SAN FRANCISCO, Jan. 16, 2026 /PRNewswire/ -- 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. On January 15 (PST), 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.

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 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.

Henlius' Forward Looking Statements

Shanghai Henlius Biotech, Inc. (the "Company", together with its subsidiaries, the "Group") provides the following cautionary statement: This document contains certain forward-looking statements with respect to the operations, performance and financial condition of the Group, including, among other things, statements about expected or targeted revenues, margins, earnings per share or other financial or other measures, as well as the Group's pipeline products and their expected development, regulatory approval and commercialisation timelines (including the Financial Ambition Statements (as defined below) described in this document). Although the Group believes its expectations and targets are based on reasonable assumptions and has used customary forecasting methodologies used in the biopharmaceutical industry and risk-adjusted projections for individual products (which take into account the probability of success of individual clinical trials, based on industry-wide data for relevant clinical trials at a similar stage of development), any forward-looking statements, by their very nature, involve risks and uncertainties and may be influenced by factors that could cause actual outcomes and results to be materially different from those predicted. The forward-looking statements reflect knowledge and information available at the date of preparation of this document and the Group undertakes no obligation to update these forward-looking statements. The Group identifies the forward-looking statements by using the words 'anticipates', 'believes', 'expects', 'intends' and similar expressions in such statements. Certain statements contained in this document that are not statements of historical fact constitute forward-looking statements, notwithstanding that such statements are not specifically identified. Important factors that could cause actual results to differ materially from those contained in forward-looking statements, certain of which are beyond the Group's control, include, among other things: the risk of failure or delay in delivery of pipeline or launch of new products, considering that most of the Group's drug candidates are still under development and are in the clinical development stages, and the course of clinical development involves a lengthy and expensive process with uncertainties in various aspects, as there can be no assurance from the Group for the development and clinical results, and that if the clinical development and regulatory approval process of the drug candidates are delayed or terminated, the successful development and commercialisation of the Group's drug candidates in a timely manner may be adversely affected; the risk of failure to meet regulatory or ethical requirements for medicine development or approval; the risk of failures or delays in the quality or execution of the Group's commercial strategies; the risk of pricing, affordability, access and competitive pressures from pharmaceutical companies around the world in respect of various factors such as indication treatment, drug novelty, drug quality and reputation, breadth of drug portfolio, manufacturing and distribution capacity, drug price, breadth and depth of customer coverage, consumer behaviour and supply chain relationships; the risk of unfavourable policies to the Group, which may include the advancement and implementation of the relevant centralised procurement policies in the People's Republic of China; the risk of failure to maintain supply of compliant, quality products; the risk of illegal trade in the Group's products; the impact of reliance on third-party goods and services; the risk of failure in information technology or cybersecurity; the risk of failure of critical processes; the risk of failure to collect and manage data in line with legal and regulatory requirements and strategic objectives; the risk of failure to attract, develop, engage and retain a diverse, talented and capable workforce; the risk of failure to meet regulatory or ethical expectations on environmental impact, including climate change; the risk of the safety and efficacy of marketed products being questioned; the risk of adverse outcome of litigation and/or governmental investigations; intellectual property-related risks to the Group's products; the risk of failure to achieve strategic plans or meet targets or expectations; the risk of failure in financial control or the occurrence of fraud; the risk of unexpected deterioration in the Group's financial position; the risk of any natural disasters or other unanticipated catastrophic events such as earthquakes, fires, terrorist attacks and wars; and the impact that global and/or geopolitical events may have, or continue to have, on these risks, on the Group's ability to continue to mitigate these risks, and on the Group's operations, financial results or financial condition. There can be no guarantees that the Company's pipeline products will receive the necessary regulatory approvals, be successfully developed, manufactured, or commercialised. This presentation includes references to pipeline products that are being investigated in current or future clinical trials, and as such have not been approved by any regulatory agency. For the Group's latest product portfolio and pipeline, see Henlius official website: http://www.henlius.com. 

The basis of the Company's ambitions, forecasts and targets in this document (the "Financial Ambition Statements") is derived from the Company's most recent risk-adjusted mid- and long-term plans, adjusted for developments in the business since those plans were finalised. Financial Ambition Statements presented are based on management's risk-adjusted projections for individual products and individual clinical trials. Estimates for these probabilities are based on industry-wide data for relevant clinical trials in the biopharmaceutical industry at a similar stage of development adjusted for management's view on the risk profile of the specific asset. Estimates are based on customary forecasting methodologies used in the biopharmaceutical industry. The development of biopharmaceutical products has inherent risks given scientific experimentation and there are a range of possible outcomes in clinical results, safety, efficacy and product labelling. Clinical results may not achieve the desired product profile and competitive environment; pricing and reimbursement may have material impact on commercial revenue forecasts. By their nature, forecasts are based on a multiplicity of assumptions and actual performance in future years may vary, significantly and materially, from these assumptions. The Financial Ambition Statements in this document are based on stated exchange rates. All subsequent written and oral forward-looking statements attributable to the Company or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements referenced above. The Company undertakes no obligation to update those statements based on future currency movements. This document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. By attending the presentation relating to this document, or by reading this document, you agree to be bound by the above limitations.

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