Kelun-Biotech Clears IND for PD-1/VEGF Bispecific in China, Expanding Global Trial Footprint

Event summary

  • Kelun-Biotech received IND approval from China's CDE for SKB118, a PD-1/VEGF bispecific antibody, to treat advanced solid tumors.
  • The approval follows a December 2025 collaboration with Crescent Biopharma for exclusive Greater China rights to SKB118.
  • Crescent's global ASCEND Phase I/II trial (NCT07335497) for SKB118 began in January 2026 after FDA clearance, targeting 290 patients.
  • Kelun-Biotech plans to explore combinations of SKB118 with its proprietary ADC assets under its ADC+IO strategy.

The big picture

Kelun-Biotech's IND approval for SKB118 underscores China's growing role in global biopharma innovation, particularly in oncology. The simultaneous China and U.S. trial strategy reflects a broader trend of cross-border collaboration to expedite drug development. With over 30 pipeline projects, Kelun-Biotech is positioning itself as a key player in next-generation immuno-oncology therapies, leveraging its ADC expertise to differentiate its portfolio.

What we're watching

Combination Strategy
How Kelun-Biotech's integration of SKB118 with its ADC portfolio will impact clinical outcomes and market positioning.
Regulatory Alignment
Whether simultaneous China and global trials will accelerate approval timelines or create operational complexities.
Competitive Dynamics
The pace at which other PD-1/VEGF bispecifics advance, potentially reshaping the solid tumor treatment landscape.