Clinical Development - Glecirasib monotherapy for ≥2L NSCLC has completed patient recruitment from approximately 60 centers in China, with safety and efficacy data expected to be announced in the second half of 2024[2]. - The NDA application for Glecirasib monotherapy in ≥2L NSCLC is anticipated to be submitted to CDE in the second quarter of 2024[2]. - The combination treatment of Glecirasib and JAB-3312 for 1L NSCLC has shown better safety and efficacy compared to the current standard treatment, with a Phase III trial design approved by CDE[3]. - Glecirasib has been granted breakthrough therapy designation for KRAS G12C mutation pancreatic cancer patients after progression on first-line standard treatment[3]. - JAB-8263, a BET inhibitor, is set to initiate Phase II trials in the second half of 2024, showing promising safety and tolerability signals[4]. - JAB-2485, an Aurora A kinase inhibitor, has commenced global Phase I/IIa trials in the US and China, with encouraging clinical efficacy signals observed[4]. - JAB-30355, a potent oral P53 activator, has received IND approval from the FDA, with trials expected to start in the second half of 2024[4]. - The company is conducting a Phase I/IIa dose escalation trial for JAB-BX102 (anti-CD73 humanized monoclonal antibody) in China, with the RP2D expected to be determined in Q2 2024[5]. - IND applications for JAB-26766 (PARP7 inhibitor), JAB-24114 (glutamine-utilizing enzyme inhibitor), and JAB-BX300 (anti-LIF humanized monoclonal antibody) have been approved, with clinical development strategies being optimized[5]. - The company plans to submit an IND application for JAB-23E73 (KRAS multi-inhibitor) in Q2 2024, which is a first-in-class oral small molecule targeting multiple KRAS mutations[5]. - The iADC platform is being developed, with JAB-BX400 (HER2-STING iADC) showing effectiveness in preclinical studies, and clinical candidates expected to be nominated in H2 2024[5]. - The Phase III pivotal trial for JAB-3312 combined with Glecirasib in 1L NSCLC patients received approval from China's CDE in February 2024, with plans to initiate in Q3 2024[10]. - Glecirasib is undergoing a single-arm Phase II pivotal study for PDAC in China, with trial design submitted to CDE, expected approval in Q2 2024[11]. - The clinical development of JAB-3312 and Glecirasib shows significant synergistic anti-tumor effects in preclinical studies, prioritizing their combination therapy[10]. - Glecirasib has demonstrated favorable pharmacokinetic properties and tolerability compared to competitors' KRAS G12C inhibitors in internal studies[12]. - Short-term safety and efficacy results for JAB-3312 combined with Glecirasib were reported at the 2023 ESMO conference in October 2023[10]. - Long-term safety and efficacy data for the combination therapy will be presented at the 2024 ASCO annual meeting in June 2024[10]. - Glecirasib is a highly active, selective, and orally available small molecule targeting the KRAS G12C mutation, showing promising preclinical anti-tumor effects[12]. - Glecirasib monotherapy for ≥2L NSCLC showed a confirmed overall response rate (cORR) of 42.5% (17/40) and a disease control rate (DCR) of 95% (38/40) with a median progression-free survival (mPFS) of 9.6 months[13]. - In the combination treatment of Glecirasib with JAB-3312 for 1L NSCLC, the overall response rate (ORR) was 65.5% (38/58) and the DCR was 100%[14]. - Glecirasib monotherapy for ≥2L PDAC demonstrated a confirmed overall response rate (cORR) of 41.9% (13/31) and a DCR of 93.5% (29/31) with an mPFS of 5.6 months[16]. - In the ongoing trial for Glecirasib in advanced colorectal cancer (CRC), the monotherapy showed an overall response rate (ORR) of 33.3% (11/33) and a DCR of 90.9% (30/33)[18]. - The combination of Glecirasib with cetuximab in CRC patients resulted in an ORR of 62.8% (27/43) and a DCR of 93% (40/43)[18]. - Glecirasib has been granted breakthrough therapy designation for KRAS G12C mutation in advanced or metastatic NSCLC, allowing for expedited review by CDE[13]. - The clinical activity of Glecirasib in various solid tumors has been presented at major oncology conferences, indicating ongoing development and interest in its efficacy[19]. - The company is in discussions with regulatory authorities for a Phase II pivotal trial for Glecirasib in patients with KRAS G12C and STK 11 co-mutations[20]. - Glecirasib is the first KRAS G12C inhibitor to enter registration trials for ≥2L pancreatic cancer globally, highlighting its innovative position in the market[16]. - Glecirasib's Phase I dose escalation global study completed in August 2022, with Phase II initiated in September 2022, showing similar clinical responses in Chinese patients[21]. - JAB-3312, a clinical-stage oral SHP2 inhibitor, has an IC50 value of 0.7-3.0 nM in preclinical studies, with FDA orphan drug designation for esophageal cancer treatment[22]. - JAB-8263, a selective BET family protein inhibitor, shows 80-90% c-Myc suppression for over 48 hours at low doses, with plans for Phase II trials in late 2024[25]. - JAB-2485, a selective Aurora kinase A inhibitor, has shown promising clinical efficacy signals, with dose escalation ongoing and RP2D expected in Q2 2024[26]. - JAB-30355, a p53 activator for tumors with p53 Y220C mutation, has received FDA IND approval, with Phase I trials expected to start in late 2024[27]. - JAB-BX102, a humanized monoclonal antibody targeting CD73, began I/IIa trials in September 2022, with RP2D anticipated in Q2 2024[29]. - JAB-3312 is being evaluated in combination with KRAS G12C inhibitors and anti-PD-1 antibodies, with early clinical responses observed[24]. Financial Performance - The company's revenue for the year ended December 31, 2023, was RMB 635 million, primarily due to reimbursement from a collaboration agreement with AbbVie for the development, manufacturing, and commercialization of SHP2 inhibitors[6]. - Research and development expenses decreased by RMB 73.3 million or 16.4% to RMB 372.3 million for the year ended December 31, 2023, compared to RMB 445.6 million for the year ended December 31, 2022[6]. - Administrative expenses increased by RMB 4.0 million or 9.4% to RMB 46.6 million for the year ended December 31, 2023, mainly due to increased depreciation and amortization related to the new Beijing headquarters[6]. - The net loss for the year ended December 31, 2023, was RMB 359.1 million, a decrease from RMB 371.9 million for the year ended December 31, 2022[6]. - Revenue for the year ended December 31, 2023, was RMB 63.5 million, a decrease of 33.5% from RMB 95.7 million in 2022, primarily due to the reimbursement of R&D costs related to the SHP2 inhibitor collaboration with AbbVie[47]. - Cost of revenue for the same period was RMB 60.3 million, down from RMB 83.1 million in 2022, reflecting reduced clinical trial expenses for the SHP2 inhibitor[47]. - Gross profit decreased to RMB 3.2 million in 2023 from RMB 12.6 million in 2022, indicating a significant decline in profitability[47]. - Other income increased significantly to RMB 7.5 million in 2023 from RMB 1.9 million in 2022, mainly due to increased government subsidies related to R&D projects[48]. - R&D expenses decreased to RMB 372.3 million in 2023 from RMB 445.6 million in 2022, primarily due to a reduction in materials used and an increase in employee benefits[50]. - Administrative expenses rose to RMB 46.6 million in 2023 from RMB 42.6 million in 2022, largely due to increased depreciation and amortization related to a new lease for the Beijing headquarters[51]. - Financial income increased to RMB 47.1 million in 2023 from RMB 24.6 million in 2022, attributed to higher average interest rates on time deposits[52]. - Financial expenses increased to RMB 8.3 million in 2023 from RMB 2.3 million in 2022, due to higher interest costs on lease liabilities and borrowings[52]. - The company did not incur any income tax expenses for the years ended December 31, 2023, and 2022, as no taxable profits were generated[53]. - The net loss for the year ended December 31, 2023, was RMB 359.1 million, a decrease from RMB 371.9 million in 2022, representing a 3.7% improvement[54]. - Adjusted net loss for the same period was RMB 337.0 million, compared to RMB 356.2 million in 2022, indicating a 5.4% reduction[54]. - Cash used in operating activities increased to RMB 364.2 million in 2023 from RMB 292.4 million in 2022, an increase of RMB 71.8 million[56]. - Cash flow from investing activities decreased significantly to RMB 48.0 million in 2023 from RMB 686.3 million in 2022, a reduction of RMB 638.3 million[56]. - Cash flow from financing activities increased to RMB 246.3 million in 2023, up from RMB 9.9 million in 2022, marking a substantial increase of RMB 256.2 million[56]. - As of December 31, 2023, the company had cash and cash equivalents totaling RMB 1,197.9 million, down from RMB 1,298.7 million in 2022[58]. - The company has no significant contingent liabilities as of December 31, 2023, compared to zero in 2022[61]. - The company has a total bank credit facility of RMB 270.0 million and has no major equity financing plans[58]. - The company’s lease liabilities as of December 31, 2023, amounted to RMB 136.3 million[59]. - The company reported a significant increase in revenue, reaching $150 million for the fiscal year ending December 31, 2023, representing a 25% year-over-year growth[113]. - The company provided guidance for the next fiscal year, projecting revenue growth of 20% to $180 million[113]. - Research and development expenses increased by 30%, totaling $45 million, reflecting the company's commitment to advancing its pipeline[113]. - The company reported a net profit margin of 10%, up from 8% in the previous year, indicating improved operational efficiency[113]. Corporate Governance - The company is committed to high standards of corporate governance and has adopted the Corporate Governance Code as its own governance framework, ensuring compliance with applicable provisions[67]. - The audit committee reviewed the annual performance for the year ending December 31, 2023, confirming compliance with all applicable accounting principles and standards[71]. - The board of directors consists of three executive directors, two non-executive directors, and three independent non-executive directors, ensuring a balanced distribution of power and authority[68]. - The company continues to provide various incentives and benefits to employees, including competitive salaries, bonuses, and share-based compensation, to attract and retain qualified personnel[64]. - The company has implemented ongoing training programs for employees to enhance their skills and ensure compliance with policies and procedures[64]. - There have been no significant events affecting the company since the end of the reporting period on December 31, 2023[65]. - The company did not recommend the payment of a final dividend for the year ending December 31, 2023, consistent with the previous year where no dividend was declared[65]. - The company completed a placement and subscription agreement on February 10, 2023, selling 22,100,100 shares at HKD 7.26 per share, raising approximately HKD 158.9 million net of expenses, aimed at developing its product pipeline and strengthening its financial position[72]. - During the reporting period, the company repurchased a total of 1,807,200 shares at a total cost of HKD 6,121,110, with all repurchased shares being cancelled[73]. Market Strategy - The company aims to establish strategic partnerships with leading multinational companies to enhance the success rate of its drug candidates and maximize their clinical and commercial value globally[7]. - The pipeline includes several clinical-stage assets and one asset in the NDA pre-filing stage, showcasing broad applicability across various tumor types[8]. - The company is developing a diverse combination targeting the RAS signaling pathway, including KRAS G12C inhibitor JAB-21822 and other KRAS multi-inhibitors, addressing significant unmet medical needs in tumors with KRAS mutations[40]. - The company is advancing a pipeline targeting the MYC signaling pathway with a potent BET inhibitor JAB-8263 and a selective Aurora A kinase inhibitor JAB-2485[41]. - The company is developing a pipeline targeting P53 mutations, specifically JAB-30355 for P53 Y220C, aiming to provide more effective treatment options[42]. - The company is enhancing its drug discovery platform and aims to achieve global market leadership through innovative therapies in cancer treatment[39]. - The company is focusing on expanding its pipeline in targeted therapies and tumor immunology, with a commitment to developing and commercializing promising signaling pathways[39]. - The company is pursuing collaborations to expand its global development and commercialization footprint, particularly in unmet medical needs[45]. - The company is applying for Marketing Authorization Holder (MAH) status in China and plans to collaborate with a reputable CDMO for production[46]. - The company warns that it cannot guarantee the successful development or commercialization of its core products, advising shareholders and potential investors to exercise caution[46].
加科思-B(01167) - 2023 - 年度业绩