Serplulimab

SHANGHAI, Aug. 25, 2025 /PRNewswire/ -- Henlius (2696.HK) announced its 2025 interim results. In the first half of 2025, Henlius' revenue reached about RMB2.8195 billion, representing an increase of 2.7% YoY. The gross profit of RMB2.1992 billion, up by 10.5% YoY, with a net profit reached RMB390.1 million. Operating cash flow reached RMB770.9 million, with an increase of 206.8% YoY, maintaining a steady positive inflow. Overseas products profits surged over 200%. Cash inflows from BD agreements exceeded RMB 1 billion, surging 280% YoY. As the overseas sales volume of commercialized products continues to rise, the company expects significant growth in overseas revenue and profits for the full year of 2025, with strong momentum likely to continue into 2026. The company remains committed to reinforcing its strategic focus on innovation and globalisation, actively advancing its end-to-end ecosystem to drive sustainable R&D growth with robust growth momentum. During the reporting period, the company invested RMB995.4 million in R&D, with an increase of 21.3% YoY in expensed R&D expenditures, prioritizing preclinical development of differentiated innovative molecules and construction of core innovation platforms. Up to date, Henlius has 6 products launched in China, 4 approved for marketing in overseas markets, benefiting over 850,000 patients and reaching about 60 markets in Asia, Europe, Latin America, North America and Oceania. Meanwhile, the company is expanding its innovation pipeline in disease areas like oncology and autoimmune, advancing a differentiated portfolio of potential best-in-class (BIC) and first-in-class (FIC) candidates. Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said "2025 is a pivotal year for Henlius. It is the year we shift into Globalisation 2.0 and step up the pace of innovation. We're strengthening our end-to-end ecosystem and driving overseas revenue growth with global value at scale. Meanwhile, our core innovative products have achieved significant milestones, with the next-generation of high-potential molecules underway. Looking ahead, Henlius will adhere to patient-centricity and accelerate the delivery of superior innovative treatment solutions." Globalisation 2.0: actively advancing the end-to-end ecosystem In the first half of 2025, Henlius' global growth engine was in full swing, with global product revenue exceeding RMB2.5568 billion, representing an increase of 3.1% YoY. Several products are accelerating their expansion into international markets, further improving patient access to essential therapies. The company's core innovative product serplulimab (trade name: HANSIZHUANG in China, Hetronifly® in Europe), the world's first anti-PD-1 monoclonal antibody (mAb) approved for first-line treatment of small cell lung cancer (SCLC), has recorded a global sales revenue of RMB597.7million during the reporting period. The overseas market expansion of serplulimab has been accelerated in the first half of 2025. It has received approvals in the Europe, Singapore, Malaysia, the United Kingdom and India for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). Additionally, it has been approved in Indonesia and Thailand for the treatment of squamous non-small cell lung cancer (sqNSCLC). To date, serplulimab has been successfully approved in nearly 40 countries and regions, covering nearly half of the world's population. A head-to-head bridging trial of serplulimab versus first-line standard of care atezolizumab for ES-SCLC in the U.S will also complete patient enrolment soon. The company plans to submit the Biologics License Application (BLA) to the FDA in the first half of 2026. Henlius' core breast cancer product HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), the "China-developed" mAb biosimilar approved in China, the EU, and the U.S., has recorded a global sales revenue of RMB1.4442 billion in the first half of 2025. During the reporting period, HANQUYOU (trastuzumab) was newly approved in countries including Mexico, bringing its cumulative approvals to over 50 countries and regions worldwide. In the HER2-positive breast cancer segment, Henlius has sequentially combined HANQUYOU (trastuzumab) with HANNAIJIA (neratinib) for extended adjuvant therapy to reduce recurrence risk in early-stage patients. Meanwhile, Henlius' independently developed pertuzumab biosimilar, HLX11, has been accepted for marketing applications by regulatory agencies in China, the U.S., and Europe, and is anticipated to receive approval in th U.S. during the second half of 2025. Focusing on the breast cancer field, Henlius continues to build a comprehensive innovative product portfolio — candidates including Henlius' HLX78 (lasofoxifene), an investigational novel endocrine therapy, the company's novel epitope anti-HER2 mAb HLX22, the next-gen innovative HER2 ADC HLX87, the KAT6A/B inhibitor HLX97 with BIC potential, and the LIV-1 ADC HLX41 are accelerating their research progress. In more disease fields, HLX04-O, a recombinant anti-VEGF humanised mAb injection jointly developed by the company and Essex, for the treatment of wet age-related macular degeneration (wAMD) has been accepted for the New Drug Application (NDA) in China in August 2025. This is the company's first ophthalmic product submitted for marketing approval. The marketing applications for the denosumab biosimilar HLX14, intended for the treatment of osteoporosis and other indications, have been accepted in the U.S., EU, and Canada, with expected approvals in the second half of 2025. In the first half of the 2025, Henlius accelerated the expansion of its core products into major global markets through strategic collaboration, further enhancing the company's international influence and commercial capabilities. The company has entered into agreement with Abbott, granting it exclusive or semi-exclusive licenses for the development and commercialization of four self-developed biosimilars and one innovative biologic in 69 emerging markets including Asia and Latin America. The company has granted Dr. Reddy's exclusive rights to HLX15, an anti-CD38 mAb, covering a total of 43 countries and regions across the U.S. and Europe. Besides, the company has also entered into an exclusive commercialization and semi-exclusive development collaboration with Lotus for the anti-PD-1 antibody serplulimab in multiple indications in South Korea. Additionally, the company has signed a licensing agreement with Sandoz, granting exclusive commercialization rights for HLX13, an CTLA-4 inhibitor, in the U.S., EU, Japan, Canada, and Australia. In the first half of 2025, leveraging the advanced technologies and extensive resources, the company continued to reinforce its integrated biopharmaceutical platform including R&D, clinical trials, manufacturing, quality management, regulatory affairs, and commercialization. Up to date, the company has submitted over 800 drug registrations, and received more than 600 approvals, covering multiple countries and regions including China, the U.S., the EU, Canada, Indonesia and Japan. It has also conducted MRCTs in the U.S., the EU, Southeast Asia, Japan and other countries and regions, accelerating the globalisation process of its products. During the reporting period, Henlius continues to optimize its production operations and quality management system. The Songjiang Site has once again received the EU GMP Certificate, issued by the Federal Agency for Medicines and Health Products in Belgium, in July 2025. The completion of the Phase 1 of Songjiang Site II in August 2025 has further enhanced the company's production capabilities. Up to now, the company has delivered over 1,150 batches of commercial GMP production, ensuring stable supply to countries and regions including China, Southeast Asia, Europe and Latin America. The company has successfully passed nearly 100 on-site inspections and audits conducted by global regulatory authorities and business partners, and has obtained GMP certifications from China, the EU, the U.S. and multiple PIC/S member countries, including Indonesia and Brazil. Innovation breaks through the growth ceiling In the first half of 2025, the company continued to advance its innovation-driven strategy, accelerating breakthroughs in cutting-edge technology platforms and driving robust growth in its innovative pipeline. Core products such as HLX43, HLX22, and serplulimab have each achieved significant global milestones. HLX43 is a broad-spectrum anti-tumor ADC candidate targeting PD-L1 with BIC potential. The results of the phase 1 clinical trial of HLX43 have been first released at the 2025 ASCO Annual Meeting, demonstrating manageable safety profile and encouraging efficacy in various solid tumors especially in patients with NSCLC and thymic squamous cell carcinoma (TSCC). It shows encouraging efficacy in squamous and non-squamous NSCLC patients (sqNSCLC and nsqNSCLC), patients with or without EGFR mutation, patients with or without brain/liver metastasis, and PD-L1 positive or negative NSCLC patients, indicating its biomarker-independent antitumor potential. Previously, HLX43 has already been approved to conduct phase 2 MRCT in patients with non-small cell lung cancer (NSCLC) in China, the U.S., Japan and Australia, with first patients successfully dosed in both China and the U.S. Simultaneously, as the world's first PD-L1 ADC indicated for thymic carcinoma (TC), HLX43 has received clinical trial approvals for the indication in the U.S. and other regions. A MRCT is planned to be initiated, aiming to fill the therapeutic gap in ADC treatment for this aggressive cancer type. In addition, the company is also accelerating the phase 2 clinical development of HLX43 in various solid tumors, including cervical cancer (CC), hepatocellular carcinoma (HCC), esophageal squamous cell carcinoma (ESCC), head and neck squamous cell carcinoma (HNSCC), nasopharyngeal cancer (NPC), colorectal cancer (CRC) and gastric/gastroesophageal junction cancer (GC/GEJC). Both monotherapy and combination therapies of HLX43 with other products are ongoing simultaneously to further exploit the synergistic effects of ADC-mediated cytotoxicity and immunotherapy-induced immune activation. A phase 3 head-to-head clinical trial of Henlius' novel enpitope anti-HER2 mAb HLX22 in combination with trastuzumab and chemotherapy comparing to current first-line standard of care therapy (trastuzumab + chemotherapy ± pembrolizumab) is steadily progressing. The first patient dosing has been completed in China, the U.S., Japan, Australia, and Korea, regardless of PD-L1 expression, with the aim of overcoming current limitations in first-line treatment of HER2-positive metastatic gastric cancer. Meanwhile, HLX22 has received Orphan Drug Designations from both the U.S Food and Drug Administration (FDA) and the European Commission (EC) in the first half the year for the treatment of gastric cancer, suggesting its significant therapeutic potential. Moreover, the updated data with over two years of follow-up from the phase 2 clinical study (HLX22-GC-201) evaluating HLX22 in combination with trastuzumab and chemotherapy as a first-line treatment for HER2-positive advanced gastric cancer were presented at the 2025 ASCO Annual Meeting. The study data demonstrated that the efficacy benefit of HLX22 in HER2-positive gastric cancer remained stable with extended follow-up, outperforming previous data and providing solid data foundation for the subsequent phase 3 study. Focusing on lung and gastrointestinal cancer, Henlius is continuously advancing the global clinical development of its self-developed innovative anti-PD-1 mAb serplulimab. In the field of lung cancers, the U.S. and Japanese bridging trial of serplulimab for SCLC, and a phase 3 MRCT of serplulimab combined with chemotherapy and radiotherapy for limited-stage SCLC (LS-SCLC) are currently underway in parallel to establish a solid foundation for future overseas regulatory registration, among which the phase 3 MRCT in LS-SCLC has completed the subject enrollment. In the field of gastrointestinal cancers, a phase 3 clinical trial of serplulimab plus chemotherapy as neoadjuvant/adjuvant therapy for gastric cancer, as well as the phase 3 MRCT (ASTRUM-015) of serplulimab in combination with bevacizumab and chemotherapy in first-line treatment of metastatic colorectal cancer (mCRC) have also completed subject enrollment. During the reporting period, a total of over 20 pivotal studies, investigator-initiated trials (IITs), and real-world studies (RWS) on serplulimab in the fields of lung cancer and gastrointestinal cancer were presented at major international academic conferences such as ASCO GI, ELCC, IGCC, ASCO, and WCLC, and were published in scientific journals including Cancer Immunology, Immunotherapy and Cancer Communications. Among them, the end-of-study analysis of the phase 3 clinical trial (ASTRUM-005) of serplulimab as the first line treatment for ES-SCLC has been first released at the 2025 ASCO Annual Meeting, featuring a four-year OS data of 21.9% and thus validating its long-term survival benefit. While fully leveraging the value of its flagship molecules, the company is actively addressing unmet clinical needs and building an early-stage pipeline of high-potential candidates, creating strong momentum for sustainable, high-quality growth over the medium to long term. During the period, the company continued building and optimizing its competitive R&D platforms, including its ADC platform Hanjugator™ with independent intellectual property, T cell Engager (TCE) platforms, the one-stop drug discovery platform HAI Club, and the independently developed computing platform HAI PBD to enhance R&D capabilities. Meanwhile, building on its core antibody expertise, the company is making ongoing breakthroughs across target coverage and molecular diversity, accelerating multiple candidates toward clinical development, including the potential FIC human sialidase enzyme therapeutic HLX79, HLX701, the novel anti-CD47 SIRPα-Fc fusion protein with good safety profile, anti-PD-L1/VEGF bispecific antibody (BsAb) HLX37, potential BIC KAT6A/B small molecule inhibitor HLX97, TCE platform-derived DLL3xCD3xCD28 TCE HLX3901 and STEAP1xCD3xCD28 TCE HLX3902, Hanjugator™-based EGFRxcMET ADC HLX48, and potential FIC B7H3-sialidase enzyme HLX316. Looking ahead, Henlius will remain committed to its patient-centric mission, accelerate global expansion, drive the efficient implementation of innovation outcomes, and continuously enhance its global product supply as well as quality systems, aiming to bring more high-quality, affordable innovative treatment options to patients 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 6 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. 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