china's nmpa accepts fosun pharma’s bla for innovative botulinum toxin product rt002
(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.fosunpharma.com.
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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.