Overseas Profits Surge Over 200%, Innovative Pipeline Flourishes Globally: Henlius Launches “Globalization 2.0” New Era

On August 25, 2025, Shanghai Henlius Biotech, Inc. (2696.HK) released its 2025 interim results. In the first half of 2025, the company achieved revenue of RMB 2.8195 billion, a year-on-year increase of 2.7%; gross profit of approximately RMB 2.1992 billion, up 10.5% year-on-year; net profit of RMB 390.1 million; and operating cash flow exceeding RMB 770.9 million, a 206.8% year-on-year increase, maintaining continuous positive inflow. During the period, overseas product profits surged over 200% to RMB 40.6 million, while BD contract cash inflow exceeded RMB 1 billion, up 280% year-on-year. With the sales expansion of overseas commercialized products, the company expects substantial growth in overseas product revenue and profits for 2025, with continued rapid growth projected in 2026. Henlius continues to strengthen its long-term innovation and internationalization strategy, accelerating the construction of a global commercialization closed loop to robustly support sustainable innovation R&D.

In H1 2025, the company's R&D expenditure was RMB 995.4 million, with capitalized R&D expenses up 21.3% year-on-year, primarily focused on preclinical development of differentiated innovative molecules and building core innovation platforms. To date, Henlius has six products approved in China and four products approved internationally, reaching nearly 60 countries and regions, covering Asia, Europe, Latin America, North America, and Oceania, benefiting over 850,000 patients worldwide. Meanwhile, the company continues to expand and optimize its innovation portfolio in oncology, autoimmune, and other disease areas, actively developing more blockbuster molecules with best-in-class (BIC) or first-in-class (FIC) potential.

Dr. Zhu Jun, Executive Director and CEO of Henlius, said: “2025 is a pivotal year for accelerating ‘Globalization 2.0’ and elevating innovation across the board. We continue to strengthen our full-chain closed-loop system, drive overseas revenue breakthroughs, and release global value. Meanwhile, core innovative products have achieved multiple breakthroughs, and the next-generation high-potential molecules are ready to launch. In the future, Henlius will continue focusing on unmet patient needs, accelerating the delivery of superior innovative therapies.”

Globalization 2.0 Accelerates Construction of Global Commercialization Closed Loop

In H1 2025, Henlius’ globalization growth engine fully activated, with global product revenue exceeding RMB 2.5568 billion, up 3.1% year-on-year. Multiple products rapidly expanded overseas markets, continuously improving patient access to medications.

In oncology, the company’s core innovative product, H drug (HSRULI monoclonal antibody, China: Hanszhuang?, Europe: Hetronifly?), the world’s first approved PD-1 monoclonal antibody for first-line treatment of small cell lung cancer (SCLC), generated global sales of RMB 597.7 million during the period. In H1 2025, overseas market expansion accelerated, with approvals in the EU, Singapore, Malaysia, UK, and India for first-line treatment of extensive-stage SCLC (ES-SCLC), and in Indonesia and Thailand for squamous non-small cell lung cancer (sqNSCLC). The product is now approved in nearly 40 countries and regions, covering almost half the global population. The U.S. bridging trial of H drug versus atezolizumab in first-line ES-SCLC will soon complete enrollment, with a Biologics License Application (BLA) planned for FDA submission in H1 2026.

In breast cancer, core product Hanquyou? (Trastuzumab, U.S.: HERCESSI?, Europe: Zercepac?), a “Chinese” monoclonal antibody biosimilar approved in China, EU, and the U.S., achieved global sales of RMB 1.4442 billion in H1 2025. During the period, approvals were obtained in Mexico, with total approvals now covering over 50 countries. For HER2-positive breast cancer, sequential therapy is formed with Hanneijia? (Neratinib) and Hanquyou? to reduce recurrence risk. Additionally, the company’s trastuzumab biosimilar HLX11 has been accepted by regulatory authorities in China, U.S., and EU, with potential U.S. approval expected in H2 2025.

In other disease areas, Henlius continues to build a comprehensive innovative product matrix. Key projects include HLX78 (new endocrine therapy), HLX22 (new epitope anti-HER2 monoclonal antibody), HLX87 (HER2 ADC), KAT6A/B targeted small molecule HLX97, and LIV-1-targeted ADC HLX41. Collaboration with Yisheng Biotech on recombinant anti-VEGF antibody HLX04-O for wet age-related macular degeneration (wAMD) has been accepted for NDA review in China in August 2025. Denosumab biosimilar HLX14 for osteoporosis has received acceptance in the U.S., EU, and Canada, with approval expected in H2 2025.

In H1 2025, multiple core products accelerated global market expansion through strategic partnerships: agreements with Abbott covering 69 countries and regions in Asia and Latin America for biosimilars and one innovative biologic; HLX15 (anti-CD38 antibody) licensed to Dr. Reddy’s for 43 countries in U.S. and Europe; exclusive and semi-exclusive commercialization of H drug with Lotus in South Korea; HLX13 (anti-CTLA-4 antibody) granted exclusive commercialization rights in U.S., Europe, Japan, Canada, and Australia to Sandoz. Leveraging advanced technology and resources, the company strengthened an integrated global biopharmaceutical innovation platform covering R&D, clinical, production, quality, regulatory, and commercialization. To date, over 800 regulatory submissions have been completed globally, with 600 approvals covering China, U.S., EU, Canada, Indonesia, and Japan, along with international multicenter clinical trials accelerating globalization. The Songjiang facility received EU GMP certification in July 2025 and Phase I of Songjiang Project II passed completion inspection in August 2025. Over 1,150 commercial GMP production batches have been completed, ensuring global supply, and the quality system has passed nearly 100 audits from regulatory authorities and partners worldwide.

Innovation Leap Opens Growth Ceiling

In H1 2025, Henlius continued implementing an innovation-driven strategy, achieving breakthroughs in cutting-edge technology platforms and rapid growth of the innovative pipeline. Core products HLX43, HLX22, and H drug (Hanszhuang?) reached global development milestones.

HLX43, a PD-L1-targeting ADC, showed high efficacy and low toxicity in early clinical trials presented at ASCO 2025 for NSCLC and thymic squamous carcinoma. HLX43 is advancing into international multicenter Phase II trials in NSCLC and Phase II studies for other solid tumors including cervical, liver, esophageal, head and neck, nasopharyngeal, colorectal, and gastric cancers. Combination trials of HLX43 with other therapies are ongoing to explore “ADC+IO” synergistic effects.

HLX22, a new epitope HER2 monoclonal antibody, is progressing steadily in international Phase III trials for first-line HER2-positive gastric cancer, with first patients dosed in China, U.S., Japan, Australia, and South Korea. It has received orphan drug designation from FDA and EC, highlighting clinical and global potential. Combination therapy with Hanquyou? also shows long-term efficacy benefits.

In lung and gastrointestinal cancers, global clinical development of H drug continues. Phase III trials for LS-SCLC and metastatic colorectal cancer (mCRC) completed enrollment. H drug’s key studies have been presented at major international conferences and published in top journals, confirming long-term survival benefits (e.g., 4-year OS of 21.9% in ES-SCLC).

The company also develops potential FIC and BIC innovative molecules including HLX79, HLX701, HLX37, HLX97, HLX3901, HLX3902, HLX48, and HLX316, leveraging proprietary platforms Hanjugator?, TCE, HAI Club, and HAI PBD to improve R&D efficiency and success rates. The company continues to expand coverage of targets and molecular diversity in antibodies, accelerating development of new innovative molecules with clinical potential.

Looking Ahead

Looking forward, Henlius will continue its patient-centered philosophy, accelerate global expansion, efficiently deliver innovative products, and strengthen global supply and quality systems to benefit patients worldwide with more high-quality innovations.

Reference

[1]. https://www.henlius.com/upload/202508/25/Henlius1H25InterimResultsInvestorPresentation.pdf