Financial Performance - For the year ended December 31, 2022, the company's revenue was RMB 957 million, primarily due to reimbursement of research and development costs from a collaboration agreement with AbbVie for the development, manufacturing, and commercialization of the SHP2 inhibitor[18]. - Administrative expenses decreased from RMB 446 million for the year ended December 31, 2021, to RMB 426 million for the year ended December 31, 2022, primarily due to a reduction in professional service fees[20]. - The annual loss 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[21]. - The company recorded revenue of RMB 957.46 million for the year ended December 31, 2022, a decrease of 37.4% from RMB 1,528.09 million in 2021[118]. - Gross profit decreased slightly to RMB 126.34 million in 2022 from RMB 128.30 million in 2021, a decline of 1.5%[120]. - 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 grants by RMB 94 million[122]. - The company reported a net foreign exchange gain of RMB 825.31 million in 2022, a turnaround from a net loss of RMB 272.63 million in 2021, indicating a significant improvement[123]. - The company reported a net loss of RMB 371.9 million in 2022, compared to a net loss of RMB 301.2 million in 2021[134]. - Adjusted net loss for 2022 was RMB 356.2 million, up from RMB 284.7 million in 2021[134]. - Cash and bank balances decreased from RMB 1,537.6 million in 2021 to RMB 1,298.7 million in 2022, primarily due to cash used in operating activities[140]. Research and Development - Research and development expenses increased from RMB 808 million for the year ended December 31, 2021, to RMB 4.456 billion for the year ended December 31, 2022, an increase of RMB 1.648 billion, driven by the progress of clinical candidates and expansion of preclinical research activities[19]. - The company plans to submit an IND application for the P53 activator JAB-30300 within the year, targeting a challenging drug target in cancer therapy[10]. - The company is transitioning from a biotech to a biopharma model, preparing for the NDA submission of its candidate drug Glecirasib (KRAS G12C inhibitor) and establishing a commercialization team[14]. - The company is focusing on developing iADC projects, combining antibodies with tumor immunotherapy to provide new treatment options for patients who are unresponsive to existing therapies[11]. - The company has achieved positive efficacy and therapeutic windows in animal models for its self-developed CD73 STING iADC project, addressing unmet clinical needs[13]. - The company is continuously monitoring new technologies such as gene therapy, cell therapy, and small nucleic acids to lay the foundation for its future growth over the next five years[15]. - The company has multiple projects along the RAS pathway, including SHP2, KRAS G12C, and KRASmulti, indicating a robust pipeline in targeted cancer therapies[10]. - The company emphasizes the importance of flexibility in operations and organizational adjustments to successfully navigate its transformation[14]. - The company acknowledges the increasing difficulty in drug development and the need for innovative approaches to overcome existing challenges in the biotech industry[9]. - The company has developed an innovative pipeline of candidate drugs, including eight assets in clinical stages and several others in the IND initiation stage, showcasing broad applicability to various tumor types[42]. Clinical Trials and Approvals - Glecirasib (KRAS G12C inhibitor) received breakthrough therapy designation from the CDE for the treatment of advanced or metastatic NSCLC patients with KRAS G12C mutations in December 2022[23]. - The I/IIa trial of Glecirasib in combination with cetuximab was completed in February 2023, with key trials expected to start in Q4 2023 in China[24]. - The global I/IIa trial of JAB-2485 (Aurora A kinase inhibitor) was initiated in the US and China, with the first patient dosed in January 2023[30]. - JAB-24114 (Glutamine-utilizing Enzyme inhibitor) IND application was submitted in December 2022 and approved in March 2023[32]. - The company plans to submit IND applications for JAB-23400 (KRASmulti inhibitor) and JAB-30300 (P53 Y220C corrector) in the second half of 2023[35][36]. - The company expects to obtain preliminary safety and efficacy data for its clinical trials in the second half of 2023[48]. - The company has received approval from the CDE for the key trial of Glecirasib monotherapy in China, with active patient recruitment ongoing[49]. - The company has prioritized the clinical development of SHP2 inhibitors in combination with KRAS G12C inhibitors based on strong rationale from preclinical studies[48]. - The company has several IND candidates scheduled for initiation in 2023, including JAB-23400 and JAB-30300, targeting various solid tumors[46]. - The company has initiated Phase I dose escalation trials for JAB-8263 in the US and China, with the first patient enrolled in November 2020 and February 2022 respectively, aiming for a comprehensive evaluation of drug safety and preliminary efficacy[75]. Strategic Partnerships and Collaborations - The company is actively seeking strategic partnerships with leading multinational companies, such as AbbVie, to enhance the success rate of its candidate drugs and maximize their clinical and commercial value globally[41]. - The collaboration with AbbVie, established in May 2020, focuses on the global development and commercialization of SHP2 inhibitors, including JAB-3068 and JAB-3312, with exclusive rights retained for China, Hong Kong, and Macau[71]. - A collaboration agreement with Merck & Co was signed in March 2023 to evaluate the efficacy of JAB-BX102 in combination with KEYTRUDA® for advanced solid tumors[79]. - The company plans to explore global collaboration opportunities to expand its drug candidates' development and commercialization[115]. Corporate Governance and Management - The company has a strong leadership team with extensive experience in the pharmaceutical industry, including over 19 years for key executives[158]. - The board includes independent directors with significant backgrounds in finance and healthcare, enhancing strategic decision-making capabilities[165]. - The company has established a strong governance framework, as evidenced by the roles of independent directors and the emphasis on independent judgment in board decisions[171]. - The board consists of three executive directors, three non-executive directors, and three independent non-executive directors, ensuring a strong independent element[187]. - The company has complied with all applicable provisions of the Corporate Governance Code as of December 31, 2022, except for a deviation regarding the separation of the roles of Chairman and CEO[183]. - The independent non-executive directors play a crucial role in providing impartial opinions and judgments on the company's strategy and performance[194]. - The company has adopted a culture of openness and inclusivity in research, focusing on innovation and growth in the life sciences sector[185]. - The company has a commitment to enhancing its market presence through potential mergers and acquisitions[166]. Employee and Operational Insights - The total employee compensation cost for the year ended December 31, 2022, was RMB 1,630 million, an increase from RMB 1,287 million for the year ended December 31, 2021, reflecting growth in employee numbers and salary levels[149]. - The company emphasizes a competitive benefits package to help employees balance work and life, enhancing their sense of security[186]. - The management continuously monitors foreign exchange risks, particularly related to the US dollar, and considers hedging significant foreign exchange risks when necessary[147]. - The company is committed to providing ongoing education and training programs for employees to enhance their skills and knowledge[149]. - The company has implemented measures to mitigate the impact of the COVID-19 pandemic on its operations, ensuring the continuation of clinical trials[102].
加科思-B(01167) - 2022 - 年度财报