InventisBio (SH:688382)2023-04-25 16:00Financial Performance - The net loss attributable to the parent company for 2022 was CNY 483 million, with a cumulative unabsorbed loss of CNY 2.021 billion[4]. - The company reported a significant increase in revenue, reaching RMB 500 million, representing a 25% year-over-year growth[25]. - The company's net profit attributable to shareholders was -483,485,014.66 RMB in 2022, a decrease from -357,911,474.59 RMB in 2021, representing an increase in loss of approximately 35%[26]. - The weighted average return on equity was -37.63% in 2022, an improvement from -42.22% in 2021[27]. - The net cash flow from operating activities was -476,894,087.23 RMB in 2022, worsening from -252,066,024.95 RMB in 2021[26]. - The company reported a net loss attributable to shareholders of RMB 483 million for the reporting period, an increase of RMB 126 million compared to the same period last year, primarily due to increased R&D expenses as products entered critical registration clinical trial phases[154]. Research and Development - Research and development expenses for the year were CNY 461 million, representing a year-on-year increase of 46.49%[4]. - The company has multiple drug development projects in progress, with all products currently in the research and development stage and no commercial sales yet[5]. - The company plans to increase its R&D budget by 30% to support ongoing and future projects[25]. - The company has established partnerships with three leading research institutions to accelerate drug development timelines[25]. - The company’s R&D expenses have increased, contributing to the net loss, as it accelerates clinical research progress[27]. - The company has invested RMB 50 million in new technology for drug development, aiming to improve efficiency by 40%[25]. - The company aims to enhance its innovation capabilities and product development to adapt to changing market rules and regulatory policies[147]. Product Pipeline and Clinical Trials - The product pipeline includes BPI-D0316, which has completed registration clinical trials for non-small cell lung cancer and is currently under review by the National Medical Products Administration (NMPA)[5]. - The company has one product in the NDA stage and four products in clinical trials, with three products approved for Phase II or III clinical trials[37]. - D-1553, a KRAS G12C inhibitor, is the first of its kind in China to enter clinical trials and is currently in Phase II trials[40]. - D-0502, an oral selective estrogen receptor degrader, has commenced Phase III clinical trials for ER-positive, HER2-negative breast cancer[41]. - D-2570, a novel oral selective TYK2 inhibitor for psoriasis, received approval to start Phase I clinical trials in June 2022[43]. - The company aims to advance more preclinical candidates into clinical trials and enrich its product pipeline in the future[47]. - The company has multiple ongoing clinical projects, including D-2570 for psoriasis and other undisclosed projects targeting tumors[50]. Market Strategy and Expansion - The company emphasizes the importance of market expansion and academic promotion for new drug acceptance post-approval[7]. - The company is expanding its market presence in Europe, targeting a 15% market share within the next two years[25]. - The company plans to adopt a combination of licensing cooperation and self-sales for product commercialization as products enter the market[72]. - The company aims to capture new drug targets and technologies to enrich its preclinical pipeline, with expectations of entering one to two products into clinical trials annually over the next three years[189]. Risks and Challenges - The company faces risks related to not being profitable, with a long cycle for drug development and significant funding requirements[5]. - There is uncertainty regarding the entry of products into the National Medical Insurance Directory, which could affect price competitiveness[8]. - The company relies on third-party CMO for the production of clinical and preclinical products, which introduces quality control risks[8]. - The company is exposed to foreign exchange risks due to international clinical trials conducted in various currencies, which may negatively impact R&D costs[146]. - The company must navigate complex regulatory environments in different countries, which can affect the approval and commercialization of its products[148]. - The company is at risk of not securing adequate intellectual property protection for its research drugs, which could allow competitors to develop similar products[149]. Corporate Governance - The company held 1 annual general meeting and 1 extraordinary general meeting during the reporting period, ensuring compliance with legal requirements and protecting the rights of minority shareholders[194]. - The board of directors consists of 9 members, including 3 independent directors, and held 8 meetings during the reporting period, approving all agenda items[194]. - The supervisory board comprises 3 members, including 2 employee supervisors, and convened 4 meetings, approving all agenda items[195]. - All resolutions from the shareholder meetings were passed without any objections, indicating effective governance and decision-making processes[198].