Financial Performance - The company's operating revenue for Q3 2022 was ¥217,331,089.34, a decrease of 40.68% compared to the same period last year[4] - The net profit attributable to shareholders for Q3 2022 was ¥27,167,799.85, down 87.26% year-on-year[4] - The net profit attributable to shareholders after deducting non-recurring gains and losses for Q3 2022 was ¥14,786,510.81, a decline of 92.45% compared to the previous year[4] - The basic earnings per share for Q3 2022 was ¥0.06, down 87.15% from the previous year[4] - The weighted average return on equity for Q3 2022 was 0.90%, a decrease of 6.21 percentage points year-on-year[4] - The net profit for Q3 2022 was CNY 53,932,347.03, a decrease from CNY 134,907,629.99 in Q3 2021, representing a decline of approximately 60%[19] - The total comprehensive income for Q3 2022 was CNY 58,289,725.34, compared to CNY 134,907,629.99 in the same period last year, indicating a significant drop[20] - Basic and diluted earnings per share for Q3 2022 were both CNY 0.12, down from CNY 0.30 in Q3 2021, reflecting a 60% decrease[20] Assets and Liabilities - The total assets at the end of Q3 2022 amounted to ¥3,209,823,390.04, representing a 2.54% increase from the end of the previous year[4] - Total assets as of Q3 2022 were ¥3,209,823,390.04, compared to ¥3,130,259,503.93 at the end of Q3 2021, representing an increase of about 2.5%[17] - Total liabilities for Q3 2022 were ¥122,334,396.04, down from ¥156,994,583.02 in Q3 2021, indicating a decrease of approximately 22.0%[17] - Current liabilities decreased to ¥121,650,328.31 in Q3 2022 from ¥156,118,414.67 in Q3 2021, a reduction of approximately 22.0%[17] - Non-current assets totaled ¥1,051,644,368.18 in Q3 2022, compared to ¥755,591,182.03 in Q3 2021, reflecting an increase of about 39.2%[17] Cash Flow - The net cash flow from operating activities for the year-to-date was ¥33,891,027.22, a decrease of 62.20% compared to the previous year[4] - The net cash flow from operating activities for Q3 2022 was CNY 33,891,027.22, down from CNY 89,654,449.26 in Q3 2021, showing a decline of approximately 62%[22] - Cash inflows from operating activities totaled CNY 502,161,946.44 in the first nine months of 2022, an increase from CNY 468,037,886.54 in the same period of 2021[22] - The net cash flow from investment activities for Q3 2022 was CNY 344,523,296.53, down from CNY 517,607,389.65 in Q3 2021, indicating a decline of approximately 33%[22] - The net cash flow from financing activities for Q3 2022 was -CNY 4,794,898.20, compared to -CNY 8,887,174.60 in Q3 2021, showing an improvement[23] - The cash and cash equivalents at the end of Q3 2022 amounted to CNY 1,003,115,669.03, an increase from CNY 965,234,645.72 at the end of Q3 2021[23] Research and Development - Research and development expenses for Q3 2022 totaled ¥48,358,426.09, a decrease of 31.63% year-on-year[4] - The ratio of R&D expenses to operating revenue for Q3 2022 was 22.25%, an increase of 2.94 percentage points compared to the same period last year[4] - Research and development expenses for Q3 2022 amounted to ¥137,289,093.00, a decrease from ¥163,359,434.53 in Q3 2021, reflecting a reduction of approximately 15.9%[18] - The company continues to expand its clinical research and commercialization processes for Furmetin, demonstrating its commitment to innovation[13] - The company is focused on enhancing its market presence and product offerings through ongoing research and development efforts[13] Product Development and Market Presence - The company achieved a revenue of 518 million RMB for the first nine months of 2022, showing significant growth despite external macroeconomic challenges[13] - The sales revenue of the drug Furmetin increased after its inclusion in the national medical insurance directory at the end of 2021, with further positive impact from its approval for first-line treatment in June 2022[13] - The company is actively preparing for negotiations regarding the inclusion of Furmetin's first-line treatment in the national medical insurance directory[13] - Furmetin received approval for a Phase II clinical trial for non-small cell lung cancer with specific mutations in August 2022, indicating ongoing clinical research and expansion of its indications[13] - The company was recognized as one of the "Top 100 Hard-Core Enterprises in Shanghai" in 2022, highlighting its innovative capabilities[13] - Furmetin was awarded as one of the "Top Ten New Drugs (Domestic)" at the 14th Health China Forum, emphasizing its quality and efficacy[13]

Financial Performance - The company reported a total revenue of RMB 500 million for the first half of 2022, representing a year-on-year increase of 20%[2]. - The company achieved operating revenue of RMB 300.39 million, a year-on-year increase of 147.34% due to significant sales growth of the product Fumetinib after its approval for second-line indications[20]. - The net profit attributable to shareholders was RMB 26.76 million, marking a turnaround from a loss of RMB 78.34 million in the same period last year[22]. - The net cash flow from operating activities was RMB 5.97 million, compared to a negative cash flow in the previous year, primarily due to timely collections from accounts receivable[22]. - Basic earnings per share were RMB 0.06, compared to a loss of RMB 0.17 per share in the same period last year[21]. - The company reported a total cash balance of ¥1,020,341,070.92 as of June 30, 2022, compared to ¥615,355,555.08 at the beginning of the period, indicating a significant increase[157]. - The company reported a net loss of ¥-483,911,489.57, an improvement from ¥-510,676,036.75, indicating a reduction in losses[159]. - The total comprehensive income for the first half of 2022 was CNY 23,902,683.55, showing a recovery from a loss of CNY 37,765,299.12 in the same period of 2021[168]. Research and Development - Research and development expenses increased by 30% to RMB 100 million, focusing on innovative drug development and technology enhancements[2]. - The company's R&D investment was RMB 88.93 million, accounting for 29.61% of operating revenue, a decrease of 46.66 percentage points from the previous year[21]. - The company is developing a first-in-class small molecule targeted anti-tumor drug, with a focus on advanced non-small cell lung cancer (NSCLC) treatment[11]. - The company aims to enhance its market presence through innovative drug development and strategic partnerships with Contract Research Organizations (CROs)[12]. - The company is actively pursuing IND (Investigational New Drug) applications to facilitate clinical trials for its innovative therapies[12]. - The company has established a comprehensive new drug R&D system, focusing on drug molecule design and optimization technologies to ensure the development of best-in-class and first-in-class drugs[60]. - The company is actively pursuing the development of targeted drugs, including KRAS G12C and G12D inhibitors, and fourth-generation EGFR-TKIs[70]. Market Strategy and Expansion - The company plans to expand its market presence in Southeast Asia, targeting a 10% market share by the end of 2023[2]. - The company expects a revenue growth forecast of 25% for the second half of 2022, driven by new product launches and market expansion strategies[2]. - Future growth strategies include expanding into new markets and exploring potential mergers and acquisitions to strengthen the product pipeline[12]. - The company has initiated a new marketing strategy aimed at increasing brand awareness, with a budget allocation of RMB 50 million for 2022[2]. - The company is considering strategic acquisitions to bolster its market position, with a budget of $200 million allocated for potential deals[120]. Product Development and Clinical Trials - The core product, Vomeletinib, is positioned against major competitors such as Osimertinib and Amivantamab, which are also third-generation EGFR-TKIs[11]. - The company is conducting a Phase III clinical trial comparing the efficacy and safety of its drug against a placebo in patients with EGFR-positive non-small cell lung cancer[13]. - Fumetinib demonstrates a CNS ORR of 66% and CNS PFS of 11.6 months in patients with CNS metastases from EGFR T790M mutation-positive NSCLC[31]. - The company is actively conducting clinical trials for the drug Furmetin, with ongoing Phase Ib trials for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR 20 exon insertion mutations, and Phase II trials approved in August 2022[37]. - The company has received approval for a Phase II clinical trial targeting EGFR exon 20 insertion mutation NSCLC, with an ORR of 60% reported in initial studies[34]. Financial Management and Investments - The company has established measures to ensure compliance with environmental protection laws and standards, contributing to ecological protection and sustainable development[111]. - The total amount of funds raised was CNY 2,045,700,000, with a net amount of CNY 1,932,549,645.61 after deducting issuance costs[139]. - The company approved the use of up to RMB 1.4 billion of temporarily idle raised funds for cash management, with RMB 483 million invested in structured deposits as of June 30, 2022[143]. - The company plans to use RMB 128 million of oversubscribed funds to permanently supplement working capital, approved by the board and shareholders[143]. Shareholder and Governance - The company has established a profit distribution policy that prioritizes cash dividends, aiming for a minimum of 10% of the distributable profit to be distributed in cash if no major investment plans or significant cash expenditures occur[124]. - The company will not intervene in the management activities of the issuer and will not infringe upon the interests of the company[123]. - The company has committed to ensuring the accuracy and completeness of its IPO prospectus submitted to the Shanghai Stock Exchange, taking legal responsibility for any false statements or omissions[127]. - The controlling shareholder and actual controllers have pledged that no competitive business will be conducted by them or their controlled entities outside of the company and its subsidiaries[131]. - There are no significant lawsuits or arbitration matters during the reporting period[133]. Environmental Responsibility - The company promotes low-carbon and environmentally friendly practices among employees, including centralized and paperless offices, to reduce carbon emissions[111]. - The company has implemented a waste management system for various types of waste generated during its operations, ensuring proper disposal and treatment[110]. - The company employs activated carbon filtration for waste gas and entrusts qualified third-party companies for the treatment of hazardous waste, ensuring compliance with environmental regulations[111]. - During the reporting period, the company and its subsidiaries did not experience any environmental pollution incidents or receive administrative penalties related to environmental protection[110].

Financial Performance - The company achieved a revenue of 530.09 million yuan in 2021, representing a year-on-year growth of 94,409.96%[2]. - The net profit attributable to the parent company was 18.27 million yuan, marking a turnaround from a loss to profit[2]. - The net profit attributable to the parent company, excluding non-recurring gains and losses, was -62.04 million yuan, indicating a significant reduction in losses[2]. - The company reported a total revenue of RMB 1.5 billion for the year 2021, representing a year-over-year growth of 25%[10]. - The company reported a net profit of RMB 300 million for 2021, a 15% increase compared to the previous year[10]. - The company achieved total revenue of ¥530,094,158.47, a significant increase of 94,409.96% compared to the previous year, primarily driven by the sales of the newly approved drug, Vomecitin, which generated ¥235,710,761.40 in domestic sales[97]. - The net profit attributable to the parent company was ¥18,274,567.01, marking a turnaround from a loss, while the net loss excluding non-recurring items was reduced by ¥295,319,113.29 compared to the previous year[97]. - The company reported a significant increase in external licensing revenue, totaling 29,436.66 million RMB, representing a year-over-year increase of 53,867.27%[121]. Research and Development - The company has accumulated significant losses due to high R&D costs and has not yet achieved profitability since its establishment[3]. - The company has allocated RMB 200 million for research and development in 2022, focusing on innovative drug discovery[12]. - The company invested 222.59 million yuan in R&D, accounting for 41.99% of its revenue[32]. - The company reported a total R&D investment of ¥222,594,854.56, representing a 25.08% increase compared to the previous year[78]. - The company has established a comprehensive new drug R&D system, focusing on drug molecule design and discovery technology[70]. - The company has a well-structured technical knowledge base covering all aspects of new drug development, enhancing the efficiency of the company's R&D efforts[85]. - The company is currently conducting clinical trials for multiple indications of Furmetin, including the third-phase trial for adjuvant therapy and the first-phase trial for EGFR 20 exon insertion mutation[80]. Product Development and Market Strategy - The core product, Fumetinin, was successfully launched and included in the national medical insurance list in its first year[2]. - The company plans to expand its market presence in Europe and North America, targeting a 30% increase in market share by 2023[10]. - The company expects to launch two new products in the next 12 months, contributing an estimated RMB 500 million in additional revenue[10]. - The company is exploring potential mergers and acquisitions to enhance its product pipeline and market reach[12]. - The company has established partnerships with three leading Contract Research Organizations (CROs) to accelerate its drug development process[12]. - The company plans to enhance its commercialization capabilities and production quality control to support its innovative drug development[141]. Clinical Trials and Efficacy - The objective response rate (ORR) for the drug in clinical trials has reached 60%, indicating significant anti-tumor activity[14]. - The median progression-free survival (mPFS) reported in trials is 8.5 months, demonstrating the drug's effectiveness in delaying disease progression[14]. - Furmetinib's Phase III clinical trial results showed a median progression-free survival (PFS) of 20.8 months, extending by 9.7 months compared to the control group[32]. - The objective response rate (ORR) for Furmonertinib in treating EGFR T790M mutation NSCLC was reported at 74.1%, with a disease control rate (DCR) of 93.6%[43]. - The company is conducting a single-arm clinical trial for a new drug targeting advanced non-small cell lung cancer (NSCLC) with EGFR mutations[13]. Governance and Compliance - The company received a standard unqualified audit report from PwC Zhongtian[4]. - The company emphasizes that future plans and strategies mentioned in the report do not constitute a commitment to investors[5]. - The company has established a governance structure that includes a board of directors, supervisory board, and various committees to ensure effective management and compliance[148]. - The internal control system has been effectively maintained, with no significant deficiencies reported during the period[194]. - The company has not faced any penalties from securities regulatory authorities in the past three years[170]. Market Risks and Challenges - The company faces risks related to ongoing R&D investments and potential further increases in accumulated losses[3]. - The company is experiencing intense competition in the innovative drug market, particularly in the field of third-generation EGFR-TKIs, which may impact its business and financial performance[92]. - The company is exposed to risks related to changes in industry policies and adjustments in the medical insurance catalog, which could adversely affect sales and revenue[95]. - The company is heavily reliant on its single product, Furmetinib, which may limit its operational capabilities and expose it to market risks[91]. Employee and Talent Management - The company has a diverse educational background among employees, with 18 holding doctoral degrees and 85 holding master's degrees[180]. - The company emphasizes internal salary equity while providing attractive compensation packages to retain talent[181]. - The company has implemented a digital learning platform, "Aixuetang," to enhance employee training and development[185]. - The company emphasizes talent development, aiming to build a competitive compensation system and training programs to enhance employee skills and overall quality[142]. Sustainability and Corporate Responsibility - The board of directors emphasized the importance of sustainable practices, committing to reduce carbon emissions by J% over the next five years[160]. - The company emphasizes the importance of ESG management and adheres to relevant laws and regulations to enhance internal governance and protect shareholder rights, especially for minority investors[198]. - The company is not listed as a key pollutant discharge unit according to the Shanghai Municipal Ecological Environment Bureau's 2021 list[199]. - No administrative penalties were incurred due to environmental issues during the reporting period[200].

Financial Performance - The company achieved a revenue of 530.09 million yuan in 2021, representing a year-on-year growth of 94,409.96%[2] - The net profit attributable to the parent company was 18.27 million yuan, marking a turnaround from a loss[2] - The net profit attributable to the parent company, excluding non-recurring gains and losses, was -62.04 million yuan, indicating a significant reduction in losses[2] - The company reported a total revenue of RMB 1.5 billion for the year 2021, representing a year-over-year increase of 25%[10] - The projected earnings guidance for 2022 is set at RMB 1.8 billion, reflecting a growth rate of 20%[10] - The company achieved total revenue of RMB 530,094,158.47, a significant increase of 94,409.96% compared to the previous year, primarily driven by the sales of the newly approved drug, Vomecitin, which generated RMB 235,710,761.40 in domestic sales and RMB 293,504,547.18 from overseas licensing income[97] - The net profit attributable to the parent company was RMB 18,274,567.01, marking a turnaround from a loss, while the net loss after deducting non-recurring gains and losses was reduced by RMB 295,319,113.29 compared to the previous year[97] Research and Development - The company has accumulated significant losses due to high R&D costs and has not yet achieved profitability since its establishment[3] - The R&D budget for new drug development has been increased by 15% to RMB 300 million for the upcoming year[10] - The company's R&D investment was 222.59 million yuan, accounting for 41.99% of total revenue[32] - The company has established a complete drug development system, focusing on innovative drug research and development in the oncology field[38] - The company is developing a technology platform for evaluating drug metabolism, enhancing its drug design and optimization capabilities[73] - The company has ongoing projects with a total expected investment of ¥84,580.20 million, with significant progress in clinical trial phases for various indications of Furmetin[80] - The company plans to submit IND applications for new drug projects, including KRAS G12C and G12D inhibitors, between 2022 and 2024[38] - The company is committed to addressing unmet clinical needs and differentiating its products through innovative drug design[85] Product Development and Clinical Trials - The core product, Fumetinin, was successfully launched and included in the national medical insurance list in its first year[2] - The company is in the process of developing a new first-in-class drug, expected to enter clinical trials in Q3 2022[12] - The company has successfully completed Phase III clinical trials for its lead product, with results showing a 50% improvement in patient outcomes compared to standard treatments[12] - The company is conducting a single-arm clinical trial for a new drug targeting advanced non-small cell lung cancer (NSCLC) with EGFR mutations[13] - The objective response rate (ORR) for the drug in clinical trials has reached 60%, indicating significant anti-tumor activity[14] - The median progression-free survival (mPFS) reported in trials is 8.5 months, demonstrating the drug's effectiveness in delaying disease progression[14] - The company has established a marketing team covering approximately 1,000 hospitals and 500 DTP pharmacies across 30 provinces[38] - The company is conducting multiple clinical trials to explore Fumetinib's clinical evidence for various indications, including CNS metastasis and rare mutations[47] Market Expansion and Strategy - The company plans to expand its market presence in Europe and North America, targeting a 30% market share in these regions by 2025[10] - The company aims to achieve a gross margin of 60% by optimizing production processes and reducing costs by 10%[10] - The company has identified potential acquisition targets in the biotech sector to accelerate growth and innovation[10] - The company is exploring potential mergers and acquisitions to enhance its research and development capabilities and expand its product pipeline[15] - The company is actively expanding its market presence in the companion diagnostics sector, which is rapidly growing in China[69] - The company is focused on expanding its market presence and enhancing its product offerings through ongoing research and development initiatives[158] Governance and Compliance - The company has not made any special arrangements for corporate governance[5] - The company has established a comprehensive internal control system, which has been effectively maintained throughout the reporting period[194] - The independent auditor issued a standard unqualified opinion on the effectiveness of the internal control system for the fiscal year 2021[196] - The company has not faced any penalties from securities regulatory authorities in the past three years, indicating compliance with regulations[170] - The board of directors remains committed to maintaining transparency and accountability in its operations[158] Human Resources and Talent Development - The company emphasizes talent development, aiming to build a competitive compensation system and training programs to enhance employee skills and management capabilities[142] - The company has implemented a digital learning platform called "Aixuetang" to enhance employee training and development[185] - The total remuneration for directors, supervisors, and senior management during the reporting period was CNY 2,197.68 million[168] - The company has a diverse workforce with 64 production staff, 323 sales personnel, 130 technical staff, 14 financial staff, and 76 administrative staff[180] Environmental and Social Responsibility - The company emphasizes the importance of ESG management and adheres to relevant laws and regulations to enhance internal governance and protect shareholder rights, especially for minority investors[198] - The company is not listed as a key pollutant discharge unit according to the Shanghai Municipal Ecological Environment Bureau's 2021 list[199] - No administrative penalties were incurred due to environmental issues during the reporting period[200] - The company engages in product research and development, generating pollutants such as waste gas, waste liquid, and solid waste, which are managed through qualified third-party disposal[200]

Financial Performance - The company's revenue for Q1 2022 was ¥111,157,103.86, representing a year-over-year increase of 202.32%[3] - The net profit attributable to shareholders was -¥22,673,403.02, with a net profit excluding non-recurring items of -¥37,258,658.95[3] - Total operating revenue for Q1 2022 was CNY 111,157,103.86, a significant increase from CNY 36,767,738.1 in Q1 2021, representing a growth of approximately 202.5%[19] - Net profit for Q1 2022 was a loss of CNY 22,673,403.02, an improvement from a loss of CNY 44,298,866.33 in Q1 2021, reflecting a reduction in losses by approximately 48.8%[20] Research and Development - Research and development expenses totaled ¥49,596,570.97, accounting for 44.62% of revenue, a decrease of 56.48 percentage points compared to the previous year[3] - Research and development expenses for Q1 2022 were CNY 49,596,570.97, up from CNY 37,172,562.43 in Q1 2021, marking an increase of about 33.4%[19] - The company is advancing the Phase Ib clinical trial for Fumetinib targeting EGFR 20 exon insertion mutations, which currently has no effective drugs approved in China[13] Assets and Liabilities - The total assets at the end of the reporting period were ¥3,071,165,464.19, a decrease of 1.89% from the end of the previous year[3] - The total current assets as of March 31, 2022, were RMB 2.29 billion, a decrease from RMB 2.37 billion at the end of 2021[15] - Total liabilities for Q1 2022 were CNY 102,839,222.84, down from CNY 156,994,583.02 in the previous period, indicating a reduction of approximately 34.4%[17] Cash Flow - The company's cash flow from operating activities was -¥51,249,765.31, indicating increased operational expenditures[3] - Cash inflow from operating activities for Q1 2022 was 96,614,850.97 CNY, a significant increase from 25,709,567.52 CNY in Q1 2021, representing a growth of approximately 275%[22] - The net cash flow from operating activities for Q1 2022 was -51,249,765.31 CNY, an improvement from -86,708,716.89 CNY in Q1 2021[23] Shareholder Information - The total number of ordinary shareholders at the end of the reporting period was 12,366[8] - The largest shareholder, Shanghai Qiaoke Enterprise Development Co., Ltd., held 32.17% of the shares, totaling 144,776,786 shares[8] Sales and Marketing - The company's sales expenses rose by 94.22%, primarily due to increased marketing activities and related costs[6] - Fumetinib was included in the national medical insurance directory in December 2021, which positively impacted its sales in Q1 2022 despite some negative effects from COVID-19[12] - The exclusive promotion agreement with Jiangsu Fosun is expected to enhance market coverage and commercial potential for Fumetinib, benefiting more patients in China[12] Clinical Trials - The Phase III clinical trial results for Fumetinib showed a median progression-free survival (PFS) of 20.8 months compared to 11.1 months for the control group, representing an increase of 9.7 months and a 56% reduction in the risk of disease progression or death[13] Government Grants - The company received government grants amounting to ¥1,233,524.25 during the reporting period[4]

Financial Performance - The company's operating revenue for Q3 2021 was ¥366,401,012.10, representing an increase of 421.15% compared to the same period last year[5]. - Net profit attributable to shareholders for Q3 2021 was ¥213,249,396.43, with a year-to-date net profit of ¥134,907,629.99, reflecting significant growth[5]. - The basic earnings per share for Q3 2021 was ¥0.47, compared to ¥0.30 year-to-date last year[5]. - The total profit for Q3 2021 was CNY 134,907,629.99, a significant recovery from a loss of CNY -204,843,004.37 in the same period last year[27]. - Basic and diluted earnings per share for Q3 2021 were both CNY 0.30, compared to a loss of CNY -0.57 per share in Q3 2020[28]. - The net profit for the first three quarters of 2021 was CNY 134.37 million, a recovery from a loss of CNY 204.83 million in the same period of 2020[26]. Research and Development - R&D investment totaled ¥70,734,285.83 in Q3 2021, an increase of 70.98% year-over-year, accounting for 19.31% of operating revenue[5]. - The company is focused on continuous research and development to enhance its product pipeline and address unmet medical needs in oncology[19]. - Research and development expenses for the first three quarters of 2021 were CNY 163.36 million, up from CNY 136.60 million in 2020, indicating a growth of about 19.5%[26]. Market Expansion and Product Development - The company confirmed that the significant increase in revenue was primarily due to the domestic launch of Fumetin in March 2021 and related overseas licensing income[10]. - The core product, Vomeletin, has expanded its coverage in commercial insurance, now included in over 20 provinces or cities in China, benefiting more lung cancer patients[18]. - The company is actively expanding its market presence through new product launches and clinical trials, enhancing its competitive position in the pharmaceutical industry[18]. - The company has established partnerships for overseas licensing, contributing to its revenue growth from international markets[18]. - The company plans to continue expanding its market presence and investing in R&D to support future growth initiatives[10]. Clinical Trials and Product Efficacy - The Phase III clinical trial for Vomeletin in treating EGFR-sensitive mutations has met its primary endpoint for progression-free survival (PFS), showing significant clinical benefits compared to the control group[19]. - Vomeletin's clinical data for treating EGFR 20 exon insertion mutations was presented at the 2021 ESMO, demonstrating a 60% objective response rate (ORR) and a 100% disease control rate (DCR) in the study population[20]. - The company has not reported any grade 3 or higher treatment-emergent adverse events (TEAEs) during the trials, indicating a favorable safety profile for Vomeletin[20]. Cash Flow and Assets - The net cash flow from operating activities for the year-to-date period was ¥89,654,449.26, reflecting strong cash generation from sales[5]. - Cash flow from operating activities for the first nine months of 2021 was CNY 89,654,449.26, a turnaround from a negative cash flow of CNY -145,488,746.13 in the same period last year[30]. - The company reported a significant increase in cash and cash equivalents, totaling CNY 965.23 million as of September 30, 2021, compared to CNY 365.84 million at the end of 2020, representing a growth of approximately 164.5%[24]. - The ending balance of cash and cash equivalents as of Q3 2021 was CNY 965,234,645.72, up from CNY 169,672,791.84 in the same period last year[31]. Assets and Liabilities - Total assets at the end of Q3 2021 reached ¥3,171,611,156.60, a 6.18% increase from the end of the previous year[5]. - The total current assets amounted to CNY 2.71 billion, slightly up from CNY 2.68 billion, indicating a growth of approximately 1.5%[24]. - The company’s total liabilities decreased to CNY 102.13 million from CNY 109.01 million, showing a reduction of about 6.5%[25]. - The equity attributable to shareholders increased to CNY 3.07 billion from CNY 2.88 billion, reflecting a growth of approximately 6.6%[25]. - The total liabilities amounted to ¥109,166,586.17, showing a slight increase due to adjustments in estimated liabilities[35].

Financial Performance - As of June 30, 2021, the company reported a cumulative undistributed loss of ¥607.29 million, indicating that the company has not yet achieved profitability since its establishment[3]. - The company reported a total revenue of RMB 1.5 billion for the first half of 2021, representing a year-over-year increase of 25%[10]. - The company expects a revenue guidance of RMB 3 billion for the full year 2021, indicating a projected growth of 20%[10]. - The company's operating revenue for the first half of 2021 was ¥121,449,037.88, representing an increase of 37,211.85% compared to the same period last year[18]. - The net loss attributable to shareholders decreased to ¥78,341,766.44, a reduction of ¥55,501,803.39 from the previous year[19]. - The total assets at the end of the reporting period were ¥2,952,230,086.66, a decrease of 1.17% from the previous year[18]. - The company reported non-operating income of ¥38,303,410.50, which includes government subsidies and investment income from financial assets[21]. - The company achieved a rapid revenue growth of 121 million yuan during the reporting period, expanding its sales channels to cover nearly 800 hospitals and 250 DTP pharmacies across 30 provinces and cities in China[74]. Research and Development - The company has been heavily investing in research and development, leading to a continuous increase in cumulative unremitted losses, which are expected to remain high in the coming years[3]. - The R&D expenses for the first half of 2021 amounted to RMB 300 million, accounting for 20% of total revenue, reflecting the company's commitment to innovation[11]. - The company is exploring potential acquisition opportunities to strengthen its pipeline and expand its therapeutic areas[11]. - The company has established a comprehensive R&D model covering all stages of new drug development, including drug discovery, preclinical research, and clinical trials[35]. - The R&D team consists of 113 members, with 10 holding PhDs and 51 holding Master's degrees, reflecting a strong academic background[66]. - The company is committed to enhancing its research capabilities, particularly in pharmacokinetics and treatment-related adverse events, to improve patient outcomes[13]. - The company has initiated multiple clinical trials to expand furmonertinib's indications, including a Phase III trial for first-line treatment and a Phase III trial for adjuvant therapy[32]. Product Development and Market Strategy - The core product, Furmetinib, was officially commercialized on March 8, 2021, significantly boosting revenue and gross profit[23]. - The company plans to launch a new product line in Q4 2021, which is expected to contribute an additional RMB 500 million in revenue[10]. - The company is expanding its market presence in Europe, targeting a 15% market share in the next two years[10]. - The company has entered into a strategic partnership with a leading CRO to enhance its drug development capabilities[11]. - The company is actively pursuing new product introductions and collaborations, including a technology transfer agreement with Fudan University for a new anti-tumor drug project[76]. - The company has signed distribution agreements with quality distributors across 30 provinces and cities, covering nearly 800 hospitals and about 250 DTP pharmacies[37]. Financial Management and Governance - The company has not proposed any profit distribution or capital reserve transfer to shareholders for the reporting period[3]. - The financial report for the half-year period has not been audited[3]. - All board members attended the board meeting, ensuring the integrity of the report[5]. - The company has not disclosed any special arrangements for corporate governance[5]. - The company emphasizes the importance of its marketing team's ability to navigate market dynamics and ensure the successful commercialization of Furmonertinib amidst competitive pressures[83]. Risks and Challenges - The company anticipates ongoing substantial R&D expenditures, with the potential for further increases in cumulative unremitted losses if the commercialization progress of its core product, Furmetinib, does not meet expectations[3]. - The company is facing risks related to its reliance on a single product, Furmonertinib, which is currently the only marketed product, while other projects are still in preclinical stages[80]. - The company is exposed to significant market competition, particularly from other third-generation EGFR-TKIs that have already been approved or are in various stages of clinical trials[81]. - There is a potential risk of not having products included in the national medical insurance directory, which could adversely affect sales growth[92]. - The company faces industry policy changes that may require adjustments in business strategies to remain competitive[90]. Shareholder Commitments and Regulations - The company is committed to fulfilling its promises related to shareholding restrictions for three complete accounting years following its IPO, ensuring no transfer of shares during this period[116]. - The company will adhere to legal regulations when reducing shareholdings and will publicly disclose reasons for any non-compliance with commitments[118]. - The company has established a commitment to maintain compliance with the relevant laws and regulations regarding share transfers[118]. - The company will ensure stable operations and disclose control arrangements if any share reductions occur post-lock-up[117]. - The company has committed to ensuring that the prospectus submitted for the initial public offering (IPO) does not contain any false statements or misleading information, taking individual and joint legal responsibility for its accuracy and completeness[126].