Financial Performance - The company's operating revenue for Q1 2022 was ¥43,725,271.60, with a net profit attributable to shareholders of ¥-119,438,902.55[6] - Total revenue for Q1 2022 was CNY 43,725,271.60, with no revenue reported in Q1 2021[31] - The net loss attributable to shareholders of the parent company was CNY -119,438,902.55 in Q1 2022, compared to CNY -79,712,996.47 in Q1 2021[34] - The total comprehensive loss for Q1 2022 was CNY -127,603,412.22, compared to CNY -83,954,230.10 in Q1 2021[34] - The net loss for Q1 2022 was -¥107,906,643.71, compared to a net loss of -¥76,407,616.71 in Q1 2021, indicating a worsening financial position[49] Research and Development - R&D investment totaled ¥121,273,151.53, representing an increase of 44.61% year-on-year, accounting for 277.35% of operating revenue[9] - The company has multiple innovative drugs in critical clinical trial phases, indicating ongoing R&D progress[15] - Research and development expenses for Q1 2022 reached ¥107,446,596.38, up from ¥76,021,890.21 in Q1 2021, reflecting a year-over-year increase of approximately 41.3%[46] Assets and Liabilities - Total assets at the end of the reporting period were ¥1,689,373,448.41, a decrease of 3.24% from the end of the previous year[9] - Total liabilities increased to CNY 575,848,950.39 in the latest report from CNY 492,879,953.53 in the previous period[30] - The total assets of the company as of the reporting date were ¥1,599,458,149.33, a decrease from ¥1,645,093,055.30 in the previous year[46] - The total equity of the company decreased to ¥1,113,195,301.26 in Q1 2022 from ¥1,210,671,197.63 in Q1 2021, reflecting a decline of approximately 8%[46] Cash Flow - The net cash flow from operating activities was ¥-59,474,079.88, primarily due to increased R&D expenditures and market expansion costs[15] - The net cash flow from operating activities was -¥58,329,306.18, an improvement compared to -¥100,940,312.79 in the same quarter of the previous year[51] - Cash inflows from financing activities reached ¥121,000,000.00, compared to ¥30,300,000.00 in Q1 2021[53] - The ending balance of cash and cash equivalents was 1,121,674,220.87 CNY, down from 1,348,932,752.79 CNY year-over-year[41] Shareholder Information - The top shareholder, ZELIN SHENG, holds 20.80% of the shares, with a total of 49,909,607 shares[16] - The equity attributable to shareholders decreased by 10.62% to ¥1,068,822,286.40 compared to the end of the previous year[9] Inventory and Receivables - The company's inventory increased to CNY 64,180,122.89, up 23.6% from CNY 51,910,985.84[26] - The company reported accounts receivable of CNY 8,766,276.39, down significantly from CNY 62,370,697.78, indicating a decrease of 86.0%[22] Market Development - The company is in the early stages of commercialization, requiring significant investment in market development and academic promotion[15] - The company successfully launched a new drug, Tofacitinib, which was approved for sale in June 2021 and included in the National Medical Insurance Directory effective January 1, 2022[21]

Financial Performance - As of December 31, 2021, the company has not yet achieved profitability and has accumulated losses due to significant R&D expenditures and market expansion costs for its approved product, Donafenib Tablets[5]. - The company raised a net amount of RMB 1,908.22 million during its IPO in January 2020, but still relies heavily on external financing for its working capital[5]. - The company does not plan to distribute cash dividends or issue bonus shares for the 2021 fiscal year, as approved by the board[10]. - The company has incurred significant losses and will continue to do so in the near term, impacting its ability to distribute profits to shareholders[5]. - The net profit attributable to shareholders was a loss of CNY 450.99 million in 2021, compared to a loss of CNY 319.23 million in 2020, representing an increase in net loss of 13,176.99 million[36]. - The basic earnings per share were -CNY 1.88 in 2021, compared to -CNY 1.36 in 2020, indicating a worsening financial performance[36]. - The company reported a net cash flow from operating activities of -CNY 454.62 million in 2021, compared to -CNY 343.86 million in 2020[36]. - The company has incurred significant cash outflows since its establishment, with net cash flows from operating activities of -180.43 million, -343.86 million, and -454.62 million in 2019, 2020, and 2021 respectively[159]. - The company’s financial condition may affect employee compensation, impacting talent retention and the ability to achieve R&D and commercialization goals[145]. Research and Development - Future profitability will depend on the number and scope of drug development projects, associated costs, and the ability to generate revenue from approved products[5]. - Research and development expenses amounted to CNY 509.39 million, a 62.13% increase from the previous year, reflecting the company's commitment to enhancing its core competitiveness[36]. - The company has 16 major drugs in development, with 42 key projects, including 8 indications in NDA, Phase III, or registration clinical trial stages[49]. - The company is focused on developing innovative drugs with clear clinical value and has not yet launched any of its new drugs in the domestic or international markets[22]. - The company is actively involved in multiple clinical trials, including Phase I/II studies for various drug candidates targeting different cancers[108]. - The company has established a comprehensive new drug R&D system, covering all stages from early discovery to late development, with international-level patent candidates in various clinical trial phases[136]. - The company has developed a leading drug stability technology that ensures a high success rate in new drug development[97]. - The company has applied for a total of 205 invention patents globally, with 96 patents granted, including 28 in China and 68 overseas[109]. - The company is developing innovative drugs, including ZG5266, which is undergoing non-clinical pharmacokinetic studies[108]. - The company is expanding its research capabilities with the establishment of a U.S. R&D center, enhancing its international presence[108]. Product Development and Pipeline - The company has received approval for Donafenib Tablets for first-line treatment of advanced liver cancer as of June 2021[5]. - The company has developed a first-class new drug, Donafenib, which is approved for the treatment of unresectable hepatocellular carcinoma and is marketed under the name "Zepzelca®" in China[22]. - The company is conducting clinical trials for its core product, recombinant human thrombin, marketed as "Zepthrombin®"[22]. - The company is developing a first-class new drug, ALK or ROS1 inhibitor, marketed as "Zepcitinib®"[22]. - The company is focused on expanding its product pipeline with innovative therapies targeting various cancers and autoimmune diseases[69]. - The company aims to accelerate the market launch of its products through ongoing clinical trials and regulatory communications[70]. - The company has successfully initiated Phase III clinical trials for several drugs, including Jackatinib for severe alopecia areata and recombinant human thrombin for surgical hemostasis[49]. - The company has established strategic collaborations for combination therapies involving its products, enhancing the potential for improved efficacy[68]. - The company has multiple small molecule new drugs at different stages of research and development, with several products already on the market[97]. Market and Competitive Landscape - The company faces potential risks related to ongoing R&D, including the possibility of not completing clinical trials or obtaining regulatory approvals for its pipeline products[5]. - The company faces intense competition in the pharmaceutical market, particularly for its drug Donafenib, which has been approved for commercialization but competes with imported original drugs and generics[158]. - The oncology drug market in China is driven by an increasing number of cancer patients, with 4.57 million new cases reported in 2020, expected to rise to 5.2 million by 2025, leading to growing demand for oncology drugs[93]. - The company is exposed to risks from changes in the regulatory environment and market rules due to ongoing healthcare reforms in China[162]. - The company may encounter challenges in international markets due to varying legal and operational environments, which could hinder its revenue growth potential[164]. Strategic Initiatives - The company is planning a refinancing initiative to enhance its R&D capabilities and accelerate the development of its drug pipeline[49]. - The company is committed to maintaining high standards in clinical trials and manufacturing practices, adhering to GCP and GMP guidelines[22]. - The company has established three R&D centers in Jiangsu, Shanghai, and California, focusing on biological new drugs, chemical new drugs, and innovative antibodies[77]. - The company is actively pursuing international development of its products to enhance global competitiveness and collaboration opportunities[137]. - The company has built GMP production facilities for both small molecule drugs and biological new drugs, ensuring flexible production capabilities and cost control advantages[140]. Risks and Challenges - The company faces risks of substantial declines in sales revenue due to ongoing losses and the need for continuous investment in R&D[146]. - There is uncertainty regarding the pricing of the company's drugs post-launch, which may affect sales volume and profitability[147]. - Clinical trial progress may not meet expectations due to challenges in patient recruitment and collaboration with clinical trial institutions[152]. - The company may face significant adverse impacts if clinical trial results do not meet expectations, potentially hindering business operations[151]. - The company’s ability to commercialize its drugs is contingent upon successful regulatory approvals and market acceptance[146]. - The company faces risks related to patent disputes and reliance on key technical personnel, which could impact its R&D and commercialization goals[169]. Revenue and Sales - The company achieved a significant increase in revenue, reaching CNY 1,903.61 million in 2021, up 588.19% from CNY 276.61 million in 2020[36]. - The company’s revenue from pharmaceutical manufacturing reached ¥190,360,565.54, with a year-on-year increase of 588.19%[179]. - The sales revenue from pharmaceuticals was CNY 163.17 million, while the revenue from technology licensing for antibody products was CNY 25.82 million[170]. - The total cost of sales was ¥6,268,583.43, with direct materials constituting 68.25% of total costs[183]. - The company reported a significant change in revenue structure due to the launch of its first Class 1 new drug, leading to a notable shift in gross margin levels[185].

Revenue and Profitability - The company's operating revenue for Q3 2021 was ¥56,169,069.51, representing a year-over-year increase of 100.76%[7] - Year-to-date revenue reached ¥98,578,591.59, showing a significant increase of 252.34% compared to the same period last year[7] - The net profit attributable to shareholders was -¥115,702,656.87 for the quarter, with a year-to-date net profit of -¥292,672,771.57[7] - Total operating revenue for the first three quarters of 2021 reached ¥98,578,591.59, a significant increase from ¥27,978,335.84 in the same period of 2020, representing a growth of approximately 253%[38] - The net loss attributable to shareholders for the third quarter of 2021 was ¥292,672,771.57, compared to a loss of ¥228,372,245.34 in the same quarter of 2020[41] - The company reported a total profit loss of ¥310,845,579.98 for the third quarter of 2021, compared to a loss of ¥203,726,480.07 in the same quarter of 2020[41] Research and Development - Research and development (R&D) expenses totaled ¥139,571,000.92 for the quarter, an increase of 50.59% year-over-year[11] - R&D expenses accounted for 248.48% of operating revenue in Q3 2021, a decrease of 82.78 percentage points compared to the previous year[11] - Research and development expenses for the first three quarters of 2021 were ¥337,082,287.48, up from ¥222,024,375.43 in 2020, reflecting a growth of approximately 52%[38] Assets and Liabilities - Total assets at the end of the reporting period were ¥1,851,624,622.40, down 6.02% from the previous year[11] - The total current assets decreased to ¥1,527,201,808.79 from ¥1,669,567,723.00 in the previous year[33] - The company's inventory increased significantly to ¥48,798,341.42 from ¥23,137,763.14 year-over-year[33] - The total liabilities as of the reporting date were ¥446,064,017.62, an increase from ¥278,692,214.57 in the previous year, representing a growth of about 60%[36] - The total equity attributable to shareholders decreased to ¥1,347,663,760.81 from ¥1,617,725,382.28 year-over-year, indicating a decline of approximately 17%[38] - The total non-current liabilities increased to ¥164,922,851.45 from ¥137,815,096.70, reflecting a growth of approximately 20%[36] Cash Flow - The company reported a net cash flow from operating activities of -¥328,639,988.58 year-to-date[11] - Cash inflows from operating activities totaled 119,775,624.60 CNY, a substantial increase from 45,525,184.59 CNY year-over-year[48] - Cash outflows from operating activities amounted to 448,415,613.18 CNY, compared to 269,056,510.32 CNY in the previous year, leading to a net cash flow from operating activities of -328,639,988.58 CNY[48] - The net cash flow from investment activities was 243,336,370.65 CNY, a significant recovery from -543,158,534.96 CNY in the previous year[48] - The net cash flow from financing activities was 91,688,238.96 CNY, compared to 1,859,065,393.34 CNY in the same period last year, indicating a decrease in financing activities[50] Shareholder Information - Total number of common shareholders at the end of the reporting period is 9,754, with the largest shareholder Zelin Sheng holding 49,636,620 shares, representing 20.68%[20] - The top ten shareholders hold a total of 100,000,000 shares, representing a significant portion of the company's equity[20] - The company has no reported related party transactions or agreements among the top shareholders, except for Zelin Sheng and Lu Huiping being identified as acting in concert[28] Other Information - The company began commercial sales of its drugs in June 2021, contributing to the significant increase in revenue[16] - The company has not reported any new product developments or market expansion strategies in the current quarter[29] - The company has implemented new leasing standards effective January 1, 2021, which are not expected to have a significant impact on financial statements[58]

Financial Performance - As of June 30, 2021, the company has not yet achieved profitability and has accumulated losses due to significant expenditures on market expansion and academic promotion for its product Donafenib tablets, which was approved for sale in June 2021 [5]. - The company raised a net amount of RMB 1,908.22 million during its IPO on the STAR Market in January 2020, but still relies heavily on external financing for its working capital [5]. - The company reported a revenue of CNY 42,409,522.08 for the first half of 2021, compared to CNY 0 in the same period last year [29]. - The net loss attributable to shareholders was CNY -176,970,114.70, an increase in loss of CNY 48,355,170.22 year-over-year [32]. - The net loss after deducting non-recurring gains and losses was CNY -196,678,373.38, reflecting an increase in loss of CNY 52,942,698.15 compared to the previous year [33]. - The company's total assets at the end of the reporting period were CNY 1,925,466,235.09, a decrease of 2.27% year-over-year [33]. - The net assets attributable to shareholders decreased by 10.25% year-over-year, amounting to CNY 1,451,951,522.14 [29]. - The weighted average return on net assets was -11.51% for the reporting period [32]. - The company achieved a milestone by generating drug sales revenue for the first time, amounting to 41.2148 million yuan from the sales of Zepubrin® [53]. - The company achieved operating revenue of 42.41 million yuan, with a net loss attributable to shareholders of 17.70 million yuan, an increase in net loss by 4.84 million yuan year-on-year [132]. Research and Development - The company is currently in the product development stage, with substantial R&D expenses, and the future net loss will depend on the number and scope of drug development projects [5]. - Research and development expenses accounted for 465.72% of the revenue during the reporting period [32]. - The company is advancing multiple innovative drug projects that are currently in clinical trial stages, leading to substantial R&D expenditures [33]. - The company has established two core technology platforms for drug development: precision small molecule drug development and complex recombinant protein biopharmaceuticals [44]. - The company has 14 major drugs in development, with 39 ongoing projects, including 4 drugs in NDA or Phase III clinical trials [54]. - The company has three drugs in Phase I or II clinical trials and seven drugs in preclinical development stages [54]. - The company has a core team of 270 R&D personnel, an increase of 65.64% compared to the same period last year [60]. - The company has established a strong commercialization team to support clinical drug supply and new drug market sales [60]. - The company has developed a complete technical system for deuterated drug development, establishing a competitive advantage at an international level [61]. - The company is focusing on both major diseases and rare diseases, aiming to create a differentiated competitive advantage in its product pipeline [64]. Market and Competitive Landscape - The Chinese pharmaceutical market reached ¥1.7 trillion in 2020, driven by an aging population and increased healthcare spending [41]. - The number of new drug registrations in China increased by 26.8% in 2020, indicating a growing focus on innovative drug development [42]. - The competitive landscape in the pharmaceutical market poses risks, as the company must contend with both domestic and international competitors developing similar therapies [126]. Risks and Challenges - The company faces potential risks including the inability to achieve profitability or maintain sustained profitability, which could adversely affect shareholder returns [5]. - The company is exposed to risks from regulatory changes in the pharmaceutical industry, which could impact its operations [130]. - The company faces risks related to ongoing losses and the potential inability to achieve profitability in the near term due to high R&D costs [120]. - The company is facing risks related to rapid expansion, including challenges in team management and internal controls [130]. Environmental and Regulatory Compliance - The company has not experienced any environmental pollution incidents during the reporting period and has not received any administrative penalties related to environmental protection [156]. - The company has obtained the "Pollutant Discharge Permit" in accordance with relevant environmental regulations [156]. - The company has implemented various pollution prevention facilities, including wastewater treatment facilities with a processing capacity of 20 tons per day [162]. - The company has established an emergency response plan for environmental incidents, which was filed with the Kunshan Environmental Protection Bureau [164]. Shareholder Commitments and Lock-up Period - The company has committed to a lock-up period of 36 months for major shareholders, during which they cannot transfer or manage their shares [173]. - In the first three complete fiscal years after the company's stock listing, shareholders cannot transfer their shares until the company achieves profitability [175]. - If the company's stock price falls below the issue price for 20 consecutive trading days within the first six months post-listing, the lock-up period will automatically extend by six months [178]. - After the lock-up period, shareholders can only transfer up to 25% of their shares annually while serving as directors or senior management [179]. - The company has established a commitment to comply with all applicable laws and regulations regarding shareholding and transfer by major shareholders and executives [176].

Financial Performance - Net profit attributable to shareholders of the listed company was -CNY 79,712,996.47, compared to -CNY 62,262,940.60 in the same period last year[18]. - Basic and diluted earnings per share were both -CNY 0.33, compared to -CNY 0.28 in the same period last year[18]. - The company reported no operating revenue for the current period[18]. - The weighted average return on net assets was -5.03%, slightly down from -4.98% in the previous year[18]. - Net loss for Q1 2021 was 83,131,384.17 RMB, compared to a net loss of 65,385,205.55 RMB in Q1 2020, indicating a worsening of approximately 27%[53]. - The company reported an operating profit of -83,956,666.09 RMB for Q1 2021, compared to -66,479,383.97 RMB in Q1 2020, indicating a worsening of approximately 26%[52]. - Total comprehensive loss for Q1 2021 was CNY 76,407,616.71, compared to a loss of CNY 59,341,419.63 in Q1 2020[60]. Assets and Liabilities - Total assets at the end of the reporting period were CNY 1,915,773,589.48, a decrease of 2.77% compared to the end of the previous year[18]. - Total assets at the end of the reporting period amounted to RMB 1,602,462,510.19, a decrease from RMB 1,669,567,723.00 at the end of the previous year[37]. - Total assets decreased to CNY 1,915,773,589.48 from CNY 1,970,281,983.90, a decline of approximately 2.8%[40]. - Current liabilities increased to CNY 163,748,934.85 from CNY 140,877,117.87, representing an increase of about 16.2%[40]. - The company's total liabilities increased to CNY 300,368,161.17 from CNY 278,692,214.57, an increase of about 7.2%[42]. - The total liabilities increased to 317,970,353.39 RMB in the latest report from 297,395,912.49 RMB previously, showing a rise of about 7%[48]. - Total equity decreased to 1,539,373,712.52 RMB from 1,609,846,225.54 RMB, reflecting a decline of approximately 4.3%[48]. - The company's total current assets decreased to CNY 1,540,785,446.12 from CNY 1,606,196,149.75, a decrease of approximately 4.1%[46]. Cash Flow - Net cash flow from operating activities was -CNY 102,692,920.27, compared to -CNY 77,046,755.90 in the same period last year[18]. - The company’s cash flow from investing activities was RMB 302,344,608.78, a significant recovery from -RMB 743,098,354.19 in the previous year[33]. - Cash flow from operating activities showed a net outflow of CNY 102,692,920.27 in Q1 2021, worsening from a net outflow of CNY 77,046,755.90 in Q1 2020[62]. - Cash inflow from investment activities totaled 503,378,643.38 RMB in Q1 2021, a significant increase from 6,274,568.75 RMB in Q1 2020, representing a growth of over 7,900%[66]. - The net cash flow from investment activities was 302,344,608.78 RMB in Q1 2021, compared to -742,997,474.84 RMB in Q1 2020, showing a substantial improvement[66]. Shareholder Information - The total number of shareholders at the end of the reporting period was 10,612[23]. - The largest shareholder, ZELIN SHENG, held 20.68% of the shares, totaling 49,636,620 shares[23]. Research and Development - R&D expenses increased by 38.57% to RMB 83,863,240.72, driven by higher clinical research service costs and growth in R&D personnel[30]. - The company expects to continue incurring losses until the end of the reporting period due to ongoing R&D investments and the establishment of a commercial sales team[32]. - The company is currently awaiting approval for its first new drug application (NDA), with multiple innovative drug projects progressing steadily[32]. Expenses - Sales expenses increased by 182.72% to RMB 11,630,597.38, due to the expansion of the sales team and pre-launch market activities for new drugs[30]. - Operating costs for Q1 2021 were 98,558,109.45 RMB, compared to 73,021,269.57 RMB in Q1 2020, indicating a significant rise in expenses[52]. - Sales expenses for Q1 2021 were CNY 11,977,334.13, significantly higher than CNY 4,200,060.34 in Q1 2020, reflecting an increase of approximately 185%[58]. Financial Position - The company's financial assets decreased by 68.83% to RMB 140,234,107.87, primarily due to changes in bank principal-protected financial products[30]. - Short-term borrowings rose significantly by 172.26% to RMB 48,106,880.18, reflecting increased working capital needs[30]. - The company's long-term borrowings remained stable at CNY 30,033,733.33[40]. - The company's intangible assets decreased to CNY 123,127,354.66 from CNY 129,513,660.91, a decline of about 4.9%[40].

Financial Performance - As of December 31, 2020, the company has not yet achieved profitability and has accumulated losses due to significant R&D expenditures[5] - The company raised a net amount of RMB 1,908.22 million during its IPO on the STAR Market in January 2020[5] - The company does not plan to distribute cash dividends or issue bonus shares for the 2020 fiscal year[7] - The company's operating revenue for 2020 was CNY 27,660,909.30, a significant increase from CNY 1,311,158.07 in 2018[29] - The net loss attributable to shareholders for 2020 was CNY -319,229,251.52, an improvement compared to CNY -461,877,238.60 in 2019[29] - The net cash flow from operating activities was CNY -343,856,869.25 in 2020, compared to CNY -180,427,947.30 in 2019[31] - The total assets at the end of 2020 were CNY 1,970,281,983.90, a 515.20% increase from CNY 320,268,087.69 in 2019[31] - The net assets attributable to shareholders at the end of 2020 were CNY 1,617,725,382.28, a significant increase from CNY 3,426,155.64 in 2019[31] - The basic earnings per share for 2020 was CNY -1.36, an improvement from CNY -2.57 in 2019[32] - The net loss attributable to shareholders after deducting non-recurring gains and losses was CNY -354,674,702.82 in 2020, compared to CNY -271,744,594.58 in 2019[32] - The company reported a significant increase in total assets and net assets due to the funds raised from the public offering of new shares[33] - The company experienced an increase in net loss due to expanded operations, increased R&D investment, and pre-listing expenses[33] - The company has not declared any cash dividends, which may negatively impact shareholder returns[5] - The company achieved revenue of CNY 27.66 million during the reporting period, primarily from licensing income of antibody products and minimal R&D service income, compared to zero revenue in the same period last year[131] - R&D investment increased by 70.91% year-on-year to CNY 314.20 million, reflecting the company's commitment to advancing its product pipeline[133] Research and Development - The company is still in the product development stage and has not received commercial sales approval for any drugs, resulting in no sales revenue[5] - Future losses will depend on the number and scope of drug development projects, associated costs, and the ability to generate revenue from approved products[5] - The R&D expenditure as a percentage of operating revenue was 1,135.89% in 2020, indicating a strong focus on research and development[32] - The company has 13 major drug candidates in its pipeline, with 4 in NDA or Phase III clinical trials[46] - The company has established two core technology platforms for drug development: precision small molecule drugs and complex recombinant protein biologics[46] - The company has a dual-target antibody technology platform under development, which is part of its innovation strategy[103] - The company is developing multiple new drug candidates, including ZG5266 for primary biliary cholangitis and non-alcoholic fatty liver disease, currently in Phase I clinical trial preparation[195] - The company is actively pursuing regulatory approvals for its drug candidates, with a focus on ensuring compliance and addressing feedback from regulatory bodies[196] - The company has established a complete technical system for deuterated drug development, achieving a competitive advantage at an international level[95] - The company has successfully filled domestic gaps in complex recombinant protein drugs, establishing a unique competitive advantage[95] Clinical Trials and Drug Development - The drug Donafenib is currently in the NDA stage, while Jakafi is in Phase III clinical trials for high-risk myelofibrosis[46] - The clinical trial for donafenib in treating advanced colorectal cancer has completed patient enrollment and is currently in the data cleaning and quality control phase [50] - The clinical trial for donafenib in treating iodine-refractory differentiated thyroid cancer has completed enrollment and is in the observation and follow-up phase, with a planned interim analysis upcoming [50] - The clinical trial for the small molecule JAK inhibitor, Jackatinib, in treating high-risk myelofibrosis has shown a 51.9% efficacy rate in reducing spleen volume by ≥35% after 24 weeks, significantly outperforming the historical data of 27% for the imported drug ruxolitinib [51] - Jackatinib has received orphan drug designation from the FDA for the treatment of myelofibrosis and has obtained clinical trial approval from the FDA [53] - The external recombinant human thrombin is currently in phase III clinical trials for the treatment of capillary and small vein bleeding [54] - The injectable recombinant human thyroid-stimulating hormone has shown significant advantages in rapidly elevating TSH levels for diagnostic purposes compared to traditional methods, with a median time of 23 days to reach TSH ≥30 mIU/L [55] - The company is conducting Phase III clinical trials for Donafenib in colorectal cancer and thyroid cancer, both of which have completed clinical trials[111] - The company has ongoing projects for Jackatinib in the treatment of myelofibrosis, currently in Phase III clinical trials[111] - The company has several ongoing clinical trials, including Jackatinib for moderate to severe atopic dermatitis in Phase I/II and recombinant human coagulation factor for dermatitis in Phase III[195] Market and Competitive Landscape - The global pharmaceutical market grew from $1.1 trillion in 2015 to $1.3 trillion in 2019, with projections to reach $1.6 trillion by 2024[72] - The Chinese pharmaceutical market grew from CNY 4.1 trillion in 2015 to CNY 6.5 trillion in 2019, with a projected growth to CNY 2.2 trillion by 2024[74] - The company faces significant competition in the innovative drug development space, with potential risks from rapid technological advancements and competitor breakthroughs[143] - The competitive landscape for innovative drug development is intensifying, necessitating the company to actively engage in global competition and adapt to rapid technological changes[94] - The company is strategically positioning itself for market expansion through new product development and potential acquisitions[195] Risks and Challenges - The company faces potential risks related to the inability to complete clinical trials or obtain regulatory approvals for its drug candidates[5] - The company relies on external financing for its working capital, which may pressure its financial condition if expenses exceed available funding[5] - The company is exposed to regulatory risks due to the high level of oversight in the pharmaceutical industry, which could impact its operations if it fails to adapt to policy changes[149] - The ongoing COVID-19 pandemic poses a risk to the company's operations and could lead to economic stagnation[150] - The company’s future profitability may be affected by high R&D costs and the potential for ongoing losses if drug commercialization does not meet expectations[142] Human Resources and Operations - The core team consists of 221 R&D personnel, a 64.93% increase year-on-year, including 9 new PhDs recruited in 2020[65] - The company has reported a significant increase in R&D personnel from 134 to 221, indicating a focus on expanding its research capabilities[123] - The company has established a marketing and business team with over 10 years of experience in drug marketing, particularly in oncology[65] - The company has built three production workshops compliant with GMP standards, preparing for clinical trial drug production and future commercialization[64] - The company has established standardized operating procedures for procurement, including procurement standards and supplier management, to control costs and improve efficiency[69] Strategic Collaborations and Partnerships - The company has established strategic collaborations with multiple pharmaceutical companies to conduct clinical studies on combination therapies for advanced solid tumors, aiming to expand market opportunities[81] - The company has entered into a strategic cooperation with Shanghai Jikai Gene Technology for the development of innovative antibody drugs targeting three selected innovative targets[98] - The company has established a clinical cooperation system with top clinical experts and well-known medical institutions, ensuring high-quality clinical trial operations[129]

Financial Performance - Operating revenue for the year-to-date period (January to September) was CNY 27,978,335.84, compared to CNY 0 in the same period last year[18] - Net profit attributable to shareholders of the listed company was CNY -228,372,245.34, an improvement from CNY -398,391,627.34 in the previous year[18] - The diluted earnings per share for the current period was CNY -0.98, an improvement from CNY -2.21 in the previous year[20] - The company reported a net loss of approximately CNY 700.70 million as of September 30, 2020, compared to a loss of CNY 472.33 million at the end of 2019[47] - Net loss for Q3 2020 was CNY 80,476,671.23, compared to a net loss of CNY 59,931,920.83 in Q3 2019[59] - The company reported a total loss of CNY 243,267.35 million for the first three quarters of 2020[67] - The net loss for Q3 2020 was CNY 120,182.15 million, compared to a net loss of CNY 53,835.28 million in Q3 2019[67] - Total comprehensive income for Q3 2020 was CNY -120,182.15 million, compared to CNY -53,835.28 million in Q3 2019[69] Assets and Liabilities - Total assets reached CNY 2,002,288,329.36, an increase of 525.19% compared to the end of the previous year[18] - The company's current assets totaled approximately CNY 1.74 billion, compared to CNY 101.82 million at the end of 2019, indicating a growth of approximately 1,608%[41] - The total liabilities decreased to CNY 215.97 million from CNY 246.52 million, a reduction of about 12.3%[47] - The total assets reported were CNY 1,922,612,561.51, a significant increase from CNY 274,491,471.56 in the previous period[56] - Total liabilities decreased from CNY 275,983,846.07 in the previous period to CNY 235,314,842.94[56] Shareholder Equity - Net assets attributable to shareholders of the listed company amounted to CNY 1,705,021,464.01, a significant increase from CNY 3,426,155.64 last year[18] - Owner's equity increased significantly from CNY -1,492,374.51 to CNY 1,687,297,718.57, indicating a recovery in shareholder equity[56] - The equity attributable to shareholders increased significantly to CNY 1.70 billion from CNY 3.43 million, reflecting a growth of over 49,000%[47] Cash Flow - The company reported a net cash flow from operating activities of CNY -223,531,325.73 for the year-to-date period[18] - The net cash flow from operating activities was -223,531,325.73 CNY, compared to -133,388,576.69 CNY in the previous period, indicating a significant increase in cash outflow[72] - Cash flow from operating activities for the first three quarters of 2020 was CNY 27,975.30 million[69] - The ending cash and cash equivalents balance was 1,157,531,560.86 CNY, compared to 60,798,659.47 CNY in the previous period, showing a strong liquidity position[74] Research and Development - Research and development expenses accounted for 793.56% of operating revenue, indicating a strong focus on innovation[21] - Research and development expenses rose to RMB 222,024,375.43, an increase of 81.51% year-over-year, driven by ongoing new drug development projects[33] - Research and development expenses for Q3 2020 amounted to CNY 92,682,091.18, up from CNY 46,613,129.93 in Q3 2019, reflecting a 98.7% increase[56] Shareholder Information - The top ten shareholders held a total of 66.87% of the shares, with Zelin Sheng being the largest shareholder at 20.68%[26] - The total number of shares increased to 240,000,000, reflecting a 33.33% increase due to the initial public offering[32] Government Support - The company received government subsidies amounting to CNY 14,372,294.31 during the year-to-date period[21] Expenses - Sales expenses surged to RMB 20,195,784.13, a 431.21% increase, attributed to the expansion of the sales team and pre-launch marketing activities for new drugs[33] - Total operating costs for Q3 2020 reached CNY 103,707,936.50, compared to CNY 64,566,352.17 in Q3 2019, indicating a significant increase[56] - Management expenses for Q3 2020 were CNY 13,782.38 million, slightly increased from CNY 13,381.36 million in Q3 2019[63] Investment Activities - The company received 2,025,600,000.00 CNY from investment absorption, a notable increase from 20,561.10 CNY previously[74] - The cash outflow for investment activities reached 1,140,916,293.83 CNY, compared to 183,772,315.61 CNY previously, reflecting a major investment push[72]

Financial Performance - The company has not yet achieved profitability and has accumulated losses due to significant R&D expenditures, with no drug sales revenue as of June 30, 2020[5]. - The company reported a net loss attributable to shareholders of approximately ¥128.61 million for the first half of 2020, a decrease in loss of ¥21.25 million compared to the same period last year[27]. - The net profit attributable to shareholders after deducting non-recurring gains and losses was approximately -¥143.74 million, an increase in loss of ¥2.35 million year-on-year[28]. - The company did not achieve any operating revenue during the reporting period[27]. - The basic and diluted earnings per share were both -¥0.56 for the first half of 2020, compared to -¥1.90 in the same period last year[27]. - The company reported a net loss of CNY 128.61 million, with a net loss excluding non-recurring items of CNY 143.74 million, primarily due to increased R&D expenses and project advancements[111]. - The company anticipates continued losses until the next reporting period due to the absence of drug sales[121]. R&D and Product Development - The company is currently in the product development stage and faces risks related to the approval and commercialization of its drug candidates[5]. - The company has several core drug candidates under development, including a first-class new drug for targeted cancer therapy, with no drugs yet approved for commercial sale[16]. - The company is focused on innovative drug development, including small molecule and biologics, to address unmet medical needs[16]. - The company is in the process of clinical trials for multiple innovative drugs, which has resulted in significant R&D expenditures[28]. - The company has ongoing research and development projects for new drugs, with its first new drug currently under registration application approval[28]. - The company has 12 major innovative drugs in the clinical trial stage, focusing on oncology, bleeding and blood diseases, liver and gallbladder diseases, and immune diseases, addressing unmet clinical needs in China[85]. - The company has established two core technology platforms for drug development: precision small molecule drug development and complex recombinant protein biopharmaceuticals, with three small molecule drugs having significant clinical and market value[37]. - The company has six clinical-stage drugs in development, all from its proprietary research platforms, and has received multiple national and provincial-level project grants[55]. - The company is actively seeking new project collaboration opportunities to enrich its product pipeline[91]. Financial Position and Capital - The company raised a net amount of RMB 1,908.22 million during its IPO on the STAR Market in January 2020[6]. - Total assets at the end of the reporting period were approximately ¥2.04 billion, an increase of 536.70% year-on-year[28]. - The net assets attributable to shareholders of the listed company were approximately ¥1.80 billion, an increase of ¥524.45 million year-on-year, primarily due to funds raised from the public offering of new shares[28]. - The company has achieved a 1,594.87% increase in cash due to the successful IPO fundraising, with total assets growing significantly[81]. - Cash and cash equivalents at the end of the period amounted to RMB 1,134,213,988.31, representing 55.62% of total assets, a year-on-year increase of 1,175.94%[117]. - Trading financial assets reached RMB 615,593,945.89, accounting for 30.19% of total assets, with a year-on-year increase of 1,209.77%[117]. Risks and Challenges - The company has outlined various operational risks and countermeasures in its report, emphasizing the importance of successful clinical trials and regulatory approvals for future profitability[5]. - The company faces risks related to intense competition in the innovative drug development sector, with potential impacts from competitors launching superior drugs[100]. - There is a risk of continued losses due to high R&D expenditures and the commercialization of new drugs not meeting expectations[111]. - The company is exposed to risks from regulatory changes in the pharmaceutical industry, which could impact its operations and market environment[108]. - The marketing capabilities of the company remain unproven, and uncertainties in the commercialization of its drugs could adversely affect financial performance[105]. Shareholder Commitments and Governance - The company has committed to not transferring or entrusting the management of its shares for 36 months from the date of stock listing[141]. - The company will comply with all applicable laws and regulations regarding shareholding and transfer obligations during the lock-up period[138]. - The commitments include strict adherence to reporting requirements for any changes in shareholding by directors and senior management[138]. - The company will ensure timely and accurate reporting of any changes in shareholding by its directors and senior management[150]. - The company will not distribute dividends or bonus shares until all negative impacts from unfulfilled commitments are resolved[180]. Market Outlook and Strategic Plans - The company provided a positive outlook for the next quarter, projecting a revenue increase of B% based on current market trends and user engagement metrics[188]. - New product launches are expected to contribute an additional C million in revenue, with anticipated sales growth of D% in the upcoming fiscal year[188]. - The company is investing in R&D for new technologies, allocating E million towards innovation initiatives aimed at enhancing product offerings[188]. - Market expansion plans include entering F new regions, which are projected to increase market share by G% over the next two years[188]. - The company is considering strategic acquisitions to bolster its competitive position, with a focus on companies that align with its core business objectives[188].

Financial Performance - Net profit attributable to shareholders was -CNY 62,262,940.60, an improvement from -CNY 170,132,628.57 year-on-year[11] - Basic and diluted earnings per share were both -CNY 0.28, improving from -CNY 0.95 in the same period last year[11] - The company reported a net loss of CNY -534,591,670.93, compared to a loss of CNY -472,328,730.33 in the previous period[34] - Total operating revenue for Q1 2020 was significantly lower at 73,021,269.57 compared to 177,045,064.17 in Q1 2019, indicating a decline of approximately 58.8%[46] - Net profit for Q1 2020 was reported at -65,385,205.55, a decrease from -172,644,238.60 in Q1 2019, reflecting an improvement of about 62.1%[47] - Total comprehensive income for Q1 2020 was -63,233,146.26, an improvement from -174,772,723.78 in Q1 2019, reflecting a reduction in losses of approximately 63.8%[47] Assets and Liabilities - Total assets increased by 559.82% to CNY 2,113,204,454.12 compared to the end of the previous year[11] - Total liabilities decreased to CNY 186,190,824.88 from CNY 246,517,910.69, a decline of approximately 24.5%[34] - Current liabilities decreased to CNY 90,474,299.90 from CNY 150,168,166.60, showing a reduction of about 39.8%[33] - Non-current assets totaled CNY 229,907,758.80, up from CNY 218,443,968.60, reflecting a rise of approximately 6.3%[33] - Owner's equity increased to CNY 1,927,013,629.24 from CNY 73,750,177.00, representing a substantial increase[34] Cash Flow - Net cash flow from operating activities was -CNY 77,046,755.90, worsening from -CNY 42,189,296.87 in the same period last year[11] - The net increase in cash and cash equivalents was 1,032,654,939.89 RMB, compared to a decrease of -6,354,594.56 RMB in the same quarter last year[59] - Total cash inflow from financing activities reached 1,944,320,000.00 RMB, significantly higher than 20,000,000.00 RMB in the previous year[60] - Cash outflow from investing activities totaled 749,372,922.94 RMB, compared to 60,018,691.01 RMB in the same quarter last year[57] - The cash balance at the end of the period was 1,099,575,161.65 RMB, up from 122,577,713.08 RMB in the previous year[59] Shareholder Information - The total number of shareholders at the end of the reporting period was 17,329[17] - The largest shareholder, ZELIN SHENG, holds 20.68% of the shares, totaling 49,636,620 shares[17] - The total equity attributable to shareholders reached CNY 1,858,758,753.15, a significant increase from CNY 3,426,155.64[34] Research and Development - Research and development expenses increased by 66.32% to ¥60,519,772.20, related to clinical trial projects[24] - Research and development expenses as a percentage of operating income were not applicable for this period[11] Other Income and Expenses - Non-recurring gains and losses included government subsidies of CNY 4,822,563.38 and bank wealth management income of CNY 1,732,334.04[15] - Total revenue from other income increased by 76.60% to ¥4,822,564.11, reflecting new government subsidies[24] - Management expenses decreased by 89.49% to ¥14,715,362.29, primarily due to a reduction in share-based payment expenses[24] - The company experienced a financial expense of -6,464,578.12 in Q1 2020, a significant decrease from 514,777.16 in Q1 2019, indicating a reduction in financial costs[46] - Tax expenses for Q1 2020 were reported at 136,823.86, slightly lower than 143,314.34 in Q1 2019, showing a decrease of about 4.5%[46] Future Outlook - The company expects to continue incurring losses until at least the next reporting period due to the absence of drug sales[26] - The company has not applied the new revenue and lease standards starting from 2020[62] - There are no retrospective adjustments for prior comparative data related to the new revenue and lease standards[62] - The audit report is not applicable for the current financial period[62]

Financial Performance - As of December 31, 2019, the company has not yet achieved profitability and has accumulated losses due to significant R&D expenditures[5] - The company's operating revenue for 2019 was ¥0, compared to ¥1,311,158.07 in 2018, indicating a significant decline[28] - The net profit attributable to shareholders for 2019 was -¥461,877,238.60, slightly worse than -¥440,089,014.69 in 2018[28] - The net cash flow from operating activities for 2019 was -¥180,427,947.30, compared to -¥112,437,479.94 in 2018, reflecting increased cash outflows[28] - The total assets at the end of 2019 were ¥320,268,087.69, down 29.59% from ¥454,882,408.89 at the end of 2018[28] - The net assets attributable to shareholders decreased by 98.49% to ¥3,426,155.64 at the end of 2019, primarily due to R&D expenses and stock incentive plan costs[32] - The basic earnings per share for 2019 was -¥2.57, with diluted earnings per share also at -¥2.57[29] - The company reported a weighted average return on equity of -402.11% for 2019, indicating significant losses relative to equity[29] - The company has been continuously incurring losses over the past three years due to ongoing new drug development projects without any products on the market[32] - The company reported a net profit attributable to shareholders of -170,132,628.57 CNY in Q1 2019, -171,015,749.95 CNY in Q2, -57,243,248.82 CNY in Q3, and -63,485,611.26 CNY in Q4[33] R&D and Product Development - The company is still in the product development stage and has not received commercial sales approval for any drugs, resulting in no sales revenue[5] - The company has established two core technology platforms for drug development: a precision small molecule drug platform and a complex recombinant protein biopharmaceutical platform[42] - The product pipeline includes 11 major drugs with 29 ongoing projects, with 4 drugs in NDA and Phase II/III clinical trials, and 2 in Phase I/II trials[43] - The company is developing small molecule drugs such as Donafenib and Jakatinib, which are in different stages of clinical trials[42] - The company has a series of patented small molecule drugs and dual/triple specificity antibody products covering various cancers and diseases[42] - The company has completed Phase III clinical trials for Donafenib in treating advanced hepatocellular carcinoma and submitted a new drug application to the National Medical Products Administration on March 20, 2020[46] - The company is conducting clinical trials for multiple indications, including advanced colorectal cancer and various autoimmune diseases, indicating a robust pipeline[46] - The company has six clinical-stage drugs in development, all from its proprietary research platforms, ensuring sustainable innovation capabilities[58] - The company is advancing multiple projects, including Tofacitinib Sulfate for colorectal cancer, currently in Phase III trials, with a cumulative investment of CNY 7,395,110[74] - The company has multiple ongoing projects in various stages of clinical trials, indicating a robust pipeline for future product launches[74] Financial Strategy and Funding - The company raised a net amount of RMB 1,908.22 million through its IPO on the Sci-Tech Innovation Board in January 2020[5] - The company relies on external financing for its working capital, which may pressure its financial condition if expenses exceed available funding[5] - The company has established a cash dividend policy, stating that it will distribute profits at least once a year in cash, with a minimum of 30% of the average distributable profits over the last three years[159] - The company will actively consider the timing and conditions for cash dividends based on its operational status and cash flow needs[161] - The company will optimize its capital structure and broaden financing channels to support new drug development and business expansion[155] Market and Competitive Landscape - The global pharmaceutical market size grew from $1.0 trillion in 2014 to $1.3 trillion in 2018, with projections to reach $1.7 trillion by 2023[52] - China's pharmaceutical market size increased from CNY 1.1 trillion in 2014 to CNY 1.5 trillion in 2018, with forecasts to reach CNY 2.1 trillion by 2023[53] - The company faces significant competition from major pharmaceutical and biotech companies, which may develop superior drugs that could impact the company's market position[99] - The company is exposed to international market risks, particularly related to U.S.-China trade relations and potential tariffs affecting overseas operations[105] Operational Risks and Challenges - The company faces potential risks related to the inability to complete clinical trials or obtain regulatory approvals for its drug candidates[5] - The company has detailed various operational risks and countermeasures in its report[5] - The company is exposed to risks related to the supply of raw materials and consumables, which could impact its operational and financial performance if prices rise significantly[103] - The pharmaceutical industry is highly regulated, and changes in regulatory policies could adversely affect the company's operations if it fails to adapt[104] - The company faces risks related to rapid expansion, including challenges in team management and internal controls[106] Human Resources and Management - The company has over 100 R&D personnel and a commercial production team with GMP experience, focusing on innovative drug development[47] - The R&D team consists of 134 members, with 8.96% holding PhDs and 24.63% holding master's degrees[82] - The company relies heavily on the recruitment and retention of qualified personnel, and the loss of key employees could hinder its R&D and commercialization goals[99] - The company will continue to enhance its operational capabilities through talent recruitment, training, and performance management across various teams[154] Future Outlook and Strategy - The company aims to meet significant clinical needs both domestically and internationally with its innovative drug development strategy[41] - The company plans to continue advancing its new drug projects and expand its market presence in the pharmaceutical manufacturing industry[128] - The company aims to become a leading enterprise in the research, production, and commercialization of new drugs for oncology, bleeding and blood diseases, and liver and gallbladder diseases in China[151] - The company is committed to improving patient quality of life and extending lifespan through the development of safe and effective innovative drugs[151]