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同源康医药(02410) - 2024年股东周年大会通函
2025-05-29 08:34
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通函之內容概不負責,對其準確性或完整性亦 不發表任何聲明,並明確表示概不會就因本通函全部或任何部分內容而產生或因依賴該等內容而引致之任 何損失承擔任何責任。 此乃要件 請即處理 閣下如對本通函任何方面或應採取之行動有任何疑問,應諮詢 閣下之股票經紀或其他註冊證券交易商、 銀行經理、律師、專業會計師或其他專業顧問。 閣下如已售出或轉讓名下全部浙江同源康醫藥股份有限公司之股份,應立即將本通函及隨附代表委任表格 送交買方或承讓人,或送交經手買賣或轉讓之銀行、股票經紀或其他代理商,以便轉交買方或承讓人。 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) (1)2024年度董事會報告; (2)2024年度監事會報告; (3)2024年年度報告; (4)2024年經審核財務報表; (5)2025年度董事及監事酬金; (6)委任非執行董事; 本封面頁所用詞彙具有本通函所界定的相同涵義。董事會函件載於本通函第4至12頁。 本公司謹訂於2025年6月26日(星期四)下午一時正假座中國上海市徐匯 ...
同源康医药(02410) - 高级管理人员兼联席公司秘书辞任;及执行董事调任為非执行董事
2025-05-27 09:16
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) 高級管理人員兼聯席公司秘書辭任; 及 執行董事調任為非執行董事 浙江同源康醫藥股份有限公司(「本公司」)董事(「董事」)會(「董事會」)宣佈,本 公司執行董事、副總裁、董事會秘書及聯席公司秘書(「聯席公司秘書」)蔣鳴昱博 士(「蔣博士」)已通知本公司,彼將辭任副總裁、董事會秘書及聯席公司秘書職 務,自2025年6月13日起生效,以投入更多時間專注彼之其他業務安排。 董事會進一步宣佈,蔣博士將從執行董事調任為非執行董事,自2025年6月13日 起生效。 蔣博士的履歷資料詳載如下: 蔣博士,37歲,於2019年7月加入本集團,擔任副總裁兼董事會秘書。彼於審 計、風險管理及股權研究方面擁有逾12年經驗。自2009年10月至2011年11月,彼 於會計師事務所畢馬威華振會計師事務所 ...
同源康医药(02410) - 自愿性公告 - 纳入恒生生物科技指数成份股
2025-05-19 00:00
(股份代號:2410) 自願性公告 納入恒生生物科技指數成份股 本公告由浙江同源康醫藥股份有限公司(「本公司」)自願發佈,旨在向本公司股東 及潛在投資者通報本公司的最新業務發展。 本公司董事會(「董事會」)欣然宣佈,本公司之H股(「H股」)已獲選納入恒生生物 科技指數成份股,自2025年6月9日起生效。恒生生物科技指數旨在反映於香港上 市的生物科技公司之整體表現。 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。 董事會認為,本公司被納入恒生生物科技指數成份股,反映了資本市場對本公司 業務表現及增長前景的認可。董事會相信,此舉將有助於擴大本公司股東基礎, 提升H股的交易流動性,並進一步增強本公司的聲譽及品牌知名度。 承董事會命 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) 董事長、執行董事兼總裁 吳豫生博士 香港,2025年5月19日 於本公告日期,董事會成員包括執行董事吳豫生博士及蔣鳴昱博 ...
同源康医药(02410) - 建议委任非执行董事
2025-05-16 10:46
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) 1 待其獲股東於年度股東大會批准委任為第二屆董事會成員後,本公司將與其訂立 服務合約。服務任期自股東於年度股東大會批准之日起至第二屆董事會任期屆滿 時止。朱博士不會就擔任非執行董事收取任何固定薪酬,但將繼續就向本公司提 供諮詢服務收取薪酬每年約人民幣100,000元。 除上文披露者外,朱博士確認:(i)彼於過去三年並無於本集團擔任任何職位或於 其他公眾公司擔任任何董事職務;(ii)彼與任何董事、本公司監事、高級管理層、 主要股東或控股股東(「股東」)概無任何關係;及(iii)彼並無於本公司股份中擁有 根據《證券及期貨條例》(香港法例第571章)第XV部所界定的任何權益。概無任何 其他須予披露之資料,朱博士亦無涉及其他任何事項須根據上市規則第13.51(2) (h)至(v)條 ...
同源康医药(02410) - 2024 - 年度财报
2025-04-29 08:42
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].
同源康医药(02410) - 关连交易 - 参与设立基金
2025-04-24 11:56
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) 關連交易 參與設立基金 於2025年4月24日,本公司與騰遠長興、湖州創新、湖州產業投資、長興興長 投資及上海友南訂立合夥協議,據此,訂約方同意設立基金,本公司將作為有 限合夥人參與新成立的基金。根據合夥協議,本公司同意向基金投資人民幣 18.0百萬元。 本公司董事長兼總裁吳豫生博士於基金普通合夥人騰遠長興中擁有間接權益。 因此,根據上市規則第14A.07條,騰遠長興構成本公司的關連人士。因此,根 據上市規則第十四A章,訂立合夥協議構成本公司的一項關連交易。 由於本集團於合夥協議項下的資本承擔的最高適用百分比率超過0.1%但低於 5%,故根據上市規則第十四A章,基金的設立及本集團於合夥協議項下的資本 承擔須遵守申報及公告規定,惟獲豁免遵守通函、獨立財務意見及獨立股東批 准的 ...
同源康医药-B(02410)公布2024年业绩,关键产品商业化潜力进一步释放
智通财经网· 2025-03-30 05:31
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 ...
同源康医药(02410) - 董事会提名委员会工作细则
2025-03-27 14:03
浙江同源康醫藥股份有限公司 董事會提名委員會工作細則 (於2025年3月27日經董事會修訂並採納) 第一章 總則 第一條 為了規範公司董事、高級管理人員的產生,根據《中華人民共和國 公司法》(以下簡稱「《公司法》」)、《中華人民共和國證券法》、《境內企業境外發行 證券和上市管理試行辦法》、《監管規則適用指引 — 境外發行上市類第1號》、《香 港聯合交易所有限公司證券上市規則》(以下簡稱「《香港上市規則》」)及其他相關 法律、行政法規、部門規章、規範性文件及《浙江同源康醫藥股份有限公司章程》 (以下簡稱「《公司章程》」)的有關規定,公司董事會設立提名委員會,並制訂本工 作細則。 第二條 提名委員會是董事會設立的專門工作機構,對董事會負責,主要職 責是對公司董事(包括獨立非執行董事)、高級管理人員的人選的選擇向董事會提 出意見和建議。 第二章 人員組成 第三條 提名委員會由至少3名董事組成以及至少有一名不同性別的董事,其 中獨立非執行董事應佔多數。提名委員會設主任委員(主席)一名,由董事會主席 或獨立非執行董事擔任,並由董事會過半數選舉產生。 主任委員(主席)主持委員會工作,召集並主持委員會會議。主任委員(主席) ...
同源康医药(02410) - 董事名单与其角色和职能
2025-03-27 13:57
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) 董事名單與其角色和職能 浙江同源康醫藥股份有限公司董事會(「董事會」)成員如下。 董事會設立四個委員會。下表提供各董事會成員所在委員會的成員資料。 | | 委員會 | | 薪酬與考核 | | | | --- | --- | --- | --- | --- | --- | | 董事 | | 審計委員會 | 委員會 | 提名委員會 | 科學委員會 | | 吳豫生博士 | | | M | C | C | | 蔣鳴昱博士 | | | | | | | 李鈞博士 | | M | | | M | | 顧虹博士 | | | | | | | 孟曉英博士 | | | | | | | 何超先生 | | | | | | | 張森泉先生 | | C | M | M | | | 冷瑜婷博士 | | M | C | M | | | 許文青博士 | | | | | M | | 沈秀華博士 | | | | | | 附註: C 有關董事會委員會主席 執行董事 吳豫生博士 蔣鳴昱博士 非執行董事 李鈞博士 顧虹博士 ...
同源康医药(02410) - 2024 - 年度业绩
2025-03-27 13:50
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].