Financial Performance - Revenue for Q1 2023 was RMB 168.24 million, a year-on-year increase of 12.06%[6] - Revenue for Q1 2023 increased to RMB 168.24 million, up 12.1% from RMB 150.14 million in Q1 2022[18] - Net loss attributable to shareholders was RMB 323.77 million, with a basic and diluted loss per share of RMB 0.60[6][7] - Net loss for Q1 2023 widened to RMB 323.77 million, compared to RMB 286.83 million in Q1 2022[18] - Basic and diluted earnings per share for Q1 2023 were both negative RMB 0.60, compared to negative RMB 0.59 in Q1 2022[19] - Total comprehensive loss for Q1 2023 was RMB 326.63 million, compared to RMB 287.62 million in Q1 2022[19] - Weighted average return on equity was -6.40%, an increase of 2.28 percentage points[7] Research and Development (R&D) - R&D investment totaled RMB 249.72 million, accounting for 148.43% of revenue, a year-on-year increase of 14.46%[7] - R&D expenses for Q1 2023 rose to RMB 249.72 million, a 14.5% increase from RMB 218.17 million in Q1 2022[18] Cash Flow and Liquidity - The company's cash flow from operating activities was negative RMB 349.85 million[6] - Operating cash flow for Q1 2023 was negative RMB 349.85 million, slightly improved from negative RMB 350.48 million in Q1 2022[20] - Investment cash flow for Q1 2023 was negative RMB 584.09 million, significantly higher than negative RMB 183.07 million in Q1 2022[21] - Cash and cash equivalents at the end of Q1 2023 decreased to RMB 1.09 billion from RMB 2.07 billion at the beginning of the quarter[21] - Cash received from selling goods and providing services in Q1 2023 was RMB 186.44 million, up 181.0% from RMB 66.34 million in Q1 2022[20] - Monetary funds decreased to 1.25 billion yuan as of March 31, 2023, from 2.19 billion yuan at the end of 2022[15] Assets and Liabilities - Total assets decreased by 5.69% to RMB 5.68 billion compared to the end of the previous year[7] - Total assets decreased to 5.68 billion yuan as of March 31, 2023, from 6.02 billion yuan at the end of 2022[16] - Total liabilities decreased to 997.69 million yuan as of March 31, 2023, from 1.04 billion yuan at the end of 2022[16] - Shareholders' equity decreased by 6.02% to RMB 4.68 billion compared to the end of the previous year[7] - Shareholders' equity decreased to 4.68 billion yuan as of March 31, 2023, from 4.98 billion yuan at the end of 2022[16] - Inventory increased to 624.32 million yuan as of March 31, 2023, from 522.67 million yuan at the end of 2022[16] Shareholders and Equity - The top shareholder, HKSCC NOMINEES LIMITED, holds 34.83% of the shares[10] - Yantai Rongda Venture Capital Center holds 18.81% of the shares, all of which are restricted shares[10] - HKSCC NOMINEES LIMITED holds 189,566,228 unrestricted shares, representing 189,566,228 foreign-listed shares[12] - Total A-share common shareholders: 5,628, H-share common shareholders: 26, totaling 5,654 shareholders[14] - Hua Tai Securities Asset Management - China Merchants Bank - Hua Tai Rongchang Biotech Home 1st Employee Stock Ownership Plan lent out 2 million shares through securities lending[13] Non-Recurring Items - Non-recurring gains and losses amounted to RMB 8.02 million, mainly from government subsidies and financial asset gains[8] Sales and Expenses - Sales expenses for Q1 2023 surged to RMB 157.82 million, a 95.4% increase from RMB 80.78 million in Q1 2022[18]

Product Development and Clinical Trials - RemeGen's products treated over 23,000 patients in 2022, improving their health conditions and extending their lives[11] - RemeGen completed three Phase II clinical studies for Taitizumab targeting IgA nephropathy, Sjögren's syndrome, and myasthenia gravis, all yielding positive results[12] - Ongoing Phase III clinical studies for Taitizumab in systemic lupus erythematosus and Phase II studies in the U.S. for IgA nephropathy are in progress[12] - The company is expanding clinical applications for Vedolizumab, with ongoing Phase III studies for breast cancer and other cancer types[14] - TACI, a novel fusion protein for treating autoimmune diseases, targets BLyS and APRIL to reduce B-cell mediated autoimmune responses[24] - The company is conducting late-stage clinical trials for TACI across eight autoimmune disease indications, addressing significant unmet medical needs[24] - A Phase II trial for TACI in treating IgA nephropathy has shown positive results, with 14 patients recruited in the U.S. as of December 31, 2022[29] - The company has initiated a Phase III trial for TACI in treating primary Sjögren's syndrome (pSS) after positive Phase II results in China[29] - RC48, an antibody-drug conjugate (ADC), has shown promising efficacy in treating HER2-expressing solid tumors, with 130 patients recruited in a Phase III trial in China[34] - The company completed a Phase II clinical trial of Vidisicimab for HER2-overexpressing UC patients in China, leading to a Phase II registration trial after positive results and communication with NMPA[38] - The company has initiated a Phase II clinical trial for Vidisicimab in treating HER2-positive NSCLC, with 37 patients recruited as of December 31, 2022[39] - The company is conducting a Phase II trial for Vidisicimab in BTC patients who failed first-line chemotherapy, with 28 patients recruited as of December 31, 2022[40] - The company has initiated a Phase II basket trial for Vidisicimab in gynecological malignancies, with 60 patients recruited as of December 31, 2022[41] - The company has initiated Phase I clinical trials for RC108 targeting c-Met positive advanced solid tumors, having recruited 18 patients as of December 31, 2022[52] - RC118 has received FDA orphan drug designation for treating gastric cancer and pancreatic cancer, with 12 patients recruited for its Phase I clinical trial in China as of December 31, 2022[52] Sales and Market Expansion - The sales team for the autoimmune division consists of 639 members, covering 1,876 hospitals in China[11] - Sales of Taitizumab grew rapidly in 2022 due to its clinical advantages and inclusion in the national medical insurance drug list[11] - The oncology division has a sales team of 520 members, covering 1,419 hospitals, with significant sales growth attributed to the unique clinical advantages of the products[12] - RemeGen aims to deepen market penetration by expanding its sales team and covering more cities and hospitals[11] - The company plans to accelerate growth in 2023 by developing innovative products to meet unmet medical needs[15] - The company plans to accelerate the commercialization of TaiTasi and Vidisizumab while expanding market space in 2023[57] Financial Performance - 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 of USD 200 million received from Seagen in 2021 for the global development rights of RC48[59] - Other income and gains increased from RMB 186.0 million in 2021 to RMB 232.5 million in 2022, driven by an increase in interest income from fundraising and foreign exchange gains[60] - Sales and distribution expenses rose significantly from RMB 263.0 million in 2021 to RMB 440.7 million in 2022, attributed to the expansion of sales personnel and marketing efforts following the conditional approvals of RC48 and Tislelizumab[61] - Research and development expenses increased from RMB 711.0 million in 2021 to RMB 982.1 million in 2022, with clinical trial costs rising by RMB 114.0 million due to ongoing drug development[64] - The company recorded a loss of RMB 998.8 million in 2022, compared to a profit of RMB 276.3 million in 2021, primarily due to reduced revenue and increased expenses[71] - Cash and cash equivalents increased from RMB 1,756.8 million at the end of 2021 to RMB 2,069.2 million at the end of 2022, mainly due to funds raised from A-share issuance[72] Corporate Governance and Management - The company is committed to maintaining high standards of corporate governance and compliance with listing rules[108] - The management team collectively has over 100 years of experience in the pharmaceutical industry, providing a strong foundation for strategic decision-making[95] - The board consists of seven male members and two female members, with a gender diversity ratio of approximately 22% at the board level and 56% within the group[131] - The company has implemented a board diversity policy, considering factors such as gender, age, cultural background, and professional experience in selecting board candidates[132] - The company has established effective procedures for appointing new directors, requiring approval at the shareholders' meeting[133] - The company has purchased liability insurance for directors and senior management to provide appropriate protection against potential legal liabilities arising from their duties[125] Risk Management - The company has established a risk management framework to identify, assess, and monitor key risks related to its strategic objectives[174] - The company has implemented measures to monitor and manage operational risks effectively[174] - The audit committee has conducted an annual review and confirmed the effectiveness of the group's risk management and internal control procedures, with no significant concerns noted[176] Research and Development Focus - The company aims to address unmet clinical needs in autoimmune, oncology, and ophthalmology diseases globally[17] - The research and development platform supports the advancement of innovative biologics with breakthrough potential[17] - The company has over 40 patents, including the invention of conbercept, showcasing its strong focus on innovative drug development[91] - The company is committed to innovative drug research and development, with ongoing projects aimed at addressing unmet medical needs[91] Employee and Talent Management - The total employee count as of December 31, 2022, was 3,332, with total compensation costs rising to RMB 810.7 million in 2022 from RMB 459.0 million in 2021, attributed to increased headcount and salary levels[79] - The company has invested in continuous education and training programs for employees to enhance their skills and knowledge[79] - The company has competitive compensation packages for employees, including bonuses and stock-based remuneration, to retain talent[79]

Financial Performance - The company reported a significant increase in revenue for 2022, with total revenue reaching RMB 1.5 billion, representing a 25% growth compared to 2021[26]. - The company anticipates a revenue growth of 20% for 2023, projecting total revenue to reach RMB 1.8 billion[26]. - The company reported a net profit margin of 10% for 2022, up from 8% in 2021, indicating improved operational efficiency[26]. - The company's operating revenue decreased by 45.87% year-on-year, primarily due to the absence of a $200 million upfront payment received from Seattle Genetics in 2021 for the global development and commercialization rights of a drug[29]. - The net profit attributable to shareholders was -¥998,830,427.52, a significant decline compared to a profit of ¥276,257,887.16 in the previous year[29]. - The net cash flow from operating activities decreased by ¥1,260,252,253.29, largely due to increased R&D and sales expenses, as well as the lack of the previous year's upfront payment[29]. - The company achieved a revenue of 772 million yuan in 2022, a decrease of 45.87% compared to 1.426 billion yuan in the previous year, primarily due to the absence of a 200 million USD upfront payment from Seattle Genetics recognized in 2021[35]. - The net loss attributable to shareholders was 999 million yuan, with a net loss of 1.117 billion yuan after excluding non-recurring items, mainly due to increased R&D investments and commercialization efforts for core products[35]. - The company reported a significant increase in production and sales volume due to the inclusion of 泰它西普 and 维迪西妥单抗 in the national medical insurance catalog at the end of 2021[113]. - The company reported a significant increase in revenue, achieving a total of 1.2 billion yuan in 2022, representing a growth of 15% year-over-year[194]. Research and Development - The company is committed to maintaining a significant scale of R&D investment for ongoing clinical research and new drug preparations, which may lead to increased short-term losses[3]. - Research and development expenses increased by 15% in 2022, totaling RMB 300 million, reflecting the company's commitment to innovation[26]. - The total R&D investment for the year reached approximately CNY 982.08 million, a significant increase of 38.13% compared to CNY 710.97 million in the previous year[79]. - R&D investment accounted for 127.19% of operating revenue, an increase of 77.34 percentage points from 49.85% in the previous year[79]. - The increase in R&D expenses is attributed to the expansion of the new drug pipeline and rising clinical trial costs due to more innovative drugs entering critical research phases[80]. - The company has ongoing projects with a total expected investment of CNY 166.40 million, with CNY 23.82 million invested in the current period for the RC18 (Taitasib) project[81]. - The company is focused on developing innovative biopharmaceuticals for autoimmune diseases, tumors, and ophthalmic diseases, with a robust pipeline of first-in-class and best-in-class therapies[41]. - The company has established three core technology platforms with independent intellectual property rights, including antibody and fusion protein platforms, ADC platforms, and bispecific antibody platforms, enhancing its drug discovery and development capabilities[70][71]. - The company is actively pursuing clinical trials for its candidate drugs in the tumor treatment field to further evaluate their efficacy and safety[73]. - The company is committed to expanding its product pipeline, including ongoing clinical trials for RC88, RC108, and RC118, while exploring combination therapy options[171]. Market Expansion and Strategy - The company is actively expanding its market presence through strategic partnerships and collaborations in the biopharmaceutical sector[12]. - The company is in the process of developing two new products, expected to launch in 2024, targeting a combined market size of RMB 5 billion[26]. - The company is actively expanding its market presence, with plans to enter three new international markets by the end of 2023[26]. - The company is implementing an international development strategy to enhance its global presence and capabilities[172]. - The company is exploring partnerships with international firms to leverage new technologies and expand its global footprint[200]. - The company plans to enhance its digital marketing strategy, aiming for a 40% increase in online sales channels by the end of 2023[196]. - The company aims to enhance product sales through a collaborative marketing strategy involving medical, market, and sales teams[61]. - The company is focused on expanding its product offerings and enhancing its market presence through strategic investments and R&D initiatives[128]. Clinical Trials and Product Development - The company has submitted several Investigational New Drug (IND) applications to the FDA, indicating a robust pipeline for new drug development[12]. - The company is advancing its antibody-drug conjugates (ADCs), which combine monoclonal antibodies with cytotoxic drugs, to improve therapeutic efficacy[12]. - The company achieved a disease control rate (DCR) of 70% in clinical trials for its new drug, indicating strong efficacy[26]. - The company is conducting a Phase III trial comparing RC48 combined with Toripalimab to chemotherapy for HER2-expressing advanced or metastatic urothelial carcinoma, with 67 patients recruited as of December 31, 2022[47]. - The company is advancing the clinical development of RC28, the first dual-targeting candidate drug for eye diseases, aiming for differentiated efficacy and safety[171]. - The company has established three R&D centers in Yantai, Shanghai, and California, focusing on innovative biopharmaceutical product development[54]. - The company is exploring innovative drug delivery systems and formulations to improve patient outcomes and treatment adherence[15]. - The company is committed to expanding its product pipeline, including ongoing clinical trials for RC88, RC108, and RC118, while exploring combination therapy options[171]. Governance and Compliance - The company has received a standard unqualified audit report from Ernst & Young Hua Ming[4]. - The company’s financial report has been confirmed for authenticity, accuracy, and completeness by its management[4]. - The company’s board of directors was fully present at the board meeting, ensuring governance compliance[4]. - The company held five shareholder meetings during the reporting period, ensuring compliance with legal requirements and protecting shareholder rights[178]. - The company held its first extraordinary general meeting of shareholders on May 5, 2022, where one proposal was approved without any rejections[181]. - The annual general meeting for 2021 took place on June 29, 2022, with 12 proposals approved and no rejections[181]. - The second extraordinary general meeting of shareholders in 2022 was held on December 28, where three proposals were approved without any rejections[181]. Risks and Challenges - The company’s future plans and development strategies are subject to investment risks and do not constitute substantial commitments to investors[6]. - The company faces risks related to regulatory approval delays and market competition, which could impact future revenue growth[95]. - The company faces risks related to competition in the market, particularly if its drugs do not meet sales expectations or are not included in the national medical insurance directory[98]. - The company’s reliance on external financing for working capital may pose financial risks if it cannot secure sufficient funds for operational expenses[100].

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]