Shanghai, China, February 16, 2026—Shanghai Henlius Biotech, Inc. (2696.HK) today announced that the Investigational New Drug (IND) application for HLX15-SC, the subcutaneous formulation of HLX15, the Company’s daratumumab biosimilar candidate (recombinant anti-CD38 fully human monoclonal antibody), has been cleared by the U.S. Food and Drug Administration (FDA). The study is intended for first-line treatment of multiple myeloma. This milestone further demonstrates Henlius’ systematic capabilities in global biosimilar development and regulatory engagement.

HLX15 is a fully human anti-CD38 IgG1κ monoclonal antibody independently developed by Henlius, and is a biosimilar candidate to daratumumab, including the intravenous formulation Darzalex^® and the subcutaneous formulation Darzalex Faspro^®. As a cornerstone therapy in the treatment of multiple myeloma, daratumumab has been largely adopted across major global markets and represents a high regulatory and development benchmark for biosimilar programs. In February 2025, Henlius entered into a licensing and collaboration agreement with Dr. Reddy’s Laboratories SA, wholly-owned subsidiary of Dr. Reddy’s Laboratories Ltd, granting exclusive commercialization rights for both the intravenous and subcutaneous formulations of HLX15 in the United States and 42 European countries and regions, ensuring wider reach of the novel drug.

Currently, HLX15 is being developed following the principles of a stepwise development approach, in accordance with the biosimilars guidelines of FDA, EMA and NMPA. HLX15 and reference daratumumab are considered comparable based on analytical similarity assessment and pre-clinical studies. In June 2024, the Phase 1 clinical study (NCT05679258) of HLX15 intravenous formulation (HLX15-IV) was successfully completed, meeting its primary endpoint. The findings indicate that HLX15-IV had similar pharmacokinetic characteristics, as well as comparable safety and immunogenicity profiles to the US-, EU-, and CN-sourced daratumumab.

Building on these results, the FDA’s clearance of the IND for the subcutaneous formulation further validates Henlius’ ability to advance biosimilar candidates through multiple development pathways in alignment with international regulatory standards, supporting a structured global registration strategy for HLX15.

Henlius has established an integrated global platform encompassing R&D, regulatory affairs, and clinical development and operations, supported by manufacturing and quality management systems that meet international regulatory requirements. To date, Henlius has successfully obtained overseas marketing approvals for seven products. Henlius will continue to advance the global clinical development of HLX15 and, together with its partners, provide more high-quality and affordable treatment options for patients worldwide.

*Darzalex^® & Darzalex Faspro^® are registered trademarks of Johnson & Johnson.