Fosun Pharma subsidiary's cancer drug gains breakthrough status in China

Shanghai Fosun Pharmaceutical Group Co., Ltd. announced that its subsidiary, Shanghai Henlius Biotech, Inc., has had its drug, serplulimab injection (HansiZhuang), accepted into the breakthrough therapy designation program. This designation is for its use in combination chemotherapy as neoadjuvant/adjuvant treatment for gastric cancer. This inclusion is expected to expedite the review and market launch process for this specific indication in China.

The drug, an innovative anti-PD-1 monoclonal antibody, has already received marketing approval in several countries and regions, including China, the EU, UK, and USA. As of November 20, 2025, there are no other PD-1 monoclonal antibody drugs approved globally for gastric cancer neoadjuvant/adjuvant treatment. Fosun Pharma's cumulative R&D investment for this drug, as of October 2025, totals approximately CNY 3.495 billion.

According to IQVIA MIDAS data, global sales of PD-1 monoclonal antibody drugs reached approximately $45.704 bn in 2024. Despite the breakthrough therapy designation, the drug's launch in China for this indication remains contingent on approval from the National Medical Products Administration. New drug development is a long-term endeavor with inherent uncertainties.