公司 2023 年半年度募集资金存放与使用情况符合《上市公司监管指引第 2 号—上市公司募集资金管理和使用的监管要求》《上海证券交易所科创板上市公 司自律监管指引第 1 号—规范运作》以及公司《募集资金管理制度》等法律法规、 规范性文件和公司制度的规定，对募集资金进行了专户存储和专项使用，并及时 履行了相关信息披露义务，募集资金具体使用情况与公司已披露情况一致，不存 在变相改变募集资金用途和损害股东利益的情况，不存在违规使用募集资金的情 况。 上海艾力斯医药科技股份有限公司独立董事 关于第二届董事会第五次会议相关事项的独立意见 上海艾力斯医药科技股份有限公司（以下简称"公司"）于 2023 年 8 月 28 日召开公司第二届董事会第五次会议。根据《中华人民共和国公司法》等法律法 规及《上海艾力斯医药科技股份有限公司章程》（以下简称"《公司章程》"） 的相关规定,我们作为公司的独立董事，在仔细审阅有关文件资料后，对公司第二 届董事会第五次会议审议的相关事项，基于独立判断的立场，发表如下独立意见： 一、《关于公司<2023 年半年度募集资金存放与实际使用情况专项报告>的议 案》的独立意见 综上所述，我们一致同意《 ...

证券代码：688578 证券简称：艾力斯 公告编号：2023-038 上海艾力斯医药科技股份有限公司自愿披露关于 伏美替尼用于具有 EGFR PACC 突变或 EGFR L861Q 突变 的局部晚期或转移性 NSCLC 成人患者的一线治疗 III 期临 床试验获得药物临床试验批准通知书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈 述或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 1 （Polymerase Chain Reaction，PCR），预计会检测到更多携带非经典 EGFR 突变 的患者，这可能会增加 EGFR PACC 突变的总体检出率。 重要内容提示： 上海艾力斯医药科技股份有限公司（以下简称"公司"）于近日收到国家 药品监督管理局核准签发的《药物临床试验批准通知书》，甲磺酸伏美替尼片 （以下简称"伏美替尼"）适用于具有 EGFR PACC突变或 EGFR L861Q突变的 局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的一线治疗 III 期临床试验 获得药物临床试验批准。现将相关情况公告如下： 一、基本情况 | 药品名称 | 甲磺酸伏美替尼片 ...

Financial Performance - The company reported a profit distribution plan for 2022, which includes no cash dividends, no stock bonuses, and no capital reserve transfers to increase share capital [4]. - The company has not achieved profitability since its listing [3]. - The audit report issued by PwC confirms the financial statements are true, accurate, and complete [4]. - The company reported a significant increase in revenue for 2022, reaching RMB 1.5 billion, representing a year-over-year growth of 25% [10]. - The company's operating revenue for 2022 was CNY 791,002,454.27, representing a 49.22% increase compared to CNY 530,094,158.47 in 2021 [20]. - The net profit attributable to shareholders for 2022 was CNY 130,520,677.23, a significant increase of 614.22% from CNY 18,274,567.01 in the previous year [20]. - The net cash flow from operating activities reached CNY 91,629,611.67, up 212.82% from CNY 29,291,075.24 in 2021 [20]. - Basic earnings per share for 2022 were CNY 0.29, a 625.00% increase from CNY 0.04 in 2021 [21]. - The total assets of the company at the end of 2022 were CNY 3,442,172,227.84, reflecting a 9.96% increase from CNY 3,130,259,503.93 in 2021 [20]. - The weighted average return on net assets for 2022 was 4.24%, an increase of 3.62 percentage points from 0.62% in 2021 [21]. - The company reported a net profit of CNY 79,374,984.63 after deducting non-recurring gains and losses, marking a turnaround from a loss in the previous year [22]. Research and Development - The company is actively developing new products, including the third-generation EGFR-TKI, with a focus on late-stage non-small cell lung cancer treatment [10]. - Research and development efforts are focused on innovative drugs, with a pipeline that includes several first-in-class and best-in-class candidates [11]. - The company has established partnerships with Contract Research Organizations (CROs) to enhance its drug development capabilities [10]. - The company is focused on obtaining conditional approval for drugs that treat severe life-threatening diseases with no effective treatment options [14]. - The company aims to apply for priority review for drugs that are clinically urgent, such as innovative drugs for major infectious diseases and rare diseases [14]. - The company is dedicated to enhancing its research and development capabilities to improve drug efficacy and safety [12]. - The R&D investment for 2022 was CNY 191,750,085.89, a decrease of 13.86% from the previous year, with R&D expenses accounting for 24.24% of operating revenue [23]. - The company is focused on real-world studies to gather evidence applicable to clinical practice [13]. - The company has a comprehensive drug development system covering all stages from drug discovery to commercialization [42]. - The company has received NDA approval for AST-NI1901, which targets adult patients with specific EGFR mutations in non-small cell lung cancer (NSCLC) [126]. - The company has a diverse pipeline with multiple products in various stages of development, including both approved and investigational drugs targeting NSCLC [125][126]. Market Strategy and Expansion - Future guidance suggests an expected revenue growth of 30% for 2023, driven by new product launches and market expansion strategies [10]. - The company plans to expand its market presence in North America and Europe, targeting a 15% market share in these regions by 2025 [10]. - The company has established a marketing team of nearly 650 members to enhance the promotion of Furmonertinib [33]. - An exclusive promotion agreement was signed with Jiangsu Fosun Pharmaceutical Sales Co., Ltd., covering over 2,000 hospitals to expand market reach [34]. - The company is actively recruiting talent with international pharmaceutical experience to strengthen its workforce [36]. - The company aims to enrich its R&D product pipeline by continuously investing in product development and exploring new targets and compounds [141]. - The company will enhance its marketing capabilities by recruiting a strong marketing team and focusing on professional academic promotion to boost drug sales [140]. Clinical Trials and Product Development - The ongoing clinical trials for its lead product are expected to complete by Q4 2023, with potential market approval in early 2024 [10]. - The company plans to apply for first-line treatment indications for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or L858R mutations [12]. - The second-line treatment indication targets adult patients with locally advanced or metastatic NSCLC who have progressed after EGFR-TKI treatment and have confirmed EGFR T790M mutations [13]. - The company is conducting a randomized, double-blind, placebo-controlled Phase III trial to compare the efficacy and safety of the drug in patients with EGFR mutation-positive NSCLC after radical resection [13]. - Furmonertinib demonstrated a median progression-free survival (PFS) of 20.8 months in first-line treatment for advanced NSCLC, significantly extending PFS compared to Gefitinib (11.1 months) with a risk reduction of 56% [44]. - The overall response rate (ORR) for Furmonertinib in second-line treatment for advanced NSCLC was reported at 74%, with a disease control rate (DCR) of 94% [45]. - Furmonertinib showed a CNS ORR of 84.6% and a CNS PFS of 19.3 months in patients with CNS metastases, indicating strong efficacy in this challenging patient population [46]. Governance and Compliance - The company has not disclosed any special arrangements for corporate governance [5]. - The company emphasizes that forward-looking statements do not constitute substantive commitments to investors, highlighting investment risks [5]. - The board of directors has confirmed that all members attended the board meeting [4]. - The company has not reported any instances where more than half of the directors could not guarantee the authenticity, accuracy, and completeness of the annual report [5]. - The company has not faced any penalties from securities regulatory authorities in the past three years [162]. - The company has a commitment to ensuring the confidentiality of sensitive remuneration information for its key personnel [150]. - The company has established a compensation and assessment committee as of November 28, 2019, to review and formulate the remuneration policies for directors and management [160]. Environmental and Social Responsibility - The company invested 1.75 million RMB in environmental protection during the reporting period [194]. - The company is committed to ESG practices, enhancing internal governance and ensuring compliance with environmental laws [194]. - The company promotes green office practices and energy-saving actions, aiming to reduce electricity and water resource consumption through centralized office management and electronic processes [199]. - Major pollutants include waste gas, wastewater, noise, general solid waste, and hazardous solid waste, with specific management measures in place such as dust collection equipment and professional wastewater treatment facilities [200].

[I. Key Financial Data](index=1&type=section&id=I.%20Key%20Financial%20Data) [1. Key Accounting Data and Financial Indicators](index=1&type=section&id=1.%20Key%20Accounting%20Data%20and%20Financial%20Indicators) Operating revenue grew by nearly **150%**, turning net profit attributable to shareholders and non-recurring net profit from losses to gains, while assets and equity grew steadily Key Accounting Data and Financial Indicators (Q1 2023 vs Q1 2022) | Item | Amount for Current Period (RMB) | YoY Change (%) | | :--- | :--- | :--- | | Operating Revenue | 276,505,592.07 | 148.75 | | Net Profit Attributable to Shareholders of Listed Company | 34,877,411.06 | N/A (Turned Loss into Profit) | | Net Profit Attributable to Shareholders of Listed Company Excluding Non-Recurring Gains and Losses | 19,762,135.04 | N/A (Turned Loss into Profit) | | Net Cash Flow from Operating Activities | -20,544,885.76 | N/A | | Basic Earnings Per Share (RMB/share) | 0.08 | N/A | | Diluted Earnings Per Share (RMB/share) | 0.08 | N/A | | Weighted Average Return on Net Assets (%) | 1.06 | Increased by 1.82 percentage points | | Total R&D Investment | 63,535,586.23 | 28.10 | | R&D Investment as % of Operating Revenue | 22.98 | Decreased by 21.64 percentage points | Key Accounting Data and Financial Indicators (March 31, 2023 vs December 31, 2022) | Item | Amount at End of Current Period (RMB) | Amount at End of Prior Year (RMB) | Change from End of Prior Year (%) | | :--- | :--- | :--- | :--- | | Total Assets | 3,457,407,140.04 | 3,442,172,227.84 | 0.44 | | Total Equity Attributable to Shareholders of Listed Company | 3,236,593,857.32 | 3,187,055,657.81 | 1.55 | [2. Non-Recurring Gains and Losses Items and Amounts](index=2&type=section&id=2.%20Non-Recurring%20Gains%20and%20Losses%20Items%20and%20Amounts) Non-recurring gains and losses totaled **15.12 million RMB**, mainly from government grants and financial asset fair value changes/investment income Non-Recurring Gains and Losses Items and Amounts | Item | Amount for Current Period (RMB) | | :--- | :--- | | Government Grants Included in Current Profit/Loss | 3,797,159.69 | | Fair Value Change Gains/Losses and Investment Income from Financial Assets/Liabilities | 11,319,312.91 | | Other Non-Operating Income and Expenses Excluding the Above | -1,196.58 | | **Total** | **15,115,276.02** | [3. Changes and Reasons for Key Accounting Data and Financial Indicators](index=2&type=section&id=3.%20Changes%20and%20Reasons%20for%20Key%20Accounting%20Data%20and%20Financial%20Indicators) Key financial indicators improved due to significant **Furmonertinib** sales growth, driven by its first-line treatment indication inclusion in medical insurance, achieving overall profitability - Net profit attributable to shareholders, net profit attributable to shareholders excluding non-recurring gains and losses, basic earnings per share, and diluted earnings per share all turned losses into profits, primarily due to increased sales revenue of **Furmonertinib**[7](index=7&type=chunk) - Operating revenue increased by **148.75%** year-on-year, mainly due to increased sales volume of **Furmonertinib** after its first-line treatment indication was included in the national medical insurance catalog[8](index=8&type=chunk) - The proportion of R&D investment to operating revenue decreased by **21.64 percentage points** due to significant growth in operating revenue; sales expenses increased by **113.09%** year-on-year, primarily due to increased expenses related to marketing activities, medical promotion, and employee compensation[7](index=7&type=chunk)[8](index=8&type=chunk) - Accounts receivable increased by **33.52%** related to increased sales revenue of **Furmonertinib**; construction in progress decreased by **53.72%** as some projects were completed and transferred to fixed assets[7](index=7&type=chunk) [II. Shareholder Information](index=3&type=section&id=II.%20Shareholder%20Information) [1. Total Number of Common Shareholders, Preferred Shareholders with Restored Voting Rights, and Top Ten Shareholders' Holdings](index=3&type=section&id=1.%20Total%20Number%20of%20Common%20Shareholders%2C%20Preferred%20Shareholders%20with%20Restored%20Voting%20Rights%2C%20and%20Top%20Ten%20Shareholders%27%20Holdings) The company had **11,793 common shareholders**; this section details top ten holdings, restricted shares, related party relationships, and concerted action agreements - As of the end of the reporting period, the company had a total of **11,793 common shareholders**[9](index=9&type=chunk) Top 10 Shareholders' Holdings | Shareholder Name | Shareholder Nature | Number of Shares Held | Proportion (%) | Number of Restricted Shares Held | Share Status | | :--- | :--- | :--- | :--- | :--- | :--- | | Shanghai Qiaoke Enterprise Development Co., Ltd. | Domestic Non-State-Owned Legal Person | 144,776,786 | 32.17 | 144,776,786 | None | | Shanghai Aixiang Enterprise Development Center (Limited Partnership) | Domestic Non-State-Owned Legal Person | 36,401,021 | 8.09 | 36,401,021 | None | | Hainan Shiyu Private Equity Fund Management Co., Ltd. - Jiaxing Tangyu Investment Partnership (Limited Partnership) | Domestic Non-State-Owned Legal Person | 32,014,653 | 7.11 | 0 | None | | JEFFREY YANG GUO | Overseas Natural Person | 25,623,597 | 5.69 | 25,623,597 | None | | JENNIFER GUO | Overseas Natural Person | 14,823,596 | 3.29 | 14,823,596 | None | | Mr. Du Jinhao | Domestic Natural Person | 10,800,001 | 2.40 | 10,800,001 | None | | Shanghai Aiyun Enterprise Development Center (Limited Partnership) | Domestic Non-State-Owned Legal Person | 10,800,001 | 2.40 | 10,800,001 | None | | LAV Allist Limited | Overseas Legal Person | 7,500,000 | 1.67 | 0 | None | | Chen Xiaofa | Domestic Natural Person | 6,163,836 | 1.37 | 0 | None | | Shanghai Liyi Investment Management Partnership (Limited Partnership) - Suzhou Likang Equity Investment Center (Limited Partnership) | Domestic Non-State-Owned Legal Person | 4,687,500 | 1.04 | 0 | None | - The company's actual controller, Mr. Du Jinhao, and his wife, Ms. Qi Ju, jointly hold **100%** of Shanghai Qiaoke Enterprise Development Co., Ltd. Mr. Du Jinhao also serves as the executive partner of Shanghai Aixiang and Shanghai Aiyun. JEFFREY YANG GUO and JENNIFER GUO have signed a concerted action agreement with Mr. Du Jinhao. Some shareholders are associated with members of the Lilly Asia Ventures management team[11](index=11&type=chunk) [III. Other Reminders](index=6&type=section&id=III.%20Other%20Reminders) [1. Overall Operating Performance](index=6&type=section&id=1.%20Overall%20Operating%20Performance) The company achieved **148.75%** YoY operating revenue growth, successfully turning net profit attributable to owners and non-recurring net profit from losses to gains Overview of Q1 2023 Operating Performance | Indicator | Amount (RMB) | YoY Growth (%) | | :--- | :--- | :--- | | Operating Revenue | 277.00 million | 148.75 | | Net Profit Attributable to Owners of Parent Company | 34.88 million | Turned Loss into Profit | | Net Profit Attributable to Owners of Parent Company Excluding Non-Recurring Gains and Losses | 19.76 million | Turned Loss into Profit | [2. Commercialization Progress of Core Products](index=6&type=section&id=2.%20Commercialization%20Progress%20of%20Core%20Products) **Furmonertinib Mesylate Tablets (Aifusha®)** first-line treatment was included in the National Medical Insurance Catalog from March 1, 2023, boosting accessibility and future sales - The core product **Furmonertinib** is characterized by **strong efficacy against brain metastases, excellent therapeutic effects, good safety, and a wide therapeutic window**, with clinical study results published in multiple high-impact international academic journals and conferences[13](index=13&type=chunk) - In early 2023, the first-line treatment indication for **Furmonertinib** successfully entered the National Medical Insurance Catalog through negotiation, officially taking effect on **March 1, 2023**[13](index=13&type=chunk) - Both the second-line and first-line treatment indications for **Furmonertinib** have been included in the medical insurance reimbursement scope, which helps improve product accessibility, reduce patient medication burden, and expand the beneficiary population[13](index=13&type=chunk) [3. Company Product Pipeline Development Progress](index=6&type=section&id=3.%20Company%20Product%20Pipeline%20Development%20Progress) The company focuses on unmet clinical needs and differentiated R&D, with **Furmonertinib** new indications approved and collaborations for combination therapy and next-gen EGFR inhibitors - The company focuses on unmet clinical needs in new drug R&D, addressing limitations of existing therapies, and adopting differentiated R&D strategies[14](index=14&type=chunk) - Phase III clinical trials for **Furmonertinib** targeting first-line treatment of NSCLC with exon 20 insertion mutations and Phase Ib clinical trials for adult NSCLC patients with EGFR or HER2 kinase domain activating mutations both received IND approval in **April 2023**[14](index=14&type=chunk) - The company reached a clinical development collaboration with **Remegen Co., Ltd.** for **Furmonertinib** in combination with **RC108**, and signed a licensing agreement with **Abbisko Therapeutics Co., Ltd.** for the next-generation EGFR inhibitor **ABK3376**[14](index=14&type=chunk) [IV. Quarterly Financial Statements](index=7&type=section&id=IV.%20Quarterly%20Financial%20Statements) [1. Type of Audit Opinion](index=7&type=section&id=1.%20Type%20of%20Audit%20Opinion) The quarterly financial statements for the current reporting period are unaudited - The Q1 2023 financial statements are unaudited[3](index=3&type=chunk)[15](index=15&type=chunk) [2. Financial Statements](index=7&type=section&id=2.%20Financial%20Statements) This section presents the company's Q1 2023 consolidated balance sheet, income statement, and cash flow statement, detailing financial position and operating results [Consolidated Balance Sheet](index=7&type=section&id=Consolidated%20Balance%20Sheet) As of March 31, 2023, total assets slightly increased, with current asset adjustments, decreased total liabilities, and steadily increased owners' equity Key Items of Consolidated Balance Sheet (March 31, 2023 vs December 31, 2022) | Item | March 31, 2023 (RMB) | December 31, 2022 (RMB) | Change (%) | | :--- | :--- | :--- | :--- | | Cash and Cash Equivalents | 536,122,901.66 | 470,490,791.94 | 13.95 | | Financial Assets Held for Trading | 1,450,876,351.10 | 1,566,787,461.45 | -7.40 | | Accounts Receivable | 201,421,948.18 | 150,853,410.43 | 33.52 | | Prepayments | 32,816,699.59 | 46,915,492.17 | -30.05 | | Inventories | 40,845,899.60 | 32,072,671.46 | 27.35 | | Total Current Assets | 2,280,792,605.65 | 2,286,223,382.56 | -0.24 | | Fixed Assets | 532,051,079.29 | 523,905,661.97 | 1.55 | | Construction in Progress | 6,386,672.95 | 13,799,706.09 | -53.72 | | Development Expenditures | 19,059,566.04 | 0 | New | | Total Assets | 3,457,407,140.04 | 3,442,172,227.84 | 0.44 | | Total Current Liabilities | 218,132,503.47 | 254,618,562.47 | -14.33 | | Lease Liabilities | 2,483,369.25 | 300,597.56 | 726.14 | | Total Liabilities | 220,813,282.72 | 255,116,570.03 | -13.30 | | Total Equity Attributable to Owners of Parent Company | 3,236,593,857.32 | 3,187,055,657.81 | 1.55 | [Consolidated Income Statement](index=10&type=section&id=Consolidated%20Income%20Statement) In Q1 2023, total operating revenue grew by **148.75%**, turning operating profit and net profit from losses to gains, reflecting increased sales and R&D investments Key Items of Consolidated Income Statement (Q1 2023 vs Q1 2022) | Item | Q1 2023 (RMB) | Q1 2022 (RMB) | YoY Change (%) | | :--- | :--- | :--- | :--- | | Total Operating Revenue | 276,505,592.07 | 111,157,103.86 | 148.75 | | Operating Costs | 8,365,090.23 | 5,122,448.86 | 63.30 | | Taxes and Surcharges | 3,327,227.63 | 572,308.41 | 481.37 | | Selling Expenses | 161,097,000.64 | 75,600,531.93 | 113.09 | | Administrative Expenses | 22,979,100.16 | 20,179,798.01 | 13.87 | | R&D Expenses | 63,535,586.23 | 49,596,570.97 | 28.10 | | Financial Expenses | -4,632,475.76 | -2,826,757.89 | N/A (Increased Interest Income) | | Other Income | 3,797,159.69 | 1,233,524.25 | 207.83 | | Investment Income | 2,302,256.12 | 4,321,915.68 | -46.73 | | Operating Profit | 36,685,177.03 | -22,673,044.78 | Turned Loss into Profit | | Total Profit | 36,683,980.45 | -22,673,403.02 | Turned Loss into Profit | | Net Profit | 34,877,411.06 | -22,673,403.02 | Turned Loss into Profit | | Net Profit Attributable to Owners of Parent Company | 34,877,411.06 | -22,673,403.02 | Turned Loss into Profit | | Basic Earnings Per Share (RMB/share) | 0.08 | -0.05 | Turned Loss into Profit | [Consolidated Cash Flow Statement](index=13&type=section&id=Consolidated%20Cash%20Flow%20Statement) In Q1 2023, net operating cash flow improved significantly, investing cash flow turned positive due to increased investment recovery, and period-end cash and cash equivalents substantially increased Key Items of Consolidated Cash Flow Statement (Q1 2023 vs Q1 2022) | Item | Q1 2023 (RMB) | Q1 2022 (RMB) | | :--- | :--- | :--- | | Cash Received from Sales of Goods and Services | 260,528,608.76 | 95,701,230.22 | | Subtotal of Cash Inflows from Operating Activities | 272,071,433.11 | 96,614,850.97 | | Subtotal of Cash Outflows from Operating Activities | 292,616,318.87 | 147,864,616.28 | | Net Cash Flow from Operating Activities | -20,544,885.76 | -51,249,765.31 | | Subtotal of Cash Inflows from Investing Activities | 1,574,247,803.62 | 1,716,522,164.15 | | Subtotal of Cash Outflows from Investing Activities | 1,490,760,672.25 | 1,822,345,961.71 | | Net Cash Flow from Investing Activities | 83,487,131.37 | -105,823,797.56 | | Net Cash Flow from Financing Activities | -1,007,266.95 | -3,163,058.31 | | Net Increase in Cash and Cash Equivalents | 59,935,586.40 | -160,127,295.46 | | Cash and Cash Equivalents at End of Period | 374,809,250.57 | 683,849,810.01 |

证券代码：688578 证券简称：艾力斯 公告编号：2023-031 上海艾力斯医药科技股份有限公司 关于召开 2022 年度暨 2023 年第一季度业绩说明会的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担个别及连带责任。 重要内容提示： 投资者可于 2023 年 5 月 4 日（星期四）至 5 月 10 日（星期三）16:00 前登录 上证路演中心网站首页，点击"提问预征集"栏目，或通过公司邮箱 ir@allist.com.cn 进行提问。上海艾力斯医药科技股份有限公司（以下简称"公 司"）将在说明会上对投资者普遍关注的问题进行回答。 公司已于 2023 年 4 月 27 日、2023 年 4 月 29 日在上海证券交易所网站 （www.sse.com.cn）披露了公司 2022 年年度报告及 2023 年第一季度报告，为加 强与投资者的深入交流，在上海证券交易所的支持下，公司计划于 2023 年 5 月 11 日（星期四）下午 15:00-16:30 举行 2022 年度暨 2023 年第一季度业绩说明会， 就投资者关心的问 ...

Financial Performance - The company reported a profit distribution plan for 2022, which includes no cash dividends, no stock bonuses, and no capital reserve transfers to increase share capital[4]. - The company has not achieved profitability since its listing[3]. - The audit report issued by PwC confirms the financial statements are true, accurate, and complete[4]. - The company's operating revenue for 2022 was CNY 791,002,454.27, representing a 49.22% increase compared to CNY 530,094,158.47 in 2021[20]. - The net profit attributable to shareholders for 2022 was CNY 130,520,677.23, a significant increase of 614.22% from CNY 18,274,567.01 in the previous year[20]. - The net cash flow from operating activities reached CNY 91,629,611.67, up 212.82% from CNY 29,291,075.24 in 2021[20]. - The company achieved sales revenue of CNY 790,323,498.88 from the product Fumetin, marking a 235.29% increase compared to the previous year[22]. - Basic earnings per share for 2022 were CNY 0.29, a 625.00% increase from CNY 0.04 in 2021[21]. - The weighted average return on net assets was 4.24%, an increase of 3.62 percentage points compared to 0.62% in the previous year[21]. - The company reported a net profit of CNY 79,374,984.63 after deducting non-recurring gains and losses, marking a turnaround from a loss in the previous year[22]. - Total assets at the end of 2022 were CNY 3,442,172,227.84, a 9.96% increase from CNY 3,130,259,503.93 at the end of 2021[20]. - The company's net assets attributable to shareholders increased to CNY 3,187,055,657.81, reflecting a 7.19% growth from CNY 2,973,264,920.91 in 2021[20]. Research and Development - The company plans to invest RMB 200 million in research and development for innovative drugs over the next two years[10]. - Research and development expenses totaled CNY 191,750,085.89, a decrease of 13.86% year-over-year, with R&D expenses accounting for 24.24% of operating revenue[23]. - The company has multiple new drug candidates in preclinical research, with plans to submit IND applications for these projects in the future[41]. - The company is currently in the preclinical stage for the KRAS G12D inhibitor, with a cumulative investment of ¥5,719.64 million[79]. - The company has established a complete new drug research and development system, focusing on innovative drug development as its core strategy[72]. - The company has a strong pipeline with multiple products in various stages of development, indicating a commitment to expanding its oncology portfolio[122]. Product Development and Market Strategy - The company is advancing its core product, Vomeletinib, which is a third-generation EGFR-TKI, aimed at treating advanced non-small cell lung cancer (NSCLC) with EGFR mutations[10]. - Future guidance includes an expected revenue growth of 30% for 2023, driven by the anticipated launch of new products and market expansion strategies[10]. - The company is focusing on expanding its market presence in North America and Europe, targeting a 15% market share in these regions by 2025[10]. - The company is exploring potential mergers and acquisitions to bolster its product pipeline and expand its therapeutic offerings[10]. - The company aims to complete ongoing research and submit for conditional approval for drugs that address severe life-threatening diseases with no effective treatments available[14]. - The company is focused on obtaining priority review for innovative drugs that are urgently needed for major infectious diseases and rare diseases[14]. - The company is conducting a randomized, double-blind, placebo-controlled Phase III trial to compare the efficacy and safety of the drug in patients with EGFR mutation-positive NSCLC[13]. Corporate Governance - The company has not disclosed any special arrangements for corporate governance[5]. - The company has established a governance structure that complies with relevant laws and regulations, ensuring effective operation and management[141]. - The company held its first extraordinary general meeting of 2022 on March 28, 2022, where four proposals, including the election of non-independent directors, were approved[143]. - The annual report for 2022 indicates that the company has maintained its governance structure without any significant changes in the reporting period[144]. - The company has a total of 10 directors, with 5 being independent directors, ensuring a balanced governance structure[146]. - The company has not engaged in any significant related-party transactions that could affect its independence[145]. - The company has established specialized committees under the board, including audit, nomination, compensation, and strategic committees[167]. Environmental and Social Responsibility - The company invested 1.75 million yuan in environmental protection during the reporting period, demonstrating its commitment to sustainable practices[192]. - The company is not listed as a key pollutant discharge unit by the Shanghai Environmental Protection Department, indicating compliance with environmental regulations[193]. - The company has not faced any administrative penalties related to environmental issues during the reporting period, reflecting its adherence to environmental laws[194]. - The company has implemented carbon reduction measures, resulting in a decrease of approximately 60 tons of CO2 equivalent emissions annually[200]. - The company has established a new 64KW solar water heating system for the cafeteria and showers, expected to save 60,000 KW.H of electricity per year[200]. - The company promotes green office practices and resource conservation to enhance efficiency in electricity and water usage[197]. Market and Competitive Landscape - The domestic anti-tumor drug market reached RMB 28.1 billion in 2019, growing 46.35% from RMB 19.2 billion in 2016, with projections to exceed RMB 101.8 billion by 2030[60]. - The non-small cell lung cancer market in China grew from RMB 17.2 billion in 2016 to RMB 44.9 billion in 2020, with expectations to reach RMB 118.6 billion by 2025[62]. - The global anti-tumor drug expenditure was approximately USD 143.4 billion in 2019, with a year-on-year growth of 11.9%[59]. - The company faces risks related to reliance on a single product, Vorinostat, which may limit its operational sustainability[88]. - The competitive landscape for Vorinostat includes several approved and in-development third-generation EGFR-TKIs, increasing market competition risks[88]. Employee and Talent Management - The company emphasizes talent acquisition and training to strengthen its workforce in R&D and sales[36]. - The total number of employees in the parent company is 393, while the total number of employees in major subsidiaries is 477, resulting in a combined total of 870 employees[173][174]. - The company has implemented a competitive compensation policy that considers internal equity and industry standards, providing various benefits and incentives to attract and retain talent[176]. - A digital learning platform named "Aixuetang" was launched in 2021 to enhance employee training and development, offering various courses and resources[179]. Risk Management - The company has detailed various risk factors it may face during operations in the report[4]. - The report includes a forward-looking statement risk declaration, indicating that future plans and strategies do not constitute a substantive commitment to investors[5]. - The company is exposed to potential regulatory changes in the pharmaceutical industry, which could adversely affect its operations[90]. - If Vorinostat is removed from the medical insurance catalog, it may significantly impact its market share and sales revenue[91].

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].