On February 6, 2025, Henlius (2696. HK) announced its partnership with Dr Dr., a wholly-owned subsidiary of Reddy's Laboratories Reddy's Laboratories SA has signed an authorization license agreement for the company's self-developed biosimilar drug HLX15 (recombinant anti-CD38 whole human monoclonal antibody injection). Dr. Reddy's Laboratories (and its subsidiaries collectively referred to as "Dr. Reddy's") is listed on the Mumbai Stock Exchange (stock code: 500124) and the National Stock Exchange of India (stock code: DRREDDY）、 The New York Stock Exchange (stock code: RDY）、 The International Financial Services Centre of the National Stock Exchange of India (stock code: DRREDDY) is listed. Dr. Reddy's will have exclusive commercial rights to HLX15 subcutaneous and intravenous formulations in the United States and 42 European countries and regions, covering a total of 43 countries and regions.

According to the terms of the agreement, Henlius will be responsible for the research and development, production, and commercial supply of HLX15, and will receive $131.6 million from the transaction, of which $33 million is the down payment. In addition, Henlius will also receive a tiered royalty based on the annual net sales of the product. Dr. Reddy's is a global pharmaceutical company with operations in over 75 countries and regions worldwide. This time, Fosun Hanlin teamed up with Dr Reddy’s， We will accelerate the entry and penetration of our company's products into the European and American markets, bringing more healing possibilities to local patients.

Dr. Zhu Jun, Executive Director and CEO of Henlius, stated, "The cooperation with Dr. Reddy's on HLX15 is an important practice for us to respond to global health needs and improve the accessibility of advanced biopharmaceuticals. Dr. Reddy's has long been deeply involved in oncology, adhering to the concept of 'health cannot wait', and is committed to providing patients with affordable and high-quality drugs faster. This coincides with Henlius's patient-centered and clinically focused research and development philosophy. We firmly believe that the achievement of this cooperation will further strengthen the global market competitiveness of both parties in the field of cancer treatment, and help us benefit more patients around the world.

Cao Ping, Chief Business Development Officer and Senior Vice President of Henlius, said, "We are delighted to join hands with Dr. Reddy's, which is a crucial step for Henlius to expand its global partner network. With Henlius's strong product research and development capabilities, cutting-edge production and quality systems, and Dr. Reddy's profound experience and resources in the global commercialization network of biosimilars, we believe that this cooperation can fully leverage the strengths of both parties and bring more high-quality and affordable treatment solutions to the European and American markets.

Dr. Reddy's CEO Erez Israeli said, "We are pleased to have partnered with Henlius to launch this daratumumab biosimilar into the US and European markets. Over the years, we have developed a range of biosimilar products and sold them in multiple emerging markets. This latest collaboration with Henlius will further expand our regulatory market presence in the biosimilar field. In addition, oncology has always been a key focus of our treatment efforts. We look forward to leveraging our strong commercial capabilities in these markets to ensure that patients have access to top-notch treatment options and affordable treatment choices.

About HLX15
HLX15 is a fully human anti-CD38 IgG1 κ monoclonal antibody independently developed by Henlius, which is Darzalex monoclonal antibody ® And Darzalex Faspro ®* Candidate drugs for biosimilar drugs. Darzalex ® And Darzalex Faspro ® It has been approved for the treatment of multiple myeloma (MM). Following the requirements of the biosimilar technology guidelines in China, the European Union, and the United States, Henlius developed HLX15 using the principles of gradual progression, comparison, and similarity evaluation. Based on similarity analysis and preclinical studies, HLX15 is considered comparable to the original daratumumab. In June 2024, the Phase I clinical trial (NCT05679258) of HLX15 (recombinant anti-CD38 whole human monoclonal antibody injection) was successfully completed, achieving all predetermined study endpoints. The research results showed that HLX15 had similar pharmacokinetic characteristics to the original daratumumab available in the United States, European Union, and China, and its safety and immunogenicity were comparable. Currently, comparative studies on the efficacy of HLX15 are underway. [*Darzalex ® And Darzalex Faspro ® Registered trademark for Johnson&Johnson.]

Regarding Dr Reddy’s
Dr. Reddy's Laboratories Ltd. is a global pharmaceutical company headquartered in Hyderabad, India, and listed on the New York Stock Exchange (stock code: RDY）、 National Stock Exchange of India (Stock Code: DRREDDY）、 Listed on the International Financial Services Centre of the National Stock Exchange of India (stock code: DRREDDY) and the Mumbai Stock Exchange (stock code: 500124). Dr. Reddy's Laboratories Ltd. was founded in 1984, dedicated to providing affordable and innovative drugs. Under the principle of "health cannot wait", Dr. Reddy's Laboratories Ltd. offers a range of active pharmaceutical ingredients, generic drugs, branded generic drugs, biosimilars, and over-the-counter drugs, with major markets including the United States, India, Russia, CIS countries, China, Brazil, South Africa, and Europe. As a company with a profound scientific foundation and a leading position in the industry, we always focus on the future and continue to invest in forward-looking businesses. As early practitioners of sustainable development and ESG actions, we released our first sustainability report in 2004. At present, our ESG goals are committed to setting industry benchmarks in environmental protection, patient drug accessibility and affordability, diversification, and corporate governance. For more relevant information, please visit: www.drreddys.com.

About Fosun Hanlin
Henlius (2696. HK) is an international innovative biopharmaceutical company dedicated to providing affordable and high-quality biopharmaceuticals to patients worldwide. Its products cover fields such as oncology, autoimmune diseases, and ophthalmic diseases. Six products have been approved for market in China, four products have been approved for market internationally, and four market applications have been accepted by the China National Medical Products Administration, the US FDA, and the EU EMA. Since its establishment in 2010, Henlius has built an integrated biopharmaceutical platform, with efficient and innovative independent core capabilities running through the entire industry chain of research and development, production, and commercial operations. The company has established a comprehensive and efficient global innovation center, which produces and controls products in accordance with the international Good Manufacturing Practice (GMP) standards, and continuously consolidates the integrated comprehensive production platform. Among them, the company's commercial production bases have successively obtained GMP certifications in China, the European Union, and the United States.

Henlius has proactively laid out a diversified and high-quality product pipeline, covering more than 50 molecules, and comprehensively promoted the development of its own anti-PD-1 monoclonal antibody H drug Hansid ® Tumor immunotherapy combination therapy. As of now, the company has been approved to launch products including the first domestic biosimilar drug, Hanlikang ® (Rituximab), independently developed monoclonal antibody biosimilar Hanqu You approved in China, the United States, and Europe ® Trastuzumab, US trade name: HERCESSI ™, European product name: Zercepac ®), Han Dayuan ® (Adalimumab), Hanbeitai ® (Bevacizumab), the world's first approved first-line treatment for small cell lung cancer, anti-PD-1 monoclonal antibody Hansid ® (Sullimumab, EU trade name: Hetronifly ®） And Han Naijia ® (Naratinib). The company has also conducted over 30 clinical trials globally for 16 products, with comprehensive authorization covering mainstream biopharmaceutical markets in Europe and America, as well as numerous emerging markets.

Source: https://pharm.jgvogel.cn/c1486323.shtml