- 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

(February 6 2025, Shanghai, China) On February 5, Fosun Pharma (600196.SH; 02196.HK) announced that the Marketing Authorization Application (MAA) for serplulimab injection (marketed as Hetronifly^® in Europe and Han Si Zhuang in mainland China), a self-developed anti-PD-1 monoclonal antibody (mAb) by its subsidiary Shanghai Henlius Biotech, Inc. (02696.HK), has recently been approved by the European Commission (EC) for use in combination with carboplatin and etoposide as a first-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC). With this approval, serplulimab has received a centralized marketing authorization covering all EU member states as well as Iceland, Liechtenstein, and Norway—countries within the European Economic Area (EEA)—making it the first and only anti-PD-1 mAb approved in the EU for the treatment of ES-SCLC.

To date, Serplulimab has been approved in mainland China (excluding Hong Kong SAR, Macao SAR, and Taiwan region) for multiple indications, including first-line treatment of squamous non-small cell lung cancer (NSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsNSCLC) in combination with chemotherapy. It has also been approved for marketing in Europe, Indonesia, Cambodia, and Thailand. Additionally, several combination therapies involving Serplulimab are currently undergoing clinical trials in various countries and regions worldwide.

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”).

As a global innovation-driven pharmaceutical and healthcare industry group,Fosun Pharma remains committed to innovation driven by unmet clinical needs, strengthens core technology platforms such as antibodies/ADC, cell therapy, and small molecules. As a key antibody technology platform of Fosun Pharma, Henlius continues to drive innovation in biopharmaceuticals, expand its presence in domestic and international markets, and enhance global competitiveness for high-quality growth. The EU approval of serplulimab marks a significant milestone in Fosun Pharma’s global drug innovation and commercialization efforts, paving the way for further global market approvals and offering new treatment options for lung cancer patients worldwide.

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 10,000people^[2].InDecember 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 Administration (NMPA), European Medicines Agency (EMA), United States Food and Drug Administration (FDA), EU Qualified Person (QP), and international business partners.

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About Fosun Pharma

Founded in 1994,Shanghai Fosun Pharmaceutical (Group) Co., Ltd.*(“Fosun Pharma”; stock code: 600196.SH, 02196.HK) is a global innovation-driven pharmaceutical and healthcare industry group. Fosun Pharma directly operates businesses including pharmaceuticals, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business.

Fosun Pharma is patient-centered and unmet clinical needs-oriented. Through diversified and multi-level cooperation models such as independent research and development, cooperative development, license-in, and industrial investment, the company continues to enrich its innovative product pipeline and focus on differentiated product R&D with high-tech barriers, to continuously enhance the value of its pipeline. Fosun Pharma's innovative products focus on core therapeutic areas such as solid tumors, hematologic tumors and immunity inflammation. It also strengthens core technology platforms such as antibodies/ADC, cell therapy, and small molecules.

Guided by the 4IN strategy (Innovation, Internationalization, Intelligentization, and Integration), Fosun Pharma adheres to the business philosophy of “Innovation for Good Health”, continues to promote innovative transformation, actively deploys internationalization, strengthens business focus by product lines, promotes integrated operations and efficiency improvement, and is dedicated to being the global leading integrator of pharmaceutical and healthcare innovation.

For more information, please visit the official website:m.lukesuciu.com