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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

(C)2018 M2 COMMUNICATIONS

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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Publication:M2 Pharma
Date:Aug 28, 2018
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