China's NMPA Accepts Fosun Pharma’s BLA for Innovative Botulinum Toxin Product DAXXIFY® for the Treatment of Cervical Dystonia
(7July 2023, Shanghai, China) On7July,Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma”; stock code: 600196.SH, 02196.HK), a global innovation-driven pharmaceutical and healthcare industry group, announced that the Biologics License Application (“BLA”) for DAXXIFY® (DaxibotulinumtoxinA for injection) for the treatment of cervical dystonia in adults, which was submitted by its holding subsidiary Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. (“Fosun Pharma Industrial”) through license-in, was recently accepted for review by the National Medical Products Administration (“NMPA”).
Fosun Pharma Industrial entered into a license agreement with US-based Revance Therapeutics, Inc. (“Revance”) in December 2018, whereby Fosun Pharma Industrial was granted the exclusive rights to use, import, sell, and otherwise commercialize (excluding manufacturing) DAXXIFY® in Mainland China, Hong Kong SAR and Macao SAR.
Revance is a biotechnology company focused on innovative aesthetic and therapeutic offerings. The company’s aesthetics portfolio of products and services, includes DAXXIFY® (DaxibotulinumtoxinA-lanm), the RHA® Collection of dermal fillers, and OPUL®, the first-of-its-kind Relational Commerce platform for aesthetic practices. Revance is also evaluating DAXXIFY® in two debilitating therapeutic conditions, cervical dystonia and upper limb spasticity.
DAXXIFY® was approved by the U.S. Food and Drug Administration (“U.S. FDA”) for the temporary improvement of moderate to severe frown lines (glabellar lines) in adults in September 2022. The NMPA has accepted the BLA for the product for this indication in April 2023. Revance’s submission of its supplemental biologics license application (“sBLA”) for DAXXIFY® for the treatment of cervical dystonia was accepted by the U.S. FDA in January 2023, with a Prescription Drug User Fee Act (PDUFA) date of 19 August 2023.
DAXXIFY® is the first and only long-lasting, peptide-formulated neuromodulator product powered by Revance’s cell-penetrating Peptide Exchange Technology™(PXT), a proprietary, synthetic, 35-amino-acid stabilizing excipient. DAXXIFY® is free of any human serum albumin or animal-based components and is stable at ambient temperature. Manufactured in the U.S., DAXXIFY® is the first true innovation in neuromodulator product formulation in over 30 years.
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. Fosun Pharma directly operates businesses including pharmaceuticals, 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 pharmaceutical and healthcare markets.
For more information, please visit our official website:www.fosunpharma.com
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.
For more information, please visit www.revance.com