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 ...

Drug Development and Clinical Trials - Kintor Pharmaceutical has five innovative drug candidates in phase I-III clinical stages, focusing on unmet clinical needs in dermatology and oncology[5]. - Kintor's drug candidates include KX-826 (AR antagonist), GT20029 (AR-PROTAC compound), GT1708F (Hedgehog/SMO inhibitor), GT0486 (PI3K/mTOR inhibitor), and ALK-1 antibody (anti-angiogenesis inhibitor)[6][7][8][9][10]. - The Group plans to complete the phase III clinical trial of KX-826 tincture 1.0% for male adult AGA treatment in China by the end of 2025[32]. - The phase II clinical trial for GT20029 for acne treatment in China is expected to be completed in the second half of 2025[32]. - The phase Ib/III clinical trial of KX-826 in combination with minoxidil for treating male adults with AGA was cleared by NMPA on February 1, 2024[51]. - The clinical trial of KX-826 tincture 1.0% for treating male adult AGA received clearance by NMPA on May 24, 2024, with preclinical studies showing increased retention concentration compared to the previous formulation[51]. - The phase IIa clinical trial of AR-PROTAC compound GT20029 for AGA treatment reached its primary endpoint with significant results on April 21, 2024[53]. - The pivotal phase II/III clinical trial of KX-826 tincture 1.0% for AGA treatment completed the first subject enrollment on October 16, 2024, with the trial expected to be completed by the end of 2025[55]. - The long-term safety phase III clinical trial of KX-826 tincture for AGA treatment achieved its primary endpoint with excellent safety and efficacy results announced on March 20, 2025[55]. - The Company completed the first subject enrollment in the phase II clinical trial of AR-PROTAC compound GT20029 for acne treatment in China on June 17, 2024[56]. - The phase II clinical trial of KX-826 for acne treatment in China involved 160 patients, with treatment success observed in all experimental groups by week 12[97]. - The phase II clinical trial for female AGA in China showed clinically meaningful and statistically significant improvement in hair growth[84]. - The phase II clinical trial for male AGA in the U.S. demonstrated statistically and clinically meaningful results after 24 weeks[84]. - The phase IIa clinical trial of GT20029 for AGA in China reached its primary endpoint, demonstrating statistically significant results and good safety and tolerability[109]. - The phase I clinical trial in the U.S. for GT20029 showed no systemic exposure at all dose levels, with maximum observed concentrations not exceeding 0.015 ng/mL after 14 days of administration[106]. - The phase I clinical trial in China for GT20029 included 92 healthy subjects, with no detectable drug concentrations after single dose administration and maximum concentrations below 0.05 ng/mL after multiple doses[105]. - GT1708F has completed phase I clinical trials for hematologic malignancies in China and received conditional approval for phase II trials for idiopathic pulmonary fibrosis (IPF)[71]. - The phase I clinical trial of GT1708F for hematologic malignancies included 18 patients, with preliminary efficacy observed starting from the 180mg dose level, showing a reduction of myeloid blasts by up to 62% in AML patients[119]. - The ALK-1 antibody (GT90001) has shown a 40% partial remission rate among 20 evaluable patients in a phase II trial for advanced HCC[124]. - The combination therapy of ALK-1 antibody and Nivolumab demonstrated a good safety profile and promising anti-tumor activity in advanced HCC patients, with durable remissions reported[127]. - GT0486, a second-generation mTOR inhibitor, has received IND approval and completed phase I clinical trials for metastatic solid tumors[128]. Financial Performance - The Group's revenue increased from RMB0 million for the year ended 31 December 2023 to RMB5.0 million for the year ended 31 December 2024, primarily due to global sales of the new high-end cosmetics brand KOSHINÉ[36]. - The Group's net loss decreased by RMB905.5 million or 85.4% from RMB1,060.8 million for the year ended 31 December 2023 to RMB155.3 million for the year ended 31 December 2024, mainly due to a reduction in R&D costs[37]. - R&D costs decreased by RMB860.8 million or 91.7% from RMB938.9 million for the year ended 31 December 2023 to RMB78.1 million for the year ended 31 December 2024, attributed to lower provisions for R&D related inventories and a focus on core dermatology pipelines[38]. - Administrative expenses decreased by RMB27.2 million or 30.6% from RMB89.0 million for the year ended 31 December 2023 to RMB61.8 million for the year ended 31 December 2024, mainly due to reduced employee benefit expenses[39]. - Marketing costs increased by RMB19.6 million or 280.3% from RMB7.0 million for the year ended 31 December 2023 to RMB26.6 million for the year ended 31 December 2024, primarily due to increased marketing and promotion expenses for the cosmetics business[40]. - For the year ended December 31, 2024, the company reported revenue from contracts with customers of RMB 5 million, a gross loss of RMB 4.73 million, and an operating loss of RMB 144.57 million[46]. - The company's total equity decreased to RMB 294.08 million as of December 31, 2024, down from RMB 458.11 million in 2023[47]. - The total comprehensive loss for the year ended December 31, 2024 was RMB155.3 million, a decrease from a loss of RMB1,060.8 million for the year ended December 31, 2023[154]. - The cost of sales for the year ended December 31, 2024 was RMB9.7 million, significantly lower than RMB42.2 million for the year ended December 31, 2023[159]. - Other income increased by RMB1.1 million or 5.2% from RMB20.9 million for the year ended December 31, 2023 to RMB21.9 million for the year ended 31 December 2024, mainly due to a RMB9.0 million increase in government grants[160]. - The adjusted loss for the year ended December 31, 2024, was RMB 164.4 million, compared to RMB 1,037.8 million for the year ended December 31, 2023[192]. - Cash and cash equivalents and time deposits 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[199]. - The current ratio decreased from 210.3% as of December 31, 2023, to 103.0% as of December 31, 2024, mainly due to the decrease in cash and cash equivalents[200]. - The Group utilized bank facilities of RMB 14.4 million and had unutilized bank facilities of RMB 35.6 million as of December 31, 2024[200]. - The company renewed a bank credit quota of RMB70 million in March 2025 and has drawn a bank loan of RMB35 million[158]. - The company is actively seeking equity financing and is in discussions with potential investors regarding subscriptions for new shares[158]. - The company has implemented measures to alleviate liquidity pressure, including renewing bank credit quotas, equity financing, and expanding cosmetics sales channels[72]. Product Development and Commercialization - The company is developing KX-826 and GT20029 as core products for treating androgenic alopecia (AGA) and acne vulgaris, aiming to establish a product matrix in anti-hair loss, acne treatment, and skin whitening[27]. - Kintor launched a new high-end cosmetics brand, KOSHINÉ, marking its transition from R&D to commercialization[27]. - The strategic pivot includes a twin-track strategy focusing on functional cosmetics and innovative topical drugs, enhancing the company's market presence[27]. - The Group aims to accelerate the launch of new cosmetic products and deepen collaborations with leading e-commerce platforms to enhance market penetration[32]. - The Company launched its new high-end cosmetics brand KOSHINÉ on July 10, 2024, with KX-826 as the main ingredient, expected to provide stable revenue and cash flow[55]. - A total of six products have been launched under the KOSHINÉ brand, including anti-hair loss solutions and acne cream, with new products expected in early 2025[61]. - The Company has established a multi-channel digital marketing strategy for its cosmetics business, focusing on both traditional and emerging e-commerce platforms[62]. - The official launch of the topical anti-hair loss solution under the new high-end cosmetics brand KOSHINÉ is expected to provide a solid stream of revenue and cash flow to the Group[90]. - The company is expanding its overseas sales channels, focusing on platforms like Amazon USA to meet global consumer needs[65]. - The company is prioritizing the development of topical compounds based on its PROTAC platform, with GT20029 being the first topical PROTAC compound globally to complete phase IIa clinical stage for AGA[141]. - The company is actively seeking opportunities to accelerate the commercialization of various pipelines both in China and globally[71]. - The company has launched a topical anti-hair loss solution containing KX-826 under its high-end cosmetics brand KOSHINÉ, marking its first commercial sale in dermatology[146]. - The company expects to submit a NDA for KX-826 to the NMPA in 2026, aiming for commercialization by 2027 if successful[150]. - The company plans to allocate more resources to enhance its commercialization capabilities and increase product penetration rates[147]. Research and Development - The company has established an integrated R&D platform to support drug development from discovery to clinical stages[137]. - The R&D work is led by experienced scientists with decades of expertise in pharmaceutical R&D and entrepreneurship[145]. - Employee benefit expenses (including share-based compensation) for R&D decreased by RMB81.7 million, mainly due to a reduction in R&D staff[176]. - Clinical research expenses decreased by RMB73.0 million due to the suspension or hold of one or more clinical trials related to other drug candidates[176]. - R&D costs for the two core products KX-826 and GT20029 accounted for RMB61.0 million, representing nearly 80% of total R&D expenditures during the Reporting Period[177]. - The decrease in R&D costs was mainly due to a reduction of RMB603.9 million in provision for inventories, as no provision for R&D-related inventories was recognized in the Reporting Period[180]. - The company warns that it may not be able to successfully develop and market its drug candidates, except for KX-826 for hair loss[136]. Market and Competitive Position - The product pipeline includes drug candidates targeting significant unmet medical needs, particularly for AGA and acne, affecting hundreds of millions of patients worldwide[75]. - The company has a diversified portfolio of drug candidates in various clinical stages, with significant potential for commercialization in multiple disease areas[75]. - The company owns patents for KX-826 in multiple countries, enhancing its market position[82]. - KX-826 is a targeted topical AR antagonist, addressing significant unmet clinical needs for acne vulgaris treatment in China[95][96]. - KX-826's low AR inhibitory activity in its metabolites helps reduce systemic side effects[80]. - The core patent for KX-826 is valid until September 8, 2030, with ongoing development for tincture and gel formulations[82]. - The company is exploring other potential drug candidates, including ALK-1/VEGF bispecific antibodies for treating blood cancers and solid tumors[135]. - The c-Myc molecular glue has significant R&D potential, with studies published in high-impact journals, indicating its potential in tumor treatment[129].

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 ...

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].

Financial Performance - The net loss decreased by RMB140.6 million or 66.3% from RMB212.1 million for the six months ended June 30, 2023, to RMB71.5 million for the six months ended June 30, 2024, mainly due to reduced research and development costs and administrative expenses [11]. - The total comprehensive loss for the six months ended June 30, 2024, was RMB 71.5 million, compared to RMB 212.1 million for the same period in 2023 [85]. - The loss and total comprehensive loss for the period ended June 30, 2024, was RMB 71.5 million, a significant improvement from RMB 212.1 million for the same period in 2023, representing a reduction of approximately 66.3% [108]. - Adjusted loss and total comprehensive loss for the period was RMB 66.9 million, compared to RMB 170.3 million in the prior year, indicating a decrease of about 60.7% [108]. - The operating loss improved to RMB 66,260,000 from RMB 206,437,000, showing a 67.9% decrease in losses [142]. - The loss before income tax was RMB 71,475,000, down from RMB 212,618,000, a 66.4% improvement [142]. - The company reported a loss of RMB 71,493,000 for the period ending June 30, 2024 [145]. Research and Development - Research and development costs decreased by RMB125.3 million or 76.1% from RMB164.6 million for the six months ended June 30, 2023, to RMB39.3 million for the six months ended June 30, 2024, as the company focused on core dermatology pipelines KX-826 and GT20029 [11]. - The company has six innovative potential first-in-class/best-in-class drug candidates at phase I-III clinical stage [12]. - KX-826's phase Ib/III clinical trial for male AGA treatment in combination with minoxidil was cleared by NMPA on February 1, 2024 [12]. - The phase II clinical trial of AR-PROTAC compound GT20029 for AGA treatment reached its primary endpoint with statistically significant results [13]. - The company completed the phase III clinical trial for male AGA in China and initiated a long-term safety phase III trial for KX-826 [14]. - The company is committed to becoming a leader in the research, development, and commercialization of innovative therapies in dermatology [14]. - The company has developed six clinical-stage drugs, including KX-826, AR-PROTAC compound (GT20029), and others, with approvals for clinical trials in China, the U.S., and other regions [23]. Clinical Trials and Approvals - KX-826 tincture 1.0% clinical trial for male adult AGA in China received NMPA clearance on June 4, 2024, showing significantly increased retention concentration compared to the 0.5% formulation [12]. - The clinical trial of KX-826 tincture 1.0% is expected to maintain excellent safety and present superior efficacy compared to the 0.5% formulation [14]. - The phase II clinical trial for idiopathic pulmonary fibrosis (IPF) has been approved in October 2023 [21]. - The phase II clinical trial for KX-826 in treating acne vulgaris included 160 patients, showing significant improvement in both non-inflammatory and inflammatory lesions by week 12 compared to the placebo group [40]. - The phase II clinical trial for GT20029 in China for AGA has reached its primary endpoint with statistically significant results [16]. - The first subject has been enrolled in the phase II clinical trial in China for acne treatment using GT20029 [16]. Financial Position and Cash Flow - The Group had cash and cash equivalents and time deposits of RMB333.7 million as of June 30, 2024, with unutilized bank facilities of RMB80.0 million, indicating sufficient cash to support clinical trials and research and development [11]. - Cash and cash equivalents decreased from RMB 456.3 million as of December 31, 2023, to RMB 333.7 million as of June 30, 2024, a decline of RMB 122.6 million [115]. - The current ratio decreased from 210.3% as of December 31, 2023, to 155.9% as of June 30, 2024, primarily due to the decrease in cash and cash equivalents [115]. - Net cash used in operating activities for the six months ended June 30, 2024, was RMB 110.7 million, consisting mainly of RMB 106.6 million used in operations [117]. - The Group's cash and cash equivalents at the end of the period were RMB 319.2 million, down from RMB 690.7 million at the end of the previous year [116]. - The company has no drugs approved for commercial sale and has not generated any revenue from drug sales for the six months ended June 30, 2024 [85]. Cost Management - Administrative expenses decreased by RMB17.3 million or 33.8% from RMB51.2 million for the six months ended June 30, 2023, to RMB33.9 million for the six months ended June 30, 2024, primarily due to reductions in employee benefits and share-based compensation expenses [11]. - Employee benefit expenses (including share-based compensation) decreased by RMB16.3 million, primarily due to a reduction in staff numbers [91]. - The company is focused on optimizing its cost structure while continuing to invest in R&D and clinical trials for future product development [91]. - Marketing costs decreased by RMB6.9 million from RMB8.6 million for the six months ended June 30, 2023, to RMB1.7 million for the same period in 2024 [87]. Product Development and Commercialization - The company launched its topical anti-hair loss solution for AGA under the new high-end cosmetics brand KOSHINÉ on July 10, 2024 [13]. - The company aims to expand its product portfolio with new cosmetic products including acne cream and whitening essence [14]. - The new high-end cosmetics brand KOSHINÉ, featuring KX-826, was officially launched, expected to provide stable revenue and cash flow for the company [33]. - The company plans to launch seven cosmetic product types by 2024, including products for anti-hair loss, acne treatment, and skin whitening [83]. - The company has introduced KX-826 as the main ingredient in a new topical anti-hair loss solution under its high-end cosmetics brand KOSHINÉ, marking its first commercialization attempt in dermatology [81]. Employee and Workforce - As of June 30, 2024, the Group had a total of 175 full-time employees, with clinical and R&D roles accounting for nearly 50% of the workforce [112]. - The total staff with clinical roles was 35, representing 20% of the total workforce, while R&D roles accounted for 52 employees, or 29.7% [112]. - Employee benefit expenses for the six months ended June 30, 2024, were RMB 49,465,000, significantly lower than RMB 125,850,000 for the same period in 2023 [179].

Financial Performance - The company's net loss decreased from RMB 212.1 million for the six months ended June 30, 2023, to RMB 71.5 million for the six months ended June 30, 2024, representing a reduction of 66.3%[2]. - For the six months ending June 30, 2024, the company reported a total loss of RMB 71.5 million, compared to RMB 212.1 million for the same period in 2023[30]. - The adjusted loss for the six months ended June 30, 2024, was RMB (66,893) thousand, compared to RMB (170,322) thousand for the same period in 2023, representing a 60.7% improvement[44]. - Operating loss for the six months ended June 30, 2024, was RMB 66,260 thousand, significantly improved from an operating loss of RMB 206,437 thousand for the same period in 2023[66]. - Operating loss for the six months ended June 30, 2024, was RMB 49,465 thousand, compared to RMB 125,850 thousand for the same period in 2023, indicating a significant reduction in losses by approximately 60.7%[76]. - Other income decreased by 63.5% to RMB 6.1 million for the six months ending June 30, 2024, primarily due to reduced government subsidies and interest income[34]. - The company recorded a gross profit of RMB 1.1 million for the six months ending June 30, 2024, attributed to a land use rights impairment reversal[33]. Research and Development - Research and development costs were reduced from RMB 164.6 million to RMB 39.3 million, a decrease of 76.1%, due to a focus on core dermatology pipelines KX-826 and GT20029[2]. - The company has six potential first-in-class/best-in-class drug candidates in clinical phases I-III, focusing on unmet clinical needs in dermatology[3]. - KX-826 has received approval for multiple clinical trials, including a combination therapy with minoxidil for male pattern hair loss, and a new 1.0% topical formulation[4]. - The AR-PROTAC compound GT20029 achieved its primary endpoint in a Phase II clinical trial for hair loss, demonstrating statistical significance and good safety[5]. - The company aims to accelerate the clinical strategy for GT20029, including Phase III trials for male hair loss in China and Phase II trials in the U.S.[6]. - The company has initiated the first patient enrollment for the Phase II clinical trial of AR-PROTAC compound GT20029 for acne treatment in China[7]. - The product pipeline includes a diverse range of six clinical-stage drugs, with KX-826 and GT20029 being key products targeting significant unmet clinical needs in hair loss and acne[9]. - KX-826 is a topical medication that blocks the AR signaling pathway, with patent protection until September 8, 2030, and is being developed for hair loss and acne treatment[9]. - The clinical trials for GT20029 and GT1708F are progressing, with GT20029 expected to enter Phase II trials in 2023[8]. - The company is focusing on combination therapies to enhance drug efficacy across various disease areas, including mCRPC, liver cancer, and multiple solid tumors[8]. - The company has accumulated substantial R&D and clinical data, indicating high commercial collaboration value for its pipeline products[8]. - The Phase II clinical trial for KX-826 in acne treatment included 160 patients, showing significant improvement in both inflammatory and non-inflammatory lesions compared to the placebo group[14]. - GT20029, a new AR-PROTAC compound, is the first topical PROTAC compound to enter Phase II clinical trials, showing significant hair growth promotion in preclinical studies[15]. - The Phase I clinical trial for GT20029 in China included 92 healthy subjects, demonstrating good safety and tolerability with no detectable blood concentration after single dosing[16]. - The Phase I clinical trial in the U.S. included 123 subjects, showing good safety and pharmacokinetic characteristics after both single and multiple dosing[16]. - The Phase II clinical trial of AR-PROTAC compound GT20029 for treating hair loss in China has achieved its primary endpoint with statistically significant and clinically meaningful results, showing a mean increase of 16.80 hairs/cm² in the GT20029 0.5% QD group compared to a 6.69 hairs/cm² increase in the placebo group after 12 weeks of treatment (P<0.05)[17]. - The GT20029 1.0% BIW group demonstrated a mean increase of 11.94 hairs/cm² compared to a 7.36 hairs/cm² increase in the placebo group, also with statistical significance (P<0.05)[18]. - The Phase II clinical trial for GT20029 in treating acne has commenced with the first subject enrolled as of June 17, 2024, using dosages of 0.5% QD and 1% QD[18]. - GT1708F has completed Phase I clinical trials for malignant hematological diseases and has received conditional approval for Phase II trials in China for IPF indications[7]. - The company is developing a second-generation AR antagonist, GT0918, for treating mCRPC and AR+ metastatic breast cancer[115]. Product Development and Commercialization - The company plans to expand its product offerings, including acne creams and whitening serums, leveraging KX-826 and KT-939 as key ingredients[6]. - The company has launched a new high-end cosmetic brand KOSHINÉ, with KX-826 as the main ingredient in its first product targeting hair loss[6]. - The company launched a new high-end cosmetic brand KOSHINÉ, marking its transition from R&D to commercialization in the dermatology field[99]. - The average TAHC for over 1,000 subjects treated with KX-826 increased by up to 22.7 hairs/cm², demonstrating the drug's safety and efficacy[99]. - The company plans to launch seven new cosmetic products in 2024, targeting hair loss, acne, and skin whitening, among others[100]. - The company is actively seeking collaboration opportunities in drug development, including preclinical technologies and licensing partnerships[100]. - The company aims to enhance its global commercialization efforts for cosmetics, increasing brand awareness and product penetration in both domestic and overseas markets[100]. Financial Position and Liquidity - As of June 30, 2024, the company had cash and cash equivalents of RMB 333.7 million and unused bank financing of RMB 80.0 million, indicating strong liquidity to support clinical trials and R&D[2]. - Cash and cash equivalents decreased from RMB 456.3 million as of December 31, 2023, to RMB 333.7 million as of June 30, 2024, a reduction of RMB 122.6 million[47]. - The current ratio decreased from 210.3% as of December 31, 2023, to 155.9% as of June 30, 2024, primarily due to the decrease in cash and cash equivalents[47]. - The net cash used in operating activities for the six months ended June 30, 2024, was RMB 110.7 million, compared to RMB 213.8 million for the same period in 2023, indicating a 48.2% reduction[52]. - The net cash used in investing activities for the six months ended June 30, 2024, was RMB 0.7 million, while the net cash generated from investing activities for the same period in 2023 was RMB 0.2 million[53]. - The net cash used in financing activities for the six months ended June 30, 2024, was RMB 14.9 million, compared to net cash generated of RMB 36.6 million for the same period in 2023[55]. - As of June 30, 2024, the company had utilized bank financing of RMB 234.3 million, with unutilized bank financing amounting to RMB 80.0 million[48]. - The company maintained a liquidity reserve of RMB 133.1 million as of June 30, 2024, ensuring it can meet its financial obligations[64]. - The company faced various financial risks, including market risk, credit risk, and liquidity risk, with no significant changes in risk management policies since December 31, 2023[59]. - Total liabilities decreased from RMB 411,120 thousand as of December 31, 2023, to RMB 347,966 thousand as of June 30, 2024, representing a reduction of approximately 15.3%[68]. - Total equity decreased from RMB 458,112 thousand as of December 31, 2023, to RMB 391,575 thousand as of June 30, 2024, reflecting a decline of about 14.5%[69]. - The company has no significant contingent liabilities as of June 30, 2024[46]. - The company has no significant foreign exchange risk as most transactions are settled in RMB, and it does not have major financial assets or liabilities denominated in foreign currencies[60]. Corporate Governance and Compliance - As of June 30, 2024, the company has complied with all applicable corporate governance codes, with no violations reported among employees[102]. - The company conducted a placement in 2022 to support long-term expansion and growth strategies, aiming to raise additional funds and broaden its shareholder base[102]. - The company received approximately HKD 509.1 million from the 2022 placement after deducting professional fees and expenses[103]. - As of June 30, 2024, a total of HKD 258.0 million has been utilized from the net proceeds, with HKD 37.2 million already spent[103]. - The company has adopted new accounting standards effective from January 1, 2024, but these did not have a significant impact on the financial performance[73]. - The audit committee has reviewed the unaudited condensed consolidated financial statements for the six months ending June 30, 2024, and found them compliant with applicable accounting standards[108]. - The interim report for the six months ending June 30, 2024, will be sent to shareholders in September 2024[110].

Financial Performance - The operating loss for the year ended December 31, 2023, was RMB1,059.2 million, compared to RMB944.5 million in 2022[21]. - The total comprehensive loss for the year was RMB1,060.8 million, an increase from RMB954.4 million in 2022[21]. - The company reported a total loss of RMB 1,060.8 million for the year ended December 31, 2023, compared to RMB 954.4 million for the year ended December 31, 2022[169]. - The net loss for the year ended December 31, 2023, increased by RMB106.4 million or 11.1%, reaching RMB1,060.8 million compared to RMB954.4 million for the previous year[179]. - The company has no drugs approved for commercial sale and has not generated any revenue from drug sales for the year ended December 31, 2023[138]. Research and Development (R&D) - R&D costs decreased by RMB489.2 million or 66.6% from RMB735.0 million in 2022 to RMB245.8 million in 2023, primarily due to a focus on dermatology pipelines KX-826 and GT20029[18]. - R&D costs, excluding impairment and provision, decreased by RMB489.2 million or 66.6% from RMB735.0 million in 2022 to RMB245.8 million in 2023[200]. - The R&D team is led by experienced scientists with decades of expertise in pharmaceutical R&D and entrepreneurship[165]. - The company has established an integrated R&D platform to support drug development from discovery to clinical trials[135]. - The company has accumulated substantial R&D and clinical data, enhancing the commercial collaboration value of its products[57]. Clinical Trials and Product Development - KX-826 completed phase III clinical trials for male AGA in China and phase II trials in the U.S. and initiated additional trials for long-term safety[12]. - GT20029's phase II clinical trial for AGA in China reached its primary endpoint, and preparations for a phase II trial for acne treatment are underway[15]. - KX-826 has completed phase III clinical trials for male AGA in China and phase II trials for male AGA in the U.S. and acne in China, with a mean increase of TAHC of up to 22.7 hair counts per cm² compared to baseline[47]. - The long-term safety phase III trial for AGA treatment has been initiated, which will provide additional safety and efficacy data for KX-826[47]. - The phase II clinical trial results for acne vulgaris provide a foundation for future studies[47]. - KX-826's Phase II clinical trial for acne treatment in China has been completed, showing good safety and efficacy, with significant improvement in both inflammatory and non-inflammatory lesions by week 12[58]. - The enrollment of 180 subjects for the Phase II clinical trial of GT20029 in China has been completed, with top-line results expected soon[59]. - The company has six innovative drug candidates in clinical stages I-III, focusing on unmet clinical needs in dermatology and oncology[60]. - KX-826 and GT20029 are the core products, with KX-826 in Phase III and GT20029 in Phase II clinical stages[60]. - The company is actively exploring commercialization paths for its core products in dermatology[60]. Administrative and Operational Efficiency - Administrative expenses decreased from RMB132.2 million in 2022 to RMB89.0 million in 2023, reflecting cost management efforts[21]. - The Group's administrative expenses decreased by RMB45.8 million or 34.6% from RMB132.2 million in 2022 to RMB86.4 million in 2023, mainly due to reductions in employee benefits and share-based compensation expenses[40]. - The company has adjusted employee numbers and salaries to improve efficiency and reduce administrative expenses[40]. - Employee benefit expenses accounted for 43.7% of total administrative expenses in 2023, down from 37.9% in 2022[195]. - Clinical research expenses decreased significantly from RMB410.0 million in 2022 to RMB89.8 million in 2023[199]. Commercialization and Market Strategy - Kintor aims to achieve commercialization in 2024 and deliver satisfactory results to shareholders and society[38]. - The company plans to commercialize core products in dermatology through external licensing partnerships[188]. - The company is exploring co-development or licensing-out opportunities for its products to enhance their value and provide more options for patients[185]. - The company plans to utilize its in-house production and R&D base for the manufacture of final products, actively exploring commercialization paths for its core dermatology products[186]. - The company is actively exploring multiple paths for commercialization in the dermatology field[35]. Financial Position and Cash Flow - Cash and cash equivalents as of December 31, 2023, were RMB456.3 million, with unused bank financing of RMB110.5 million[20]. - Total equity as of December 31, 2023, was RMB458.1 million, down from RMB1,495.2 million in 2022[21]. - Other income increased by RMB2.3 million or 12.4% to RMB20.9 million for the year ended December 31, 2023, driven by higher interest income from fixed deposits and bank balances[172]. - The company recorded a full impairment provision of RMB 603.9 million for inventory related to COVID-19 treatments, reflecting a net realizable value of zero[178]. - Finance costs rose by RMB1.5 million or 18.3%, from RMB8.2 million in 2022 to RMB9.7 million in 2023, primarily due to increased interest expenses from bank borrowings[179].

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].

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： ...

Financial Performance - For the six months ended June 30, 2023, net foreign exchange gains were RMB 827, compared to RMB 13,168 for the same period in 2022, representing a decrease of approximately 93.7%[4] - The company reported a current income tax expense of (507) for the six months ended June 30, 2023, compared to 9 in the same period of 2022, indicating a change in tax provision[7] - The net loss decreased by RMB306.3 million or 59.1% from RMB518.4 million for the six months ended June 30, 2022, to RMB212.1 million for the six months ended June 30, 2023, mainly due to reduced R&D and administrative expenses[35] - For the six months ended 30 June 2023, the company reported a total comprehensive loss of RMB212.1 million, compared to RMB518.4 million for the same period in 2022[114] - The adjusted loss for the same periods, after adding back share-based compensation expenses, was RMB170.3 million for 2023 and RMB468.6 million for 2022[114] - The company did not generate any revenue for the six months ended 30 June 2023 and 2022[114] - The total loss for the reporting period was RMB (212,111,000) in 2023, compared to RMB (518,423,000) in 2022, indicating a significant reduction in losses[127] - Adjusted loss for the period was RMB (170,322,000) in 2023, down from RMB (468,578,000) in 2022[127] Research and Development - The company completed Phase II clinical trials for KX-826 in China, showing a statistically significant increase in hair count of 15.34 hairs/cm² for males and 11.39 hairs/cm² for females compared to placebo after 24 weeks of treatment[14] - The company is actively planning to initiate Phase III clinical trials for KX-826 in female alopecia in the second half of 2023 based on positive Phase II trial data[14] - The company is developing Detorsertib (GT0486) primarily for the treatment of metastatic solid tumors, completing Phase I clinical trials[16] - The company’s pipeline includes a diversified portfolio of drug candidates targeting dermatology and oncology with substantial market potential[11] - R&D costs decreased by RMB296.5 million or 64.3% from RMB461.1 million for the six months ended June 30, 2022, to RMB164.6 million for the six months ended June 30, 2023, attributed to adjustments in core business and ongoing clinical trials for KX-826 and AR-PROTAC (GT20029) for AGA and acne[35] - The company aims to continuously advance clinical trials of core products, including KX-826 and AR-PROTAC, in response to market conditions[35] - As of the report date, the company has seven innovative potential first-in-class/best-in-class drug candidates in phase I-III clinical stages[51] - The company is exploring potential cooperation opportunities for KX-826 and GT20029 to advance commercialization in China and globally[43] Clinical Trials and Drug Development - KX-826 is in phase III clinical trials for male AGA in China, with all 740 subjects enrolled, and top-line data expected in Q4 2023[41] - The phase II clinical trial of KX-826 for acne vulgaris in China has been completed with initial positive results on efficacy and safety[41] - The phase II clinical trial of male AGA in the United States has been completed, showing statistically and clinically meaningful results, with preparations for phase III trials underway[41] - The first patient enrollment in the long-term safety phase III clinical trial of KX-826 in China for AGA treatment was completed on July 19, 2023[51] - The company aims to achieve the first commercialization of KX-826 for hair loss indication on or before 2025[56] - KX-826 is the world's first topical AR antagonist in phase III clinical trial for AGA, with a patent valid until September 8, 2030[64] - The primary endpoint of the phase III trial is the change from baseline in non-vellus TAHC after 24 weeks of treatment compared to placebo[67] - The company expects to release the top-line data of the phase III clinical trial in the fourth quarter of 2023[67] - A phase II clinical trial of KX-826 for the treatment of acne vulgaris has been completed, involving 160 patients, with results showing significant improvement in lesion counts compared to placebo[74] - The safety profile of KX-826 in the acne trial was good, with most adverse events being mild local skin irritation, similar to the placebo group[76] - The phase II clinical trial of GT20029 for treating AGA in China has commenced, with the primary endpoint being the change from baseline in non-vellus TAHC after 12 weeks of treatment[78] - The company is in communication with the U.S. FDA regarding a phase III clinical trial plan for KX-826 based on phase II results[70] - KX-826 is designed to competitively inhibit androgen binding to AR in targeted tissues, addressing significant unmet clinical needs in both AGA and acne vulgaris[74] - GT20029 is the first topical PROTAC compound in the world to enter phase II clinical stage, developed by the company's in-house PROTAC platform[87] Financial Position and Cash Flow - As of June 30, 2023, the Group had cash and cash equivalents of RMB701.9 million and unutilized bank facilities of RMB90.0 million, ensuring sufficient funds for clinical trials and R&D[35] - The operating loss for the six months ended June 30, 2023, was RMB 206.4 million, significantly improved from a loss of RMB 516.1 million in the same period of 2022, indicating a reduction of approximately 60%[167] - Cash and cash equivalents at the end of the period were RMB690.7 million, compared to RMB337.3 million at the end of the same period in 2022[183] - The Group's net current assets were RMB1,064.9 million as of June 30, 2023, indicating sufficient liquidity to meet financial obligations[192] - Cash flows from investing activities generated a net cash inflow of RMB 238,000 for the six months ended June 30, 2023, compared to RMB 42,010,000 in the prior year[198] - The company reported a loss of RMB 212,111,000 for the period, contributing to accumulated losses of RMB 2,935,955,000 as of June 30, 2023[197] - Borrowings increased slightly to RMB 100,600,000 as of June 30, 2023, from RMB 98,900,000 at the end of 2022[196] - The company’s cash flow from operating activities for the six months ended June 30, 2022 was RMB708.1 million, mainly comprising cash used in operations[160] - The company had net cash used in operating activities primarily from government grants, with R&D costs and administrative expenses being the main components[157] Market and Strategic Position - The company has established an integrated R&D platform to support drug development from discovery to clinical stages[111] - The development of AR inhibitors has led to significant expertise in AR-related technology, positioning the company as a leader in the field[111] - The company is exploring other potential drug candidates, including c-Myc inhibitors and bispecific antibodies for various indications[111] - The company has a diversified drug pipeline strategically focused on dermatology and oncology, addressing significant market potential and unmet medical needs[90] - The company has not yet commercialized any drug candidates as of the report date[137] - The Group's financial risk management policies have remained unchanged since December 31, 2022, focusing on minimizing potential adverse effects from market unpredictability[165]