Fosun Pharma has signed an exclusive US licensing agreement with Shanghai Henlius Biotech for commercializing the latter’s serplulimab, an anti-PD-1 monoclonal antibody (mAb).

The financial terms of the licensing deal were not disclosed.

As per the terms of the agreement, Fosun Pharma will hold the right to commercialize serplulimab upon US Food and Drug Administration’s approval and Henlius Biotech will retain responsibility for serplulimab’s development, manufacturing, and supply.

Wu Yifang — Fosun Pharma Chairman said: “We are very happy to make full use of Fosun Pharma’s accumulated innovation capabilities, internationalization advantages and commercialization capabilities over the years to promote the commercialization of an approved anti-PD-1 mAb serplulimab in the US market and help benefit more patients around the world.

“Fosun Pharma has always been patient-centered and clinical needs-oriented. We have been practicing internationalization strategies in the dimensions of innovative R&D, license introduction, production operation and commercialization, and continuously strengthening the construction of full capacity in global operations.”

Known as HANSIZHUANG in China, serplulimab is approved in the country for two indications for the treatment of squamous non-small cell lung cancer (sqNSCLC) and MSI-H solid tumors.

Wenjie Zhang — Henlius Biotech Chairman and CEO said: “We are excited to partner with Fosun Pharma in the United States on serplulimab. The impressive clinical data of serplulimab was published in the top international medical journal and has gained international attention.

“As we move forward, we’ll seek approvals for additional indications in China, the US, and the European Union. In the US, Fosun Pharma has a fast-growing commercialization team and a dedicated sales network.

“Together, we will, upon approval, accelerate the launch of this differentiated anti-PD-1 mAb in the US market and benefit more overseas patients with high-quality biological drugs.”

  Fosun Pharma, HANSIZHUANG, serplulimab, Shanghai Henlius Biotech, USA, Wenjie Zhang, Wu Yifang