Corporate Governance and Compliance - The company received approval from the China Securities Regulatory Commission for overseas listing on March 30, 2023, and was officially listed on the Hong Kong Stock Exchange on September 25, 2023[13]. - The internal control system is deemed comprehensive and effective, aligning with national laws and the company's operational needs[162]. - The supervisory board confirmed that there were no violations of laws or regulations by directors and senior management in 2023[160]. - The company is committed to high standards of corporate governance to enhance management and protect shareholder interests[181]. - The financial statements for the year ending December 31, 2023, were audited and found to be free from false statements or significant omissions[161]. - The company was not involved in any significant litigation or arbitration during the reporting period, and there are no pending or threatening significant lawsuits against the group[186]. - The financial statements are prepared based on the International Financial Reporting Standards, with a focus on deferred tax assets and liabilities[188]. Research and Development - The company completed the enrollment for the Phase II clinical trial of Y101D for pancreatic cancer ahead of schedule[14]. - The company obtained IND approval for Y332 in April 2023, initiating Phase I clinical research for the treatment of metastatic or locally advanced solid tumors[14]. - The company achieved five invention patents in 2023 and submitted one invention patent application, enhancing its core intellectual property[16]. - The company is committed to innovation-driven development, focusing on original breakthroughs in dual antibody technology and differentiated clinical development strategies[16]. - The core product M701, targeting human cancer cell surface antigen EpCAM and human T cell surface antigen CD3, has completed Phase II clinical trials for malignant ascites and is set to enter Phase III trials approved by the National Medical Products Administration[28]. - The company has successfully completed the production of clinical trial samples for Y400 while also achieving technology transfer for multiple projects[29]. - The company has focused on team building, recruiting several core talents in 2023 to enhance R&D capabilities and professional management[31]. - The company plans to focus on accelerating the development of candidate drugs, particularly M701 and Y101D, in 2024[88]. - M701 is currently undergoing an Ib/II clinical trial in China, with 24 patients recruited for the Ib phase, showing preliminary efficacy in controlling MPE in NSCLC patients[43]. - Y101D, a candidate for treating solid tumors, is in an Ib/II clinical trial for hepatocellular carcinoma (HCC) and other advanced solid tumors, with the trial having started in March 2023[45]. - Y332, targeting multiple solid tumors, began its I phase clinical trial in October 2023, currently in the dose escalation stage[46]. - The company plans to collaborate with a contract sales organization in China and establish an internal sales team of about 20 employees for M701's commercialization[87]. Financial Performance - Non-current assets decreased to RMB 51,523 thousand in 2023 from RMB 63,885 thousand in 2022, reflecting a decline of approximately 19.5%[35]. - Current assets increased to RMB 250,101 thousand in 2023, up from RMB 238,957 thousand in 2022, marking an increase of about 4.8%[35]. - Total liabilities increased, with current liabilities rising to RMB 173,820 thousand in 2023 from RMB 146,960 thousand in 2022, an increase of approximately 18.2%[35]. - The company's net asset value decreased to RMB 127,654 thousand in 2023 from RMB 155,882 thousand in 2022, a decline of about 18.1%[35]. - The company reported other income of RMB 13,014 thousand for the year ending December 31, 2023, compared to RMB 2,560 thousand in 2022[61]. - Research and development expenses for the year were RMB (155,054) thousand, slightly down from RMB (157,329) thousand in the previous year[61]. - The company achieved a net loss of RMB (191,702) thousand for the year, compared to RMB (188,866) thousand in 2022[61]. - Government subsidies accounted for 92.0% of other income in 2023, significantly contributing to the overall revenue[77]. - The company recorded a total R&D expenditure of RMB 155,054,000 for the year ended December 31, 2023, with 61.6% or RMB 95,513,000 attributed to outsourced services[114]. - The company reported a net cash increase of RMB 43,164 thousand for the year ended December 31, 2023, compared to RMB 70,435 thousand in 2022, representing a decrease of approximately 38.7%[124]. - Total financing cash inflow for the year was RMB 176,292 thousand, down from RMB 241,334 thousand in the previous year, indicating a decline of about 26.9%[124]. - The company incurred a pre-tax loss of RMB 191,702 thousand for the year, compared to a loss of RMB 188,866 thousand in 2022, showing an increase in loss of about 1.4%[141]. - The company’s basic and diluted loss per share for the year was RMB 1.04, compared to RMB 1.10 in the previous year, indicating an improvement of about 5.5%[141]. - The company raised RMB 173,956 thousand from share issuance during the year, down from RMB 200,000 thousand in 2022, representing a decrease of approximately 13.1%[124]. - Administrative expenses increased to RMB 22,311 thousand from RMB 20,525 thousand in the previous year, reflecting an increase of about 8.7%[141]. - The company’s total liabilities included a repayment of bank loans amounting to RMB 76,500 thousand, significantly higher than RMB 28,000 thousand in 2022, indicating an increase of approximately 173.2%[124]. - The company’s listing expenses for the year were RMB 24,629 thousand, compared to RMB 11,775 thousand in 2022, representing an increase of about 109.5%[141]. Strategic Goals and Market Position - The company aims to maintain a competitive advantage in the development of First-in-Class and Best-in-Class products[16]. - The company aims to enhance its commercialization capabilities and expand its market presence in China while seeking collaboration opportunities for overseas promotion of its candidate drugs[51]. - The company has established a solid foundation for internal management and operational stability, ensuring sustainable growth[32]. - The company is committed to advancing the R&D and commercialization of candidate drugs to continuously create value for all stakeholders[33]. - The company has made significant progress in its candidate drug pipeline and business operations, with a focus on M701 for treating malignant ascites (MA) and malignant pleural effusion (MPE)[41].
友芝友生物(02496) - 2023 - 年度财报