"Shanghai Henlius Biotech, Inc. today announced it has entered into a license agreement with Dr. Reddy’s Laboratories SA, wholly-owned subsidiary of Dr. Reddy’s Laboratories Ltd. for the company's independently developed investigational daratumumab biosimilar HLX15, a recombinant anti-CD38 fully human monoclonal antibody injection. Dr. Reddy’s will gain exclusive rights to commercialize both subcutaneous and intravenous formulation of HLX15 in a total of 43 countries and regions, comprising 42 European countries and regions and the United States (U.S.).
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 a $33 million upfront payment and additional milestone payments. In addition, Henlius is eligible to receive royalties on annual net sales of the product. Dr. Reddy’s is a global pharmaceutical company, operating in over 75 countries across the globe. Through a partnership with Dr. Reddy’s, Henlius aims to boost the growth and reach of its products in the European and U.S. markets, providing local patients with enhanced treatment options.
“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 that ‘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.”
“We are pleased to join hands with Dr. Reddy’s, signifying a pivotal moment in Henlius’ journey to expand our global partner network,” said Ping Cao, Chief Business Development Officer and SVP of Henlius, “Henlius' robust product development capabilities in biosimilars, along with its advanced manufacturing and quality systems that meet global standards, paired with Dr. Reddy’s vast experience and resources in the global commercialization of biosimilars, positions this collaboration to effectively harness the strengths of both organizations. Together, we aim to deliver more high-quality and affordable treatment options to the U.S. and European markets.”
Erez Israeli, Chief Executive Officer of Dr. Reddy’s, said: “We are pleased to collaborate with Henlius to make this daratumumab biosimilar available to patients in the U.S., and Europe. Over the years, we have created a portfolio of biosimilar products that are being marketed in several emerging markets. This latest collaboration with Henlius further progresses our regulated markets journey in biosimilars. Additionally, oncology has been a top focus therapy area for us. We look forward to leveraging our strong commercial capabilities in these markets to ensure patients receive access to best-in-class therapies and affordable treatment options.”