Wuxi to Help Develop, Manufacture ADC Candidate in China

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Wuxi to Help Develop, Manufacture ADC Candidate in China

Related tags: Pre-clinical development

Ambrx and Zhejiang Medicine have selected Wuxi to accelerate the development of a potential ADC (antibody drug conjugate) targeting Her2-positive breast cancer.

In this deal, WuXi will provide contract services to Ambrx and Zhejiang from process development, manufacturing clinical drug including conjugating antibody with toxin, preclinical studies and potentially perform clinical trials in China​,” Wuxi spokesman Aaron Shi told us.

San Diego-based biopharma company Ambrx sought the partnership with Zhejiang and Wuxi to gain access to the Chinese market for ARX788, which is the company’s most advanced ADC for breast and gastric cancer indications.

Zhejiang will bear the development costs and will gain commercial rights in China, while Ambrx keeps its commercial rights outside of China and will receive royalties on sales of the ADC in China.

Ambrx and Zhejiang will “leverage WuXi's capabilities to bring innovative antibody-ADC drug to China much faster than they can do by themselves​,” Shi said.

The partnership shows further progress the company is making in the development of biologics, which it said would be expected in comments from its latest earnings call​.

Wuxi is the only company in China to have this integrated biologics drug discovery, development and manufacturing capabilities that meet global quality standard​,” Shi added.

Last October, the company opened a biologics manufacturing facility​ in Wuxi, China, and which the company claims is the country’s first site to comply with US and EU GMP (good manufacturing practice) standards.

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