Financial Performance - For the year ended December 31, 2022, the company's revenue was RMB 957 million, primarily due to reimbursement from a collaboration agreement with AbbVie for the development, manufacturing, and commercialization of the SHP2 inhibitor[12]. - The net loss for the year increased from RMB 3,012 million for the year ended December 31, 2021, to RMB 3,719 million for the year ended December 31, 2022[12]. - The company reported revenue of RMB 957.46 million for the year ended December 31, 2022, a decrease of 37.5% from RMB 1,528.09 million in 2021[68]. - The gross profit decreased slightly to RMB 126.34 million in 2022 from RMB 128.30 million in 2021, representing a decline of about 1.5%[68]. - Other income fell significantly to RMB 18.54 million in 2022 from RMB 109.97 million in 2021, primarily due to a decrease in government subsidies by RMB 94 million[69]. - The adjusted loss for the year was RMB 356.2 million in 2022, compared to RMB 284.7 million in 2021, reflecting an increase of 25.1%[78]. - The company reported a loss attributable to owners of RMB 371,861 thousand for the year ended December 31, 2022, compared to a loss of RMB 301,187 thousand in 2021, representing an increase of approximately 23.4%[128]. - The basic loss per share for 2022 was RMB (0.49), compared to RMB (0.40) in 2021, indicating a deterioration in earnings performance[128]. Research and Development - Research and development expenses increased from RMB 808 million for the year ended December 31, 2021, to RMB 1,456 million for the year ended December 31, 2022, mainly due to the progress of clinical candidates and expansion of preclinical research activities[12]. - The company has developed a pipeline of eight clinical-stage assets and several other assets awaiting IND initiation, showcasing broad applicability across various tumor types[14]. - The company plans to submit IND applications for JAB-23400 and JAB-30300 in the second half of 2023[8][9]. - The company has initiated a Phase IIa trial for JAB-21822 in CRC, PDAC, and other solid tumors, with the first patient enrolled in March 2022[15]. - The company is actively recruiting patients for the combination therapy of JAB-3312 and Sotorasib (KRAS G12C inhibitor) in a Phase I trial, with plans to expand to Europe[17]. - The company has established a collaboration with Merck for a clinical trial evaluating the combination of Glecirasib and Cetuximab in KRAS G12C mutant colorectal cancer patients[27]. - The company is developing therapies targeting KRAS mutations, addressing significant unmet medical needs in tumors like pancreatic cancer and CRC[58]. - The company is also working on a pipeline to correct specific mutations in the P53 gene, which is mutated in approximately 50% of invasive tumors[59]. Clinical Trials and Approvals - Glecirasib received breakthrough therapy designation from the CDE in China for the treatment of advanced or metastatic NSCLC patients with KRAS G12C mutations in December 2022[1]. - The company completed patient recruitment for the I/IIa trial of Glecirasib in combination with cetuximab in China in February 2023, with preliminary results submitted to the 2023 American Society of Clinical Oncology Annual Meeting[1]. - The key trial for Glecirasib in NSCLC patients with KRAS G12C mutations received CDE approval in September 2022, actively recruiting patients from approximately 60 centers in China[21]. - Preliminary clinical data for Glecirasib in KRAS G12C NSCLC patients showed an overall response rate (ORR) of 56.3% and a disease control rate (DCR) of 90.6% as of April 1, 2022[21]. - The company anticipates submitting a New Drug Application (NDA) for Glecirasib in NSCLC by the end of 2023, expecting accelerated approval[21]. - The company has initiated a clinical collaboration agreement with Merck & Co. to evaluate the combination of JAB-BX102 with KEYTRUDA®[5]. Financial Position and Investments - The company reported a total revenue of RMB 95.746 million for the year ended December 31, 2022, compared to RMB 152.809 million in 2021, showing a decline[106]. - The total assets decreased to RMB 1,574.647 million in 2022 from RMB 1,721.834 million in 2021, reflecting a reduction in the company's asset base[108]. - Cash and bank balances were reported at RMB 1,298.688 million, down from RMB 1,537.583 million in the previous year, indicating a decrease in liquidity[108]. - The total liabilities amounted to RMB 292,123,000, an increase of 244.5% compared to RMB 84,746,000 in the previous year[120]. - The company has no significant investments, acquisitions, or disposals during the reporting period[83]. - The company currently has a bank credit line of RMB 230.0 million and no major equity financing plans[83]. Strategic Partnerships and Collaborations - The company has established a strategic partnership with AbbVie to enhance the success rate of its innovative allosteric SHP2 inhibitors[13]. - The collaboration with AbbVie, established in May 2020, allows for the global development and commercialization of SHP2 inhibitors, including JAB-3068 and JAB-3312, with exclusive rights retained for development in China, Hong Kong, and Macau[34]. - The company plans to explore global partnership opportunities to expand the development and commercialization of its drug candidates[66]. Operational Developments - The company is expanding its manufacturing capabilities in China with a new facility covering approximately 22,000 square meters, aimed at R&D, production, and administrative purposes[67]. - The company is committed to ongoing employee training and development, enhancing skills and compliance with policies[89]. - The company has a strong patent portfolio with 280 patents or applications globally, of which 53 have been granted or allowed in major markets as of December 31, 2022[55]. Market Outlook and Future Plans - The company anticipates a positive outlook for revenue growth driven by new product launches and market expansion strategies[144]. - The company is actively pursuing regulatory approvals from the U.S. FDA for its new drug applications (NDA) in 2023[144]. - The company aims to achieve a recommended Phase II dose (RP2D) for its new therapies by the end of the current fiscal year[144].
加科思-B(01167) - 2022 - 年度业绩