Hyphens Pharma Launches Winlevi® In Singapore And Malaysia, Expanding Acne Treatment Options In Southeast Asia

Hyphens Pharma Pte. Ltd., a subsidiary of Hyphens Pharma International Limited, has announced the official launch of Winlevi® (clascoterone) cream 1% in Singapore and Malaysia, marking the product’s debut in Southeast Asia. The launch is part of an exclusive licensing and supply agreement with Italy-based Cassiopea S.p.A., a subsidiary of Cosmo Pharmaceuticals, covering Winlevi and its future innovations in 10 Southeast Asian countries.

Giovanni Di Napoli, CEO of Cosmo, said, "The launch of Winlevi in Southeast Asia represents an important milestone in its global expansion. Together with Hyphens, we are bringing a truly differentiated dermatology innovation to a region where demand for advanced acne care is growing rapidly. This partnership reflects our shared commitment to addressing unmet needs and delivering meaningful impact for patients across Asia."

Winlevi represents the first new class of acne treatment in over four decades. Its novel mechanism targets the androgen receptor pathway in the skin, reducing sebum production and inflammation without systemic anti-androgenic effects. The topical treatment is suitable for both male and female acne patients and is now available by prescription through clinics and hospitals in Singapore and Malaysia, with plans for expansion across Southeast Asia.

Mr Lim See Wah, Executive Chairman and CEO of Hyphens Pharma, said, "We're proud to be the first to introduce Winlevi to Southeast Asia. Acne affects millions in the region, yet for decades, patients have had limited treatment options. This launch marks a significant advancement in acne care, our dermatology portfolio and partnership with Cosmo. We appreciate their trust in us to bring this transformative treatment to the region. Acne isn't just skin-deep it can impact psychosocial well-being. By expanding access to Winlevi, we aim to support doctors in their practice and empower patients to manage acne with greater confidence, improving their quality of life." Winlevi is currently approved and launched in Canada, the U.S., the U.K., Australia, New Zealand and Jordan. Since its initial launch in the U.S. in 2021, Winlevis has become the most prescribed branded topical acne treatment in the country with over 1.3 million prescriptions from more than 17,900 healthcare providers as of 2024.

The launch significantly bolsters Hyphens Pharma’s dermatology portfolio—one of its core focus areas, which already includes therapies for atopic dermatitis, pigmentation, hair loss, and acne. To support regional integration, Hyphens has convened an Advisory Board of 12 leading dermatologists from Singapore, Malaysia, the Philippines, and the U.S. to guide clinical adoption and best practices.