Accord Healthcare Secures MHRA Approval for Hetronifly® in Small Cell Lung Cancer Therapy

Accord Healthcare Announces Approval for Hetronifly®



Accord Healthcare Limited has recently received the green light from the Medicines and Healthcare Regulatory Agency (MHRA) for Hetronifly® (Serplulimab), targeting adults with extensive-stage small cell lung cancer (ES-SCLC) who haven't undergone prior treatment. This milestone approval, announced on June 24, 2025, highlights the urgency of developing effective therapies for this aggressive cancer type.

Overview of Hetronifly®



Hetronifly® is an anti-PD-1 monoclonal antibody that has garnered attention not just for its efficacy but also for being the first such therapy approved in the UK specifically for ES-SCLC. This approval arrives amidst an ongoing global campaign for broader access to innovative cancer therapies.

Expanding Access to Treatment



Accord Healthcare, along with its parent company Intas Pharmaceuticals, is tasked with marketing Hetronifly® across Europe and India. With this approval, the total number of regions granting approval to the drug exceeds 40, including significant markets like China, Europe, and several Southeast Asian countries. The urgency of creating and implementing drugs that can effectively treat aggressive cancers like SCLC is paramount given the high mortality rates associated with them.

The Global Impact of Lung Cancer



Lung cancer is the leading cause of cancer-related deaths globally, with small cell lung cancer accounting for about 15% of all lung cancer cases. Its aggressive nature often leaves patients with limited therapeutic options and a poor prognosis. Dr. Julian Beach, interim Executive Director of Quality and Access at the MHRA, underscores the importance of Hetronifly®, noting that it represents a crucial new therapeutic option for those struggling against this aggressive form of cancer.

Clinical Background and Efficacy



Serplulimab has previously been designated as an orphan drug in the EU for the treatment of SCLC. The European Society for Medical Oncology (ESMO) rated it a 4 out of 5 on their clinical benefit scale (MCBS) for ES-SCLC. With over 110,000 patients treated globally, its safety and efficacy have been prominently established, laying a solid foundation for its extensive approval.

Among the notable features of Serplulimab is its recognition as a groundbreaking development by Henlius Biotech, which initially developed the drug. A partnership established in 2023 with Intas Pharmaceuticals has allowed for exclusive rights to advance its development and commercialization in over 50 countries.

Commitment to Patient Care



Paul Tredwell, Executive Vice President at Accord Healthcare, has emphasized the company's dedication to supporting cancer patients, stating: "The MHRA's approval of Hetronifly® represents a significant therapeutic option in the treatment of extensive-stage small cell lung cancer, reinforcing our commitment to delivering specialized medication for challenging diseases."

Conclusion and Future Directions



As the fight against cancer continues, approvals like that of Hetronifly® exemplify the critical need for ongoing innovation. With extensive clinical trials supporting its efficacy, Serplulimab is positioned not only to be a viable option for patients currently battling this aggressive form of cancer but also to enhance the entire landscape of cancer treatment protocols.

By expanding access to effective therapies, Accord Healthcare and its partners are making strides in making significant contributions toward extending and improving the lives of patients afflicted by this devastating disease.

Topics Health)

【About Using Articles】

You can freely use the title and article content by linking to the page where the article is posted.
※ Images cannot be used.

【About Links】

Links are free to use.