Sichuan Kelun-Biotech (6990.HK) announced it has received Investigational New Drug (IND) approval from Chinese regulators for its bispecific antibody, SKB118, for the treatment of advanced solid tumors.
"We are pleased to see the approval of the IND application for SKB118 in China, which marks the simultaneous advancement of clinical development in China and globally," Dr. Michael Ge, CEO of Kelun-Biotech, said. He added the company will "actively explore the potential of combining SKB118 with our proprietary ADC assets to unlock the synergistic value."
The approval from the Center for Drug Evaluation (CDE) allows Kelun-Biotech to begin clinical trials in mainland China. This follows a similar clearance from the U.S. Food and Drug Administration (FDA) in January 2026 for a global Phase I/II trial, which is currently enrolling up to 290 patients. SKB118, also known as CR-001, is a tetravalent bispecific antibody that simultaneously blocks programmed cell death protein-1 (PD-1) and vascular endothelial growth factor (VEGF). This dual mechanism is designed to restore T-cell anti-tumor activity while also inhibiting the tumor's blood supply.
This regulatory milestone is a key step for Kelun-Biotech's strategy of combining its antibody-drug conjugates (ADCs) with immuno-oncology (IO) therapies. The approval validates the company's research and development efforts and allows it to proceed with a crucial phase of drug development within the world's second-largest pharmaceutical market.
The IND approval allows Kelun-Biotech to gather clinical data specific to the Chinese patient population, a critical step for potential commercialization in the region. Investors will now watch for initial data from both the U.S. and new China trials as the next major catalysts for the company.
This article is for informational purposes only and does not constitute investment advice.
