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Summary

Founded in 2019, we are an R&D-driven, dermatology-focused biopharmaceutical company focused on the broader dermatology treatment and care therapeutic areas, including localized adipose accumulation management medication, scalp diseases and care, skin diseases and care and topical anesthesia. We have one Core Product and eight other pipeline product candidates. We also distributed two commercialized products developed by overseas collaboration partners. Our Core Product, CU-20401, is a recombinant mutant collagenase that targets adipose accumulation as a manifestation of metabolic diseases such as obesity and overweight. As of the Latest Practicable Date, we held one patent in relation to our Core Product. WE MAY NOT BE ABLE TO SUCCESSFULLY DEVELOP AND/OR MARKET OUR CORE PRODUCT. Our Pipeline Localized Adipose Accumulation Management Medication ‧ Core Product CU-20401. CU-20401 is an acquired recombinant mutant collagenase that targets adipose accumulation as a manifestation of metabolic diseases such as obesity and overweight. We acquired CU-20401 from Rejuven Dermaceutical Co., Ltd. in August 2020. CU-20401 is being reviewed and will potentially be approved by the NMPA as a drug to be administered by registered healthcare practitioners. The route of administration of CU-20401 is subcutaneous injection. Fat cells are normally attached to the extracellular matrix composed of collagen network. CU-20401 acts as a collagenase that degrades extracellular matrix collagen in the subcutaneous fat layer, leading to apoptosis of adipocytes. CU-20401 is a recombinant collagenase II with the E451D mutation. The recombinant with the E451D mutation does not affect enzyme-substrate binding, but decreases enzymatic cleavage rate in vivo. CU-20401 is modified with reduced rate to catalyze the collagen degradation and is effective to reduce adipose accumulation with mild catalytic activity, thus reducing the adverse effects of wild-type collagenase, such as bruising and pain. The modification of E451D mutation for CU-20401 was carried out before our acquisition of CU-20401. The formulation of CU-20401 includes recombinant mutant collagenase, tromethamine, sucrose, calcium chloride, dihydrate hydrochloric acid and water. We have completed Phase I clinical trial on human subjects for CU-20401 for submental adipose accumulation (submental fat) and are conducting another Phase I clinical trial for abdominal adipose accumulation (abdominal fat). The significance of Phase I clinical trial is that its results suggested that CU-20401 is safe and well tolerated in subjects with submental adipose accumulation (submental fat). As we completed the Phase I clinical trial with no objection of entering a Phase II clinical trial, based on the NMPA’s IND approval, we expect to initiate a Phase II clinical trial of CU-20401 for submental adipose accumulation (submental fat) in the third quarter of 2023 to evaluate its efficacy profiles. Scalp Diseases and Care ‧ Key Product CU-40102. CU-40102 is an in-licensed product and the first and only topical finasteride product approved for androgenetic alopecia treatment globally and the only topical finasteride under clinical development in China. We in-licensed CU-40102 from Polichem S.A. in November 2020. Finasteride can treat androgenetic alopecia in male patients by acting as a competitive and specific inhibitor of Type II 5-alpha reductase to inhibit the conversion of testosterone to DHT in the scalp. ‧ CU-40101. CU-40101 is an in-licensed topical liniment to treat androgenetic alopecia. We in-licensed CU-40101 from TechnoDerma Medicines Inc. in May 2020. It contains a potent small molecule hormone receptor agonist that binds to thyroid receptor in hair follicle cells and induces hair growth. CU-40101 is to be applied to the scalp directly, reducing systemic exposure to the drug and the associated adverse effects. ‧ CU-40103. CU-40103 is a self-developed topical minoxidil foam for the treatment of alopecia. The active ingredient, minoxidil, is widely used and proven efficacious in clinical practice for both male and female hair regrowth. ‧ CU-40104. CU-40104 is a self-developed topical dutasteride to treat androgenetic alopecia. CU-40104’s topical formulation is being developed for direct dutasteride application to the site of action on the scalp. The topical formulation is expected to reduce systemic exposure and side effects as compared with oral dutasteride. Skin Diseases and Care ‧ Key Product CU-10201. CU-10201 is an in-licensed product and the first and only topical minocycline approved for acne vulgaris treatment globally and the only topical minocycline under clinical development in China. We in-licensed CU-10201 from Foamix Pharmaceuticals Ltd. in April 2020. FDA approved CU-10201 for the treatment of moderate to severe acne vulgaris in the United States in 2019 under the brand name Amzeeq with Foamix Pharmaceuticals Inc. as the marketing authorization holder. ‧ CU-10101. CU-10101 is an in-licensed non-hormonal, small molecule drug targeting atopic dermatitis. We in-licensed CU-10101 from Wuhan Yingnashi Pharmaceutical Co., Ltd. in November 2019. ‧ CU-10401. CU-10401, an acquired aryl hydrocarbon receptor (AhR) targeted non-steroidal small molecule chemical drug in topical form, is a generic tapinarof cream targeting psoriasis currently being developed in pre-clinical stage. We acquired CU-10401 from Wuhan Yingnashi Pharmaceutical Co., Ltd. in June 2020. The active ingredient of CU-10401, tapinarof, is reported to bind and activate AhR, decrease pro-inflammatory cytokines, and regulate skin barrier protein expression to promote skin barrier normalization. Topical Anesthesia ‧ CU-30101. CU-30101 is an acquired localized lidocaine and tetracaine compound topical anesthesia cream. We acquired CU-30101 from Sparkmed Research, LLC. in November 2019. Distributed Products ‧ CUP-MNDE. CUP-MNDE is a commercialized, over-the-counter minoxidil spray indicated for alopecia developed by Laboratoires Bailleul International S.A. We have exclusive distribution rights to develop the distribution and marketing of CUP-MNDE in Mainland China. Laboratoires Bailleul International S.A. is the market authorization holder. We commenced distribution with the brand name Bailleul in January 2022 in Mainland China excluding Hong Kong, Macao and Taiwan. ‧ CUP-SFJH. CUP-SFJH, as a cosmetic product, is a commercialized hair growth serum featuring a non-hormonal formula of natural plant extracts developed by Van Montfort Laboratories B.V. We have exclusive distribution rights to develop the distribution and marketing of CUP-SFJH in Mainland China. Van Montfort Laboratories B.V. is the market authorization holder of CUP-SFJH. We commenced commercialization with the brand name ESTHECIN in August 2022 in Mainland China excluding Hong Kong, Macao and Taiwan. Source: Cutia-B (02487) Prospectus (IPO Date : 2023/05/31)
Listing Market	MAIN
Industry	Biotechnology - Pharmaceuticals
Background	Others
Major Business Area	N/A

Corporate Information

Substantial Shareholders	Zhang Qiping (27.14%) 6 Dimensions Capital GP, LLC (20.41%) Aurora Cutis Limited (16.96%) Yunfeng Fund III, L.P. (12.43%) Shen Nan Peng (8.07%)
Directors	Chen Lian Yong (Chairman and Non-Executive Director) Zhang Lele (Chief Executive Officer and Executive Director) Huang Yuqing (Chief Financial Officer and Executive Director) Huang Xiao (Non-Executive Director) Xie Qin (Non-Executive Director) Yang Yunxia (Non-Executive Director) Chung Ming Kit (Independent Non-Executive Director) Tao Tak Yan Dennis (Independent Non-Executive Director) Ye Xiaoxiang (Independent Non-Executive Director)
Company Secretary	Chan Sze Ting
Principal Bankers	China Merchants Bank Shanghai Pudong Development Bank Co., Ltd.
Solicitors	Eric Chow & Co. in Association with Commerce & Finance Law Offices
Auditors	Ernst & Young
Registered Office	5th Floor, Manulife Place 348 Kwun Tong Road Kowloon, Hong Kong
Share Registrars	Tricor Investor Services Ltd. [Tel: (852) 2980-1333]
Share Registrars Tel No	(852) 2980-1333
Internet Address	http://www.cutiatx.com
Email Address	ir@cutiatx.com
Tel No	(852) 3180-9568
Fax No

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