Galderma’s Relfydess™ (relabotulinumtoxinA) Receives Approval in China for Frown Lines

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Postmedia has not reviewed the content. by Business Wire Galderma's Relfydess™ (relabotulinumtoxinA) Receives Approval in China for Frown LinesAuthor of the article:The Chinese National Medical Products Administration (NMPA) has approved Relfydess™, the first and only ready-to-use liquid neuromodulator designed with PEARL™ Technology, for the temporary improvement of moderate-to-severe glabellar lines (frown lines) in adults1,2The approval is based on phase III results from a local clinical trial conducted in China as well as global READY clinical trials, with local results reinforcing that Relfydess delivers significant improvements in frown lines, with a fast onset of action as early as day one, and sustained results for up to six months in some patients3-7This approval underscores Galderma’s continued leadership in the Asia-Pacific region and further expands the global reach of Relfydess, which is already authorized in more than 35 markets worldwideTHIS CONTENT IS RESERVED FOR SUBSCRIBERS ONLYSubscribe now to read the latest news in your city and across Canada.Exclusive articles from Barbara Shecter, Joe O'Connor, Gabriel Friedman, and others.Daily content from Financial Times, the world's leading global business publication.Unlimited online access to read articles from Financial Post, National Post and 15 news sites across Canada with one account.National Post ePaper, an electronic replica of the print edition to view on any device, share and comment on.Daily puzzles, including the New York Times Crossword.SUBSCRIBE TO UNLOCK MORE ARTICLESSubscribe now to read the latest news in your city and across Canada.Exclusive articles from Barbara Shecter, Joe O'Connor, Gabriel Friedman and others.Daily content from Financial Times, the world's leading global business publication.Unlimited online access to read articles from Financial Post, National Post and 15 news sites across Canada with one account.National Post ePaper, an electronic replica of the print edition to view on any device, share and comment on.Daily puzzles, including the New York Times Crossword.REGISTER / SIGN IN TO UNLOCK MORE ARTICLESCreate an account or sign in to continue with your reading experience.Access articles from across Canada with one account.Share your thoughts and join the conversation in the comments.Enjoy additional articles per month.Get email updates from your favourite authors.THIS ARTICLE IS FREE TO READ REGISTER TO UNLOCK.Create an account or sign in to continue with your reading experience.Access articles from across Canada with one accountShare your thoughts and join the conversation in the commentsEnjoy additional articles per monthGet email updates from your favourite authorsSign In or Create an AccountThis advertisement has not loaded yet, but your article continues below.ZUG, Switzerland — Galderma (SIX: GALD) today announced that the Chinese NMPA has approved Relfydess for the temporary improvement of moderate-to-severe frown lines in adults, marking a significant expansion of the company’s Injectable Aesthetics portfolio in China – one of the world’s largest and fastest-growing aesthetics markets.8,9 This approval follows successful authorizations and launches of Relfydess in more than 35 markets worldwide.Get the latest headlines, breaking news and columns.By signing up you consent to receive the above newsletter from Postmedia Network Inc.A welcome email is on its way. If you don't see it, please check your junk folder.The next issue of Top Stories will soon be in your inbox.We encountered an issue signing you up. Please try againRelfydess is the first and only ready-to-use liquid neuromodulator developed with PEARL Technology, designed to deliver a highly active, innovative, complex-free molecule that addresses the real needs of patients and healthcare professionals.1,2,4,5 It is optimized for simple volumetric dosing, without reconstitution, to increase ease-of-use and help ensure consistent dose/volume every time.1,10 At a time when patients and healthcare professionals are increasingly seeking high-performance neuromodulators that rapidly deliver long-lasting, natural-looking outcomes, Relfydess’ introduction to China will help to meet the increasing needs of this large and diverse market by providing an innovative new treatment option.11 Insights from a Galderma survey on anti-wrinkle treatments indicate that the market is set to expand further, with 97% of surveyed patients in China indicating they plan to maintain or increase their use in the future.11 Additionally, the survey found that 88% of Chinese patients ranked natural-looking results as one of their top three treatment benefits, and 86% ranked long lasting results up to six months in their top three.11“Relfydess represents a breakthrough in neuromodulation, the first in decades. As a clinician, I have seen patients increasingly seek treatments that fit seamlessly into their lifestyles, delivering both rapid onset and long-lasting results. With its ready-to-use liquid formulation requiring no reconstitution, Relfydess also offers a new level of convenience and innovation. I am delighted to bring this treatment to aesthetic patients in China and help usher in a new era in neuromodulation.”PROF. WU YANCHIEF PHYSICIAN OF DERMATOLOGY DEPARTMENTPEKING UNIVERSITY FIRST HOSPITAL, CHINA The Chinese NMPA approval is based on data from a local phase III study conducted in China, as well as the global READY (RElabotulinumtoxin Aesthetic Development studY) clinical trials, with more than 2,300 participants.3-7 Across trials, Relfydess demonstrated:This advertisement has not loaded yet, but your article continues below.Significant improvements in frown lines, with a composite ≥2-grade improvement responder rate* at Month 1 of 82.9% in READY-1 and 72.4% in the China study vs. 0% and 1.6% for placebo, respectively3,4Rapid onset of action, with 39% of patients reporting improvements in frown lines from day one (READY-1)4Sustained results lasting through six months in up to 75% of patients, not returning to baseline severity (READY-1)4Favorable safety profile, with a low incidence of treatment-related adverse events that were predominantly local or expected effects, such as injection-site reactions, headache, and eyelid ptosis3-7*A composite responder was defined as a subject with a glabellar line severity score of 0 or 1 and an improvement of at least 2 grades from baseline on both the glabellar line investigator live assessment and glabellar line subject live assessment.Relfydess is developed and manufactured at Galderma’s Aesthetic Center of Excellence in Uppsala, Sweden, a world-class facility that reflects the company’s longstanding expertise in product development, manufacturing excellence, and commitment to quality.“The approval of Relfydess in China marks a significant milestone for Galderma and reinforces our commitment to bringing differentiated, science-based innovations to patients and healthcare professionals worldwide. With approvals in more than 35 markets globally, Relfydess continues to build strong momentum, and we are excited to now bring it to patients in China, one of the world’s biggest and most dynamic aesthetics markets.”FLEMMING ØRNSKOV, M.D., MPHCHIEF EXECUTIVE OFFICERGALDERMAWith Relfydess’ approval in China, Galderma expands its footprint and further strengthens its Injectable Aesthetics leadership within the fast-growing Asia-Pacific market.8,9 This milestone reinforces Galderma’s long-term growth strategy and commitment to delivering scientifically proven innovation, representing another important step forward in Galderma’s ambition to make Relfydess available to even more patients globally, following its authorizations in more than 35 markets, including the European Union, the United Kingdom, and Australia.About Relfydess (relabotulinumtoxinA)Pioneered by Galderma, Relfydess is the first and only ready-to-use liquid neuromodulator created with PEARL Technology that is designed to preserve molecule integrity.1,2 PEARL Technology is designed to deliver a highly active, innovative, complex-free molecule, creating a product that enables up to 39% of patients seeing effects from day one, and up to 75% of patients maintaining improvements for six months, based on four phase III studies from the READY clinical trial program.1,2,4-7 Relfydess is optimized for simple volumetric dosing, without reconstitution, to increase ease-of-use and help ensure consistent dose/volume every time.1,10 Relfydess was entirely created and manufactured by Galderma to expand its neuromodulator portfolio as part of the broadest Injectable Aesthetics portfolio on the market. Relfydess has received marketing authorization in numerous markets. Authorization conditions may vary internationally.This advertisement has not loaded yet.This advertisement has not loaded yet, but your article continues below.Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.Sundberg AL and Stahl U. Relabotulinum toxin – a novel, high purity BoNT-A1 in liquid formulation. Presented at: TOXINS 2021; Jan 16-17, 2021; virtual meeting.Do M, et al. Purification process of a complex-free highly purified botulinum neurotoxin type A1 (BoNT-A1) – relabotulinumtoxinA. Presented at: TOXINS 2022; July 27-30, 2022; New Orleans, LA.Galderma. Data on File. China RelabotulinumtoxinA study. 43QMCH1908.Shridharani SM, et al. Efficacy and safety of RelabotulinumtoxinA, a new ready-to-use liquid formulation botulinum toxin: Results from the READY-1 double-blind, randomized, placebo-controlled phase 3 trial in glabellar lines. Aesthet Surg J. 2024;44(12):1330-1340. doi: 10.1093/asj/sjae131.Ablon G, et al. Treatment of lateral canthal lines with RelabotulinumtoxinA, an investigational liquid botulinum toxin: clinical efficacy and safety results from the READY-2 phase 3 trial. Toxicon. 2024;237(1):107353. doi: 10.1026/j.toxicon.2024.107353.Galderma. Data on file. Clinical Study Report for Protocol 43QM1902: READY-3. Galderma Laboratories; 2021.Galderma. Data on file. Clinical Study Report for Protocol 43AM1903: READY-4. Galderma Laboratories; 2021.Deloitte. China Aesthetic Medicine Outlook Report. Accessed October 2026. Available online.Grand View Horizon. China Aesthetic Medicine Market Size & Outlook, 2026-2033. Accessed October 2026. Available online.Persson C, et al. Patient and Investigator Treatment Experience with Ready-to-Use AbobotulinumtoxinA Solution Versus Powder BotulinumtoxinA for Treatment of Glabellar Lines. Presented at: TOXINS 2024; Jan 17-20, 2024, Berlin.Galderma. Data on File. Anti-wrinkle Treatment Aesthetic Future Survey.This advertisement has not loaded yet, but your article continues below.View source version on businesswire.com: Christian Marcoux, M.Sc. Chief Communications Officer christian.marcoux@galderma.com +41 76 315 26 50Richard Harbinson Corporate Communications Director richard.harbinson@galderma.com +41 76 210 60 62Céline Buguet Franchises and R&D Communications Director celine.buguet@galderma.com +41 76 249 90 87Emil Ivanov Head of Strategy, Investor Relations, and ESG emil.ivanov@galderma.com +41 21 642 78 12Jessica Cohen Investor Relations and Strategy Director jessica.cohen@galderma.com +41 21 642 76 43This advertisement has not loaded yet.Notice for the Postmedia NetworkThis website uses cookies to personalize your content (including ads), and allows us to analyze our traffic. Read more about cookies here. By continuing to use our site, you agree to our Terms of Use and Privacy Policy.