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 ...

这样我们是跑在最前面的细胞免疫制药产品的研发和商业化的这样的公司 我们核心产品叫EL是中国首款获准进入到二期临床实验适应症为实体流的细胞免疫治疗产品因为这个适应症是肝癌肝癌基本现在是一个无药可治的一个状态所以整个的这个药品在 这款药可能大概应该是在2021年就可以跑出来但是整个疫情对临床实验的冲击还是比较大的这个一会我在介绍的时候呢也会详细的给各位投资人做一个介绍这个刚才在说的时候也在也都提到了这个整个都是公司是基于T细胞的细胞免疫制造产品的研发和商业化 这块就不多说我们在讲管线的时候我一会儿再做一个详细的解释这是公司目前的股权结构说一点就是华润医药和天师利呢都是我们公司的股东华润医药是在2021年占有10%的一个股份天师利呢是在去年因为我刚才提到了整个研发管线是有一个这个临床试验有一个延后 这个市场的规模就不多介绍了这个我们在招股书里也都有披露在年报里也都会有设立 听下来会比较的惊讶人体的免疫系统什么时候是达到一个顶峰的状态其实可能比大家想的这个时间都要早我们在20出头的时候人体的免疫系统就是顶峰的状态那这句话怎么理解呢你20岁之后你每一天的你的身体是每况愈下的我们可以想一想我们现在比十年前是不是 都是你往 ...

Financial Performance - Other income increased by approximately 14.6% from RMB 4.8 million for the six months ended June 30, 2022, to RMB 5.5 million for the six months ended June 30, 2023, primarily due to an increase in government subsidies recognized during the reporting period [10]. - Administrative expenses decreased by approximately 45.9% from RMB 46.3 million for the six months ended June 30, 2022, to RMB 25.0 million for the six months ended June 30, 2023, mainly due to reductions in employee costs, professional fees, and depreciation expenses [12]. - The company's loss before tax decreased by approximately 16.6% from RMB 142.2 million for the six months ended June 30, 2022, to RMB 118.6 million for the six months ended June 30, 2023 [15]. - The company reported a net loss of approximately RMB 20.3 million for the six months ended June 30, 2023, compared to a profit of approximately RMB 3.1 million for the same period in 2022, primarily due to fair value losses on financial assets [11]. - The total employee compensation for the six months ended June 30, 2023, was approximately RMB 38.3 million, down from RMB 62.9 million for the same period in 2022 [125]. Capital Structure and Liabilities - As of June 30, 2023, the company's capital structure was 62.6% liabilities and 37.4% equity, compared to 42.4% liabilities and 57.6% equity as of December 31, 2022 [22]. - The group's total liabilities as of June 30, 2023, amounted to RMB 145,461,000, down from RMB 167,989,000 as of December 31, 2022, showing a decrease of approximately 13.5% [48]. - The company has a total non-current liability of RMB 1,629,000,000 in contract liabilities as of June 30, 2023, compared to RMB 1,984,000,000 in the previous year [56]. - The fair value of convertible bonds as of June 30, 2023, is RMB 309,818,000, which serves as collateral for the company's payment obligations [52]. - The group has a total of RMB 885 million in credit financing related to property, plant, and equipment investments, contingent upon meeting certain conditions [98]. Investments and Funding - The company plans to utilize approximately RMB 102.3 million of the RMB 300 million raised from the issuance of convertible bonds for clinical trials of EAL® and expects to use the funds by the end of 2023 [24]. - The group’s investment in Shaoxing Fund includes a subscription amount of RMB 500,000,000 for convertible bonds with an annual interest rate of 6%, maturing in May 2024 [45]. - The company has invested RMB 320,221,000 in convertible bonds as of June 30, 2023, with no convertible bonds reported in the previous year [78]. - The company entered into a subscription agreement for convertible bonds with a principal amount of RMB 300 million, with an initial conversion price of HKD 4.81 per share [95]. - The company reported a total investment of HKD 1,127.8 million for ongoing clinical trials and commercialization of EAL®, with 34.2% allocated for clinical trials and 5.0% for working capital [142]. Research and Development - The company is conducting research on gene modification pathways affecting T cell signaling to enhance the effectiveness of T cells against tumor cells, with the first product expected to enter clinical research being a targeted immunosuppressive molecule [6]. - The company has developed a systematic technical platform for cell immunotherapy product research, allowing for customized services based on customer needs [8]. - The company is focused on CAR-T cell therapy, which involves genetically engineered T cells to target specific proteins on cancer cells [189]. - The company has developed a monoclonal antibody, COC166-9, to simulate ovarian cancer-related antigens, indicating progress in its oncology pipeline [185]. - The company is advancing its OCIK injection product, aimed at treating ovarian cancer, as part of its biopharmaceutical product line [186]. Employee and Management - The company had 203 employees in China and 3 in South Korea as of June 30, 2023 [125]. - The company emphasizes training for employees to enhance technical and product knowledge across different positions [145]. - The company’s stock option plans were established to reward and incentivize participants for their contributions to the company's achievements [127]. - The company has confirmed compliance with all applicable corporate governance codes during the six-month period ending June 30, 2023 [154]. - The audit committee has reviewed the financial reporting procedures and confirmed adherence to applicable accounting principles and standards [158]. Government and Regulatory - The group has adopted new and revised International Financial Reporting Standards for the preparation of its financial statements, indicating a commitment to compliance and transparency [32]. - The group confirmed zero share-based payment expenses related to pre-IPO stock options for the six months ended June 30, 2023, compared to RMB 2,583,000 for the same period in 2022 [83]. - The company has not recognized any share-based payment transactions related to the pre-IPO share option plan, which would have reduced the loss per share [66]. - The company did not declare or propose any dividends during the reporting period [140]. - The group received government subsidies totaling RMB 41,039,000 as of June 30, 2023, down from RMB 42,510,000 at the beginning of the year [94].

Equity and Shareholding - The company reported a total equity interest of 165,595,721 shares, representing 32.18% in controlled entities[10] - The company has a significant shareholder, Tian Shili Holdings Group, holding 165,595,721 shares, which is 32.18% of the total equity[11] - The company has a total of 23,450,000 shares under the pre-IPO stock option plan, representing a potential equity interest of 4.56%[7] - The company has a total of 26,000,000 shares with a pledged interest, representing 5.05% of the total equity[10] - The company has a total of 44,820,000 shares held by Evodevo Ltd, representing 8.71% of the total equity[11] - The company has a total of 51,458,400 shares held by China Resources Limited, representing 10.00% of the total equity[11] Stock Option Plans - The company has established a stock option plan aimed at incentivizing key employees for long-term contributions to the company and its shareholders[17] - The total number of shares that can be issued upon the exercise of all options granted under the pre-IPO option plan is 37,500,000 shares[36] - The exercise price per share for options granted under the post-IPO option plan will be determined by the board, but must not be lower than the higher of the closing price on the date of the offer or the average closing price over the five trading days preceding the offer[27] - The remaining validity period of the post-IPO option plan is approximately 7 years, starting from June 6, 2020[28] - The total number of shares that may be issued under all option plans must not exceed 10% of the shares issued on the date of listing, equivalent to 50,000,000 shares[42] - No options have been granted, exercised, canceled, or lapsed under the post-IPO option plan from the date of listing to the date of this report[29] - The company aims to attract and retain employees and reward eligible employees, directors, and other selected participants for their past contributions through the post-IPO option plan[40] - The options will be granted in multiple batches as determined by the board[20] - The exercise period for options must end within 10 years from the date of grant, unless terminated earlier according to the plan's terms[26] - The company must seek shareholder approval to grant options exceeding the general plan limit at the shareholders' meeting[23] Financial Performance and Revenue - As of December 31, 2022, the company did not generate any product sales revenue, with total sales percentage from customers being zero[48] - The company's major suppliers accounted for approximately 68.1% of total procurement in the year ending December 31, 2022, up from 48.0% in 2021[49] - The largest supplier contributed about 33.0% of total procurement in the year ending December 31, 2022, compared to 15.8% in 2021[49] - The company has a share premium reserve available for distribution amounting to RMB 1,402,498,000 as of December 31, 2022, unchanged from 2021[54] - No revenue was recorded by Yongtai Ruike during the reporting period[111] Corporate Governance - The company has adopted the corporate governance code as per the listing rules, ensuring compliance since the listing date[119] - The independent auditor confirmed that there were no related party transactions during the reporting period[116] - The company has maintained high levels of corporate governance to protect shareholder interests and enhance corporate value[98] - The company is committed to high standards of corporate governance, believing it is essential for protecting shareholder interests and enhancing corporate value[136] - The board of directors has maintained compliance with public float requirements under listing rules[127] - The company has appointed Deloitte as the auditor, which provided a standard unqualified audit opinion on the financial statements for the reporting period[132] - The board of directors consists of nine members, including two executive directors, four non-executive directors, and three independent non-executive directors[154] - The company held five board meetings and one annual general meeting during the reporting period[141] - The company has established formal and informal channels for independent non-executive directors to express their views openly[143] - The company has made changes to its board, with several directors resigning and new appointments effective from March 24, 2023[148] - The company held four board meetings during the year ending December 31, 2022, ensuring compliance with corporate governance guidelines[167] - The Audit Committee has reviewed the audited consolidated financial statements for the year ended December 31, 2022, and met with the independent auditor Deloitte[187] - The Audit Committee believes that the internal review and risk management functions of the company are reasonable, effective, and adequate[188] - The Remuneration Committee held one meeting during the year ended December 31, 2022, to review the remuneration policy and structure for directors and senior management[191] - The Nomination Committee reviewed the structure, size, and diversity of the board during the year ended December 31, 2022[194] - The company has established three committees: Audit Committee, Remuneration Committee, and Nomination Committee, each with defined written terms of reference[185] Contractual Arrangements and Risks - The company has established a structural contract arrangement with its subsidiary, which includes a buyout option at a fixed exercise price[62] - The company has established a contractual arrangement with Beijing Yongtai to maintain effective control over Yongtai Ruike's financial and operational management, ensuring all economic benefits generated by Yongtai Ruike are accessible to Beijing Yongtai[80] - The service fee for the exclusive business cooperation agreement is set to include 100% of Yongtai Ruike's pre-tax profits, with adjustments based on various factors including service complexity and market rates[87] - The company has received a waiver from the Stock Exchange regarding compliance with certain listing rules, allowing for continued economic benefits from the contractual arrangement[75] - There are significant risks associated with the contractual arrangement, including potential bankruptcy of Yongtai Ruike which could result in loss of critical licenses and intellectual property[83] - The contractual arrangement is subject to a maximum applicable percentage rate under listing rules, which is expected to exceed 5%, necessitating compliance with disclosure and independent shareholder approval requirements[94] - The company has not entered into any new contractual arrangements during the reporting period, and there have been no significant changes to existing arrangements[92] - The company has been advised that the contractual arrangements do not violate applicable Chinese laws and regulations, although enforcement of certain terms may be uncertain[81] - The exclusive purchase rights and equity custody agreement allows Beijing Yongtai to exercise its rights in the event of a default, ensuring protection of its interests[89] - The contractual arrangements will automatically terminate under specific conditions, including breach of agreement or bankruptcy of Yongtai Ruike[87] Utilization of Proceeds - The net proceeds from the global offering, after deducting underwriting fees and other expenses, amount to approximately HKD 1,127.8 million, with HKD 1,067.2 million already utilized[103] - Approximately HKD 382.7 million has been allocated for investment in ongoing clinical trials and commercialization of EAL®[103] - Investment of about HKD 322.7 million is directed towards CAR-T-19 clinical trials and TCR-T series products under development[103] - R&D expenditures related to expanding other clinical indications for EAL® account for approximately HKD 212.5 million[103] - The company anticipates that the net proceeds will be fully utilized by 2025[106] - As of December 31, 2022, the remaining unutilized amount was HKD 60.6 million, indicating a significant deployment of funds[146] - The company plans to complete the utilization of the remaining funds by the end of 2023[146] Gender Diversity and Recruitment - The company achieved a board gender diversity of approximately 22.22%, with two out of nine board members being female as of December 31, 2022[172] - The company ensures that all levels of personnel recruitment follow structured procedures to attract diverse candidates[172] - The overall gender ratio of the group is approximately 4:5, and the company aims to maintain this ratio while reviewing and monitoring it[196]

Financial Performance - The total loss for the year ended December 31, 2022, was approximately RMB 321.1 million, a decrease of RMB 33.5 million or about 9.4% from the previous year's loss of RMB 354.6 million[5]. - Total revenue decreased by approximately 48.9% from RMB 17.8 million in 2021 to RMB 9.1 million in 2022, primarily due to reduced interest income from bank deposits and government subsidies[125]. - Loss before tax decreased by approximately 9.4% from RMB 354.6 million in 2021 to RMB 321.1 million in 2022[138]. - The company incurred a net loss attributable to owners of the company of RMB 318.1 million for the year ended December 31, 2022, compared to a net loss of RMB 354.2 million for the year ended December 31, 2021, representing a decrease of approximately 10.2%[151]. - Basic and diluted loss per share improved from RMB 0.69 in 2021 to RMB 0.62 in 2022[1]. Expenses and Costs - Other income decreased by approximately RMB 8.7 million or about 48.9% to RMB 9.1 million for the year ended December 31, 2022, compared to RMB 17.8 million for the previous year[21]. - Research and development expenses decreased by approximately RMB 64.4 million or about 26.8% to RMB 176.2 million for the year ended December 31, 2022, from RMB 240.6 million in the previous year[22]. - Administrative expenses decreased by approximately RMB 6.6 million or about 6.3% to RMB 97.7 million for the year ended December 31, 2022, compared to RMB 104.3 million for the previous year[4]. - Financial costs increased by approximately 64.9% from RMB 3.7 million in 2021 to RMB 6.1 million in 2022, mainly due to increased interest expenses on lease liabilities[136]. - Other expenses surged by approximately 4,500.0% from RMB 0.3 million in 2021 to RMB 13.8 million in 2022, primarily due to increased issuance costs of convertible bonds[137]. Clinical Trials and Product Development - The company completed the enrollment of 430 target patients in the Phase II clinical trial for EAL® aimed at preventing postoperative recurrence of liver cancer, with plans to submit a new drug application in 2023 and anticipate product launch in 2024[6][17]. - The company has received clinical approval from NMPA for the injection of Dinolonesa, targeting TGF-β for the treatment of relapsed refractory diffuse large B-cell lymphoma, with clinical trials expected to commence in 2023[18]. - The CAR-T cell product pipeline focuses on CAR-T-19 series, with ongoing clinical research for B-cell acute lymphoblastic leukemia (B-ALL) and IND application processing since August 2019[7]. - The company has initiated Phase I clinical trials for CAR-T-19 injection, with enrollment of nine target patients completed as of the announcement date, and expects to finalize patient enrollment and release preliminary analysis results in 2023[25]. - The company is planning to set up R&D and production centers in densely populated areas to accelerate clinical trial progress and meet future commercialization needs[67]. Financial Position and Capital Structure - As of December 31, 2022, the company's total issued share capital amounted to $514,584,000, divided into 514,584,000 shares, with a capital structure of 42.4% liabilities and 57.6% equity[54]. - The liquidity ratios as of December 31, 2022, were 0.57 for the current ratio and 0.53 for the quick ratio, indicating a significant decrease from 2.29 and 2.23 in 2021, respectively[57]. - The company's cash and cash equivalents decreased from approximately RMB 353.3 million on December 31, 2021, to approximately RMB 58.4 million on December 31, 2022, primarily due to net losses from operations and construction[145]. - Total liabilities increased to RMB 208,474 thousand in 2022 from RMB 180,101 thousand in 2021, representing an increase of about 15.7%[187]. - The company has completed the issuance of convertible bonds and received proceeds of RMB 300 million on February 20, 2023[145]. Strategic Initiatives and Collaborations - The company established a joint venture with Beijing Yongtai and Shanghai Xinkaiyuan to enter the tumor treatment companion diagnosis market, aiming to provide related products and services[12]. - The company has formed a joint venture with Shanghai New Origin, which is a wholly-owned subsidiary of New Origin Medical, listed on the Shenzhen Stock Exchange[28]. - The company is expanding its strategic collaborations and exploring acquisition opportunities to enhance its product pipeline for solid tumors and non-solid tumors[112]. - The company has established a systematic technical platform for the development of cell immunotherapy products, enabling customized services based on client needs[111]. Employee and Governance - As of December 31, 2022, the total employee compensation (including director remuneration) amounted to approximately RMB 114.2 million, a decrease from RMB 183.1 million in 2021[162]. - The total number of employees as of December 31, 2022, was 246, with 32 in management, 31 in R&D, and 65 in quality control[164]. - The company has implemented a performance evaluation system to determine salary increases, bonuses, and promotions for employees[163]. - The company provides social insurance and housing provident fund for all employees in China[166]. - The company has adopted the corporate governance principles and code as per the listing rules during the reporting period[64].