Shanghai Henlius Biotech, Inc. (HENLIUS, 02696) has obtained National Medical Products Administration (NMPA) clearance to initiate a Phase 1 clinical trial of HLX3901, its in-house developed tetra‐specific antibody (DLL3xDLL3xCD3xCD28) for patients with advanced or metastatic solid tumours.
HLX3901 is engineered to engage T cells by concurrently binding two DLL3 epitopes alongside CD3 and CD28. This dual engagement strategy is designed to: 1) Stimulate T-cell cytotoxicity through simultaneous activation of the primary CD3 signal and CD28 co-stimulatory pathway, enhancing tumour cell lysis; and 2) Prolong anti-tumour immune responses by boosting T-cell activation, proliferation and survival.
Pre-clinical studies cited in the announcement demonstrated robust anti-tumour efficacy and a favourable safety profile, underpinning the decision to progress to human trials.
As of the announcement date, no tetra-specific antibody targeting DLL3 dual epitopes, CD3 and CD28 has received marketing authorisation worldwide, positioning HLX3901 as a potential first-in-class asset.
The company reiterates that IND approval initiates early-stage clinical evaluation and does not assure eventual regulatory approval or commercialisation success. Shareholders and investors are advised to exercise caution in trading HENLIUS shares.
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