Recombinant humanized anti-HER2-ADC for injection approved by Zhejiang Pharmaceutical Subsidiary

On April 22, Zhejiang Pharmaceutical announced that its subsidiary, Xinma Bio, received the approval and issuance of the recombinant humanized anti-HER2 monoclonal antibody-AS269 conjugate for injection (ARX788) (referred to as "anti-HER2") approved and issued by the State Food and Drug Administration.

Recombinant humanized anti-HER2 monoclonal antibody-AS269 conjugate for injection (ARX788) is a new generation of monoclonal antibody conjugated drug jointly developed by the company and Ambrx in the United States on June 14, 2013.

The company launched a phase I clinical study of ARX788 monotherapy in HER2-positive advanced breast cancer in 2017.

In 2019, the company launched a phase I clinical study of ARX788 in the treatment of patients with HER2-positive advanced metastatic gastric cancer and gastroesophageal junction adenocarcinoma.

As of March 31, 2022, the company's ARX788 project has invested a total of 555 million yuan in research and development expenses

At present, HER2-targeting drugs that have been marketed at home and abroad include trastuzumab (original research by Roche, trade name Herceptin, with sales of CHF 2.

According to EVALUATEPHARMA, the global sales of the HER2-targeted anti-tumor market reached US$11.