NMPA Approves IND for Henlius' Pembrolizumab Biosimilar

Shanghai Henlius Biotech, Inc. (2696.HK) has announced that the National Medical Products Administration (NMPA) has approved the investigational new drug (IND) application for HLX17, a biosimilar to pembrolizumab. The approval paves the way for clinical trials targeting conditions for which the original pembrolizumab is already approved, including melanoma, non-small cell lung cancer, esophageal cancer, head and neck squamous cell cancer, colorectal cancer, hepatocellular carcinoma, biliary tract cancer, triple-negative breast cancer, microsatellite instability-high or mismatch repair deficient cancer, and gastric cancer.

HLX17, developed independently by Henlius, adheres to the guidelines for biosimilars set by the NMPA, as well as referencing standards from the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). Comparative pharmacologic studies and preclinical investigations on pharmacology, pharmacodynamics, pharmacokinetics, and immunogenicity have shown that HLX17 is comparable to the reference pembrolizumab.

Immune checkpoint inhibitors have emerged as a transformative approach in immunotherapy, providing a novel method to target tumor cells. HLX17 is a monoclonal antibody designed to bind with the PD-1 receptor on T cells, preventing its interaction with PD-L1 and PD-L2. This blocking action lifts the PD-1 pathway-mediated inhibition of the immune response, which includes anti-tumor effects. Consequently, it restores T-cell immune surveillance on tumors, thereby enhancing anti-tumor efficacy.

Henlius leverages a robust integrated antibody drug research and development platform to expedite the creation of immunotherapies. The company has built a diverse product pipeline featuring high-potential immune checkpoints such as PD-1/L1, CTLA-4, LAG-3, and TIGIT. These checkpoints are expected to be effective across multiple indications, fostering synergy with Henlius’s in-house products and other innovative treatments.

Moving forward, Henlius aims to address unmet medical needs by expanding its focus to a broader range of diseases. The company is committed to delivering high-quality and affordable treatment options to patients globally.

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