China's NMPA grants approval nearly 4 years after IND filing; commercialization targeted for Q1 2027

Inibo follows Hugel and Huons Biopharma as third Korean toxin to enter Chinese market

GC WellBeing aesthetic synergy eyed as China market set to triple by 2030

Botulinum toxin. [Getty Images Bank]
Botulinum toxin. [Getty Images Bank]

Inibio, an affiliate of GC WellBeing, has secured Chinese regulatory approval for its botulinum toxin product Inibo, clearing a major hurdle in one of the world's fastest-growing medical aesthetics markets.

The approval makes Inibo the third product from a Korean company to receive the green light in China, following Hugel's Letybo and Huons Biopharma's Hutox, and gives Inibio a foothold in the rapidly expanding Chinese medical aesthetics market.

China's National Medical Products Administration granted marketing approval for Inibo, Inibio's proprietary type-A botulinum toxin formulation. The product is now the ninth botulinum toxin drug approved in China overall, and the third domestically manufactured Korean botulinum toxin to enter the Chinese market.

Inibio filed an investigational new drug application in China in January 2023 and completed the approval process — including local clinical trials and a marketing authorization review — in approximately three years and nine months.

China is the world's second-largest botulinum toxin market after the United States. Market research firm Frost & Sullivan projects the Chinese botulinum toxin market will grow from about 12.6 billion yuan ($1.89 billion) in 2025 to roughly 39 billion yuan by 2030, more than tripling over five years. Analysts attribute the growth to rising demand for medical aesthetic procedures and the mainstreaming of botulinum toxin treatments among Chinese consumers.

Inibo was developed using strains with clearly documented origins and Inibio's own manufacturing and quality-control systems. The company accumulated safety and efficacy data through regulatory-purpose clinical trials conducted in both South Korea and China. Inibio plans to build a distribution network centered on major medical aesthetic institutions by leveraging its local partner's industry expertise and hospital network, with commercialization targeted for the first quarter of 2027.

The Chinese approval is also expected to benefit GC WellBeing, which holds a 21.35 percent stake in Inibio, by supporting the expansion of its medical aesthetics business. GC WellBeing has been broadening its medical aesthetics portfolio to include botulinum toxin, fillers and extracellular matrix skin boosters.

Inibio is also pursuing marketing approval for Inibo in Brazil. The company plans to expand its global business footprint through entry into major overseas markets including China and Brazil, while strengthening synergies across its aesthetics lineup of toxins, fillers and skin boosters.

"The NMPA approval is a critical turning point that allows us to enter the rapidly growing Chinese botulinum toxin market in earnest," an Inibio official said. "We will work closely with our local partner to ensure commercialization proceeds on schedule in the first quarter of 2027, and we will accelerate our global expansion through entry into major overseas markets including Brazil and through synergies with GC WellBeing's medical aesthetics portfolio."


silverpaper@heraldcorp.com