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科笛-B(02487.HK):CU-40105(自研外用非那雄胺喷雾剂)简略新药上市申请获得国家药监局受理
Ge Long Hui· 2025-11-18 22:44
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。 ...
科笛-B:CU-40105(自研外用非那雄胺喷雾剂)简略新药上市申请获得国家药监局受理
Zhi Tong Cai Jing· 2025-11-18 22:14
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]
科笛-B(02487):CU-40105(自研外用非那雄胺喷雾剂)简略新药上市申请获得国家药监局受理
智通财经网· 2025-11-18 22:13
Core Viewpoint - The company has received acceptance from the National Medical Products Administration of China for its new drug application for CU-40105, a topical finasteride spray aimed at treating androgenetic alopecia, which is expected to provide a new treatment option for patients [1] Group 1: Product Development - CU-40105 is a self-developed topical finasteride spray that inhibits the conversion of testosterone to dihydrotestosterone in the scalp, addressing androgenetic alopecia [1] - Unlike oral finasteride, the topical formulation allows for precise application on the scalp, potentially reducing systemic exposure to the drug [1] - The product's formulation, dosage form, specifications, indications, administration route, and usage are consistent with the reference preparation [1] Group 2: Market Strategy - The company believes that the topical finasteride will be more readily accepted by patients suffering from androgenetic alopecia, providing a new treatment choice [1] - CU-40105 will enhance the company's product matrix for hair diseases, targeting a diverse consumer and patient base with a differentiated commercialization strategy [1] - The company anticipates that CU-40105 will expand the coverage of topical finasteride among the target population, addressing the broad treatment needs in the androgenetic alopecia market [1]
科笛集团(02487) - 自愿公告 - CU-40105(自研外用非那雄胺喷雾剂)简略新药上市申请...
2025-11-18 22:01
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 ...
近两个月股价“腰斩”,科笛-B押注新品商业化何时迎反弹时刻?
Zhi Tong Cai Jing· 2025-11-18 09:42
在今年3月被调出港股通名单后,科笛-B(02487)的股价便开始了"过山车行情"。 虽然在退通后的一个月内迅速下探至年内最低点3.64港元,但在4月22披露年报后,科笛又凭借财报展示的扎实基本面迅速止跌,并在市场低估和港股创新 药牛市双重因素推动下,于接下来两个月走出一波2.5倍股价涨幅的拉升行情。 通过叠加恒生医疗保健指数不难看出,4月9日至6月16日这段时间区间内,科笛的股价涨幅斜率表现明显优于指数,但从时间跨度来看,科笛这波主升行情 仅持续至6月16日,而指数则是爬升到9月初才开始逐步调整。 实际上,从4月至今的涨跌表现来看,科笛与指数在走势上存在一定的同频波动,但振幅明显更大,在此过程中,"出通"带来的流动性问题则被一步步放 大。 拉升行情加速港股通资金出清 智通财经APP观察到,今年4月9日,科笛股价触底3.64港元,创下上市以来股价新低,但在随后的1个半月内持续反弹。5月20日,科笛盘中股价最高涨幅达 20%,最高价达到7.62港元,突破退通前的前高股价。也就是说,经过2个多月的股价震荡,科笛股价最终修复了"出通"后全部跌幅。 支撑其股价迅速拉升的原因除了港股医药板块回暖外,年报显示的扎实基本面是 ...
科笛-B(02487.HK)涨超10%
Mei Ri Jing Ji Xin Wen· 2025-11-14 06:59
每经AI快讯,科笛-B(02487.HK)涨超10%,截至发稿,涨10.11%,报7.19港元,成交额577.63万港元。 (文章来源:每日经济新闻) ...
港股异动 | 科笛-B(02487)涨超10% 外用米诺环素泡沫剂、非那雄胺喷雾剂国内开启销售
智通财经网· 2025-11-14 06:41
消息面上,近期,科笛集团宣布,原研进口4%盐酸米诺环素泡沫剂(安佐清®)首批商业化产品正式 从科笛无锡工厂发往全国各地。作为全球首款且唯一的外用4%盐酸米诺环素泡沫剂,适用于9岁及以上 儿童和成人患者的非结节性中度至重度寻常痤疮炎症性病变的局部治疗。此外,10月17日,科笛集团宣 布原研进口非那雄胺喷雾剂(商品名:纷永维®Finjuve®)首批商业化产品正式从上药国际供应链有限 公司发往全国各地。10月20日,在中国正式开启销售。 智通财经APP获悉,科笛-B(02487)涨超10%,截至发稿,涨10.11%,报7.19港元,成交额577.63万港 元。 财通证券指出,公司是泛皮肤病治疗新星,两大核心产品具备较强差异化优势,伴随商业化逐步落地有 望为公司注入业绩增长动能。开源证券认为,公司已形成覆盖毛发疾病、皮肤护理和医美领域的多元化 产品布局,看好密集管线落地和商业化进程加速下的成长空间。 ...
科笛-B涨超10% 外用米诺环素泡沫剂、非那雄胺喷雾剂国内开启销售
Zhi Tong Cai Jing· 2025-11-14 06:39
消息面上,近期,科笛集团宣布,原研进口4%盐酸米诺环素泡沫剂(安佐清)首批商业化产品正式从科笛 无锡工厂发往全国各地。作为全球首款且唯一的外用4%盐酸米诺环素泡沫剂,适用于9岁及以上儿童和 成人患者的非结节性中度至重度寻常痤疮炎症性病变的局部治疗。此外,10月17日,科笛集团宣布原研 进口非那雄胺喷雾剂(商品名:纷永维Finjuve)首批商业化产品正式从上药国际供应链有限公司发往全国 各地。10月20日,在中国正式开启销售。 财通证券(601108)指出,公司是泛皮肤病治疗新星,两大核心产品具备较强差异化优势,伴随商业化 逐步落地有望为公司注入业绩增长动能。开源证券认为,公司已形成覆盖毛发疾病、皮肤护理和医美领 域的多元化产品布局,看好密集管线落地和商业化进程加速下的成长空间。 科笛-B(02487)涨超10%,截至发稿,涨10.11%,报7.19港元,成交额577.63万港元。 ...
大消费反攻!布局时点到了?丨每日研选
Sou Hu Cai Jing· 2025-11-11 01:05
Core Viewpoint - The consumer sector is showing signs of recovery, driven by favorable policies, rising CPI, and the imminent closure of Hainan Free Trade Port, leading to increased investment enthusiasm in the sector [2][4]. Group 1: Consumer Sector Analysis - The consumer sector is believed to be at the bottom, with fundamentals gradually improving, as indicated by the third-quarter reports [4]. - The "14th Five-Year Plan" emphasizes the importance of consumption, suggesting a positive outlook for the sector [4]. - Key investment opportunities include the restaurant chain sector, which is nearing the end of price wars, and companies like Anjiexin Foods and Lihai Foods are seeing improved net profit margins [4]. Group 2: Duty-Free Industry Insights - Hainan's duty-free sales data shows a significant recovery in Q3 2025, with a notable increase in average transaction value, and a stable outlook for Q4 [5]. - Continuous policy support, including a clear timeline for the island's closure and an expanded range of duty-free products, is expected to enhance the operational conditions for companies like China Duty Free Group and Hainan Development [5]. Group 3: Structural Upgrades in Consumption - The toy industry is evolving with IP incubation and category innovation, favoring leading companies with strong design and supply chain capabilities [6]. - The beauty industry is integrating medical, beauty, and health services, which is expected to enhance customer spending and repeat purchases [6]. - The consumer industry is transitioning from "functional supply" to "scenario value supply," indicating a structural upgrade in brand consumer goods [6]. Group 4: New Consumption Trends - Four new consumption themes are emerging: 1. Brand globalization 2.0, focusing on pricing power and emerging markets [7]. 2. Emotional value sectors like trendy toys and pet products are expected to benefit from rising GDP per capita [7]. 3. AI-driven consumption in service sectors is showing potential for profitability [7]. 4. Channel transformation emphasizing user experience and operational efficiency, particularly in instant retail and cost-effective dining [7]. Group 5: High-Growth Opportunities in Emotional Consumption - The gold and jewelry sector is undergoing significant changes, with rising gold prices and a shift towards emotional consumption, suggesting opportunities in high-end and trendy gold segments [8]. - Retail e-commerce is focusing on offline retail transformation and AI-enabled cross-border e-commerce leaders [8]. - The cosmetics sector is seeing growth in domestic brands that meet emotional value and safety ingredient innovation [8]. - The medical beauty sector remains resilient, with opportunities in differentiated products and mergers in downstream medical beauty institutions [8].
科笛-B(02487):CU-10201(外用4%米诺环素泡沫剂)一项中国III期临床试验的事后分析被选为在第二十届CDA年会口头发言
Zhi Tong Cai Jing· 2025-11-10 00:32
Core Viewpoint - The announcement highlights the early efficacy of CU-10201, a topical 4% minocycline foam, for treating moderate to severe acne vulgaris, which has been selected for presentation at the 20th CDA Annual Meeting [1] Group 1: Product Information - CU-10201 is the first and only approved topical minocycline for acne treatment globally and has received priority review and approval from the National Medical Products Administration of China [1] - The product has demonstrated efficacy and safety in a 12-week Phase III clinical trial for Chinese patients with moderate to severe acne vulgaris [1] Group 2: Clinical Trial Insights - The post-hoc analysis aims to evaluate the early efficacy of CU-10201 in Chinese patients with moderate to severe facial acne during the first and second weeks of treatment [1] - Efficacy analysis indicates that CU-10201 shows a significant characteristic of rapid onset, with notable improvement in inflammatory lesions observed in the first week and further enhancement by the second week [1] - These early efficacy data suggest that CU-10201 can provide a rapid symptom relief treatment option for acne vulgaris patients, holding important clinical significance [1]