Shanghai, China, March 9, 2026 — Shanghai Henlius Biotech, Inc. (2696.HK) announced that the Investigational New Drug (IND) application for HLX316, a potential first‑in‑class (FIC) B7‑H3–targeting sialidase fusion protein, has been approved by the National Medical Products Administration (NMPA) of China. The approval enables the initiation of first‑in‑human (FIH) clinical studies of HLX316 in patients with advanced or metastatic solid tumors, representing an important translational milestone in the development of glyco‑immune checkpoint–modulating therapies.
Scientific Rationale: Targeting Dual Immune Evasion Pathways
HLX316 is an engineered human sialidase fusion protein targeting B7‑H3 (CD276), developed based on an innovative protein engineering platform. The molecule is engineered to address two major immune evasion mechanisms commonly observed in solid tumors: B7‑H3 overexpression and tumor hypersialylation.
B7‑H3 is an immune checkpoint protein that is overexpressed in many solid tumors—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).
Through its enzymatic activity, HLX316 removes terminal sialic acids and preferentially enriches its activity in B7‑H3–positive tumor cells, thereby relieving glyco‑immune checkpoint–mediated immunosuppression and restoring innate and adaptive antitumor immune functions within the tumor microenvironment.
By exerting sialidase activity specifically in B7‑H3–expressing tumor cells and their microenvironment, HLX316 has the potential to simultaneously alleviate protein‑ and glycan‑mediated immune suppression, expand the applicability of immunotherapy in solid tumors, and overcome the limitations of existing treatment modalities. Preclinical studies have demonstrated that HLX316 induces potent B7‑H3–directed desialylation of tumor cells with a favorable tolerability profile.
Systematic Innovation Driving a Diversified and Differentiated Pipeline
HLX316 is one of the innovative programs arising from the strategic collaboration with Palleon Pharmaceuticals. Palleon was co-founded by Nobel laureate Carolyn Bertozzi, whose pioneering discoveries in glycobiology enabled development of the company’s therapeutic platform. By leveraging the complementary strengths of both parties, HLX316 is advancing toward global clinical development. The IND approval of HLX316 further reflects the accelerated momentum of Henlius’ innovation engine. Leveraging its PD‑(L)1–centered immune checkpoint inhibitor platform, immune cell engager platforms (including multispecific T‑cell engager technologies), Hanjugator™ ADC platform, fusion protein technologies, and the AI‑powered one‑stop early discovery platform HAI Club, Henlius is systematically building a multi‑modal innovation ecosystem spanning multi-specific antibodies, ADCs, fusion proteins and small‑molecule inhibitors.
Within this framework, several differentiated assets are advancing through early‑stage development. HLX37 (anti-PD-(L)1/VEGF bispecific antibody) has received IND approval and completed dosing of the first patient. HLX701 (novel SIRPα-Fc fusion protein) has initiated a phase 2 clinical study in China. In addition, HLX97, a potential best-in-class KAT6A/B inhibitor, and HLX3901, a DLL3xDLL3xCD3xCD28 tetra‑specific T‑cell engager (TCE) developed from Henlius’ proprietary TCE platform, received IND acceptance concurrently with HLX316.
In parallel, several other programs are progressing toward clinical development, including HLX3902 (STEAP1 × CD3 × CD28 trispecific T‑cell engager), HLX49 (HER2 × HER2 bsADC), HLX48 (EGFR × cMET bsADC), and HLX105 (a fusion protein). Collectively, these programs form a well‑tiered and technology‑diverse early‑stage pipeline.
Henlius is building a sustainable innovation pipeline with long‑term value creation capabilities. As core products advance into global pivotal clinical stages and progressively move toward registration and commercialization, the company has transitioned from “breakthrough innovation” to a new phase of “systematic innovation.” Looking ahead, Henlius will continue to deepen its Globalization 2.0 strategy, while maintaining robust cash flow to support R&D investment, accelerating the global development and translation of differentiated innovative assets, and bringing more internationally competitive products to mature markets in Europe and the United States, steadily advancing toward its vision of becoming a global biopharmaceutical company by 2030.