iBio, Inc. (NYSE AMERICAN:IBIO) today announced that it has
expanded the scope of its business venture with CC-Pharming Ltd. by
granting it an exclusive, royalty-bearing commercial license to
iBio’s bio-better rituximab (“iBio Rituximab”) product candidates
for the territory of China. In addition, the Company will grant to
CC-Pharming a research license to iBio’s
FastPharming System and know-how for the
evaluation of multiple product opportunities.
Rituximab was first approved by the U.S. Food
and Drug Administration in 1997 for treatment of certain B cell
non-Hodgkin lymphomas. Since that time, its clinical uses have
expanded to encompass treatment of chronic lymphocytic leukemia, as
well as a range of autoimmune diseases, including certain types of
rheumatoid arthritis. It was ranked as one of the world’s top-10
selling pharmaceuticals in 2018.
According to industry reports, Rituximab is
Roche Holding AG’s second-biggest selling drug in China, with
estimated annual sales of approximately 5 billion yuan ($708
million). About 88,000 new patients are diagnosed with lymphoma in
China each year, and 90% of them have non-Hodgkin’s lymphoma.
Rituximab has been placed on the World Health Organization’s List
of Essential Medicines, but despite the introduction of competition
via the China National Medical Products Administration’s first-ever
approval of a biosimilar version in February 2019, iBio and
CC-Pharming believe it may still be too expensive for many patients
that could benefit from its use. Accordingly, the companies are
jointly pursuing the medical and business goal of introducing a
bio-better rituximab that is more affordable in price.
The commercial license provides for
CC-Pharming’s use of iBio’s FastPharming System to
develop iBio Rituximab, and fulfills the companies’ intention to
share revenue from CC-Pharming’s sale of the product in China. The
license provides for CC-Pharming to be responsible for the
development, launch and commercialization of iBio’s bio-better
rituximab in China, including costs associated with the marketing
and sales of the licensed product. Under the terms of the license,
iBio retains all rights to commercialize iBio technology-based
products in markets outside of China.
The companies plan to develop additional
products for the Chinese market in other product categories,
particularly research and clinical reagents, non-pharmaceutical
skincare products and botanical derivatives. iBio and CC-Pharming
are currently evaluating the business feasibility of developing
additional biopharmaceutical products for oncology, metabolic
disorders, and fibrotic disease.
“We believe this is an important strategic
relationship for both parties: it enables us to participate in the
vast Chinese market using our existing assets, while CC Pharming
uses our technology to provide China’s massive population with
access to cost-effective critical drugs,” commented Robert B. Kay,
iBio’s Chairman and CEO. “The expanded scope of our partnership
with CC-Pharming aims first to advance our plant-derived,
bio-better rituximab toward commercialization in the near term,
while we jointly explore opportunities to develop and commercialize
additional high value products.”
“iBio’s plant-based production technology is an
elegant approach to biopharmaceutical manufacturing, particularly
when applied to rituximab, one of the world’s top-selling drugs,”
said Dr. Kevin Wang, CC-Pharming’s Chairman and Chief Scientific
Officer. “China was a relative newcomer to the biopharmaceutical
industry. With economic development, the country is becoming a top
destination for complex biologics. The total value of China’s
biopharma market reached $130 billion in 2018. iBio’s plant-based
production system has the potential to produce biopharmaceuticals,
as well as non-pharmaceutical products, in a more timely and
cost-efficient manner, so we are excited to identify other
opportunities to apply iBio’s technology.”
“A steadily growing product category of great
interest to CC-Pharming is the skincare market, which reached a
sales volume of $67 billion in China last year,” noted Ms. Yujiao
Chen, CC-Pharming’s Vice President for International Business and
Intellectual Property. “We believe CC-Pharming and iBio have a very
attractive joint opportunity to fulfill consumers’ rising
aspirations with plant-derived skincare ingredients, including for
use in a variety of high-tech beauty products.”
The Agreement expands the scope of iBio and
CC-Pharming’s July 2018 Master Joint Development Agreement, which
provides for the co-development of products and manufacturing
facilities, utilizing iBio’s technology, for the Chinese
biopharmaceutical market.
About Beijing CC-Pharming
Ltd.
CC-Pharming is located in Zhongguancun
Biomedical Engineering Transformation Center, Shunyi District,
Beijing, China. The company is specialized in plant molecular
medicine technology research and product development using
proprietary tobacco and lettuce transient expression platforms,
focusing on the use of plant bioreactors for the development of
animal-free, safe, high-value recombinant protein and peptide
product for industrial and clinical applications. The Company
develops innovative indoor vertical farming system for efficient
plant-based expression systems, and offers therapeutic biomedicine,
life science research, cosmetics, and CRO/CMO services to clients
in China. Further information is available at:
www.cc-pharming.com.
About iBio
iBio is a global leader in plant-based
biopharmaceutical contract development and cGMP manufacturing
services. Our wholly-owned subsidiary, iBio CDMO LLC, uses
the FastPharming™ System – which combines plant
protein expression, automated hydroponics, and glycan engineering
technologies – to rapidly deliver gram quantities of high-quality
biologics for research or further manufacturing uses from its
120,000 square foot facility in Bryan, Texas. In addition to
contract manufacturing, iBio also offers process development,
bioanalytical, and fill-finish services, along with Factory
Solutions for the design and build of facilities for plant-made
monoclonal antibodies, vaccines, bioinks and more. iBio also uses
its advanced manufacturing capabilities in the development of its
own therapeutic pipeline, including its lead asset, CFB-03 for the
treatment of fibrotic diseases. For more information, visit
www.ibioinc.com.
FORWARD-LOOKING
STATEMENTSSTATEMENTS INCLUDED IN THIS NEWS RELEASE RELATED
TO IBIO, INC. MAY CONSTITUTE FORWARD-LOOKING STATEMENTS WITHIN THE
MEANING OF THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995.
SUCH STATEMENTS INVOLVE A NUMBER OF RISKS AND UNCERTAINTIES SUCH AS
COMPETITIVE FACTORS, TECHNOLOGICAL DEVELOPMENT, MARKET DEMAND, AND
THE COMPANY'S ABILITY TO OBTAIN NEW CONTRACTS AND ACCURATELY
ESTIMATE NET REVENUES DUE TO VARIABILITY IN SIZE, SCOPE, AND
DURATION OF PROJECTS. FURTHER INFORMATION ON POTENTIAL RISK FACTORS
THAT COULD AFFECT THE COMPANY'S FINANCIAL RESULTS CAN BE FOUND IN
THE COMPANY'S REPORTS FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION.
Contact:
Stephen KilmerInvestor Relations(646) 274-3580
skilmer@ibioinc.com
iBio (AMEX:IBIO)
Historical Stock Chart
From Mar 2024 to Apr 2024
iBio (AMEX:IBIO)
Historical Stock Chart
From Apr 2023 to Apr 2024