Financial Performance - Total revenue for the year ended December 31, 2022, was RMB 160.1 million, a significant increase of 458% from RMB 28.8 million in the previous year[3] - The net loss for the year narrowed to RMB 601.5 million, a decrease of 8.2% from RMB 655.5 million in the previous year[6] - Adjusted net loss, excluding equity-settled share-based payment expenses, decreased to RMB 550.2 million, down 10.3% from RMB 613.4 million[7] - The company reported a loss attributable to ordinary shareholders of approximately RMB 617.82 million for the reporting period[43] - The total comprehensive loss for the year was RMB (96,977) thousand, compared to a profit of RMB 16,039 thousand in the previous year[138] - The company reported a pre-tax loss for the year, with basic loss per share calculated at RMB 601,488,000 for 2022, compared to RMB 655,529,000 in 2021[168] Revenue Growth - Other income and gains rose to RMB 293.9 million, up 590% from RMB 42.6 million, primarily due to foreign exchange gains[5] - Revenue increased from RMB 288 million in 2021 to RMB 1,601 million in 2022, primarily due to the commercial launch of the first-in-class XPO1 inhibitor, Selinexor (XPOVIO), in mainland China on May 13, 2022[196] - The revenue from the Greater China region for 2022 was RMB 154,870,000, a significant increase from RMB 28,531,000 in 2021, representing a growth of approximately 442%[146] - Total revenue from customer contracts for 2022 was RMB 160,135 thousand, a significant increase from RMB 28,769 thousand in 2021, representing a growth of 457%[129] Research and Development - Research and development costs increased to RMB 488.5 million, a rise of 20.6% from RMB 405.0 million, attributed to higher drug development expenses and expansion of R&D personnel[5] - The company plans to continue expanding its product pipeline and R&D capabilities to support future growth[9] - The company continues to pursue a "combination, complementary" R&D strategy to discover, develop, and commercialize first-in-class and best-in-class therapies globally[30] - The company has a pipeline of 9 clinical-stage oncology candidates, including ATG-031, which is about to enter the IND submission phase[34] - The company is advancing nine clinical-stage assets, including ATG-031 (CD24 monoclonal antibody), across various therapeutic areas and implementing a dual-engine approach for pipeline development[117] Product Development and Approvals - The lead product, XPOVIO® (Selinexor), was commercially launched in mainland China in May 2022, contributing to revenue growth[5] - XPOVIO® received multiple regulatory approvals in Singapore and Australia for various indications, enhancing market presence[9] - The company received orphan drug designation (ODD) from the FDA for ATG-101, a novel PD-L1/4-1BB bispecific antibody, for the treatment of pancreatic cancer in September 2022[24] - The company has received FDA approval for ATG-031 in the US and South Korea, with NDA submissions completed in Greater China and other regions[35] - XPOVIO® has received NDA approval in mainland China, Australia, South Korea, Singapore, and Taiwan, with plans to submit NDA applications in Malaysia and Thailand for treating relapsed/refractory multiple myeloma and diffuse large B-cell lymphoma[33] Clinical Trials and Collaborations - The company completed the first patient dosing in the single-arm Ib phase study (MATCH study) in April 2022, evaluating the safety, tolerability, and preliminary efficacy of XPOVIO® (selinexor) combined with onatasertib (ATG-008) for relapsed/refractory diffuse large B-cell lymphoma[11] - A clinical trial collaboration was established with BeiGene to evaluate the safety and preliminary efficacy of selinexor combined with BeiGene's anti-PD-1 checkpoint inhibitor in T-cell and NK-cell lymphoma patients[30] - The company is conducting a global clinical collaboration with Merck for the STAMINA-001 trial, exploring ATG-037 as a monotherapy and in combination with pembrolizumab for locally advanced or metastatic solid tumors[30] - The company has entered into a clinical trial collaboration with BeiGene to evaluate the safety and efficacy of XPOVIO® in combination with BeiGene's anti-PD-1 inhibitor[71] Operational Expenses - Sales and distribution expenses surged to RMB 355.4 million, an increase of 523% from RMB 67.9 million, driven by milestone payments related to the commercialization of the lead product[6] - Administrative expenses slightly decreased to RMB 167.1 million from RMB 169.5 million, mainly due to reduced professional fees[6] - Employee benefits expenses, excluding directors and senior management, rose to RMB 289,136 thousand in 2022 from RMB 183,540 thousand in 2021, an increase of 57%[132] - Total expenses for the year reached RMB 488,491 thousand in 2022, compared to RMB 405,029 thousand in 2021, indicating a rise in operational costs[198] Market Strategy and Future Plans - The company plans to build its commercial team in preparation for the launch of Selinexor tablets in Greater China and other Asia-Pacific regions, addressing unmet medical needs[136] - The company anticipates continued growth in revenue driven by the expansion of its product offerings and market presence[196] - The company plans to continue expanding its market presence, particularly in the Greater China region, which has shown substantial revenue growth[146]
德琪医药-B(06996) - 2022 - 年度业绩