Financial Performance - For the year ended December 31, 2022, the group's revenue was approximately RMB 767.8 million, with a gross profit of approximately RMB 497.8 million[2]. - The group reported a loss before tax of approximately RMB 998.8 million for the year, compared to a profit of approximately RMB 276.3 million in the previous year[3]. - The company's revenue decreased from RMB 1,423.9 million in 2021 to RMB 767.8 million in 2022, primarily due to the absence of a one-time payment from Seagen in 2022[48]. - The gross profit for the year was RMB 497,836,000, down 63.3% from RMB 1,356,739,000 in the previous year[72]. - The net loss for the year was RMB 998,830,000, compared to a profit of RMB 276,258,000 in 2021, indicating a significant decline in performance[72]. - Total revenue from customer contracts for 2022 was RMB 767,775,000, a decrease of 46% compared to RMB 1,423,902,000 in 2021[95]. - The company reported a net loss attributable to ordinary shareholders of RMB 998.83 million for the year, compared to a profit of RMB 276.26 million in the previous year[109]. Research and Development - The total expenses incurred by the group for the year amounted to approximately RMB 1,695.3 million, including RMB 982.1 million for research and development expenses[2]. - Research and development expenses increased by approximately RMB 271.1 million or about 38.1% to approximately RMB 982.1 million for the year[2]. - R&D expenses grew from RMB 711.0 million in 2021 to RMB 982.1 million in 2022, reflecting increased spending on clinical trials and related activities[52]. - The company has developed a robust pipeline with over ten candidate drugs, seven of which are in clinical development targeting more than twenty indications[10]. - The proprietary drug Tai Ai® (RC18) is being evaluated in late-stage clinical trials for eight autoimmune disease indications, addressing significant unmet medical needs in this therapeutic area[13]. - The company has established a fully integrated end-to-end drug development capability, covering all key functions of biopharmaceutical development, including discovery, preclinical pharmacology, clinical development, and GMP-compliant production[10]. Product Development and Clinical Trials - Product sales revenue for the year was approximately RMB 738.4 million, a significant increase of 462.4% compared to RMB 131.3 million in the same period last year[4]. - The company has successfully commercialized two products: RC18 (brand name: Tai Ai®) and RC48 (brand name: Ai Di Xi®), which are currently undergoing clinical trials for 18 indications in China and the United States[10]. - The product RC18 has initiated a Phase III international multi-center clinical study in the United States for the treatment of systemic lupus erythematosus (SLE) and has received approvals from the EU and CDE[5]. - The company has initiated discussions with CDE regarding the clinical trial plan for RC18 for the treatment of primary Sjögren's syndrome (pSS) and has started a Phase III clinical study in China by the end of 2022[5]. - The company completed a Phase II clinical trial for Taitasip in China for the treatment of generalized myasthenia gravis (gMG) with positive results in February 2022[6]. - The company is conducting a Phase III clinical trial for Taitasip in treating neuromyelitis optica spectrum disorder (NMOSD), having recruited 149 patients by December 31, 2022[22]. Market Expansion and Commercialization - The company aims to become a leading player in the global biopharmaceutical industry, focusing on innovative and differentiated biologics to meet unmet medical needs[10]. - The company is actively pursuing market expansion and collaboration opportunities, including partnerships with global firms[12]. - The company has successfully included the products RC18 and RC48 in the updated National Reimbursement Drug List (NRDL) effective from March 1, 2023[4]. - The company is expanding its market presence in Southeast Asia, with plans to establish partnerships in three new countries by the end of the year[120]. - The company is investing 15% of its revenue into R&D for new technologies and product innovations[120]. Financial Management and Compliance - The financial statements are prepared in accordance with International Financial Reporting Standards and Hong Kong Companies Ordinance, ensuring compliance and transparency[79]. - The group has adopted revised International Financial Reporting Standards (IFRS) for the current financial year, including IFRS 3, IFRS 16, and IFRS 37, with no significant impact on financial position or performance[82]. - The company has received NMPA approval for its drug Taitasip on March 9, 2021, and for its injectable drug Vidisitan on June 8, 2021, indicating successful product development[79]. - The company has made significant investments in research and development, as evidenced by the establishment of multiple subsidiaries dedicated to this purpose[78]. - The company has a strong commitment to maintaining its operational capabilities and financial stability through strategic management of its subsidiaries[81]. Employee and Operational Insights - The company has established a sales and marketing team for its immunology and oncology products, with 639 members in the immunology team and 520 members in the oncology team as of December 31, 2022[43]. - Employee benefits expenses increased by RMB 103.4 million, primarily due to an increase in R&D personnel, rising employee salary levels, and increased stock-based compensation[53]. - Total employee compensation costs rose to RMB 810.7 million in 2022 from RMB 459.2 million in 2021, driven by an increase in employee numbers and salary levels[65]. - The company plans to increase its workforce by 10% to support growth initiatives and new projects[120]. Revenue and Income Sources - Other income and gains increased from RMB 186.0 million in 2021 to RMB 232.5 million in 2022, driven by increased interest income from fundraising and foreign exchange gains[49]. - Total other income for 2022 was RMB 219,204,000, up from RMB 185,876,000 in 2021, representing an increase of approximately 17.9%[100]. - Government grants received amounted to RMB 141,221,000 in 2022, slightly up from RMB 140,026,000 in 2021[100].

Financial Performance - The company's revenue for Q3 2022 reached ¥219,260,922.75, representing a year-over-year increase of 162.30%[4] - Total operating revenue for the first three quarters of 2022 reached RMB 569,635,902.97, a significant increase from RMB 114,506,776.26 in the same period of 2021, representing a growth of approximately 397.5%[19] - The total profit (loss) for Q3 2022 was -688,219,233.92 RMB, compared to -688,259,394.55 RMB in the previous period[20] - The net profit (loss) attributable to shareholders of the parent company was -688,219,233.92 RMB, consistent with the previous period[20] - The total comprehensive income for Q3 2022 was -680,108,752.02 RMB, compared to -688,616,249.38 RMB in the previous period[20] Profitability and Loss - The net profit attributable to shareholders was -¥199,094,007.06, with a year-to-date net profit of -¥688,219,233.92[4] - The basic and diluted earnings per share for the quarter were both -¥0.37, with a year-to-date figure of -¥1.32[5] - The basic and diluted earnings per share for Q3 2022 were both -1.32 RMB, compared to -1.41 RMB in the previous period[20] - The company reported a net loss of RMB 1,031,670,017.72 for the first three quarters of 2022, compared to a net loss of RMB 343,450,783.80 in the same period of 2021[18] Research and Development - R&D expenses totaled ¥212,869,547.05 for the quarter, accounting for 97.09% of revenue, a decrease of 139.80 percentage points compared to the same period last year[5] - The company plans to continue its R&D activities, despite the high proportion of R&D expenses relative to revenue[8] - Research and development expenses for the first three quarters of 2022 amounted to RMB 662,541,383.59, up from RMB 524,624,528.96 in 2021, reflecting a growth of approximately 26.3%[19] Assets and Liabilities - Total assets at the end of the reporting period were ¥5,971,303,165.55, reflecting a 43.57% increase from the end of the previous year[5] - The company's total assets as of September 30, 2022, were RMB 5,971,303,165.55, compared to RMB 4,159,208,876.60 at the end of 2021, marking an increase of about 43.5%[18] - The total liabilities as of September 30, 2022, were RMB 703,549,537.44, slightly down from RMB 712,787,425.02 in the previous year[18] - The total equity attributable to shareholders as of September 30, 2022, was RMB 5,267,753,628.11, compared to RMB 3,446,421,451.58 at the end of 2021, representing an increase of about 52.9%[18] Cash Flow - The company reported a net cash flow from operating activities of -¥1,080,292,854.28 for the year-to-date period[5] - Cash inflow from operating activities for the first three quarters of 2022 was 374,115,692.77 RMB, up from 235,496,564.18 RMB in the same period of 2021[22] - Cash outflow from operating activities totaled 1,454,408,547.05 RMB, compared to 955,305,059.59 RMB in the previous year[22] - The net cash flow from operating activities for the first three quarters of 2022 was 1,080,292,854.28 RMB[22] - Cash inflow from investment activities was 685,653,675.14 RMB, compared to 86,580,323.21 RMB in the previous year[22] - Cash inflow from financing activities was 2,612,462,448.00 RMB, with a net cash flow of 2,438,024,300.14 RMB[22] - The ending cash and cash equivalents balance was 1,967,108,319.61 RMB, compared to 1,003,253,752.77 RMB in the previous period[23] Inventory and Other Metrics - The company's inventory as of September 30, 2022, was RMB 442,285,036.79, an increase from RMB 280,314,179.90 in 2021, indicating a growth of approximately 57.8%[17] - The company's cash and cash equivalents increased to RMB 2,034,818,774.76 as of September 30, 2022, from RMB 1,835,498,496.42 at the end of 2021, showing a growth of approximately 10.9%[17] - The equity attributable to shareholders increased to ¥5,267,753,628.11, a rise of 52.85% compared to the previous year[5] - The company has not reported any significant new product launches or market expansions during the reporting period[16] Revenue Drivers - The increase in revenue was primarily driven by the inclusion of certain products in the national medical insurance directory, leading to increased sales volume[8] - The company experienced a significant increase in technical service revenue from Seagen, contributing to overall revenue growth[8]

Financial Performance - The company's revenue for Q3 2022 was ¥219,260,922.75, representing a year-on-year increase of 162.30%[6] - The net profit attributable to shareholders for Q3 2022 was -¥199,094,007.06, with a year-to-date net profit of -¥688,219,233.92[6] - Total operating revenue for the first three quarters of 2022 reached ¥569,635,902.97, a significant increase from ¥114,506,776.26 in the same period of 2021, representing a growth of approximately 397%[21] - The net loss for the third quarter of 2022 was ¥688,219,233.92, slightly improved from a net loss of ¥688,259,394.55 in the same quarter of the previous year[22] - The total comprehensive loss for the third quarter of 2022 was ¥680,108,752.02, compared to a loss of ¥688,616,249.38 in the prior year[22] - Basic and diluted earnings per share for the third quarter of 2022 were both -¥1.32, compared to -¥1.41 in the same quarter of 2021[22] Research and Development - Research and development expenses totaled ¥212,869,547.05 for Q3 2022, accounting for 97.09% of revenue, a decrease of 139.80 percentage points compared to the previous year[7] - The company has seen a substantial increase in R&D spending, which is expected to continue as it develops new products and technologies[10] - Research and development expenses for the first three quarters of 2022 were ¥662,541,383.59, up from ¥524,624,528.96 in 2021, reflecting a growth of approximately 26%[21] Assets and Liabilities - Total assets at the end of Q3 2022 were ¥5,971,303,165.55, an increase of 43.57% compared to the end of the previous year[7] - The equity attributable to shareholders at the end of Q3 2022 was ¥5,267,753,628.11, reflecting a 52.85% increase year-on-year[7] - Current assets reached RMB 3,559,051,782.58, up from RMB 2,299,951,998.84 year-over-year[19] - Cash and cash equivalents were RMB 2,034,818,774.76, compared to RMB 1,835,498,496.42 at the end of 2021, reflecting a growth of approximately 10.9%[19] - Inventory increased to RMB 442,285,036.79 from RMB 280,314,179.90, representing a growth of about 57.8%[19] - The company reported accounts receivable of RMB 142,552,160.15, a significant increase from RMB 2,311,600.59 in the previous year[19] - The company has no short-term borrowings reported as of September 30, 2022[19] - The total liabilities include accounts payable of RMB 63,812,763.95, which increased from RMB 36,521,319.13[19] - The company's total liabilities as of the third quarter of 2022 were ¥703,549,537.44, a decrease from ¥712,787,425.02 in the previous quarter[20] Cash Flow - The net cash flow from operating activities for the year-to-date was -¥1,080,292,854.28, indicating increased cash outflows primarily due to higher material costs and personnel expenses[7] - The net cash flow from operating activities for the first three quarters of 2022 was -1,080,292,854.28 RMB, compared to -719,808,495.41 RMB in the same period of 2021, indicating a decline of approximately 50.1%[23] - Total cash inflow from investment activities was 685,653,675.14 RMB, while cash outflow was 1,845,377,906.56 RMB, resulting in a net cash flow from investment activities of -1,159,724,231.42 RMB, a significant increase in losses compared to -470,640,588.01 RMB in 2021[23] - The net cash flow from financing activities was 2,438,024,300.14 RMB, a recovery from a negative cash flow of -569,256,534.70 RMB in the same period last year[23] - The ending balance of cash and cash equivalents increased to 1,967,108,319.61 RMB, up from 1,003,253,752.77 RMB in the previous year, reflecting a growth of approximately 96.0%[25] Shareholder Information - The company has a total of 6,764 common shareholders as of the report date[12] - The top shareholder, HKSCC NOMINEES LIMITED, holds 189,566,228 shares, representing 34.83% of total shares[12]

Financial Performance - Revenue for the six months ended June 30, 2022, was RMB 348.779 million, significantly up from RMB 29.192 million in the same period of 2021, representing a growth of approximately 1,192%[10]. - Gross profit for the first half of 2022 was RMB 181.274 million, compared to RMB 24.552 million in the prior year, indicating a substantial increase[10]. - The company's net loss increased from RMB 444.0 million for the six months ended June 30, 2021, to RMB 489.1 million for the six months ended June 30, 2022[61]. - Total comprehensive loss for the period was RMB 486,630 thousand, compared to RMB 445,407 thousand in the previous year, indicating a year-over-year increase of about 9.3%[114]. - The company reported a pre-tax loss of RMB 489,126 thousand for the first half of 2022, compared to a loss of RMB 444,043 thousand in the same period of 2021, indicating an increase in losses of approximately 10.1% year-over-year[119]. Assets and Liabilities - Total assets as of June 30, 2022, reached RMB 6,109.215 million, an increase from RMB 4,159.209 million as of December 31, 2021[10]. - Total liabilities as of June 30, 2022, were RMB 662.611 million, a decrease from RMB 712.787 million as of December 31, 2021[10]. - The total equity as of June 30, 2022, was RMB 5,446.604 million, up from RMB 3,446.422 million as of December 31, 2021[10]. - The debt-to-asset ratio decreased to 10.8% as of June 30, 2022, from 17.1% as of December 31, 2021[63]. - Cash and cash equivalents increased from RMB 1,756.8 million as of December 31, 2021, to RMB 2,590.0 million as of June 30, 2022, mainly due to funds raised from the A-share issuance[62]. Research and Development - Research and development expenses for the first half of 2022 totaled RMB 449.672 million, up from RMB 326.604 million in the same period of 2021, reflecting a 37.5% increase[10]. - The company has developed over ten candidate drugs, with seven currently in clinical development targeting more than twenty indications[12]. - The company is currently conducting late-stage clinical trials for its proprietary fusion protein, TACI, targeting seven autoimmune diseases, addressing significant unmet medical needs[17]. - The company has a rich pipeline of candidates, including various indications for autoimmune diseases and multiple malignancies, with several in different stages of clinical trials[15]. - The company is focused on addressing significant unmet medical needs in the treatment of autoimmune diseases through innovative therapies[17]. Clinical Trials and Product Development - Two products, RC18 (brand name: 泰愛®) and RC48 (brand name: 愛地希®), have entered commercialization and are undergoing clinical trials for fourteen indications in China and the United States[12]. - TACI received conditional approval for moderate to severe systemic lupus erythematosus (SLE) in China on March 9, 2021, based on a completed Phase IIb trial, with Phase III trials initiated in July 2019[17]. - The company has initiated a Phase III clinical trial for Tai Tasi Pi in treating NMOSD in China, with 133 patients recruited as of June 30, 2022[21]. - The company has received conditional marketing approval for the antibody-drug conjugate RC48 in China on June 9, 2021, and it was included in the national medical insurance drug list in December 2021[25]. - The company is exploring the clinical potential of combining RC48 with PD-L1 antibody for treating HER2-positive locally advanced or metastatic gastric cancer[25]. Shareholder Information - As of June 30, 2022, the total number of shares outstanding is 544,263,003, which includes 189,581,239 H shares and 354,681,764 A shares[97]. - Major shareholder Yantai Rongda Venture Capital Center holds 102,381,891 A shares, representing 28.87% of the A shares and 18.81% of total equity[93]. - The largest individual shareholder, Mr. Wang Xudong, holds 192,803,132 A shares, which is 54.36% of A shares and 35.42% of total equity[93]. - The company has multiple shareholders with over 5% equity, including individuals and investment funds[92]. - The company adopted the first H-share incentive trust plan on March 23, 2021, with a maximum limit of 7,347,550 H-shares to be purchased by the trustee[101]. Future Outlook and Strategy - The company aims to become a leading player in the global biopharmaceutical industry, focusing on innovative biologics for unmet medical needs[12]. - The company plans to utilize all remaining unutilized net proceeds by December 31, 2024, based on market conditions[82]. - The company expects a revenue growth of 25% for the second half of 2022, driven by new product launches and market expansion[190]. - Future guidance indicates a focus on sustainable growth and innovation, with a commitment to invest at least 15% of revenue back into R&D[190]. - The company is exploring potential mergers and acquisitions to enhance its product portfolio and market reach[190].

Financial Performance - The company's operating revenue for the first half of the year reached ¥350,374,980.22, a significant increase of 1,033.35% compared to ¥30,915,051.58 in the same period last year[17]. - The net profit attributable to shareholders was -¥489,125,226.86, compared to -¥444,042,993.77 in the previous year, indicating a continued loss[17]. - The net cash flow from operating activities was -¥698,888,452.45, worsening from -¥514,465,392.02 year-on-year[17]. - The company's total assets increased by 46.88% to ¥6,109,215,017.45 from ¥4,159,208,876.60 at the end of the previous year[17]. - The total operating costs for the first half of 2022 were ¥839,918,272.42, compared to ¥483,799,954.54 in the previous year, indicating an increase of about 74%[193]. - The net loss for the first half of 2022 was ¥489,125,226.86, compared to a net loss of ¥444,042,993.77 in the same period of 2021, reflecting a deterioration in financial performance[193]. Research and Development - The proportion of R&D investment to operating revenue decreased significantly to 128.34% from 1,056.46% in the previous year, reflecting a reduction of 928.12 percentage points[18]. - The total R&D investment for the period reached ¥449,671,836.54, a 37.68% increase compared to ¥326,604,422.39 in the same period last year[39]. - The increase in R&D expenses is attributed to the expansion of the R&D pipeline and rising personnel costs due to salary increases[40]. - The company has 1,107 R&D personnel, up from 891 in the previous year, with R&D personnel constituting 44.28% of the total workforce[45]. - The average salary for R&D personnel increased to ¥15.07 million from ¥10.31 million year-on-year[45]. Clinical Trials and Product Development - The company has developed Taitasip, a first-in-class dual-target fusion protein for treating autoimmune diseases, which has received multiple patent approvals globally[25]. - Taitalisip received conditional approval for moderate to severe SLE in China in March 2021, with ongoing Phase III trials expected to report results by the end of 2022[26]. - The company has initiated a Phase III clinical trial for Taitalisip in the treatment of IgA nephropathy in China, following positive results from a Phase II trial[27]. - The company has entered into a licensing agreement with Seattle Genetics for the antibody-drug conjugate RC48, with a deal value of up to $2.6 billion, setting a record for overseas licensing of a single product by a Chinese pharmaceutical company[29]. - The company is advancing several projects, including RC88 and RC98, both in the I phase of clinical trials, with significant investments of ¥14,290.24 million and ¥9,047.89 million respectively[43]. Environmental Compliance - The company generated 43,480 tons of wastewater during the reporting period, with ammonia nitrogen concentration at 15.7 mg/L, well below the limit of 45 mg/L[80]. - Chemical oxygen demand (COD) was reported at 146 mg/L, significantly under the limit of 500 mg/L, with a total discharge of 6.902 tons[80]. - The company has implemented a comprehensive waste management system, ensuring proper handling of both general and hazardous waste[89]. - No administrative penalties were imposed on the company for environmental issues during the reporting period[88]. Shareholder Commitments and Governance - The company reported a lock-up period of 36 months for major shareholders, during which they cannot transfer or manage their shares[94]. - Major shareholders are restricted from selling more than 2% of their shares in the first five fiscal years after the IPO, with specific conditions tied to profitability[94]. - The company has established strict compliance measures for major shareholders regarding share lock-up and reduction policies[97]. - The company has committed to not repurchasing shares held by major shareholders during the lock-up period[94]. - The company will ensure compliance with the Shanghai Stock Exchange's regulations regarding share reduction and information disclosure[112]. Market and Sales Strategy - The company has established a sales team of 241 members for autoimmune products, covering 1,021 hospitals across 31 provincial-level administrative units in China[54]. - The oncology sales team consists of 291 members, with the product Vidi Xi Tuo Monoclonal Antibody being included in the national medical insurance directory, enhancing its market accessibility[54]. - The company plans to expand its raw material production capacity to over 80,000 liters by the end of 2025, supported by a production system compliant with global GMP standards[56]. - The company is focused on expanding its product pipeline across multiple disease treatment areas, maintaining significant R&D investments for clinical trials and new drug preparations[62]. Financial Management and Fundraising - The company successfully completed its A-share issuance on the Sci-Tech Innovation Board, raising a total of 2.612 billion yuan, which will support R&D and production facility expansion[59]. - The total amount of raised funds from the initial public offering on the Sci-Tech Innovation Board was ¥2,612,462,448, with a net amount of ¥2,505,945,496 after deducting issuance costs[166]. - The cumulative investment in the biopharmaceutical industrialization project reached ¥112,694,465.49, representing 11.53% of the committed investment of ¥1,600,000,000[167]. - The company has engaged in cash management of idle raised funds, investing a total of ¥589,500,000 in structured deposits[172]. Compliance and Legal Matters - The company confirmed that there were no significant lawsuits or arbitration matters during the reporting period[158]. - The company has no non-operating fund occupation by controlling shareholders or related parties[156]. - The company has no significant guarantees during the reporting period[157]. - The company has established binding measures in the relevant commitments to ensure compliance[126].

Revenue and Profitability - Revenue for Q1 2022 reached ¥150,135,067.62, representing a significant increase of 3406.56% compared to the same period last year[4] - Net profit attributable to shareholders was -¥286,830,516.15, reflecting a decrease of 55.48% year-on-year[4] - The company reported a basic and diluted earnings per share of -¥0.59, a decrease of 56.91% year-on-year[6] - The net loss for Q1 2022 was ¥286,830,516.15, compared to a net loss of ¥184,482,710.79 in Q1 2021, representing an increase in losses of approximately 55.5%[22] - The total comprehensive loss for Q1 2022 was ¥287,615,486.11, compared to a loss of ¥184,491,494.35 in Q1 2021[23] Expenses and Costs - R&D expenses totaled ¥218,173,558.62, an increase of 60.29% compared to the previous year[6] - The gross profit margin was impacted by a significant increase in sales costs, which rose by 7585.76% due to the sales of new products[9] - The company reported a substantial increase in operating expenses, with sales expenses rising by 271.62% due to increased market development activities[9] - Total operating costs for Q1 2022 were ¥438,730,733.58, compared to ¥195,520,624.96 in Q1 2021, indicating a rise of approximately 124%[20] - The company incurred sales expenses of ¥80,784,391.23 in Q1 2022, significantly higher than ¥21,738,574.92 in Q1 2021, marking an increase of approximately 270%[20] Assets and Liabilities - Total assets at the end of the reporting period were ¥6,345,143,075.38, up 52.56% from the end of the previous year[6] - The company's cash and cash equivalents amounted to RMB 3,819,310,806.98, compared to RMB 1,835,498,496.42 in the same period last year, reflecting a growth of approximately 108.3%[16] - Total current assets reached RMB 4,389,341,093.64, up from RMB 2,299,951,998.84, indicating a year-over-year increase of about 91%[17] - The company's total liabilities were RMB 676,891,679.41, a decrease from RMB 712,787,425.02 in the previous year[18] - The equity attributable to shareholders of the parent company was RMB 5,668,251,395.97, compared to RMB 3,446,421,451.58 in the previous year, representing a growth of approximately 64.4%[19] Cash Flow - The net cash flow from operating activities was -¥350,478,067.32, a decrease of 29.06% compared to the previous year[6] - Cash flow from operating activities in Q1 2022 showed a net outflow of ¥350,478,067.32, worsening from a net outflow of ¥271,564,180.13 in Q1 2021[27] - The net cash flow from financing activities amounted to approximately ¥2.51 billion, after accounting for cash outflows of ¥120.36 million[28] - The total cash and cash equivalents at the end of the period reached ¥3.74 billion, an increase from the beginning balance of ¥1.76 billion[28] - The net increase in cash and cash equivalents for the period was approximately ¥1.98 billion[28] Shareholder Information - The company issued a total of 189,581,239 shares in Hong Kong, accounting for approximately 34.83% of the total share capital, and 354,681,764 shares on the Shanghai Stock Exchange, representing about 65.17%[13] - The top 10 shareholders held a significant portion of the company's shares, with HKSCC NOMINEES LIMITED holding approximately 96.52% of the Hong Kong shares[14] Future Plans and Developments - The company has plans for market expansion and new product development, although specific details were not disclosed in the report[15] - The company is actively engaging in research and development of new technologies to enhance its competitive edge in the market[15] - The company launched new products, including injectable Taitasip and injectable Vidisimo monoclonal antibodies, contributing to revenue growth[9] Accounting Standards - The company did not apply the new accounting standards for the year 2022[29]

Financial Performance - The company's revenue for Q1 2022 reached ¥150,135,067.62, representing a significant increase of 3406.56% compared to the same period last year[6] - The net profit attributable to shareholders was -¥286,830,516.15, reflecting a decrease of 55.48% year-over-year[7] - The net cash flow from operating activities was -¥350,478,067.32, a decline of 29.06% compared to the previous year[7] - The basic earnings per share were -¥0.59, a decrease of 56.91% year-over-year[7] - Net loss for Q1 2022 was ¥286,830,516.15, compared to a net loss of ¥184,482,710.79 in Q1 2021[26] - Basic and diluted earnings per share for Q1 2022 were both -¥0.59, compared to -¥0.38 in Q1 2021[27] Operating Costs and Expenses - The operating costs surged by 7585.76% due to increased sales costs associated with new product launches[11] - Total operating costs for Q1 2022 amounted to ¥438,730,733.58, compared to ¥195,520,624.96 in Q1 2021[25] - The company experienced a notable increase in operating expenses, with a rise of 8307.24% attributed to increased donations for drug donations and patient assistance programs[13] - The company reported a significant increase in personnel costs due to staff additions and rising wage levels, contributing to overall expenses[13] Research and Development - Research and development expenses totaled ¥218,173,558.62, an increase of 60.29% year-over-year[7] - Research and development expenses in Q1 2022 were ¥218,173,558.62, up from ¥136,115,384.97 in Q1 2021, indicating a focus on innovation[25] - The company is focused on expanding its market presence and enhancing its product offerings through ongoing research and development initiatives[13] - The company is focusing on expanding its market presence and enhancing product offerings through ongoing research and development efforts[25] Assets and Liabilities - The total assets at the end of the reporting period were ¥6,345,143,075.38, up 52.56% from the end of the previous year[7] - As of March 31, 2022, the company had total assets of approximately CNY 6.35 billion, up from CNY 4.16 billion at the end of 2021, reflecting a growth of about 53.5%[22] - Total liabilities as of Q1 2022 were ¥676,891,679.41, an increase from ¥712,787,425.02 in the previous period[24] - Shareholders' equity totaled ¥5,668,251,395.97 in Q1 2022, up from ¥3,446,421,451.58 in Q1 2021[24] Cash Flow - The company reported a decrease in cash flow from operating activities, reflecting challenges in cash generation[27] - The net cash flow from operating activities for Q1 2022 was -¥350,478,067.32, compared to -¥271,564,180.13 in Q1 2021, indicating a deeper cash outflow[30] - Total cash inflow from financing activities in Q1 2022 was ¥2,612,462,448.00, while cash outflow was ¥98,713,721.14, resulting in a net cash flow of ¥2,513,748,726.86[31] - The company's cash and cash equivalents at the end of Q1 2022 totaled ¥3,735,640,216.30, up from ¥2,194,813,283.64 at the end of Q1 2021[31] - The company reported a total cash outflow from operating activities of ¥466,158,621.88 in Q1 2022, compared to ¥329,254,831.22 in Q1 2021[30] Shareholder Information - The company issued a total of 189,581,239 shares in Hong Kong, accounting for 34.83% of the total share capital, and 354,681,764 shares on the Shanghai Stock Exchange, accounting for 65.17%[18] - The top ten shareholders held a combined 28.85% of the shares, with HKSCC NOMINEES LIMITED being the largest shareholder[14] Government Support and Other Income - The company reported government subsidies of ¥7,390,154.09, which were included in other income[8] - Cash received from tax refunds in Q1 2022 was ¥27,420,872.62, down from ¥39,351,502.71 in Q1 2021[29]

Company Transition and Product Launches - RemeGen successfully transitioned from a pure R&D biotech company to a fully integrated biopharmaceutical company, launching two products in China in 2021[9]. - TaiTianxi received conditional marketing approval for the treatment of systemic lupus erythematosus (SLE) in March 2021 and was included in the national medical insurance drug list in December 2021[9]. - RemeGen's other product, VidiXimab, received conditional marketing approval for the treatment of locally advanced or metastatic gastric cancer in June 2021 and was also included in the national medical insurance drug list in December 2021[10]. Sales and Market Expansion - The company established a sales team of 132 members covering 445 hospitals across 168 cities in 31 provinces in China for its product TaiTianxi[9]. - RemeGen's sales team for oncology products consists of 180 members, covering 29 provinces in China[10]. - The company plans to expand its sales team and increase market penetration to boost sales of its products[9]. - The company aims to continue its international expansion, marking 2021 as a significant year with the licensing agreement with Seagen Inc. as a key milestone[13]. Collaborations and Financial Agreements - The company entered into a $2.6 billion collaboration deal with Seagen Inc., marking one of the largest partnerships for a Chinese biotech company[9]. - The company has received a $200 million upfront payment from Seagen Inc. as part of an exclusive global licensing agreement for the development and commercialization of injectable Vadisizumab (RC48) outside of Asia, with potential milestone payments of up to $2.4 billion and royalties of high single-digit percentages on cumulative net sales[13]. Clinical Development and Trials - RemeGen has made progress in developing additional indications for TaiTianxi, including completed Phase II clinical studies for IgA nephropathy and Sjögren's syndrome[9]. - The company initiated a Phase II clinical study for IgA nephropathy in the U.S. and plans to start a Phase III clinical study for SLE in the first quarter of 2022[9]. - The company is expanding its clinical applications for Vadisizumab, currently conducting two Phase III clinical trials in China for breast cancer patients with HER2 high expression and low expression, and continuing trials for non-small cell lung cancer (NSCLC) and biliary tract cancer (BTC)[13]. - The company is currently conducting late-stage clinical trials for the novel fusion protein Taci (RC18) targeting seven autoimmune diseases, addressing significant unmet medical needs[19]. Financial Performance - The total revenue for the year ended December 31, 2021, increased to RMB 1,423.9 million, primarily due to product sales from TaiTasiPu and Vidisitamab[40]. - The company recorded a net profit of RMB 276.3 million in 2021, a turnaround from a net loss of RMB 697.8 million in 2020[51]. - Cash and cash equivalents decreased from RMB 2,768.5 million in 2020 to RMB 1,756.8 million in 2021, a reduction of RMB 1,011.7 million due to increased R&D and industrialization expenditures[51]. Research and Development - The company has a pipeline of over ten candidate drugs, with seven in clinical development targeting more than twenty indications[15]. - The company is developing the antibody-drug conjugate (ADC) candidate, RC48, for HER2-expressing solid tumors, with promising results in late-stage clinical trials for gastric cancer and urothelial carcinoma[23]. - The company completed a randomized, double-blind, placebo-controlled Phase II clinical trial for TaiTasi in treating IgA nephropathy, showing significant reduction in urinary protein levels compared to the placebo group[20]. Corporate Governance and Management - The management team includes experienced professionals with extensive backgrounds in pharmaceutical research and development, ensuring strategic oversight[61][63]. - The company has a strong leadership team with extensive experience in the pharmaceutical sector, including over 26 years of experience in the industry for the current president[67]. - The board consists of four executive directors, two non-executive directors, and three independent non-executive directors, ensuring a balanced composition for effective governance[78]. Shareholder and Equity Structure - As of December 31, 2021, the total number of shares was 489,836,702, including 189,581,239 H shares, 230,248,596 domestic shares, and 70,006,867 non-listed foreign shares[167]. - The ownership structure indicates a concentrated control among a few major shareholders, which may impact corporate governance and strategic decisions[170]. - The company has established a concert party agreement among key individuals to ensure unified action in management and decision-making[168]. Compliance and Risk Management - The company has complied with all relevant laws and regulations with no significant violations reported as of December 31, 2021[152]. - The audit committee is responsible for reviewing and managing overall risks related to the company's operations[123]. - The company has a risk management framework in place to identify, assess, and monitor major risks related to its strategic objectives[124]. Community Engagement and Social Responsibility - The group made charitable donations of approximately RMB 39.58 million for the year ended December 31, 2021, compared to RMB 1.46 million in 2020[158]. - The company has implemented environmental, health, and safety policies in compliance with industry standards and regulatory requirements[150].

Financial Performance - Revenue for the six months ended June 30, 2021, was RMB 29,192 thousand, with a gross profit of RMB 24,552 thousand[6]. - The company reported a pre-tax loss of RMB 444,043 thousand, compared to RMB 249,835 thousand in the same period last year[6]. - The company's net loss increased from RMB 249,835 thousand to RMB 444,043 thousand for the six months ended June 30, 2021[40]. - Revenue for the six months ended June 30, 2021, increased to RMB 29.2 million, primarily due to the commercialization of injectable Taitasib[30]. - Other income and gains rose from RMB 19.5 million for the six months ended June 30, 2020, to RMB 32.5 million for the same period in 2021, mainly due to increased interest income[31]. - The company reported a significant percentage of shares held by various entities, with the highest being 64.66% by RongChang Holding Group[60]. Research and Development - Research and development expenses increased to RMB 326,604 thousand from RMB 188,242 thousand in the previous year, reflecting a significant investment in innovation[6]. - The company has over ten drug candidates in its pipeline, with seven in clinical development targeting more than twenty indications[7]. - The drug candidate RC18 for systemic lupus erythematosus received conditional marketing approval in March 2021[7]. - The drug candidate RC48 for gastric cancer was granted marketing approval in June 2021[7]. - The company aims to prioritize indications with large unmet medical needs and substantial potential patient populations for Taitasip's global approval and commercialization[14]. - The company is conducting clinical trials for its candidates in both China and the United States[7]. Clinical Trials - As of June 30, 2021, 360 patients have been recruited for the Phase III clinical trial of Taitasip for rheumatoid arthritis (RA) in China, with completion expected in early 2022[14]. - The company is conducting a Phase II clinical trial for Taitasip in treating IgA nephropathy, having recruited 44 patients by December 31, 2020, with preliminary data expected in August 2021[13]. - The company has initiated multiple late-stage clinical trials for RC48, its leading antibody-drug conjugate (ADC), targeting various solid tumors expressing HER2[15]. - The company has completed patient recruitment for the Phase III clinical trial of Taitasip for neuromyelitis optica spectrum disorder (NMOSD), with 125 patients enrolled as of June 30, 2021[14]. - The company is exploring the efficacy of RC48 in treating other HER2-expressing cancers, including non-small cell lung cancer (NSCLC) and cholangiocarcinoma (BTC)[18]. Financial Position - Total assets as of June 30, 2021, were RMB 3,494,813 thousand, compared to RMB 4,117,691 thousand in 2020[6]. - The company's total equity decreased to RMB 2,939,800 thousand from RMB 3,594,621 thousand at the end of 2020, indicating a decline in shareholder value[79]. - Cash used in operating activities amounted to RMB 525.1 million, with cash and cash equivalents decreasing from RMB 2,768.5 million to RMB 1,534.0 million[41]. - The debt-to-asset ratio rose to 15.9% as of June 30, 2021, compared to 12.7% on December 31, 2020[42]. - The company’s cash and cash equivalents were RMB 1,533,998 thousand as of June 30, 2021, down from RMB 2,768,521 thousand at the end of 2020[78]. Shareholder Information - The total number of shares outstanding as of June 30, 2021, was 489,836,702, including 189,581,239 H shares and 230,248,596 domestic shares[56]. - Major shareholder RongChang Holding Group holds 148,873,474 shares, representing 64.66% of the total shares[59]. - The company has a diverse shareholder base, with multiple entities holding significant stakes, including 10.74% by Guotou (Shanghai) Technology Achievement Transformation Venture Capital Fund[60]. - The company completed the full circulation of H-shares by converting 71,232,362 unlisted shares into H-shares, listed on June 3, 2021, enhancing liquidity and potentially increasing the overall valuation of the company[67]. Corporate Governance - The independent auditor, Ernst & Young, reviewed the interim financial data and found no significant issues regarding compliance with International Accounting Standards[74]. - The company has adopted corporate governance principles and has complied with all applicable codes during the reporting period[68]. - The board confirmed that all directors and supervisors adhered to the standard code of conduct for securities trading during the six months ending June 30, 2021[69]. Future Plans - The company plans to expand its sales team for Taitisib after it is included in the national medical insurance catalog[24]. - The company aims to conduct Phase III clinical trials for Taitasib in SLE and Phase II trials for IgA nephropathy in the U.S. in the second half of the year[28]. - The company plans to use the remaining RMB 81.83 million from the global offering for general corporate and operational purposes[51].

Company Overview - RemeGen Co., Ltd. successfully listed on the Hong Kong Stock Exchange on November 9, 2020, attracting high-quality institutional investors[5]. - The company is a biopharmaceutical firm focused on discovering, developing, and commercializing innovative biologics for unmet medical needs in autoimmune, oncology, and ophthalmology diseases[119]. Product Development and Clinical Trials - The China National Medical Products Administration approved Taitazis for conditional marketing in China for the treatment of SLE in March 2021, with sales commencing in April 2021[5]. - RemeGen submitted a new drug application for disitamab vedotin for HER2-positive gastric cancer patients in China in 2020, anticipating approval within 2021[6]. - The company completed patient enrollment for two Phase II studies targeting IgA nephropathy and Sjögren's syndrome, continuing to recruit patients for trials on four autoimmune disease indications[6]. - RemeGen initiated a Phase III study in China for treating HER2-low expressing breast cancer patients, currently in the patient recruitment phase[6]. - Disitamab vedotin received breakthrough therapy designation and fast track designation from the FDA, with plans to initiate Phase II trials in the US in 2021 for HER2-overexpressing urothelial carcinoma patients[8]. - The company has confirmed the design of a Phase III clinical trial for Taihuai (RC18) to treat SLE patients, with patient recruitment planned to start in 2021[8]. - Taihuai's NDA for SLE treatment was accepted by the NMPA in November 2019 and received conditional approval in March 2021[10]. - The company has a robust pipeline with over ten candidate drugs, six of which are in clinical development targeting seventeen indications[10]. - The company has completed patient recruitment for a Phase II clinical trial of Taitasip for Sjögren's syndrome (SS) in China as of December 31, 2020[16]. - A Phase III clinical trial for neuromyelitis optica spectrum disorder (NMOSD) has recruited 115 patients since its initiation in September 2017[16]. - The company has enrolled 269 patients in a Phase III clinical trial for rheumatoid arthritis (RA) in China as of December 31, 2020[16]. - The company is conducting an open-label Phase Ib dose-expansion trial for RC28, targeting wet age-related macular degeneration (AMD), with 37 patients recruited as of December 31, 2020[24]. - RC88, a novel mesothelin-targeting ADC, is in Phase I clinical trials for various advanced solid tumors, with 7 patients recruited as of December 31, 2020[25]. - The company has received IND approval for RC98, a new PD-L1 monoclonal antibody, and has initiated Phase I clinical trials for multiple advanced solid tumors, with 2 patients recruited as of December 31, 2020[25]. Financial Performance - The group’s loss increased from RMB 430.3 million in 2019 to RMB 697.8 million in 2020[41]. - Other income and gains increased from RMB 385 million in 2019 to RMB 754 million in 2020, primarily due to an increase in government subsidies by RMB 368 million[33]. - Administrative expenses increased from RMB 684 million in 2019 to RMB 2,176 million in 2020, mainly due to higher employee benefits and listing expenses[35]. - R&D expenses grew from RMB 3,521 million in 2019 to RMB 4,658 million in 2020, with significant increases in employee benefits, raw materials, and clinical trial costs[36]. - The company reported a net loss of RMB 697,821 thousand for 2020, compared to a net loss of RMB 430,280 thousand in 2019, representing a 62.2% increase in losses year-over-year[197]. - Total comprehensive loss for the year amounted to RMB 697,403 thousand, up from RMB 428,917 thousand in 2019, indicating a significant increase in overall losses[199]. - Research and development expenses rose to RMB 465,821 thousand in 2020, compared to RMB 352,066 thousand in 2019, reflecting a 32.3% increase in R&D investment[197]. - The company reported a financial cost of RMB 29,226 thousand in 2020, down from RMB 43,789 thousand in 2019, indicating a decrease of 33.5% in financial expenses[197]. Market Strategy and Expansion - The company aims to deepen market penetration and increase sales in China through its unique clinical advantages and expanding sales team[5]. - The company has established offices in multiple locations including Yantai, Shanghai, Beijing, Hong Kong, South San Francisco, and Rockville, MA, indicating market expansion efforts[8]. - The company is focused on transitioning into a fully commercialized biopharmaceutical company, with steady growth expected in 2021[5]. - The company is focused on developing first-in-class and best-in-class products to meet unmet medical needs while delivering substantial returns to shareholders[8]. - The company is expanding its market presence in Europe, targeting a 20% market share by 2025[56]. Corporate Governance - The company has adhered to the corporate governance code since its listing on November 9, 2020, ensuring high standards of corporate governance to protect shareholder interests[69]. - The roles of Chairman and CEO are held by different individuals, with Mr. Wang Weidong as Chairman and Dr. Fu Jianmin as CEO, aligning with corporate governance recommendations[71]. - The company has implemented a clear delegation of authority to management, composed of executive directors and senior management, to execute strategies adopted by the board[74]. - The board is responsible for overseeing all major matters, including policy formulation, overall strategy, internal controls, and risk management systems[73]. - The company has established a corporate governance framework, including various committees to oversee specific areas of business[94][95][97][98]. - The company has maintained a strong emphasis on corporate governance, with independent directors providing critical oversight and judgment[60][62]. Risks and Challenges - The company faces uncertainties related to clinical development and potential delays in obtaining regulatory approvals for its candidate drugs[122]. - The company faces significant risks related to production capacity and regulatory approvals, which could adversely impact its business and financial performance[124]. - The regulatory approval process for candidate drugs is lengthy and unpredictable, which poses a significant risk to the company's business[123]. - The company has experienced delays in obtaining regulatory approvals, which may affect the commercialization of its candidate drugs[127]. - The company may face challenges in maintaining sufficient patent and intellectual property protection globally, which could impact its ability to develop and commercialize products[126]. Shareholder Engagement - Shareholders holding more than 10% of shares can request a special general meeting within 10 days of submission to the board[109]. - Shareholders holding 3% or more of voting shares can propose new resolutions at shareholder meetings, enhancing shareholder engagement[111]. - The company emphasizes the importance of timely and accurate information disclosure to enhance transparency and investor relations[115]. - The company has established effective communication channels with investors through its website and regular disclosures[114]. Research and Development Focus - The company emphasized that R&D activities are a core part of its business operations, significantly impacting the financial statements[188]. - The audit process included evaluating the effectiveness of internal controls related to R&D expenditure recognition[188]. - The company is required to assess its ability to continue as a going concern and disclose relevant matters[191]. Employee and Management Structure - The company has a diverse management team with backgrounds in investment management, biomedical production, and legal affairs, enhancing its operational capabilities[64]. - The company aims to increase its workforce by 10% to support growth initiatives[57]. - The total salary cost for 2020 was RMB 235.5 million, up from RMB 138.5 million in 2019, due to an increase in employee numbers and salary levels[50].