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科笛集团(02487) - (经修订) 截至二零二五年十一月三十日止月份之股份发行人的证券变动月报表
2025-12-11 12:06
致:香港交易及結算所有限公司 公司名稱: 科笛集团 (於開曼群島註冊成立的有限公司) 呈交日期: 2025年12月11日 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年11月30日 狀態: 重新提交 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02487 | 說明 | 普通股 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 2,500,000,000 | USD | | 0.00002 | USD | | 50,000 | | 增加 / 減少 (-) | | | | | | | USD | | | | 本月底結存 | | | 2,500,000,000 | USD | | 0.00002 | USD | | 50 ...
科笛集团(02487) - 截至二零二五年十一月三十日止月份之股份发行人的证券变动月报表
2025-12-04 13:00
股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年11月30日 狀態: 新提交 II. 已發行股份及/或庫存股份變動 致:香港交易及結算所有限公司 公司名稱: 科笛集团 (於開曼群島註冊成立的有限公司) 呈交日期: 2025年12月4日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02487 | 說明 | 普通股 | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 2,500,000,000 | USD | 0.00002 | USD | | 50,000 | | 增加 / 減少 (-) | | | | | | USD | | | | 本月底結存 | | | 2,500,000,000 | USD | 0.00002 | USD | | 50, ...
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
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]
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
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]