Clinical Trials and Product Development - The company is conducting a Phase II clinical trial for EAL® targeting postoperative recurrence of liver cancer, with 397 patients enrolled as of the report date, and plans to submit for commercialization in China in 2023[6]. - The CAR-T-19 injection, which expresses anti-CD19 chimeric antigen receptor T cells, has received IND approval and has initiated Phase I clinical trials, with six patients enrolled as of the report date[7]. - The company has completed patient enrollment for the Phase I clinical trial of 6B11-OCIK injection with three patients, aiming to complete enrollment by Q3 2022[8]. - EAL® is also undergoing preclinical research for gastric cancer, with pharmacodynamics studies completed and pharmacology and toxicology studies ongoing, with plans to submit a clinical research application in 2022[9]. - The company has submitted a new drug clinical trial communication application for RC19D2 injection, targeting TGF-ß to treat relapsed and refractory diffuse large B-cell lymphoma[10]. - The core product EAL® has been in development for over 15 years, demonstrating efficacy against various cancers and utilizing proprietary technology for cell production[5]. - The company has established a research and development organizational structure to expedite product development from early research to commercialization[5]. - The company’s pipeline includes non-gene modified and gene modified products, as well as multi-target and single-target cell immunotherapy products[5]. - The company has a dedicated technical platform for the development of cell immunotherapy products and has set up an organization for clinical trial management[5]. - The company aims to address the challenges of CAR-T cell therapy for solid tumors with its RC19D2 and aT19 injection products, which are currently under research[21]. - The company has multiple TCR-T cell therapy products in preclinical research targeting antigens such as NY-ESO-1, EBV, and HPV[22]. - The company plans to expand EAL®'s indications to include lung cancer, gastric cancer, and acute myeloid leukemia following its market approval[29]. - The first product targeting the immunosuppressive molecule TGF-ß, RC19D2, is expected to enter clinical research soon, with ethical approval already obtained[30]. - The company is investing in CAR-T and TCR-T cell product pipelines, with the goal of entering clinical trials for RC19D2 and aT19 by 2022[30]. Financial Performance - Other income increased from approximately RMB 6.0 million for the year ended December 31, 2020, to approximately RMB 17.8 million for the year ended December 31, 2021, representing an increase of approximately 195.7%[17]. - Net other gains and losses decreased from a loss of approximately RMB 40.5 million for the year ended December 31, 2020, to a loss of approximately RMB 23.5 million for the year ended December 31, 2021, a reduction of approximately 41.8%[17]. - Research and development expenses decreased from approximately RMB 278.6 million for the year ended December 31, 2020, to approximately RMB 240.6 million for the year ended December 31, 2021, a decrease of approximately 13.6%[17]. - Administrative expenses increased from approximately RMB 68.6 million for the year ended December 31, 2020, to approximately RMB 104.3 million for the year ended December 31, 2021, an increase of approximately 51.9%[17]. - Pre-tax loss decreased from approximately RMB 439.1 million for the year ended December 31, 2020, to approximately RMB 354.6 million for the year ended December 31, 2021, a reduction of approximately 19.2%[18]. - Cash and bank balances decreased by approximately RMB 492.0 million from RMB 845.4 million in 2020 to RMB 353.3 million in 2021, mainly due to net losses from operations and construction activities[49]. - The company’s effective tax rate for its high-tech enterprise in China is 15% due to its recognition as a high-tech enterprise[48]. - The company's issued share capital as of December 31, 2021, totaled USD 514,584,000, with a capital structure of 25.0% debt and 75.0% equity[52]. - The company reported 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[86]. - The company anticipates needing additional financing to support its operations, including research and commercialization efforts, which may dilute shareholder equity[86]. Strategic Partnerships and Collaborations - The company has established a strategic cooperation framework agreement with China Resources Pharmaceutical Group for sales and distribution of EAL® in China[12]. - The company aims to expand strategic partnerships and explore acquisition opportunities to enhance its product pipeline for both solid and non-solid tumors[34]. - The company has achieved collaborations and may seek further strategic alliances or licensing arrangements in the future[87]. Corporate Governance and Management - The management team includes experienced professionals with over 20 years in the pharmaceutical industry, enhancing strategic planning and operational oversight[66][67]. - The company is committed to maintaining high standards of corporate governance to protect shareholder interests and enhance corporate value[152]. - The company has established three committees: audit committee, remuneration committee, and nomination committee, each with defined written terms of reference[187]. - The audit committee consists of three members, including two independent non-executive directors, ensuring a balance in oversight and governance[190]. - The roles of the chairman and CEO are separated, with the chairman responsible for leading the board and the CEO managing daily operations[182]. - All independent non-executive directors confirmed their independence in accordance with the listing rules, ensuring compliance with the requirement for at least three independent non-executive directors[183]. - Continuous professional development is encouraged for directors to update their knowledge and skills[200]. Risks and Challenges - The company faces risks related to the inability to identify or obtain licenses for new research products, which could lead to investor losses[86]. - The company is exposed to regulatory risks in the Chinese pharmaceutical industry, which may affect the approval and commercialization of its products[88]. - The company faces intense competition and may not be the first to discover, develop, or commercialize competitive products[87]. - The company relies on third parties for preclinical research and clinical trials, necessitating effective collaboration with partners[87]. - The company is subject to significant risks related to intellectual property, including potential challenges to patent validity and enforcement[87]. Shareholder Information and Stock Options - The company has established a stock option plan to incentivize and reward its directors and eligible employees[98]. - The total number of shares available for issuance under the pre-IPO share option plan is capped at 37,500,000 shares[114]. - The exercise price for any share options granted under the pre-IPO share option plan is set at HKD 5.5 per share[117]. - The stock options granted will expire seven years from the grant date, with no minimum holding period required before exercise[118]. - The company has a total of 36,050,000 share options available after accounting for cancellations[115]. - The stock options are intended to align the interests of employees with those of shareholders, promoting long-term growth and performance[121]. Operational Developments - The company has established a research and production center in Beijing with a total area of approximately 13,640 square meters to support clinical trials and early production needs[23]. - The company plans to invest approximately RMB 1.2 billion in the Beijing production center, expecting an annual output of over 200,000 batches of cell drugs post-completion[25]. - A collaboration framework agreement was signed to establish a research and production center in East China, with an expected total investment of around RMB 1 billion[25]. - The company has established production centers in Beijing and Shaoxing, with plans to expand to major cities like Shanghai, Guangzhou, Shenzhen, and Chengdu to cover densely populated areas in China[28]. Employee Relations and Training - The company emphasizes employee training to enhance technical and product knowledge, providing various training programs for different positions[62]. - The company is committed to maintaining good relationships with employees and suppliers to achieve its business goals[84].

Financial Performance - Total revenue for the six months ended June 30, 2021, was RMB 6,435,000, representing a 560.0% increase compared to RMB 975,000 in the same period of 2020[5]. - The company reported a pre-tax loss of RMB 147,604,000, a 15.2% improvement from a loss of RMB 174,067,000 in the previous year[5]. - Other income increased by approximately 560.0% from RMB 975,000 in the six months ended June 30, 2020, to RMB 6,435,000 in the six months ended June 30, 2021, primarily due to increased interest income from bank deposits[22]. - The company reported a net loss attributable to owners of the company of RMB 147,296,000 for the six months ended June 30, 2021, compared to RMB 174,019,000 for the same period in 2020, reflecting a decrease of approximately 15.4%[22]. - The total comprehensive loss for the six months ended June 30, 2021, was RMB 147,604,000, compared to RMB 174,067,000 for the same period in 2020, indicating a reduction in total comprehensive loss by 15%[76]. - Basic and diluted loss per share for the first half of 2021 was RMB 0.29, compared to RMB 0.46 for the same period in 2020, showing a decrease in loss per share by 37%[76]. Research and Development - Research and development expenses increased by 13.0% to RMB 107,321,000 from RMB 94,955,000 year-over-year[5]. - The company is focused on the commercialization of its core product EAL®, which has shown therapeutic effects against various cancers[6]. - EAL® clinical trials are aimed at preventing postoperative recurrence of liver cancer, with plans to submit for commercialization upon achieving statistically significant results[6]. - The company has established a proprietary technology platform for the production of EAL® cells, enhancing its research capabilities[6]. - The product pipeline includes non-gene modified and gene modified cell immunotherapy products, including 6B11, CAR-T cell series, and TCR-T cell series[6]. - The company has built a research and development organizational structure to expedite product development from early research to commercialization[6]. - The company is investing in CAR-T and TCR-T cell product pipelines, with the CAR-T-19-D2 product expected to enter clinical trials in 2022[18]. - The company aims to expand the clinical indications for EAL® to include gastric cancer, lung cancer, and acute myeloid leukemia, with preclinical studies ongoing and a clinical research application for gastric cancer expected to be submitted in 2021[18]. Clinical Trials - The company has completed the enrollment of 272 target patients for the Phase II clinical trial of EAL®, with interim data analysis expected by Q4 2021[9]. - EAL® is currently undergoing a Phase II clinical trial aimed at preventing postoperative recurrence of liver cancer, with plans to apply for market approval based on statistically significant results[8]. - The CAR-T-19 injection product has received IND approval from the drug review center in December 2020, with the first patient enrolled in the Phase I clinical trial in June 2021[10]. - The company plans to complete the enrollment of target patients for the CAR-T-19 injection by Q1 2022 and release preliminary analysis results in 2022[10]. - The Phase I clinical trial for 6B11-OCIK injection for ovarian cancer is expected to resume by Q4 2021, with all target subjects enrolled by mid-2022[13]. - The company has resumed clinical trials for its product 6B11-OCIK, which is intended for the treatment of ovarian cancer, indicating a focus on advancing its product pipeline[87]. Investments and Assets - Non-current assets rose by 46.0% to RMB 476,610,000 compared to RMB 326,506,000 at the end of 2020[5]. - The company has established a research and production center in Beijing covering approximately 13,640 square meters, supporting clinical and preclinical development of cell immunotherapy products[14]. - An investment of approximately RMB 1.2 billion is expected for the construction of a research and industrialization base in Beijing, with an anticipated annual production capacity of over 200,000 batches of cell drugs[14]. - The total investment for establishing the EAL® R&D and production center in East China is estimated to be approximately RMB 1 billion, with the first phase expected to be completed within 24 months after obtaining land ownership certificates[15]. - The company reported investments in financial assets at fair value through profit or loss totaling RMB 181,969,000 as of June 30, 2021, compared to RMB 131,969,000 as of December 31, 2020[95]. Employee and Management - As of June 30, 2021, the company employed a total of 432 staff, with 426 in China and 6 in South Korea[47]. - The employee distribution includes 54 in general management, 40 in R&D, 15 in senior management, 46 in product and technology R&D, 117 in production, equipment, and safety, 116 in quality, and 44 in clinical support and business development[47]. - The company emphasizes employee training to enhance technical and product knowledge, providing various training programs for different positions[48]. - The remuneration for key management personnel was RMB 28,764,000 for the first half of 2021, compared to RMB 67,923,000 in the same period of 2020, reflecting a decrease of 58%[109]. Corporate Governance - The company has adhered to all applicable corporate governance codes during the six-month period ending June 30, 2021, ensuring high levels of corporate governance to protect shareholder interests[66]. - The audit committee has reviewed the unaudited consolidated interim results for the six months ending June 30, 2021, confirming compliance with applicable accounting principles and standards[69]. - The company did not purchase, sell, or redeem any of its listed securities during the six-month period ending June 30, 2021[68]. Future Plans and Market Strategy - The company plans to expand strategic partnerships and explore acquisition opportunities to rapidly enhance its product pipeline for both solid and non-solid tumors[21]. - The company is actively pursuing market expansion in South Korea and China, aiming to increase its market share by 15% in these regions by the end of 2021[113]. - A new product line is set to launch in Q4 2021, which is expected to contribute an additional HKD 20 million in revenue[112]. - The company is exploring potential mergers and acquisitions to bolster its competitive position in the biotechnology sector[113].

Clinical Trials and Research - The company has completed the enrollment of 272 target patients for the Phase II clinical trial of EAL® for postoperative recurrence of liver cancer, with mid-term data analysis expected in Q2 2021[21]. - The company plans to submit an application for a new drug preparatory meeting to the National Medical Products Administration following the statistical significance of clinical trial results[21]. - The CAR-T-19 injection has received IND approval and the Phase I clinical trial is set to begin with the first patient enrollment expected in May 2021, aiming for completion of target patient enrollment by Q1 2022[22]. - The company is conducting preclinical research on EAL® for gastric cancer, with pharmacodynamics studies completed and pharmacology and toxicology studies ongoing, aiming to submit a clinical research application in 2021[26]. - The company aims to address the challenges of CAR-T cell therapy for solid tumors with its CAR-T-19-DNR and aT19 injection products[32]. - TCR-T cell therapy is being developed based on tumor antigen-specific T cell infusion, utilizing a single-cell sequencing technology platform[33]. - The company aims to expand the indications for EAL® to include lung cancer, gastric cancer, and acute myeloid leukemia, with clinical studies already showing efficacy beyond liver cancer[40]. - The company expects to resume Phase I clinical trials for 6B11-OCIK injection in Q3 2021, with plans to complete patient enrollment by H2 2022[48]. Financial Performance - Other income increased by approximately RMB 3.1 million or about 107.9% to approximately RMB 6.0 million for the year ended December 31, 2020[27]. - Net other gains and losses decreased by approximately RMB 46.8 million or about 740.5% to a loss of approximately RMB 40.5 million for the year ended December 31, 2020[27]. - R&D expenses increased by approximately RMB 216.7 million or about 349.6% to approximately RMB 278.6 million for the year ended December 31, 2020[27]. - Loss before tax increased by approximately RMB 330.0 million or about 302.7% to approximately RMB 439.1 million for the year ended December 31, 2020[27]. - The company reported a net loss of RMB 439.1 million for the year ended December 31, 2020, compared to a net loss of RMB 109.1 million for the previous year, with basic and diluted loss per share of RMB 0.99[50]. - The company's other income and loss decreased by approximately 740.5% from a profit of RMB 6.3 million for the year ended December 31, 2019, to a loss of RMB 40.5 million for the year ended December 31, 2020, primarily due to foreign exchange losses from the depreciation of HKD against RMB[52]. - Administrative expenses increased by approximately 147.2% from RMB 27.8 million for the year ended December 31, 2019, to RMB 68.6 million for the year ended December 31, 2020, mainly due to increased employee salaries and stock options granted to directors and employees[53]. - Research and development expenses rose by approximately 349.6% from RMB 62.0 million for the year ended December 31, 2019, to RMB 278.6 million for the year ended December 31, 2020, driven by stock options granted to R&D staff and an increase in the number of R&D employees[54]. Investments and Partnerships - The company has entered into a subscription agreement with Tasly Bioscience for a total investment of HKD 156.8 million in a healthcare investment fund, expected to yield returns[23]. - The company is establishing an industrial fund to set up an EAL® R&D and production center in East China, focusing on the upstream and downstream industry chain of cell immunotherapy[25]. - The company has signed an exclusive licensing agreement with T-Cure for TCR immunotherapy targeting renal cell carcinoma, enhancing its competitive advantage in this indication in China[24]. - 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 after completion[35]. - The company plans to establish additional production centers in major cities such as Chengdu, Wuhan, Xi'an, and Shenyang to cover densely populated areas in China[38]. - The company has invested RMB 50 million in an industry fund aimed at promoting the development of the biomedical industry in the Shaoxing Binhai New Area, focusing on cell immunotherapy and related fields[47]. Corporate Governance and Compliance - The company has maintained compliance with corporate governance codes since its listing date[156]. - The company has confirmed that all directors have adhered to the standard code of conduct regarding securities transactions since the listing date[157]. - The board consists of three executive directors, three non-executive directors, and three independent non-executive directors, ensuring compliance with listing rules regarding board composition[175]. - The company has established appropriate insurance arrangements for directors against potential legal actions[168]. - The audit committee has reviewed the accounting principles and policies adopted by the group, discussing risk management and internal controls with management[172]. - The company has established a dedicated audit department to analyze and independently assess risk management and internal control policies[195]. - The company has implemented monitoring procedures to prevent unauthorized access and use of insider information[195]. - The company has adopted a dividend policy with no preset dividend payout ratio, intending to retain most of its available funds for business operations and expansion[190]. Shareholder Relations - The company emphasizes the importance of effective communication with shareholders to strengthen investor relations and understanding of business performance and strategy[200]. - The company is committed to maintaining ongoing dialogue with shareholders, particularly through annual general meetings and other shareholder meetings[200]. - Shareholders are required to submit formal written inquiries to the company’s designated address for any queries directed to the board[199]. Risks and Challenges - The company faces significant risks, including the inability to identify or develop new products, which could lead to investor losses[93]. - The company is subject to intense competition, with the risk that other companies may develop or commercialize competing products more successfully[95]. - The company has faced challenges in obtaining regulatory approvals for its in-development products, which are currently in preclinical or clinical development stages[93]. - The company may seek strategic alliances or licensing arrangements in the future, although it may not be able to realize the benefits from such partnerships[95]. - The company faces risks related to its contractual arrangements, including potential non-compliance with Chinese laws that could lead to loss of interests in Yongtai Ruike[144]. Employee and Management - The company employed a total of 250 employees as of December 31, 2020, with 241 in China and 9 in South Korea, focusing on various functions including R&D and quality assurance[69][68]. - The company emphasizes employee training to enhance technical and product knowledge, providing tailored training programs for different positions[70]. - The company has established a performance evaluation system to determine salary increases, bonuses, or promotions for employees, ensuring competitive compensation[69]. - The leadership team consists of experienced professionals with over 20 years of industry experience, enhancing the company's strategic direction[85]. Future Outlook - The company provided guidance for the next quarter, projecting revenue growth of 20% to $600 million[84]. - New product launches are expected to contribute an additional $50 million in revenue over the next fiscal year[85]. - The company plans to pursue strategic acquisitions to enhance its product portfolio, with a budget of $100 million set aside for potential deals[82].

Financial Performance - Total revenue for the six months ended June 30, 2020, was RMB 975,000, an increase of 39.5% compared to RMB 699,000 in 2019[6]. - Net other income and losses amounted to RMB 2,878,000, a significant increase of 7,894.4% from RMB 36,000 in the previous year[6]. - The company reported a pre-tax loss of RMB 174,067,000, representing a 244.5% increase compared to RMB 50,533,000 in the same period last year[6]. - Basic and diluted loss per share was RMB 0.46, compared to RMB 0.13 in 2019[6]. - The company's net asset value dropped by 58.1% to RMB 71,381,000 from RMB 170,335,000[7]. - The company reported a net loss of RMB 174,067,000 for the six months ended June 30, 2020, compared to a loss of RMB 50,533,000 for the same period in 2019, representing an increase in loss of approximately 244%[74]. - The company reported a loss attributable to owners of RMB 174,019,000 for the six months ended June 30, 2020, compared to a loss of RMB 50,445,000 for the same period in 2019, representing an increase in loss of approximately 245%[102]. Research and Development - Research and development expenses surged by 306.1% to RMB 94,955,000 from RMB 23,384,000 in 2019[6]. - The company is focused on the commercialization of its core product EAL® for the prevention of liver cancer recurrence[8]. - The product pipeline includes CAR-T and TCR-T cell series, indicating ongoing innovation in cell immunotherapy[8]. - EAL® is currently undergoing a Phase II clinical trial for the indication of preventing postoperative recurrence of liver cancer, with 186 patients enrolled as of the mid-term report date[13]. - The company aims to recruit a total of 272 liver cancer postoperative patients for the EAL® Phase II clinical trial by the end of 2020, despite potential exclusions of up to 35 patients due to trial pauses[13]. - The CAR-T-19 series is the core of the company's CAR-T cell product pipeline, with the IND application for CAR-T-19 accepted for processing by the drug review center in August 2019[14]. - The company plans to submit supplementary research materials for the CAR-T-19 IND application by September 2020, with expectations to begin clinical trials by the end of 2020[14]. - The company is developing multiple TCR-T cell products targeting specific antigens, including NY-ESO-1 and EBV, currently in preclinical research[15]. - The company anticipates completing mid-term data analysis for EAL® and submitting for market approval to the National Medical Products Administration in the first half of 2021[13]. - The company has communicated with the drug review center regarding the statistical significance of interim results for EAL® to facilitate further discussions for market approval[11]. Clinical Trials and Approvals - The company has received ethical committee approvals from 14 medical institutions for the EAL® clinical trial, estimating over 30 patients can be enrolled monthly in the second half of 2020[12]. - Clinical data shows that EAL® treatment group had a total survival time (OS) of 27.0 months compared to 13.9 months for the control group in a study involving 84 patients with advanced gastric cancer[19]. - The company aims to expand the indications for EAL® to include lung cancer, gastric cancer, and acute myeloid leukemia after obtaining market approval[19]. - The company plans to accelerate the clinical trial process for EAL® and expand its investment in ongoing Phase II trials to speed up patient enrollment and data acquisition[18]. Financial Position and Assets - Non-current assets increased by 43.9% to RMB 156,545,000 from RMB 108,821,000[7]. - Current assets decreased by 32.5% to RMB 207,925,000 from RMB 308,150,000[7]. - The company's current ratio decreased from 1.49 on December 31, 2019, to 0.82 on June 30, 2020, while the quick ratio fell from 1.47 to 0.80 during the same period[39]. - The total equity attributable to owners of the company decreased to RMB 70,036 thousand as of June 30, 2020, down from RMB 168,942 thousand as of December 31, 2019, a decline of 58.6%[77]. - The company's cash and cash equivalents decreased to RMB 174,229 thousand as of June 30, 2020, down from RMB 282,247 thousand as of December 31, 2019, a reduction of 38.3%[80]. Employee and Corporate Governance - As of June 30, 2020, the company had a total of 207 employees, with 199 in China and 8 in South Korea[45]. - The company has implemented a performance evaluation system to determine salary increases, bonuses, and promotions for employees[45]. - The company is focused on maintaining competitive salary and bonus structures in line with market rates[45]. - The company is committed to maintaining high levels of corporate governance to protect shareholder interests and enhance corporate value[62]. Shareholder Information - The company has a significant shareholder, Tan Zheng Ltd, holding 180,480,000 shares, representing 36.10% of the total equity[49]. - Evodevo Ltd, another major shareholder, holds 134,948,571 shares, accounting for 26.99% of the total equity[53]. - The passive minority shareholders have delegated their voting rights to Tan Zheng Ltd, allowing it to exercise these rights at shareholder meetings[54]. Capital Structure and Financing - As of June 30, 2020, the company's capital structure consisted of 80.42% debt and 19.58% equity, compared to 59.15% debt and 40.85% equity on December 31, 2019[36]. - The company maintains a conservative financing policy to minimize financial risks and regularly reviews financing needs to support operations and R&D[47]. - The company raised approximately HKD 1.1 billion from the initial public offering by issuing 100,000,000 shares at an issue price of HKD 11 per share[140]. Other Financial Metrics - The company incurred listing expenses of RMB 35,004,000 during the reporting period, compared to RMB 6,389,000 in the previous year, marking an increase of approximately 448%[74]. - The fair value loss on convertible redeemable preferred shares rose from RMB 386,000 in the six months ended June 30, 2019, to RMB 19.4 million in the six months ended June 30, 2020, an increase of approximately 4,929.8%[25]. - The company recognized a share-based payment expense of RMB 75,113,000 for the six months ended June 30, 2020, compared to zero for the same period in 2019[127].