Shanghai Henlius Biotech Receives IND Approval for Nivolumab Biosimilar HLX18 Phase 1 Trial in China

Key Highlights from the Announcement

• Regulatory Milestone Achieved: Shanghai Henlius Biotech, Inc. (“Henlius” or “the Company”) has received approval from the National Medical Products Administration (NMPA) of China for its Investigational New Drug (IND) application to initiate a Phase 1 clinical trial of HLX18, a nivolumab biosimilar.
• HLX18 Overview: HLX18 is a recombinant anti-PD-1 humanized monoclonal antibody injection, independently developed by Henlius for the treatment of multiple solid tumors.
• Potential Indications: HLX18 is positioned as a biosimilar to nivolumab, with potential applications in a broad range of cancers including melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma, esophageal cancer, colorectal cancer, and hepatocellular carcinoma.
• Mechanism of Action: Like the reference drug nivolumab, HLX18 targets the PD-1 pathway, blocking PD-1 interactions with PD-L1 and PD-L2. This releases immune inhibition and boosts anti-tumor immune responses, a mechanism validated in the oncology therapeutics market.
• International Development: HLX18 was previously approved to commence a Phase 1 clinical trial in the United States as of December 2025.
• Market Potential: According to IQVIA MIDAS™, global sales of nivolumab reached approximately USD 11.785 billion in 2025, underlining a significant market opportunity for biosimilars.

Price-Sensitive Considerations for Shareholders

• Clinical Progress as a Value Driver: The IND approval for HLX18 marks a critical step in the asset’s clinical and commercial pathway, potentially enhancing Henlius’s pipeline value and future revenue streams if development progresses successfully.
• Competitive Biosimilar Market Entry: With HLX18 targeting major cancer indications served by the high-revenue reference drug nivolumab, successful development and future commercialization could significantly impact the Company’s competitive positioning and financial performance.
• Regulatory Risk Disclosure: The Company explicitly warns investors that it cannot guarantee the successful development and commercialization of HLX18. Investors should be aware that clinical and regulatory risks remain, which could affect the timing and probability of market entry and related revenues.
• Potential Stock Price Impact: Given the size of the global nivolumab market and the strategic importance of biosimilars, material progress in HLX18’s clinical program could be share price sensitive. Conversely, setbacks or clinical failures may negatively impact the stock.

Additional Details

• Corporate Leadership: The announcement was formally made by the Chairman of the Board, Wenjie Zhang. The Board consists of a mix of executive, non-executive, and independent non-executive directors, reflecting robust corporate governance.
• Disclosure Compliance: The Company issued a warning statement in line with Hong Kong Stock Exchange listing rules, advising shareholders and potential investors to exercise caution in trading the Company’s shares based on this announcement.

Conclusion

The IND approval for HLX18, Henlius’s nivolumab biosimilar, represents a significant regulatory and developmental milestone for the Company. Considering the multi-billion-dollar market for nivolumab and the strategic importance of biosimilar entrants, this development has the potential to be a material value driver for Henlius, pending successful clinical outcomes and subsequent commercialization. However, investors should remain mindful of the inherent risks associated with drug development and regulatory approval processes.

Disclaimer

The information provided in this article is based on the official announcement by Shanghai Henlius Biotech, Inc. and aims to inform investors. The Company and its representatives cannot guarantee the successful development or commercialization of HLX18. Shareholders and potential investors are advised to exercise caution and consult with professional advisers before making investment decisions. This article does not constitute investment advice.

View HENLIUS Historical chart here