Galderma Wins China Approval for Relfydess After 72.4% Response Rate
Key Facts
Galderma said on October 23, 2026, that China’s National Medical Products Administration had approved Relfydess for the temporary improvement of moderate to severe frown lines in adults. The decision gives the company a new regulatory approval in China, in the injectable aesthetics category. The company says the approval is based on a local Phase III study conducted in China, alongside global READY trials that included more than 2,300 participants. The approval dossier thus combines data from Chinese patients with results from an international clinical program. The decision comes as the company records growth in its injectable aesthetics and neurotoxin business.
In the Chinese study, the composite response rate for improvement of two or more grades in the lines was 72.4% one month after treatment, compared with 1.6% for placebo. In the READY-1 trial, the rate reached 82.9%, while the placebo group recorded 0%. These results compare the drug with placebo at two points in the clinical program, one in China and the other in the global trials. The company also said that 39% of patients in READY-1 noticed an improvement in frown lines from Day 1. Results lasted up to six months in as many as 75% of patients, with line severity not returning to baseline, according to the trial data.
Relfydess is offered as a ready-to-use liquid that does not require reconstitution, a feature that Professor Wu Yan, chief physician in the Department of Dermatology at Peking University First Hospital, said offers added convenience. Wu said he was excited to make the product available to patients in China, noting that its ready-to-use liquid formulation does not require reconstitution. Galderma said the drug had been approved in more than 35 markets worldwide at the time of the China approval announcement. The decision thus expands its regulatory presence to China, following its rollout in dozens of other markets. The company also reported results from a survey it conducted in China on patient preferences for wrinkle treatments.
Galderma said 97% of participants in its China survey intend to maintain or increase their use of wrinkle treatments in the future. Some 88% of participants selected natural-looking results among the top three benefits of treatment, while 86% included long-lasting results, lasting up to six months, among the top three benefits. These preferences come as the company recorded record net sales of $4.765 billion in the first nine months of 2026, up 25.1% year over year at constant currency. The company attributed the growth mainly to higher volume, with a favorable product mix also contributing. Sales in the injectable aesthetics category totaled $2,174 million, up 13.2% year over year at constant currency over the same period.
Within the injectable aesthetics category, neurotoxin sales reached $1,259 million in the first nine months of 2026, up 16.9% year over year at constant currency. Galderma raised its 2026 net sales growth outlook to a range of 22.5–23.5% at constant currency, compared with its previous forecast of 19% to 21%. The company meanwhile reaffirmed its outlook for an underlying EBITDA margin of around 26%. The figures reflect sales expansion and growth in the category to which Relfydess belongs, as the company sets its updated financial targets for the current year. Galderma aims to resubmit a biologics license application for the active ingredient relabotulinumtoxinA to the U.S. Food and Drug Administration in the first quarter of 2027, after receiving a complete response letter in June 2026, subject to additional regulatory comments.