Henlius Reports 2026 Interim Results: Sustained Profitability Leap, Advancing Global Value Validation

SHANGHAI, Aug. 21, 2026 /PRNewswire/ -- On August 21, Henlius (2696.HK) announced its interim results for the 2026 fiscal year. During the reporting period, the company showcased strong organic growth momentum and sustainable earnings generation, with revenue reaching RMB 3.5882 billion, a 27.3% increase YoY, and net profit amounting to RMB 430.4 million, up 10.3% YoY. In the first half of 2026, Henlius reported non-IFRS profit of RMB 572.3 million, a 46.7% YoY increase, and adjusted EBITDA (a non-IFRS measure) of RMB 904.1 million, rising 35.2% YoY. Key financial and operational metrics maintained a steady upward trajectory. Driven by sustained global growth of its core products and end-to-end lean operations across the entire value chain, the company continues to strengthen both revenue scale and earnings quality.

Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, stated: "2026 marks a pivotal year of acceleration in Henlius' journey toward becoming a C-MNC. In the first half of the year, our core products continued to generate tangible value through global commercialization, while multiple differentiated pipeline assets entered critical stages of value validation. The benefits of this dual-engine growth model are increasingly taking shape. Looking ahead, we will remain anchored in addressing unmet patient needs, build on the virtuous cycle of 'global commercialization fueling innovation and differentiated innovation driving global expansion', further deepen our Globalization 2.0 strategy, and advance steadily toward high-quality, sustainable growth."

Global Commercialization Advances Across Multiple Fronts, Core Portfolio Reinforces the Foundation for Growth

As of the reporting period, Henlius has 10 products approved in over 60 countries and regions across Asia, Europe, Latin America, North America, and Oceania, and has benefited over 1.1 million patients worldwide. In the first half of 2026, the company maintained its strategic focus on key therapeutic areas, including breast cancer, lung cancer, and gastrointestinal cancers. Global product sales revenue amounted to RMB 2.9386 billion, up 14.9% YoY. Notably, sales revenue from ex-China markets increased significantly by 159.4% year on year to RMB 105.3 million, while product profit from ex-China markets reached RMB 59.5 million, more than four times that of the same period last year, further strengthening the company's ability to generate value from global commercialization.

In the breast cancer therapeutic area, the company continued to advance its "Full-Course, All-Domain, Global" breast cancer treatment landscape, with global sales revenue from its breast cancer product portfolio reaching RMB 1.6983 billion during the reporting period. The four marketed products collectively delivered strong volume growth, with HANQUYOU (trastuzumab, HERCESSI™ in the U.S. and Zercepac^® in Europe), HANBEIYOU (pertuzumab, POHERDY^® in the U.S. and Europe), HANNAIJIA (neratinib), and fovinaciclib generating sales revenues of RMB 1.4844 billion, RMB 7.7 million, RMB 195.5 million, and RMB 10.7 million, respectively. In the first half of 2026, HANBEIYOU received sequential marketing authorizations from the European Commission and China's NMPA, marking it as the first and only** Chinese-developed pertuzumab biosimilar approved across all three major markets—China, the U.S., and the EU. In combination with HANQUYOU, it establishes the first Chinese-developed dual HER2-targeted regimen combining trastuzumab and pertuzumab approved in China, the U.S., and the EU, spanning the treatment continuum from neoadjuvant setting to first-line treatment of advanced disease. Furthermore, the company is accelerating the development of a diversified breast cancer pipeline including lasofoxifene (HLX78), a novel endocrine therapy; dulpatatug* (HLX22), a novel-epitope monoclonal antibody (mAb) targeting HER2; HLX87, a HER2-targeted ADC; HLX97, an oral KAT6A/B inhibitor; HLX49, a HER2 biparatopic ADC; and HLX319, the first Chinese-developed fixed-dose subcutaneous co-formulation of pertuzumab and trastuzumab—all aimed at establishing a comprehensive, multidimensional breast cancer treatment portfolio across the disease continuum.

In solid tumor indications, including lung cancer and gastrointestinal malignancies, a multi-product synergistic strategy is cultivating new growth momentum. Serplulimab (Hetronifly^® in Europe) recorded global sales revenue of RMB 0.5975 billion in the first half of 2026. In June, the product received approval in China for the perioperative treatment of gastric cancer through a priority review pathway, becoming the first and only*** anti-PD-1 mAb globally to be approved for this indication and thereby addressing a significant unmet need in this treatment setting. In terms of international expansion, serplulimab has secured marketing approvals in over 50 countries and regions. During the reporting period, it has obtained approvals for three additional first-line indications—non-squamous non-small cell lung cancer (nsqNSCLC), esophageal squamous cell carcinoma (ESCC), and squamous non-small cell lung cancer (sqNSCLC) in the EU—and has been incorporated into the national healthcare or public reimbursement systems of 12 European countries, including the United Kingdom (UK), Germany, Italy, Spain, and Sweden. HANBEITAI (bevacizumab), another key oncology product in the company's portfolio, generated sales revenue of RMB 0.2182 billion in the first half of the year, up 87.6% YoY, with a decision on its Biologics License Application expected in the second half of 2026. Furthermore, HLX903, a third-generation oral EGFR-TKI introduced via a licensing-in arrangement, is expected to receive marketing approval in the first half of 2027 and address targeted treatment needs among patients with EGFR-mutant NSCLC upon approval.

In parallel, mature products including HANLIKANG (rituximab) and HANDAYUAN (adalimumab) continued to deliver stable cash flow contributions in the hematology and autoimmune disease therapeutic areas, generating RMB 335.7 million and RMB 30.4 million in sales revenue and licensing income, respectively, in accordance with the relevant collaboration agreements. HLX14 (denosumab), available in two dosage strengths as BILDYOS^® (60mg/mL) and BILPREVDA^® (120mg/1.7mL), secured regulatory approvals in the U.S. and European Union, and UK during the second half of 2025, and contributed sales revenue and licensing income of RMB 73.1 million in the reporting period.

In the first half of 2026, with China as its global headquarters, the company moved swiftly to build out its international proprietary commercialization organization, establishing five core functional pillars—commercial alliance, affiliate commercial, market access and pricing, commercial strategy and operations, and medical affairs—thereby creating a dual-engine model combining in-house commercialization with strategic partnerships. Since the start of 2026, the company has announced three major international strategic collaborations in succession, reinforcing its Globalization 2.0 strategy across multiple fronts: in high-value mature markets, the company entered into an agreement with Eisai Co., Ltd., granting Eisai exclusive commercialization rights for serplulimab in Japan; to accelerate its presence in emerging markets, the company formed a strategic collaboration with Abbott to expand serplulimab's commercial footprint across Asia-Pacific, Africa, Central Asia, and Eastern Europe; and to maximize the global potential of its biosimilar portfolio, the company established a broad-based strategic partnership with Sandoz, covering up to ten biosimilar products, thereby substantially broadening the commercial reach of its pipeline assets across key global markets.

Innovation Pipeline Accelerates, Global Biosimilar Expansion Drives Further Value Creation

Meanwhile, the company continues to ramp up its innovation efforts, with R&D expenditure reaching RMB 1.4507 billion during the reporting period, representing a 45.7% YoY increase. The company's differentiated innovation pipeline continues to expand, and it has now established multiple technology platforms—next-generation IO, Hanjugator ADC, multi-specific T-cell engager (TCE), and AI—with more than 50 early-stage pipeline molecules in reserve, covering therapeutic areas including oncology, immunology and inflammation, neuroscience, and metabolism diseases.

As a potential best-in-class (BIC) broad-spectrum anti-tumor PD-L1 ADC, HLX43 has demonstrated encouraging preliminary efficacy and a favorable safety profile across multiple solid tumors, including NSCLC. Its phase 2 and phase 2/3 international multi-center studies in NSCLC are advancing across regions including China, Europe, the United States, Japan, and Australia. Specifically, the phase 2/3 study in advanced sqNSCLC has received implied approval from Japan's PMDA and has dosed its first patient in China. In addition, the phase 1b/2 study of HLX43 in combination with serplulimab or pimurutamab (HLX07) for the treatment of advanced/metastatic colorectal cancer (mCRC) has also completed first-patient-in dosing in China. To date, the company has initiated more than ten clinical studies of HLX43 as monotherapy or in combination regimens, with over 1,500 patients enrolled globally, continuing to evaluate its broad therapeutic potential across multiple solid tumors.

Other key pipeline assets are also advancing efficiently. Among them, dulpatatug* is making steady progress in an international multi-center phase 3 clinical study that features a head-to-head comparison against the current first-line standard of care for HER2-positive gastric cancer. First patient enrollment has been completed across a broad geographic footprint, including China, the U.S., Europe, Japan, Australia, South Korea, and Latin America. Concurrently, a phase 2 study of dulpatatug* for HER2-low breast cancer and a phase 2/3 study of dulpatatug* in combination with the HER2-directed ADC HLX87 for first-line treatment of HER2-positive breast cancer are also advancing steadily. The phase 2/3 clinical trial of pimurutamab in combination with serplulimab and chemotherapy for first-line treatment of advanced sqNSCLC has completed clinical trial notification with Australia's Therapeutic Goods Administration (TGA) and has reached first patient dosing in China. Meanwhile, next-generation innovative molecules with BIC/FIC potential, including HLX3901 (DLL3 x DLL3 x CD3 x CD28 tetra-specific TCE), HLX3902 (STEAP1 x CD3 x CD28 tri-specific TCE), HLX48( c-MET x EGFR bispecific ADC) , HLX97 (small-molecule KAT6A/B inhibitor) and HLX316 (B7-H3 sialidase fusion protein), are advancing efficiently in parallel with high efficiency, continuously strengthening the company's long-term growth pipeline. Furthermore, the Company will accelerate the development of early-stage assets, including HLX105 (PD-1×IL-2v fusion protein), HLX109 (IL-1R3 mAb), HLX49 (HER2 biparatopic ADC), and HLX403 (CDH17 ADC), with plans to submit Investigational New Drug (IND) applications for these candidates in the second half of 2026. By leveraging its robust CMC capabilities, the company is further increasing the probability of success in developing complex molecules, thereby enhancing overall drug developability. In addition, the company is proactively applying AI-powered approaches to the R&D of innovative molecules such as HLX203, with the goal of continuously improving the efficiency of drug discovery and development.

In line with its Globalization 2.0 strategy, the company remains committed to unlocking the global potential of its biosimilar portfolio through a parallel China-U.S. development and registration pathway. HLX05-N (proposed cetuximab biosimilar) and HLX18 (proposed nivolumab biosimilar) have each received clinical trial authorizations from regulators in both China and the U.S., and dosed their first patient. In addition, HLX13 (proposed ipilimumab biosimilar), HLX15 (proposed daratumumab biosimilar), and HLX17 (proposed pembrolizumab biosimilar) have all achieved first subject dosing in both China and the U.S. The company is continuously accumulating global clinical data for these assets, laying the foundation for subsequent regulatory development and commercialization.

Globalization 2.0 in Place, Integrated End-to-End Capabilities Reinforce the C-MNC Ambition

Henlius has established a comprehensive and systematic capability for global expansion spanning R&D, clinical development, regulatory affairs, manufacturing, and commercialization, steadily advancing its Globalization 2.0 strategy and marking the initial formation of its "C-MNC" model—a China-headquartered multinational biopharmaceutical company.

On clinical development and regulatory affairs, the company has established dedicated in-house teams in Europe, the U.S., Japan, and Australia, with clinical trials concurrently ongoing in nearly 30 countries and regions, in partnership with over 1,000 clinical research centers. During the reporting period, the company received 32 new clinical trial approvals and 25 marketing authorizations worldwide, covering nearly 50 countries and regions. On manufacturing and supply, its delivery capabilities continued to strengthen. To date, the company has completed more than 1,400 GMP commercial production batches and successfully passed over 100 on-site inspections and audits conducted by regulatory authorities worldwide and international collaborators, with a 100% pass rate. During the period, it also completed 9 first commercial shipments and 18 batch shipments to ex-China markets.

In the first half of 2026, the clinical value of Henlius' core innovative pipeline continued to emerge, while international regulatory and commercialization milestones were achieved in succession. Synergies across global R&D, manufacturing, and commercialization were further strengthened, collectively demonstrating that the company's Globalization 2.0 strategy has entered a critical phase of accelerated validation. Looking toward 2030, Henlius will continue to pursue innovation-driven and global growth, accelerating its journey toward becoming a C-MNC. The company aims to bring 10 new products to markets worldwide, with over 5 expected to reach European and U.S. markets, and to grow into a globally influential innovative biopharmaceutical company.

* Status: pINN
** Received U.S. FDA approval in November 2025, EC approval in April 2026, and NMPA approval in May 2026. As of August 2026, it remains the only one.
*** In June 2026, serplulimab received NMPA approval as the world's first anti-PD-1 mAb for perioperative gastric cancer treatment. As of August 2026, it remains the only one.

About Henlius

Shanghai Henlius Biotech, Inc. (2696.HK) is a global, innovation-driven biopharmaceutical company committed to delivering high-quality, affordable biologic therapies to patients worldwide. The Company focuses on major disease areas including oncology, autoimmune diseases, and ophthalmic diseases. Founded in 2010, Henlius has established an integrated, end-to-end biopharmaceutical platform encompassing global R&D, clinical operations, regulatory affairs, manufacturing, and commercialisation. The Company employs nearly 4,000 people globally and operates across multiple regions, including China, the United States, and Japan. Leveraging the stable cash flow generated from its biosimilar portfolio to support innovation, Henlius is steadily advancing into its "Globalisation 2.0" phase, building a scalable and sustainable global growth model. Up to date, Henlius has achieved regulatory approvals for 10 products across over 60 countries and regions worldwide, including eight approvals in China. The Company has also reached multiple milestones in major biopharmaceutical markets, with four products approved by the U.S. Food and Drug Administration (FDA) and five products approved by the European Commission (EC), reflecting its globally aligned R&D capabilities, quality systems, and manufacturing standards.

Driven by innovation, Henlius has built a diversified, platform-based technology ecosystem through coordinated R&D efforts across Shanghai, the United States, and other regions. Its innovation platforms span immune checkpoint inhibitors, immune cell engager technologies (including multispecific T cell engagers), antibody-drug conjugates (ADCs), and AI-enabled early discovery platforms. The Company currently has more than 50 early-stage innovative assets, approximately 70% of which are expected to be best-in-class, with over 30 clinical trials ongoing globally. Henlius' core product, serplulimab (trade name: Hetronifly^® in Europe), is the world's first anti–PD-1 mAb approved for first-line treatment of small cell lung cancer and for perioperative gastric cancer. Up to date, it has been approved in 50 markets worldwide with an accelerated globalisation process. In parallel, multiple high-potential innovative assets—including the PD-L1 ADC HLX43 and the novel epitope anti-HER2 mAb dulpatatug (HLX22) — are advancing through global pivotal clinical development. Supported by a biologics manufacturing network with a total capacity of 84,000L and GMP certifications from regulatory authorities in China, Europe, and the United States, Henlius has established a stable global supply system serving six continents. Guided by a patient-centred mission, Henlius remains focused on addressing unmet medical needs and translating scientific innovation into meaningful clinical value and patient access, contributing sustainably to the global biopharmaceutical ecosystem.

To learn more about Henlius, visit https://www.henlius.com/en/index.html and connect with us on LinkedIn at https://www.linkedin.com/company/henlius/.

SOURCE Henlius