Shanghai Henlius Biotech, Inc. (2696.HK) has secured a significant milestone with the European Commission (EC) approval of HANSIZHUANG (serplulimab, marketed as Hetronifly® in Europe), making it the first and only anti-PD-1 monoclonal antibody (mAb) approved in the EU for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). This approval not only underscores Henlius' commitment to addressing unmet clinical needs in lung cancer but also marks a pivotal step in expanding global access to innovative oncology treatments.

With its approval in China, Europe, and several Southeast Asian countries, serplulimab has already benefited over 90,000 patients. The latest EU authorization extends to all 27 member states and the European Economic Area, including Norway, Iceland, and Liechtenstein, with Accord Healthcare Ltd, a subsidiary of Intas Pharmaceuticals, spearheading commercialization across Europe.

Dr. Jason Zhu, Executive Director and CEO of Henlius, emphasized the transformative potential of this milestone, stating, "The EU approval of serplulimab reinforces our leadership in oncology innovation and strengthens our global footprint. By bringing a new immunotherapy option to ES-SCLC patients in Europe, we remain dedicated to expanding access to life-changing treatments worldwide."

Advancing Lung Cancer Treatment with Breakthrough Innovation

Lung cancer remains the leading cause of cancer-related mortality globally, with over 2.48 million new cases diagnosed in 2022. Small cell lung cancer (SCLC) accounts for 15-20% of all lung cancers, characterized by aggressive progression, early metastasis, and poor prognosis. The prevalence of SCLC in the EU ranges from 1 to 5 per 10,000 people, presenting a critical unmet clinical need for effective treatment options.

Serplulimab's journey in Europe began with orphan drug designation by the EC in 2022, providing regulatory incentives to accelerate development and commercialization. In September 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending Hetronifly® for approval, paving the way for today's decision.

The EC approval is backed by robust clinical evidence from the ASTRUM-005 Phase 3 trial, a randomized, double-blind, placebo-controlled study across 128 sites worldwide. The trial enrolled 585 patients, including 31.5% Caucasian participants, demonstrating superior efficacy of serplulimab combined with chemotherapy over the existing standard of care. Data from ASTRUM-005 was first presented at ASCO 2022 and later published in JAMA, making it the first SCLC immunotherapy trial to be featured in this prestigious medical journal.

Building on its momentum, Henlius is also conducting a head-to-head bridging trial in the U.S. to compare serplulimab with atezolizumab, a widely used PD-L1 inhibitor, to support its future U.S. regulatory submission.

Scaling Global Reach for Serplulimab

Henlius’ commitment to stringent manufacturing standards played a critical role in securing EC approval. In 2023, its state-of-the-art facilities in Shanghai successfully passed EU GMP inspections, ensuring a stable and high-quality global supply. With a 48,000-liter commercial production capacity across three sites, Henlius is positioned to serve markets across China, Europe, Latin America, the Middle East, North America, and Southeast Asia.

Through strategic partnerships with Accord, KGbio, and Fosun Pharma, Henlius has expanded its oncology pipeline into over 70 countries and regions. Looking ahead, the company remains committed to accelerating access to serplulimab, delivering a next-generation immunotherapy solution to patients worldwide.