First-line treatment of squamous non-small cell lung cancer! Kangfang Bio-PD-1 monoclonal antibody submitted a new indication for marketing application

July 02, 2021

On July 2, 2021, Kangfang Bio-Bio announced that the PD-1 monoclonal antibody drug Paimrizumab (R&D code: AK105, trade name) jointly developed by the company and China Biopharmaceutical Co., Ltd. (stock code: 1177.HK) : Annikol) combined with chemotherapy for the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer. A marketing application has been submitted to the National Medical Products Administration (NMPA) and has been accepted. This is the successful submission of BLA in the U.S. through the RTOR New Deal for the third-line treatment of metastatic nasopharyngeal carcinoma with Paimrizumab, and the successful submission of the NDA in China for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after at least second-line chemotherapy. , The third listing application successfully submitted. Paimpulizumab (AK105, PD-1 monoclonal antibody) is owned by Kangfang Bio and China Biopharmaceutical Co., Ltd. (1177.HK) (and its subsidiaries, collectively referred to as "China Biopharmaceuticals") under the Chia Tai Tianqing Pharmaceutical Group Joint development and commercialization of joint ventures established by a company limited by shares. Paimrizumab is the only new drug that can be used by China Biopharmaceuticals to develop PD-1 antibody-based monotherapy or combination therapy. It is also the company's late-stage clinical development, differentiated and possibly the most innovative PD-1 of its kind. One of monoclonal antibody drug candidates. Paimrizumab is currently the world's only new PD-1 monoclonal antibody with IgG1 subtype and modified by the Fc segment. The antigen binding and dissociation rate is slower. The crystal structure analysis shows that it has a unique binding epitope, which can block PD for a long time. The combination of -1/PD-L1 and the differentiation from other PD-1 products on the market may enable Paimrizumab to more effectively enhance the efficacy of immunotherapy and reduce immune-related adverse reactions.