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Media Release

Hyphens Pharma introduces novel acne treatment, Winlevi®, to Singapore and Malaysia

  • Available for the first time in Southeast Asia, Winlevi® is a novel topical acne treatment with a
    unique mechanism of action.

  • This launch reinforces Hyphens Pharma’s strategic expansion in the dermatology space.

  • Registration is underway in other Southeast Asian markets, with rollout to follow
    progressively.

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Singapore, 17 July 2025 – Hyphens Pharma Pte. Ltd., a subsidiary of Hyphens Pharma International Limited, Singapore’s leading specialty pharmaceutical and consumer healthcare group (“Hyphens Pharma”, “凯帆药剂国际有限公司”, or the “Company”, and its subsidiaries, the “Group”), is pleased to announce the launch of Winlevi® (clascoterone) cream 1% in Singapore and Malaysia – marking its first entry into Southeast Asia.

This launch is made possible through an exclusive license and supply agreement (the “Agreement”) with Cassiopea S.p.A., a subsidiary of Cosmo Pharmaceuticals N.V. (SIX: COPN, XETRA: C43) (“Cosmo”). The Agreement covers Winlevi® and its future product extensions and improvements across 10 Southeast Asian countries (Singapore, Malaysia, Indonesia, Philippines, Vietnam, Thailand, Brunei, Cambodia, Laos and Myanmar).

Winlevi® is the first new class of molecule in acne treatment in over 40 years, acting through a novel mechanism of action that targets the androgen sebum pathway directly within the skin. Its active ingredient, clascoterone, is the first commercially available topical androgen receptor inhibitor for acne, reducing sebum production and inflammation without causing systemic anti-androgen side effects. This makes it a safe choice for both male and female patients with acne.

With the addition of Winlevi®, Hyphens Pharma strategically advances its dermatology portfolio, one of its core therapeutic focus areas. The Company’s proprietary dermatology portfolio currently includes treatments for acne, atopic dermatitis, hyperpigmentation, and hair loss, distributed through dermatologists, paediatricians, general practitioners and major retail pharmacies across Southeast Asia.

Winlevi® officially launched in Singapore and Malaysia in July 2025 and will be available via prescription through clinics and hospitals. Registration in other Southeast Asian markets is currently underway, with a progressive rollout planned across the region in due course. To support this initiative, Hyphens Pharma has convened a multinational Advisory Board of 12 leading dermatologists from Singapore, Malaysia, the Philippines, and the U.S. to contribute medical insights and facilitate the integration of Winlevi® into clinical practice.

Giovanni Di Napoli, CEO of Cosmo, commented: “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.”

Mr 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.”
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, Winlevi® 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.

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About Hyphens Pharma International Limited                 (www.hyphensgroup.com)

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, the Group also develops, markets and sells its own proprietary range of dermatological products and health supplement products. Additionally, the Group operates a medical hypermart catering to healthcare providers and retail pharmacies, as well as an e-pharmacy that allows doctors to prescribe medications for home delivery to their patients.

About Cosmo                (www.cosmohealthconfidence.com)

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).

Issued on behalf of : Hyphens Pharma International Limited
For media enquires contact : Ms Chong Yi Sze / Ms Karina Choo / Mr Gerald Woon
Email / DID / Mobile : [email protected] / (65) 9729 6694
[email protected] / (65) 6704 9280 / (65) 9107 6991 [email protected] / (65) 6704 9268 / (65) 9694 8364

This media release has been reviewed by the Company’s sponsor, SAC Capital Private Limited (the “Sponsor”). It has not been examined or approved by the Singapore Exchange Securities Trading Limited (the “SGX-ST”) and the SGX-ST assumes no responsibility for the contents of this media release, including the correctness of any of the statements or opinions made or reports contained in this media release.

The contact person for the Sponsor is Ms Lee Khai Yinn (Tel: (65) 6232 3210) at 1 Robinson Road, #21- 00 AIA Tower, Singapore 048542.