Allist(SH:688578)2022-08-05 16:00Financial 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].