Drug Development Pipeline - The company has established a pipeline of 12 candidate drugs since its inception in 2017, including the core product TY-9591 and seven clinical-stage products[7]. - The company is developing multiple candidate drugs in preclinical or early clinical development stages to further enrich its product pipeline[8]. - TY-9591 is currently undergoing critical Phase II trials in China for EGFR-mutant lung cancer brain metastases and Phase III trials for EGFR L858R mutation in advanced or metastatic NSCLC[21]. - The company plans to initiate a Phase II clinical trial for TY-302 in combination with abiraterone for first-line treatment of prostate cancer in the first half of 2025[13]. - The company received IND approval for the Phase II and III clinical trials of TY-9591 in combination with pemetrexed and platinum-based chemotherapy for advanced or metastatic lung cancer[12]. - The company has a diverse pipeline targeting various cancers, including NSCLC, breast cancer, and prostate cancer, with multiple products in different stages of clinical trials[22]. - TY-2136b, an oral ROS1/NTRK inhibitor, has shown good safety in preclinical studies and has received orphan drug designation from the FDA for treating ROS1-positive and NTRK fusion-positive NSCLC[33]. - The company is also preparing for a Phase II trial of TY-9591 in combination with pemetrexed and platinum-based chemotherapy for advanced lung cancer[29]. Financial Performance - The total comprehensive loss for the year ended December 31, 2024, was RMB 387,928 thousand, slightly higher than RMB 383,171 thousand in 2023[11]. - Research and development costs for 2024 were RMB 235,446 thousand, a decrease from RMB 249,252 thousand in 2023[11]. - Revenue increased from RMB 0 in the year ending December 31, 2023, to RMB 107,000 in 2024, mainly driven by increased revenue from research and development services[41]. - Gross profit rose from RMB 0 to RMB 14,000, with a gross margin of 13.1% for the year ending December 31, 2024, attributed to the increase in research and development service revenue[43]. - Administrative expenses surged by 82.7% to RMB 108.3 million in 2024 from RMB 59.3 million in 2023, mainly due to increased listing expenses and operational costs[48]. - Financial costs decreased by 42.4% to RMB 12.8 million in 2024 from RMB 22.2 million in 2023, primarily due to reduced transaction costs related to equity redemption liabilities[49]. - Other income and gains for the year ending December 31, 2024, were RMB 30.5 million, an increase of RMB 5.1 million from RMB 25.4 million in 2023, mainly due to higher government subsidies and bank interest income[44]. Clinical Trial Updates - The key Phase II clinical trial for TY-9591, targeting EGFR mutation lung cancer brain metastasis, completed enrollment of 224 patients in November 2024, with a conditional NDA submission expected in Q2 2025[8]. - The registration Phase III clinical trial for TY-9591, focusing on EGFR L858R mutation lung cancer, completed enrollment of 528 patients in early February 2025, with an NDA submission anticipated in 2026[8]. - TY-302, a CDK4/6 inhibitor, achieved a disease control rate (DCR) of 71.4% in 14 breast cancer patients previously treated with two or more lines of therapy[30]. - The company plans to enter the registration phase for TY-302 in 2026, focusing on its use in breast cancer treatment[30]. - The company has completed five dose escalation studies for TY-2699a, a selective CDK7 inhibitor, and expects to complete the monotherapy escalation phase by the first half of 2025[35]. Market Position and Strategy - The company aims to enhance its market share and brand influence through strengthened marketing and commercialization capabilities[9]. - The company is actively expanding its commercialization team to explore market potential and enhance brand promotion through various academic and industry collaborations[40]. - The company intends to selectively acquire or invest in innovative technologies to strengthen its R&D capabilities and explore potential combination therapy partnerships for TY-9591[69]. - The company is committed to building sales and marketing capabilities through internal efforts and partnerships with external collaborators[69]. - The company aims to explore commercial cooperation opportunities with leading industry peers to accelerate the development of its candidate drugs in key international markets[69]. Governance and Management - The board consists of 11 members, including 4 independent non-executive directors, ensuring compliance with listing rules[176]. - The company has expanded its management team with independent non-executive directors appointed in January 2024, enhancing governance and oversight[86][87]. - The company has purchased liability insurance for directors and senior management to cover potential legal responsibilities[182]. - The board is responsible for strategic decisions, financial oversight, and risk management, ensuring effective governance[181]. - The company has established a committee to oversee the implementation of the employee incentive plan, which includes senior management and key personnel[130]. Risks and Challenges - The company faces significant risks related to the competition in drug development, which may adversely affect its ability to commercialize candidate drugs[106]. - Clinical drug development is a lengthy and costly process, and unexpected difficulties may arise during clinical trials and commercialization[106]. - The company may face significant liabilities related to product liability claims or litigation during drug discovery, development, and commercialization[108]. - The company may not be able to obtain or maintain sufficient patent and other intellectual property protection for its candidate drugs in selected global markets, which could allow third parties to develop and commercialize similar products[111]. - Regulatory approval processes from agencies like the FDA are time-consuming and inherently uncertain, and failure to obtain necessary approvals could severely damage the company's business[113]. Capital and Financing - Cash and bank balances as of December 31, 2024, amounted to RMB 460,463,000, representing a 146.5% increase from RMB 186,830,000 as of December 31, 2023[53]. - The company may require significant additional financing to fund its operations and expansion, and failure to secure such financing could hinder the development and commercialization of its candidate drugs[116]. - The maximum payable amount for technical service fees to Huayu Pharmaceutical under the TY-9591 continuing connected transaction agreement is RMB 4,690,000, with actual transaction amounts being RMB 3,236,000[123]. - The company has entered into a continuing connected transaction agreement with Huayu Pharmaceutical, which will remain effective until the end of 2025[121]. Corporate Social Responsibility - The company made charitable donations amounting to RMB 1.1 million during the reporting period[150]. - The company has not declared any dividends for the year 2024, resulting in no income tax obligations for shareholders[138]. - The company has complied with the relevant provisions of the listing rules regarding related party transactions[126].

公司预计将在2025年第四季度实现TY9591的商业化，面对中国非小细胞肺癌及肺癌脑转移治疗中亟待 满足的临床需求，TY9591的商业化潜力有望得到快速释放，预计2027年公司将实现收支平衡。 公司于2025年3月9日发布自愿性公告，宣布其自主研发的核心产品TY-9591(商品名：卡达沙®)在治疗 EGFR 突变肺癌脑转移等方面取得了积极进展，计划近期向国家药品监督管理局药品审评中心提交 NDA 上市申请。在对比奥希替尼(商品名：泰瑞沙®)作为一线治疗EGFR突变肺癌脑转移的关键II期临 床试验中，根据研究者数据显示，TY-9591(商品名：卡达沙®)具有统计学显著意义和重大临床获益，已 达到研究预期。由于出色的关键II期临床试验结果，TY-9591有望成为全球第一个获批脑转移适应症的 三代EGFR抑制剂，也有望成为全球第一个单药头对头击败奥希替尼的产品。 智通财经APP了解到，浙江同源康医药股份有限公司(02410)于2025年3月27日发布2024年业绩。集团总 收入10.7万元人民币，主要得益于研发服务收入的增加。报告期内亏损 3.87 亿元，研发成本约 2.35 亿 元，同比收窄 5.5%，这显示出公 ...

Financial Performance - Total comprehensive loss for the year ended December 31, 2024, was RMB 387,928 thousand, a slight increase of 1.2% compared to RMB 383,171 thousand in 2023[3]. - Revenue for the year was RMB 107 thousand, with a gross profit of RMB 14 thousand, indicating minimal sales activity[5]. - The company reported a basic and diluted loss per share of RMB 1.15, compared to RMB 1.32 in the previous year, indicating a slight improvement in loss per share[5]. - The pre-tax loss for 2024 is RMB (387,928,000), slightly higher than the pre-tax loss of RMB (383,171,000) in 2023, indicating a marginal increase in losses[29]. - The company's loss increased by 1.2% from RMB 383,171,000 for the year ended December 31, 2023, to RMB 387,928,000 for the year ended December 31, 2024[82]. Expenses and Costs - Research and development costs decreased by 5.5% to RMB 235,446 thousand from RMB 249,252 thousand in the previous year[3]. - Administrative expenses surged by 82.7% to RMB 108,332 thousand, up from RMB 59,306 thousand in 2023[3]. - Total financial costs decreased to RMB 12,817,000 in 2024 from RMB 22,236,000 in 2023, a reduction of approximately 42.3%[26]. - Employee costs, including director remuneration, totaled RMB 72,778,000 in 2024, compared to RMB 70,831,000 in 2023, reflecting a slight increase of about 2.8%[22]. - The depreciation of property, plant, and equipment increased to RMB 9,272,000 in 2024 from RMB 7,798,000 in 2023, an increase of about 18.9%[22]. Assets and Liquidity - Cash and bank balances increased significantly to RMB 460,463 thousand from RMB 186,830 thousand in 2023, reflecting improved liquidity[6]. - Current net assets improved to RMB 279,894 thousand from a deficit of RMB 1,067,270 thousand in the previous year[7]. - Total assets less current liabilities stood at RMB 626,612 thousand, a recovery from a negative position of RMB 727,841 thousand in 2023[7]. - Non-current total assets increased to RMB 346,718 thousand from RMB 339,429 thousand in 2023, showing stability in long-term asset management[6]. - Cash and cash equivalents increased to RMB 374,988,000 in 2024 from RMB 186,830,000 in 2023, with RMB 280,912,000 held in HKD and RMB 90,597,000 in RMB[39]. Research and Development - The company is primarily engaged in the research, development, and commercialization of pharmaceutical products, with a focus on drug discovery[8]. - Revenue from research and development services for 2024 is RMB 107,000, compared to RMB 0 in 2023[18]. - The company expects to recognize revenue from research and development services over the service period, indicating a focus on long-term projects[19]. - The company has a R&D team of 110 members as of December 31, 2024, with approximately 57% holding master's or doctoral degrees in relevant fields[69]. - The company is focusing on the development of its proprietary drug design and screening platform, which has led to the identification and synthesis of multiple drug candidates[68]. Clinical Trials and Product Development - The company has initiated a key Phase II clinical trial for its core product TY-9591, with 224 patients enrolled as of November 2024, and plans to submit a Pre-NDA application in April 2025[43]. - The company is conducting a Phase II clinical trial for TY-302 in breast cancer, with plans to enter the registration phase by 2026, and will initiate a Phase II trial for prostate cancer in the first half of 2025[44]. - The company has received IND approval for TY-2136b and is currently conducting a Phase I clinical trial in the U.S., with plans to communicate with the FDA regarding future development[45]. - TY-0540 is in Phase I clinical trials in China for advanced solid tumors, with an expansion cohort study for breast and ovarian cancer initiated in February 2025[47]. - The company has established a pipeline of 12 candidate drugs since its inception in 2017, including core product TY-9591, which is undergoing critical Phase II and III trials in China for lung cancer[52]. Market and Commercialization - The company successfully listed on the Hong Kong Stock Exchange on August 20, 2024, raising approximately HKD 579.3 million from the issuance of 47,880,000 H shares at HKD 12.10 per share[51]. - The company is actively expanding its commercialization team to enhance brand promotion and market potential through various academic and industry collaborations[70]. - The company plans to actively explore commercial collaboration opportunities with leading industry peers to accelerate the development of its candidate drugs and enhance their clinical and commercial value in key international markets[97]. - The company has established a commercialization team with experienced core management to meet its commercialization needs and will continue to integrate capital, talent, and technology advantages[97]. Governance and Compliance - The company has complied with all provisions of the corporate governance code since its listing, except for the deviation regarding the roles of the Chairman and President being held by the same person[99]. - The audit committee is composed of two independent non-executive directors and one non-executive director, ensuring a strong independence in its composition[106]. - The audit committee's responsibilities include overseeing the financial reporting system, risk management, and internal control systems[107]. - The company will continue to regularly review and monitor its corporate governance practices to ensure compliance with the corporate governance code[100]. Future Outlook - The company aims to enter the registrational clinical stage for several products by 2026, including TY-302 for prostate cancer and TY-2699a for breast and pancreatic cancers[53]. - The company plans to enhance its R&D capabilities and has developed several innovative drug candidates targeting YAP-TEAD, CDK4, and EGFR (PROTAC)[94]. - The company is developing next-generation ADCs utilizing high-activity small molecule inhibitors and PROTAC technology to improve safety and efficacy in cancer treatment[94][95]. - The company aims to leverage AI models in drug discovery to enhance R&D efficiency and drive sustainable growth[96].

浙江同源康醫藥股份有限公司 浙江同源康醫藥股份有限公司 TYK Medicines, Inc 股份代號 : 2410 2024 中期報告 目錄 2 釋義 5 公司資料 8 財務摘要 9 業務摘要 11 管理層討論及分析 30 企業管治及其他資料 40 獨立審閱報告 41 中期簡明綜合損益及其他全面收入表 42 中期簡明綜合財務狀況表 44 中期簡明綜合權益變動表 45 中期簡明綜合現金流量表 47 中期簡明綜合財務資料附註 2024 年中期報告 2 釋義 | --- | --- | --- | |----------------------|-------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | | 「審計委員會」 | 指 | 董事會審計委員會 | | 「董事會」 | 指 | 董事會 | | 「企業管治守 ...

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意見，並明確表示概不就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。 TYK Medicines, Inc* 浙江同源康醫藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2410） 截至2024年6月30日止六個月中期業績公告 | --- | --- | --- | --- | --- | |----------------|--------------|--------------|------------|-------| | | | | | | | 財務摘要 | | | | | | | 截至 6 月 30 | 日止六個月 | | | | | 2024 年 | 2023 年 | 變動 | | | | 人民幣千元 | 人民幣千元 | 人民幣千元 | % | | | （未經審計） | （未經審計） | | | | | | | | | | 研發成本 | (137,758) | (119,436) | (18,322) | 15.3 | | 行政開支 | ...