HLX15 is a recombinant anti-CD38 fully human monoclonal antibody injection, with intravenous as well as subcutaneous formulations. HLX15 is being developed as a biosimilar of Darzalex® & Darzalex Faspro®*, which are indicated for the treatment of multiple myeloma. The agreement combines Dr. Reddy’s global commercial presence with Henlius’ proven capabilities in developing biosimilars for markets worldwide. Under the terms of the agreement, Henlius will be responsible for development, manufacturing and commercial supply, and may receive up to a total of $131.6 million, including an upfront payment of $33 million and milestone payments. In addition, Henlius is eligible to receive royalties on annual net sales of the product. Dr. Reddy’s gets exclusive rights to commercialize the subcutaneous as well as intravenous formulations of HLX15 in the United States (U.S.) and Europe.
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This collaboration with Dr. Reddy’s on HLX15 is a significant step in our response to global health needs and improving access to advanced biologics,” said Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius. “Dr. Reddy’s has a long-standing dedication to oncology, driven by the purpose of ‘Good Health Can’t Wait’, and is committed to timely access to affordable and high-quality medicines, which complement Henlius’ focus on addressing unmet medical needs in research and development. We are confident that this partnership will enhance the global market competitiveness of both organizations in oncology treatment, ultimately allowing us to reach and support more patients around the world.
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