Shanghai, China, July 31, 2026 – Henlius (2696.HK) today announced that the investigational new drug (IND) application for HLX43, the company’s innovative programmed death-ligand 1 (PD-L1)-targeting antibody-drug conjugate (ADC), in combination with bevacizumab with or without chemotherapy, for the treatment of advanced/metastatic solid tumors has been approved by China’s National Medical Products Administration (NMPA).
In recent years, multiple clinical studies have confirmed the synergistic antitumor effect of PD-(L)1 inhibitors in combination with anti-VEGF agents such as bevacizumab. Specifically, PD-(L)1 inhibitors restore antitumor immunity by blocking the PD-(L)1 pathway, while anti-VEGF agents may enhance the efficacy of the former by reversing VEGF-mediated immunosuppression and promoting T-cell infiltration into tumor tissues.1 Currently, the NCCN Guidelines recommend atezolizumab plus bevacizumab and platinum-based doublet chemotherapy as a Category 1 preferred regimen for the first-line treatment of advanced non-squamous NSCLC with negative driver genes. Meanwhile, the efficacy of conventional topoisomerase inhibitors combined with bevacizumab has been well validated in clinical studies.2-3 To date, the irinotecan plus bevacizumab regimen has been uniformly recommended by authoritative domestic and international guidelines including NCCN and CSCO as a standard first- and second-line treatment for metastatic colorectal cancer (mCRC). With ADC therapies demonstrating compelling clinical efficacy in oncology,4 several ADC monotherapies targeting different antigens, when combined with bevacizumab, have shown promising antitumor activity in solid tumors including colorectal cancer, with a generally manageable safety profile and no unexpected additive toxicities observed.5⁻7 These findings provide a clinical rationale and practical support for further development and application of ADC in combination with antiangiogenic agents.
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.
Bevacizumab is the first globally approved anti-angiogenic therapy. By inhibiting tumor neovascularization, it has been established as a backbone treatment across multiple solid tumors, including colorectal and lung cancer.8 HLX04, a bevacizumab biosimilar independently developed by the company, was approved by the NMPA in November 2021. It is indicated for metastatic colorectal cancer (mCRC), advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), recurrent glioblastoma, cervical cancer, hepatocellular carcinoma, epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer. It is also being proposed for combination with serplulimab (PD-1) for immuno-oncology combination therapies to treat various tumors.
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.
References
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