Shanghai Henlius Biotech, Inc. Announces IND Approval for Groundbreaking Lung Cancer Therapy Combination

Key Milestone Reached in Innovative Cancer Treatment Development

Shanghai Henlius Biotech, Inc. (Stock code: 2696) has announced a significant development that could potentially impact its share value and investor sentiment. The company has received approval from the National Medical Products Administration (NMPA) for an Investigational New Drug (IND) application to initiate clinical trials for a novel combination therapy targeting advanced squamous non-small cell lung cancer (sqNSCLC).

Key Highlights of the Announcement

• Regulatory Approval: The IND approval by NMPA allows Henlius to commence clinical trials of pimurutamab HLX07 (a recombinant anti-EGFR humanised monoclonal antibody injection) in combination with HANSIZHUANG (serplulimab injection) and chemotherapy for the treatment of advanced sqNSCLC.
• First-of-its-Kind Combination: As of the announcement date, no similar combination therapy has been approved globally, positioning Henlius as a pioneer in this treatment strategy.
• Innovative Drug Pipeline:
  • HLX07: This innovative biologic targets EGFR and is being developed primarily for advanced solid tumours. Previous studies, including a Phase 1b/2 clinical trial, have demonstrated that HLX07 is safe and well tolerated in combination with chemotherapy.
  • Multiple Phase 2 trials are ongoing in Mainland China, including trials for HLX07 monotherapy in advanced cutaneous squamous cell carcinoma (CSCC) and for HLX07 in combination with HANSIZHUANG for sqNSCLC and other solid tumours.
• HANSIZHUANG (Serplulimab):
  • An anti-PD-1 monoclonal antibody developed by Henlius, already approved for multiple indications in Mainland China, including first-line therapy in sqNSCLC, extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous NSCLC.
  • International Approvals & Recognition: HANSIZHUANG has received approvals in the EU, UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, India, and more. It has also been granted Orphan Drug Designation in the US, EU, Switzerland, South Korea, and other regions.
  • Pipeline Expansion: Ongoing global clinical studies are evaluating HANSIZHUANG and its combinations in a broad spectrum of cancers, including lung, head and neck, colorectal, and gastric cancers.
  • In December 2025, the NMPA accepted the New Drug Application for HANSIZHUANG in combination with chemotherapy for neo-/adjuvant treatment for gastric cancer and granted it priority review.

Potential Market Impact and Shareholder Considerations

• Market Differentiation: The lack of any globally approved combination similar to HLX07 plus HANSIZHUANG and chemotherapy for sqNSCLC sets Henlius apart as a leader in innovative cancer therapies.
• Pipeline Strengthening: The approval bolsters Henlius’ already robust oncology pipeline, potentially enhancing its future revenue streams and market position if clinical trials are successful and lead to commercialisation.
• Investment Risk: Despite this positive development, the company has explicitly cautioned that there is no guarantee of successful development or commercialisation of HLX07. Shareholders and potential investors should be aware that clinical and regulatory risks remain.

Board and Governance Update

The board of directors, chaired by Mr. Wenjie Zhang, continues to oversee the company’s strategic direction, supported by a mix of executive, non-executive, and independent non-executive directors.

Conclusion

This announcement represents a major milestone for Shanghai Henlius Biotech, Inc. The IND approval for a globally first-in-class combination therapy for advanced sqNSCLC could be a catalyst for the company’s share price, subject to the progress and outcomes of the upcoming clinical trials. Investors should monitor future disclosures closely as further clinical data emerges.

Disclaimer: This article is for informational purposes only and does not constitute investment advice. The successful development and commercialisation of biopharmaceutical products are subject to significant risks and uncertainties. Investors are advised to exercise caution and conduct their own due diligence before making any investment decisions.

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