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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]
科笛集团(02487) - 自愿公告 - CU-10201(外用4%米诺环素泡沫剂)一项中国III期...
2025-11-10 00:00
CU-10201(外用4%米諾環素泡沫劑) 一項中國III期臨床試驗的事後分析被選為在第二十屆CDA年會口頭發言 本公告由科笛集團(「本公司」,連同其附屬公司統稱「本集團」)自願刊發,以告知 本公司股東及潛在投資者有關本集團最新業務發展資料。 本公司董事會(「董事會」)欣然宣佈,本集團CU-10201(外用4%米諾環素泡沫劑) 治療中度至重度面部尋常痤瘡的早期療效的一項中華人民共和國(「中國」)III期臨 床試驗的事後分析被選為在第二十屆中國醫師協會皮膚科醫師年會暨全國美容皮 膚科學大會(「第二十屆CDA年會」)上口頭發言。 CU-10201是全球首個且唯一一個獲批用於尋常痤瘡治療的外用米諾環素,也是 首個獲得中國國家藥品監督管理局優先審評審批資格批准上市的外用米諾環素。 CU-10201針對中國中度至重度尋常痤瘡患者的 12 週療效與安全性已通過 III 期臨 床試驗證實。本事後分析旨在評估CU-10201在中國中度至重度面部尋常痤瘡患者 於治療第一週和第二週的早期療效。 療效分析顯示,CU-10201在治療中國中度至重度面部尋常痤瘡患者中,表現出快 速起效的顯著特點。於治療第一週即可觀察到炎性皮損的顯著改 ...
科笛-B根据股份计划发行1499.8万股
Zhi Tong Cai Jing· 2025-11-03 13:49
Group 1 - The company, 科笛-B (02487), announced the issuance of a total of 14.998 million shares under its share scheme on November 3, 2025 [1]
科笛集团(02487) - 翌日披露报表
2025-11-03 13:34
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11月3日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司(「香港聯交所」)證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露,必須填妥第一章節 。 | 第一章節 | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 不適用 | | | 於香港聯交所上市 | 是 | | | | 證券代號 (如上市) | 02487 | 說明 普通股 | | | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | 事件 | 已發行股份(不包括庫存股份)變動 | | | 庫存股份變動 | 每股發行/出售價 (註4) | 已發行股份總數 | | | | | 已發行股份(不包括庫存股份)數 目 | 佔有關事件前的現有已發 | 行股份(不包括庫存 ...
科笛集团(02487) - 截至二零二五年十月三十一日止月份之股份发行人的证券变动月报表
2025-11-03 13:30
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10月31日 狀態: 新提交 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11月3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 | | | 50,0 ...
科笛集团(02487) - 截至二零二五年九月三十日止月份之股份发行人的证券变动月报表
2025-10-03 13:00
呈交日期: 2025年10月3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 | | | 50,000 | 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9月30日 狀態: 新提交 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 ...
科笛集团(02487) - 2025 - 中期财报
2025-09-26 08:30
Regulatory Approvals and Product Development - The company has received regulatory approval for two major products: CU-10201 (4% minocycline foam) and CU-40102 (topical finasteride spray) from the National Medical Products Administration (NMPA) in China[11]. - CU-40102 is the first and only approved topical finasteride product for androgenetic alopecia, with approval granted in June 2025, and is expected to be commercialized soon[14]. - CU-10201 is the first approved topical minocycline for the treatment of moderate to severe acne, with approval received in November 2024, and is also preparing for commercialization in China[14]. - The company has successfully completed Phase III clinical trials for CU-10201, demonstrating significant efficacy and safety in treating acne[14]. - The company is actively preparing for the commercialization of CU-40102 and CU-10201 in the Chinese market[14]. - The company has received a drug marketing authorization application for CU-30101 (topical lidocaine-dinoprost cream) from the NMPA[11]. - CU-10101, a non-hormonal small molecule drug for treating mild to moderate atopic dermatitis, received IND approval in May 2024 and completed the first subject enrollment for Phase I clinical trials in September 2024[6]. - CU-30101, a local anesthetic cream, completed Phase III clinical trials in January 2024, with its drug registration application accepted by the National Medical Products Administration in July 2024, showing comparable analgesic efficacy to the reference product Pliaglis®[6]. - CU-20401, a recombinant collagenase for local fat accumulation, completed Phase II clinical trials in December 2024, with significant efficacy observed across different dosage groups compared to the placebo group, and is expected to receive regulatory approval for commercialization in China by 2028[6]. Financial Performance - Revenue decreased by 30.6% from approximately RMB 95.6 million for the six months ended June 30, 2024, to approximately RMB 66.3 million for the six months ended June 30, 2025, primarily due to the termination of the agency cooperation with a U.S. skincare brand[30]. - Gross profit for the six months ended June 30, 2025, was approximately RMB 32.1 million, a decrease of 36.3% from approximately RMB 50.3 million for the same period in 2024, with gross margin at 48%[32]. - The company recorded a loss of approximately RMB 239.4 million for the six months ended June 30, 2025, an increase of about 19.1% from a loss of approximately RMB 200.9 million in 2024[44]. - The company’s net loss attributable to equity holders for the period was RMB 239,387,000, resulting in a basic and diluted loss per share of RMB 0.75, compared to RMB 0.66 in 2024[129]. - The total equity attributable to equity holders decreased to RMB 756,620,000 from RMB 974,730,000, a decline of 22.4%[131]. - The company reported a pre-tax loss of RMB 239,387,000, compared to a loss of RMB 200,926,000 in the previous year, representing an increase in loss of 19.1%[129]. - Research and development costs decreased by 20.3% to approximately RMB 78.9 million for the six months ended June 30, 2025, compared to approximately RMB 99.0 million for the same period in 2024[35]. - The company reported a net cash outflow from operating activities of RMB 171,703,000, an improvement from RMB 246,160,000 in 2024[135]. Shareholder Information and Equity Incentives - The company successfully placed 28,904,000 new shares at a price of HKD 8.40 per share, raising approximately HKD 242.79 million, with a net amount of about HKD 240.27 million after expenses[24]. - As of June 30, 2025, major shareholders include 6 Dimensions Capital, L.P. with 61,771,710 shares (19.25%) and 6 Dimensions Capital GP, LLC with 65,022,855 shares (20.27%)[66]. - The company has 298 employees as of June 30, 2025, with 53.7% in sales, marketing, and management roles[61]. - The company has established a stock incentive plan that requires participants to sign a reward agreement approved by management[88]. - The total number of shares that may be issued under the post-IPO equity incentive plan is capped at 10% of the issued shares on the date of trading commencement, amounting to 30,402,446 shares, which represents 9.5% of the issued shares excluding treasury shares[104]. - The post-IPO equity incentive plan was conditionally approved by shareholders on May 30, 2023, in accordance with the listing rules[101]. - The total number of options and/or share awards granted to a participant within 12 months must not exceed 1% of the relevant class of issued shares[105]. Market Strategy and Operations - The company is focused on expanding its product pipeline in dermatology, targeting hair diseases, skin diseases, epidermal anesthesia, and localized fat accumulation management[8]. - The company has established a dedicated marketing team across various provinces to penetrate the extensive skin disease treatment market in China, successfully developing hundreds of cooperative terminals and hospitals nationwide[19]. - The company aims to enhance commercialization activities for CU-10201 and CU-40102, leveraging both online and offline channels to increase product visibility and competitiveness[27]. - The company has established a comprehensive product portfolio addressing diverse needs in the dermatology market[8]. - The company is one of the few participants in the Chinese dermatology market with comprehensive capabilities across the value chain[8]. Compliance and Governance - The company has complied with all applicable corporate governance codes and principles for the six months ending June 30, 2025[110]. - The audit committee consists of three independent non-executive directors, with the chairman being Mr. Zhong Mingjie, and Mr. Zhang Zhishong and Mr. Ye Xiaoxiang as members[119]. - The independent auditor, Ernst & Young, reviewed the interim financial information for the six months ended June 30, 2025, and found no issues that would indicate non-compliance with International Accounting Standard 34[126]. - The company did not declare an interim dividend for the six months ended June 30, 2025, consistent with the previous year where no dividend was declared[122].
南京江北新区获批设立十周年,成为江苏发展生物医药优势产业的重中之重南京“江之北”崛起科创新高地
Xin Hua Ri Bao· 2025-09-16 23:24
Core Insights - Jiangbei New Area in Nanjing has evolved into a national-level innovation hub, particularly in the biopharmaceutical and semiconductor industries, showcasing significant technological advancements and industry breakthroughs [1][2][3]. Biopharmaceutical Industry - Jiangbei New Area is designated as a key area for developing a world-class biopharmaceutical industry cluster, with over 200 new drugs under research and more than 1,300 biopharmaceutical companies [1][2]. - Notable achievements include the first CAR-T drug for cross-border supply by Reindeer Biotech and the first nucleic acid drug ER2001 injection by Aima Biotech, highlighting the area's innovative capabilities [2]. - The area has attracted major pharmaceutical companies, with recent approvals for new drugs such as the anti-flu drug and an antibody drug, indicating a robust pipeline of innovative products [2]. Semiconductor Industry - Jiangbei New Area hosts a significant number of semiconductor companies, including Nanjing University’s collaboration with Nanjing Jiangbei New Area to establish a leading photonic chip production line [3]. - Companies like Chipstar Technology have made strides in high-end chips, with their 7nm chip achieving significant market penetration [3]. - The area is recognized for its comprehensive semiconductor ecosystem, covering all aspects from design to manufacturing [3]. Educational and Research Institutions - The establishment of a technology transfer center in Jiangbei New Area has facilitated collaboration with 78 universities, resulting in numerous projects and a high concentration of talent [4][5]. - Nanjing University and Southeast University are key players in the area, contributing to a rich educational environment that supports innovation and research [4][5]. Innovation Ecosystem - Jiangbei New Area is focused on creating an integrated ecosystem that combines education, research, industry, and application, fostering a collaborative environment for innovation [5]. - The area has seen significant investment from venture capital, supporting the growth of local companies and enhancing the overall innovation landscape [5]. Community and Lifestyle - The demographic profile of Jiangbei New Area shows a high concentration of highly educated individuals, with over 30% of the local population holding advanced degrees [6]. - The community is actively engaged in various cultural and educational activities, contributing to a vibrant lifestyle that attracts young talent [6]. Infrastructure Development - The construction of Nanjing North Station as a major transportation hub is expected to enhance connectivity and attract resources, further supporting the innovation ecosystem in Jiangbei New Area [7]. Conclusion - Jiangbei New Area is positioned as a rising highland in Jiangsu, with a strong focus on biopharmaceuticals and semiconductors, supported by a robust educational framework and community engagement [8].
科笛-B股东将股票存入华泰香港 存仓市值2.86亿港元
Zhi Tong Cai Jing· 2025-09-08 00:27
Group 1 - The latest data from the Hong Kong Stock Exchange shows that on September 5, shareholders of Kedi-B (02487) deposited shares into Huatai Hong Kong, with a market value of HKD 286 million, accounting for 8.26% [1] - Kedi-B announced that the placement was completed on September 5, 2025, in accordance with the terms and conditions of the placement agreement [1] - The placement agent successfully placed a total of 28.904 million shares to TruMed Health Innovation Fund LP, Octagon Investments Master Fund LP, and Octagon Private Opportunities Fund II LP, at a price of HKD 8.40 per share [1] Group 2 - The total amount raised from the placement is approximately HKD 243 million, with a net amount of about HKD 240 million [1]