非那雄胺作为特异性I I型5α－还原酶竞争抑制剂抑制头皮中睾酮转化为双氢睾酮，可治疗雄激素性脱 发。与口服非那雄胺不同，外用非那雄胺便于患者将药物直接精确地涂抹在头皮表面，与口服药比较， 可降低药物的全身暴露。集团相信外用非那雄胺将更容易被雄激素性脱发患者接受，并为患者提供一种 新的用药选择。 格隆汇11月19日丨科笛-B(02487.HK)宣布，集团的CU-40105(自研外用非那雄胺喷雾剂)的简略新药上市 申请(ANDA)已获得中华人民共和国国家药品监督管理局("国家药监局")受理，适应症为治疗雄激素性 脱发。 CU-40105将进一步丰富集团的毛发疾病产品矩阵。CU-40105的处方组成、剂型、规格、适应症、给药 途径及用法用量，均与参比制剂保持一致。CU-40105的关键辅料更由原研厂家独家供应，以确保产品 的质量和性能与参比制剂一致。面对雄激素性脱发市场广泛的治疗需求，集团预计CU-40105将有利于 针对多样化的消费者和患者，实施差异化的商业化战略，进一步扩大外用非那雄胺在目标人群中的覆盖 范围。 ...

Core Viewpoint - The announcement indicates that the company's self-developed topical finasteride spray, CU-40105, has received acceptance for its abbreviated new drug application (ANDA) by the National Medical Products Administration of China, aimed at treating androgenetic alopecia [1] Group 1: Product Development - CU-40105 is a topical formulation that inhibits the conversion of testosterone to dihydrotestosterone in the scalp, similar to oral finasteride but with reduced systemic exposure [1] - The product is expected to be more acceptable to patients suffering from androgenetic alopecia, providing a new treatment option [1] Group 2: Market Strategy - The introduction of CU-40105 will enhance the company's product matrix for hair disorders, addressing the diverse treatment needs in the androgenetic alopecia market [1] - The company plans to implement a differentiated commercialization strategy to expand the coverage of topical finasteride among target consumer groups [1]

本公司董事會（「董事會」）欣然宣佈，本集團的CU-40105（自研外用非那雄胺噴霧 劑）的簡略新藥上市申請(ANDA)已獲得中華人民共和國國家藥品監督管理局（「國 家藥監局」）受理，適應症為治療雄激素性脫髮。 非那雄胺作為特異性I I型5α－還原酶競爭抑制劑抑制頭皮中睾酮轉化為雙氫睾 酮，可治療雄激素性脫髮。與口服非那雄胺不同，外用非那雄胺便於患者將藥物 直接精確地塗抹在頭皮表面，與口服藥比較，可降低藥物的全身暴露。本集團相 信外用非那雄胺將更容易被雄激素性脫髮患者接受，並為患者提供一種新的用藥 選擇。 CU-40105將進一步豐富本集團的毛髮疾病產品矩陣。CU-40105的處方組成、劑 型、規格、適應症、給藥途徑及用法用量，均與參比製劑保持一致。CU-40105的 關鍵輔料更由原研廠家獨家供應，以確保產品的質量和性能與參比製劑一致。面 對雄激素性脫髮市場廣泛的治療需求，本集團預計CU-40105將有利於針對多樣化 的消費者和患者，實施差異化的商業化戰略，進一步擴大外用非那雄胺在目標人 群中的覆蓋範圍。 1 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任 ...

Core Viewpoint - The company Codex-B (02487) has received approval from the Hong Kong government for its product CU-40102, a topical finasteride spray, for the treatment of androgenetic alopecia, marking a significant advancement following its approval by the National Medical Products Administration of China [1] Group 1: Product Approval and Features - CU-40102 is a topical formulation that inhibits the conversion of testosterone to dihydrotestosterone in the scalp, providing a treatment option for androgenetic alopecia [1] - Unlike oral finasteride, CU-40102 allows for precise application directly to the scalp, potentially reducing systemic exposure to the drug [1] Group 2: Market Implications - The approval of CU-40102 is a crucial step for the company in the hair disease and care sector, indicating extensive commercialization preparations in China [1] - This approval is expected to enhance the international presence of CU-40102, expanding its market reach and benefiting more patients suffering from androgenetic alopecia [1]

Core Viewpoint - The company Codex-B (02487) has received approval from the Hong Kong Department of Health for its product CU-40102, a topical finasteride spray for the treatment of androgenetic alopecia, marking a significant advancement following its approval by the National Medical Products Administration of China [1] Group 1: Product Details - CU-40102 is a topical formulation that inhibits the conversion of testosterone to dihydrotestosterone in the scalp, which is effective in treating androgenetic alopecia [1] - Unlike oral finasteride, CU-40102 allows for precise application directly to the scalp, potentially reducing systemic exposure to the drug [1] Group 2: Market Implications - The approval of CU-40102 is a crucial step for the company in the hair disease and care sector, as it prepares for extensive commercialization activities in China [1] - This approval will enhance the international positioning of CU-40102, expanding its market reach and benefiting more patients suffering from androgenetic alopecia [1]