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].
开拓药业-B(09939) - 2024 - 年度财报