Kelun-Biotech Secures China IND Approval for ITGB6-Targeted ADC, Expands Global Partnership
Event summary
- Kelun-Biotech received Investigational New Drug (IND) approval from the NMPA in China for SKB105, an ITGB6-targeted ADC, for the treatment of advanced solid tumors.
- In December 2025, Kelun-Biotech entered a strategic collaboration with Crescent Biopharma, granting Crescent rights to SKB105 outside of Greater China.
- Crescent Biopharma holds rights to commercialize SKB118 (PD-1 x VEGF bispecific antibody) in Greater China.
- The FDA has cleared the IND application for SKB118, and a global Phase I/II trial is slated to begin shortly.
The big picture
This IND approval and partnership represent a significant step for Kelun-Biotech, demonstrating its commitment to developing innovative oncology therapies and expanding its global reach. The deal with Crescent Biopharma allows Kelun-Biotech to focus on its core R&D and manufacturing capabilities while leveraging Crescent’s commercial expertise in key markets. The simultaneous development of both SKB105 and SKB118 highlights a strategic focus on combination therapies within the solid tumor space, a rapidly evolving area of oncology drug development.
What we're watching
- Clinical Efficacy
- The initial Phase I/II trial data for SKB105 will be crucial in determining its potential efficacy and safety profile in human patients, which will inform future development and regulatory pathways.
- Commercialization
- The success of the partnership with Crescent Biopharma will hinge on their ability to navigate regulatory hurdles and establish a commercial footprint for SKB105 in key global markets.
- Pipeline Synergy
- Kelun-Biotech’s plans to submit an IND application for SKB118 to the NMPA will reveal the company’s commitment to leveraging the partnership and expanding its presence in the Chinese market.
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