Henlius and Dr. Reddy's Ink Licensing Deal for HLX15 (investigational daratumumab biosimilar) Expansion in Europe and the U.S.

Rhea-AI Summary

Henlius Biotech has entered into a license agreement with Dr. Reddy's Laboratories for HLX15, an investigational daratumumab biosimilar. The deal grants Dr. Reddy's exclusive commercialization rights in 43 countries, including 42 European regions and the United States.

Under the agreement terms, Henlius will handle development, manufacturing, and commercial supply. The deal includes a $33 million upfront payment and potential additional milestone payments totaling up to $131.6 million, plus royalties on annual net sales.

The partnership aims to leverage Henlius' biosimilar development and manufacturing capabilities with Dr. Reddy's global commercialization experience. The collaboration focuses on expanding access to affordable oncology treatments in the U.S. and European markets.

Positive

• Secured $33 million upfront payment from Dr. Reddy's
• Potential additional milestone payments up to $131.6 million
• Additional revenue stream through royalties on annual net sales
• Expansion into 43 new markets including U.S. and European regions

Negative

• None.

Insights

Financial Analyst

This strategic licensing agreement marks a significant expansion of Dr. Reddy's biosimilar portfolio, particularly in the lucrative oncology segment. The deal structure, featuring a $33 million upfront payment and potential milestone payments totaling $131.6 million plus royalties, is well-structured to align incentives while managing upfront investment risks.

The market opportunity is substantial - the reference product Darzalex® (daratumumab) generated over $7.5 billion in global sales in 2023, with significant portions from the U.S. and European markets. The biosimilar rights for both subcutaneous and intravenous formulations across 43 key markets position Dr. Reddy's to capture meaningful market share as patents expire.

The deal leverages complementary strengths - Henlius' development and manufacturing capabilities combined with Dr. Reddy's established commercial infrastructure and experience in regulated markets. This partnership model optimizes resource allocation while accelerating market access. The royalty structure provides ongoing revenue potential tied to market success, while milestone payments help offset development and regulatory costs.

For investors, this represents a strategic enhancement to Dr. Reddy's biosimilar portfolio in oncology, a high-growth therapeutic area. The deal structure balances near-term investments with long-term value creation potential through multiple revenue streams. The expansion into regulated markets with a potentially significant product strengthens the company's competitive position in the evolving biosimilar landscape.

Pharmaceutical Industry Analyst

This licensing agreement represents a strategic advancement in Dr. Reddy's biosimilar portfolio, particularly in oncology. HLX15, targeting CD38, addresses multiple myeloma treatment - a high-value therapeutic area with significant unmet needs. The deal structure demonstrates careful risk management while securing rights in key regulated markets.

The inclusion of both subcutaneous and intravenous formulations is particularly noteworthy, as the subcutaneous version typically offers competitive advantages in terms of administration time and patient preference. This dual-formulation strategy could enhance market penetration and competitive positioning once launched.

The partnership model effectively leverages each company's core strengths - Henlius maintains control of development and manufacturing, ensuring quality and supply chain reliability, while Dr. Reddy's can focus on commercialization in regulated markets where it has established infrastructure. This arrangement optimizes resource allocation and potentially accelerates time to market.

For the broader biosimilar market, this deal signals continued investment in complex biologics and highlights the importance of strategic partnerships in navigating regulatory and commercial challenges in key markets. The focus on regulated markets aligns with industry trends toward higher-value opportunities in mature healthcare systems.

SHANGHAI, Feb. 6, 2025 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) today announced it has entered into a license agreement with Dr. Reddy's Laboratories SA, wholly-owned subsidiary of Dr. Reddy's Laboratories Ltd., (BSE: 500124 | NSE: DRREDDY | NYSE: RDY | NSEIFSC: DRREDDY, along with its subsidiaries hereafter referred to as "Dr. Reddy's") 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."

About HLX15

HLX15 is a fully human anti-CD38 IgG1κ monoclonal antibody independently developed by Henlius, and is a biosimilar candidate to Darzalex^® & Darzalex Faspro^®* which are indicated for the treatment of multiple myeloma. In accordance with the biosimilar guidelines of NMPA, EMA, and USFDA, HLX15 is being developed following the principles of stepwise development. 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 was successfully completed, meeting its primary endpoint. The findings indicate that HLX15 had similar pharmacokinetic characteristics, as well as comparable safety and immunogenicity profiles to the US-, EU-, and CN-sourced daratumumab. Comparative efficacy studies are currently underway.

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

About Dr. Reddy's

Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of 'Good Health Can't Wait', we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com.

About Henlius

Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 4 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.

Henlius has pro-actively built a diversified and high-quality product pipeline covering over 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac^® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly^® in the EU), the world's first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What's more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets.

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SOURCE Henlius

FAQ

What is the total value of the Henlius-Dr. Reddy's (RDY) licensing deal for HLX15?

The deal is valued at up to $131.6 million, including a $33 million upfront payment plus additional milestone payments and royalties on annual net sales.

How many countries are included in the Dr. Reddy's (RDY) licensing agreement for HLX15?

The agreement covers 43 countries and regions, including 42 European countries and regions plus the United States.

What are Henlius's responsibilities in the RDY partnership for HLX15?

Henlius will be responsible for development, manufacturing, and commercial supply of HLX15.

What formulations of HLX15 are included in the Dr. Reddy's (RDY) licensing deal?

The deal includes both subcutaneous and intravenous formulations of HLX15, the daratumumab biosimilar.