NICE recommends Henlius lung cancer drug for NHS use

NICE has recommended Henlius’ Hetronifly, also known as serplulimab, for routine NHS use in England and Wales for adults with extensive-stage small cell lung cancer. The decision gives the Chinese-developed PD-1 inhibitor a new reimbursement route in the UK after trial data showed longer survival versus placebo.

Why it matters: - NICE’s recommendation opens routine NHS access in England and Wales for a new immunotherapy option in extensive-stage small cell lung cancer. - The decision could expand treatment choices for a cancer with limited long-term survival outcomes. - Hetronifly is the first PD-1 monoclonal antibody independently developed by Henlius in China to win a NICE recommendation for routine NHS use.

What happened: - NICE recommended Hetronifly, the trade name in Europe for serplulimab, for routine use within the NHS in England and Wales. - The drug is used with standard chemotherapy in adult patients with extensive-stage small cell lung cancer. - The recommendation follows global pivotal trial data.

The details: - Trial data showed a median overall survival of 15.8 months for serplulimab plus chemotherapy versus 11.1 months for placebo. - About 22% of patients were alive four years after starting treatment. - Serplulimab is a humanised PD-1 blocking immunotherapy that works by helping T-lymphocytes identify and attack tumour cells. - The European Medicines Agency assessment said Hetronifly’s safety profile is similar to other cancer medicines in the same class. - Some immune-related side effects can be severe, but they are considered manageable. - Extensive-stage small cell lung cancer is described as an aggressive, fast-growing lung cancer with limited treatment options. - Henlius developed Hetronifly independently in Shanghai.

Between the lines: - The NICE decision strengthens Hetronifly’s commercial and clinical footprint in a major Western health system. - The UK reimbursement step adds to the drug’s broader European momentum and may support adoption in other markets. - The approval narrative centers on overall survival, which remains the clearest benchmark in advanced lung cancer.

What’s next: - Hetronifly will move into routine NHS use in England and Wales under the NICE recommendation. - Henlius is likely to continue leveraging the UK decision as it expands reimbursement and access across Europe and beyond. - The company says Hetronifly now has marketing authorisations in four EU tumour settings and approvals in 16 European nations. - Henlius says serplulimab has been approved in more than 50 countries and regions worldwide, with more than 110,000 patients treated to date.

The bottom line: - NICE’s green light turns a Chinese-developed PD-1 drug into a routine NHS treatment option for a difficult-to-treat lung cancer, backed by survival gains in late-stage trial data.