Cosmo Announces Launch of Winlevi(R) for Treatment of Acne in Singapore and Malaysia
Cosmo Pharmaceuticals (OTC:CMOPF) has launched Winlevi庐 (clascoterone) cream 1% in Singapore and Malaysia through its partnership with Hyphens Pharma, marking its first entry into Southeast Asia. Winlevi庐 is the first topical androgen receptor inhibitor for acne treatment in over 40 years, approved for patients aged 12 and older.
The treatment demonstrated superior efficacy in two Phase III studies, showing significant improvements in both non-inflammatory and inflammatory lesion counts. Hyphens Pharma has in-licensed the product for distribution across ten Southeast Asian countries, with progressive rollout planned for other markets in the region.
This launch aligns with Cosmo's 2030 vision for sustainable revenue growth through geographic expansion, addressing a market where acne affects over 90% of the population at some point in their lives.
Cosmo Pharmaceuticals (OTC:CMOPF) ha lanciato la crema Winlevi庐 (clascoterone) 1% a Singapore e in Malesia grazie alla collaborazione con Hyphens Pharma, segnando il suo primo ingresso nel Sud-est asiatico. Winlevi庐 猫 il primo inibitore topico del recettore degli androgeni per il trattamento dell'acne in oltre 40 anni, approvato per pazienti dai 12 anni in su.
Il trattamento ha dimostrato un'efficacia superiore in due studi di Fase III, evidenziando miglioramenti significativi sia nelle lesioni non infiammatorie che in quelle infiammatorie. Hyphens Pharma ha acquisito la licenza per la distribuzione del prodotto in dieci paesi del Sud-est asiatico, con un piano di espansione progressiva verso altri mercati della regione.
Questo lancio 猫 in linea con la visione 2030 di Cosmo per una crescita sostenibile dei ricavi tramite l'espansione geografica, affrontando un mercato in cui l'acne colpisce oltre il 90% della popolazione almeno una volta nella vita.
Cosmo Pharmaceuticals (OTC:CMOPF) ha lanzado la crema Winlevi庐 (clascoterona) al 1% en Singapur y Malasia a trav茅s de su alianza con Hyphens Pharma, marcando su primera entrada en el sudeste asi谩tico. Winlevi庐 es el primer inhibidor t贸pico del receptor de andr贸genos para el tratamiento del acn茅 en m谩s de 40 a帽os, aprobado para pacientes de 12 a帽os en adelante.
El tratamiento mostr贸 una eficacia superior en dos estudios de Fase III, con mejoras significativas tanto en lesiones no inflamatorias como inflamatorias. Hyphens Pharma ha obtenido la licencia para distribuir el producto en diez pa铆ses del sudeste asi谩tico, con un despliegue progresivo planeado para otros mercados de la regi贸n.
Este lanzamiento est谩 alineado con la visi贸n 2030 de Cosmo para un crecimiento sostenible de ingresos mediante la expansi贸n geogr谩fica, abordando un mercado donde el acn茅 afecta a m谩s del 90% de la poblaci贸n en alg煤n momento de su vida.
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Cosmo Pharmaceuticals (OTC:CMOPF) a lanc茅 la cr猫me Winlevi庐 (clascot茅rone) 1 % 脿 Singapour et en Malaisie gr芒ce 脿 son partenariat avec Hyphens Pharma, marquant ainsi sa premi猫re entr茅e en Asie du Sud-Est. Winlevi庐 est le premier inhibiteur topique des r茅cepteurs androg猫nes pour le traitement de l'acn茅 depuis plus de 40 ans, approuv茅 pour les patients de 12 ans et plus.
Le traitement a d茅montr茅 une efficacit茅 sup茅rieure dans deux 茅tudes de phase III, montrant des am茅liorations significatives tant sur les l茅sions non inflammatoires qu'inflammatoires. Hyphens Pharma a obtenu la licence pour la distribution du produit dans dix pays d'Asie du Sud-Est, avec un d茅ploiement progressif pr茅vu dans d'autres march茅s de la r茅gion.
Ce lancement s'inscrit dans la vision 2030 de Cosmo pour une croissance durable des revenus gr芒ce 脿 l'expansion g茅ographique, ciblant un march茅 o霉 l'acn茅 touche plus de 90 % de la population 脿 un moment donn茅 de leur vie.
Cosmo Pharmaceuticals (OTC:CMOPF) hat die Winlevi庐 (Clascoteron) Creme 1% in Singapur und Malaysia 眉ber eine Partnerschaft mit Hyphens Pharma eingef眉hrt und damit seinen ersten Eintritt in S眉dostasien markiert. Winlevi庐 ist der erste topische Androgenrezeptor-Inhibitor zur Aknebehandlung seit 眉ber 40 Jahren, zugelassen f眉r Patienten ab 12 Jahren.
Die Behandlung zeigte in zwei Phase-III-Studien eine 眉berlegene Wirksamkeit mit signifikanten Verbesserungen sowohl bei nicht-entz眉ndlichen als auch entz眉ndlichen L盲sionen. Hyphens Pharma hat die Lizenz f眉r den Vertrieb in zehn s眉dostasiatischen L盲ndern erworben, mit einem schrittweisen Rollout in weiteren M盲rkten der Region geplant.
Dieser Launch entspricht Cosmos Vision 2030 f眉r nachhaltiges Umsatzwachstum durch geografische Expansion und adressiert einen Markt, in dem Akne 眉ber 90 % der Bev枚lkerung irgendwann im Leben betrifft.
- First-in-class topical acne treatment launched in 40 years with novel mechanism of action
- Successful Phase III clinical trials demonstrating superior efficacy versus vehicle cream
- Geographic expansion into 10 Southeast Asian markets through strategic partnership
- Addresses large market opportunity with 90% of population affected by acne
- Progressive rollout to other Southeast Asian markets still pending regulatory approvals
Dublin, Ireland--(Newsfile Corp. - July 17, 2025) - Cosmo Pharmaceuticals N.V. (SIX: COPN), a global leader in AI-driven healthcare and specialty pharmaceuticals, is pleased to announce the launch of Winlevi® (clascoterone) cream
Winlevi® is the first topical acne treatment in over 40 years with a first-in-class mechanism of action. Its active ingredient, clascoterone, is the first commercially available topical androgen receptor inhibitor acting directly in the sebaceous glands with no systemic anti-androgen effects; as such, it can be used safely in both males and females. This approach is believed to help reduce sebum production and intervene early in acne pathogenesis. Two identical Phase III studies demonstrated that clascoterone cream
As part of the agreement signed in December 2022, Hyphens Pharma has in-licensed the product from Cosmo Pharmaceuticals for distribution across ten Southeast Asian countries (Singapore, Malaysia, Indonesia, Philippines, Vietnam, Thailand, Brunei, Cambodia, Laos and Myanmar), bringing this innovative therapy first to Singapore and Malaysia markets. Registration in other Southeast Asian markets is currently underway, with a progressive rollout planned across the region in due course. This collaboration underscores the dedication of Cosmo and Hyphens Pharma to expanding its dermatology portfolio and addressing the unmet needs of patients with acne vulgaris, a condition that affects millions of individuals worldwide and can cause both physical discomfort and psychological distress.
Giovanni Di Napoli, Chief Executive Officer of Cosmo, commented: “The launch of Winlevi® in Southeast Asia is an important step in our ongoing global expansion and directly supports our 2030 vision of driving sustainable revenue growth through strategic geographic expansion. Together with Hyphens Pharma, we are bringing a truly differentiated dermatology innovation to a rapidly growing market with increasing demand for advanced acne care. This partnership demonstrates tangible progress in executing our long-term growth strategy and underscores our shared commitment to addressing unmet medical needs while delivering meaningful impact for patients across Asia.”
Lim See Wah (林世华), Executive Chairman and CEO of Hyphens Pharma, added: “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.”
Acne vulgaris is one of the most common skin conditions, impacting more than
About Hyphens Pharma International Limited
Hyphens Pharma International Limited and its subsidiaries (the "Group") is Singapore’s leading specialty pharmaceutical and consumer healthcare group, leveraging its diverse footprint in ASEAN countries. The Group has a direct presence in Singapore, Vietnam, Malaysia, Indonesia and the Philippines, and is supplemented by a marketing and distribution network covering 15 other markets – Bangladesh, Brunei, Cambodia, Hong Kong S.A.R., Macau S.A.R., Myanmar, South Korea, Sri Lanka, Thailand and Gulf Cooperation Council countries, including Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and United Arab Emirates. The Group is headquartered in Singapore, where its strategic planning, finance, regulatory affairs, research and development, legal, business development and logistics operations are based. The Group’s core business comprises the following segments: Specialty Pharma Principals, Proprietary Brands, and Medical Hypermart & Digital. Besides marketing and selling a range of specialty pharmaceutical products in selected ASEAN countries through exclusive distributorship or licensing and supply agreements with brand principals mainly from Europe and the United States, the Group also develops, markets and sells its own proprietary range of dermatological products and health supplement products. In addition, the Group operates a medical hypermart for healthcare professionals, healthcare institutions and retail pharmacies, to supply pharmaceutical products and medical supplies and an online pharmacy for doctors to prescribe and have medications delivered to their patients’ homes. For more information, visit .
About Cosmo
Cosmo is a life sciences company focused on MedTech AI, dermatology, gastrointestinal diseases, and contract development and manufacturing (CDMO). We design, develop, and manufacture advanced solutions that address critical medical needs and raise the standard of care. Our technologies are trusted by leading global pharmaceutical and MedTech companies and reach patients and healthcare providers around the world. Guided by our purpose - Building Health Confidence - our mission is to empower patients, healthcare professionals, and partners by innovating at the intersection of science and technology. Founded in 1997, Cosmo is headquartered in Dublin, Ireland, with offices in San Diego (USA), and in Lainate, Rome, and Catania (Italy).
For more information, visit .
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FAQ
What is Winlevi and how does it work for acne treatment?
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In which Southeast Asian countries will Winlevi be available?
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Who is distributing Winlevi in Southeast Asia?
