Ascletis gains licence to develop and commercialise drug candidate for viral diseases, including hepatitis B, in Greater China. Credit: Sanofi Pasteur / Flickr.

Ascletis Pharma has signed an exclusive licensing agreement with Suzhou Alphamab to develop an investigational candidate, KN035, for the treatment of viral diseases such as hepatitis B in Greater China.

KN035 is a programmed cell death ligand-1 (PD-L1) monoclonal antibody that has been assessed in more than 500 patients during various clinical trials in the US, China and Japan.

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As part of the deal, Ascletis Pharma will gain an exclusive licence to develop and commercialise ASC22 (KN035) for viral diseases in Greater China.

In turn, the company will make an upfront cash payment to Alphamab, which is also eligible for development and commercial milestones along with tiered royalties from future sales of the product.

Ascletis Pharma founder, chairman and CEO Jinzi Wu said: “Through the strategic collaboration with Alphamab, we have the opportunity to develop ASC22 (KN035) as a potential first-in-class HBV immunotherapy and offer a clinical cure for hepatitis B patients.

“Alphamab will be responsible for manufacturing ASC22 (KN035) for use in clinical trials and commercialisation of viral indications in Greater China.”

“Following the recent collaboration with Roche on Pegasys, this collaboration marks another major step forward for Ascletis to expand its pipeline and platform with biological drugs and to fulfil its commitment to developing innovative hepatitis B therapies.”

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Alphamab will be responsible for manufacturing ASC22 (KN035) for use in clinical trials and commercialisation of viral indications in Greater China.

For viral indications in other global regions, Ascletis will be eligible to share select upfront, milestone payments and royalties, based on the product’s development and regulatory status in Greater China.

Alphamab chairman Ting Xu said: “With Ascletis’ demonstrated clinical development expertise in liver infectious diseases, we are confident that KN035 immunotherapy may lead to an effective clinical cure for hepatitis B.

“With KN035 collaboration as a good starting point, Alphamab is looking forward to a much broader and long-term partnership with Ascletis in viral and liver diseases.”