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]

R&D Investment and Development - The company is committed to maintaining a significant scale of R&D investment for ongoing product clinical trials and new drug market preparations[4]. - The total R&D investment amounted to ¥540,452,903.93, representing a 20.19% increase compared to ¥449,671,836.54 in the same period last year[53]. - Research and development expenses amounted to 540 million RMB, reflecting a growth of 20.19% year-over-year, indicating a continued commitment to expanding the R&D pipeline[66]. - The research and development expenditure accounted for 127.94% of operating revenue, slightly down from 128.34% in the previous year[24]. - The increase in R&D expenses is attributed to the expansion of the new drug pipeline and the advancement of multiple innovative drugs into critical trial phases[55]. - The company has established three core technology platforms with independent intellectual property rights, including antibody and fusion protein platform, ADC platform, and bifunctional antibody platform[49]. - The company has developed candidate drugs for tumor treatment based on its bifunctional antibody platform, which have shown significant biological activity in preclinical studies[49]. - The company has a comprehensive integrated ADC platform, making it one of the few biopharmaceutical companies in China with such capabilities[49]. - The company has established various original technologies for screening monoclonal antibodies with drug-like potential, including hybridoma monoclonal antibody platform and human antibody library phage display platform[49]. - The company is focused on innovative therapeutic antibody drugs, including antibody-drug conjugates (ADC) and bispecific antibodies, aiming to address unmet clinical needs in autoimmune diseases, oncology, and ophthalmology[29]. Financial Performance - The company reported a significant increase in the objective response rate (ORR) for its leading oncology product, indicating improved efficacy in patient outcomes[14]. - The company's operating revenue for the first half of 2023 was ¥422,427,546.05, representing a year-on-year increase of 20.56% compared to ¥350,374,980.22 in the same period last year[23]. - The net profit attributable to shareholders of the listed company was -¥703,360,797.19, a decrease from -¥489,125,226.86 in the previous year, indicating ongoing losses despite increased sales[23]. - The net assets attributable to shareholders decreased by 13.76% to ¥4,295,151,715.61 from ¥4,980,299,629.44 at the end of the previous year[23]. - The total assets decreased by 3.16% to ¥5,831,113,332.45 from ¥6,021,189,680.87 at the end of the previous year[23]. - Basic earnings per share for the first half of 2023 were -¥1.30, compared to -¥0.96 in the same period last year[24]. - The company reported a net cash flow from operating activities of -¥707,725,149.63, which is a slight increase in losses compared to -¥698,888,452.45 in the previous year[23]. - The weighted average return on net assets was -15.10%, a decrease of 4.06 percentage points from -11.04% in the previous year[24]. - The increase in sales revenue was attributed to higher sales of injectable drugs, specifically TaiTasi and VidiXimab, despite ongoing high costs for commercialization and R&D[25]. Clinical Trials and Product Development - The company is actively involved in clinical trial management through Site Management Organizations (SMOs) to enhance trial quality and compliance with regulations[13]. - The company is leveraging Contract Development and Manufacturing Organizations (CDMOs) for innovative drug process development and small-scale production[13]. - The company has achieved breakthrough therapy designation for new drugs that show substantial improvement in clinical endpoints during early trials, allowing access to expedited development and review[13]. - The company received orphan drug designation for treatments targeting diseases affecting fewer than 200,000 patients in the U.S., which grants a 7-year exclusivity period post-FDA approval[13]. - The company is committed to advancing its pipeline with a focus on diseases like systemic lupus erythematosus (SLE) and multiple sclerosis (MS), which are critical areas of unmet medical need[14]. - The company is exploring new market opportunities through strategic partnerships and potential acquisitions to expand its product offerings and market reach[14]. - The company has completed the first patient enrollment in several ongoing clinical trials, indicating progress in its research and development pipeline[31]. - The company has received breakthrough therapy designation for Tai'aisip in treating myasthenia gravis (MG) and is conducting a Phase III trial in China[32]. - The company has also initiated a Phase III clinical trial for Tai'aisip in treating primary Sjögren's syndrome (pSS) in China, with promising results from a previous Phase II trial published in a reputable journal[32]. - The company is conducting a Phase III clinical trial for Taitasip in treating NMOSD, which started in September 2017, with patient recruitment ongoing[34]. Market and Strategic Initiatives - The company is exploring Taitasip for other autoimmune diseases, with numerous investigator-initiated studies underway[35]. - The company is considering strategic acquisitions to bolster its market position, with a budget of up to 500 million earmarked for potential targets[125]. - The company is planning to expand its market presence in Southeast Asia, targeting a 15% market share by the end of 2024[149]. - The company is investing heavily in R&D, with a budget allocation of 200 million for new technologies aimed at enhancing user experience and operational efficiency[153]. - The company is implementing new strategies to enhance its research and development capabilities, aiming for faster time-to-market for innovative therapies[14]. - The company is actively recruiting talent across R&D, management, sales, and production to support its business growth and product pipeline expansion[71]. Environmental and Regulatory Compliance - The company has established an environmental protection mechanism and is classified as a key pollutant discharge unit[102]. - The company reported a total wastewater discharge of 88,343 tons for the year 2022, with ammonia nitrogen concentration at 15.7 mg/L, well below the limit of 45 mg/L[104]. - The chemical oxygen demand (COD) in wastewater was recorded at 146 mg/L, significantly lower than the permissible limit of 500 mg/L, with a total COD discharge of 14.475 tons[104]. - The company has implemented a self-monitoring plan for environmental compliance, with all monitored pollutants meeting discharge standards[109]. - The company has not reported any administrative penalties related to environmental issues during the reporting period[110]. - The company has not taken specific measures to reduce carbon emissions during the reporting period[112]. Shareholder and Governance Commitments - The company commits to not reducing its holdings of A shares before achieving profitability for three complete fiscal years post-listing[120]. - The company will comply with relevant laws and regulations regarding share lock-up and reduction, ensuring that any share reduction does not occur below the issue price within two years post-lock-up[120]. - The company has established a commitment to not transfer or manage shares for 12 months post-listing or for six months after leaving the company[121]. - The company will report any changes in shareholdings during the tenure of directors and senior management, with a maximum transfer limit of 25% of their holdings per year[120]. - The company will adhere to the Shanghai Stock Exchange regulations regarding share reduction and lock-up periods[120]. - The company has established a three-year shareholder dividend return plan post-IPO, focusing on stable returns based on profitability and business development[138]. - The company emphasizes the importance of governance structure improvement to enhance operational efficiency[137]. - The company will strictly adhere to its profit distribution policy as outlined in its articles of association and the prospectus post-IPO[140]. - The company has committed to timely disclosure of any failure to fulfill its commitments and will seek to protect investor rights through supplementary commitments[140]. - The company will not distribute dividends or compensation to its executives if commitments are not fulfilled[144].

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]

| 证券代码：688331 | 证券简称：荣昌生物 | 公告编号： | 2023-023 | | --- | --- | --- | --- | | 港股代码：09995 | 港股简称：榮昌生物 | | | 荣昌生物制药（烟台）股份有限公司 2023年半年度募集资金存放与实际使用情况的专项报告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 根据中国证券监督管理委员会发布的《上市公司监管指引第 2 号——上市公 司募集资金管理和使用的监管要求》和上海证券交易所颁布的《上海证券交易所 科创板上市公司自律监管指引第 1 号——规范运作》等的相关规定，荣昌生物制 药（烟台）股份有限公司（以下简称"公司"）将 2023 年上半年募集资金存放 与使用情况专项报告如下： 一、募集资金基本情况 （一）实际募集资金金额及资金到账情况 经中国证券监督管理委员会《关于同意荣昌生物制药（烟台）股份有限公司 首次公开发行股票注册的批复》（证监许可[2022]62 号）核准，公司首次公开 发行人民币普通股（A 股）股票 5,442.6301 万股， ...

荣昌生物制药（烟台）股份有限公司 第二届监事会第二次会议决议公告 | 证券代码：688331 | 证券简称：荣昌生物 | 公告编号： | 2023-022 | | --- | --- | --- | --- | | 港股代码：09995 | 港股简称：榮昌生物 | | | 本公司监事会及全体监事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 准确、完整，所载资料不存在任何虚假记载、误导性陈述或者重大遗漏。 一、监事会会议召开情况 荣昌生物制药（烟台）股份有限公司（以下简称"公司"）第二届监事会第二 次会议，于 2023 年 8 月 21 日在公司会议室以现场方式召开，会议已于 2023 年 8 月 7 日以邮件方式发出会议通知。会议应出席监事 3 名，实际出席监事 3 名， 会议由任广科先生主持，会议的召集、召开、表决程序符合《中华人民共和国公 司法》和《荣昌生物制药（烟台）股份有限公司章程》（以下简称"公司章程"） 的相关规定，所作决议合法有效。经与会监事表决，会议形成如下决议： 二、监事会会议审议情况 1、审议通过《关于公司 2023 年半年度 ...

Financial Performance - The company's operating revenue for Q1 2023 was ¥168,238,991.99, representing a year-on-year increase of 12.06%[4] - The net profit attributable to shareholders was -¥323,774,631.80, and the net profit after deducting non-recurring gains and losses was -¥331,792,406.63[4] - The company reported a net loss of CNY 322,166,168.74 for Q1 2023, compared to a loss of CNY 282,670,647.07 in Q1 2022, indicating a worsening of about 14.0%[16] - Total comprehensive income for Q1 2023 was -326,630,103.58 RMB, compared to -287,615,486.11 RMB in Q1 2022, reflecting a decline of about 13.6% year-over-year[17] - Basic and diluted earnings per share were both -¥0.60[5] - Basic and diluted earnings per share for Q1 2023 were both -0.60 RMB, slightly worse than -0.59 RMB in Q1 2022[17] Cash Flow - The net cash flow from operating activities was -¥349,845,397.38[4] - Cash inflows from operating activities totaled 224,413,979.30 RMB in Q1 2023, up from 115,680,554.56 RMB in Q1 2022, representing an increase of approximately 93.9%[19] - Cash outflows from operating activities amounted to 574,259,376.68 RMB in Q1 2023, compared to 466,158,621.88 RMB in Q1 2022, an increase of about 23.2%[19] - The net cash flow from operating activities was -349,845,397.38 RMB in Q1 2023, slightly improved from -350,478,067.32 RMB in Q1 2022[19] - Cash and cash equivalents decreased to CNY 1,250,643,639.07 as of March 31, 2023, down from CNY 2,187,326,306.04 at the end of 2022, a decline of approximately 42.7%[14] - Cash and cash equivalents at the end of Q1 2023 were 1,086,332,437.19 RMB, down from 3,735,640,216.30 RMB at the end of Q1 2022, a decrease of approximately 70.1%[19] - The company reported cash inflows from investment activities of 68,289,252.05 RMB in Q1 2023, with cash outflows totaling 652,378,663.59 RMB, resulting in a net cash flow from investment activities of -584,089,411.54 RMB[19] - The company did not report any cash inflows from financing activities in Q1 2023, contrasting with significant inflows of -2,612,462,448.00 RMB in the same period of the previous year[19] Assets and Liabilities - The total assets at the end of the reporting period were ¥5,678,394,849.53, a decrease of 5.69% compared to the end of the previous year[5] - Total assets as of March 31, 2023, were CNY 5,678,394,849.53, down from CNY 6,021,189,680.87 at the end of 2022, representing a decrease of about 5.7%[15] - The total liabilities decreased to CNY 997,690,914.23 as of March 31, 2023, from CNY 1,040,890,051.43 at the end of 2022, a reduction of approximately 4.1%[15] - The equity attributable to shareholders decreased by 6.02% to ¥4,680,703,935.30 compared to the end of the previous year[5] - The company’s total equity attributable to shareholders was CNY 4,680,703,935.30 as of March 31, 2023, down from CNY 4,980,299,629.44 at the end of 2022, a decrease of about 6.0%[15] Research and Development - Research and development expenses totaled ¥249,722,218.25, accounting for 148.43% of operating revenue, an increase of 3.11 percentage points year-on-year[5] - Research and development expenses for Q1 2023 were CNY 249,722,218.25, up from CNY 218,173,558.62 in Q1 2022, reflecting a rise of approximately 14.5%[16] - The company plans to continue focusing on R&D and market expansion strategies to improve future performance[16] Shareholder Information - The company had a total of 8,017,774.83 shares outstanding at the end of the reporting period[7] - The top shareholder, HKSCC NOMINEES LIMITED, held 34.83% of the shares, totaling 189,566,228 shares[8] - The number of common shareholders as of the reporting date was 5,654, with 5,628 A-share and 26 H-share shareholders[12] Accounting Practices - The company has not adopted new accounting standards for the year 2023, indicating continuity in financial reporting practices[20]

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].