Financial Performance - The company has not achieved profitability in the first half of 2022, with increasing R&D expenses not covered by operating income[4]. - The company's operating revenue for the first half of the year was ¥946,048,587.10, a decrease of 55.26% compared to ¥2,114,448,449.63 in the same period last year[18]. - The net profit attributable to shareholders was -¥912,405,010.11, a significant decline from ¥9,346,950.67 in the previous year, representing a decrease of 9,861.53%[18]. - The net cash flow from operating activities was -¥458,226,892.00, compared to ¥45,616,436.03 in the same period last year, marking a decline of 1,104.52%[18]. - The company's total assets decreased to ¥9,886,339,569.09, down 10.41% from ¥11,034,911,100.95 at the end of the previous year[18]. - The net assets attributable to shareholders decreased to ¥7,128,935,853.59, a reduction of 10.27% from ¥7,945,095,398.41 at the end of the previous year[18]. - Basic earnings per share were -¥1.00, a decrease of 10,118.10% from ¥0.01 in the previous year[19]. - The weighted average return on net assets was -11.94%, a decrease of 12.10 percentage points from 0.16% in the same period last year[19]. Research and Development - Significant progress was made in product commercialization, clinical trials, and pipeline expansion during the reporting period[4]. - The company is committed to maintaining a substantial scale of R&D investment for ongoing clinical research and global clinical trials[4]. - Research and development expenses accounted for 112.28% of operating revenue, an increase of 67.48 percentage points compared to 44.80% in the same period last year[19]. - The company has developed a first-in-class PD-1 monoclonal antibody, Tretinoin, which has been approved for 5 indications in China, including treatment for metastatic melanoma and nasopharyngeal carcinoma[26]. - The company has a comprehensive R&D pipeline that includes small molecules, peptide drugs, antibody-drug conjugates, and next-generation therapies for cancer and autoimmune diseases[27]. - The company is focusing on innovative drug discovery and has developed multiple technology platforms for antibody screening and production[27]. - The company has established a global integrated R&D process with centers in San Francisco, Maryland, Shanghai, and Suzhou[27]. - The company has received IND approval for its first-in-human anti-BTLA monoclonal antibody, tifcemalimab, and is conducting multiple Ib/II clinical trials in China and the US[27]. Product Pipeline and Commercialization - The commercialized product, Toripalimab (JS001), is China's first domestically developed PD-1 monoclonal antibody, approved for over 15 indications and has conducted more than 30 clinical studies globally[35]. - The company’s product pipeline includes three commercialized products: Toripalimab, Etesevimab, and Adalimumab, with ongoing key registration clinical trials for several candidates[35]. - The company has established partnerships with international biotech firms to enhance its product pipeline, including collaborations for Toripalimab in the U.S. and Canada[34]. - The sales revenue of Toripalimab in the domestic market reached approximately 298 million yuan in the first half of 2022, with a 212% increase in Q1 2022 compared to Q4 2021, and a 70% increase in Q2 2022 compared to Q1 2022[36]. - Toripalimab has been included in the medical insurance directory for multiple indications, allowing for supplementary reimbursement in 113 provinces/cities, benefiting more patients[36]. - The company has achieved over 4,000 medical institution sales and nearly 2,000 pharmacy sales for Toripalimab, indicating strong market penetration[35]. Clinical Trials and Regulatory Approvals - The company has received FDA acceptance for the Biologics License Application (BLA) for Toripalimab, indicating progress towards market expansion in the U.S.[34]. - The company has received clinical trial approval for Tifcemalimab from both the FDA and NMPA, marking a significant milestone in its drug development[97]. - The company is conducting multiple ongoing clinical trials for VV116 (JT001) and other drugs, including a Phase III trial for a PCSK9 monoclonal antibody in broader patient populations[105]. - The company has received IND approvals for several monoclonal antibodies, including JS105 and JS107, which have received IND approvals in both China and the U.S.[87]. Financial Risks and Challenges - The company anticipates that high costs associated with new drug applications and market promotion may further increase short-term losses[4]. - The company has detailed various risk factors it may encounter in its production and operation processes[4]. - The financial risk associated with foreign currency fluctuations remains a concern, particularly with assets and liabilities denominated in currencies such as HKD, USD, EUR, CHF, and GBP[114]. - The company faces risks related to high R&D costs and potential delays in clinical trials due to the ongoing impact of the COVID-19 pandemic[117]. Environmental and Social Responsibility - The company has established a dedicated environmental health and safety department to manage pollutant discharge effectively[141]. - The company has implemented an environmental self-monitoring plan for 2022, with all monitored pollutants meeting discharge standards[144]. - The company has committed to environmental responsibility by adhering to pollution prevention measures and ensuring compliance with environmental regulations[148]. - The company actively adjusted its electricity consumption behavior to reduce carbon emissions, promoting green office practices and resource conservation among employees[148]. Shareholder and Corporate Governance - The company has a long-term commitment to a profit distribution policy, as detailed in the prospectus, ensuring transparency and adherence to investor protection measures[165]. - The company has confirmed that there are no significant legal violations or ongoing major litigation that could impact investor rights or public interest[165]. - The company is committed to maintaining transparency and integrity in its shareholding practices, especially during management transitions[156]. - The company has pledged to maintain independence in its operations, assets, and finances, ensuring no direct or indirect competition with its controlling shareholder or related entities[167].

Financial Performance - The company's revenue for Q1 2022 was RMB 629,519,132.31, representing a decrease of 61.02% compared to the same period last year[4] - The net loss attributable to shareholders was RMB -396,395,486.59, a decline of 205.06% year-over-year[4] - The company reported a net profit excluding non-recurring items of RMB -429,583,325.21, a decline of 218.99% compared to the same period last year[4] - The net profit attributable to the parent company for Q1 2022 was -396,395,486.59 CNY, compared to a profit of 377,321,280.11 CNY in Q1 2021, indicating a significant decline[19] - The total comprehensive income for Q1 2022 was -471,770,135.33 CNY, compared to 379,422,645.53 CNY in Q1 2021, reflecting a substantial decrease[19] - The basic and diluted earnings per share for Q1 2022 were both -0.44 CNY, down from 0.43 CNY in Q1 2021[19] Cash Flow and Liquidity - The net cash flow from operating activities was RMB 570,432,127.10, an increase of 42.75% compared to the previous year[4] - Cash flow from operating activities for Q1 2022 was 570,432,127.10 CNY, a decrease from 399,613,641.51 CNY in Q1 2021[20] - Cash and cash equivalents increased to ¥4,259,927,063.42 in Q1 2022, up from ¥3,506,637,890.39 at the end of 2021, representing a growth of 21.5%[14] - The company’s cash and cash equivalents at the end of Q1 2022 stood at 4,258,353,489.75 CNY, up from 3,282,286,048.21 CNY at the end of Q1 2021[21] - The company received 380,000,000.00 CNY from minority shareholders in Q1 2022, marking a significant inflow compared to the previous year[20] - The cash outflow for investing activities in Q1 2022 was -175,320,677.30 CNY, an improvement from -489,544,165.73 CNY in Q1 2021[20] Research and Development - R&D expenses totaled RMB 510,912,040.65, accounting for 81.16% of revenue, which is an increase of 53.26 percentage points year-over-year[5] - R&D expenses increased to ¥510,912,040.65 in Q1 2022, up 13.3% from ¥450,649,443.76 in Q1 2021[18] Assets and Liabilities - The total assets at the end of the reporting period were RMB 10,953,222,268.79, a decrease of 0.74% from the end of the previous year[5] - Total assets as of March 31, 2022, were ¥10,953,222,268.79, slightly down from ¥11,034,911,100.95 at the end of 2021[17] - Total liabilities decreased to ¥2,651,629,271.81 in Q1 2022 from ¥2,718,536,814.27 in Q4 2021, a reduction of 2.5%[16] - The company reported a significant increase in long-term equity investments to ¥502,348,197.82 in Q1 2022, up from ¥457,791,434.27 in Q4 2021[16] Shareholder Information - The total number of ordinary shareholders at the end of the reporting period was 33,735, with HKSCC NOMINEES LIMITED holding 24.08% of shares[9] - The number of A-share shareholders was 33,727 as of the report date[12] Sales Performance - The sales revenue from the product Tuoyi® (JS001) in Q1 2022 was RMB 110 million, showing significant growth compared to previous periods[5] - Operating costs for Q1 2022 were ¥1,012,253,166.19, down from ¥1,154,773,625.99 in Q1 2021, reflecting a reduction of 12.3%[18] Other Financial Metrics - The weighted average return on net assets was -5.10%, a decrease of 11.34 percentage points year-over-year[5] - The company experienced a significant decline in technology licensing income, which contributed to the overall revenue drop[7]

Revenue and Profitability - The company's revenue for Q1 2022 was RMB 629,519,132.31, representing a decrease of 61.02% compared to the same period last year[5] - The net loss attributable to shareholders was RMB -396,395,486.59, a decline of 205.06% year-over-year[5] - The basic and diluted earnings per share were both -0.44 yuan, reflecting a decline of 202.33% year-over-year[5] - The net profit attributable to shareholders of the parent company for Q1 2022 was -396,395,486.59 CNY, compared to 377,321,280.11 CNY in Q1 2021, indicating a significant decline[19] - The total comprehensive income for Q1 2022 was -471,770,135.33 CNY, compared to 379,422,645.53 CNY in Q1 2021, reflecting a substantial decrease[19] Cash Flow - The net cash flow from operating activities was RMB 570,432,127.10, an increase of 42.75% compared to the previous year[5] - Cash flow from operating activities in Q1 2022 was 1,544,045,956.19 CNY, slightly down from 1,572,798,247.65 CNY in Q1 2021[20] - The net cash flow from operating activities for Q1 2022 was 570,432,127.10 CNY, compared to 399,613,641.51 CNY in Q1 2021, showing an improvement[20] - The net cash flow from investing activities for Q1 2022 was -175,320,677.30 CNY, compared to -489,544,165.73 CNY in Q1 2021, indicating reduced cash outflow[20] - The net cash flow from financing activities for Q1 2022 was 357,189,314.87 CNY, compared to -18,839,104.49 CNY in Q1 2021, showing a positive shift[20] - The cash and cash equivalents at the end of Q1 2022 amounted to 4,258,353,489.75 CNY, up from 3,282,286,048.21 CNY at the end of Q1 2021[21] - The company received 380,000,000.00 CNY from investments in Q1 2022, marking a significant inflow compared to the previous year[20] Research and Development - Research and development expenses totaled RMB 510,912,040.65, accounting for 81.16% of revenue, which is an increase of 53.26 percentage points year-over-year[6] - R&D expenses increased to ¥510,912,040.65 in Q1 2022, compared to ¥450,649,443.76 in Q1 2021, reflecting a growth of 13%[18] Assets and Liabilities - The total assets at the end of the reporting period were RMB 10,953,222,268.79, a slight decrease of 0.74% from the end of the previous year[6] - Total assets as of Q1 2022 were ¥10,953,222,268.79, slightly down from ¥11,034,911,100.95 at the end of the previous period[17] - Total liabilities amounted to ¥2,651,629,271.81 in Q1 2022, compared to ¥2,718,536,814.27 in the previous period[16] - The company reported a decrease in total equity to ¥8,301,592,996.98 from ¥8,316,374,286.68[16] Shareholder Information - The total number of ordinary shareholders at the end of the reporting period was 33,735, with HKSCC NOMINEES LIMITED holding 24.08% of shares[10] Other Income - The company reported non-operating income of RMB 33,187,838.62, primarily from non-current asset disposal gains and government subsidies[7] - The company reported a decrease in other comprehensive income, with a net amount of -50,581,534.74 CNY for Q1 2022, compared to 2,101,658.95 CNY in Q1 2021[19] Inventory and Receivables - Accounts receivable decreased to ¥352,440,767.40 from ¥1,293,122,136.21, indicating a significant reduction of 73%[15] - Inventory increased to ¥509,224,927.05 from ¥484,601,367.48, showing a growth of 5%[15]

Financial Performance - For the year ended December 31, 2021, the total revenue of the group reached RMB 4,025 million, an increase of 152% compared to 2020[9]. - Revenue for the year ended December 31, 2021, reached RMB 4,024.84 million, a significant increase from RMB 1,594.90 million in 2020, representing a growth of approximately 152.3%[27]. - Gross profit for the same period was RMB 2,766.65 million, up from RMB 1,222.37 million in 2020, indicating a growth of about 126.4%[27]. - The company reported a net loss from continuing operations of RMB 728.18 million for 2021, compared to a loss of RMB 1,665.64 million in 2020, showing an improvement of about 56.3%[27]. - The total comprehensive expenses for the year were RMB 718.58 million, a decrease from RMB 1,687.57 million in 2020, reflecting a reduction of approximately 57.4%[27]. - The total adjusted comprehensive expenses for the year ended December 31, 2021, amounted to RMB (485,888) thousand, a significant decrease from RMB (1,644,065) thousand in 2020, reflecting a reduction of approximately 70.5%[156]. - The company achieved sales revenue of RMB 412 million for the drug Tuoyi® in 2021, despite a price drop of over 60% compared to the initial pricing in 2020[20]. Research and Development - Research and development expenses totaled RMB 2,069 million, a 16% increase from 2020, primarily due to expanded R&D investments and team growth[9]. - The company has developed a range of innovative therapies across five major therapeutic areas, including malignant tumors and autoimmune diseases[10]. - The company has expanded its R&D capabilities to include small molecules, peptide drugs, and nucleic acid drugs, among others[10]. - The company has advanced over ten innovative drugs from preclinical development to clinical trial stages, including potential first-in-class candidates like IL-21 and CD112R (PVRIG)[37]. - The company is actively pursuing research and development projects across various disease areas, including oncology and autoimmune diseases[74]. - The company has established a pipeline of over 51 products across five major therapeutic areas, including monoclonal antibodies, small molecule drugs, antibody-drug conjugates (ADCs), bispecific fusion proteins, and cell therapies[37]. Clinical Trials and Approvals - Three products are in the commercialization stage, while 23 products are in clinical trials, including four in Phase III trials[10]. - The company has received IND approvals for several new products, including JS110 and JS111, which target specific mutations in cancer treatment[12]. - The company has initiated a Phase III clinical study (JUPITER-15) for Tuoyi® as an adjuvant treatment for gastric or gastroesophageal junction adenocarcinoma, with the first patient dosed in February 2022[25]. - The company is conducting an international multi-center, randomized, double-blind Phase III clinical study to evaluate the efficacy and safety of VV116 for moderate to severe COVID-19 patients[19]. - The company has initiated a Phase II/III clinical study for VV116 targeting mild to moderate COVID-19 patients, with the first patient dosed in Shanghai[19]. - Tuoyi® has been recognized with several designations from the FDA, including priority review and orphan drug status, enhancing its market competitiveness[50]. - The company has received approval for the drug Junmai Kang® (Adalimumab) for the treatment of rheumatoid arthritis, ankylosing spondylitis, and psoriasis in March 2022[25]. Collaborations and Partnerships - The company signed an exclusive licensing and commercialization agreement with Coherus, potentially worth up to $1.11 billion, including a $150 million upfront payment[10]. - In January 2022, Coherus exercised an option to develop TAB006/JS006, resulting in a one-time payment of $35 million and potential milestone payments up to $255 million, plus an 18% sales share on net sales in Coherus' region[26]. - The company has entered into a partnership with Jiangsu Chia Tai Tianqing Pharmaceutical to develop a joint venture focused on mRNA technology for various diseases, with both parties holding 50% ownership[20]. - The company signed a strategic collaboration with Coherus for the development and commercialization of its proprietary drug, with potential total payments up to $1.11 billion, including a $150 million upfront payment[60]. Market and Sales Strategy - The company is focused on global expansion while maintaining a strong foundation in the Chinese market[10]. - The company is optimistic about achieving over 50% market share in newly diagnosed patients for the indications included in the national medical insurance catalog[21]. - The company aims to achieve over 50% market share in newly diagnosed patients for indications included in the National Medical Insurance Catalogue[82]. - The commercialization team experienced significant instability in 2021, affecting execution and market activity effectiveness[79]. Financial Position and Capital Management - The net cash inflow from financing activities was RMB 2,666 million, mainly from the successful placement of new H shares and capital increase from a subsidiary[9]. - The company completed a placement of 36,549,200 new H-shares at a price of HKD 70.18 per share, generating a net cash inflow of approximately RMB 2,105 million, intended for drug research and pipeline expansion[21]. - The company plans to issue up to 70 million A-shares to raise a total of no more than RMB 3.98 billion, aimed at supporting R&D and production facility expansion[69]. - The company has approximately RMB 3,505 million in cash and cash equivalents as of the end of the reporting period, providing strong support for R&D and clinical trial needs[69]. - The company has a secured loan of RMB 500 million with a fixed interest rate of 3.90%, maturing on July 28, 2028, to support ongoing clinical trials and the construction of the Wujiang production base[188]. Employee and Organizational Development - The workforce has expanded to 2,805 employees, with 896 in drug R&D, 846 in product commercialization, and 742 in production, emphasizing the importance of talent retention and development[65]. - The company has established a performance management system to differentiate high and low performers, fostering a positive cycle for organizational performance[65]. - The company granted 7,129,000 restricted shares to eligible employees under the 2020 A-share restricted stock incentive plan during the reporting period[200].

Financial Performance - For the period ending June 30, 2021, the total revenue reached RMB 2,114 million, representing a 268% increase compared to the same period in 2020, primarily driven by growth in licensing income[12]. - The company reported a profit of RMB 11 million, a turnaround from a loss of RMB 598 million in the same period of 2020, attributed to a significant revenue increase from RMB 575 million to RMB 2,114 million[12]. - The company achieved a net profit of RMB 10,533 thousand for the six months ended June 30, 2021, a significant turnaround from a net loss of RMB 597,899 thousand in the same period of 2020, marking a 102% improvement[22]. - The adjusted total comprehensive income (expenses) for the period was RMB 97,527 thousand, compared to a loss of RMB 588,765 thousand in the same period of 2020[98]. - The company reported a basic loss per share of RMB 0.01 for the six months ended June 30, 2021, compared to a loss of RMB 0.76 for the same period in 2020[100]. - The company reported a total comprehensive loss of RMB 4,210 thousand for the period, a significant improvement from a loss of RMB 593,273 thousand in the previous year[196]. Research and Development - Research and development expenses totaled RMB 947 million, a 34% increase year-over-year, due to increased investment in independent R&D and expansion of the R&D pipeline[12]. - The company has expanded its innovative R&D to include small molecules, peptides, antibody-drug conjugates (ADCs), and nucleic acid drugs, covering five major therapeutic areas[13]. - The company’s innovative R&D has expanded from monoclonal antibodies to include small molecule drugs, peptide drugs, antibody-drug conjugates (ADCs), and nucleic acid drugs, covering five major therapeutic areas[42]. - The company has developed a robust pipeline of innovative drugs, including small molecules and antibody-drug conjugates, targeting cancer and autoimmune diseases[25]. - The R&D pipeline includes drugs targeting various diseases, including cancer, autoimmune diseases, and metabolic disorders, showcasing a diverse therapeutic focus[46]. - R&D expenses for the reporting period amounted to RMB 947 million, a 34% increase compared to the same period in 2020, driven by the expansion of the product pipeline and the acceleration of clinical projects[161]. Product Development and Commercialization - Two products are in the commercialization stage, while one product is in the new drug application stage, and 16 products are in clinical trials, with three in Phase III trials[13]. - The product Tuoyi® (Tremelimumab) received Fast Track Designation from the FDA for the treatment of mucosal melanoma and has been approved for a Phase III clinical trial[13]. - The company signed an exclusive licensing and commercialization agreement with Coherus BioSciences, Inc., granting Coherus exclusive rights for Tuoyi® (Tremelimumab) in the U.S. and Canada, with potential payments totaling up to $1.11 billion, including a $150 million upfront payment[15]. - The company received conditional approval from NMPA for Tuoyi® (Tremelimumab) in combination with chemotherapy for advanced or metastatic esophageal squamous cell carcinoma[18]. - The core product, Toripalimab (JS001), is the first domestically approved anti-PD-1 monoclonal antibody in China, with multiple indications for advanced melanoma and nasopharyngeal carcinoma[25]. - The company has accelerated clinical trials for Toripalimab across more than 30 studies covering over 15 indications in China and internationally, with significant progress in perioperative treatments for various cancers[31]. Financial Position and Cash Flow - Net cash generated from operating activities was RMB 48 million, mainly due to cash received from revenue growth[12]. - Net cash from financing activities amounted to RMB 2,028 million, primarily due to the successful placement of new H-shares, raising approximately RMB 2,106 million[12]. - As of the reporting period, the company had cash and cash equivalents of approximately RMB 4,269 million, providing strong support for R&D and production facility expansion[41]. - The company’s total assets increased by 25% to RMB 10,042,191 thousand as of June 30, 2021, compared to RMB 8,010,864 thousand at the end of 2020[23]. - The company’s non-current assets rose by 34% to RMB 4,442,796 thousand from RMB 3,312,147 thousand at the end of 2020[23]. - As of June 30, 2021, cash and bank balances increased to RMB 4,269 million from RMB 3,385 million as of December 31, 2020, primarily due to fundraising activities and revenue growth[97]. Market and Competitive Landscape - The company continues to explore innovative therapies and expand its product pipeline to enhance its competitive position in the domestic PD-1 market[29]. - The company is facing intense market competition in terms of market share, promotion, and distribution for its products, particularly in the anti-PD-1 segment[164]. - The company is actively expanding its product pipeline across multiple disease treatment areas and will maintain significant R&D investments for preclinical research and global clinical trials[161]. - The company faces risks related to long profit cycles in the biopharmaceutical industry, with profitability dependent on the progress of drug approvals and sales post-launch[161]. - The company is committed to strategic research to mitigate risks associated with new drug development, including regular evaluations of ongoing projects[164]. Shareholder and Equity Information - As of June 30, 2021, the company had a total of 910,756,700 issued shares, including 691,461,000 A shares and 219,295,700 H shares[141]. - Major shareholder 熊鳳祥 directly holds 41,060,000 A shares, representing 5.94% of the total share capital[153]. - The combined holdings of the concerted action parties amount to 155,310,736 A shares, which is 22.46% of the total share capital[153]. - The company’s equity structure shows a diverse range of stakeholders, including institutional investors and individual shareholders[152]. - The company has a significant presence in the H share market, with multiple controlled entities holding substantial stakes[157]. Regulatory and Compliance - The company has received NMPA approval for several products and has submitted BLA to the FDA, indicating progress in regulatory approvals[43]. - The company has adopted high standards of corporate governance, with a board consisting of five executive directors, four non-executive directors, and five independent non-executive directors[176]. - The company has confirmed compliance with the securities trading standards for directors and supervisors during the reporting period[177]. - The company plans to adapt its operations to regulatory changes to mitigate potential policy risks[166].

Financial Performance - The company achieved operating revenue of RMB 2.114 billion in the first half of 2021, with a net profit attributable to shareholders of RMB 0.09 billion[4]. - The company's operating revenue for the first half of 2021 reached approximately CNY 2.11 billion, representing a significant increase of 267.77% compared to the same period last year[16]. - The net profit attributable to shareholders was CNY 9.35 million, a substantial improvement from a net loss of CNY 599.53 million in the previous year[16]. - The net cash flow from operating activities increased to CNY 45.62 million, compared to a negative cash flow of CNY 518.30 million in the same period last year[16]. - The company reported non-operating income of CNY 122.68 million, primarily from government subsidies and other income sources[20]. - The company reported a total comprehensive income for the first half of 2021 of CNY -5,396,524.54, which includes a net profit of CNY 9,346,950.67[196]. Research and Development - R&D expenses amounted to RMB 0.947 billion, representing a year-on-year increase of 33.62% as the company expanded its product pipeline and accelerated clinical projects[4]. - The company plans to maintain significant R&D investments for ongoing clinical trials and new drug preparations, which may lead to further short-term losses[4]. - Research and development expenses accounted for 44.80% of operating revenue, a decrease of 78.50 percentage points from the previous year[17]. - The company has developed a comprehensive drug pipeline, including first-in-class and best-in-class drugs, with core products such as the PD-1 monoclonal antibody, Trelipilumab, which is the first domestically approved product in China[22]. - The company has established three major R&D centers in the US and China, significantly improving R&D efficiency and reducing costs[72]. - The company has a diverse pipeline of 25 products in preclinical development and 16 products in clinical trials, with 2 products in the commercialization stage and 1 product in the new drug application stage[27]. Clinical Trials and Product Development - The clinical trial pipeline includes multiple drugs at various stages, with Trelipilumab having received NMPA approval for several indications and ongoing clinical trials in China[25]. - The company has multiple ongoing clinical trials, including Phase III studies for various cancers, which are crucial for future product approvals and market expansion[27][29]. - The company is actively collaborating with domestic research institutions to develop COVID-19 neutralizing antibodies, contributing to disease prevention efforts[22]. - The company has received breakthrough therapy designation from the FDA for Toripalimab in the treatment of recurrent or metastatic nasopharyngeal carcinoma, which is expected to expedite the approval process[33]. - The company has received emergency use authorization for its JS110 monoclonal antibody therapy in the U.S., highlighting its innovative capabilities[78]. Market Expansion and Commercialization - The company plans to continue expanding its market presence and investing in new technologies and product development[18]. - The company has established a commercial collaboration with AstraZeneca for the exclusive promotion rights of Toripalimab in non-core cities, aiming to expand its market reach[28]. - The company is actively working on technology transfer for Toripalimab at the Shanghai Lingang production base, which will enhance its competitive production costs[101]. - The company has established commercial collaboration with AstraZeneca for Tuo Yi® in the urological oncology field, expanding its market reach[92]. - The company aims to strategically expand into key grassroots markets while considering price pressures and market layout[71]. Financial Position and Investments - Total assets grew by approximately CNY 2.03 billion, reflecting a 25.38% increase from the end of the previous year[18]. - The net assets attributable to shareholders increased to CNY 8.04 billion, marking a 38.04% rise compared to the previous year[16]. - The company raised approximately RMB 2.106 billion through the issuance of 36,549,200 new H shares at HKD 70.18 per share to enhance R&D and business development[99]. - The company’s cash and cash equivalents stood at approximately RMB 4.269 billion, providing strong support for R&D and clinical trial needs[99]. - The total investment in key projects reached CNY 719,237.17 million, with CNY 76,457.24 million invested in the current period and a cumulative investment of CNY 394,374.94 million[84]. Environmental and Safety Compliance - The company generated 9.6 million tons of wastewater in the first half of 2021, with no exceedances in pollutant discharge limits[124]. - The company’s nitrogen oxides emissions were 0.57 tons, well below the limit of 50 mg/m³[124]. - The company has established a dedicated environmental health and safety department to manage pollutant emissions effectively[127]. - The company has committed to reducing carbon emissions, although specific measures and effects were not disclosed in the report[134]. - The company has established an environmental monitoring plan for 2021, ensuring that all monitored pollutants meet the discharge standards[130]. Shareholder and Governance - The company has a commitment period of 36 months from the date of its A-share listing, during which certain share transfer restrictions apply[137]. - The company reported a lock-up period of 12 months for shareholders post-IPO, during which no shares can be transferred or managed by others[138]. - The company emphasizes compliance with legal regulations regarding shareholding and transfer for directors and senior management[140]. - The company has committed to maintaining transparency in reporting shareholdings and any changes therein[140]. - The company confirmed that there are no significant related party transactions that affect its independence or fairness during the reporting period[156].

Financial Performance - Net profit attributable to shareholders reached CNY 377,321,280.11, a significant turnaround from a loss of CNY 229,358,722.62 in the same period last year[5] - Operating revenue surged by 838.81% to CNY 1,615,115,584.67, compared to CNY 172,039,232.78 in the previous year[5] - Basic and diluted earnings per share were CNY 0.43, compared to a loss of CNY -0.29 in the same period last year[5] - Net profit for Q1 2021 was ¥377,320,986.58, compared to a net loss of ¥229,359,114.54 in Q1 2020, indicating a turnaround in profitability[20] - The total comprehensive income for Q1 2021 was approximately ¥648 million, contrasting with a total comprehensive loss of ¥190 million in Q1 2020[22] Cash Flow - Net cash flow from operating activities was CNY 399,613,641.51, a recovery from a negative cash flow of CNY -353,500,138.36 in the same period last year[5] - The company reported a net cash flow from operating activities of approximately ¥400 million in Q1 2021, compared to a negative cash flow of ¥354 million in Q1 2020[23] - Total cash inflow from operating activities reached ¥1,723,618,457.21, while cash outflow was ¥1,061,995,803.38, resulting in a net cash inflow of ¥661,622,653.83[25] Assets and Liabilities - Total assets increased by 6.94% to CNY 8,552,401,128.61 compared to the end of the previous year[5] - Total assets as of March 31, 2021, amounted to ¥8,552,401,128.61, up from ¥7,997,409,506.14 at the end of 2020[17] - Total liabilities as of March 31, 2021, were ¥1,490,203,703.39, up from ¥1,183,603,327.38 at the end of 2020, representing an increase of about 26%[19] Research and Development - R&D expenditure as a percentage of operating revenue decreased by 98.41 percentage points to 27.90% from 126.31% in the previous year[5] - R&D expenses rose to ¥450,649,443.76, a 107.38% increase from ¥217,301,553.90, attributed to the expansion of the R&D pipeline and collaborative projects[13] - Research and development expenses for Q1 2021 amounted to approximately ¥290 million, up from ¥183 million in Q1 2020, reflecting a year-over-year increase of about 59%[22] Shareholder Information - The total number of shareholders at the end of the reporting period was 26,672[8] - The top shareholder, HKSCC NOMINEES LIMITED, held 20.94% of the shares[8] Government Subsidies and Other Income - The company reported a government subsidy of CNY 23,159,002.63 related to its normal business operations[7] - Other income surged to ¥22,477,472.48, a 5,971.57% increase from ¥370,208.48, mainly due to new government subsidies[13] - The company reported other income of ¥22,477,472.48 in Q1 2021, compared to ¥370,208.48 in Q1 2020, indicating a substantial increase[20]

Financial Performance - For the year ended December 31, 2020, the total revenue reached RMB 1,595 million, representing a 106% increase compared to 2019[9]. - Revenue for 2020 reached RMB 1,594.9 million, a significant increase from RMB 775.1 million in 2019, representing a growth of approximately 105%[26]. - The company reported a net loss of RMB 1,668.6 million for 2020, compared to a net loss of RMB 747.7 million in 2019, indicating a worsening financial performance[26]. - The gross profit for 2020 was RMB 1,214.6 million, up from RMB 677.1 million in 2019, reflecting a gross margin improvement[26]. - Total comprehensive expenses for the period were RMB 1,688 million, a 128% increase from 2019, due to rising R&D and administrative expenses[9]. - The adjusted total comprehensive expenses for the year ended December 31, 2020, amounted to RMB (1,644,065) thousand, compared to RMB (699,221) thousand in 2019[88]. - The basic loss per share attributable to the owners of the company was RMB (1,665,639) thousand for the year ended December 31, 2020, compared to RMB (743,922) thousand in 2019[90]. - Cash and cash equivalents grew to RMB 3,385 million as of December 31, 2020, up from RMB 1,214 million at the end of 2019, mainly due to funds raised from the A-share listing and increased sales revenue[85]. Research and Development - R&D expenses totaled RMB 1,778 million, an increase of 88% from 2019, driven by significant progress in key clinical trials and preclinical research[9]. - The company is expanding its R&D pipeline to include small molecule drugs, antibody-drug conjugates (ADCs), bispecific fusion proteins, and cell therapies[9]. - The company has 30 products in the pipeline, including 28 innovative drugs and 2 biosimilars, covering five major therapeutic areas: malignant tumors, autoimmune diseases, chronic metabolic diseases, neurological diseases, and infectious diseases[10]. - The company has initiated clinical trials for several new products, including JS004 and JS006, which are progressing simultaneously in China and the US[30]. - The company has received NMPA approval for multiple clinical trials, including TAB004/JS004 and JS108, indicating progress in its clinical development pipeline[10]. - The company is advancing multiple research and development projects across various disease areas, including solid tumors and metabolic diseases[48]. - The company has several drug candidates in the pipeline, including JS009, JS011, and JS012, targeting various mechanisms such as CD112R/PVRIG and IL-21[48]. - The company is focusing on expanding its market presence in China and the United States, with specific strategies for market penetration[47]. Product Development and Commercialization - Tuoyi® was successfully included in the new National Medical Insurance catalog, enhancing affordability and accessibility for domestic patients[9]. - Tuoyi® received conditional approval for a new indication for the treatment of recurrent/metastatic nasopharyngeal carcinoma patients who failed second-line or higher systemic therapy[9]. - The company has accelerated clinical trial progress for Tuoyi® in China and overseas, covering over 15 indications across more than 30 clinical studies[9]. - The commercialization team expanded to over 900 employees, increasing product penetration to nearly 1,500 hospitals and over 1,100 pharmacies across almost 300 cities by December 31, 2020[35]. - The company aims to enhance the brand presence of Tuoyi® and expand its market coverage in hospitals and pharmacies across different city tiers in China[51]. - The company has initiated a collaboration with Eli Lilly for the development and commercialization of potential therapeutic antibodies for COVID-19, with etesevimab being a key focus[13]. - The company has signed a collaboration and licensing agreement with Revitope to develop next-generation T cell engagers for tumor immunotherapy[40]. - The company is exploring potential mergers and acquisitions to enhance its product portfolio and market presence, with a focus on biotech firms[150]. Strategic Collaborations and Partnerships - The company has formed strategic collaborations with AstraZeneca and Coherus to enhance commercialization efforts in both domestic and international markets[32]. - A licensing agreement with Eli Lilly for etesevimab grants exclusive rights outside Greater China, with an upfront payment of $10 million and potential milestone payments up to $245 million[37]. - The company is collaborating with Microenvironment Biotech for the global development and commercialization of four anti-tumor small molecule drugs[40]. - The company has established a joint venture with Beijing Enrini in September 2020 to develop CD39 drugs, with both parties holding 50% equity[74]. Market and Financial Outlook - The global biopharmaceutical market is expected to grow to USD 402.1 billion by 2023, with a compound annual growth rate (CAGR) of 9.0% from 2018 to 2023[121]. - Future outlook includes a projected revenue growth of 15% for the next fiscal year, driven by new product launches and market expansion strategies[150]. - The company plans to increase R&D investment to accelerate the clinical trial and market entry of innovative drugs[126]. - The company aims to expand production capacity while ensuring drug quality and reducing unit costs to cope with potential price reductions[126]. Corporate Governance - The company has complied with all applicable principles and code provisions of the Corporate Governance Code during the reporting period ending December 31, 2020[169]. - The board consists of 15 members, including 5 executive directors, 5 non-executive directors, and 5 independent non-executive directors[173]. - The company has established appropriate liability insurance for directors and senior management against legal actions arising from company activities[181]. - The board meets at least four times a year, ensuring active participation from the majority of directors[174]. - The company has adopted a board diversity policy to support sustainable and balanced development, emphasizing the importance of diversity in achieving strategic goals[193].