Financial Performance - Revenue increased by RMB 12.3 million or 5.9% from RMB 209.7 million for the year ended December 31, 2022, to RMB 222.0 million for the year ended December 31, 2023[2]. - Other income decreased by RMB 7.7 million or 11.5% from RMB 67.0 million to RMB 59.3 million, primarily due to a reduction in government subsidies and fair value gains from financial instruments[2]. - Loss increased by RMB 42.8 million or 4.8% from RMB 882.9 million to RMB 925.7 million for the year ended December 31, 2023[3]. - The company reported a net loss of RMB 925.71 million for the year ended December 31, 2023, compared to a net loss of RMB 882.92 million in 2022[32]. - The total comprehensive loss for the fiscal year ending December 31, 2023, was RMB 899.45 million, compared to RMB 821.43 million for the fiscal year ending December 31, 2022[64]. - The company's total assets decreased to RMB 1,566.22 million in 2023 from RMB 1,949.11 million in 2022, indicating a decline of approximately 19.6%[34]. - The company's total liabilities included a deferred tax credit of RMB (7,150,000) for the year, compared to RMB (4,248,000) in 2022[55]. - The company's basic loss per share for the fiscal year ending December 31, 2023, was RMB 925.64 million, compared to RMB 882.92 million for the fiscal year ending December 31, 2022[57]. Research and Development - R&D expenses decreased by RMB 36.1 million or 4.9% from RMB 743.1 million to RMB 707.0 million, mainly due to a reduction in outsourced services[3]. - The company has conducted over 40 ongoing Phase I/II clinical trials globally, leveraging its proprietary platform for drug development targeting apoptosis and immune modulation[6]. - The core product, Olverembatin (APG-2575), has been approved for commercialization in China, marking a significant milestone in the company's product pipeline[6]. - The company has developed a rich pipeline of nine clinical-stage small molecule candidates, including next-generation multi-kinase inhibitors targeting FAK/ALK/ROS1[6]. - The company is focused on addressing unmet clinical needs for patients globally, aiming to benefit more patients through its innovative therapies[6]. - The company aims to enhance its R&D capabilities to develop innovative therapies that address unmet medical needs[92]. Product Development and Clinical Trials - Cumulative sales of Nairike® (Aorebatin) reached RMB 362.1 million since its launch in November 2021, with a 259% increase in sales volume in 2023 compared to 2022[4]. - The number of patients increased by 123% and the number of hospitals with access increased by 567% for Nairike® (Aorebatin) in 2023[4]. - Nairike® (Aorebatin) was included in the 2022 National Medical Insurance Drug List and received approval for clinical trials in various indications[4]. - The company received clinical trial approvals from the NMPA for the global pivotal Phase III studies of lisaftoclax (APG-2575) for treating newly diagnosed elderly/fragile acute myeloid leukemia (AML) patients in December 2023 and for first-line treatment in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients in October 2023[5]. - Lisaftoclax (APG-2575) has been approved for 21 clinical studies in China, the US, Australia, and Europe, targeting various hematological malignancies and solid tumors, with over 800 patients treated, including more than 400 CLL/SLL patients[12]. - The company is actively pursuing key registration studies for GIST and Ph+ ALL indications[10]. - Recent clinical data presented at the 2023 ASH Annual Meeting showed promising results for Nairike® (Aorebatin) in CML-CP patients resistant to second-generation TKIs[11]. Market and Commercialization - The commercialization team has expanded to approximately 100 members, covering 117 distributors and over 800 hospitals, with 526 hospitals and DTP pharmacies included in 2023[29]. - The product Nairike (Aorebatin) was successfully included in the National Reimbursement Drug List (NRDL) in January 2023, enhancing patient accessibility[29]. - The company aims to expand the commercialization and accessibility of Nairike® (Aorebatin) in both domestic and international markets[8]. - The company is advancing its late-stage commercialization and marketing teams to support its innovative drug development efforts[6]. - The company is investing $20 million in the development of APG-2575, a novel oral Bcl-2 inhibitor, with expected completion in 2025[119]. Financial Position and Assets - The company's production facility in Suzhou has a capacity of 250 million tablets/capsules per year, supporting its transition from Biotech to Biopharma[30]. - The company's net asset value dropped from RMB 408,658 thousand in 2022 to RMB 70,632 thousand in 2023, a decrease of around 82.7%[36]. - The company's long-term payables decreased from RMB 35,331 thousand in 2022 to RMB 18,299 thousand in 2023, a reduction of approximately 48.2%[35]. - The total amount of bank and other borrowings due within one year was RMB 616.4 million, compared to RMB 518.4 million in the previous year[83]. - The group had no significant contingent liabilities as of December 31, 2023[84]. Governance and Compliance - The financial statements were prepared in accordance with International Financial Reporting Standards, reflecting a commitment to transparency and compliance[38]. - The company confirmed compliance with the corporate governance code during the reporting period[93]. - The audit committee has reviewed the financial performance for the year ended December 31, 2023, ensuring compliance with relevant accounting standards[110]. Employee and Organizational Structure - The group employed 583 full-time employees as of December 31, 2023, with 401 (68.8%) in R&D roles[87]. - Employee benefit expenses for the years ended December 31, 2022, and 2023 were RMB 427.6 million and RMB 413.0 million, respectively[88]. - The board of directors includes Dr. Dajun Yang as the chairman and CEO, along with other non-executive and independent directors[124].
亚盛医药(06855) - 2023 - 年度业绩