文件显示，为预备向美国食品药品监督管理局提交后期试验数据以获取上市批准，该公司已着手开展患 者识别、医生教育等工作，并计划直接面向消费者启动产品营销。Veradermics将在后续提交的文件中披 露本次发行的具体条款，随后开始股票推介。 智通财经APP获悉，生物科技公司Veradermics(MANE.US)已正式提交首次公开募股申请，旨在为其口服 生发药的商业化进程提供资金支持。 此次IPO计划最快于本月下旬启动。此前，Veradermics已于去年10月完成1.5亿美元的C轮融资。该轮融 资由SR One领投，Viking Global Investors、Marshall Wace和Invus等新投资者，以及Longitude Capital与 Suvretta Capital Management等现有投资方也参与了此轮投资。 根据周五向美国证券交易委员会提交的文件，Veradermics正在研发一种适用于男女性雄激素性脱发(又 称"模式性脱发")的口服非激素疗法。该公司称，美国约有8000万人受此病症影响。公司由联合创始 人、皮肤科医生雷德·沃尔德曼和蒂姆·杜尔索领导。 本次发行由杰富瑞金融集团、L ...

Core Viewpoint - The company Codex-B (02487.HK) has announced that its self-developed topical finasteride spray, CU-40105, has received acceptance for a 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 finasteride spray that acts as a specific type II 5α-reductase competitive inhibitor, preventing the conversion of testosterone to dihydrotestosterone in the scalp, which is effective for treating androgenetic alopecia [1] - Unlike oral finasteride, the topical formulation allows patients to apply the medication directly to the scalp, potentially reducing systemic exposure to the drug [1] - The company believes that the topical finasteride will be more readily accepted by patients suffering from androgenetic alopecia, providing a new treatment option [1] Group 2: Market Strategy - CU-40105 will enhance the company's product matrix for hair diseases, with its formulation, dosage form, specifications, indications, administration route, and usage consistent with the reference formulation [1] - Key excipients for CU-40105 are exclusively supplied by the original manufacturer to ensure product quality and performance align with the reference formulation [1] - Given the broad treatment needs in the androgenetic alopecia market, the company anticipates that CU-40105 will facilitate a differentiated commercialization strategy targeting diverse consumers and patients, thereby expanding the coverage of topical finasteride among the target population [1]

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]