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NMPA Approves IND Application for Henlius' Pembrolizumab Biosimilar

04 Sep 2024
Admin
News Article

NMPA Approves IND Application for Henlius' Pembrolizumab Biosimilar

Overview

Shanghai Henlius Biotech has made an announcement indicating that their investigational new drug (IND), which is known as HLX17 and is a biosimilar version of pembrolizumab, has been approved by the National Medical Products Administration (NMPA).

HLX17 Development

Henlius has developed HLX17 independently and plans to carry out clinical trials for multiple indications including melanoma, non-small cell lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, hepatocellular carcinoma, biliary tract cancer, triple-negative breast cancer as well as microsatellite instability-high or mismatch repair-deficient cancers and gastric cancer.

As Per NMPA Biosimilar Guidelines

According to NMPA biosimilar guidelines HLX17 was developed while taking into consideration various standards from EMA and FDA. Studies have shown that HLX17 is comparable to reference pembrolizumab in terms of pharmacology, pharmacodynamics, pharmacokinetics and immunogenicity.

HLX17 in the Management of Cancer

As checkpoint inhibitors of immunity gain more and more significance to immunotherapy, HLX17 becomes a promising option in management of cancers.
This monoclonal antibody targets PD-1 receptor on T cells thereby preventing interaction with PD-L1 and PD-L2 molecules.
In this way, it releases the inhibition of immune response by PD-1pathway enabling T-cells to better identify and attack tumour cells.

Henlius for Immunotherapy Development

On its part, Henlius has made great strides in immunotherapy development with a portfolio that includes a diverse range of potential immune checkpoints like PD-1/L1, CTLA-4, LAG-3 and TIGIT.
The company anticipates that these therapies will be effective across various indications as well as complementing its other in-house products and innovative treatments.

Moving forward Henlius intends to focus on addressing unmet medical needs while expanding their disease areas coverage. The plan is for the firm to provide affordable but quality drugs worldwide for patients.