Compared with intravenous infusion, subcutaneous administration of macromolecular drugs can significantly enhance safety, patient compliance, and accessibility. Our high-concentration formulation platform overcomes the challenges of stability and high viscosity associated with concentrated protein formulations, enabling administration within 30 seconds and making subcutaneous injection feasible. Furthermore, compared to hyaluronidase-based co-formulations for subcutaneous infusion, our high-concentration subcutaneous formulations offer greater convenience.
The representative product, Envafolimab (KN035)* , received market approval in 2021 as the world's first subcutaneous injected PD-L1 inhibitor. Additionally, we have successfully extended this platform to ADCs, with clinical validation. The representative ADC candidate, JSKN033* , is currently in Phase I/II clinical studies.
