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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
Core Viewpoint - After being removed from the Hong Kong Stock Connect list in March, the stock price of Kedi-B (02487) experienced significant volatility, initially dropping to a low of HKD 3.64 but later rebounding by 250% due to strong financial results and market conditions [1][4][10]. Financial Performance - Kedi reported a total revenue increase of approximately 103% year-on-year for the fiscal year 2024, with gross profit rising by about 102% [4]. - The net loss for the period narrowed by 77.91% compared to the previous year, attributed to increased sales of hair loss and skincare products, as well as cost-cutting measures [4][12]. - The company’s half-year report for 2023 showed a revenue decrease of 30.6% to approximately HKD 66.3 million, with a net loss of about HKD 239 million, reflecting challenges due to strategic changes in partnerships [11][12]. Stock Price Movement - Following the announcement of its annual report on April 22, Kedi's stock price rebounded significantly, reaching a peak of HKD 7.62 on May 20, recovering all losses incurred after being removed from the Stock Connect [4][5]. - The stock price saw a decline from a high of HKD 12 to a low of HKD 5.87, marking a maximum drop of 51.08% over two months [8][10]. Market Dynamics - The stock's performance was influenced by the overall recovery of the Hong Kong pharmaceutical sector and the company's solid financial fundamentals [4][11]. - The liquidity issues stemming from the removal from the Stock Connect were exacerbated by the stock's volatility, with a significant reduction in the proportion of holdings by Stock Connect investors from 10.09% to 4.10% between March and June [5][7]. Future Prospects - Kedi plans to issue 28.9 million shares at a price of HKD 8.40 each to raise approximately HKD 240 million, with 45% of the proceeds allocated for the marketing and development of new products CU-40102 and CU-10201 [12]. - Market forecasts suggest that CU-40102 could achieve first-year revenues exceeding HKD 100 million, with peak sales potential estimated between HKD 1 billion and HKD 2 billion, while CU-10201 is projected to generate around HKD 50 million in its first year [12].
科笛-B(02487.HK)涨超10%
Mei Ri Jing Ji Xin Wen· 2025-11-14 06:59
Core Viewpoint - 科笛-B (02487.HK) shares increased by over 10%, reaching a price of 7.19 HKD with a trading volume of 5.7763 million HKD [2] Summary by Category - **Stock Performance** - The stock price of 科笛-B rose by 10.11% [2] - The current trading price is 7.19 HKD [2] - The total trading volume amounted to 577.63 million HKD [2]
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
Core Viewpoint - The stock of Kedi Group (02487) has risen over 10%, currently trading at 7.19 HKD, with a transaction volume of 5.7763 million HKD, following the announcement of the commercialization of its innovative products [1] Product Launch - Kedi Group has officially launched the first batch of its original imported 4% Minocycline Hydrochloride Foam (Anzqing®) from its Wuxi factory, which is the world's first and only topical 4% Minocycline Hydrochloride foam for treating moderate to severe inflammatory lesions of acne in patients aged 9 and above [1] - On October 17, Kedi Group announced the commercialization of its original imported Finasteride Spray (Finjuve®), with the first batch being dispatched from Shanghai Pharmaceutical International Supply Chain Co., Ltd. to various locations across the country, officially starting sales in China on October 20 [1] Market Position and Growth Potential - According to Caitong Securities, Kedi Group is emerging as a new star in the field of dermatological treatments, with its two core products possessing strong differentiation advantages, which are expected to drive performance growth as commercialization progresses [1] - According to Kaiyuan Securities, the company has established a diversified product portfolio covering hair diseases, skin care, and medical aesthetics, indicating a promising growth space with the acceleration of product pipeline commercialization [1]
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
Core Viewpoint - The stock of Kedi-B (02487) has risen over 10%, currently up 10.11% at HKD 7.19, with a trading volume of HKD 5.7763 million, following the announcement of the commercialization of its innovative products [1] Group 1: Product Launches - Kedi Group has announced the first batch of its original imported 4% Minocycline Hydrochloride Foam (Anzqing) has been shipped from its Wuxi factory to various locations across the country, marking it as the world's first and only topical 4% Minocycline Hydrochloride Foam for treating moderate to severe inflammatory lesions of acne in patients aged 9 and above [1] - On October 17, Kedi Group announced the first batch of its original imported Finasteride Spray (brand name: Finjuve) has been shipped from Shanghai Pharmaceutical International Supply Chain Co., Ltd. to various locations nationwide, with sales officially starting in China on October 20 [1] Group 2: Market Position and Growth Potential - According to Caitong Securities, the company is emerging as a new star in the field of dermatological treatments, with its two core products possessing strong differentiation advantages, which are expected to inject growth momentum into the company's performance as commercialization progresses [1] - According to Kaiyuan Securities, the company has established a diversified product portfolio covering hair diseases, skin care, and medical aesthetics, and is optimistic about the growth potential under the accelerated commercialization process of its dense pipeline [1]
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]
科笛-B: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 00:20
Core Viewpoint - The announcement highlights the early efficacy of CU-10201, a topical 4% minocycline foam, for treating moderate to severe facial acne, which has been selected for oral 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 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 moderate to severe acne patients in China [1] Group 2: Clinical Trial Insights - The post-hoc analysis aims to evaluate the early efficacy of CU-10201 in 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 provides a rapid symptom relief treatment option for acne patients, holding important clinical significance [1]
科笛-B(02487.HK):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
Ge Long Hui· 2025-11-10 00:12
Core Viewpoint - The company announced that the post-hoc analysis of the early efficacy of CU-10201 for treating moderate to severe acne vulgaris has been selected for oral presentation at the 20th CDA Annual Meeting, highlighting the significance of this treatment option in the dermatology field [1] Group 1: Product Information - CU-10201 is the first and only approved topical minocycline for the treatment of acne vulgaris globally, and it has received priority review and approval from the National Medical Products Administration of China [1] - The efficacy and safety of CU-10201 for moderate to severe acne vulgaris patients in China have been confirmed through a Phase III clinical trial [1] Group 2: Clinical Findings - The post-hoc analysis aimed to evaluate the early efficacy of CU-10201 in patients with moderate to severe facial acne vulgaris during the first and second weeks of treatment [1] - The analysis showed that CU-10201 demonstrated significant rapid efficacy, with noticeable improvement in inflammatory lesions observed in the first week and further enhancement of efficacy by the second week [1] - These early efficacy data indicate that CU-10201 can provide a rapid symptom relief treatment option for acne vulgaris patients, which holds important clinical significance [1]