Shanghai Henlius Biotech Secures IND Approval for HLX3901 Injection Targeting Advanced/Metastatic Solid Tumours

Key Highlights

• Regulatory Milestone Achieved: Shanghai Henlius Biotech, Inc. (“Henlius” or “the Company”) has announced that the National Medical Products Administration (NMPA) has formally approved the Investigational New Drug (IND) application for HLX3901 injection, a novel tetra-specific antibody targeting advanced/metastatic solid tumours.
• First-in-Class Potential: As of the announcement date, HLX3901 represents a potential first-in-class therapy. There are no other tetra-specific antibodies globally that target DLL3 dual epitopes, CD3, and CD28 for this indication.
• Innovation in Cancer Immunotherapy: HLX3901 is designed to act as a T-cell engager, leveraging a unique mechanism that could potentially overcome immune suppression and improve the therapeutic window for T-cell engaging therapies.

Details of the Announcement

On 9 March 2026, Henlius announced that the NMPA has approved its IND application for a phase 1 clinical trial of HLX3901. This drug is a tetra-specific antibody capable of simultaneously targeting DLL3 dual epitopes, CD3, and CD28. The IND approval paves the way for clinical evaluation in patients with advanced or metastatic solid tumours.

About HLX3901

HLX3901 is a proprietary, independently developed tetra-specific antibody. Its design enables it to:

• Target DLL3 dual epitopes found on tumour cells, while also engaging CD3 and CD28 on T cells.
• Enhance targeted T-cell mediated tumour lysis: By engaging both the primary activation signal (CD3) and the co-stimulatory signal (CD28) on T cells, HLX3901 aims to significantly boost the anti-tumour immune response.
• Improve T-cell activation, proliferation, and survival in vivo: The drug is designed to prolong the duration and effectiveness of anti-tumour immunity, potentially leading to improved clinical outcomes.

Preclinical studies have indicated that HLX3901 demonstrates both strong anti-tumour efficacy and a favorable safety profile, supporting its progression into clinical trials.

Market & Competitive Position

The announcement emphasizes that, at present, no tetra-specific antibody targeting DLL3 dual epitopes, CD3, and CD28 has been approved worldwide. This positions Henlius as a possible first-mover in this innovative therapeutic segment, potentially allowing the Company to secure significant competitive advantages and market share in the field of advanced solid tumour immunotherapy.

Important Considerations for Shareholders

• Significant Development Risk: While the IND approval is a critical milestone, HLX3901 is still at an early (phase 1) clinical stage. The success of development, regulatory approval, and eventual commercialization remain uncertain.
• Potential Share Price Impact: Given HLX3901’s first-in-class status and preclinical promise, positive progress in clinical trials could have a material impact on Henlius’s valuation. However, setbacks or negative results could also pose risks to share value.
• Regulatory Caution: The company has explicitly reminded investors that there is no guarantee of HLX3901’s ultimate success or commercial viability. Caution is advised when dealing in the Company’s shares.

Conclusion

The approval of HLX3901’s IND application marks a major milestone for Shanghai Henlius Biotech, highlighting the Company’s innovation in the immuno-oncology field. As a potential first-in-class tetra-specific antibody for advanced/metastatic solid tumours, HLX3901 has the potential to significantly impact the Company’s future growth trajectory and share value, subject to successful clinical development.

Disclaimer: This article is for informational purposes only. It is not investment advice. The development and commercialization of pharmaceutical products are subject to significant risks and uncertainties. Investors should exercise caution and consider their own circumstances before making investment decisions.

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