Financial Performance - The net loss for the year ended December 31, 2023, was RMB 748 million, a decrease of RMB 144 million compared to the net loss of RMB 892 million for the year ended December 31, 2022[3]. - Adjusted net loss for the year ended December 31, 2023, was RMB 733 million, down RMB 115 million from RMB 848 million for the year ended December 31, 2022[3]. - The company reported a net loss of RMB 747.794 million for the year ended December 31, 2023, compared to a net loss of RMB 892.247 million for the year ended December 31, 2022, indicating a reduction in losses of approximately 16.2%[42]. - Adjusted net loss decreased from RMB 848.252 million in 2022 to RMB 733.336 million in 2023, reflecting a 13.5% improvement[42]. - The operating loss for the year ended December 31, 2023, was RMB 768 million, compared to RMB 881 million for the year ended December 31, 2022, primarily due to reduced R&D and administrative expenses[38]. - The company reported a net loss before tax of RMB (30,837) thousand in 2023 compared to a net loss of RMB (100,796) thousand in 2022, indicating an improvement in financial performance[71]. - The company’s basic loss per share for 2023 was RMB (1.34), a decrease from RMB (1.62) in 2022, with total losses attributable to ordinary equity holders amounting to RMB (747,794) thousand in 2023 compared to RMB (892,247) thousand in 2022[80]. Cash and Bank Balances - Cash and bank balances as of December 31, 2023, were RMB 1,850 million, a decrease of RMB 418 million from RMB 2,268 million as of December 31, 2022[3]. - The company had cash and cash equivalents of RMB 1.849752 billion at the end of 2023, down from RMB 2.268036 billion at the end of 2022[49]. - Cash used in operating activities was RMB 454.935 million for the year ended December 31, 2023, compared to RMB 643.048 million in 2022, showing a decrease of about 29.3%[49]. - The net cash generated from investment activities was RMB 39.251 million in 2023, significantly lower than RMB 2.38699 billion in 2022, primarily due to the redemption of fixed-term deposits[52]. - The net cash used in financing activities was RMB 22.142 million in 2023, compared to RMB 236.514 million in 2022, indicating a substantial reduction in financing outflows[53]. Research and Development - The company is focused on developing innovative CAR-T therapies to address significant challenges in safety and efficacy for solid tumors and blood malignancies[10]. - The company has established a comprehensive R&D platform for CAR-T cell therapy, from target discovery to commercial-scale production[10]. - The company aims to continue investing in research and development to expedite the approval of candidate products for market launch, anticipating future operational revenue[51]. - The company is actively pursuing regulatory approvals, including BLA submissions, to expedite the market entry of its innovative therapies[93]. - The company has initiated several clinical trials, including Phase I and II studies, to evaluate the safety and efficacy of its drug candidates[96]. Clinical Trials and Approvals - CT041 is the world's first CAR-T cell candidate for solid tumors to enter Phase II clinical trials, with IND approval received in April 2023 for treating Claudin18.2 positive pancreatic cancer[5]. - CT071 received IND approval from the FDA on November 30, 2023, for treating relapsed or refractory multiple myeloma and relapsed/refractory primary plasma cell leukemia[7]. - Zewokaiolun is currently in a Phase II clinical trial for treating relapsed/refractory multiple myeloma, with over 100 patients enrolled in the North American trial[14]. - The Phase 1b/2 clinical trial for CT041 in advanced GC/GEJ was initiated in May 2023 but has been paused due to CMC-related issues at the RTP manufacturing facility[17]. - The company plans to conduct additional clinical trials to develop Zewokaiolun as an early-line treatment for multiple myeloma[15]. Manufacturing and Production Capacity - The RTP manufacturing facility is expected to provide additional capacity to produce autologous CAR-T cell products for 700 patients annually, supporting clinical research and early commercialization in the US, Canada, and Europe[7]. - The company has established a vertically integrated production capability for CAR-T manufacturing, including plasmid production, lentiviral vector production, and CAR-T cell production[7]. - The Shanghai Jinshan commercial production facility, covering approximately 7,600 square meters, is estimated to support CAR-T cell treatment for up to 2,000 patients annually and has received the first production license for CAR-T cell therapy in China[30]. - The company is expanding its production capacity in China and the United States to support clinical trials and future commercialization of its pipeline products[30]. - The company has developed comprehensive manufacturing and commercialization capabilities, raising HKD 601.6 million, with HKD 545.2 million utilized[87]. Collaborations and Partnerships - The company signed a collaboration agreement with Huadong Medicine for the commercialization of its lead candidate, Zewokaiolun, in mainland China in January 2023[8]. - The collaboration with Moderna aims to explore the combination effects of CT041 with Moderna's experimental vaccine[8]. - The company has established a licensing agreement with HK Inno.N Corporation for the development and commercialization of CT032 and a related injection in South Korea, with potential upfront payments totaling up to $50 million[34]. - A commercialization cooperation agreement was signed with East China Pharmaceutical for the drug Sai Kai Ze®, which includes an upfront payment of RMB 200 million and potential milestone payments up to RMB 1,025 million[33]. Market and Growth Strategy - The company aims to become a global leader in biopharmaceuticals by providing innovative and differentiated cell therapies for cancer patients[10]. - The global CAR-T cell therapy market has been experiencing strong growth, driven by rising cancer incidence and the approval of more CAR-T therapies for various cancer types[36]. - The company plans to continue expanding in both domestic and global markets through self-development, mergers, and acquisitions[62]. - The company is focusing on expanding its market presence through strategic partnerships and collaborations in the biopharmaceutical sector[94]. Risks and Forward-Looking Statements - The company emphasizes that it cannot guarantee the successful development or commercialization of its products, urging shareholders and potential investors to act cautiously[16]. - The company advises stakeholders to refer to its annual and interim reports for detailed information on major risks and uncertainties[97]. - The announcement highlights that actual events or results may differ significantly from those projected in forward-looking statements due to uncontrollable assumptions and factors[97]. - The company does not make any representations or guarantees regarding the realization or reasonableness of any forecasts, targets, estimates, or expectations mentioned in the announcement[97].
科济药业-B(02171) - 2023 - 年度业绩