Dr. Reddy’s gets exclusive rights to
commercialize the subcutaneous as well as intravenous formulations
of HLX15 in the U.S. and Europe
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”), today announced that it has entered into a
license agreement with Shanghai Henlius Biotech, Inc. (2696.HK)
related to the development and commercialization of HLX15,
Henlius’s investigational daratumumab biosimilar candidate to
Darzalex® & Darzalex Faspro®.
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.
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. The launch of our pegfilgrastim through our
collaborator in the U.S. in 2023, and bevacizumab in the United
Kingdom last year marked the start of our biosimilars journey in
regulated markets. Last year, we also signed a collaboration with
Alvotech for the commercialization of their denosumab biosimilar in
the U.S. and Europe. 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.”
“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.”
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®*. 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 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. To learn more about
Henlius, visit https://www.henlius.com/en/index.html and connect
with us on LinkedIn at
https://www.linkedin.com/company/henlius/.
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.
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