Game-Changer in Lung Cancer Care: Serplulimab by Henlius Gains First-Line Approval in UK & India 

In June 2025, Henlius’s Serplulimab became the first-line treatment of extensive small cell lung cancer (ES-SCLC) and secured its approval across UK and India. 

“Serplulimab is the first and only anti-PD-1 monoclonal antibody approved in the UK for small cell lung malignancy. This approval marks as an important step towards treating patients with the aggressive type of such chronic conditions, dealing with limited choices and also facing a poor prognosis”, said by Julian Beach, Interim Executive Director of Healthcare Quality and Access at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). 

Serplulimab Approval Lights the Way for SCLC Patients with Limited Treatment Options 

Recent approval of the innovative anti-PD-1 monoclonal antibody, Serplulimab (Hetronifly), in the United Kingdom and India, signifies an advancement in oncology, as it provides new ray of hope for patients facing one of the deadliest chronic conditions. 

Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius, said: “The approval of this advanced therapeutics represents the focus of company towards putting its patients first and its approach in providing advanced treatment in the oncology segment". 

Why Is the Approval of Serplulimab a Turning Point in the Fight Against Lung Cancer? 

The approval of Serplulimab is a turning point towards the treatment of such chronic condition, as it accounts for approximately 15% of all cases and has very limited treatment options.

Furthermore, it also accounts for the fourth major type of cancer across India, which signifies the need for advanced therapeutics. 

Therefore, the approval of Serplulimab, presents as a milestone in treating these chronic conditions, due to the rise in cases of SCLC, which further emphasis on the growing need to improve access to innovative therapies. 

The Executive Vice-President of EMENA, Accord Healthcare, Paul Tredwell, said: “The approval of Serplulimab via the MHRA, reflects the ongoing commitment of the company in providing advanced medicines for treating major chronic conditions.” 

How Serplulimab is Driving Innovation, Diagnostics, and Supply Chain Growth in Future? 

The market entry of this innovative therapeutics will encourage the innovation among the other pharma companies. It sets as a new benchmark in cancer treatment, that also encourages other companies to invest in the research and development of monoclonal antibodies for the treatment of severe diseases. Overall, this fosters into the development of healthier innovation pipeline in oncology treatments. 

Furthermore, the clinical success and the regulatory acceptance of Serplulimab, encourages the development of new monoclonal antibodies, especially in the emerging markets, such as India, where the cost-effective alternatives, ensures broader accessibility.