Financial Performance - The net loss for the year ended December 31, 2022, was RMB 892 million, a decrease of RMB 3,852 million compared to the net loss of RMB 4,744 million for the year ended December 31, 2021[3]. - Adjusted net loss for the year ended December 31, 2022, was RMB 848 million, an increase of RMB 299 million from RMB 549 million for the year ended December 31, 2021[3]. - The company incurred a foreign exchange loss of RMB 97 million for the year ended December 31, 2022, compared to a foreign exchange gain of RMB 7 million for the previous year, resulting in a net impact of RMB 104 million[3]. - Operating losses for the years ended December 31, 2022, and 2021 were RMB 881 million and RMB 574 million, respectively, primarily due to R&D and administrative expenses[37]. - The company has not recognized any income tax liabilities for the years ended December 31, 2022, and 2021, due to the absence of taxable profits[75]. - The total expenses for the year ended December 31, 2022, were RMB 816,096 thousand, up from RMB 627,552 thousand in 2021, reflecting a rise in operational costs[71]. - The company reported a total revenue of RMB 353,228 thousand for the year ended December 31, 2022, compared to RMB 235,435 thousand for the year ended December 31, 2021, representing an increase of approximately 50%[69]. Research and Development - Zevor-cel, a CAR-T cell therapy candidate for treating relapsed/refractory multiple myeloma, has had its new drug application accepted for priority review by the National Medical Products Administration in China[5]. - The company has made significant progress in technology innovation and product pipeline development in both the U.S. and China during the reporting period[5]. - The company aims to address major challenges in CAR-T therapy, such as improving safety, enhancing efficacy for solid tumors, and reducing treatment costs[7]. - The company has established a comprehensive R&D platform covering the entire CAR-T development cycle, enhancing efficiency from early discovery to clinical trials[21]. - The company is focused on advancing clinical development of its candidates, zevor-cel and CT041, both domestically and internationally[36]. - The company is committed to developing innovative CAR-T therapies to address unmet medical needs, particularly for solid tumors[35]. Clinical Trials and Product Development - Ongoing Phase II clinical trials for Zevor-cel are being conducted in the United States and Canada, with updates presented at major conferences[5]. - CT041 is the world's first and only CAR-T cell candidate for solid tumors to enter Phase II clinical trials, with ongoing trials for advanced gastric and pancreatic cancers in the US and Canada[6]. - The company’s core candidate, Zevor-cel, is in the most advanced stage of development for treating relapsed/refractory multiple myeloma (R/R MM)[8]. - CT041 is currently in confirmatory Phase II clinical trials, while CT011 is in Phase I and AB011 is in Phase Ib clinical trials[8]. - The company plans to conduct additional clinical trials for both Zevor-cel and CT041 as early treatment options for multiple myeloma and solid tumors, respectively[12][15]. - The company showcased updated results for Zevor-cel at the 64th ASH Annual Meeting in December 2022, highlighting its efficacy and safety[11]. Manufacturing and Production - The RTP manufacturing facility in North Carolina has commenced GMP production of autologous CAR-T cell products, with the capacity to produce for 700 patients annually to support clinical research and early commercialization in the US, Canada, and Europe[6]. - The company has established independent vertical integration for CAR-T manufacturing, including plasmid production, lentiviral vector production, and CAR-T cell production[6]. - The company has established a GMP-compliant production capacity for vertical integration of CAR-T manufacturing, with a clinical production facility in Shanghai supporting CAR-T therapy for 200 patients annually and a commercial-scale facility capable of supporting up to 2,000 patients per year[26]. - The RTP facility has successfully released its first GMP batch for clinical trials, marking a significant milestone in the company's production capabilities[27]. Collaborations and Partnerships - The company signed a collaboration agreement with East China Pharmaceutical Co., Ltd. for the commercialization of its lead candidate, Zevor-cel, in mainland China[6]. - A collaboration agreement was established with F. Hoffmann-La Roche Ltd to evaluate the clinical trial of AB011 in combination with Roche's PD-L1 inhibitor and standard chemotherapy for GC/GEJ patients[6]. - The collaboration with Roche involves a clinical trial for AB011 combined with Roche's PD-L1 inhibitor, with both companies sharing the costs of the trial[31]. - The partnership with HK Inno.N Corporation includes a licensing agreement for the development and commercialization of CT032 and zevor-cel in South Korea, with potential payments totaling up to $50 million[32]. Intellectual Property and Patents - As of December 31, 2022, the company holds over 300 patents, including 83 global patents, with an increase of 25 granted patents and 51 patent applications compared to the end of 2021, indicating a strong focus on intellectual property generation[25]. - The company is exploring multiple targets for CAR-T therapies, including CLDN18.2, GPC3, and mesothelin, to enhance treatment efficacy[21]. Employee and Organizational Changes - As of December 31, 2022, the company employed 539 staff members and strengthened its leadership team by hiring a new Chief Medical Officer and a Senior Vice President for Global Regulatory Affairs[33]. - The employee count decreased from approximately 573 as of December 31, 2021, to 539 as of December 31, 2022, with 64.38% being female employees[60]. Future Outlook and Strategic Plans - The company plans to fully utilize the remaining net proceeds by 2025, later than originally planned due to cost savings from operational efficiencies[95]. - The company is expanding its research efforts in artificial receptor technology, which is similar to the synNotch system, to enhance therapeutic efficacy[106]. - The company is exploring new markets and potential partnerships to enhance its growth strategy and product offerings[109].
科济药业-B(02171) - 2022 - 年度业绩