• Serplulimab is the world's first anti-PD-1 monoclonal antibody (mAb) approved for first-line treatment of ES-SCLC
• Serplulimab is the first and only anti-PD-1 mAb approved in the European Union (EU) for the treatment of ES-SCLC
• Serplulimab has now been approved in China, Europe, and several Southeast Asian countries, benefiting over 90,000 patients

SHANGHAI, Feb. 5, 2025 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that its anti-PD-1 mAb, HANSIZHUANG (serplulimab, marketed as Hetronifly^® in Europe), has been officially approved by the European Commission (EC) for use in combination with carboplatin and etoposide as a first-line treatment of adult patients with ES-SCLC. This approval establishes serplulimab as the first and only anti-PD-1 mAb approved in the EU for the treatment of ES-SCLC.

Serplulimab is the world's first anti-PD-1 mAb approved for first-line treatment of ES-SCLC. Underpinned by clinical needs, Henlius has carried out a differentiated and multi-dimensional layout of serplulimab in the fields of lung cancer and gastrointestinal cancer. To date, more than 4,800 subjects have been enrolled worldwide for clinical trials of serplulimab. In 2023, Henlius entered into a collaboration with Intas Pharmaceuticals, granting Intas exclusive rights to develop and commercialise serplulimab in over 50 countries across Europe and India. This latest approval covers all 27 EU member states as well as the European Economic Area countries, including Norway, Iceland, and Liechtenstein. Commercialisation in Europe will be led by Intas' subsidiary, Accord Healthcare Ltd ("Accord").

Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, stated: "The approval of serplulimab in the EU represents another significant step forward in our mission to benefit patients worldwide. This milestone not only underscores our leadership in innovative drug development and global strategy, but also brings new hope to ES-SCLC patients in Europe and beyond. Moving forward, we will continue to collaborate with our partners to enhance the accessibility of advanced therapies and work together to make a meaningful difference in patients' lives."

Breakthrough Innovation to Address Unmet Clinical Needs

Lung cancer is the most common cancer worldwide in terms of incidence and mortality. According to GLOBOCAN 2022, there were over 2.48 million new cases of lung cancer globally in 2022, accounting for 12.4% of all new cancer cases.^[1] Small cell lung cancer (SCLC), which accounts for 15% to 20% of all lung cancers, is characterised by high malignancy, early metastasis, rapid progression, and poor prognosis. Among SCLC patients, approximately 30% to 40% are diagnosed at a limited stage, while the remaining cases are in extensive stage. In the EU, the prevalence of SCLC ranges from 1 to 5 per 10,000 people.^[2] In December 2022, serplulimab received orphan drug designation from the EC for the treatment of SCLC. The orphan-drug designation granted by the EC is beneficial for serplulimab to enjoy certain policy supports in the R&D, registration and commercialisation in the treatment of SCLC in the EU. In September 2024, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending Hetronifly^® for approval in the EU.

The approval of serplulimab by the EC is primarily based on data from the ASTRUM-005 study, a randomized, double-blind, placebo-controlled international multi-centre Phase 3 study evaluating the efficacy and safety event profile of serplulimab in combination with chemotherapy versus placebo with chemotherapy as a first-line treatment for ES-SCLC. The study has set up a total of 128 sites across countries including China, Poland, Turkey, and Georgia, enrolling 585 subjects, of whom around 31.5% were Caucasians. Results from ASTRUM-005 were first presented orally at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and later published in the Journal of the American Medical Association (JAMA), making it the first SCLC immunotherapy study to publish on JAMA. Based on ASTRUM-005, serplulimab has been approved in China, Southeast Asian countries, and the EU for the first-line treatment of ES-SCLC, establishing it as the world's first anti-PD-1 mAb approved for the indication. Additionally, Henlius is conducting a head-to-head bridging trial in the U.S. comparing serplulimab with atezolizumab, the current standard of care, to further support its U.S. regulatory submission.

Global Expansion to Benefit More Patients

Henlius' commitment to stringent quality standards has been instrumental in achieving EC approval for serplulimab. In 2023, Henlius' manufacturing facilities and production lines of serplulimab successfully passed EU GMP inspections, ensuring a stable and high-quality supply of serplulimab for the European market. Henlius operates three facilities in Shanghai—Xuhui Facility, Songjiang First Plant, and Songjiang Second Plant—with a total commercial capacity of 48,000 litres, ensuring consistent global supply to regions including China, Europe, Latin America, the Middle East, North America, and Southeast Asia. The company has implemented a comprehensive quality management system in line with international standards, covering the entire product continuum ranging from R&D to material management, product manufacturing, quality control, product supply management and post-marketing surveillance. The company's facilities and quality systems have been audited and certified by regulatory authorities including the National Medical Products Agency (NMPA), European Medicines Agency (EMA), United States Food and Drug Administration (FDA), and international business partners.

Henlius has established a robust global presence through partnerships with Accord, KGbio, and Fosun Pharma, extending its reach to over 70 countries and regions, including the U.S., Europe, Southeast Asia, and emerging markets. Looking ahead, Henlius will continue to work closely with its partners to expand the availability of serplulimab to more countries and regions, providing broader treatment options to patients worldwide.

About Serplulimab

HANSIZHUANG (recombinant humanized anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first anti-PD-1 mAb for the first-line treatment of SCLC and has been approved in China, the EU and several SEA countries. Focusing on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. Up to date, HANSIZHUANG has been approved by the National Medicinal Products Administration (NMPA) for the treatment of squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC) and non-squamous non-small cell lung cancer (nsNSCLC). Serplulimab was granted orphan drug designations by the FDA and the EC for the treatment of SCLC, and its bridging head-to-head trial in the United States to compare HANSIZHUANG to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC is well under way.

The results of 4 pivotal trials of HANSIZHUANG were published in the Journal of the American Medical Association (JAMA), Nature Medicine, Cancer Cell and British Journal of Cancer, respectively. Furthermore, HANSIZHUANG was respectively recommended by the CSCO Guidelines for Small Cell Lung Cancer, the CSCO Guidelines for Non-Small Cell Lung Cancer, the CSCO Guidelines for Esophageal Cancer, the CSCO Clinical Practice Guidelines on Immune Checkpoint Inhibitor, the China Guidelines for Radiotherapy of Esophageal Cancer, and other definitive guides, providing valuable references for clinical diagnosis and treatment of tumours.

About Henlius

Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 4 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.

Henlius has pro-actively built a diversified and high-quality product pipeline covering over 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac^® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG, the world's first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What's more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets.

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SOURCE Henlius