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

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

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