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Regulatory

Galderma's Relfydess Approved in China for Frown Lines

China's NMPA has approved Relfydess, a ready-to-use liquid neuromodulator, for moderate-to-severe glabellar lines, marking Galderma's entry into one of the world's largest aesthetics markets.

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Primary document: Galderma’s Relfydess™ (relabotulinumtoxinA) Receives Approval in China for Frown Lines · Published: 2026-10-23

China's National Medical Products Administration (NMPA) has approved Relfydess, Galderma's ready-to-use liquid neuromodulator, for the temporary smoothing of moderate-to-severe frown lines in adults, according to the company's announcement. The approval, announced October 23, 2026, expands Relfydess to more than 35 markets worldwide and marks a significant entry into what Galderma describes as one of the world's largest and fastest-growing aesthetics markets.

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Thirty-nine percent of patients in READY-1 reported improvements by day one, and up to 75% maintained improvements through six months.

Relfydess is formulated as a ready-to-use liquid—no mixing required—and uses what Galderma calls PEARL Technology, designed to preserve molecule integrity without additives. The company manufactures it at its Aesthetic Center of Excellence in Uppsala, Sweden. The product is optimized for simple volumetric dosing to increase ease-of-use and help ensure consistent dose and volume every time.

The NMPA approval rests on data from a local phase III trial conducted in China plus the global READY clinical trial program, which enrolled more than 2,300 participants across four studies. In the China study, 72.4% of patients achieved a composite responder outcome—defined as a glabellar line severity score of 0 or 1 with at least 2-grade improvement from baseline on both investigator and patient assessments—at month one, compared to 1.6% for placebo. The READY-1 trial showed 82.9% responder rate versus 0% for placebo.

Onset matters in this market. Thirty-nine percent of patients in READY-1 reported improvements by day one. Up to 75% of patients maintained improvements through six months without returning to baseline severity. Adverse events were predominantly local—injection-site reactions, headache, eyelid ptosis—with low rates overall. The safety profile was favorable across all trials, with adverse events described as predominantly local or expected effects.

Galderma's own survey data on Chinese patients signals demand. Ninety-seven percent of surveyed patients said they plan to maintain or increase their use of anti-wrinkle treatments. Eighty-eight percent ranked natural-looking results in their top three treatment benefits; 86% ranked results lasting up to six months in their top three. These figures come from Galderma's Anti-wrinkle Treatment Aesthetic Future Survey, conducted in China.

The approval matters because China's aesthetics market is expanding fast, and neuromodulators are a core category. Relfydess now competes in a market where practitioners need products that deliver speed, longevity, and ease of administration. The ready-to-use format eliminates mixing steps, reducing prep time and potential for dosing errors—a practical advantage in high-volume practices.

Galderma (SIX: GALD) is a Swiss dermatology company present in approximately 90 countries. The company positions Relfydess as the first and only ready-to-use liquid neuromodulator with PEARL Technology, setting it apart from powder formulations that require mixing. Relfydess was entirely created and manufactured by Galderma to expand its neuromodulator portfolio as part of what the company calls the broadest Injectable Aesthetics portfolio on the market.

The company has already secured authorizations in numerous markets. Authorization conditions may vary internationally. In addition to China, Relfydess has received marketing authorization in the European Union, the United Kingdom, and Australia, among other regions. The approval in China represents another step in what Galderma describes as its long-term growth strategy to make Relfydess available to even more patients globally.

Whether that advantage translates to market share in China depends on pricing, distribution, and how quickly practitioners adopt the product. The document does not disclose pricing or launch timeline details for China.

Business information, not medical or legal advice. Verify regulatory status at FDA.gov.

Source: original report ↗

Business information, not medical or legal advice. Verify product status at FDA.gov.

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