香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內 容概不負責，對其準確性或完整性亦不發表任何聲明，並明確表示，概 不就因本公告全部或任何部分內容而產生或因倚賴該等內容而引致的 任何損失承擔任何責任。 RemeGen Co., Ltd.* 榮 昌 生 物 製 藥（煙 台）股 份 有 限 公 司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：9995） 有 關2022年 年 報 的 補 充 公 告 茲提述榮昌生物製藥（煙台）股份有限公司於2023年4月27日刊發的年報（「2022 年 年 報」）。除 另 有 指 明 外，本 公 告 所 用 詞 彙 與2022年 年 報 所 界 定 者 具 有 相同涵義。本公告為年報提供補充資料，並應與2022年年報一併閱讀。 關 於 根 據H股 計 劃 授 出 的 獎 勵 詳 情（載 於2022年 年 報 第56頁）及 根 據A股 計 劃 授 出 的 獎 勵 詳 情（載 於2022年 年 報 第58頁），本 公 司 謹 此 提 供 以 下 補 充資料（修訂資料以下劃線列示）： ...

Financial Performance - For the six months ended June 30, 2023, the company reported revenue of RMB 419,073 thousand, an increase from RMB 348,779 thousand in the same period of 2022, representing a growth of approximately 20.1%[2] - The gross profit for the same period was RMB 316,418 thousand, compared to RMB 181,274 thousand in 2022, indicating a significant increase of approximately 74.5%[2] - The company reported a loss before tax of RMB 703,362 thousand for the six months ended June 30, 2023, compared to a loss of RMB 489,126 thousand in the prior year, representing an increase in loss of approximately 43.8%[2] - The basic loss per share for the period was RMB 1.30, compared to RMB 0.96 in the same period of 2022, indicating a deterioration in earnings per share[2] - There were no income tax expenses reported for the periods in question, consistent with prior reporting[2] Research and Development - Research and development costs rose to RMB 540,453 thousand, up from RMB 449,672 thousand in 2022, reflecting an increase of about 20.2%[2] - The company continues to focus on expanding its research and development efforts, as indicated by the significant increase in R&D expenditure[2] Reporting and Compliance - The company clarified that the financial results are unaudited and should be read in conjunction with the full interim report for the six months ended June 30, 2023[3] - The announcement serves as a correction to the previous interim results announcement dated August 21, 2023, ensuring accuracy in the reported figures[1] - The company advises shareholders to refer to the full interim report for comprehensive details on financial performance and strategic direction[3]

Financial Performance - The company's product sales and R&D service revenue for the six months ended June 30, 2023, was approximately RMB 419.1 million, a 20% increase compared to RMB 348.8 million in the same period last year, driven by strong sales of its immunotherapy product Tai Aisi (RC18) and anti-tumor product Ai Di Xi (RC48) [2] - As of June 30, 2023, the group reported revenue of approximately RMB 419.1 million and gross profit of approximately RMB 316.4 million [5] - The company's revenue increased from RMB 348.8 million for the six months ended June 30, 2022, to RMB 419.1 million for the six months ended June 30, 2023, driven by strong sales of the self-immune product Taitasip and the anti-tumor product Vidisitimab [39] - The gross profit for the same period was RMB 316,418 thousand, compared to RMB 181,274 thousand in 2022, indicating a significant increase in profitability [61] - The company reported a loss before tax of RMB 703,362 thousand for the six months ended June 30, 2023, compared to a loss of RMB 489,126 thousand in the same period of 2022 [61] - The company's loss for the period rose from RMB 489.1 million to RMB 703.4 million [50] Research and Development - In January 2023, the FDA approved Tai Aisi (RC18) for the treatment of generalized myasthenia gravis (gMG) and granted it Fast Track designation [3] - In February 2023, the company received approval for the clinical trial application of Ai Di Xi (RC48) in combination with Ma Lai Suan Pi Luo Ti Ni tablets for patients with HER2 gene mutations [3] - The company is expanding its product pipeline with multiple new drug clinical trial applications approved in 2023, indicating a strong focus on R&D and market expansion [4] - The company has established a comprehensive end-to-end drug development capability, with seven candidate drugs currently in clinical development [7] - The company is conducting late-stage clinical trials for its proprietary fusion protein, Tai Tasi Pi (RC18), targeting eight autoimmune diseases [10] - The company is exploring the potential of Taitasib for other indications, including IgG4-related diseases and antiphospholipid syndrome, while continuing to seek global approval pathways for autoimmune diseases [19] Clinical Trials and Approvals - The company initiated a Phase III clinical trial for RC28-E, an injection for the treatment of wet age-related macular degeneration (wAMD), in January 2023 [4] - In April 2023, the NMPA approved Ai Di Xi (RC48) for a clinical trial in combination with radiotherapy for patients with HER2-expressing locally advanced solid tumors [4] - The NMPA approved the company's product RC48 for a Phase II clinical study in July 2023, targeting recurrent or metastatic cervical cancer patients [5] - The company received NMPA approval for its first bispecific antibody product RC148 for solid tumor patients in July 2023 [5] - The company has achieved agreement with the CDE on the Phase III clinical trial protocol for Taitasib in treating pSS in August 2022, indicating regulatory progress [15] Financial Expenses and Losses - Total expenses for the six months ended June 30, 2023, were approximately RMB 1,059.2 million, with R&D expenses accounting for approximately RMB 540.5 million, an increase of about RMB 90.8 million or approximately 20.2% [6] - Adjusted net loss increased by approximately RMB 182.2 million or about 38.2% to approximately RMB 659.7 million [6] - Sales and distribution expenses surged from RMB 150.0 million to RMB 350.2 million, primarily due to the expansion of the sales scale and increased marketing expenses [41] - Administrative expenses increased from RMB 106.9 million to RMB 168.6 million, mainly due to higher employee costs and depreciation from new facilities [43] - The total employee compensation cost for the six months ended June 30, 2023, was approximately RMB 571.7 million, an increase from RMB 335.3 million in the same period of 2022, primarily due to an increase in employee numbers and salary levels [56] Market Strategy and Expansion - The company aims to expand its market presence in China and internationally, focusing on clinical trials for Taitasip and Vidisitimab [38] - The company is expanding its marketing strategy to interact directly with key opinion leaders and physicians to promote its products effectively [36] - The company has established independent sales teams for autoimmune and oncology products, with over 600 hospitals approved for the sales of its products as of June 30, 2023 [36] Assets and Liabilities - As of June 30, 2023, the company's cash and cash equivalents decreased to RMB 1,119.7 million from RMB 2,069.2 million as of December 31, 2022, primarily due to increased operating and investment expenditures [51] - The company's debt, including bank loans and other borrowings, amounted to RMB 542.8 million as of June 30, 2023, with a debt-to-asset ratio of 26.3%, up from 17.3% as of December 31, 2022 [52] - Total liabilities increased to RMB 1,535,961 thousand from RMB 1,040,891 thousand, reflecting a rise of 47.5% [64] - The company's total equity decreased to RMB 4,295,152 thousand from RMB 4,980,300 thousand, a decline of 13.8% [64] Corporate Governance and Compliance - The company is subject to regulatory oversight from the National Medical Products Administration (NMPA) in China [92] - The company’s governance adheres to the corporate governance code as per the listing rules [90] - The company is listed on both the Hong Kong Stock Exchange (H shares) and the Shanghai Stock Exchange (A shares) [90]

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 - 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 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 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].