On January 16, 2026 Dr. Jason Zhu, Executive Director and Chief Executive Officer of Shanghai Henlius Biotech, Inc. (2696.HK), delivered a keynote presentation outlining Henlius’ "Globalisation 2.0" strategy, diversified innovation pipeline, and its mid-to-long-term development blueprint. The 44th J.P.Morgan Healthcare Conference (JPMHC) was successfully held in San Francisco, the United States, from January 12 to 15. As one of the most influential annual events in the global healthcare sector, JPM serves as a key platform for the capital markets and industry leaders to observe emerging trends in pharmaceutical innovation and industry development. The conference attracted more than 8000 global industry leaders, innovators, entrepreneurs, and investors.
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A Global Biopharmaceutical Vision Toward 2030
Building on its expanding innovation pipeline and accelerating global footprint, Dr. Zhu shared Henlius’ mid-to-long-term vision as a global biopharmaceutical company. To date, Henlius has achieved regulatory approvals for 10 products across 60 markets worldwide, benefiting more than 950,000 patients globally. The Company’s international business continues to grow at a rapid pace. Looking ahead to 2030, Henlius anticipates launching more than 20 products globally, including over 15 products in the U.S. and European markets. The Company will continue to advance innovative modalities such as ADCs, multi-specific antibodies and T-cell engagers (TCEs), covering oncology, autoimmune, metabolic and central nervous system (CNS) diseases. With the continued strengthening of its global commercialisation capabilities, international market revenue is expected to grow further, reinforcing Henlius’ global scale and competitiveness as a global biopharma.
Five Core Capabilities Strengthen the Globalisation Foundation
Dr. Zhu highlighted Henlius’ continuous growth trajectory and phased achievements under its "Globalisation 2.0" strategy:
"With multiple products approved successively in Europe and the United States, and an increasingly mature integrated global operating model, our international business has maintained strong growth momentum. Leveraging our integrated R&D, regulatory and manufacturing capabilities, together with an increasingly mature global clinical and commercialisation network, we have established a systematic capacity to continuously deliver innovative assets worldwide. Over the next five years, stable cash flows from our biosimilar portfolio will further support innovation investment, enabling the advancement of more differentiated molecules, including ADCs, multi-Abs and TCEs, into global markets and building a sustainable, replicable globalisation growth model."
Henlius has established a fully integrated biopharmaceutical platform covering R&D, clinical operations, regulatory affairs, manufacturing and commercialisation. In R&D, the Company has built a diversified pipeline of more than 50 early-stage assets, with approximately 70% classified as best-in-class (BIC) and 15% as first-in-class (FIC). In clinical operations, it operates in-house global clinical teams across China, the United States and other regions, with nearly 600 professionals supporting clinical development in more than 20 countries and over 1000 research centres worldwide, possessing the capability to independently conduct international multicentre clinical trials. In regulatory affairs, the Company has secured a total of 164 IND approvals and 66 New Drug Application (NDA) approvals globally, including 4 Biologics License Application (BLA) approvals from the U.S. FDA, continuously validating its international regulatory and quality management capabilities. In manufacturing and quality, it has completed over 1150 commercial GMP batches, with production facilities certified by regulatory authorities in China, the European Union, the United States and many other countries, providing a strong guarantee for the stable supply of products in the global market. In commercialisation, the company has established a strong oncology-focused commercial team of approximately 1600 professionals in China, while working with more than 20 international commercialisation partners, with its products now marketed in approximately 60 countries and regions.
Core Innovation Assets: Clear 2026 Clinical and Regulatory Milestones
Henlius also outlined clear timelines and development plans for its key innovation assets in 2026:
Serplulimab (trade name: Hetronifly in Europe) – Anti-PD-1 mAb
Approved in over 40 markets globally. By the end of 2026, Henlius expects to achieve:
Accelerated approval for perioperative treatment of gastric cancer in China;
U.S. BLA filings for extensive-stage and limited-stage small cell lung cancer (ES-SCLC and LS-SCLC);
Approval of various indications in the EU;
Completion of enrolment and achievement of primary endpoints in the Japanese bridging study for ES-SCLC.
HLX22 – Novel Epitope Anti-HER2 mAb with a Differentiated Modality
Phase 2 data readout in HER2-low breast cancer in China is expected in the first half of 2026.
HLX43 – PD-L1 ADC ("Pipeline-in-a-Pill") with High-Efficacy, a Favourable Safety Profile and I/O Effects, Potential BIC
By the end of 2026, Henlius anticipates to:
Initiate three global pivotal trials in second-line EGFR wild-type nsqNSCLC, third-line and later sqNSCLC, and second-line sqNSCLC;
Launch two PoC trials in HR-positive and triple-negative breast cancer;
Present clinical data across ESCC, NSCLC, NPC, cervical and ovarian cancers at major congresses (ESCC data were recently presented at ASCO (Free ASCO Whitepaper) GI);
Complete PoC readouts of combination trials with serplulimab ± HLX07 in NSCLC, SCLC and mCRC.
HLX07 – Anti-EGFR mAb with a Dual-Target Synergistic Effect, Expected to Open Up a New First-Line treatment Pathway for EGFR-overexpressing sqNSCLC
Two studies are planned by the end of 2026:
A pivotal Phase 2 trial in cutaneous squamous cell carcinoma;
A global multicentre Phase 2/3 trial in first-line sqNSCLC.
Platform-Driven Innovation Ensures Sustained Output, Building a Next-Generation Pipeline of High-Potential Assets
Henlius’ systematic, platform-based R&D ecosystem continues to generate differentiated innovation candidates. Over the next five years, the Company expects more than 40 new clinical trial applications. At present, the company has established a multi-dimensional innovation platform matrix covering the entire early R&D continuum, from early-stage target screening and validation, to candidate molecule design and optimisation, and through to systematic preclinical development. This integrated platform ecosystem includes a PD-(L)1-centred immune checkpoint inhibitor platform, immune cell engager platforms such as multi-specific T-cell engagers (TCEs), the Hanjugator ADC platform, and the AI-driven one-stop early discovery platform HAI Club. These platforms not only ensure the quality and efficiency of individual R&D programs, but more importantly provide a sustainable, system-level capability to support the development of a globally competitive mid- to long-term innovation pipeline. As a result, the company is able to continuously and efficiently translate cutting-edge scientific discoveries into clinically valuable drug candidates.
Key early-stage assets include:
HLX37: PD-L1 × VEGF bispecific antibody developed based on the immune checkpoint inhibitor platform. It demonstrates high PD-L1 binding affinity and achieves higher tumour microenvironment (TME) enrichment vs. combination therapies, positioning it as a next-generation immunotherapy candidate following serplulimab.
HLX97: Novel oral small-molecule KAT6A/B inhibitor with potential BIC profile, broadly applicable for the treatment of breast cancer, castration-resistant prostate cancer, and NSCLC.
HLX3901: DLL3 × DLL3 × CD3 × CD28 tetravalent TCE developed on the Company’s proprietary TCE platform, featuring longer persistence of activated T cells and greater efficacy in solid tumour treatment.
HLX3902: Potential FIC STEAP1 × CD3 × CD28 trispecific TCE developed on the proprietary TCE platform, demonstrating superior antitumour activity, and increased T-cell infiltration and persistence in TME.
HLX316: Novel potential FIC B7-H3–sialidase fusion protein developed based on Palleon Pharmaceuticals’ EAGLE platform, designed to remove tumour sialic acid to enhance immune response.
HLX48: Safer and more effective cMET x EGFR ADC developed on the Hanjugator ADC platform, designed to maximize antibody function while delivering a stronger bystander effect, for the treatment of NSCLC and colorectal cancer.
HLX49: Potential BIC HER2xHER2 novel bi-paratopic ADC developed on the Hanjugator ADC platform, offering improved efficacy, higher and safer tolerance, and maximized function of antibodies.
At present, the Company’s preclinical asset portfolio spans multiple molecular modalities, including antibodies, multispecific TCEs, ADCs, fusion proteins and small molecules, with a primary focus on solid tumors. Its differentiated development strategy targets both established and emerging targets such as PD-(L)1, DLL3, B7-H3, HER2, EGFR, c-Met and KAT6A/B. The portfolio comprises a balanced mix of potential FIC and BIC candidates, as well as fast-follow programs with higher clinical and commercialisation certainty, laying a solid foundation for the sustained advancement of the mid- to long-term clinical pipeline. By proactively structuring its preclinical portfolio to encompass diverse innovation profiles including FIC, BIC and fast-follow programs, the company has established a tiered R&D architecture that balances frontier innovation with development efficiency and risk management, thereby supporting the continuous progression of its innovation pipeline.
(Press release, Shanghai Henlius Biotech, JAN 16, 2026, View Source;302663316.html [SID1234662075])