Two injections of Sansheng Guojian were approved for clinical use

On October 8, Sansheng Guojian issued an announcement stating that the company has recently received 4 "Drug Clinical Trial Approval Notices" approved and issued by the State Food and Drug Administration for 2 injections, and will carry out relevant clinical trials in the near future

1.

Approval conclusion: According to the "Drug Administration Law of the People's Republic of China" and related regulations, after review, the recombinant anti-PD-1 humanized monoclonal antibody injection accepted on July 27, 2021 meets the relevant requirements of drug registration, and it is agreed to be used Clinical trials for the treatment of HER2-positive breast cancer, specifically: evaluation of PD-1 monoclonal antibody combined with Inituzumab, Pertuzumab, and chemotherapy compared with trastuzumab combined with Pertuzumab and chemotherapy A randomized, open, parallel controlled phase II clinical study of the effectiveness and safety of inituzumab combined with Pertuzumab and chemotherapy in neoadjuvant treatment of early HER2-positive breast cancer patients

Acceptance Number: CXSL2101221

2.

Approval conclusion: According to the "Drug Administration Law of the People's Republic of China" and related regulations, after review, the initumab for injection accepted on July 28, 2021 meets the relevant requirements of drug registration, and agrees to carry out treatment for HER2-positive breast cancer The specific clinical trials of PD-1 monoclonal antibody combined with inituzumab, pertuzumab, chemotherapy and inituzumab compared with trastuzumab and pertuzumab and chemotherapy A randomized, open, parallel controlled phase II clinical study of the effectiveness and safety of combined Pertuzumab and chemotherapy in neoadjuvant treatment of patients with early HER2-positive breast cancer

Acceptance Number: CXSL2101223

3.

Approval conclusion: According to the "Drug Administration Law of the People's Republic of China" and related regulations, after review, the recombinant anti-PD-1 humanized monoclonal antibody injection accepted on July 29, 2021 meets the relevant requirements for drug registration

Acceptance Number: CXSL2101225

4.

Approval conclusion: According to the "Drug Administration Law of the People's Republic of China" and related regulations, after review, the recombinant anti-PD-1 humanized monoclonal antibody injection accepted on July 29, 2021 meets the relevant requirements of drug registration, and this time is agreed The clinical trial applied for is specifically: a 609A combined with bevacizumab-assisted transarterial chemoembolization (TACE) compared with the safety and effectiveness of TACE first-line treatment of hepatocellular carcinoma (HCC) that is not suitable for radical treatment II / Phase III clinical study

Acceptance Number: CXSL2101226

Recombinant anti-PD-1 humanized monoclonal antibody injection

Recombinant anti-PD-1 humanized monoclonal antibody injection (609A) is a Sino-US dual anti-PD-1 humanized monoclonal antibody product.

609A and the two domestically imported drugs that have been on the market (ie Bristol-Myers Squibb’s Odivo® and Merck’s Creta®) target the same target, but have different amino acid sequences.

The situation with initumab

Inituzumab (Ceptin) was officially approved by the National Food and Drug Administration in June 2020

In order to further explore and expand more clinical indications, at present, Inituzumab is still carrying out more clinical trials, including: 1) The aim is to explore the drug regimen suitable for patients who progressed after trastuzumab treatment.
Nituzumab SPORT study; 2) 602 (company's product code under development), which aims to explore dual targeted therapy of anti-EGFR and anti-HER2, combined with initumumab and chemotherapy clinical research; 3) aims to evaluate initumumab A clinical study on the safety, tolerability and efficacy of the dual-drug combination of anti-IMM01 (CD47 recombinant protein drug developed by ImmuneOnco)
.