to more effective combination therapies, potentially improving outcomes for patients with advanced solid tumors. The collaboration with Crescent Biopharma and the simultaneous advancement of clinical trials in China and globally underscore Kelun-Biotech's commitment to addressing unmet medical needs and establishing itself as a leader in innovative drug development.
What's Next?
Kelun-Biotech plans to explore the potential of combining SKB118 with its proprietary antibody-drug conjugates (ADCs) to enhance treatment efficacy. The ongoing global Phase I/II clinical trial, expected to enroll up to 290 patients, will provide valuable data on SKB118's safety and efficacy. As the trial progresses, Kelun-Biotech aims to leverage its ADC+IO strategies to unlock synergistic value and expand treatment possibilities for cancer patients. The company will continue to collaborate with Crescent Biopharma to drive the research and development of SKB118 and other innovative drug candidates.
