Core Viewpoint - The core product TY-9591 from Sameorigin Pharma made its debut at the ASCO annual meeting, gaining significant attention due to its promising clinical results against the leading lung cancer drug, Osimertinib [1] Group 1: Product Overview - TY-9591 is an oral, irreversible third-generation EGFR inhibitor specifically targeting non-small cell lung cancer (NSCLC) with brain metastases, aiming to challenge Osimertinib's market dominance [2] - It is the first and only drug to show significant improvement over Osimertinib in head-to-head clinical studies for this indication [2] - The drug's pharmacokinetic properties have been optimized by substituting hydrogen atoms in Osimertinib's molecule with deuterium, resulting in a threefold increase in brain tissue concentration compared to Osimertinib [2] Group 2: Clinical Trial Results - In a key Phase II clinical trial, TY-9591 achieved the primary endpoint of intracranial objective response rate (iORR), demonstrating statistically significant and clinically meaningful improvements over Osimertinib across various patient subgroups [3] - The drug is positioned as the fastest-developing candidate for treating NSCLC with brain metastases, potentially reshaping the treatment landscape in China [3] Group 3: Market Potential - The EGFR-TKI market in China has shown significant growth, increasing from 3.1 billion yuan in 2017 to 14.5 billion yuan in 2023, with a compound annual growth rate of 29.3% [4] - The market for third-generation EGFR-TKIs is expected to exceed 20.1 billion yuan by 2027 and 28.4 billion yuan by 2033 [4] - There is a pressing need for innovative treatments for NSCLC with brain metastases, as current standard therapies have limited efficacy, with objective response rates of only 23%-45% [5][6] Group 4: Commercialization Outlook - TY-9591 is set to submit its NDA for conditional approval in China, with the potential to capture significant market share given Osimertinib's current sales exceeding 8 billion yuan [6] - The successful commercialization of TY-9591 is crucial for Sameorigin Pharma's path to profitability [6]

经历了三年多低谷后，今年港股创新药等来了价值重估的机会。近两个月来，AH两地医药板块上涨明 显，其中恒生生科指数在今年1至6月已累涨超60%，直到近日才迎来回调窗口期。当指数面对多空分歧 时，市场却在继续挖掘创新药板块内低估待涨的稀缺标的，同源康医药-B(02410)由此脱颖而出。 智通财经APP观察到，6月20日，港股生科板块仍处在回调期时，同源康医药股价率先启动，盘中最高 涨幅飙升至18.79%，当日成交量达到760.66万股，创下公司上市以来单日股票成交量新高。 同源康医药股价此轮先于指数启动，究其原因，则在于近期利好催化下，公司的"投资确定性"得到进一 步验证。 今年3月，同源康医药自主研发的核心品种TY-9591在与肺癌治疗"明星药物"奥希替尼的头对头较量中显 示出统计学意义和临床意义的明显改善。根据公司指引，TY-9591已于今年4月提交Pre-NDA申请，并预 计今年Q2正式提交附条件上市NDA申请。这无疑是同源康医药TY-9591的关键里程碑，预示着该产品商 业化正式进入倒计时。 作为有望跻身国内肺癌一线治疗竞争阵营的核心品种，TY-9591在上市后有望极大释放同源康医药的内 生增长潜力，成为 ...

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].

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].