Financial Performance - The company reported a significant revenue increase from product sales, with sales of Envafolimab reaching RMB 567.4 million in 2022, up 841.6% from RMB 60.3 million in 2021[17]. - Revenue for 2022 reached RMB 567,392,000, a significant increase of 841.6% compared to RMB 60,260,000 in 2021[34]. - The company reported a total comprehensive loss of RMB 1,052.0 million for the year, a 28.0% improvement from a loss of RMB 1,461.8 million in 2021[21]. - The adjusted total comprehensive loss was RMB 253.2 million, down 26.1% from RMB 342.4 million in 2021[21]. - The group reported a total loss of RMB 1,052,030 thousand for the year ended December 31, 2022, compared to a loss of RMB 1,461,825 thousand in 2021[153]. - The basic and diluted loss per share for the year was RMB (22.52), compared to RMB (36.72) in 2021, reflecting an improvement in loss per share[153]. Cost and Expenses - The cost of sales for the company was RMB 42.2 million in 2022, an increase of 887.0% compared to RMB 4.3 million in 2021, primarily due to the increased product costs associated with Envafolimab[17]. - Sales and marketing expenses rose to RMB 357.7 million in 2022, a 735.0% increase from RMB 42.8 million in 2021, driven by marketing activities for Envafolimab[17]. - Research and development expenses decreased by 5.5% to RMB 350.9 million in 2022 from RMB 371.2 million in 2021, attributed to reduced milestone payments and increased outsourcing costs[17]. - Financial costs rose from RMB 1.5 million in 2021 to RMB 3.1 million in 2022, primarily due to increased interest on lease liabilities and bank loans[108]. - The total employee benefits expenses for the group amounted to approximately RMB 277.9 million, which includes salaries, social security, and stock-based compensation[166]. Product Development and Clinical Trials - The company has submitted five clinical applications, including one FDA-approved global registration clinical study[22]. - The company is actively pursuing new product development, with ongoing clinical trials for its tumor vaccine Galinpepimut-S and five patent applications submitted[22]. - The company is conducting a Phase III trial comparing chemotherapy with and without chemotherapy for advanced biliary tract cancer[30]. - The company is conducting a Phase III pivotal trial for 3D229 in the US and Europe, with enrollment completed[54]. - The company is conducting a Phase III pivotal trial for 3D189 in the treatment of AML in the U.S. and Europe[82]. - The company has received IND approval for multiple clinical trials, including those for NSCLC, RCC, and UC patients[42]. Market Presence and Product Acceptance - Envafolimab has been included in seven clinical treatment guidelines in China, indicating its growing acceptance in the medical community[22]. - Envafolimab generated sales revenue exceeding HKD 500 million in its first full fiscal year post-commercialization[38]. - Envafolimab (PD-L1) sales covered over 1,000 hospitals and more than 1,000 pharmacies across 200 cities in China by the end of 2022[70]. - Six CSCO guidelines and one Chinese Anti-Cancer Association guideline have adopted Envafolimab since its launch[32]. - The company has received recommendations from professional clinical guidelines to support the commercialization of Envafolimab[69]. Financial Position and Assets - Cash and cash equivalents as of December 31, 2022, were RMB 942,028,000, a 14.3% increase from RMB 824,484,000 in 2021[34]. - As of December 31, 2022, total assets amounted to RMB 1,332,063 thousand, an increase from RMB 1,060,293 thousand in 2021[134]. - The total liabilities to total assets ratio decreased to 33% as of December 31, 2022, from 314% as of December 31, 2021, primarily due to a reduction in preferred stock liabilities post-IPO[136]. - The net cash flow from financing activities was RMB 408.4 million in 2022, primarily from issuing ordinary shares (RMB 313.5 million) and new bank loans (RMB 149.0 million)[112]. Corporate Governance and Future Plans - The company is committed to maintaining high standards of corporate governance to enhance shareholder value and accountability[171]. - The company does not recommend the payment of a final dividend for the year ended December 31, 2022, as it plans to retain all future earnings for business operations and expansion[170]. - The company aims to enhance its market position by discovering, developing, and commercializing innovative drugs for cancer patients[120]. - The company plans to expand the indications for Envafolimab through additional clinical studies, including non-small cell lung cancer and renal cancer[119]. - The company is actively exploring financing channels to strengthen its capital reserves for ongoing R&D efforts[87].