ZUG, Switzerland--(BUSINESS WIRE)-- 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. This approval follows successful authorizations and launches of Relfydess 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. It is optimized for simple volumetric dosing, without reconstitution, to increase ease-of-use and help ensure consistent dose/volume every time.
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. 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. 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.
“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 YAN
CHIEF PHYSICIAN OF DERMATOLOGY DEPARTMENT
PEKING 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. Across trials, Relfydess demonstrated:
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, respectively
Rapid onset of action, with 39% of patients reporting improvements in frown lines from day one (READY-1)
Sustained results lasting through six months in up to 75% of patients, not returning to baseline severity (READY-1)
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 ptosis
*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., MPH
CHIEF EXECUTIVE OFFICER
GALDERMA
With Relfydess’ approval in China, Galderma expands its footprint and further strengthens its Injectable Aesthetics leadership within the fast-growing Asia-Pacific market. 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.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. Relfydess is optimized for simple volumetric dosing, without reconstitution, to increase ease-of-use and help ensure consistent dose/volume every time.
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.
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