Beijing Aosaikang’s ASKG315 Receives NMPA Approval for Solid Tumor Trial

Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) announced that its clinical trial application for ASKG315, an in-house developed recombinant human interleukin-15 prodrug Fc fusion protein, has been accepted by China’s National Medical Products Administration (NMPA). This marks a significant milestone for the company’s oncology pipeline.

Drug Mechanism and Innovation
ASKG315 is the first cytokine drug developed using Aosaikang’s proprietary SmartKine platform. Designed to target advanced malignant solid tumors, the drug circulates as a complete prodrug and is activated specifically within the tumor microenvironment. This activation stimulates the expansion and activation of natural killer (NK) cells and effector T cells (Teff), enhancing antitumor efficacy while minimizing systemic toxicity.

Preclinical Findings
Preclinical pharmacodynamic studies demonstrated that ASKG315 exhibits high binding affinity and activity post-activation. The drug has shown significant tumor growth inhibition across multiple models, confirming its ability to achieve site-specific activation. Additionally, ASKG315 boasts the longest half-life among similar cytokine drugs, allowing for longer dosing intervals and offering significant pharmacoeconomic benefits.-Fineline Info & Tech

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