Shanghai Henlius Biotech Announces Major Clinical Trial Milestone for HLX07 Combination Therapy in Australia

Key Points from the Announcement

• Regulatory Approval in Australia: Shanghai Henlius Biotech, Inc. has received approval to commence a Phase 2/3 clinical trial of its novel anti-EGFR antibody pimurutamab (HLX07) in combination with HANSIZHUANG (serplulimab) and chemotherapy for the first-line treatment of advanced squamous non-small cell lung cancer (sqNSCLC).
• Trial Design: The study compares the combination of HLX07, HANSIZHUANG, and chemotherapy against a control arm of placebo plus HANSIZHUANG or pembrolizumab with chemotherapy.
• First Global Approval of Its Kind: As of the announcement date, no similar combination therapy has been approved for marketing anywhere in the world, highlighting Henlius’s pioneering status in this therapeutic area.
• Regulatory Endorsements: The trial has been cleared by the Human Research Ethics Committee and acknowledged by the Therapeutic Goods Administration (TGA) of Australia, signaling strong regulatory support outside China.

Details for Investors

• HLX07 (Pimurutamab):
  • An innovative, independently developed recombinant anti-EGFR humanised monoclonal antibody targeting advanced solid tumors.
  • Previous phase 1b/2 study data (February 2023) demonstrated HLX07, in combination with chemotherapy, was safe and well-tolerated.
  • Ongoing phase 2 studies in mainland China include HLX07 as monotherapy for advanced cutaneous squamous cell carcinoma (CSCC) and other solid tumors, plus combinations with HANSIZHUANG for sqNSCLC and other indications.
• HANSIZHUANG (Serplulimab):
  • Henlius’s proprietary anti-PD-1 monoclonal antibody, already approved in China for multiple indications, including first-line sqNSCLC, extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous NSCLC.
  • Additional global approvals: European Union, United Kingdom, Indonesia, Cambodia, Thailand, Malaysia, Singapore, India, and more.
  • Orphan-drug designation granted by the US, Switzerland, South Korea, and other jurisdictions.
  • New Drug Application (NDA) for combination with chemotherapy as neo-/adjuvant treatment for gastric cancer accepted by China’s NMPA and granted priority review.
  • Multiple ongoing global clinical studies exploring its use in lung cancer, head and neck squamous cell carcinoma, colorectal cancer, gastric cancer, and related combination regimens.
• Recent Regulatory Progress:
  • In March 2026, the IND application for the combination of HLX07, HANSIZHUANG, and chemotherapy for advanced sqNSCLC was approved by China’s NMPA.

Potential Price-Sensitive and Shareholder-Relevant Information

• No Similar Combination Therapy Approved Globally: This positions Henlius as a potential first-mover in the sqNSCLC market with a novel biologic combination, which could offer significant competitive and commercial advantages if successful.
• Global Expansion and Regulatory Milestones: The approval to conduct an advanced-stage clinical trial in Australia marks a critical step in Henlius’s global expansion and international recognition of its product pipeline.
• Clinical Risk Warning: The company explicitly warns that there can be no guarantee of the successful development and commercialization of HLX07. Investors are advised to exercise caution due to inherent risks in clinical development.

Additional Corporate Information

• The board of directors includes Chairman Wenjie Zhang, Executive Director Dr. Jun Zhu, and a diverse group of non-executive and independent non-executive directors, reflecting strong leadership and governance.

Conclusion

This announcement is highly relevant for investors and shareholders. The regulatory approval to initiate a critical late-stage trial of HLX07 in combination with HANSIZHUANG and chemotherapy for advanced sqNSCLC in Australia significantly advances Henlius’s international presence and underscores the company’s ambition to pioneer novel oncology therapies. Should the trial prove successful, Henlius could capture a sizable share of the global lung cancer therapeutics market, potentially driving substantial long-term value for shareholders. However, the inherent risks of clinical development remain, and investors should monitor further updates closely.

Disclaimer: The above article is based on the company’s voluntary announcement and public disclosures. It contains forward-looking statements and is not investment advice. The success of clinical development is subject to significant uncertainty, and actual outcomes may differ materially. Investors should exercise due caution and consult professional advisors before making investment decisions.

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