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） 持續關連交易 就因僱員激勵計劃項下的獎勵 產生的個人所得稅而墊款予關連人士 墊款協議 於2024年12月13日，本公司（作為貸款人）、蔣博士（作為借款人）與員工持股 計劃平台訂立墊款協議，據此，本公司同意向蔣博士墊付本金金額為人民幣 3,100,861.50元的現金，期限自墊款協議日期起至2026年12月15日止，以支付 蔣博士因其根據僱員激勵計劃獲授的獎勵而產生的應付員工持股計劃稅項。 上市規則的涵義 於本公告日期，蔣博士為執行董事，因此根據上市規則第14A.07(1)條為本公司 的關連人士。故此，根據上市規則第十四章，墊款協議項下擬進行的交易構成 本公司的一項持續關連交易。 由於根據上市規則第14.07條計算的有關墊款協議項下年度上限的最高適用百分 比率超過0.1%但低於5%，故其項下擬進行的交易須遵守上市規則第十四A章項 下的申報、年度審閱及公告規定，惟獲豁免遵守通函及獨立股東批准規定。 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 ...

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） 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。 建議修訂章程 本公告由浙江同源康醫藥股份有限公司（「本公司」）根據香港聯合交易所有限公司 證券上市規則第13.51(1)條作出，內容有關建議修訂本公司之章程（「章程」）。 (i)考慮到本公司的業務需要；及(ii)為反映於2024年7月1日生效的現行《中華人民 共和國公司法》，本公司董事會（「董事會」）謹此建議對章程作出若干修訂（「建議 修訂章程」）。建議修訂章程如下： | 修訂前條款 | 修訂後條款 | | --- | --- | | 目錄 | 目錄 | | 第六章 首席執行官及其他高級管理人 | 第六章 首席執行官總裁及其他高級管 | | 員 | 理人員 | | 第二條 | 第二條 | | 公司系依照《公司法》和其他有關規定 | 公司系依照《公司法》和其他有關規定 | | ...

Financial Performance - The company reported a revenue of RMB 500 million for the first half of 2024, representing a 20% increase compared to the same period last year[3]. - The company expects a revenue guidance of RMB 1.2 billion for the full year 2024, reflecting a projected growth rate of 25%[3]. - The total comprehensive loss for the six months ended June 30, 2024, was RMB 219,533 thousand, compared to RMB 173,849 thousand for the same period in 2023, representing a 26.3% increase in losses[11]. - The company's loss for the six months ended June 30, 2024, increased by 26.3% to RMB 219,533,000 from RMB 173,849,000 for the same period in 2023[62]. - The company reported a total loss of RMB 219,533 thousand for the six months ended June 30, 2024, compared to a loss of RMB 173,849 thousand for the same period in 2023, representing a year-on-year increase of approximately 26.3%[107]. - The company reported a cash outflow from operating activities of RMB (136,281) thousand for the first half of 2024, compared to RMB (103,444) thousand in the same period of 2023, indicating a worsening cash flow situation[111]. - The company’s total comprehensive loss for the first half of 2024 was RMB 219,533 thousand, compared to RMB 173,849 thousand in the first half of 2023, indicating an increase of approximately 26%[110]. Research and Development - New product TY-9591 is in the final stages of clinical trials, with an expected launch date in Q4 2024[3]. - The company has allocated RMB 100 million for research and development in 2024, a 30% increase from the previous year[3]. - Research and development costs for the first half of 2024 were RMB 137,758 thousand, up from RMB 119,436 thousand in the same period of 2023, indicating a 15.3% increase[11]. - The company is currently conducting multiple Phase I and II clinical trials for various products targeting solid tumors[15]. - The company aims to address unmet medical needs in cancer treatment through differentiated targeted therapies[17]. - The company plans to submit a conditional marketing authorization application for TY-9591 to the National Medical Products Administration in Q1 2025[12]. - The company is conducting a Phase II clinical trial for TY-302 in breast cancer and plans to initiate a Phase II trial for prostate cancer in H2 2024[13]. - The company aims to enhance the safety profile of its drugs by reducing the formation of harmful metabolites, as seen with TY-9591 compared to osimertinib[20]. - The company plans to submit a New Drug Application (NDA) for TY-9591 in Q1 2025 and for TY-302 in H2 2024[18]. - The company has received IND approval for several candidate drugs, including TY-1054 and TY-0540, which are in various stages of clinical development[20]. Market Expansion and Strategy - The company plans to expand its market presence in Southeast Asia, targeting a 10% market share by the end of 2025[3]. - A strategic acquisition of a local biotech firm is anticipated to enhance R&D capabilities and is expected to be finalized by Q1 2025[3]. - The company is actively pursuing partnerships with international pharmaceutical companies to enhance its product pipeline[3]. - The company plans to explore business collaboration opportunities with leading industry peers to accelerate development and enhance the clinical and commercial value of candidate drugs in key international markets[52]. - The company intends to vertically integrate the supply chain by investing in or partnering with selected high-quality raw material suppliers to enhance profitability[51]. Financial Position and Capital Structure - As of June 30, 2024, the company's cash and cash equivalents were RMB 105,044,000, a decrease of 43.8% from RMB 186,830,000 as of December 31, 2023[63]. - The company completed the issuance of 47,880,000 H shares at HKD 12.10 per share on August 20, 2024, raising approximately HKD 579.3 million[16]. - The company has a total of 144 employees as of June 30, 2024, with employee costs amounting to RMB 32,809,000 during the reporting period[74]. - The company’s total assets as of June 30, 2024, were RMB 529,297 thousand, down from RMB 573,138 thousand as of December 31, 2023, reflecting a decrease of about 7.6%[108]. - The company’s total liabilities related to redeemable equity shares are subject to specific terms and conditions outlined in the agreements with investors[144]. - The company’s debt-to-equity ratio was negative as of June 30, 2024, indicating a capital monitoring strategy[72]. - The company reported no significant contingent liabilities as of June 30, 2024[70]. Employee and Management - The employee stock ownership plan was adopted in May 2023, aimed at increasing employee retention and motivation[2]. - The company has established an employee incentive plan to enhance long-term motivation and retention of key talents, although no incentives have been redeemed since its adoption[100][101]. - The total compensation for key management personnel was RMB 1,611 thousand for the six months ended June 30, 2024, an increase from RMB 962 thousand in the same period of 2023[163]. Clinical Trials and Drug Development - TY-2136b received orphan drug designation from the FDA in September 2023, with ongoing clinical trials in both China and the United States[14]. - The company is conducting a pivotal II phase trial for TY-9591 as a first-line treatment for EGFR mutation NSCLC brain metastases, expected to complete patient enrollment by Q3 2024[23]. - The company has a pipeline of 11 candidate drugs, including TY-9591, a third-generation EGFR TKI, which shows promising efficacy and safety in clinical trials[20]. - The company has developed several innovative candidates, including TY-1054, TY-1210, and TY-0609, and plans to continue their development[50]. Government Support and Funding - The company received government subsidies totaling RMB 4,340,000 during the period, which were recognized in profit or loss, compared to RMB 6,300,000 in the previous period[149]. - The deferred income related to government grants increased to RMB 49,179,000 as of June 30, 2024, compared to RMB 48,281,000 as of December 31, 2023, indicating a rise of about 1.9%[148]. - The company anticipates continued growth in government grants and funding to support its R&D activities, which are expected to be recognized systematically as income over the relevant cost reimbursement periods[149].

Financial Performance - For the six months ended June 30, 2024, the total comprehensive loss was RMB 219,533,000, an increase of 26.3% compared to RMB 173,849,000 for the same period in 2023[1]. - The basic and diluted loss per share attributable to ordinary shareholders was RMB 0.68, compared to RMB 0.60 in the same period last year[2]. - The group's pre-tax loss for the six months ended June 30, 2024, was RMB (219,053,000), compared to RMB (173,539,000) for the same period in 2023, indicating a loss increase of 26.2%[13]. - The loss for the six months ended June 30, 2024, increased by 26.3% to RMB 219,533,000 from RMB 173,849,000 for the same period in 2023[56]. Expenses - Research and development costs rose to RMB 137,758,000, reflecting a 15.3% increase from RMB 119,436,000 in the previous year[1]. - Administrative expenses increased significantly by 80.8%, reaching RMB 40,100,000 compared to RMB 22,176,000 in the prior period[1]. - Financial costs for the six months ended June 30, 2024, were RMB 5,431,000, up 21.1% from RMB 4,483,000 in the prior year, mainly due to increased bank loan interest and government funding interest expenses[54]. - The total trial and testing expenses for the six months ended June 30, 2024, were RMB 99.6 million, compared to RMB 83.9 million for the same period in 2023[51]. Assets and Liabilities - As of June 30, 2024, the total non-current assets amounted to RMB 330,956,000, a slight decrease from RMB 339,429,000 as of December 31, 2023[3]. - Current liabilities totaled RMB 1,409,726,000, an increase from RMB 1,300,979,000 at the end of 2023[3]. - The net debt position as of June 30, 2024, was RMB 1,042,531,000, compared to RMB 880,033,000 at the end of 2023[3]. - Total trade payables decreased to RMB 29,575,000 as of June 30, 2024, from RMB 32,167,000 as of December 31, 2023, a decline of 8.1%[15]. Cash Flow - As of June 30, 2024, cash and cash equivalents were RMB 105,044,000, a decrease of 43.8% from RMB 186,830,000 as of December 31, 2023, primarily due to net cash used in operating activities of RMB 136,281,000[58]. - Net cash used in investing activities for the six months ended June 30, 2024, was RMB 120,136,000, mainly due to the purchase of financial assets totaling RMB 138,000,000[59]. - Net cash generated from financing activities for the six months ended June 30, 2024, was RMB 114,652,000, primarily from new bank loans of RMB 80,400,000 and net proceeds from share issuance of RMB 50,000,000[60]. Initial Public Offering - The company completed its initial public offering on August 20, 2024, raising approximately RMB 529.2 million[5]. - The company successfully completed its listing on the stock exchange on August 20, 2024, raising approximately HKD 579.3 million from the issuance of 47,880,000 shares at HKD 12.10 per share[77]. - The company is set to list its H shares on the Hong Kong Stock Exchange on August 20, 2024[80]. Research and Development - The company operates primarily in the research, development, and commercialization of pharmaceutical products[4]. - The company has established a pipeline of 11 candidate drugs, including the core product TY-9591, with ongoing clinical trials in China for non-small cell lung cancer (NSCLC) brain metastases and advanced NSCLC[18]. - The company is actively seeking partnerships with leading pharmaceutical companies to maximize the clinical and commercial value of its candidate drugs[19]. - The company has established four proprietary technology platforms focused on developing new small molecule drugs, enhancing its R&D capabilities[44]. Clinical Trials and Product Development - TY-9591 is currently undergoing a pivotal Phase II clinical trial for EGFR mutation NSCLC brain metastases, with an NDA submission expected in Q1 2025[18]. - The company is also conducting a registrational Phase III trial for TY-9591 in advanced NSCLC with EGFR L858R mutation, targeting NDA submission in the second half of 2026[18]. - The company plans to initiate a Phase II trial for TY-9591 in combination with pemetrexed and platinum-based chemotherapy for advanced or metastatic NSCLC in H2 2024[24]. - The company has received IND approval for multiple candidates, including TY-4028 for NSCLC, expected to enter Phase I in December 2024[18]. Market Analysis - The market for EGFR TKI targeting the L858R mutation in China grew from RMB 1.4 billion in 2017 to RMB 5.6 billion in 2023, with a compound annual growth rate (CAGR) of 26.2%[25]. - The total number of lung cancer patients in China is projected to reach 1.8 million by 2033, with approximately 30% to 55% of NSCLC patients experiencing brain metastases during treatment[26]. - The overall market for third-generation EGFR-TKIs is highly competitive, with Osimertinib generating global sales of $5,799 million in 2023[28]. Corporate Governance - The company is committed to adhering to the corporate governance code as outlined in the listing rules[80]. - The board of directors includes both executive and non-executive members, ensuring diverse governance[81]. - The company has established a robust audit committee to oversee financial reporting and compliance[80]. Future Plans - The company plans to establish a cGMP-compliant internal production facility in Huzhou, Zhejiang Province, expected to commence commercial-scale production by the end of 2025[19]. - The company aims to enhance its R&D capabilities and expand its product pipeline by developing innovative candidates such as TY-1054, TY-1210, and TY-0609[70]. - The company plans to continue investing in internal R&D to seize market opportunities and develop innovative compounds[70].