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开拓药业-B(09939):KT-939人体长期安全性试验完成全部受试者入组
智通财经网· 2025-09-08 22:26
Core Viewpoint - The company has completed the long-term safety trial for its new tyrosinase inhibitor KT-939, which effectively inhibits melanin production and has antioxidant and anti-inflammatory properties, positioning it as a promising new ingredient for cosmetics [1][2]. Group 1: Trial Details - The long-term safety trial is an open-label, single-arm, single-center study aimed at assessing the potential adverse skin reactions from long-term use of cosmetics containing 0.2% KT-939 over 48 weeks [2]. - The trial received ethical approval from the Shanghai Skin Disease Hospital in mid-August, with Professor Tan Yimei as the principal investigator [2]. - The main endpoints of the trial include monitoring all adverse events reported by participants and those observed by the research institution during the trial [2]. Group 2: Safety and Efficacy - KT-939 has completed multiple safety and toxicology assessments, as well as a 28-day efficacy trial, showing good performance in both efficacy and safety [2]. - The company is preparing to submit a registration application to the National Medical Products Administration (NMPA) in China in the third quarter of next year, based on comparisons with other common whitening agents [2]. Group 3: Market Potential - KT-939 is expected to become the first domestically developed whitening cosmetic ingredient approved in China, marking a significant milestone in achieving complete independent intellectual property rights in this field [3]. - The company has officially launched nationwide recruitment for strategic partnerships with whitening cosmetic brands to jointly promote product development and market positioning [3]. - According to Chinese cosmetic regulations, whitening products must obtain special registration before being marketed, and the government encourages simultaneous registration applications for effective cosmetics and innovative ingredients [3].
开拓药业-B:KT-939人体长期安全性试验完成全部受试者入组
Zhi Tong Cai Jing· 2025-09-08 22:20
Core Viewpoint - The company has completed the long-term safety trial for its newly developed tyrosinase inhibitor KT-939, which effectively inhibits melanin production and has antioxidant and anti-inflammatory properties, positioning it as a promising new ingredient for cosmetics [1][2]. Group 1: Trial Details - The long-term safety trial is an open-label, single-arm, single-center study aimed at assessing the potential adverse skin reactions from long-term use of cosmetics containing 0.2% KT-939 over 48 weeks [2]. - The trial received ethical approval from the Shanghai Skin Disease Hospital in mid-August, with Professor Tan Yimei as the principal investigator [2]. - The primary endpoints include all adverse events reported by participants and those observed by the research institution during the trial [2]. Group 2: Safety and Efficacy - KT-939 has completed multiple safety and toxicology assessments, as well as a 28-day efficacy trial, showing good performance in both efficacy and safety [2]. - The company is preparing for the registration application of KT-939, aiming to submit it to the National Medical Products Administration in the third quarter of next year [2]. Group 3: Market Position and Strategy - KT-939 is expected to become the first domestically developed and approved whitening cosmetic ingredient in China, marking a significant milestone in the field of independent intellectual property rights [3]. - The company has officially launched nationwide recruitment for strategic partnerships with whitening cosmetic brands to jointly promote product development and market positioning [3].
开拓药业(09939) - 自愿公告 - KT-939人体长期安全性试验完成全部受试者入组
2025-09-08 22:07
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之內容概不負責,對其準確 性或完整性亦不發表任何聲明,並明確表示概不就因本公告全部或任何部份內容而產生或因 倚賴該等內容而引致的任何損失承擔任何責任。 開 拓 藥 業 有 限 公 司 * KINTOR PHARMACEUTICAL LIMITED ( 於 開 曼 群 島 註 冊 成 立 的 有 限 公 司 ) (股 份 代 號:9939) 自願公告 KT-939人體長期安全性試驗完成全部受試者入組 本公告由開拓藥業有限公司*(「本公司」,連同其附屬公司統稱「本集團」)自願 刊發,以知會本公司股東及潛在投資者有關本集團的最新進展。 本公司董事(「董事」)會(「董事會」)欣然宣佈,其自主研發的抑制黑色素生成 的新型高效酪氨酸酶抑制劑KT-939的人體長期安全性試驗(「該項長期安全性 試驗」)已於近日完成全部130名受試者入組。KT-939能夠精準鎖定酪氨酸酶, 高效阻斷酪氨酸的氧化進程,進而有效遏制黑色素生成,同時兼具抗氧化和抗 炎作用,在化妝品的功效活性和安全性方面有突出優勢。 根據2021年頒佈的《化妝品監督管理條例》,在我國國家藥品監督管理局(「藥監 ...
KT International Investment Limited增持开拓药业-B(09939)20万股 每股作价2.2港元
智通财经网· 2025-09-04 12:57
Group 1 - KT International Investment Limited increased its stake in Kintor Pharmaceutical Limited (09939) by purchasing 200,000 shares at a price of HKD 2.2 per share, totaling HKD 440,000 [1] - After the acquisition, KT International's total shareholding in Kintor Pharmaceutical is approximately 48.25 million shares, representing a new ownership percentage of 10.31% [1]
KT International Investment Limited增持开拓药业-B20万股 每股作价2.2港元
Zhi Tong Cai Jing· 2025-09-04 12:56
Group 1 - KT International Investment Limited increased its stake in Kintor Pharmaceutical Limited (09939) by purchasing 200,000 shares at a price of HKD 2.2 per share, totaling HKD 440,000 [1] - After the acquisition, KT International's total shareholding in Kintor Pharmaceutical is approximately 48.25 million shares, representing a holding percentage of 10.31% [1]
开拓药业(09939) - 截至二零二五年八月三十一日止月份之股份发行人的证券变动月报表
2025-09-02 08:44
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 II. 已發行股份及/或庫存股份變動 | 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) | 09939 | 說明 | | | | | | | | | 已發行股份(不包括庫存股份)數目 | | 庫存股份數目 | | 已發行股份總數 | | | 上月底結存 | | | 447,499,600 | | 0 | | 447,499,600 | | 增加 / 減少 (-) | | | 20,673,000 | | 0 | | | | 本月底結存 | | | 468,172,600 | | 0 | | 468,172,600 | 第 2 頁 共 10 頁 v 1.1.1 | 截至月份: | 2025年8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: | ...
开拓药业-B(09939.HK)公布中期业绩 进一步推动化妆品在全球商业化
Ge Long Hui· 2025-08-28 16:47
Group 1 - The company reported an increase in revenue from RMB 0 million to RMB 6.0 million for the six months ending June 30, 2025, primarily driven by global sales of its new high-end cosmetics brand KOSHINé [1] - Research and development costs rose by RMB 9.3 million or 23.6% from RMB 39.3 million for the six months ending June 30, 2024, to RMB 48.6 million for the six months ending June 30, 2025, due to a focus on core dermatology pipelines KX-826 and GT20029 [1] - The company has five potential first-in-class/best-in-class drug candidates in clinical stages I-III and one new whitening ingredient KT-939, with significant progress in clinical trials for KX-826 and GT20029 in China [1] Group 2 - The company is in a transitional phase from research and development to commercialization of its cosmetics, planning to allocate more resources to explore various methods, including launching new products and increasing promotion in both domestic and overseas markets [2] - Future strategies include deepening partnerships with leading e-commerce platforms such as Tmall, JD.com, Douyin, Xiaohongshu, and Amazon, and establishing a diversified sales channel system [2] - The company aims to enhance customer resource expansion and loyalty through various promotional activities and refined membership management, including hosting exclusive member events and collaborating with selected KOLs and KOCs to accelerate online sales growth [2]
开拓药业-B公布中期业绩 净亏损8326.8万元 同比增长16.47%
Zhi Tong Cai Jing· 2025-08-28 15:00
开拓药业-B(09939)公布2025年中期业绩,收益由去年同期0元增至600万元,净亏损8326.8万元,同比增 长16.47%;每股亏损0.19元。 公告称,收益增加主要由于全新高端化妆品品牌KOSHIN化妆品的全球销售。集团将持续探索不同的方 法,进一步推动公司化妆品在全球商业化。亏损增加主要由于集团研发成本及营销成本增加。 ...
开拓药业-B(09939)公布中期业绩 净亏损8326.8万元 同比增长16.47%
智通财经网· 2025-08-28 14:54
Core Viewpoint - The company reported a significant increase in revenue for the first half of 2025, driven by the global sales of its new high-end cosmetics brand KOSHINÉ, despite an increase in net loss due to rising R&D and marketing costs [1] Financial Performance - Revenue increased from 0 to 6 million yuan compared to the same period last year [1] - Net loss amounted to 83.268 million yuan, representing a year-on-year increase of 16.47% [1] - Earnings per share reported a loss of 0.19 yuan [1] Strategic Initiatives - The company plans to continue exploring various methods to further commercialize its cosmetics globally [1]
开拓药业(09939) - 2025 - 中期业绩
2025-08-28 14:15
[Announcement Summary](index=1&type=section&id=Announcement%20Summary) [Financial Highlights](index=2&type=section&id=Financial%20Highlights) H1 2025 revenue reached **RMB 6.0 million** from cosmetics sales, but net loss widened by **16.5%** to **RMB 83.3 million**, driven by increased R&D and marketing expenses H1 2025 Financial Highlights | Metric | For the six months ended June 30, 2025 (RMB million) | For the six months ended June 30, 2024 (RMB million) | Change (RMB million) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Revenue | 6.0 | 0.0 | 6.0 | N/A | | Net Loss | (83.3) | (71.5) | (11.8) | 16.5% | | R&D Costs | (48.6) | (39.3) | (9.3) | 23.6% | | Administrative Expenses | (25.2) | (33.9) | 8.7 | (25.6%) | | Marketing Costs | (8.3) | (1.8) | (6.5) | 369.0% | | Cash and Cash Equivalents (End of Period) | 52.9 | - | - | - | - The Board resolved **not to declare any interim dividend** for the six months ended June 30, 2025[3](index=3&type=chunk) [R&D Milestones and Achievements](index=3&type=section&id=R%26D%20Milestones%20and%20Achievements) The company's core dermatological pipelines, KX-826 and GT20029, achieved positive clinical progress in alopecia and acne indications, while new raw material KT-939 also launched global sales, forming a 'three-pronged' business model [KX-826](index=3&type=section&id=KX-826) KX-826 topical solution for Chinese alopecia showed positive topline data in long-term safety Phase III, combination therapy observation, and pivotal Phase II trials, demonstrating excellent safety and efficacy; Phase III has enrolled **666 patients**, expected to complete by early 2026 - KX-826 topical solution for Chinese alopecia's long-term safety Phase III clinical trial achieved topline data, meeting primary endpoints with statistically significant and clinically meaningful results, demonstrating excellent safety and efficacy[4](index=4&type=chunk) - The clinical observation study of KX-826 combined with minoxidil for Chinese adult male alopecia met its primary endpoint, aiming to optimize future formal Phase III clinical trial design[4](index=4&type=chunk) - KX-826 topical solution **1.0%** for alopecia's pivotal Phase II clinical trial achieved topline data, meeting primary endpoints with statistically significant and clinically meaningful results, demonstrating excellent efficacy and safety[4](index=4&type=chunk) - KX-826 topical solution **1.0%** for alopecia's pivotal Phase III clinical trial has completed enrollment of **666 patients**, expected to finish by early 2026[4](index=4&type=chunk) [AR-PROTAC Compound (GT20029)](index=4&type=section&id=AR-PROTAC%20Compound%20%28GT20029%29) GT20029 gel for acne's China Phase II clinical trial reported topline data, successfully meeting primary endpoints with excellent efficacy, safety, and PK characteristics, and determined the recommended Phase III dose at **0.5%** - AR-PROTAC compound GT20029 gel for acne's China Phase II clinical trial reported topline data, successfully meeting primary endpoints with excellent efficacy, safety, and PK characteristics, and determined the recommended Phase III dose at **0.5%**[5](index=5&type=chunk) [New Raw Material (KT-939)](index=4&type=section&id=New%20Raw%20Material%20%28KT-939%29) KT-939, a whitening and spot-reducing cosmetic active ingredient, completed its first sale, marking the launch of the company's B2B active cosmetic ingredient business and forming a 'three-pronged' business model - KT-939 as a whitening and spot-reducing cosmetic active ingredient completed its first sale, marking the launch of global sales for active ingredients[6](index=6&type=chunk) - The company has formed a 'three-pronged' business model encompassing B2B active cosmetic ingredient business, B2C active cosmetic product business, and topical innovative drug R&D business[6](index=6&type=chunk) [Management Discussion and Analysis](index=4&type=section&id=Management%20Discussion%20and%20Analysis) [Business Overview](index=4&type=section&id=Business%20Overview) The company is a clinical-stage innovative drug enterprise focused on dermatology and functional cosmetics, with 5 drug candidates in Phase I-III clinical trials; its cosmetics business complements drug R&D by providing funding and market data, with core products KX-826 and GT20029 advancing to Phase II/III and Phase II, respectively, and the high-end cosmetics brand KOSHINÉ launched in H2 2024 - The company is a clinical-stage innovative drug enterprise in China focused on addressing unmet clinical needs and extending into functional cosmetics[7](index=7&type=chunk) - The cosmetics business provides funding for drug R&D activities and market data for future drug sales strategies[7](index=7&type=chunk) - The company has **5** potential first-in-class/best-in-class drug candidates in Phase I-III clinical stages, with a pipeline primarily covering dermatological (e.g., alopecia, acne) and oncology indications[7](index=7&type=chunk) - In H2 2024, the company officially launched sales of its new high-end cosmetics brand KOSHINÉ, with a total of **eight** products currently on the market, including anti-hair loss liquid series, anti-acne cream, and whitening series[8](index=8&type=chunk) - The company has developed a multi-channel digital marketing strategy, expanding to traditional e-commerce platforms like Tmall and JD.com, actively deploying on emerging content-driven e-commerce platforms like Douyin and Xiaohongshu, and also expanding global sales channels such as Amazon US[8](index=8&type=chunk)[9](index=9&type=chunk) [Corporate Strategy and Product Pipeline](index=4&type=section&id=Corporate%20Strategy%20and%20Product%20Pipeline) The company's strategy focuses on dermatology and functional cosmetics, aiming to develop first-in-class/best-in-class drugs to address unmet clinical needs; the cosmetics business supports drug R&D with funding and market insights, with **5** drug candidates in Phase I-III clinical trials, and core products KX-826 and GT20029 in Phase II/III - The company is committed to becoming a leader in the research, development, and commercialization of innovative therapies and high-end cosmetics[7](index=7&type=chunk) - The pipeline primarily covers dermatological (e.g., alopecia, acne) and oncology indications, with cosmetic categories including anti-hair loss, anti-acne, and whitening products[7](index=7&type=chunk) - Two core products, KX-826 and GT20029, have advanced to Phase II/III and Phase II clinical trials, respectively[7](index=7&type=chunk) [Cosmetics Business Development and Marketing Strategy](index=5&type=section&id=Cosmetics%20Business%20Development%20and%20Marketing%20Strategy) Since H2 2024, the company officially launched sales of its high-end cosmetics brand KOSHINÉ, with eight products already on the market; through outsourced production and prioritizing online sales channels, the company implements multi-channel digital marketing strategies, including traditional e-commerce platforms and content-driven platforms, and actively expands into overseas markets like Amazon US, to enhance brand awareness and market penetration - The KOSHINÉ brand has launched **eight** products, including anti-hair loss liquid series, anti-acne cream, and whitening series, with the KX-826-based anti-acne cream and KT-939-based whitening series launched in early 2025[8](index=8&type=chunk) - The company outsources cosmetics production, prioritizes online sales channels, and has developed a multi-channel digital marketing strategy[8](index=8&type=chunk) - Through data-driven precise advertising, conversion rates on major platforms like Tmall Global, Douyin Flagship Store, and JD Worldwide have significantly improved[9](index=9&type=chunk) - The company highly values fostering deep consumer interaction on high-quality content platforms like Xiaohongshu and WeChat, achieving a closed-loop marketing model of 'content seeding—brand cultivation—sales conversion'[9](index=9&type=chunk) [Core Products and R&D Progress](index=6&type=section&id=Core%20Products%20and%20R%26D%20Progress) The company deeply focuses on AR targets in dermatology, with core products KX-826 and GT20029 achieving multiple positive clinical advancements in alopecia and acne indications, including completing several Phase II/III clinical trials and obtaining topline data; concurrently, other pipeline products such as GT1708F, ALK-1 antibody, GT0486, and c-Myc molecular glue have also progressed in oncology and other disease areas, and new raw material KT-939 has initiated commercialization - The company possesses a risk-balanced and diversified portfolio of drug candidates, committed to addressing numerous unmet clinical needs with significant market potential[13](index=13&type=chunk) - The company has developed **5** clinical-stage drugs and **1** new raw material, obtaining clinical trial approvals in China (including Taiwan), the US, and other countries and regions[14](index=14&type=chunk) [KX-826 (AR Antagonist)](index=8&type=section&id=KX-826%20%28AR%E6%8B%AE%E6%8A%97%E5%89%82%29) KX-826 is a topical AR antagonist that treats alopecia and acne by blocking the AR signaling pathway, holding patents globally; for alopecia, several China and US clinical trials showed excellent safety, efficacy, and statistical significance, with China's Phase III trial completing patient enrollment; for acne, China's Phase II trial demonstrated preliminary efficacy and good safety - KX-826 is a topical drug that blocks the AR signaling pathway, reducing the sensitivity of AR in hair follicles and sebaceous glands to androgens, thereby minimizing systemic side effects[14](index=14&type=chunk) - The company holds patents for KX-826 in multiple countries globally and in China, with the core patent valid until September 8, 2030