Financial Performance - Total revenue for the year ended December 31, 2023, was RMB 20,085,000, an increase of 44.3% compared to RMB 13,923,000 in 2022[2] - The company reported a pre-tax loss of RMB 249,350,000, a reduction of 65.6% compared to a loss of RMB 725,180,000 in 2022[2] - The net loss for the year was RMB 249,350,000, down from RMB 725,180,000 in the previous year, reflecting a 65.6% improvement[3] - Basic and diluted loss per share for the year was RMB 1.25, compared to RMB 4.98 in 2022[3] - The group incurred a total loss before tax of RMB 249,350,000 for the year ended December 31, 2023, compared to a loss of RMB 725,180,000 in 2022, indicating an improvement in performance[15] - The adjusted loss for the period increased by approximately 46.6% to RMB 222,891,000 for the year ended December 31, 2023, compared to RMB 152,092,000 in 2022, primarily due to increased R&D expenses[66] Research and Development - Research and development expenses rose significantly to RMB 172,685,000, an increase of 88.9% from RMB 91,426,000 in the previous year[2] - The company successfully completed the Phase II clinical trial for LZ901 in China, with no serious adverse events reported[2] - The company plans to initiate a Phase III clinical trial for LZ901 in January 2024, involving approximately 26,000 participants across multiple provinces in China[2] - LZ901, a recombinant herpes zoster vaccine, has shown high immunogenicity and safety in clinical trials, with a geometric mean concentration (GMC) significantly higher in the high-dose group compared to the low-dose group[43] - The Phase II clinical trial of LZ901 was completed in May 2023, and the company plans to submit a Biologics License Application (BLA) to the National Medical Products Administration in Q4 2024[44] - The company has decided to suspend the development of its recombinant rabies vaccine and reallocate resources to the development of a recombinant respiratory syncytial virus (RSV) vaccine[40] - The company has established an innovative protein engineering platform to support the full cycle of drug development, enhancing its capabilities in developing human vaccines and monoclonal antibodies[41] - The company has received IND approval from the FDA for LZ901 and plans to complete the Phase I clinical trial in the U.S. by Q2 2024[44] - The company has three R&D patents and six pending applications related to its core product in China, Russia, and Japan[40] - The company’s proprietary dual-specific antibody development platform, Fabite®, offers competitive advantages in treating recurrent/refractory hematological malignancies[42] - K3, a biosimilar to Humira®, is expected to enter Phase III clinical trials in China in the second half of 2024, with commercialization anticipated in 2026[45] - K193, a bispecific antibody for treating B-cell leukemia and lymphoma, began Phase I clinical trials in China in December 2019, with completion expected in the second half of 2024[46] - The company has four products in preclinical stages, including the recombinant RSV vaccine, which is being prioritized over the rabies vaccine[47] Assets and Liabilities - The company’s total assets increased to RMB 1,070,382,000 as of December 31, 2023, compared to RMB 976,056,000 in 2022[4] - The company’s equity totalled RMB 1,020,628,000, up from RMB 937,466,000 in the previous year[4] - Non-current assets (excluding financial instruments) increased to RMB 545,391,000 as of December 31, 2023, from RMB 468,853,000 as of December 31, 2022[8] - Total property, plant, and equipment increased from RMB 258,046,000 as of December 31, 2022, to RMB 422,831,000 as of December 31, 2023, reflecting a growth of approximately 64%[19] - The company’s accumulated depreciation for property, plant, and equipment increased from RMB 28,419,000 in 2022 to RMB 38,926,000 in 2023[19] - The right-of-use assets increased from RMB 62,462,000 as of December 31, 2022, to RMB 104,591,000 as of December 31, 2023, showing a growth of approximately 67%[21] - The company has a lease liability of RMB 12,216 thousand as of December 31, 2023, which is slightly higher than RMB 11,219 thousand in the previous year, reflecting an increase of approximately 8.9%[33] - The company’s total liabilities related to lease obligations over five years decreased to RMB 5,036 thousand in December 2023 from RMB 6,770 thousand in December 2022, reflecting a decline of approximately 25.7%[33] Cash Flow and Financing - Cash and cash equivalents increased significantly to RMB 257,891 thousand as of December 31, 2023, compared to RMB 68,976 thousand in the previous year, marking an increase of approximately 274%[28] - The company obtained a new bank loan of RMB 10,000,000 in March 2023, with a remaining balance of RMB 7,000,000 after partial repayment in September 2023[36] - Cash and bank balances increased by approximately RMB 196,000,000 to RMB 265,000,000 as of December 31, 2023, from RMB 69,000,000 as of December 31, 2022, mainly due to net proceeds from the global offering[68] - The company completed a public offering on May 8, 2023, raising net proceeds of approximately HKD 241.6 million, equivalent to about RMB 300.18 million[40] - The net proceeds from the global offering amounted to approximately HKD 241.6 million, with no over-allotment option exercised as of May 8, 2023[73] Corporate Governance and Compliance - The company has complied with all applicable corporate governance codes since its listing date[80] - The audit committee reviewed the consolidated financial statements for the year ended December 31, 2023, and discussed matters related to auditing and internal controls[84] - Deloitte has agreed that the figures in the preliminary announcement are consistent with the audited financial statements to be approved on March 15, 2024[85] - The board does not recommend the payment of a final dividend for the year ended December 31, 2023[86] Employee and Operational Insights - A total of 133 full-time employees were employed as of December 31, 2023, with 54.2% in R&D[76] - The production team consists of 28 members, ensuring compliance with quality control standards and regulations[50] - The internal R&D team is involved in all stages of drug development, enhancing the company's capabilities in recombinant protein design and optimization[49] - The company maintains a conservative financing and treasury policy to ensure optimal financial condition and minimal financial risk[78] - The employee incentive plan adopted on December 15, 2021, does not involve the issuance of new shares but grants rights in a partnership[79] Future Plans and Strategic Initiatives - The company plans to expand production capacity to meet growing market demand and accelerate the clinical development of its pipeline products[51] - The company aims to promote the commercialization process both domestically and internationally through strategic planning and partnerships[51] - Funding for ongoing and planned clinical trials of LZ901 in China and the US is set at HKD 97.0 million (40.2%), with HKD 32.8 million already utilized[75] - The company plans to allocate HKD 53.4 million (22.1%) for clinical development and manufacturing of K3, with HKD 38.8 million (16.1%) specifically for planned clinical trials between 2023 and 2024[75]

Financial Performance - The company reported a total revenue of RMB 5,339,000 for the six months ended June 30, 2023, a decrease of 16.1% compared to RMB 6,363,000 for the same period in 2022[6]. - The net loss for the period was RMB 79,352,000, significantly reduced by 87.8% from RMB 652,080,000 in the previous year[6]. - The adjusted loss for the period was RMB 52,893,000, down 39.9% from RMB 88,021,000 in the same period last year[6]. - The total comprehensive loss for the period was RMB 79,352,000, reflecting a substantial improvement compared to the previous year's loss[6]. - The company achieved a net loss before tax of RMB 79.4 million for the six months ended June 30, 2023, representing an 87.8% improvement compared to a net loss of RMB 652.1 million for the same period in 2022[21]. - The company reported a loss attributable to owners of RMB 79,352,000 for the six months ended June 30, 2023, a significant improvement compared to a loss of RMB 652,080,000 for the same period in 2022[90]. - The company reported other income of approximately RMB 5.3 million for the six months ended June 30, 2023, a decrease of 16.1% from RMB 6.4 million for the same period in 2022[22]. - The company reported a significant reduction in other expenses, down 90.3% to RMB 0.3 million for the six months ended June 30, 2023, from RMB 2.9 million in the same period of 2022[24]. Research and Development - The company has three clinical-stage products in its pipeline, including the core product LZ901, and four preclinical-stage products as of June 30, 2023[7]. - The company has established an innovative precision protein engineering platform for drug development, supporting the development of human vaccines and monoclonal antibodies[10]. - LZ901, the company's recombinant shingles vaccine, has shown high immunogenicity and safety in clinical trials, with a geometric mean concentration (GMC) significantly higher in the high-dose group compared to the low-dose group[11]. - The Phase II clinical trial of LZ901 in China was completed in May 2023, with plans to initiate a Phase III trial in Q3 2023 and submit a Biologics License Application (BLA) in H2 2024[11]. - K3, a biosimilar to Humira®, is set to enter Phase III clinical trials in China in Q1 2024, with BLA submission expected in Q4 2024 or Q1 2025[13]. - K193, a bispecific antibody for treating B-cell leukemia and lymphoma, is expected to complete its Phase I trial in Q1 2024 and enter Phase II trials in Q2 2024[14]. - The company has multiple advanced product pipelines, including recombinant vaccines and bispecific antibodies, currently in various stages of clinical development[10]. - The company received IND approval from the FDA for LZ901 in July 2022, indicating progress in its international clinical development strategy[12]. - The company plans to advance clinical development of pipeline products including LZ901, K3, and K193, and to expedite the development of other preclinical products[20]. Financial Position - The company’s total assets as of June 30, 2023, were RMB 1,151,773,000, compared to RMB 937,466,000 as of December 31, 2022[6]. - The company’s equity increased to RMB 1,151,773,000 as of June 30, 2023, up from RMB 937,466,000 at the end of 2022, marking an increase of about 22.8%[74]. - The company's bank balance and cash increased from approximately RMB 690.0 million as of June 30, 2022, to approximately RMB 3,662.0 million as of June 30, 2023, mainly due to net proceeds from the global offering[38]. - The debt-to-asset ratio was 7.9% as of June 30, 2023, compared to 12.4% as of December 31, 2022[39]. - The company’s total liabilities and equity as of June 30, 2023, were reported to be consistent with the fair value of financial assets and liabilities measured at amortized cost[115]. Shareholder Information - As of June 30, 2023, the beneficial ownership of H shares by Hengqin Green Bamboo Limited Partnership is 12,307,500 shares, representing approximately 8.62% of the H shares and 6.08% of the total issued share capital[57]. - Beijing Yizhuang holds 19,645,000 H shares, accounting for approximately 13.76% of the H shares and 9.70% of the total issued share capital[57]. - The total beneficial ownership of H shares by Yitang Saiying is 37,969,696 shares, which constitutes approximately 26.60% of the H shares and 18.76% of the total issued share capital[57]. - The company has a diverse shareholder base, including both domestic and H-share holders[123]. Corporate Governance - The audit committee, consisting of three members, has reviewed the unaudited interim results for the six months ending June 30, 2023, confirming compliance with applicable accounting principles[66]. - The company has complied with all applicable corporate governance code provisions since its listing date up to June 30, 2023[63]. - There have been no arrangements allowing directors or supervisors to benefit from purchasing shares or debt securities of the company during the six months ending June 30, 2023[67]. - The company has not engaged in any major litigation or arbitration as of June 30, 2023[65]. Future Plans and Market Strategy - The company plans to expand the age range for participants in the Phase III trial of LZ901 to include adults aged 40 and above[11]. - The company aims to expand its production capacity to meet growing market demand and to promote commercialization processes domestically and internationally[20]. - The company is exploring market expansion opportunities and potential mergers and acquisitions[123]. - The company anticipates utilizing the net proceeds from the global offering by 2026[48]. Employee Information - The company has employed 129 full-time employees as of June 30, 2023, with 55.8% in R&D[49]. - The company’s production team consisted of 29 personnel as of June 30, 2023, with ongoing training to ensure compliance with quality control requirements[18]. - The company’s quality control team comprised 28 experienced members as of June 30, 2023, all trained in regulatory and GMP standards[19]. Capital Expenditures and Investments - Capital expenditures increased from approximately RMB 135.0 million as of December 31, 2022, to approximately RMB 257.0 million as of June 30, 2023, primarily due to contracted but not yet incurred expenditures for machinery and equipment[40]. - The total capital commitments contracted but not provided for as of June 30, 2023, related to the acquisition of equipment and construction projects amounted to RMB 25,701,000, an increase of 90.5% compared to RMB 13,498,000 as of December 31, 2022[119]. Compliance and Reporting - The company emphasizes compliance with the Hong Kong Stock Exchange listing rules and regulations[123]. - The company is committed to maintaining transparency and accuracy in its financial reporting[123].

Financial Performance - Total revenue for the six months ended June 30, 2023, was RMB 5,339,000, a decrease of 16.1% compared to RMB 6,363,000 in the same period of 2022[2]. - The net loss for the period was RMB 79,352,000, representing an 87.8% reduction from a loss of RMB 652,080,000 in the prior year[2]. - The company recorded no revenue for the six months ended June 30, 2023, consistent with the same period in 2022[11]. - The company reported a net loss attributable to owners of RMB (79,352,000) for the six months ended June 30, 2023, compared to a net loss of RMB (652,080,000) in the same period of 2022, indicating a significant improvement[16]. - The company’s basic and diluted loss per share improved to RMB 0.41 from RMB 6.64 in the same period last year[4]. - The pre-tax loss decreased by approximately 87.8% from RMB 652.1 million in the six months ended June 30, 2022, to RMB 79.4 million in the six months ended June 30, 2023[47]. - The adjusted loss for the period decreased by approximately 39.9% from RMB 880 million in the six months ended June 30, 2022, to RMB 529 million in the six months ended June 30, 2023[50]. Research and Development - Research and development expenses decreased by 39.9% to RMB 33,157,000 from RMB 55,186,000 in the previous period[2]. - The company successfully completed Phase II clinical trials for its core product LZ901 in China, with statistically significant results and good safety profiles[3]. - The company plans to initiate Phase III clinical trials for LZ901 in China in Q3 2023, based on the Phase II trial data[3]. - The company has established an innovative precision protein engineering platform for drug development, supporting the development of human vaccines and monoclonal antibodies[28]. - LZ901, the company's recombinant herpes zoster vaccine, has shown high immunogenicity and safety in Phase II clinical trials, with significant antibody geometric mean concentrations compared to placebo[30]. - The company plans to initiate a Phase III clinical trial for LZ901 in China in Q3 2023 and submit a Biologics License Application (BLA) to the National Medical Products Administration in H2 2024[30]. - The company aims to expand the participant age range for the Phase III trial of LZ901 to adults aged 40 and above in China[30]. - The company has received IND approval from the FDA for LZ901 and plans to complete Phase I trials in the U.S. by Q1 2024[30]. - K3, a biosimilar to Humira®, is expected to enter Phase III clinical trials in Q1 2024 and aims for commercialization by Q4 2025 in China[31]. - K193, a bispecific antibody for B-cell leukemia and lymphoma, is projected to complete Phase I trials by Q1 2024 and enter Phase II trials in Q2 2024[32]. - Other pipeline products include recombinant varicella vaccine and rabies vaccine, with the latter submitting a Pre-IND application in Q4 2023[33]. Expenses and Costs - Administrative expenses decreased by 7.5% to RMB 41,239,000 from RMB 44,603,000 year-on-year[2]. - The company incurred listing expenses of RMB 26,459,000, an increase of 111.5% compared to RMB 12,513,000 in the previous period[2]. - The cost of sales for the immune reagent testing kits was RMB 280,000, down from RMB 348,000 in the previous year, reflecting a 19.5% decrease[13]. - Other expenses significantly decreased by approximately 90.3% from RMB 2.9 million to RMB 0.3 million for the same period, mainly due to the absence of costs related to financial liabilities from a previous financing round[40]. - Financing costs increased by 12.5% from RMB 3 million in the six months ended June 30, 2022, to RMB 4 million in the six months ended June 30, 2023[45]. - Listing expenses increased by approximately 111.5% from RMB 125 million in the six months ended June 30, 2022, to RMB 265 million in the six months ended June 30, 2023[46]. Assets and Liabilities - The total assets as of June 30, 2023, were RMB 1,250,495,000, compared to RMB 1,070,170,000 as of December 31, 2022[5]. - The company’s net asset value increased to RMB 1,151,773,000 from RMB 937,466,000 year-on-year[5]. - The estimated unused tax losses as of June 30, 2023, were approximately RMB 242,129,000, up from RMB 170,512,000 as of December 31, 2022[15]. - Right-of-use assets increased by RMB 46,622,000 during the reporting period, reflecting investments in R&D and commercial production facilities in Beijing[18]. - The construction in progress for commercial production facilities in Zhuhai and Beijing increased by RMB 42,846,000 and RMB 77,277,000, respectively, during the reporting period[19]. - Total prepayments and other receivables decreased significantly to RMB 42,311,000 as of June 30, 2023, from RMB 190,469,000 as of December 31, 2022[20]. - The company obtained a new bank loan of RMB 10,000,000 at an annual interest rate of 2.35%, due within one year[22]. - As of June 30, 2023, the total deferred government grants amounted to RMB 34,186,000, a decrease from RMB 36,771,000 as of December 31, 2022[23]. - The company reported a capital expenditure commitment of RMB 25,701,000 for equipment and construction projects as of June 30, 2023, compared to RMB 13,498,000 as of December 31, 2022[27]. - The debt-to-asset ratio decreased to 7.9% as of June 30, 2023, compared to 12.4% as of December 31, 2022[52]. Corporate Governance and Compliance - The company has complied with all applicable corporate governance codes since the listing date[60]. - The company emphasizes the importance of regulatory compliance with the National Medical Products Administration in China[67]. - The company aims to comply with Good Manufacturing Practices (GMP) to ensure quality assurance in its production processes[66]. - The company is committed to reducing risks of contamination and errors in drug production through adherence to regulatory guidelines[66]. - The board of directors includes key figures such as Mr. Kong Jian, who serves as the executive director and chairman[68]. Employee and Organizational Structure - The company employed 129 full-time employees as of June 30, 2023, and has established a performance evaluation system for employee assessments[58]. - The employee incentive plan adopted prior to the listing does not involve the issuance of new shares or options[59]. - The production team consists of 29 members, and the quality control team has 28 members, both trained in regulatory and GMP standards[36]. Capital and Funding - The net proceeds from the global offering amounted to approximately HKD 241.6 million, after deducting underwriting commissions and other expenses[55]. - As of June 30, 2023, the allocation of net proceeds from the global offering includes HKD 140.7 million (58.2%) for clinical development, manufacturing, and commercialization of core product LZ901[56]. - Funding for ongoing and planned clinical trials of LZ901 in China and the U.S. is allocated HKD 97.0 million (40.2%)[56]. - The company expects to fully utilize the net proceeds from the global offering by 2026[58]. Stock and Listing Information - The company’s H-shares were listed on the Hong Kong Stock Exchange on May 8, 2023[67]. - The company’s shares have a par value of RMB 1.00 each, with both domestic and H-shares included in its capital structure[68]. - The board did not recommend an interim dividend for the six months ended June 30, 2023, consistent with the previous year[54].