CMS: Rxilient Obtained Commercialization Rights for Dermatology Improved New Drug Finjuve and Branded Drug Ciclopoli in Southeast Asia and Other Markets

Date:
2026-07-27
Category:
Company News
  • Finjuve, animproved new drug, is the first and only topical finasteride product worldwide approved for the treatment of androgenetic alopecia. Its efficacy is comparable to oral finasteride, while showing 100-fold lower systemic exposure and less impact on serum DHT levels compared with oral finasteride, offering an effective hair-loss treatment option with lower risk.
  • Ciclopoli, a branded drug, uses patented HPCH water-soluble transungual technology. It does not require nail filing or organic solvents to remove the film, combining strong efficacy, safety, and convenience, and offering a superior topical treatment option for onychomycosis patients.
  • Leveraging itsestablished registration and commercialization capabilities across Southeast Asia, Rxilient will accelerate the launch of both products, injecting new momentum into business growth in the region.

 

Recently, the Southeast Asia business subsidiary of China Medical System (“CMS”), Rxilient Medical Pte. Ltd. (“Rxilient”), entered into a partnership with Polichem S.A., a subsidiary of Almirall S.A. (ALM), a global biopharmaceutical company focused on medical dermatology. Rxilient obtained exclusive commercialization rights for two dermatology products in Southeast Asia and other markets: Finjuve (topical finasteride spray), an improved new drug, and Ciclopoli (ciclopirox medicated nail lacquer), a branded drug.

Under these agreements, Rxilient has obtained the exclusive distribution rights to commercialize Ciclopoli in the Hong Kong SAR, Macao SAR, Taiwan region, and 11 Southeast Asian countries. Rxilient has also obtained the exclusive commercialization rights to commercialize Finjuve in Singapore, Malaysia, the Philippines, Thailand, and Indonesia.

This collaboration further enriches Rxilient’s dermatology portfolio and will strengthen its professional capabilities and market position in the dermatology field. Leveraging its mature regulatory and registration capabilities, well-established commercialization infrastructure, and extensive network of medical specialists across Southeast Asia and other emerging markets, Rxilient will accelerate registration and market introduction of the two new products and fully unlock operational synergies. Meanwhile, Finjuve has been approved for marketing in Singapore and Malaysia in 2025, becoming the first and only topical finasteride product approved locally for the treatment of androgenetic alopecia, and is expected to rapidly drive revenue growth in the Southeast Asia business.

 

Finjuve: The first and only topical finasteride approved worldwide for androgenetic alopecia

Finjuve is a prescription topical finasteride formulation for the treatment of androgenetic alopecia in adult men, particularly those with mild to moderate disease. Previously, Finjuve has been approved in China, multiple EU countries, the Middle East and LATAM, making it the first and only topical finasteride product globally approved for androgenetic alopecia. Finjuve is administered once daily as a scalp spray. By inhibiting type II 5α-reductase in the scalp, it reduces local levels of dihydrotestosterone (DHT)—a key driver of follicular miniaturization—thereby promoting hair growth and preventing further hair loss. Its primary use is as an alternative to oral finasteride, especially for patients concerned about systemic adverse effects.

An international Phase III study of Finjuve showed that after 24 weeks of treatment, hair count increased by approximately 20 hairs/cm² versus baseline, with efficacy comparable to oral finasteride[1]. At the same time, Finjuve shows 100-fold lower systemic exposure and less impact on serum DHT levels compared with oral finasteride; the incidence of systemic adverse reactions was not significantly different from placebo, and local tolerability was good[2].

Finjuve addresses the rapidly growing global hair-loss treatment market, driven by high prevalence (up to ~80% of men may be affected during their lifetime[3]), increasing consumer awareness, and strong demand for non-invasive, dermatologist-led solutions. Compared with traditional OTC products such as minoxidil, topical and dermatologist-prescribed therapies represent a more effective and premium segment. Positioned as a next-generation differentiated topical anti-androgen therapy balancing efficacy and safety, Finjuve serves a large and expanding patient population by offering an effective hair-loss treatment option with lower risk.

 

Ciclopoli: A superior topical treatment option for onychomycosis patients

Ciclopoli is a topical antifungal nail lacquer containing ciclopirox, mainly used for mild to moderate onychomycosis, particularly in cases not involving the nail matrix. It is a first-line option for mild to moderate disease[4], and is also suitable for patients who wish to avoid—or do not prioritize—systemic therapies such as oral antifungals due to safety concerns.

Ciclopoli’s key advantage lies in its patented HPCH (hydroxypropyl chitosan) water-soluble transungual technology[5,6]. HPCH is a bio-polymer film-former that significantly improves the depth of penetration and local drug concentration of ciclopirox in the nail[6]. Importantly, it does not require organic solvents or nail filing for removal; the film can be removed simply by washing with water, helping avoid secondary damage to the nail and surrounding skin[5,6]. In clinical studies in mild to moderate onychomycosis, 8% ciclopirox HPCH nail lacquer demonstrated significantly better complete cure, treatment success, and mycological cure rates than 5% amorolfine nail lacquer[7]. Its efficacy is also superior to commercially available water-insoluble 8% ciclopirox nail lacquer[6]. Moreover, ciclopirox inhibits fungal metal-dependent enzymes through a unique chelation mechanism[8,9]. It has over 40 years of clinical use as a topical antifungal, with no clinical resistance reported[9,10].

Globally, Ciclopoli is positioned in the topical sub-segment of the onychomycosis treatment market, where comparable topical nail products include amorolfine, efinaconazole, and tavaborole, among others. With an established safety profile, lower cost, and broad accessibility, Ciclopoli has strong competitive advantages. Overall, it is a foundational, high-volume dermatology product addressing a large patient population and meeting demand for safe, non-systemic treatment options.

The global prevalence of onychomycosis is 5.5%[11], with the highest prevalence in Southeast Asia[12]. Due to the warm and humid climate, frequent use of closed footwear, and rising rates of diabetes and obesity, substantial unmet needs remain in the region[12]. Treatment options in relevant markets are currently limited, creating favorable opportunities for new entrants such as Ciclopoli.

 

About Rxilient

Rxilient is an innovative pharmaceutical company deeply engaged in global emerging markets, with end-to-end capabilities spanning product development and registration, manufacturing, and localized commercialization. Its operating network covers Southeast Asia, the Middle East, North Africa, and Hong Kong/Macao/Taiwan.

 

Reference:

  1. Piraccini BM, Blume-Peytavi U, Scarci F, et al. Efficacy and safety of topical finasteride spray solution for male androgenetic alopecia: a phase III, randomized, controlled clinical trial. J Eur Acad Dermatol Venereol. 2022;36(2):286-294.
  2. Finjuve Summary of Product Characteristics. Apotex Inc.
  3. Piraccini BM, Alessandrini A, Starace M. Androgenetic alopecia. G Ital Dermatol Venereol. 2014;149(1):15-24.
  4. Product-related information can be found on the Polichemwebsite at: https://www.polichem.com/products/ciclopoli-nail-lacquer/
  5. Baran R, Tosti A, Hartmane I, et al. An innovative water-soluble biopolymer improves efficacy of ciclopirox nail lacquer in the management of onychomycosis. J Eur Acad Dermatol Venereol. 2009;23(7):773-781.
  6. Piraccini BM, Iorizzo M, Lencastre A, et al. Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer: A Review of Its Use in Onychomycosis. Dermatol Ther (Heidelb). 2020;10(5):917-929.
  7. Iorizzo M, Hartmane I, Derveniece A, et al. Ciclopirox 8% HPCH Nail Lacquer in the Treatment of Mild-to-Moderate Onychomycosis: A Randomized, Double-Blind Amorolfine Controlled Study Using a Blinded Evaluator. Skin Appendage Disord. 2016;1(3):134-140.
  8. Sonthalia S, Agrawal M, Sehgal VN. Topical Ciclopirox Olamine 1%: Revisiting a Unique Antifungal. Indian Dermatol Online J. 2019;10(4):481-485.
  9. Subissi A, Monti D, Togni G, Mailland F. Ciclopirox: Recent nonclinical and clinical data relevant to its use as a topical antimycotic agent. Drugs. 2010;70(16):2133-2152.
  10. WHO Essential Medicines List Expert Committee. Proposal for the Inclusion of Ciclopirox Hydroxypropyl Chitosan in the WHO Model List of Essential Medicines for the Treatment of Onychomycosis in Adult Patients.
  11. Onychomycosis: background, pathophysiology, etiology. Medscape. 2024. Available from: https://emedicine.medscape.com/article/1105828-overview
  12. Wongyikul P, Lumkul L, Preechasuth K, Phinyo P, Chieosilapatham P. Global and regional prevalence, aetiology and socioeconomic distribution of onychomycosis: a systematic review and meta-analysis (2013–2023). J Epidemiol Community Health. 2026;doi:10.1136/jech-2025-224978.

 

 

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