(April 13, 2023, Shanghai, China) Recently,Shanghai
Fosun Pharmaceutical (Group) Co., Ltd.("Fosun Pharma"; stock
code: 600196.SH, 02196.HK), a global innovation-driven pharmaceutical and
healthcare industry group deep-rooted in China, announced that the Biologics
License Application (“BLA”) for RT002 (DaxibotulinumtoxinA for injection) for
the temporary improvement of moderate to severe glabellar lines caused by
movements of corrugator or procerus muscles in adults, which was submitted by
its holding subsidiary Shanghai Fosun Pharmaceutical Industrial Development
Co., Ltd. ("Fosun Pharma Industry") through license-in, was recently
accepted for review by the National Medical Products Administration (“NMPA”).
Fosun Pharma Industry entered into a license
agreement with US-based Revance Therapeutics, Inc. ("Revance") in
December 2018, whereby Fosun Pharma Industry was granted the exclusive rights
to use, import, sell, and otherwise commercialize (excluding manufacturing)
RT002 in Mainland China, Hong Kong SAR and Macao SAR.
RT002 is a long-acting neuromodulator developed
based on Revance's proprietary peptide technology and is manufactured in the
United States. RT002 doesn't contain any human serum albumin or animal-based
components and is stable at ambient temperature.
Revance’s clinical programs have investigated RT002
for aesthetic indications including glabellar lines and upper facial lines and therapeutic
indications including cervical dystonia and upper limb spasticity. RT002
temporarily blocks nerve impulses causing relaxation of local muscles that is
reversible, resulting in reduced appearance of facial wrinkles and lines.
Revance’s BLA for RT002 indicated to improve
moderate to severe glabellar lines in adults was approved by the U.S. Food and
Drug Administration (“U.S. FDA”) in September 2022. Up to now, the supplemental
biologics license application (“sBLA”) for the new indication of this product
to treat cervical dystonia in adults is under regulatory review by the U.S. FDA.
Further, Fosun Pharma Industry has completed its Phase Ⅲ clinical trial for
RT002 for cervical dystonia in China (excluding Hong Kong, Macao, and Taiwan).
***
About Fosun Pharma
Founded in 1994, Shanghai Fosun Pharmaceutical
(Group) Co., Ltd.*("Fosun Pharma"; stock code: 600196. SH,
02196. HK) is a global innovation-driven pharmaceutical and healthcare industry
group deep-rooted in China. Fosun Pharma directly operates businesses including
pharmaceutical manufacturing, medical devices, medical diagnosis, and
healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma
expands its areas in the pharmaceutical distribution and retail business.
Fosun Pharma is patient-centered and clinical
needs-oriented. The company continuously enriches its innovative product
pipeline through independent research and development, cooperative development,
license-in, and in-depth incubation. Fosun Pharma improves the research and
clinical development capabilities of FIC (First-in-class) and BIC (Best-in-class)
new drugs as well as accelerates the R&D and launch of innovative
technologies and products.
Guided by the 4IN strategy (Innovation,
Internationalization, Intelligentization, and Integration), Fosun Pharma will
uphold the development model of “Innovation Transformation, Integrated
Operation and Steady Growth", with the mission of creating shareholder
values through strengthening its independent R&D and external cooperation
and enriching its product pipelines, as well as promoting the global networks
and enhancing operational efficiency. Fosun Pharma will actively promote the
digital and physical business layout in the pharmaceutical and healthcare
industry and is committed to becoming a first-class enterprise in the global
medical and health market.
For more information, please visit our official
website: www.lukesuciu.com.
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Looking Statement:
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press release contains a Forward Looking Statement. In addition to the
historical factual statements contained in this press release, all the
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About Revance
Revance is a biotechnology company setting the new
standard in healthcare with innovative aesthetic and therapeutic offerings that
elevate patient and physician experiences. Revance’s aesthetics portfolio of
expertly created products and services, including DAXXIFY® (DaxibotulinumtoxinA-lanm) for injection, the RHA® Collection of dermal
fillers, and OPUL®, the first-of-its-kind Relational Commerce platform for
aesthetic practices, deliver a differentiated and exclusive offering for the
company’s elite practice partners and their consumers. Revance has also
partnered with Viatris Inc. to develop a biosimilar to onabotulinumtoxinA for
injection, which will compete in the existing short-acting neuromodulator
marketplace. Revance’s therapeutics pipeline is currently focused on muscle
movement disorders including evaluating DAXXIFY® in two debilitating
conditions, cervical dystonia and upper limb spasticity.
Revance is headquartered in Nashville, Tennessee,
with additional office locations in Newark, Pleasanton and Irvine, California.
“Revance” and the Revance logo, DAXXIFY®, and OPUL® are registered trademarks of Revance Therapeutics, Inc.
Resilient Hyaluronic Acid® and RHA® are trademarks
of TEOXANE SA.
