Hyundai Pharm to sell Cosmo product approved in South Korea

Cosmo Pharmaceuticals announced on Oct. 7 that South Korea’s Ministry of Food and Drug Safety (MFDS) has approved Winlevi (clascoterone) cream 1% for the treatment of acne vulgaris in patients aged twelve and older.

Cosmo noted that the approval marked a significant milestone in the company’s worldwide dermatology expansion and reinforces its commitment to delivering innovative, patient-centered therapies.

Winlevi represents the first new topical acne treatment in more than four decades with a completely novel mechanism of action, according to Cosmo.

Its active ingredient, clascoterone, is the world’s first commercially available topical androgen-receptor inhibitor.

The compound acts locally within the sebaceous glands to reduce sebum production and inflammation, without inducing systemic hormonal side effects, thus making it safe and effective for both male and female patients, the firm said.

Under a June 2023 license agreement, Hyundai Pharm holds the exclusive rights to register and commercialize Winlevi in South Korea, while Cosmo serves as the exclusive product supplier.

This strategic partnership combines Cosmo’s proprietary science and global manufacturing capabilities with Hyundai Pharm’s local dermatology expertise, ensuring broader patient access to cutting-edge acne therapies across the region.

“Approval of Winlevi in South Korea is a meaningful milestone in our global dermatology expansion and a clear demonstration of our commitment to the Cosmo 2030 Vision,” Cosmo CEO Giovanni Di Napoli said.

“By bringing innovative, differentiated therapies to new markets, we’re strengthening our global footprint while improving quality of care for patients.”

He added that Winlevi’s novel mechanism and strong safety profile would make it a valuable addition to acne management for dermatologists and patients in South Korea.

Winlevi is now approved in 10 countries, including the United States, Canada, Australia, the United Kingdom, New Zealand, Jordan, Singapore, Malaysia, and Mexico, on top of Korea, Cosmo said.

Founded in 1997, Cosmo is a life sciences company specializing in MedTech AI, dermatology, gastrointestinal diseases, and contract development and manufacturing.