KINTOR PHARMA(09939)

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开拓药业-B(09939):KX-826与米诺地尔联合治疗中国成年男性雄激素脱发临床观察试验结果显著优于米诺地尔单药
智通财经网· 2025-05-02 00:23
有效性方面。与米诺地尔组相比,联合用药组显示出统计学显著的疗效优势及临床意义。治疗24周后, 联合用药组的TAHC较基线增加30.54根/cm2,较米诺地尔酊组增加10.29根/cm2,结果具有统计学意义 (P=0.0075)。第24周TAHC较基线变化≤0根/cm2共有4例患者,全部为米诺地尔组。第24周TAHC较基线 变化≥20根/cm2共有49例患者,即联合用药组30例和米诺地尔组19例。第24周TAHC较基线变化≥40 根/cm2共有11例患者,即联合用药组10例和米诺地尔组1例。 与米诺地尔组相比,联合用药组的研究者和受试者的HGA指标均有数值上的增加。第24周HGA研究者 评估=3分共有24例患者,即联合用药组14例和米诺地尔组10例。第24周HGA受试者评估=3分共有15例 患者,即联合用药组8例和米诺地尔组7例。 安全性方面。联合用药组在临床观察试验显示出良好的安全性和耐受性,两组在治疗过程中发生的不良 事件相当。此外,该试验未观察到非预期不良事件。 智通财经APP讯,开拓药业-B(09939)发布公告,有关KX-826与米诺地尔联合治疗中国成年男性雄激素 性脱发("AGA"或"脱发")的Ib ...
开拓药业-B(09939) - 2024 - 年度财报
2025-04-29 12:42
開拓藥業有限公司 KINTOR PHARMACEUTICAL LIMITED * Stock Code 股份代號 : 9939 (於開曼群島註冊成立的有限責任公司) (Incorporated in the Cayman Islands with limited liability) 2024年報 Annual Report *For identification purpose only 僅 供 https://www.kintor.com.cn 識 CAL LIMITED 開拓藥業有限公司 * 2024 Annual Report 別 KINTOR PHARMACEUTICAL LIMITED 開拓藥業有限公司* KIN TOR PHARM ACEUTI 年報 CONTENTS 目錄 Directors' Report 87 董事會報告 Independent Auditor's Report 115 獨立核數師報告 Consolidated Statement of Comprehensive Income 123 綜合全面收益表 Consolidated Statement of Financial ...
开拓药业-B(09939)获行政总裁童友之增持145万股
智通财经网· 2025-04-17 10:23
公告称,本次增持事项彰显童博士对公司的商业化前景及增长潜力的坚定信心以及对公司长期投资价值 的充分认可。集团将继续围绕皮肤科领域,深耕现有化妆品产品,拓宽产品覆盖场景,加快推动新化妆 品产品,进一步丰富产品矩阵。同时,考虑到功效性原料的市场潜力,公司正在积极开拓 KT-939 和 KX-826 化妆品原料市场,寻求与化妆品品牌商的合作机会,持续拓展化妆品塬料业务以培育新利润增 长点。 智通财经APP讯,开拓药业-B(09939)发布公告,该公司董事会主席、执行董事兼行政总裁童友之博士于 2025 年 3 月 28 日通过其全资拥有公司 KT International Investment Limited 于公开市场以自有资金 25.9 万 港元(平均成交价格为每股 1.295 港元)增持公司 20万 股股份,占公司于本公告日期已发行股本总额 约 0.0447%。此外,童博士行使了根据公司 2020 年雇员激励计划授予的 125万 份受限制股票单位(对应 公司 125万 股普通股)所赋予的权利。该等股票已于 2025 年 3 月 31 日完成归属。紧随本次增持事项 后,童博士于合共 4920.03万 股股份中 ...
开拓药业-B(09939) - 2024 - 年度业绩
2025-03-26 13:49
Financial Performance - The group's revenue increased from RMB 0 million for the year ended December 31, 2023, to RMB 5.0 million for the year ended December 31, 2024, primarily due to global sales of the new high-end cosmetic brand KOSHINÉ[3]. - The net loss decreased by RMB 905.5 million or 85.4% from RMB 1,060.8 million for the year ended December 31, 2023, to RMB 155.3 million for the year ended December 31, 2024, mainly due to reduced R&D costs[3]. - The total loss for the year ending December 31, 2024, was RMB 155.3 million, down from RMB 1,060.8 million for the year ending December 31, 2023[47]. - The adjusted loss and total comprehensive loss for the year ended December 31, 2024, was RMB 164.4 million, a significant improvement from RMB 1,037.8 million in 2023, reflecting a reduction of approximately 84.2%[63]. - The company reported a net loss of RMB 155,292,000 for 2024, significantly improved from a loss of RMB 1,060,820,000 in 2023, representing a reduction of approximately 85.3%[110]. - Basic loss per share improved to RMB (0.36) in 2024 from RMB (2.47) in 2023, indicating a positive trend[110]. Research and Development - R&D costs decreased by RMB 860.8 million or 91.7% from RMB 938.9 million for the year ended December 31, 2023, to RMB 78.1 million for the year ended December 31, 2024, due to a significant reduction in inventory impairment provisions[4]. - The company has five potential first-in-class/best-in-class drug candidates in clinical phases I-III and one new ingredient KT-939 in the whitening field[9]. - KX-826 has received approval for multiple clinical trials, including a combination treatment for male pattern hair loss, with significant milestones achieved in 2024[9]. - The company has developed 5 clinical-stage drugs and 1 new ingredient, obtaining clinical trial approvals in China, the US, and other regions[20]. - The R&D costs for the two core products KX-826 and GT20029 amounted to RMB 61.0 million, representing nearly 80% of total R&D expenditures[57]. Clinical Trials and Drug Development - The company announced the completion of the first patient enrollment in the Phase III clinical trial of KX-826 1.0% for treating male pattern hair loss in China, with an expected completion date by the end of 2025[12]. - The long-term safety Phase III clinical trial of KX-826 for hair loss in China achieved its primary endpoint, demonstrating statistical significance and clinical relevance, with excellent safety and efficacy results[12]. - The company has initiated a combination therapy trial of KX-826 with minoxidil for hair loss, which is expected to further explore the value of KX-826 in this area[16]. - The Phase II clinical trial for female hair loss in China showed clinically meaningful and statistically significant results in promoting hair growth[22]. - The Phase II clinical trial for GT20029 in treating acne has commenced with the first subject enrolled, using doses of 0.5% QD and 1% QD[32]. Marketing and Sales - Marketing costs increased by RMB 19.6 million or 280.3% from RMB 7.0 million for the year ended December 31, 2023, to RMB 26.6 million for the year ended December 31, 2024, mainly due to increased marketing and promotional expenses for the cosmetics business[5]. - The company is actively expanding its online sales channels, focusing on platforms like Tmall, JD.com, Douyin, and Xiaohongshu to enhance its digital marketing strategy[14]. - The company launched the KOSHINÉ brand, generating sales revenue of RMB 5.0 million during the reporting period, with a total of six products now available, including hair loss and acne treatment products[13]. - The company is focusing on customer resource expansion and member management to improve repurchase rates and member contribution to revenue[119]. - The company plans to enhance its commercialization capabilities and expand its product offerings in the dermatology field, focusing on market promotion and global expansion[46]. Financial Position and Liquidity - As of December 31, 2024, the group had cash and cash equivalents of RMB 147.4 million and unused bank credit facilities of RMB 35.6 million[5]. - Cash and cash equivalents decreased by RMB 308.9 million or 67.7% from RMB 456.3 million as of December 31, 2023, to RMB 147.4 million as of December 31, 2024[66]. - The current ratio dropped from 210.3% as of December 31, 2023, to 103.0% as of December 31, 2024, primarily due to the decrease in cash and cash equivalents[66]. - The net cash used in operating activities for the year ended December 31, 2024, was RMB 199.1 million, compared to RMB 387.6 million in 2023, indicating a reduction of approximately 48.6%[70][71]. - The company has secured a bank credit facility renewal of RMB 70,000,000, with RMB 35,000,000 drawn down as of March 2025[93]. Corporate Governance and Future Plans - The board has resolved not to declare any final dividend for the year ended December 31, 2024[6]. - The company is exploring potential collaboration opportunities to accelerate the commercialization of its pipeline across various disease areas[18]. - The company is committed to adhering to international financial reporting standards, ensuring transparency and accuracy in its financial disclosures[143]. - The company is actively pursuing new drug applications (NDA) to expedite the approval process for its innovative therapies[143]. - The company is in a transitional phase from R&D to commercialization for its cosmetic products, with plans to allocate more resources for market expansion[118].
开拓药业-B(09939) - 2024 - 中期财报
2024-09-26 22:09
KIN TOR PHARM ACEUTI CAL LIMITED 開拓藥業有限公司 開拓藥業有限公司* KINTOR PHARMACEUTICAL LIMITED 2024 2024 中期報告 INTERIM REPORT 中期報告 INTERIM REPORT 2024 INTERIM REPORT 中期報告 開拓藥業有限公司 KINTOR PHARMACEUTICAL LIMITED * Stock Code 股份代號 : 9939 (於開曼群島註冊成立的有限責任公司) (Incorporated in the Cayman Islands with limited liability) * For identification purpose only 僅供識別 https://www.kintor.com.cn | --- | --- | --- | |-------------------------------------------------------------------|-------|-------------------------------------------------- ...
开拓药业-B(09939) - 2024 - 中期业绩
2024-08-26 12:55
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何聲明,並明確表示,概不對因本公告全部或任何部分內容而產生或 因倚賴該等內容而引致的任何損失承擔任何責任。 本公告載有涉及風險及不明確因素的前瞻性陳述。除過往事實陳述以外的所有陳述均為前瞻 性陳述。該等陳述涉及已知及未知的風險、不明確因素及其他因素,當中部分並非本公司所 能控制,且可導致實際業績、表現或成果與該等前瞻性陳述所明示或暗示者存在重大差異。 閣 下不應依賴前瞻性陳述作為未來事件的預測。本公司概不承擔任何更新或修訂任何前瞻性陳 述的責任,無論是否由於新資料、未來事件或其他因素所致。 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) 截至2024年6月30日止六個月之 中期業績公告 本公司董事(「董事」)會(「董事會」)欣然宣佈本集團截至2024年6月30日止六個 月的未經審核中期簡明綜合業績,連同截至2023年6月30日止六個月的比較數字。 – 1 – | --- | ...
开拓药业-B(09939) - 2023 - 年度财报
2024-04-29 04:11
Independent Auditor's Report 122 獨立核數師報告 (Incorporated in the Cayman Islands with limited liability) (於開曼群島註冊成立的有限責任公司) Stock Code 股份代號 : 9939 Company Profile 2 公司簡介 Consolidated Statement of Changes in Equity 136 綜合權益變動表 Definitions and Glossary of Technical Terms 254 釋義及技術詞彙 Financial Highlights 9 財務摘要 Corporate Governance Report 70 企業管治報告 KINTOR PHARMACEUTICAL LIMITED ANNUAL REPORT 2023 2 GT0486 is an inhibitor of the PI3K/mTOR signalling pathway and a second generation mTOR inhibitor. We are currently d ...
开拓药业-B(09939) - 2023 - 年度业绩
2024-03-28 12:11
Financial Performance - The company reported total losses of RMB 954.4 million and RMB 1,060.8 million for the years ending December 31, 2022, and December 31, 2023, respectively, primarily due to R&D costs and administrative expenses[63]. - The company reported a total comprehensive loss attributable to equity holders of RMB 1,060.8 million for the year ended December 31, 2023, compared to a loss of RMB 954.4 million in the previous year[153]. - For the fiscal year ended December 31, 2023, the company reported a net loss of RMB 1,060,820,000, compared to a net loss of RMB 954,369,000 for the same period in 2022, reflecting an increase in losses of approximately 11.1%[190]. - The basic loss per share for the year ended December 31, 2023, was RMB (2.47), slightly improved from RMB (2.53) in 2022, indicating a reduction in loss per share by 2.4%[190]. - The company recognized a net loss of RMB 29 million due to foreign exchange losses during the reporting period[103]. - The company recorded a loss of RMB 3.1 million in foreign exchange for 2023, compared to a gain of RMB 16.3 million in 2022, indicating a significant shift in foreign exchange performance[185]. Clinical Trials and Drug Development - The company announced the successful completion of the U.S. Phase II clinical trial for KX-826 in treating male pattern hair loss, showing statistically and clinically significant results after 24 weeks of treatment[3]. - The company received approval for the Phase Ib/III clinical trial of KX-826 combined with minoxidil for treating male pattern hair loss in China[4]. - The Phase II clinical trial for GT20029 in treating hair loss has completed enrollment of 180 subjects, with top-line data results expected soon[6]. - GT20029 is the first topical PROTAC compound to enter Phase II clinical trials globally, demonstrating good safety and pharmacokinetic characteristics in previous trials[8]. - KX-826 demonstrated a statistically significant increase of 11.39 hairs per square centimeter compared to placebo after 24 weeks of treatment[14]. - The long-term safety Phase III clinical trial for KX-826 has completed enrollment of 271 male and female hair loss patients, with a treatment duration of 52 weeks[17]. - The KX-826 treatment for male androgenetic alopecia completed a Phase III clinical trial in China, showing a statistically significant increase in hair growth with an average increase of 22.73 hairs/cm² compared to baseline after 24 weeks of treatment (P<0.001)[39]. - The Phase II clinical trial for GT20029, a new generation treatment for hair loss and acne, has shown significant efficacy in promoting hair growth and reducing acne lesions in preclinical studies[46]. - The company is preparing to initiate Phase II clinical trials for GT20029 in treating acne based on positive results from Phase I trials[8]. - The company has developed a pipeline of six clinical-stage drugs, including KX-826 and GT20029, which are progressing through clinical trials in China, the United States, and other regions[36]. - The company is actively seeking commercialization pathways for its core products, with cash reserves expected to support clinical and R&D advancements necessary for product commercialization[27]. - The company is focused on developing a diversified pipeline of drugs to meet substantial clinical demands, with a strong emphasis on AR-targeted therapies[36]. - The company has initiated a long-term safety Phase III clinical trial for KX-826 and a combination trial with minoxidil, aiming to further explore the treatment's efficacy in hair loss[34]. - The company is continuing to explore two core drugs, KX-826 and GT20029, for the treatment of hair loss and acne, with KX-826 showing an average increase of up to 22.7 hairs/cm² in over 1,000 trial participants[199]. - GT20029 is the first topical PROTAC compound to enter Phase II clinical trials globally, with plans to disclose top-line results from the Chinese hair loss Phase II clinical trial soon[199]. Administrative and Operational Expenses - Administrative expenses decreased by RMB 45.8 million or 34.6% to RMB 86.4 million for the year ended December 31, 2023, primarily due to reduced employee compensation and equity incentive costs[1]. - Employee benefits expenses amounted to RMB 38.9 million, representing 43.7% of total administrative expenses, while share-based compensation expenses were RMB 10.7 million, accounting for 12.0%[67]. - Total administrative expenses decreased by RMB 45.8 million or 34.6% to RMB 86.4 million, excluding impairment effects, compared to RMB 132.2 million for the year ended December 31, 2022[68]. - Marketing costs decreased from RMB 203 million in 2022 to RMB 70 million in 2023, a drop of RMB 133 million or 65.5%[110]. - Research and development costs, excluding impairment and write-downs, decreased from RMB 735 million in 2022 to RMB 246 million in 2023, a decline of RMB 489 million or 66.6%[102]. - R&D expenses increased by RMB 110.9 million or 13.4% to RMB 938.9 million for the year ended December 31, 2023, primarily due to inventory impairment provisions and impairment tests on intangible assets[115]. Financial Position and Liquidity - As of December 31, 2023, the company's cash and cash equivalents, along with time deposits, amounted to RMB 456.3 million, with unused bank financing of RMB 110.5 million[27]. - Cash and cash equivalents decreased to RMB 444.0 million as of December 31, 2023, from RMB 864.5 million at the end of the previous year[124]. - The current ratio dropped from 474.0% to 210.3% due to the decrease in cash and cash equivalents and inventory impairment provisions[136]. - The company had no significant investments or acquisitions during the reporting period[123]. - The company's total liabilities decreased from RMB 559.9 million as of December 31, 2022, to RMB 411.1 million as of December 31, 2023[155]. - The company's cash and cash equivalents exceeded total borrowings as of December 31, 2023, indicating a favorable liquidity position[145]. - The company had bank borrowings totaling RMB 83.0 million in long-term loans and RMB 20.0 million in short-term loans as of December 31, 2023[144]. - The company reported a total asset value of RMB 869.2 million as of December 31, 2023, down from RMB 2,055.1 million in 2022, indicating a decrease of approximately 57.7%[176]. - Non-current assets decreased to RMB 396.7 million in 2023 from RMB 547.3 million in 2022, a decline of about 27.5%[176]. - Current assets fell to RMB 472.6 million in 2023, compared to RMB 1,507.9 million in 2022, representing a decrease of approximately 68.7%[176]. - The company had a net liquidity position of RMB 247.8 million as of December 31, 2023, indicating sufficient cash and cash equivalents to meet financial obligations[174]. Corporate Governance and Future Outlook - The board of directors resolved not to declare any final dividend for the year ended December 31, 2023[2]. - The company plans to commercialize core products in the dermatology field through external licensing partnerships[92]. - The company has not commercialized any investigational drugs as of the announcement date[92]. - The company is actively seeking commercialization and overseas collaboration opportunities for GT0918, including regulatory approvals for COVID-19 indications[49]. - The company plans to seek collaboration opportunities across various aspects of drug development, including preclinical technologies and clinical combination therapies, to expedite commercialization[200]. - The company has established an integrated R&D platform to support drug development from discovery to clinical trials[60]. - The company aims to address significant unmet clinical needs in dermatology, particularly in hair loss and acne, which affect millions globally[36].
开拓药业-B(09939) - 2023 - 年度业绩
2023-09-28 09:24
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何聲明,並明確表示,概不對因本公告全部或任何部分內容而產生或 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) 2022年度報告及2023中期報告補充公告 茲提述:(1)開拓藥業有限公司*(「公司」)於2023年4月28日發佈的截至2022 年 12月31日止的2022 年度報告(「2022年度報告」);及(2)公司於2023 年9月27日發 佈的截至2023年6月30日止六個月的2023中期報告(「2023中期報告」)。除另有 界定者外,本公告所用詞條與2022年度報告及2023中期報告所界定者具有相同 涵義。 2022年度報告補充資料 本董事會謹此提供截至2022年12月31日止財政年度有關全球發售及2021年先舊 後新配售所募集資金的使用明細及說明的2022年度報告補充資料,詳情以底線 標記如下: ...
开拓药业-B(09939) - 2023 - 中期财报
2023-09-27 08:30
Government grants relating to the purchase of property, plant and equipment are included in liabilities as deferred income and they are credited to profit or loss on a straight-line basis over the expected lives of the related assets. 附註: KINTOR PHARMACEUTICAL LIMITED INTERIM REPORT 2023 52 NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION 簡明綜合中期財務資料附註 | --- | --- | --- | --- | |-----------------------------------------------|---------------------------------|------------------------|------- ...