Dermatology company Galderma (SIX:GALD) said on Friday that it has received approval from China's National Medical Products Administration for Relfydess (relabotulinumtoxinA) to temporarily improve moderate-to-severe frown lines in adults, expanding its injectable aesthetics portfolio in a key growth market.
The ready-to-use liquid neuromodulator, developed using PEARL Technology, is designed to simplify administration by eliminating reconstitution and supporting consistent dosing.
The approval is supported by a Phase III clinical trial conducted in China and global READY trials involving more than 2,300 participants, with results demonstrating significant wrinkle reduction, onset of improvement as early as day one and effects lasting up to six months in some patients.
In the READY-1 trial, 82.9% of participants achieved a composite improvement of at least two grades in frown lines at one month, compared with 0% receiving placebo; the corresponding response rate in the China study was 72.4%, versus 1.6% for placebo.
Relfydess demonstrated a favourable safety profile, with treatment-related adverse events occurring infrequently and predominantly involving local or expected effects, including injection-site reactions, headache and eyelid ptosis.
Already authorised in more than 35 markets worldwide, Relfydess' entry into China further strengthens Galderma's presence in the Asia-Pacific region and supports its strategy to expand global access to its injectable aesthetics products.
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