Financial Performance - Revenue for the year ended December 31, 2022, was RMB 27,149,000, representing a year-on-year increase of 21.1% from RMB 22,426,000[2] - Gross profit for the same period was RMB 19,362,000, up 24.6% from RMB 15,545,000 in 2021[2] - The net loss for the year was RMB 118,316,000, a decrease of 6.5% compared to a loss of RMB 126,497,000 in the previous year[4] - Other income increased to RMB 8,750,000 in 2022 from RMB 4,405,000 in 2021, representing a growth of about 98.5%[25] - The group reported a pre-tax loss of RMB 118,316,000 for 2022, slightly improved from a loss of RMB 126,497,000 in 2021[31] - Cumulative tax losses in mainland China amounted to RMB 574,129,000 as of December 31, 2022, compared to RMB 477,847,000 in 2021, reflecting an increase of 20.2%[31] - The group did not declare any dividends for the year, consistent with 2021[33] - The company reported a credit loss rate of 100% for trade receivables amounting to RMB 74,000, indicating a complete impairment expectation[38] - The company did not recommend the payment of a final dividend for the reporting period[95] Cash and Assets - Cash and cash equivalents increased by 43.4% to RMB 226,422,000 from RMB 157,867,000[2] - Total assets less current liabilities amounted to RMB 268,129,000, compared to RMB 203,404,000 in the previous year[7] - Trade receivables remained unchanged at RMB 74,000 for both 2022 and 2021, with no impairment losses recorded[34] - Other receivables decreased from RMB 19,970,000 in 2021 to RMB 17,858,000 in 2022, reflecting a reduction of approximately 10.6%[40] - The company’s accounts payable increased significantly from RMB 314,000 in 2021 to RMB 1,763,000 in 2022, marking a growth of over 461%[42] - Total other payables and accrued expenses rose from RMB 23,699,000 in 2021 to RMB 37,275,000 in 2022, an increase of approximately 57.3%[43] Research and Development - Research and development expenses for the year were RMB 59,933,000, down from RMB 89,827,000 in 2021[4] - The company has established a product development team consisting of 86 internal R&D staff and 37 clinical operation staff as of December 31, 2022[69] - The company has a total of 120 patents and 48 patent applications as of December 31, 2022, to protect its core technologies[69] - Employee costs increased by RMB 140 million, contributing to the rise in R&D expenses, which included a total of RMB 322.85 million for the year ended December 31, 2022, representing 53.8% of total R&D expenses[77][78] - The company plans to invest significantly in R&D to develop innovative solutions and improve operational efficiency[112] Product Development and Regulatory Approvals - The Cryofocus cryoablation system was designated as a "Breakthrough Device" by the U.S. Food and Drug Administration in December 2022[3] - The bladder cryoablation system received regulatory approval from the National Medical Products Administration in June 2022 and was commercialized in December 2022[48] - The endoscopic stapler was approved in August 2022 and commercialized in October 2022, targeting patients with acute gastrointestinal bleeding and perforations[49] - The cardiac cryoablation system is expected to receive regulatory approval in the second quarter of 2023 after submitting the registration application in July 2022[50] - The pulmonary hypertension cryoablation system is currently in preclinical research, with anticipated regulatory approval in the first half of 2026[52] - The COPD cryo-spray treatment system entered the confirmatory clinical trial phase in March 2023, with expected registration submission in the second half of 2025 and approval in the second half of 2026[53] - The asthma cryoablation system also entered the confirmatory clinical trial phase in March 2023, with similar timelines for registration submission and approval as the COPD system[54] Corporate Governance and Compliance - The Audit Committee has been established, consisting of one non-executive director and two independent non-executive directors, with the main function to provide independent opinions on financial reporting procedures and internal controls[98] - The annual financial performance for the year ended December 31, 2022, has been reviewed and deemed compliant with relevant accounting standards and regulations[98] - The consolidated financial statements for the year ended December 31, 2022, have been agreed upon by the external auditor, Ernst & Young, confirming consistency with the preliminary figures[99] - The company confirms compliance with corporate governance codes as per listing regulations[107] - The board of directors emphasizes the importance of adhering to the listing rules and corporate governance standards[112] Market and Strategic Outlook - The company aims to maintain strict control over outstanding receivables to minimize credit risk, with management regularly reviewing overdue balances[35] - The company has identified a significant market opportunity in minimally invasive procedures, focusing on both natural orifice transluminal endoscopic surgery and vascular intervention therapies[45] - Future outlook includes strategic market expansion and potential mergers and acquisitions to drive growth[112] - The company aims to leverage its subsidiary, Ningbo Shengjie Kang Biotechnology Co., Ltd., to enhance its market presence in the biotechnology sector[112] - The board is optimistic about achieving sustainable growth and profitability in the coming years[112]