Shanghai Henlius Biotech,  announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of HANSIZHUANG (serplulimab), the company’s independently developed anti-PD-1 monoclonal antibody (mAb), as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). This marks a significant step towards bringing serplulimab to Europe, where it is expected to become the first and only anti-PD-1 mAb available for first-line treatment of ES-SCLC.

The approval would allow Accord Healthcare Ltd, a subsidiary of Intas Pharmaceuticals Limited, to market serplulimab in Europe. This follows Henlius’ exclusive licensing agreement with Intas in 2023, covering over 50 countries in Europe and India. If approved, HANSIZHUANG will expand treatment options for patients across Europe, with a particular focus on those with limited therapeutic alternatives.

Expanding Access to Innovative Lung Cancer Treatments

Dr. Jason Zhu, Executive Director and CEO of Henlius, commented: “This positive opinion from CHMP is a major milestone in our global strategy. It validates Henlius' commitment to providing innovative treatments for patients globally. We look forward to receiving final approval in Europe and helping more patients with ES-SCLC access effective treatment options."

Paul Tredwell, Executive Vice President of EMENA at Accord, added: “We are excited about the CHMP's positive opinion. Serplulimab’s approval would provide a valuable new treatment option for patients with extensive-stage small cell lung cancer, where therapeutic choices remain limited.”

Addressing Clinical Needs for SCLC

Lung cancer remains the most diagnosed and deadliest cancer worldwide, accounting for more than 2.48 million new cases in 2022, with small cell lung cancer (SCLC) comprising 15-20% of all lung cancer cases. SCLC is marked by rapid progression and poor prognosis, particularly in its extensive stage (ES-SCLC), where treatment options are limited. In December 2022, HANSIZHUANG was granted orphan drug designation by the European Commission (EC) for the treatment of SCLC, and in March 2023, EMA validated the marketing authorization application for HANSIZHUANG in ES-SCLC.

The CHMP recommendation is based on the results of the ASTRUM-005 study, a double-blind, placebo-controlled, international multi-centre clinical trial that demonstrated the efficacy and safety of serplulimab combined with chemotherapy as a first-line treatment for ES-SCLC. Conducted across 128 sites globally, the study enrolled 585 patients, with clinical data first presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and published in JAMA.

Global Expansion of HANSIZHUANG

HANSIZHUANG has already been approved in several countries, including China, Indonesia, Cambodia, and Thailand, benefiting around 80,000 patients to date. Henlius continues to expand globally, with approvals and marketing efforts across more than 70 countries, including the U.S., Europe, Southeast Asia, and the Middle East. Henlius also received EU GMP certification for its production facilities in late 2023, allowing for its first overseas shipment in early 2024.

Looking ahead, Henlius is committed to addressing unmet medical needs and delivering high-quality biologics to patients worldwide, including further efforts to secure approvals in additional markets, such as the U.S.