Fosun Pharma announces NMPA approval for Daxxify®, Marking the license-in of the world’s first and only peptide-powered botulinum toxin product to Mainland China
(September 10, 2024, Shanghai, China) On September 9, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma” or “the Group”; Stock Code: 600196.SH; 02196.HK) announced that the Biologics License Application (“BLA”) for the licensed product RT002 (DaxibotulinumtoxinA-lanm, Chinese trademark:达希斐®, English trademark: DAXXIFY®, hereinafter referred to as “the product”) for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients, was recently approved by the National Medical Products Administration (“NMPA”), becoming the first DaxibotulinumtoxinA-lanm approved for marketing in Mainland China.
In December 2018, Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. *(“Fosun Pharma Industrial”), a subsidiary of Fosun Pharma, entered into a license agreement with US-based Revance Therapeutics, Inc., whereby Fosun Pharma Industrial was granted the exclusive rights to import, use, develop and otherwise commercialize (excluding manufacturing) RT002 in Mainland China, Hong Kong SAR and Macao SAR. RT002 is intended for aesthetic indications including the temporary improvement of moderate to severe glabellar lines in adults, and therapeutic indications such as the treatment of cervical dystonia in adults. At present, the aesthetic indication is approved in China, and the marketing authorization application for the therapeutic indication was accepted by the National Medical Products Administration (NMPA) in July 2023.
The rights to relevant commercial activities of DAXXIFY® with respect to its aesthetic indications (such as improvement in the appearance of moderate to severe glabellar lines in adults) were sublicensed by Fosun Pharmaceutical Industrial to Sisram Medical (01696.HK), a subsidiary of Fosun Pharm.
Dr. Xingli Wang, Executive President and CEO of Global R&D Center of Fosun Pharma said, “We are pleased that DAXXIFY®, which is the world first DaxibotulinumtoxinA-lanm - an innovative product licensed by Fosun Pharma, has been approved by the NMPA for marketing with its unique innovative technology and excellent clinical efficacy. The introduction of DAXXIFY® into Mainland China market will enhance Fosun Pharma’s portfolio of injectable fillers, offering consumers in China safer and more efficacious options for their aesthetic and health aspirations.”
As the first innovation of its kind in over 20 years, DAXXIFY® brings together botulinum toxin and Revances’s proprietary Peptide Exchange Technology™(PXT) to deliver outstanding efficacy. Results from DAXXIFY® can be seen as early as day following treatment for some people, and typically within 2 days[i]. The treatment is also considered long-lasting and keeps frown lines smoother with the convenience of as few as 2 treatments a year[ii], and results slowly soften over a prolonged period of time[iii]. Additionally, DAXXIFY® is known to result in a better look to skin texture after treatment[iv], smoothing even the deepest lines.
Alongside its outstanding clinically proven results, the high-end injectable botulinum toxin offers high safety. Free of human albumin or animal-based components, it has a lower probability of neutralizing antibodies or allergic reactions occurring during treatment sessions. DAXXIFY® also provides practitioners with more convenient and controllable storage management, aligning with clinic day operations. It can be kept at room temperature 20℃-25℃, and after reconstitution, it can be stored in a refrigerator at 2℃-8℃, protected from light for 72 hours.
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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 unmet clinical needs-oriented. Through diversified and multi-level cooperation models such as independent research and development, cooperative development, license-in, and industrial investment, the company continues to enrich its innovative product pipeline and focus on differentiated product R&D with high-tech barriers, to continuously enhance the value of its pipeline. Fosun Pharma's innovative products focus on core therapeutic areas such as solid tumors, hematologic tumors and immunity inflammation. It also strengthens core technology platforms such as antibodies/ADC, cell therapy, and small molecules.
Guided by the 4IN strategy (Innovation, Internationalization, Intelligentization, and Integration), Fosun Pharma adheres to the business philosophy of “Innovation for Good Health”, continues to promote innovative transformation, actively deploys internationalization, strengthens business focus by product lines, promotes integrated operations and efficiency improvement, and is dedicated to being the global leading integrator of pharmaceutical and healthcare innovation.
[i]64% of patients achieved an improvement in the appearance of skin texture at week 2 from a post hoc analysis of a phase 2 study with 60 patients
[ii]At least 50% of patients in SAKURA 1 and SAKURA 2 had none or mild frown lines for 24 weeks (6 months) and 23.9 weeks (6 months) or longer, respectively, per both investigator’s and patient’s assessments.
[iii]Median time to return to baseline wrinkle severity was 27.7 weeks in SAKURA 1 and 26 weeks in SAKURA 2
[iv]Based on pooled patient diary data from SAKURA 1 and SAKURA 2