Shanghai, China, July 10, 2026 – Henlius (2696.HK) today announced that a Phase 1 clinical trial of HLX37, the company’s self-developed recombinant humanized anti-PD-L1 and VEGF bispecific antibody, as monotherapy and in combination with chemotherapy or HLX43, an innovative programmed death-ligand 1 (PD-L1)-targeting antibody-drug conjugate (ADC), for the treatment of advanced/metastatic solid tumors has been approved by the China’s National Medical Products Administration (NMPA). Concurrently, a Phase 1 study evaluating HLX37 as a monotherapy for advanced/metastatic solid tumors is also ongoing.
HLX37: A Differentiated PD-L1xVEGF BsAb Strengthening the Foundation of Next-Generation Immuno-Oncology Therapy
In recent years, immune checkpoint inhibitors (ICIs), particularly PD-(L)1 inhibitors, have driven significant advancements in immuno-oncology (IO) and established themselves as the first-line standard of care across multiple solid tumor types. However, despite their growing clinical practice, PD-(L)1 inhibitor monotherapy is associated with limited objective response rates and is often limited by adaptive resistance and T-cell exhaustion, leading to disease relapse or progression.1 These challenges have spurred the exploration of next-generation IO strategies. Among the most promising approaches, PD-(L)1/VEGF bispecific antibodies, which combine the mechanisms of immune activation and anti-angiogenesis, have demonstrated clear synergistic potential. While anti-PD-(L)1 immunotherapy aims to reverse T-cell inhibition and restore antitumor activity, VEGF-driven aberrant tumor vasculature can create a hypoxic and acidic microenvironment that exacerbates T-cell exhaustion. Anti-angiogenic agents, by remodeling the tumor vascular structure, can enhance immune cell infiltration and drug delivery, thereby potentiating the efficacy of anti-PD-(L)1 therapy.2-3 This dual-targeting strategy is expected to overcome the limitations of current treatments, positioning PD-(L)1/VEGF bispecific antibodies as a potential cornerstone of next-generation IO.4
HLX37 is a novel recombinant humanized anti-PD-L1 and VEGF bispecific antibody independently developed by Henlius. Its mechanism of action integrates two therapeutic pathways: (1) blocking the PD-1/PD-L1 interaction and (2) inhibiting the an-giogenic pathway. This dual-targeting design is anticipated to generate synergistic antitumor effects and potentially mitigate the risk of drug resistance. By specifically binding to PD-L1 on tumor cells, HLX37 enables the enrichment of the anti-VEGF-functional bispecific antibody within the tumor microenvironment, achieving a superior therapeutic effect compared to the combination of anti-PD-L1 and anti-VEGF monoclonal antibodies. Preclinical studies demonstrated that HLX37 has strong antitumor activity and favorable safety profile, with enhanced tumor enrichment, indicating its broad therapeutic potential across multiple tumor types. These findings were first presented at the 2025 American Association for Cancer Research (AACR) Annual Meeting.5
HLX43: A Potential Best-in-Class PD-L1 ADC Expanding the Boundaries of IO+ADC Combination Therapy
Meanwhile, as the frontiers of IO continue to expand—from IO monotherapy to the established "IO+Chemotherapy" standard of care, and now to the emerging "IO+ADC (antibody-drug conjugates)" paradigm—combination strategies have become central to enhancing IO clinical outcomes. Currently, PD-(L)1 inhibitor plus chemotherapy is recognized as a standard first-line regimen across multiple tumor types.6-7 Building upon this foundation, multiple large-scale clinical studies have further demonstrated that, in non-small cell lung cancer (NSCLC) and gastrointestinal tumors, PD-(L)1xVEGF bispecific antibodies combined with chemotherapy yield significant survival benefits over PD-(L)1 inhibitor plus chemotherapy. Furthermore, given the remarkable clinical efficacy demonstrated by ADCs in oncology,8 the mechanistic rationale for combining PD-(L)1xVEGF bispecific antibodies with ADCs is well-supported, with early clinical data preliminarily validating the synergistic potential of such combinations.9-10
HLX43 is a potentially best-in-class and broad-spectrum PD-L1-targeting ADC that features a dual mechanism of action combining immune checkpoint blockade with payload-mediated cytotoxicity. To date, Preliminary clinical data has indicated a manageable safety profile and encouraging efficacy in various solid tumors, with notable anti-tumor activity observed in various NSCLC patient subgroups. Henlius is currently advancing HLX43's clinical development with significant momentum, having initiated over ten clinical studies evaluating HLX43 as a monotherapy or in combination with other therapies across a broad range of solid tumors, including cervical cancer (CC), esophageal squamous cell carcinoma (ESCC), head and neck squamous cell carcinoma (HNSCC), nasopharyngeal carcinoma (NPC), metastatic colorectal cancer (mCRC), gastric/gastroesophageal junction (G/GEJ) cancer, pancreatic ductal adenocarcinoma (PDAC), and breast cancer (BC), with over 1,000 patients enrolled globally to date. Beyond monotherapy, the Company is actively exploring combination strategies with other proprietary molecules, including the innovative anti-EGFR monoclonal antibody pimurutamab (HLX07) and the anti-PD-1 monoclonal antibody serplulimab (trade name: Hetronifly® in Europe), to further evaluate its potential in earlier lines of therapy and various combination settings.
Platform-Driven Synergy: Building Competitiveness in IO 2.0 through a Combination Matrix
Henlius has established an integrated antibody R&D platform covering the entire value chain from discovery to commercial manufacturing, anchored by a next-generation IO platform centered on PD-(L)1, which serves as the core engine driving sustained innovation in differentiated antibody therapeutics.
At the molecular discovery stage, the antibody R&D platform is focused on the development of function-blocking antibodies, featuring diverse antibody libraries including naïve, synthetic humanized, and immune camelid VHH libraries. This enables flexible screening of high-affinity, high-specificity nanobodies (VHH) and scFv against various targets, providing a continuous pipeline of novel candidates for the early discovery of multispecific antibodies and other innovative molecules. In parallel, building on decades of industry expertise, the Company has systematically constructed a comprehensive database for the design and functional characterization of multispecific antibodies (bispecific, trispecific, and tetraspecific antibodies) and antibody fusion proteins, significantly enhancing the efficiency and success rate of developing complex antibody molecules. On the clinical and commercial front, leveraging the efficient translational capabilities of its antibody R&D platform, Henlius has successfully secured market approval for 10 products and is advancing 19 clinical-stage assets (including innovative monoclonal antibodies, ADCs, fusion proteins, and biosimilars) with over 30 ongoing clinical trials. In CMC (chemistry, manufacturing, and controls), the Company has built a robust technical system with proven capabilities in developing complex molecules, covering the entire spectrum from discovery to commercialization. This integrated R&D capability, combined with a well-validated quality system, synergistically accelerates the translation of promising candidate molecules into high-quality clinical and commercial products.
Looking ahead, Henlius remains steadfast in its patient-centered commitment, dedicated to deepening its presence in the key therapeutic area of solid tumors. By continuously addressing unmet clinical needs, the Company will further strengthen its differentiated portfolio of innovative molecules, striving to deliver high-quality, affordable novel therapeutic options to more cancer patients worldwide.
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