Sansheng Guojian PD-1 monoclonal antibody combined with initumab for the treatment of solid tumors was approved for phase Ib/II clinical trials

November 05, 2021

On November 2, China's antibody drug pioneer Sansheng Guojian (stock code: 688336) announced that the company has recently received the "Drug Clinical Trial Approval Notice" approved and issued by the National Medical Products Administration (NMPA), and agreed to carry out a reorganization The safety and effectiveness of anti-PD-1 fully human monoclonal antibody injection (609A) combined with initumab in HER2-positive unresectable locally advanced or metastatic solid tumors is an open, single-arm, multi-center Ib/ Phase II clinical study.

609A is an anti-PD-1 humanized monoclonal antibody developed by Sunshine Guojian. It targets the same target with two imported drugs (Keytruda and Opdivo), but has different amino acid sequences. The humanized PD-1 mouse model showed stronger tumor activity than Keytruda and Opdivo. The results of in vivo and in vitro comparisons indicate that SSGJ-609A is similar to the two imported drugs in terms of biological activity, efficacy, pharmacokinetics, etc.; preclinical research results show that SSGJ-609A has a clear molecular structure and stable product Good performance, drug activity, animal pharmacokinetics (PK)/pharmacodynamics (PD) have reached or surpassed similar foreign drugs. Initumab is China's first innovative anti-HER2 monoclonal antibody with Fc segment modification, optimized production process, and stronger ADCC effect. Combined with chemotherapy drugs, it has been proven to delay the progression of HER2-positive metastatic breast cancer patients. , And bring survival benefits. Inituzumab was approved for marketing in June 2020 and entered the national medical insurance in the same year. In April of this year, initumumab was included in the CSCO breast cancer diagnosis and treatment guidelines and became the basic drug for the entire course of anti-HER2 treatment. Not long ago, 609A was also approved to carry out three other clinical studies, namely: (1) Evaluation of PD-1 monoclonal antibody combined with Inituzumab, compared with trastuzumab combined with Pertuzumab and chemotherapy. A randomized, open, parallel controlled phase II clinical study of the effectiveness and safety of Pertuzumab, chemotherapy and Inituzumab combined with Pertuzumab and chemotherapy in neoadjuvant treatment of patients with early HER2-positive breast cancer ( 2) A single-arm, open, multi-center phase II clinical study to evaluate the effectiveness and safety of combined doxorubicin hydrochloride in the treatment of metastatic/unresectable unspecified soft tissue sarcoma (3) combined with bevacizumab adjuvant Phase II/III clinical study on the safety and effectiveness of transarterial chemoembolization (TACE) compared with TACE first-line treatment of hepatocellular carcinoma (HCC) that is not suitable for radical treatment. Dr. Jing Lou, Chairman of Sansheng Guojian, said: "The preclinical data of 609A is very competitive among similar drugs, and it is believed that it will bring better survival benefits to patients in clinical trials. Anti-PD-1 antibody It has gradually become one of the cornerstone drugs for tumor treatment. In the future, we will carry out more clinical trials of 609A combination therapy, explore more indications, and promote the successful listing of 609A as soon as possible to provide patients with better treatment options."

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