Core Technology and R&D Platform: The CATAME Platform

The cornerstone of Cutia’s product development is its proprietary CATAME technology platform. Delivering active pharmaceutical ingredients (APIs) topically or locally to the skin and hair follicles presents significant physiological barriers. The CATAME platform overcomes these challenges through six specialized formulation capabilities:

• C - Colloidal Formulation Technology: Optimizes the dispersion of active ingredients in stable, colloidal structures to enhance skin absorption.
• A - Aerosol and Foam Technology: Enables the creation of stable, non-greasy foam formulations that improve patient compliance, particularly on hair-bearing areas of the body.
• T - Topical Patch Technology: Designed for controlled, sustained release of therapeutic agents through the epidermal layer.
• A - Anhydrous Ointment Technology: Formulates moisture-sensitive active ingredients without water, preserving compound stability and ensuring therapeutic efficacy.
• M - Micro/Nano-emulsion Technology: Utilizes ultra-fine droplets to facilitate deep penetration of APIs into the dermis and hair follicles.
• E - Emulsion Formulation Technology: Standard and advanced emulsion techniques that balance cosmetic elegance with therapeutic delivery.

Through this platform, Cutia reformulates proven systemic drugs into topical applications, thereby reducing systemic side effects while maximizing local therapeutic concentration.

Comprehensive Product Portfolio and Pipeline

Cutia has built a diversified pipeline consisting of both clinical-stage drug candidates and commercialized over-the-counter (OTC) products and efficacy skincare lines.

1. Scalp Diseases and Hair Care (Alopecia)

Scalp care, particularly the treatment of Androgenetic Alopecia (AGA), is one of Cutia’s most advanced and commercially promising segments.

• CU-40102 (Topical Finasteride Spray): This is Cutia's core product and the first topical finasteride product approved by the National Medical Products Administration (NMPA) in China for the treatment of male androgenetic alopecia. Unlike oral finasteride, which carries risks of systemic adverse effects, CU-40102 is applied directly to the scalp as a spray, significantly reducing systemic exposure while maintaining high therapeutic efficacy in the hair follicles.
• CU-40103 and CU-40104: Supplementary scalp care and hair restoration formulations currently under development to target different stages of hair thinning and scalp inflammation.
• Cupilo Hair Care Series: A commercialized line of cosmetic and efficacy-based hair care products distributed through retail and e-commerce channels to address scalp health, dandruff, and hair loss prevention.

2. Skin Diseases (Acne and Atopic Dermatitis)

Cutia targets common inflammatory skin diseases with innovative topical formulations designed to replace systemic antibiotics or steroids.

• CU-10201 (Topical Minocycline Foam): CU-10201 is the world's first topical minocycline foam approved for the treatment of acne vulgaris. Standard oral minocycline is widely used for acne but is associated with systemic side effects like vestibular symptoms and gastrointestinal distress. Cutia’s topical foam delivers the drug directly to the sebaceous glands, minimizing systemic absorption and offering a safer, highly effective option for acne patients.
• CU-10101: A non-steroidal, small-molecule topical gel under development for the treatment of mild-to-moderate atopic dermatitis (eczema). It aims to offer an effective anti-inflammatory response without the safety risks associated with long-term topical corticosteroid use.
• CU-10401: A topical treatment targeting psoriasis, designed to inhibit specific inflammatory pathways in the skin.

3. Topical Aesthetics and Localized Fat Reduction

Aesthetics represents a high-growth sector in China, and Cutia is leveraging its localized drug delivery platforms to enter this market.

• CU-20401 (Recombinant Mutant Collagenase): A highly innovative, localized injection therapy designed for fat reduction. It selectively degrades collagen in the subcutaneous adipose tissue, leading to the reduction of localized fat accumulations such as submental fat (double chin) and abdominal fat. It is currently undergoing Phase II/III clinical trials in China and represents a non-surgical alternative to liposuction.
• CU-30101 (Topical Lidocaine/Tetracaine Cream): A fast-acting topical anesthetic cream designed to numb the skin prior to dermatological, aesthetic, or minor surgical procedures. It offers rapid onset and prolonged anesthetic effects to improve patient comfort during aesthetic injections or laser therapies.

Manufacturing and Supply Chain Infrastructure

To support its clinical development and commercialization strategy, Cutia has established a state-of-the-art manufacturing facility in Wuxi, Jiangsu Province, China. This facility is built in strict compliance with current Good Manufacturing Practices (cGMP) standards in China, the United States, and the European Union.

The Wuxi facility houses dedicated production lines for topical foams, sprays, ointments, creams, and liquids. By maintaining in-house manufacturing, Cutia ensures rigorous quality control over its CATAME-based formulations, secures its intellectual property, and achieves cost-efficiency as products transition from clinical phases to commercial-scale production.

Commercialization and Market Strategy

Cutia utilizes an omni-channel commercialization strategy tailored to the Chinese healthcare and consumer landscape:

• Clinical and Hospital Channels: For prescription products like CU-40102 and CU-10201, Cutia deploys an in-house medical sales team targeting dermatologists in Class III Grade A hospitals and private aesthetic clinics across China.
• Retail and OTC Pharmacies: The company collaborates with leading retail pharmacy chains to distribute OTC dermatological treatments.
• E-Commerce and Digital Marketing: For its efficacy skincare and non-prescription scalp care lines, Cutia operates flagship stores on major Chinese e-commerce platforms, including Tmall, JD.com, and Douyin (TikTok). The company leverages key opinion leaders (KOLs) and dermatological experts to educate consumers on scientific hair and skin care.

With its robust R&D engine, clinically proven pipeline, and modern manufacturing capabilities, Cutia Therapeutics is positioned as a comprehensive leader in the rapidly growing Chinese dermatology and medical aesthetics sector.