Serplulimab

Intas and its subsidiary Accord Healthcare lead commercialisation in Europe and India. In December 2022, serplulimab received orphan drug designation from the EC for the treatment of SCLC, this was recently reviewed by the committee and renewed. ESMO has scored serplulimab 4 out of 5 on their magnitude of clinical benefit scale (MCBS) in ES-SCLC. Serplulimab is the only anti-PD-1 mAb approved for the first-line treatment of ES-SCLC and has now reached over 110,000 patients. It has been approved in nearly 40 countries, including China, Europe, India and multiple Southeast Asian countries. LONDON, June 24, 2025 /PRNewswire/ -- Accord Healthcare Limited (Accord) is delighted to announce that the anti-PD-1 mAb, serplulimab, marketed as Hetronifly®, has been approved by the MHRA to treat adults in the UK with extensive-stage small cell lung cancer (ES-SCLC), which has not previously been treated and has spread within the lungs or to other parts of the body. This approval comes in the same week as the announcement in India, bringing the total number of countries and regions in which the medicine is approved to over 40 — including Europe, China, Indonesia, and Singapore. Accord Healthcare will lead commercialisation in both the UK and India on behalf of its parent company, Intas, and its commercial partner, Henlius. Lung cancer remains the leading cause of cancer-related death globally. Small cell lung cancer (SCLC), one of the most aggressive subtypes, accounts for approximately 15% of all lung cancer cases and is associated with limited treatment options[1]. Julian Beach, Interim Executive Director of Healthcare Quality and Access at the UK's Medicines and Healthcare products Regulatory Agency (MHRA), commented: "As the first and only anti-PD-1 monoclonal antibody approved in the UK for small cell lung cancer, this marks an important new treatment option for patients with this aggressive type of lung cancer who currently have limited choices and face a poor prognosis."[2] Henlius Biotech originally developed Serplulimab. In 2023, Henlius entered into a collaboration with Intas Pharmaceuticals, granting Intas exclusive rights to develop and commercialise the medicine in over 50 countries across Europe and India. Welcoming the news, Paul Tredwell, Executive Vice-President EMENA, Accord Healthcare, said: "At Accord, we are dedicated to supporting patients with cancer. The MHRA's approval of Hetronifly® provides a new treatment option in the fight against extensive-stage small cell lung cancer — one of the most aggressive forms of lung cancer. This milestone reflects our ongoing commitment to providing novel specialty medicines for difficult-to-treat conditions." Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius said: "The approvals of serplulimab in the UK and India not only represent continued progress in our globalisation strategy but also reflect our concrete commitment to putting patients first. We are steadily expanding the global reach of the product, aiming to bring high-quality innovative therapies to more patients around the world." In December 2022, serplulimab received orphan drug designation from the EC for the treatment of SCLC, this was recently reviewed by the committee and renewed. ESMO has also scored serplulimab 4 out of 5 on their magnitude of clinical benefit scale (MCBS) in ES-SCLC. About Serplulimab Serplulimab (recombinant humanised anti-PD-1 monoclonal antibody injection)) is an anti-PD-1 mAb for the first-line treatment of SCLC and has been approved in China and several SEA countries. Serplulimab has been approved by the National Medicinal Products Administration (NMPA) in China 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 serplulimab 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 serplulimab were published in the Journal of the American Medical Association (JAMA), Nature Medicine, Cancer Cell and British Journal of Cancer, respectively. Furthermore, serplulimab 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. The approvals were primarily based on the results of the global phase 3 clinical study ASTRUM-005, which enrolled 585 patients across 128 trial sites worldwide. At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, the results from the final analysis of ASTRUM-005 were presented, showing a median follow-up of 42.4 months and a 4-year overall survival (OS) rate of 21.9% (95% CI: 17.6–26.6%) for the serplulimab plus chemotherapy group. These results further confirm the long-term survival benefit of this immunotherapy-based regimen for patients with ES-SCLC. About Lung Cancer 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 an extensive stage. Within Europe, the prevalence of SCLC ranges from 1 to 5 per 10,000 people.[3] References Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. doi:10.3322/caac.21834 MHRA approves the UK's first anti-PD-1 monoclonal antibody for the treatment of an aggressive form of lung cancer. last accessed June 2025 Dingemans AC, Früh M, Ardizzoni A, et al. Small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up☆. Ann Oncol. 2021;32(7):839-853. doi:10.1016/j.annonc.2021.03.207 Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SHANGHAI, April 16, 2025 /PRNewswire/ -- Henlius (2696.HK) held its 2025 Global R&D Day under the theme of "Collaborate to Create". Senior executives from Henlius gathered with leading experts, scholars, and heads of innovation from across the industry to engage in in-depth discussions on the latest advances in R&D, future strategic planning, and the deployment of cutting-edge technologies and therapies. The event drew hundreds of guests from academia, industry, and the investment community, making it a grand gathering of shared insight and collaboration. Jason Zhu, Executive Director and CEO of Henlius, stated: "At Henlius, we remain steadfast in our patient-centric philosophy and continue to strengthen our differentiated competitive edge through innovation-driven R&D. We are advancing the development of several key innovative assets, including HANSIZHUANG (serplulimab, anti-PD-1 mAb), HLX22 (anti-HER2 mAb), and HLX43 (PD-L1 ADC), with the potential to reshape the treatment landscape for lung and gastrointestinal cancers. Beyond that, we are actively exploring frontier technologies such as targeted therapies, immunotherapies, and glyco-editing, as we build a diversified innovation platform. In terms of global expansion, Henlius is strategically focused on major markets such as the U.S., EU, and Japan. Through full value chain integration and deepening international partnerships, we are making a strategic leap from exporting products to building a global value chain. Looking ahead, Henlius will continue to focus on antibody drug innovation, accelerate breakthroughs in targeted and immune therapies, and drive the global advancement of China's innovative biologics. Our goal is to deliver high-quality, affordable biologics to patients around the world while forging a sustainable, globally integrated value core." Jijun Yuan, CSO of Henlius, elaborated on the company's differentiated innovation strategy: "Henlius' R&D strength is reflected not only in our innovative pipeline but also in the continuous expansion of our platform capabilities. We focus on key therapeutic areas such as oncology and autoimmune diseases, extending our innovation reach to diverse modalities—including protein-based therapies, small molecules, and ADCs—to maximize synergistic potential across pipeline assets. Our three flagship technology platforms—the Hinova TCE (tri-specific T-cell engager) platform, the independently developed ADC platform Hanjugator™, and the AI-driven drug discovery platform HAI Club—have formed a collaborative R&D matrix. Leveraging these platforms and AI-driven approaches, we are accelerating the development of differentiated molecules, such as TCEs for solid tumors, to rapidly deliver more potential blockbuster therapies." In Henlius' innovative pipeline, late-stage clinical assets such as HLX22 and HLX43 have emerged as breakthrough candidates, underscoring the company's potential to drive future growth. Lixin Feng, Strategic Products Deputy GM of Henlius, shared that, "HLX43 is a precisely designed ADC targeting the pan-tumor antigen PD-L1. Its core framework incorporates the company's proprietary novel anti-PD-L1 mAb, combined with MediLink Therapeutics' innovative linker-toxin payload featuring a dual-release mechanism (intracellular and extracellular). As the world's second and China's first PD-L1 ADC to enter clinical development, HLX43 has demonstrated early potential as an innovative PIP (pipeline in a pill).Preclinical studies have shown favorable druggability and safety profiles with significant tumor-killing activity. Meanwhile, clinical studies of HLX43 as both monotherapy and in combination with HANSIZHUANG are accelerating across multiple solid tumors, with the potential to deliver superior treatment options for patients." At the event, Professor Lin Shen, the leading principal investigator of the MRCT Phase 3 trial for HLX22, remarked: "Henlius' HLX22 is a highly promising HER2-targeted therapy distinguished by both its mechanism of action and clinical performance. Its differentiated molecular design enables simultaneous binding to HER2 alongside trastuzumab, synergistically blocking all HER2 dimer formation and disrupting HER2-mediated signaling pathways. Moreover, HLX22's clinical development strategy is both pioneering and ambitious—it targets gastrointestinal cancers, a field with urgent unmet needs and high heterogeneity, where the drug has demonstrated exceptional antitumor efficacy. This positions HLX22 to potentially redefine first-line treatment for HER2-positive gastric cancer. HLX22 has demonstrated clinical development potential as a pan-tumor therapeutic for all HER2-positive cancers. We look forward to HLX22 benefiting more patients worldwide." Henlius is strategically advancing key innovations in biopharma by harnessing AI to sharpen its cutting-edge capabilities. Simon Hsu, CTO and SVP of Henlius, highlighted breakthroughs in AI-driven drug development, with a focus on next-generation hyaluronidase Henozye™, "Utilizing AI modeling, Henozye™ achieved significantly faster development cycles versus conventional methods while demonstrating superior enzyme activity and stability. Its exceptional performance across buffer systems and co-formulations provides critical support for subcutaneous delivery—overcoming injection volume limits to enable high-dose drug development," He emphasized that this hyaluronidase platform will transform the subcutaneous delivery market. "Through collaborative partnerships, we're accelerating subcutaneous formulations for both novel drugs and biosimilars, extending product lifecycles sustainably." While deepening its presence in Europe and the U.S. and expanding into emerging markets in Southeast Asia, Henlius is advancing its Globalization 2.0 strategy with a focused breakthrough in the Japanese market. Leveraging the advantages of geographic proximity and ethnic similarity for clinical development, along with Japan's status as the world's third-largest pharmaceutical market—supported by an aging population and a robust universal healthcare system—Henlius positions Japan as a strategic stronghold for the global rollout of its innovative biologics. Jin Li, Vice President of Henlius Regulatory Affairs, stated that "We are advancing our Internationalization 2.0 Strategy with Japan as a key market, leveraging the differentiated advantages of our core pipeline assets HLX22 (anti-HER2 mAb) and serplulimab (HLX10, anti-PD-1 mAb) in gastric cancer and lung cancer. We have initiated clinical trials in Japan to establish foundational support for indication development. Japan represents a strategic priority as a global pharmaceutical hub, offering unique opportunities through its aging population dynamics and innovative drug policy environment. We are systematically building local operational capabilities while strengthening our market position through innovative biologics. By integrating global clinical resources with localized strategies, we are creating an end-to-end value chain from clinical development to commercialization. As a Chinese biopharma innovator, we are reshaping the landscape in global markets through this approach." Henlius is committed to building a global innovation network and fostering an international collaborative ecosystem, setting a benchmark for partnerships spanning product development, market access, and localized operations. During the panel discussion moderated by Henlius SVP and Chief Business Development Officer, Ping Cao, 2022 Nobel Laureate and Palleon Co-founder Professor Carolyn Bertozzi, Palleon CEO James Broderick, MediLink CMO Steve Chin, KGbio CEO Sie Djohan and Sermonix Founder and CEO David Portman joined the discussion under the theme "Partnering for Success - Building a Global Biopharma Ecosystem." Professor Carolyn Bertozzi highlighted the critical role of sialoglycans in disease treatment, particularly their mechanism in tumor immune evasion and autoimmune diseases, as well as their vast potential as a cutting-edge global technology for novel drug development. Palleon is actively advancing its proprietary Enzyme-Antibody Glycan Ligand Editing (EAGLE) platform and has entered into collaborations with Henlius to develop bifunctional antibody-sialidase fusion proteins and human sialidase fusion protein HLX79 (E-602)—leveraging the EAGLE platform to target cancer and autoimmune diseases, respectively. During the follow-up discussion, panelists unanimously recognized Henlius' comprehensive capabilities spanning cutting-edge innovation, clinical development, and manufacturing excellence, while particularly commending the team's efficient collaboration and responsive partnership approach. Industry partners emphasized that their decision to collaborate with Henlius was rooted in strong confidence in the company's fully integrated biopharmaceutical platform that covers the entire value chain from research to commercialization. With established expertise in antibody development and a demonstrated ability to execute rapid yet reliable clinical strategies, Henlius has built a world-class manufacturing quality system meeting international standards, creating a robust foundation for global commercialization. Ping articulated the company's partnership philosophy: "We build on trust as our foundation, drive progress through efficiency, and connect through innovation." This guiding principle continues to shape Henlius' growing global collaborative ecosystem. Moving forward, the company remains committed to deepening complementary technology partnerships and accelerating exploration in frontier therapeutic areas. By leveraging its strong partner network, Henlius aims to enhance worldwide access to innovative therapies and deliver high-quality treatment solutions to patients across the globe. In biopharmaceutical R&D, the translational gap from preclinical research to clinical application remains a persistent challenge across the industry. For Henlius, this very gap represents a critical breakthrough point to truly deliver clinical benefit by staying centered on the patient. At the close of the event, Jijun Yuan moderated a panel discussion on the theme "From Discovery to Delivery: Patient-Centric Innovation in Practice." He was joined by Lei Tang, Head of Translational Medicine Unite China R&D at Sanofi; Li Peng, CSO of Palleon; Feng Ren, Co-CEO and CSO of Insilico; and Guoqiang Hua, Founder and Chairman of Dan1Med. Guests shared insights from the perspectives of multinational pharma, cutting-edge biotech, AI-driven biopharma company and technology platform company. Discussions spanned innovations in tools that enhance precision in clinical trial design, the acceleration of R&D through advanced AI-driven data strategies, and the current challenges faced. Ultimately, all perspectives converged on a shared vision: building a collaborative, barrier-free ecosystem is essential to truly achieving a seamless transition "from discovery to delivery." From biosimilars to first-in-class therapies, and from deepening presence in mainstream markets to expanding into multi-polar global markets, Henlius continues to push the boundaries of the industry with its multiple driving forces such as innovation and globalization. In 2025, Henlius will remain committed to its core theme of "Collaborate to Create", further powering its innovation engine to accelerate the transformation from technological strength to clinical value. The company aims to drive explosive growth across its innovative pipeline while advancing both technological breakthroughs and international collaboration. Looking ahead, Henlius will continue to write a new chapter for China's biopharmaceutical industry on the global stage—bringing Chinese innovation to contribute to the advancement of human health worldwide. 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. SOURCE Henlius WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED