· Serplulimab is the world’s first anti-PD-1 monoclonal antibody approved for first-line treatment of ES-SCLC, benefiting over 110,000 patients to date

· The product has been approved in nearly 40 countries and regions, covering close to half of the world’s population

· Serplulimab becomes the first and only commercialized anti-PD-1 therapy for first-line treatment of SCLC in India

Shanghai, China, July 31, 2025 — Henlius (2696.HK) today announced that the company’s independently developed and manufactured anti-PD-1 monoclonal antibody, serplulimab (trade name in Europe: Hetronifly^®), has completed its first shipment to the Indian market. This milestone marks the official entry of this innovative therapy developed in China into the world’s most populous country, further addressing the urgent clinical needs in the treatment of small cell lung cancer (SCLC). Serplulimab is the world’s first anti-PD-1 therapy approved for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) and has been approved in nearly 40 countries and regions including China, the United Kingdom, Germany, India, Indonesia, and Singapore, reaching close to half of the global population ^[1].

Ms. Wei Huang, President of Henlius, stated: “Improving global patient access remains at the heart of Henlius’ strategic vision. The first shipment of serplulimab to India not only demonstrates the strength and efficiency of our global supply system, but also represents another solid step forward in the journey of Chinese innovation benefiting patients worldwide. Since launch, serplulimab has benefited over 110,000 patients globally, and continues to expand the accessibility of immuno-oncology worldwide. Moving forward, we will continue to leverage our integrated global capabilities in R&D, manufacturing and commercialisation to deliver more high-quality innovative medicines to patients around the world.”

Ms. Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius, stated: “We remain committed to addressing the clinical needs of patients worldwide and delivering on our promises to partners through practical action. The swift commercial supply of serplulimab following its approval in India is a result of the close collaboration and efficient execution between Henlius and our partner Intas. By leveraging the differentiated strengths of serplulimab and Intas' deep expertise and robust commercial network in the local market, we aim to bring more high-quality, affordable innovative medicines to patients in need and further enhance treatment accessibility globally.”

In June 2025, serplulimab was approved by the Central Drugs Standard Control Organization (CDSCO) of India for the first-line treatment of ES-SCLC, making it the first anti-PD-1 therapy approved for this indication in the country. As the world’s most populous nation ^[2], India faces a significant burden from lung cancer, which ranks among the leading causes of cancer incidence and mortality. In 2022 alone, India reported over 81,000 new lung cancer cases and more than 75,000 related deaths ^[3]. The launch and commercialisation of serplulimab in India is expected to provide an innovative treatment option for patients and improve survival outcomes in this historically underserved area.

Henlius’ partner, Intas, is responsible for the commercialization of serplulimab in India. As a leading pharmaceutical company in India, Intas brings deep local market expertise and an extensive commercial network, which is expected to accelerate patient access and product availability across the country. Looking ahead, Henlius will continue to deepen collaboration with global partners and advance the worldwide availability of high-quality therapies to benefit more patients.

References:

[1] World Population Prospects 2024 Demographic indicators by region, subregion and country

[2] UNFPA (United Nations Population Fund), 2025. “The Real Fertility Crisis: The pursuit of reproductive agency in a changing world.” ¬State of World Population 2025. New York: UNFPA. ISBN: 9789211542837

[3] Bray F, Laversanne M, Sung H, et al.CA Cancer J Clin. 2024: 1-35.

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 5 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 about 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 (serplulimab, trade name: Hetronifly^® in Europe), 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 19 products, expanding its presence in major markets as well as emerging markets.