Galderma’s Relfydess™ (relabotulinumtoxinA) Receives Approval in China for Frown Lines
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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 adults1,2 -
The 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 patients3-7 -
This 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 worldwide
Relfydess 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
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“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 |
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PROF. |
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CHIEF PHYSICIAN OF DERMATOLOGY DEPARTMENT |
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PEKING UNIVERSITY FIRST HOSPITAL, |
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The Chinese NMPA approval is based on data from a local phase III study conducted in
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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, respectively3,4 - Rapid onset of action, with 39% of patients reporting improvements in frown lines from day one (READY-1)4
- Sustained results lasting through six months in up to 75% of patients, not returning to baseline severity (READY-1)4
- Favorable 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
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“The approval of Relfydess in |
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FLEMMING ØRNSKOV, M.D., MPH |
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CHIEF EXECUTIVE OFFICER |
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GALDERMA |
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With Relfydess’ approval in
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.
About Galderma
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.
References
- 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.
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For further information:
Christian Marcoux, M.Sc.
Chief Communications Officer
christian.marcoux@galderma.com
+41 76 315 26 50
Richard Harbinson
Corporate Communications Director
richard.harbinson@galderma.com
+41 76 210 60 62
Céline Buguet
Franchises and R&D Communications Director
celine.buguet@galderma.com
+41 76 249 90 87
Emil Ivanov
Head of Strategy, Investor Relations, and ESG
emil.ivanov@galderma.com
+41 21 642 78 12
Jessica Cohen
Investor Relations and Strategy Director
jessica.cohen@galderma.com
+41 21 642 76 43
Source: Galderma