SHANGHAI YIZHONG(SH:688091)2022-03-30 16:00Financial Performance - The company reported a total revenue of 4.0775 million yuan for the year 2021, indicating that it has not yet achieved profitability[5]. - The net profit attributable to the parent company was -3.9971 million yuan, and the net profit after deducting non-recurring gains and losses was -17.7327 million yuan[5]. - The net loss attributable to shareholders was CNY 3.99 million in 2021, an improvement from a loss of CNY 21.85 million in 2020[34]. - The company achieved sales revenue of RMB 4.08 million in 2021, with a net profit attributable to shareholders of -RMB 3.9971 million, reducing losses by 81.7% compared to the previous year[54]. - The net profit attributable to shareholders after deducting non-recurring gains and losses was -RMB 17.7327 million, a reduction in losses of 41.01% year-on-year[54]. - The basic earnings per share for 2021 was -CNY 0.05, an improvement from -CNY 0.28 in 2020[38]. - The diluted earnings per share for 2021 was also -CNY 0.05, consistent with the basic earnings per share[38]. - The weighted average return on equity was -0.84% in 2021, showing a significant recovery from -8.59% in 2020[38]. - The company reported a net cash flow from operating activities of -CNY 48.78 million in 2021, worsening from -CNY 20.21 million in 2020[37]. - The gross profit margin for the paclitaxel micelle injection was 92.75%, with a cost of sales amounting to CNY 295,806.16[128]. Product Development and Market Position - The company initiated commercial production and sales of its core product, paclitaxel polymer micelles injection, after receiving approval on October 26, 2021[38]. - The core product, paclitaxel polymer micelles, was approved for marketing on October 26, 2021, marking a significant milestone for the company[51]. - The injectable paclitaxel polymer micelle is classified as a Category 2.2 new drug, with a broad market application potential for over 80% of breast cancer patients[88]. - The company achieved revenue of CNY 4.0775 million in the reporting period, marking its first year of sales since the approval of the paclitaxel micelle injection in October 2021[120]. - The injectable paclitaxel polymer micelle has significant clinical advantages over other chemotherapy drugs, establishing a sustained first-mover advantage in the chemotherapy field[77]. - The company’s core product, injectable paclitaxel polymer micelles, received approval from the National Medical Products Administration on October 26, 2021, as a Class 2.2 new drug, suitable for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR gene mutation negative and ALK gene negative[182]. Research and Development - The total R&D investment for the year was approximately ¥13.24 million, representing a decrease of 26.01% compared to the previous year[87]. - The company has three invention patents related to the injectable paclitaxel polymer micelles, highlighting its commitment to innovation[58]. - The company is actively conducting preclinical research on cabazitaxel micelles, utilizing advanced core technologies to develop innovative drug excipients[81]. - The R&D department collaborates with production and quality management to ensure compliance with GMP standards and to prepare for new drug applications[70]. - The company is in the preclinical research stage for cabazitaxel micelles, with plans to increase R&D investment based on progress to enhance future profitability[94]. - Research and development investment for the anti-tumor drug, injectable paclitaxel polymer micelles, amounted to ¥12,471,171.89, representing a decrease of 30.30% compared to the same period last year[4]. Market Strategy and Sales - The company plans to increase investment in marketing network construction and expansion to enhance product market coverage[54]. - The company employs a self-operated sales model, focusing on brand establishment and innovative product positioning to enhance market penetration[67]. - The company signed cooperation agreements with several pharmaceutical groups to expand sales channels[54]. - The company aims to meet market demand and adapt its business strategies according to market conditions[50]. - The company has established a long-term incentive mechanism and talent training plan to strengthen its marketing capabilities[5]. Risks and Challenges - The uncertainty regarding the timing of the product's inclusion in the national medical insurance directory poses a risk to commercial sales, which currently depend on out-of-pocket payments by patients[113]. - The company faces competitive pressure from new therapies and drugs that may emerge in the oncology market, particularly in the field of lung cancer treatment[116]. - The regulatory environment in the pharmaceutical industry is highly dynamic, and changes in policies could adversely affect the company's operations and pricing strategies[117]. - The ongoing impact of the COVID-19 pandemic introduces uncertainties that may affect the company's market expansion and product promotion activities[117]. - The company is facing new challenges from the patent linkage system, which grants original drug companies the right to protect their commercial interests against generic drugs[175]. Financial Management - The company reported a substantial increase in interest income due to effective cash management of its own and raised funds[122]. - The company's cash and cash equivalents at the end of the period were RMB 110,430,532.95, representing 9.20% of total assets, a significant increase from 0.07% in the previous year[156]. - Investment activities resulted in a net cash outflow of RMB -785,629,589.39, a decrease of 4721.83% compared to the previous year[154]. - Financing activities generated a net cash inflow of RMB 944,652,787.24, an increase of 28,966.24% compared to the previous year[154]. - The company experienced a significant increase in management expenses due to personnel growth and costs associated with its initial public offering[122].