Shanghai, China, December 30, 2025 – Henlius (2696.HK) announced that the Investigational New Drug (IND) applications for three differentiated innovative candidates have been accepted by the National Medical Products Administration (NMPA). These products include HLX3901, a DLL3xDLL3xCD3xCD28 tetra-specific T-cell engager (TCE) developed from its proprietary TCE platform; HLX97, a potential best-in-class (BIC) oral small-molecule inhibitor targeting KAT6A/B; and HLX316, a potential first-in-class (FIC) B7H3-sialidase fusion protein. All are these innovative products intended for the treatment of solid tumors.
Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, stated, "The simultaneous acceptance of INDs for three innovative projects marks a significant milestone in our ongoing efforts to build and enhance cutting-edge innovation platforms and systematic R&D capabilities. These molecules represent Henlius' active exploration in the fields of immune cell engagers, small molecules, and fusion proteins, demonstrating the company's independent R&D capabilities and innovative vision in cutting-edge protein-based therapeutics.It also fully validates the critical role of our CMC (Chemistry, Manufacturing, and Controls) system in supporting the entire development process of complex molecules, such as multispecific antibodies, antibody-drug conjugates, from preclinical stages through to commercial manufacturing. This provides a solid foundation for efficiently advancing global clinical development and industrialization. Moving forward, we will remain patient-centered and continue to drive progress in science and technology, accelerating the expansion and strengthening of our innovation pipeline to deliver better treatment options for patients worldwide."
Platform-Powered R&D: Accelerating Breakthroughs
The accelerating pace of innovation at Henlius can be attributed directly to its platform-based R&D system, which is designed to steadily deliver a stream of differentiated, high-potential drug candidates. The company has built a multidimensional innovation platform matrix that supports the entire R&D continuum—from early target discovery and candidate optimization through systematic preclinical development. This integrated infrastructure includes a PD(L)1-based checkpoint inhibitor platform, an immune cell engager platform (e.g.multispecific TCEs), the proprietary Hanjugator™ ADC platform, and the AI-powered, all-in-one early-stage R&D platform HAI Club. More than ensuring quality and efficiency in individual programs, this interconnected platform system provides the sustainable capability needed to build a globally competitive mid‑to‑long‑term pipeline. It enables Henlius to consistently translate cutting‑edge science into high‑value clinical‑stage drug candidates.
Focusing on unmet clinical needs, the three molecules target key challenges and emerging frontiers in cancer therapy:
HLX3901 is a novel, proprietary tetra-specific antibody targeting DLL3 dual enpitope and the T-cell co-stimulatory receptors CD3 and CD28. Its bispecific engagement of DLL3 enhances precise tumor targeting, while concomitant activation of CD3 (Signal 1) and CD28 (Signal 2) potentiates T‑cell cytotoxicity, activation, proliferation, and persistence against DLL3‑expressing tumors. Developed through the synergistic integration of AI‑driven molecular design and the company’s T‑cell engager (TCE) platform, HLX3901 exemplifies a next‑generation TCE engineered to overcome key limitations of earlier constructs in solid tumors—achieving sustained and specific T‑cell activation, better efficacy in the tumor microenvironment (TME) with low TIL density, and a reduced occurrence of cytokine release syndrome (CRS). It holds significant promise as a breakthrough therapeutic for refractory cancers such as small cell lung cancer (SCLC).
HLX97 is a novel, oral KAT6A/B inhibitor with best-in-class potential. KAT6A/B represents a promising therapeutic target in breast cancer and other solid tumors, with its dysregulation closely related to the pathogenesis of multiple hematologic and solid malignancies. By precisely inhibiting KAT6A/B activity, HLX97 modulates tumor cell proliferation, differentiation, and apoptosis. It exhibits a fast‑on/fast‑off pharmacokinetic profile and high selectivity, aiming to maximize anti-tumor efficacy while minimizing hematologic toxicity. With its favorable therapeutic profile, HLX97 holds promise as a new treatment option for patients with breast cancer and other relevant tumor types. Based on deep biological insight, Henlius has developed a differentiated R&D capability that spans both validated and emerging targets. By combining the strengths of both small and large molecules, the company is synergistically advancing a pipeline of first-in-class and best-in-class therapies.
HLX316 is an engineered human sialidase fusion protein targeting B7H3 (CD276), developed based on an innovative protein engineering platform. B7H3 is an immune checkpoint protein that is overexpressed in many epithelial cancers—including lung, breast, colorectal, pancreatic, prostate, and ovarian cancers—and is associated with tumor progression and poor prognosis, while exhibiting limited expression in normal tissues. High levels of sialylation on tumor cells engage inhibitory Siglec receptors on leukocytes, suppressing both innate and adaptive immune effector functions and contributing to resistance to immune checkpoint inhibitors (ICI). By enzymatically removing terminal sialic acids and concentrating its activity in B7H3‑positive tumors, HLX316 releases glyco‑immune checkpoint inhibition and restores innate and adaptive anti‑tumor immunity in the tumor microenvironment. HLX316 has the potential to target immunosuppressive mechanisms beyond PD‑1/PD‑L1, thereby broadening the applicability of immunotherapy in solid tumors and overcoming the limitations of current treatments.
Patient‑Centric Focus: Pipeline Continues to Expand as Clinical Value Materializes
Henlius has established a forward-looking, diversified, and high-quality innovation pipeline, comprising about 20 clinical-stage candidates and a discovery- and preclinical-stage portfolio of about 40 molecules across key therapeutic areas such as oncology, immunology, and inflammatory diseases. Core innovative assets—including serplulimab(anti‑PD‑1 mAb), HLX43 (PD‑L1 ADC), HLX22 (novel epitope HER2 mAb), and HLX07 (anti‑EGFR mAb), are key value drivers for the company, continuing to build compelling clinical profiles as they progress.
Rooted in addressing high-unmet medical needs, Henlius is systematically strengthening its early-stage pipeline with promising candidates. Recent pipeline progress includes several key milestones: HLX37 (anti-PD-L1/VEGF bispecific antibody) has received IND clearance for advanced solid tumors; HLX701 (novel SIRPα-Fc fusion protein) will initiate a Phase 2 clinical trial in China based on a potentially improved safety profile; and the potential first-in-class asset HLX79 (human sialidase fusion protein) has also entered a Phase 2 trial in China for active glomerulonephritis. Additionally, multiple preclinical candidates—including HLX3902 (STEAP1xCD3xCD28 trispecific TCE), HLX49 (HER2xHER2 bsADC), HLX48 (EGFRxcMET bsADC), and HLX105 (a fusion protein)—are advancing toward the clinic, injecting sustained innovation momentum into the company’s pipeline portfolio.
Looking ahead, Henlius will remain dedicated to its patient‑centric approach to drug development. Leveraging its integrated, platform‑based innovation engine, the company will accelerate the advancement of a differentiated, globally competitive pipeline, delivering more accessible and effective treatment options to patients worldwide.