CStone receives CNDA approval for anti-CTLA-4 antibody CS1002.

M2 PHARMA-August 28, 2018-CStone receives CNDA approval for anti-CTLA-4 antibody CS1002

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Biopharmaceutical company CStone Pharmaceuticals (CStone) reported on Monday the receipt of approval from the China National Drug Administration (CNDA) for its IND application for the investigational cytotoxic T-lymphocyte-associated protein-4 (CTLA-4) monoclonal antibody,CS1002.

To date, the company has built a portfolio of 14 oncology products, eight of which are at clinical development stage, including three in registration studies.

According to the company, Cytotoxic T lymphocyte associated antigen 4 (CTLA-4), also known as CD152, is a transmembrane protein encoded by the CTLA-4 gene that can down-regulate the activity of T cells when binding with its ligands, B7.1 and B7.2, a pathway used by tumour cells to avoid T lymphocyte attack. Consequently, blockade of the CTLA-4 pathway can stimulate T cell activation and proliferation to induce or enhance anti-tumour immune responses.

CTLA-4 provides a new immuno-therapeutic approach to a number of diseases, including tumors, stated the company.

The company added that Bristol-Myers Squibb's Yervoy (ipilimumab) is currently the only anti-CTLA-4 antibody to gain a market approval worldwide, although Yervoy has not yet been approved in China. Pre-clinical tests have shown that CS1002 has a relatively strong affinity to CTLA-4 and is expected to match Yervoy in terms of efficacy.

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