永泰生物製藥有限公司（「本公司」）董 事（「董 事」）會（「董事會」）謹 此 宣 佈，本 公 司 計劃於2025年8月20日（星 期 三）舉 行 董 事 會 會 議，藉 以（其 中 包 括）考慮及批准本 公司及其附屬公司截至2025年6月30日 止 六 個 月 之 中 期 業 績 及 其 發 佈。 承董事會命 永泰生物製藥有限公司 香 港 交 易 及 結 算 所 有 限 公 司、香 港 聯 合 交 易 所 有 限 公 司 及 香 港 中 央 結 算 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 聲 明，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 依 賴 該 等 內 容 而 引 致 的 任 何 損 失 承 擔 任 何 責 任。 Immunotech Biopharm Ltd 永泰生物製藥有限公司 （於 開 曼 群 島 註 冊 成 立 的 有 限 公 司） （股 份 代 號：6978） 董事會會議日期 主席兼執行董事 譚 錚 香 港，2025年8月8日 於 本 公 告 日 期，董 ...

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年7月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 永泰生物製藥有限公司 呈交日期: 2025年8月1日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 06978 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 5,000,000,000 | USD | | 0.001 | USD | | 5,000,000 | | 增加 / 減少 (-) | | | | | | | USD | | | | 本月底結存 | | | 5,000,000,000 | USD | | 0.001 | USD | | 5,000,000 | FF301 II. ...

Core Insights - As of March 2025, China's foreign financial assets are projected to reach 106,978 billion USD, with foreign liabilities at 70,854 billion USD, resulting in a net foreign asset of 36,124 billion USD [1] Summary by Category Foreign Financial Assets - Direct investment assets amount to 32,765 billion USD - Securities investment assets total 15,818 billion USD - Financial derivative assets are valued at 211 billion USD - Other investment assets stand at 22,845 billion USD - Reserve assets are recorded at 35,339 billion USD [1] Foreign Liabilities - Total foreign liabilities are 70,854 billion USD [1] Net Foreign Assets - The net foreign assets are calculated to be 36,124 billion USD [1] SDR Valuation - In terms of Special Drawing Rights (SDR), foreign financial assets are valued at 80,513 billion SDR, while foreign liabilities are at 53,326 billion SDR, leading to a net foreign asset of 27,188 billion SDR [1]

Clinical Trials and Product Development - The company has completed the enrollment of 430 target subjects for the Phase II clinical trial of its core candidate product EAL®, with conditional NDA acceptance by the National Medical Products Administration[9]. - The company plans to submit for commercialization of EAL® in the Chinese market following statistically significant clinical trial results[7]. - The company has completed the enrollment of six target patients for the Phase I clinical trial of 6B11-OCIK injection, with preliminary analysis and mid-term results ongoing[10]. - The CAR-T-19 injection has received breakthrough therapy designation from the drug review center for treating relapsed/refractory B-ALL patients aged 25 and under, expediting its clinical development[13]. - The company has completed the enrollment of 47 target patients for the Phase II clinical trial of CAR-T-19 injection[14]. - The company has completed the enrollment of 12 target patients for the Phase I clinical trial of Dinolansai injection as of the report date[16]. - The company has received IND approval for the Phase I clinical trial of aT19 injection in February 2024[17]. - The group has obtained clinical implicit approval from the National Medical Products Administration for Dinolansai injection, aimed at treating patients with relapsed refractory diffuse large B-cell lymphoma[33]. - The group has completed the enrollment of 12 target patients in the Phase I clinical trial for Dinolansai injection[34]. - The company aims to address the challenges of CAR-T cell therapy's persistence and efficacy with the development of Dinolansai and aT19 injections[17]. - The company is progressing with the clinical development of multiple TCR-T cell products targeting renal clear cell carcinoma and viral infections[18]. Financial Performance - Other income increased from approximately RMB 10.5 million for the year ending December 31, 2023, to approximately RMB 33.8 million for the year ending December 31, 2024, representing a growth of about 220.4%[21]. - The net loss decreased from approximately RMB 106.5 million for the year ending December 31, 2023, to approximately RMB 11.8 million for the year ending December 31, 2024, a reduction of about 88.9%[21]. - R&D expenses decreased from approximately RMB 177.3 million for the year ending December 31, 2023, to approximately RMB 154.2 million for the year ending December 31, 2024, a decrease of about 13.0%[21]. - The total loss and comprehensive expenses decreased from approximately RMB 335.5 million for the year ending December 31, 2023, to approximately RMB 187.3 million for the year ending December 31, 2024, a reduction of about 44.2%[22]. - The net loss decreased by approximately 44.4% from RMB 335.5 million in 2023 to RMB 186.4 million in 2024, reflecting improvements in operational efficiency[60]. - Research and development expenses decreased by approximately 13.0% from RMB 177.3 million in 2023 to RMB 154.2 million in 2024, mainly due to increased material costs offset by reduced contracted costs and employee expenses[57]. - Administrative expenses decreased by approximately 16.4% from RMB 53.2 million in 2023 to RMB 44.5 million in 2024, attributed to reductions in employee costs and professional fees[56]. - Cash and cash equivalents decreased from approximately RMB 52.2 million in 2023 to RMB 47.0 million in 2024, primarily due to cash consumption for R&D[63]. - The company reported a financial cost reduction of approximately 12.0% from RMB 8.5 million in 2023 to RMB 7.5 million in 2024, mainly due to decreased interest expenses on lease liabilities[58]. Research and Development Initiatives - The company has established a proprietary technology platform for the production of EAL® cells, enhancing its R&D capabilities[7]. - The company’s product pipeline includes non-gene modified and gene modified products, with a focus on multi-target and single-target cell immunotherapy products[7]. - The company has been focusing on T-cell immunotherapy research and commercialization for nearly 18 years, demonstrating a strong commitment to cancer treatment[7]. - The company aims to advance its clinical research and commercialization processes through a well-structured R&D organization[7]. - The company aims to develop a TCR gene database targeting new tumor antigens for personalized cancer immunotherapy[47]. - The company has established a virus vector production system that meets GMP standards, enabling large-scale production of viral vectors for CAR-T cell therapy[48]. Strategic Partnerships and Market Expansion - The company plans to expand strategic partnerships and explore acquisition opportunities to enhance the sales and development of existing and new products[49]. - The company aims to expand its market presence and enhance its product offerings through strategic partnerships and acquisitions[96]. - The management team is committed to exploring new strategies for market expansion and product development[88]. - The company is focused on advancing its research and development initiatives, particularly in biotechnology and pharmaceuticals[93][96]. Corporate Governance and Management - The management team includes experienced professionals with over 20 years in the pharmaceutical industry, contributing to strategic planning and operational oversight[86][87]. - The independent non-executive directors provide independent opinions and judgments to the board, ensuring governance and oversight[93][94]. - The company is committed to maintaining high standards of corporate governance through the involvement of experienced independent directors[93][94]. - The management team has a strong educational background, with degrees from prestigious institutions, contributing to informed decision-making[90][91][96]. Employee and Operational Management - The company is focused on employee training to enhance technical and product knowledge, offering various training programs tailored to different positions[81]. - The company provides social insurance and housing provident fund contributions for all employees in China[82]. - The total employee compensation for the year was approximately RMB 70.1 million, a decrease from RMB 77.0 million in 2023[77]. - The company has 154 employees as of December 31, 2024, with the largest functional group being production, purification, equipment, and safety, comprising 56 employees[78]. Risks and Challenges - The company has incurred a net loss during the reporting period and has not generated any revenue from self-sales of its research products, with no guarantee of future profitability[105]. - The company anticipates needing additional financing to support its operations, including research and commercialization efforts, due to negative operating cash flow during the reporting period[105]. - The company faces significant risks related to the inability to identify or develop new products, which could lead to investor losses[105]. - The company may face challenges in obtaining regulatory approvals for its research products, which are currently in preclinical or clinical development stages[105]. - The company is subject to strict regulatory oversight in drug development and commercialization, which may impact its operational timelines[108]. - The company faces risks related to its operations in China, including potential fines for non-compliance with employee welfare regulations and challenges in managing growth[110]. Shareholder and Financial Structure - The company issued convertible bonds totaling RMB 300 million on February 20, 2023, with an initial conversion price of HKD 4.81 per share[68]. - As of December 31, 2024, the company utilized approximately RMB 256.6 million of the proceeds from the convertible bonds, with RMB 102.3 million allocated for EAL® clinical trials and RMB 197.7 million for the construction of a new R&D and production center[72]. - The company's capital structure as of December 31, 2024, was 102.9% debt and -2.9% equity, compared to 79.8% debt and 20.2% equity as of December 31, 2023[67]. - The company has a distributable reserve of RMB 1,402,498,000 as of December 31, 2024, unchanged from 2023[172]. - The company has adopted a stable and conservative financing policy to maintain optimal financial conditions and minimize financial risks[124]. Legal and Compliance Matters - There are ongoing lawsuits from two suppliers regarding overdue payments, but the board believes the impact on the financial statements is not significant[174]. - The company has established contractual arrangements to maintain effective control over its operations in China, particularly in the field of immunotherapy[179]. - The exclusive business cooperation agreement grants the company exclusive and proprietary rights to all intellectual property developed by its subsidiary[183]. - The share pledge agreement was established on September 10, 2018, to secure the obligations of the registered shareholders towards Beijing Yongtai[184].

Financial Performance - Other income increased from approximately RMB 10.5 million for the year ended December 31, 2023, to approximately RMB 33.8 million for the year ended December 31, 2024, representing a growth of about 220.4%[3]. - Net loss from other gains and losses decreased from approximately RMB 106.5 million for the year ended December 31, 2023, to approximately RMB 11.8 million for the year ended December 31, 2024, a reduction of about 88.9%[3]. - Loss before tax decreased from approximately RMB 335.5 million for the year ended December 31, 2023, to approximately RMB 186.4 million for the year ended December 31, 2024, a decrease of about 44.4%[3]. - Total loss and comprehensive expenses decreased from approximately RMB 335.5 million for the year ended December 31, 2023, to approximately RMB 187.3 million for the year ended December 31, 2024, a reduction of about 44.2%[4]. - The total loss for the year ended December 31, 2024, was RMB 187.3 million, compared to RMB 335.5 million for the year ended December 31, 2023[38]. - The company reported a net loss of RMB 187,343,000 for the year ending December 31, 2024, compared to a net loss of RMB 335,479,000 in the previous year, indicating an improvement[97]. - The group reported a net loss attributable to shareholders of RMB 186,912,000 for the year ended December 31, 2024, compared to a loss of RMB 334,819,000 in 2023, indicating an improvement of approximately 44%[129]. Research and Development - R&D expenses decreased from approximately RMB 177.3 million for the year ended December 31, 2023, to approximately RMB 154.2 million for the year ended December 31, 2024, a decline of about 13.0%[3]. - The company has completed the enrollment of 430 target patients for the Phase II clinical trial of EAL®, with the application for conditional approval submitted to the NMPA[5]. - The company has completed the enrollment of six target patients for the Phase I clinical trial of 6B11-OCIK injection and is conducting preliminary analysis of the trial results[6]. - CAR-T-19 injection has received breakthrough therapy designation for the treatment of patients aged 25 and under with relapsed/refractory B-ALL, expediting its clinical development[8]. - The company has completed the enrollment of 12 target patients for the Phase I clinical trial of Dinolones injection[9]. - The company has multiple TCR-T cell products in preclinical research targeting indications such as renal cell carcinoma and viral infections like CMV and EBV[12]. - The YT007 injection for treating advanced renal cell carcinoma has completed preclinical research[13]. - The core candidate product EAL® has received acceptance for its NDA from the NMPA, with a focus on preventing postoperative recurrence of liver cancer[14][19]. - The company has established a technical platform necessary for the development of cell immunotherapy products[15]. - The company has established a virus vector production system that meets GMP standards, enabling large-scale production of viral vectors for CAR-T cell enterprises[36]. - The company aims to continue investing in CAR-T and TCR-T cell product pipelines, targeting CMV infections in patients post-transplant[34]. - The company is focused on the research and development of new drugs, particularly in the field of immune cell therapy[151]. Financial Management - Cash and bank balances decreased from approximately RMB 52.2 million as of December 31, 2023, to RMB 47.0 million as of December 31, 2024, primarily due to cash used in R&D[52]. - The liquidity ratios showed a decline, with the current ratio decreasing from 0.40 in 2023 to 0.20 in 2024, and the quick ratio decreasing from 0.39 to 0.19 during the same period[63]. - The company has no interest-bearing debt as of December 31, 2024, making the debt-to-equity ratio not applicable[67]. - The company aims to enhance its operational capital and financial condition through the issuance of convertible bonds, despite potential dilution effects on existing shareholders[58]. - The company has significant uncertainties regarding its ability to continue as a going concern due to ongoing losses and cash flow issues[94]. - The group has significant uncertainty regarding its ability to continue as a going concern, dependent on the successful implementation of its plans and measures[113]. - The company has received recognition as a "High-tech Enterprise," allowing it to benefit from a reduced corporate income tax rate of 15%[122]. Employee and Operational Costs - Employee compensation for the year totaled approximately RMB 70.1 million, down from RMB 77.0 million in 2023[75]. - Total employee costs for 2024 are RMB 70,053,000, down from RMB 77,034,000 in 2023, reflecting a decrease of approximately 9.5%[127]. - The company employed a total of 154 employees as of December 31, 2024[76]. - The quality department had 39 employees as of December 31, 2024, and reports directly to the CEO[32]. Capital and Investment - The company issued convertible bonds totaling RMB 300 million on February 20, 2023, with an initial conversion price of HKD 4.81 per share[57]. - The company raised a total of RMB 300 million through the issuance of convertible bonds, with RMB 102.3 million allocated for EAL® clinical trials and RMB 197.7 million for the construction of a new R&D and production center[60]. - As of December 31, 2024, the company utilized approximately RMB 240.2 million of the funds raised from the convertible bonds, with RMB 102.3 million fully used for EAL® clinical trials and RMB 154.3 million used for the new R&D center[61]. - The company plans to invest approximately RMB 1.2 billion in the Beijing production center, expected to produce over 200,000 batches of cell drugs annually[30]. - A project in the East China region is expected to have a total investment of around RMB 1 billion, with the first phase of the EAL® R&D and production center to be completed within 48 months after obtaining land ownership[30]. Compliance and Governance - The audit committee has confirmed compliance with applicable accounting principles and standards for the financial year ending December 31, 2024[90]. - Deloitte has agreed that the preliminary announcement figures align with the audited consolidated financial statements to be approved on March 31, 2025[91]. - The company has adopted the standards set forth in the listing rules to regulate securities trading by directors and related employees[86]. - The company is focused on ensuring compliance with the listing rules of the Hong Kong Stock Exchange[151]. Future Outlook - The company plans to accelerate the commercialization of EAL® and is focusing on government affairs, hospital admissions, market, medical, and sales-related work[33]. - The company is actively seeking equity financing and applying for applicable government subsidies[112]. - The company is exploring market expansion opportunities in the biopharmaceutical sector[152]. - The company plans to fully utilize the net proceeds by 2025[72].

Financial Performance - Total revenue for the six months ended June 30, 2024, was RMB 6,526,000, representing a 17.9% increase from RMB 5,533,000 in the same period of 2023[16]. - The pre-tax loss for the period was RMB 92,556,000, a decrease of 22.0% from RMB 118,602,000 in the previous year[16]. - Basic and diluted loss per share was RMB 0.18, improved from RMB 0.23 in the same period last year[16]. - Other income increased by approximately 17.9% to RMB 6.5 million for the six months ended June 30, 2024, compared to RMB 5.5 million for the same period in 2023, primarily due to increased government subsidies[32]. - The group recorded a net other income of approximately RMB 19.8 million for the six months ended June 30, 2024, compared to a net loss of approximately RMB 20.3 million for the same period in 2023, mainly due to fair value gains on other financial liabilities[33]. - Administrative expenses decreased by approximately 7.9% to RMB 23.0 million for the six months ended June 30, 2024, from RMB 25.0 million for the same period in 2023, mainly due to reduced travel and other expenses[34]. - The group's loss before tax decreased by approximately 22.0% to RMB 92.6 million for the six months ended June 30, 2024, compared to RMB 118.6 million for the same period in 2023[37]. - The company reported a total comprehensive loss for the period attributable to owners of the company of RMB 92,515,000, compared to RMB 118,114,000 in the previous year, reflecting a decrease of 21.7%[88]. - The company reported a loss attributable to owners of RMB 92,515,000 for the six months ended June 30, 2024, compared to a loss of RMB 118,114,000 in the same period of 2023[109]. Research and Development - Research and development expenses increased by 22.6% to RMB 91,118,000 compared to RMB 74,315,000 in the prior year[16]. - The company is focused on the commercialization of its core product EAL® for the prevention of postoperative recurrence of liver cancer[17]. - The product pipeline includes non-gene modified and gene modified cell immunotherapy products, with ongoing research on 6B11, CAR-T cell series, and TCR-T cell series[17]. - EAL® is undergoing a Phase II clinical trial for preventing postoperative recurrence of liver cancer, with interim results expected to support a New Drug Application (NDA) submission in the second half of 2024[19]. - The company has completed enrollment of 430 target patients for the Phase II clinical trial of EAL® and anticipates submitting the NDA to the National Medical Products Administration in the second half of 2024, with a product launch expected in 2025[20]. - The 6B11-OCIK injection for ovarian cancer has completed enrollment of six target patients in its Phase I clinical trial, with preliminary analysis and mid-term results ongoing[21]. - CAR-T-19 injection, targeting B-ALL in patients aged 25 and under, has completed enrollment of 25 target patients for its Phase II clinical trial, with preliminary results expected in the first half of 2026[21]. - The company has completed enrollment of eight target patients for the Phase I clinical trial of the dinutuximab injection, with completion expected by the end of 2024 and preliminary results in the first half of 2025[22]. - The company is developing TCR-T-CMV, the first product targeting CMV-related malignancies, with plans to enter clinical trials in 2025[29]. - The company is focused on enhancing the efficacy and durability of CAR-T cell therapies through innovative product development[23]. - The company is actively pursuing regulatory approvals and clinical trials to bring its innovative therapies to market[20]. Financial Position - Non-current assets as of June 30, 2024, were RMB 538,889,000, down 14.8% from RMB 632,390,000 at the end of 2023[16]. - Current assets decreased by 15.5% to RMB 180,830,000 from RMB 213,894,000 at the end of 2023[16]. - Current liabilities were RMB 478,206,000, a reduction of 9.8% from RMB 530,275,000 at the end of 2023[16]. - The company's capital structure as of June 30, 2024, consisted of 89.1% debt and 10.9% equity, compared to 62.6% debt and 37.4% equity as of June 30, 2023[42]. - The company has no outstanding mortgages, pledges, or significant contingent liabilities as of June 30, 2024[41]. - The company reported a bank balance and cash increase from approximately RMB 52.2 million to approximately RMB 79.6 million as of June 30, 2024, primarily due to the sale of deposit notes[40]. - The company has accumulated losses of RMB 1,712,662,000 as of June 30, 2024, which has expanded from the previous reported losses[93]. - The company plans to implement measures to improve liquidity, including financial support from a major shareholder for at least 15 months starting December 31, 2023[93]. - The company is actively applying for applicable government subsidies to enhance its financial position[94]. Investments and Capital Expenditures - The company plans to invest approximately RMB 1.2 billion in the Beijing production center, which is expected to produce over 200,000 batches of cell drugs annually, covering the northern and northeastern markets of China[26]. - A production center in the East China region is projected to have a total investment of around RMB 1 billion, with the first phase of construction expected to be completed within 60 months after obtaining land rights[27]. - The company plans to utilize approximately RMB 197.7 million for the construction costs of a new R&D and production center, with expected utilization by the end of 2025[44]. - The company has capital commitments for machinery, leased land, and construction projects as of June 30, 2024, amounting to RMB 561,406,000, a decrease from RMB 573,993,000 as of December 31, 2023[126]. Shareholder Information - The company has issued convertible bonds totaling RMB 300 million in February 2023, with an annual interest rate of 6%[43]. - Approximately RMB 102.3 million of the funds from the convertible bonds will be used for EAL® clinical trials, with expected utilization by the first half of 2025[44]. - The company has a total of 5,000,000 shares held by Mr. Tan Zheng, representing 0.97% of the company's equity[55]. - Major shareholder China Resources Limited holds 217,054,121 shares, representing 42.18% of the company's equity[59]. - The company has a total of 38,400,000 shares held by Tan Zheng Ltd, representing 7.46% of the company's equity[60]. - The company has issued a total of 514,584,000 shares as of the mid-term report date[61]. Corporate Governance and Compliance - The company has maintained compliance with corporate governance codes throughout the six months ending June 30, 2024, ensuring shareholder rights and enhancing corporate value[68]. - The audit committee, consisting of three members, has reviewed the unaudited interim results for the six months ending June 30, 2024, confirming compliance with applicable accounting principles and standards[71]. - The company emphasizes the importance of regulatory compliance in its operations, adhering to the Securities and Futures Ordinance of Hong Kong[137]. Future Outlook - The company has a future outlook focused on market expansion and new product development, although specific figures were not disclosed in the provided content[58]. - The company is exploring strategic partnerships and potential acquisitions to enhance its market position[58]. - The company is committed to ongoing research and development in new technologies to drive future growth[58]. - The company aims to expand its market presence through strategic collaborations and investments in innovative technologies[138].

[Interim Results Announcement Summary](index=1&type=section&id=Interim%20Results%20Announcement%20Summary%20for%20the%20Six%20Months%20Ended%20June%2030%2C%202024) [Financial Summary](index=1&type=section&id=Financial%20Summary) For the six months ended June 30, 2024, the company's pre-tax loss narrowed by **22.0%** to **RMB92.6 million**, driven by a net gain in other income and reduced administrative expenses, while R&D expenses increased by **22.6%** | Indicator | As of June 30, 2024 (RMB thousands) | As of June 30, 2023 (RMB thousands) | Change (%) | | :--- | :--- | :--- | :--- | | Other income | 6,526 | 5,533 | 17.9 | | Net gain (loss) on other income and losses | 19,836 | (20,269) | (197.9) | | Administrative expenses | (23,048) | (25,035) | (7.9) | | Research and development expenses | (91,118) | (74,315) | 22.6 | | Finance costs | (3,851) | (4,372) | (11.9) | | Other expenses | (901) | (144) | 525.7 | | Loss before tax | (92,556) | (118,602) | (22.0) | | Loss and total comprehensive expenses for the period | (92,556) | (118,602) | (22.0) | | Loss per share (basic and diluted) | (0.18) | (0.23) | - | | Indicator | As of June 30, 2024 (RMB thousands) | As of December 31, 2023 (RMB thousands) | Change (%) | | :--- | :--- | :--- | :--- | | Non-current assets | 538,889 | 632,390 | (14.8) | | Current assets | 180,830 | 213,894 | (15.5) | | Current liabilities | (478,206) | (530,275) | (9.8) | | Net current liabilities | (297,376) | (316,381) | (6.0) | | Non-current liabilities | (163,179) | (145,119) | 12.4 | | Net assets | 78,334 | 170,890 | (54.2) | [Company Overview](index=2&type=section&id=Company%20Overview) [Overview](index=2&type=section&id=Overview) Yongtai Biological Pharmaceutical Co., Ltd. is a leading Chinese T-cell immunotherapy biopharmaceutical company with nearly 18 years of R&D and commercialization experience, featuring core product EAL® and a pipeline of non-genetically modified and genetically modified products - The company is a leading cell immunotherapy biopharmaceutical company in China, focusing on T-cell immunotherapy R&D and commercialization for nearly **18 years**[3](index=3&type=chunk) - The core investigational product EAL® is a multi-target cell immunotherapy product with over a decade of clinical application track record, demonstrating therapeutic effects on various cancers[3](index=3&type=chunk) - The product pipeline covers non-genetically modified and genetically modified products, with key investigational products including EAL®, 6B11, CAR-T cell series, and TCR-T cell series[4](index=4&type=chunk) [Business Review](index=3&type=section&id=Business%20Review) [R&D of Pipeline Products](index=3&type=section&id=R%26D%20of%20Pipeline%20Products) The company is advancing multiple cell immunotherapy products, with core product EAL® completing Phase II patient enrollment, receiving breakthrough therapy designation, and expected NDA submission in H2 2024, while CAR-T and TCR-T pipelines also show significant progress - EAL® was granted breakthrough therapy designation by the Center for Drug Evaluation for preventing recurrence of liver cancer after surgery, expected to accelerate clinical development[6](index=6&type=chunk) - EAL® has completed Phase II clinical trial enrollment of **430** target patients, with NDA submission to the NMPA expected in H2 2024 and product launch in **2025**[6](index=6&type=chunk) - CAR-T-19 Injection has completed Phase II clinical trial enrollment of **25** target patients, with preliminary analysis and results expected in H1 **2026**[8](index=8&type=chunk) [Non-Genetically Modified Cell Product Pipeline](index=4&type=section&id=Non-Genetically%20Modified%20Cell%20Product%20Pipeline) The non-genetically modified product pipeline, centered on EAL®, has completed Phase II patient enrollment for liver cancer recurrence prevention and received breakthrough therapy designation, while 6B11-OCIK injection has completed Phase I enrollment - EAL® is undergoing a Phase II clinical trial for preventing recurrence of liver cancer after surgery, with **430** target patients enrolled[6](index=6&type=chunk) - EAL® was granted breakthrough therapy designation for preventing recurrence of liver cancer after surgery by the Center for Drug Evaluation in September **2023**[6](index=6&type=chunk) - 6B11-OCIK Injection has completed Phase I clinical trial enrollment of **six** target patients, with Phase II clinical trials to commence as appropriate based on business arrangements[7](index=7&type=chunk) [Genetically Modified Cell Products in Development](index=5&type=section&id=Genetically%20Modified%20Cell%20Products%20in%20Development) The genetically modified cell product pipeline includes CAR-T and TCR-T series, with CAR-T-19 completing Phase II enrollment, Dinolunsa Injection and aT19 Injection entering Phase I trials, and TCR-T products in preclinical research targeting renal cell carcinoma and viral antigens - CAR-T-19 Injection has completed Phase II clinical trial enrollment of **25** target patients, with preliminary analysis and results expected in H1 **2026**[8](index=8&type=chunk) - Dinolunsa Injection has received clinical approval from the NMPA and completed Phase I clinical trial enrollment of **eight** target patients, with preliminary analysis and results expected in H1 **2025**[9](index=9&type=chunk) - aT19 Injection received IND approval for Phase I clinical trials in February **2024**, aiming to enhance the persistence and immune memory function of CAR-T cells[10](index=10&type=chunk) - The TCR-T cell product pipeline currently has multiple investigational products undergoing preclinical research, targeting HERV-E antigen, CMV, and HBV viral antigens[12](index=12&type=chunk) [The Group's Facilities](index=7&type=section&id=The%20Group%27s%20Facilities) The company operates a **27,604 sqm** R&D and production center in Beijing and is expanding production facilities in populous regions like Beijing, Shaoxing, and Shanghai to address EAL®'s transport limitations and future commercialization needs, significantly boosting annual output - The Beijing R&D and production center has a total area of approximately **27,604 sqm**, capable of supporting preclinical and clinical R&D, as well as early-stage production needs for investigational products[13](index=13&type=chunk) - The Beijing production center is expected to involve an investment of **RMB1.2 billion**, with an annual cell drug production capacity exceeding **200,000 batches** upon completion, covering the North and Northeast China markets[13](index=13&type=chunk) - The Shaoxing EAL® production center project in East China has an estimated total investment of approximately **RMB1 billion** and has commenced construction[14](index=14&type=chunk) [Quality Assurance](index=8&type=section&id=Quality%20Assurance) The company has established a GMP-compliant quality management system ensuring product quality consistency, with standardized manufacturing for EAL® and CAR-T-19 Injection, and an independent quality department of **45 employees** reporting directly to the CEO - The Group has developed quality management documents in accordance with GMP, covering production process procedures, product quality standards, equipment, and facility operating procedures[16](index=16&type=chunk) - The production of EAL® and CAR-T-19 Injection has been standardized to ensure consistent product quality[16](index=16&type=chunk) - The head of the Quality Department reports directly to the CEO, with two sub-teams for Quality Assurance and Quality Control, comprising **45 employees** as of June 30, 2024[16](index=16&type=chunk) [Future and Outlook](index=8&type=section&id=Future%20and%20Outlook) [Accelerate EAL® Clinical Trial Progress and Advance Commercialization Layout](index=8&type=section&id=Accelerate%20EAL%C2%AE%20Clinical%20Trial%20Progress%20and%20Advance%20Commercialization%20Layout) The company plans to accelerate EAL® Phase II clinical trial submission, production, and quality validation for faster registration and early commercialization, establishing R&D and production centers in populous regions like Guangzhou and Chengdu to address EAL®'s transport radius limitations - The company plans to comprehensively advance the EAL® Phase II clinical trial submission, production, and quality validation to accelerate registration and obtain necessary data[17](index=17&type=chunk) - To address EAL®'s six-hour transport radius, the company plans to establish R&D and production centers in populous regions of China, such as Guangzhou and Chengdu[18](index=18&type=chunk) - The company expects to submit the NDA for EAL® to the NMPA in H2 **2024** and launch the product in **2025**[18](index=18&type=chunk) [Advance Preclinical Research of Pipeline Products and Accelerate Entry into Clinical Trial Stage](index=9&type=section&id=Advance%20Preclinical%20Research%20of%20Pipeline%20Products%20and%20Accelerate%20Entry%20into%20Clinical%20Trial%20Stage) The company will continue investing in CAR-T and TCR-T cell product pipelines, with Dinolunsa Injection and aT19 Injection already clinically approved, and the first TCR-T-CMV product targeting clinical trials by **2025** for CMV infection-related malignancies post-hematopoietic stem cell transplantation - The company will continue to invest in CAR-T and TCR-T cell product pipelines, with Dinolunsa Injection and aT19 Injection having received clinical approval from the NMPA[18](index=18&type=chunk) - The first TCR-T-CMV investigational product is targeted to enter clinical trials in **2025**, for the treatment of CMV infection-related malignancies after hematopoietic stem cell transplantation[18](index=18&type=chunk) [Enhance Technology Platform and Further Enrich Product Pipeline](index=9&type=section&id=Enhance%20Technology%20Platform%20and%20Further%20Enrich%20Product%20Pipeline) The company is committed to developing cell immunotherapy products for various tumor types and stages, enhancing existing product efficacy, and will focus on TCR identification for solid tumor neoantigens, establishing a TCR gene database, and researching TCR-T cell products targeting viral antigens - The company is committed to developing cell immunotherapy products suitable for different tumor types and stages, and improving the efficacy of existing products[19](index=19&type=chunk) - The company plans to conduct TCR identification for individualized tumor mutation neoantigens in solid tumors and establish a TCR gene database targeting tumor neoantigens[19](index=19&type=chunk) - Research on TCR-T cell products targeting viral antigens (such as CMV and HBV viruses) is currently underway[19](index=19&type=chunk) [Develop Viral Vector Production and Early R&D Services Business](index=10&type=section&id=Develop%20Viral%20Vector%20Production%20and%20Early%20R%26D%20Services%20Business) The company has established a GMP-compliant viral vector production system for large-scale manufacturing and is developing CDMO services based on its systematic cell immunotherapy R&D platform, offering customized solutions to meet domestic CAR-T cell companies' needs - A viral vector production system compliant with pharmaceutical GMP production quality standards has been established, capable of large-scale production[20](index=20&type=chunk) - The company is developing CDMO services based on its systematic technology platform for cell immunotherapy product R&D, offering customized services according to client needs[20](index=20&type=chunk) [Expand Strategic Cooperation and Explore Acquisition Opportunities Based on Organic Growth](index=10&type=section&id=Expand%20Strategic%20Cooperation%20and%20Explore%20Acquisition%20Opportunities%20Based%20on%20Organic%20Growth) The company plans to expand strategic collaborations and explore M&A opportunities to enhance sales, technology transfer, and strategic partnerships for existing and pipeline products, while continuously seeking new potential development directions for cell immunotherapy products - The company plans to expand strategic collaborations, explore M&A opportunities, and seek sales, technology transfer, and strategic partnerships for existing and pipeline products[21](index=21&type=chunk) - The company continuously seeks new potential development directions for cell immunotherapy products, exploring M&A and strategic cooperation opportunities[21](index=21&type=chunk) [Financial Information](index=10&type=section&id=Financial%20Information) [Financial Review](index=11&type=section&id=Financial%20Review) For the six months ended June 30, 2024, the company's pre-tax loss decreased by **22.0%** to **RMB92.6 million**, with other income increasing by **17.9%** and a net gain in other income and losses, while administrative expenses decreased by **7.9%** and R&D expenses increased by **22.6%** Operating Performance Overview | Indicator | For the six months ended June 30, 2024 (RMB thousands) | For the six months ended June 30, 2023 (RMB thousands) | Change (%) | | :--- | :--- | :--- | :--- | | Other income | 6,526 | 5,533 | 17.9 | | Net gain (loss) on other income and losses | 19,836 | (20,269) | (197.9) | | Administrative expenses | (23,048) | (25,035) | (7.9) | | Research and development expenses | (91,118) | (74,315) | 22.6 | | Finance costs | (3,851) | (4,372) | (11.9) | | Loss before tax | (92,556) | (118,602) | (22.0) | - Other income increased by **17.9%** to **RMB6.5 million**, primarily due to an increase in government grants for machinery[24](index=24&type=chunk) - Net gain (loss) on other income and losses turned from a loss of **RMB20.3 million** in the same period of **2023** to a gain of **RMB19.8 million** in **2024**, mainly due to fair value gains on other financial liabilities[25](index=25&type=chunk) - Research and development expenses increased by **22.6%** to **RMB91.1 million**, primarily due to higher contracting costs[27](index=27&type=chunk) [Income Tax Expense](index=14&type=section&id=Income%20Tax%20Expense) The company incurred no income tax expense during the reporting period, primarily due to tax losses generated by Chinese subsidiaries and the **15%** preferential tax rate enjoyed by Beijing Yongtai and Yongtai Ruike as high-tech enterprises - For the six months ended June 30, 2024, the company had no income tax expense[31](index=31&type=chunk) - Beijing Yongtai and Yongtai Ruike are recognized as high-tech enterprises, enjoying a **15%** preferential corporate income tax rate[31](index=31&type=chunk) [Liquidity and Capital Resources](index=14&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2024, bank balances and cash increased to **RMB79.6 million** due to the sale of certificates of deposit, with the capital structure shifting to **89.1%** debt and **10.9%** equity, and **RMB192.7 million** of the **RMB300 million** convertible bonds utilized for EAL® clinical trials and new R&D and production centers - Bank balances and cash increased from **RMB52.2 million** as of December 31, 2023, to **RMB79.6 million** as of June 30, 2024, primarily due to the sale of certificates of deposit[32](index=32&type=chunk) - As of June 30, 2024, the company's capital structure was **89.1%** debt and **10.9%** equity, compared to **62.6%** debt and **37.4%** equity as of June 30, 2023[35](index=35&type=chunk) - In February **2023**, secured convertible bonds with a principal amount of **RMB300 million** were issued for EAL® clinical trials and the construction of new R&D and production centers[36](index=36&type=chunk)[37](index=37&type=chunk) Use of Proceeds from Convertible Bonds | Use of Proceeds | Allocated (RMB millions) | Unutilized as of January 1, 2024 (RMB millions) | Utilized as of June 30, 2024 (RMB millions) | Unutilized as of June 30, 2024 (RMB millions) | Expected Timeline for Full Utilization | | :--- | :--- | :--- | :--- | :--- | :--- | | EAL® clinical trials | 102.3 | 43.2 | 32.6 | 10.6 | H1 2025 | | Construction costs for new R&D and production centers | 197.7 | 117.7 | 21.0 | 96.7 | End of 2025 | | **Total** | **300.0** | **160.9** | **53.6** | **107.3** | - | [Selected Financial Ratios](index=17&type=section&id=Selected%20Financial%20Ratios) As of June 30, 2024, both current and quick ratios decreased, primarily due to a reduction in financial assets at fair value through profit or loss, with the debt-to-equity ratio not applicable due to no interest-bearing borrowings Selected Financial Ratios | Indicator | As of June 30, 2024 (Unaudited) | As of December 31, 2023 (Audited) | | :--- | :--- | :--- | | Current ratio | 0.38 | 0.40 | | Quick ratio | 0.36 | 0.39 | | Debt-to-equity ratio | – | – | - The current ratio and quick ratio decreased, mainly due to a reduction in financial assets at fair value through profit or loss[41](index=41&type=chunk) [Notes to the Condensed Consolidated Financial Statements](index=21&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) The financial statements are prepared under IAS 34, with retrospective application of IAS 1 amendments reclassifying convertible bonds from non-current to current liabilities, and other key notes detailing other income, net gains/losses, income tax, loss per share, and financial assets/liabilities - The condensed consolidated financial statements are prepared in accordance with International Accounting Standard **34** "Interim Financial Reporting"[47](index=47&type=chunk) - Following the application of amendments to IAS **1**, convertible bonds were reclassified from non-current liabilities to current liabilities as they are exercisable within **12 months**[51](index=51&type=chunk) Details of Net Gain (Loss) on Other Income and Losses | Item | For the six months ended June 30, 2024 (RMB thousands) | For the six months ended June 30, 2023 (RMB thousands) | | :--- | :--- | :--- | | Fair value gain (loss) on financial assets at fair value through profit or loss | 3,323 | (10,126) | | Fair value gain (loss) on other financial liabilities | 41,048 | (10,152) | | Loss on termination of an intangible asset | (19,316) | – | | Impairment loss on prepayments to a supplier | (5,183) | – | | Exchange gain, net | 11 | 76 | | Loss on disposal of property, plant and equipment | (41) | (83) | | Others | (6) | 16 | | **Total** | **19,836** | **(20,269)** | - The termination of the T-Cure license agreement resulted in the recognition of a loss on intangible assets of **RMB19,316,000** and an impairment loss on prepayments of **RMB5,183,000**[56](index=56&type=chunk) [Other Information](index=32&type=section&id=Other%20Information) [Use of Net Proceeds from Listing and Over-allotment Option](index=32&type=section&id=Use%20of%20Net%20Proceeds%20from%20Listing%20and%20Over-allotment%20Option) The company's net proceeds of approximately **HKD1,127.8 million** from its **2020** listing and over-allotment option have been substantially utilized, with **HKD1,124.8 million** expended by June 30, 2024, primarily for EAL® clinical trials and commercialization, and other R&D, with remaining funds expected to be depleted by end of **2025** - The net proceeds from the listing and over-allotment option amounted to approximately **HKD1,127.8 million**[75](index=75&type=chunk) - As of June 30, 2024, approximately **HKD1,124.8 million** has been utilized, primarily for EAL® clinical trials and commercialization, CAR-T-19 and TCR-T clinical trials, expansion of EAL®'s other clinical indications R&D, other investigational product development, and working capital[75](index=75&type=chunk) - The remaining net proceeds are expected to be fully utilized by the end of **2025**[77](index=77&type=chunk) [Material Investments, Acquisitions and Disposals](index=34&type=section&id=Material%20Investments%2C%20Acquisitions%20and%20Disposals) As of June 30, 2024, the company held financial assets at fair value through profit or loss totaling approximately **RMB65.7 million**, including unlisted limited partnership interests, financial products, and certificates of deposit, having disposed of some certificates of deposit for **RMB82.6 million** while retaining **RMB30.0 million** - As of June 30, 2024, the Group recorded financial assets at fair value through profit or loss of approximately **RMB65.7 million**[78](index=78&type=chunk) - During the reporting period, the company disposed of **eight** certificates of deposit for a total consideration of approximately **RMB82.6 million**, and still held **three** certificates of deposit totaling **RMB30.0 million**[78](index=78&type=chunk) [Employees and Remuneration Policy](index=34&type=section&id=Employees%20and%20Remuneration%20Policy) As of June 30, 2024, the company had **202 employees** (**201** in China, **1** in Korea), with total employee remuneration of approximately **RMB36.6 million**, supported by a regular evaluation system, training, and social insurance and housing provident fund contributions for Chinese employees - As of June 30, 2024, the Group had a total of **202 employees**, with **201** in China and **1** in Korea[79](index=79&type=chunk) - For the six months ended June 30, 2024, total employee remuneration was approximately **RMB36.6 million**[79](index=79&type=chunk) Number of Employees by Function | Function | Number of Employees | | :--- | :--- | | General Management and Administration | 29 | | Research and Development | 22 | | Senior Management | 10 | | Product and Technology R&D | 30 | | Production, Purification, Equipment and Safety | 37 | | Quality | 45 | | Clinical Support and Business Development | 29 | | **Total** | **202** | [Share Option Schemes](index=35&type=section&id=Share%20Option%20Schemes) The company operates pre-IPO and post-IPO share option schemes to reward and incentivize employees, with **35,930,000** unexercised options under the pre-IPO scheme as of June 30, 2024, representing **6.98%** of total issued shares, and no activity under the post-IPO scheme since adoption - The company adopted the Pre-IPO Share Option Scheme on December 31, **2019**, and the Post-IPO Share Option Scheme on June 6, **2020**[82](index=82&type=chunk) - As of June 30, 2024, **35,930,000** share options remained unexercised under the Pre-IPO Share Option Scheme, representing approximately **6.98%** of the total issued shares[83](index=83&type=chunk)[85](index=85&type=chunk) - No share options have been granted, exercised, cancelled, or lapsed under the Post-IPO Share Option Scheme from the listing date to the date of this announcement[86](index=86&type=chunk) [Corporate Governance and Audit Committee](index=38&type=section&id=Corporate%20Governance%20and%20Audit%20Committee) The company maintains high corporate governance standards, complying with all applicable code provisions during the reporting period, and the Audit Committee has reviewed the unaudited consolidated interim results for the six months ended June 30, 2024, confirming adherence to accounting principles and disclosure requirements - The company has complied with all applicable code provisions of the Corporate Governance Code throughout the six months ended June 30, 2024[87](index=87&type=chunk) - The Audit Committee has reviewed the company's unaudited consolidated interim results for the six months ended June 30, 2024, and confirmed compliance with applicable accounting principles, standards, and requirements[91](index=91&type=chunk) [Definitions and Glossary of Technical Terms](index=40&type=section&id=Definitions%20and%20Glossary%20of%20Technical%20Terms)

2023年年度報告 10 管理層討論及分析 業務回顧 在研產品的研發 | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | |-----------------|-------|----------------|-------------|----------------------------------------------------------------|------------|--------------|-------|--------|----------------------------------|-------| | | | | | \n產品類別 產品代號 治療領域 適應症 | \n早期研發 | \n臨床前研究 | IND | 臨床 I | 臨床階段 \n期 臨床 II 期 /III 期 | NDA | | | | | | 肝癌術後 | | | | | | | | 非基因 修飾產品 | | EAL® | 實體瘤 | 胃癌術後 | | | | | | | | | | 6B11 | | 鉑抗藥性卵巢癌 ( ...

Financial Performance - Total revenue for the year ended December 31, 2023, was RMB 10,547,000, an increase of 16.1% compared to RMB 9,087,000 for the year ended December 31, 2022[28]. - Revenue from technical services increased significantly to RMB 590,000 from RMB 75,000, representing a growth of 685.3% year-over-year[28]. - Government subsidies received amounted to RMB 6,216,000, up from RMB 5,101,000, reflecting a growth of 21.8%[28]. - The company reported a basic and diluted loss per share based on the financial data provided[36]. - The net loss for the year ending December 31, 2023, increased by approximately RMB 70.2 million or 193.4% to a total loss of approximately RMB 106.5 million compared to a loss of approximately RMB 36.3 million for the year ending December 31, 2022[126]. - Total loss and comprehensive expenses for the year increased by approximately RMB 14.4 million or 4.5% to approximately RMB 335.5 million for the year ending December 31, 2023, compared to approximately RMB 321.1 million for the year ending December 31, 2022[128]. Employee Compensation and Structure - The total employee compensation for the year was approximately RMB 77.0 million, a decrease of 32.6% from RMB 114.2 million in 2022[5]. - The company had a total of 210 employees in China and 1 employee in South Korea as of December 31, 2023[5]. - Employee costs totaled RMB 77,034,000, down 32.5% from RMB 114,162,000 in the previous year[35]. - The company is focused on providing training to employees to enhance technical and product knowledge[6]. - The company’s accrued salaries and other benefits decreased from RMB 16,287,000 in 2022 to RMB 10,372,000 in 2023, a reduction of approximately 36.2%[68]. Assets and Liabilities - Non-current assets, including property, plant, and equipment, amounted to RMB 527.3 million, showing an increase from RMB 500.8 million[18]. - Current assets totaled RMB 761.3 million, compared to RMB 632.4 million in the previous year, indicating a growth of 20.3%[18]. - The company's total liabilities were RMB 208.5 million, slightly decreasing from RMB 203.4 million[18]. - The total liabilities increased from RMB 167,989,000 in 2022 to RMB 176,911,000 in 2023, indicating a growth of approximately 5.5%[68]. - The net value of current assets (liabilities) was RMB (90.4) million, a significant decline from RMB 10.5 million[18]. Investments - Investments in Tasly Fund decreased to RMB 2,393,000 from RMB 88,913,000, indicating a significant decline[37]. - Total investments as of December 31, 2023, were RMB 171,174,000, an increase of 6.2% from RMB 161,185,000 in 2022[37]. - The company’s investment in Tasly Fund and Shaoxing Fund amounted to RMB 46,609,000 as of December 31, 2023, which was not present in 2022[84]. - The fair value of investments in Shaoxing Fund decreased from RMB 51,524,000 on January 1, 2022, to RMB 43,969,000 on December 31, 2023, reflecting a decline of approximately 14.6%[63]. Corporate Governance - The company has established a review committee to ensure compliance with corporate governance standards[13]. - The company is committed to adhering to corporate governance standards as outlined in the listing rules[112]. - The group has been recognized as a "High-tech Enterprise" by the Beijing Science and Technology Bureau, allowing it to enjoy a reduced corporate income tax rate of 15%[53]. Research and Development - The company is developing a monoclonal antibody product targeting ovarian cancer, which is part of its pipeline for biological drugs[96]. - The company is also advancing its CAR-T cell therapy products, specifically CAR-T-19, aimed at treating B-cell malignancies[112]. - The company has a research facility located in Beijing, which supports its R&D efforts[100]. - The EAL® product is undergoing a Phase II clinical trial for the indication of preventing postoperative recurrence of liver cancer, with the company expecting to submit the NDA to the National Medical Products Administration in the second half of 2024 and anticipating product launch in 2025[129]. - The company has completed the enrollment of six target subjects for the Phase I clinical trial of 6B11-OCIK injection and is conducting preliminary analysis and interim results of the ongoing clinical trial[130]. - Multiple TCR-T cell products are currently in preclinical research targeting antigens from renal clear cell carcinoma and various virus-derived antigens such as CMV, EBV, HBV, and HPV[135]. Financial Reporting and Taxation - The company has implemented new international financial reporting standards effective January 1, 2023, impacting the presentation of financial statements[41]. - The company has not made any provisions for corporate income tax due to tax losses incurred in the past two years[31]. - Deferred tax liabilities as of December 31, 2023, were RMB 17,695,000, down from RMB 21,684,000 in 2022[55]. Clinical Trials and Product Pipeline - The company has initiated Phase II clinical trials for CAR-T-19 injection, with five target subjects enrolled as of October 2023, and expects to complete enrollment and release preliminary analysis by the first half of 2026[144]. - The company has completed enrollment of two target subjects for the Phase I clinical trial of Dinutuximab injection, with expected completion of target enrollment by the end of 2024 and preliminary results to be announced in the first half of 2025[145]. - The company plans to start the Phase I clinical trial of aT19 injection in February 2024, following IND approval from the drug evaluation center[189]. - The company aims to address the challenges of CAR-T cell therapy's durability and effectiveness in treating solid tumors through the development of dinutuximab and aT19 injections[161]. - The company plans to expand the clinical applications of EAL® to include lung cancer, gastric cancer, glioblastoma, and colorectal cancer after receiving approval for liver cancer[200].

截至2023年6月30日止六個月摘要 本集團是中國一家領先的細胞免疫治療生物醫藥公司，近17年來專注於T細胞免疫治療的研發和商業化。EAL®－其核心 在研產品－屬多靶點細胞免疫治療產品，在臨床應用方面積累了超過十年的往績，並對多種癌症顯示出療效。EAL®相 關的研究始於2006年，且本集團對細胞培養體系和方法進行了改進，並開發出具有獨立知識產權、用於生產EAL®細胞 的專有技術平台。 本公司亦已建立細胞免疫治療產品研發所需的技術平台，並設立一個用於臨床試驗的組織及管理平台。 下表載列於本中期報告日期在研產品的概要及其研發狀況： EAL®屬多靶點細胞免疫治療產品，在癌症治療的臨床應用方面具有逾十年的往績。EAL®為最初取自患者自體外周血中 的T細胞經使用專利方法活化、擴增培育而成的制劑。產品以CD8+殺傷性T細胞（表面標記為CD3分子）為主要活性成分。 於本中期報告日期，本公司已完成II期臨床試驗430名目標患者的入組工作。本公司深信其將於2023年向國家藥監局提 交產品舉行新藥預備會議的申請，且有望於2024年推出該產品。 於2023 年3月，本公司已就迪諾侖賽注射液取得國家藥監局的臨床批准。迪諾侖賽注射液原 ...