Kangningjierui recombinant CTLA-4 variant Fc fusion protein injection obtained clinical approval

Source: Kangning Jierui 2017-10-09 read the clinical approval of CFDA for the recombinant CTLA-4 variant Fc fusion protein injection (moderate to severe rheumatoid arthritis indication) developed by Suzhou Kangning Jierui Biotechnology Co., Ltd (Kangning Jierui) Recently, the recombinant CTLA-4 variant Fc fusion protein injection (moderate to severe rheumatoid arthritis indication) developed by Suzhou kangningjierui Biotechnology Co., Ltd (kangningjierui) obtained the clinical approval of CFDA Kn019 project is a biological analogue of bilatacept (commercial name: nulojix) of BMS It is the fusion protein of extracellular domain variant (a29y and l104e) of CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) and Fc fragment, which has complex molecular structure and is difficult to imitate Belatacept can bind to CD80 / CD86 on the surface of antigen-presenting cells, inhibit the activation and proliferation of T cells, and have immunosuppressive effect The company further develops new indications for moderate to severe rheumatoid arthritis based on its original indications for preventing organ rejection in adult patients undergoing kidney transplantation Belatacept is modified with many n-and o-sugars, which is very challenging for production process and quality control The pilot production rate of kn019 project developed by kangningjierui is high The primary structure, advanced structure and post-translational modification of the protein are highly similar to those of the original drug belatacept The results of pharmacological and toxicological studies are also highly consistent with those of belatacept It is expected to become the first and only drug in belatacept in China Ra (rheumatoid arthritis) is a common, chronic, systemic autoimmune disease The long-term prognosis of RA is poor, lack of appropriate treatment, 80% of patients will form disability within 20 years, with an average life expectancy of 3-18 years At present, the main drugs for RA treatment are NSAIDs and DMARDs Kn019 has a clear target It has a completely different mechanism from that of TNF inhibitor represented by adalimumab It is expected that kn019 will still be effective in patients who do not respond or do not respond adequately to TNF inhibitor