Shanghai Henlius Biotech's lung cancer drug gets EU approval

Hong Kong-listed Shanghai Henlius Biotech Inc, a subsidiary of Fosun Pharma, announced on Wednesday that its anti-PD-1 mAb, HANSIZHUANG, or serplulimab, has been approved by the European Commission to treat extensive-stage small cell lung cancer for adult patients.

The approval makes the medicine, which is marketed as Hetronifly in Europe, as the first and only anti-PD-1 mAb approved in the EU for the treatment of extensive-stage small cell lung cancer. The approval covers all 27 EU member states as well as the European Economic Area countries, including Norway, Iceland, and Liechtenstein.

Jason Zhu, executive director and CEO of Henlius, said, "The approval of serplulimab in the EU represents another significant step forward in our mission to benefit patients worldwide. This milestone not only underscores our leadership in innovative drug development and global strategy, but also brings new hopes to patients suffering from the disease in Europe and beyond."

Lung cancer is the most common cancer worldwide in terms of incidence and mortality. According to statistics from Globocan, there were more than 2.48 million new cases of lung cancer globally in 2022, accounting for 12.4 percent of all new cancer cases.

Small cell lung cancer, which accounts for 15 to 20 percent of all lung cancers, is characterized by high malignancy, early metastasis, rapid progression, and poor prognosis.

Henlius said its commitment to stringent quality standards has been instrumental in achieving the approval from the European Commission for the medicine. In 2023, Henlius' manufacturing facilities and production lines of serplulimab passed EU GMP inspections, ensuring a stable and high-quality supply for the European market. Henlius operates three facilities in Shanghai with a total commercial capacity of 48,000 liters, ensuring consistent global supply to regions including China, Europe, Latin America, the Middle East, North America, and Southeast Asia.

The company said it will continue to work closely with partners to expand the availability of the medicine to more countries and regions, providing broader treatment options to patients worldwide.