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

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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.

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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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