Financial Performance - For the six months ended June 30, 2023, the company recorded revenue of RMB 40.3 million, attributed to licensing and collaboration agreements related to the development, manufacturing, and commercialization of the SHP2 inhibitor[5]. - The company recorded revenue of RMB 40,335,000 for the six months ended June 30, 2023, a decrease of 26.3% compared to RMB 54,687,000 for the same period in 2022[90]. - The gross profit for the period was RMB 2,402,000, down from RMB 8,833,000 in the previous year, indicating a significant decline in profitability[79]. - The net loss for the period increased from RMB 127.8 million for the six months ended June 30, 2022, to RMB 166.3 million for the same period in 2023[5]. - The operating loss for the period was RMB 184,563,000, compared to a loss of RMB 135,414,000 in the same period last year, representing a deterioration in operational performance[79]. - The net loss attributable to the owners of the company was RMB 166,281,000, compared to RMB 127,825,000 in the previous year, marking a 30% increase in losses[79]. - Other income net amount decreased from RMB 49.2 million for the six months ended June 30, 2022, to RMB 37.8 million for the six months ended June 30, 2023, a reduction of RMB 11.4 million or 23.2%[53]. - The company reported a loss of RMB 166.3 million for the six months ended June 30, 2023, compared to a loss of RMB 127.8 million for the same period in 2022[59]. - Adjusted loss for the six months ended June 30, 2023, was RMB 158.3 million, compared to an adjusted loss of RMB 128.4 million for the same period in 2022[59]. Research and Development - R&D expenses increased from RMB 176.6 million for the six months ended June 30, 2022, to RMB 198.8 million for the same period in 2023, primarily due to clinical trial progress and increased personnel costs in related R&D departments[5]. - The company has developed a pipeline of eight clinical-stage assets and several others in the IND initiation stage, showcasing broad applicability across various tumor types[7]. - The key trial for JAB-21822 (Glecirasib) in NSCLC patients with KRAS G12C mutation is expected to complete patient recruitment by September 2023, with NDA submissions planned for late 2023 and early 2024[1]. - Glecirasib received BTD from CDE for treating second-line or above pancreatic cancer patients, with preliminary clinical data expected to be presented at the 2024 ASCO GI meeting[1]. - The I/IIa clinical trial for JAB-3312 in combination with Glecirasib is actively recruiting patients, with preliminary data to be presented at the 2023 ESMO meeting in October[3]. - The IND application for JAB-24114 was approved in March 2023, and the IND application for JAB-BX300 was approved in April 2023[4]. - The company plans to submit the IND application for JAB-23400, a novel oral KRAS multi-inhibitor, in the first half of 2024[4]. - The company has established its own iADC platform, with plans to submit IND applications for JAB-BX400 and JAB-X1800 between 2024 and 2025[4]. - Glecirasib (JAB-21822), a KRAS G12C inhibitor, is currently undergoing a pivotal Phase II study in China for NSCLC and PDAC, with patient enrollment expected to complete by September 2023[8]. - The company has achieved significant progress in clinical development during the first half of 2023, particularly with Glecirasib showing promising efficacy and tolerable safety in clinical results for advanced colorectal cancer[11]. Corporate Governance and Strategy - The company is focusing on establishing strategic partnerships with leading multinational companies to enhance the success rate of its drug candidates[6]. - The company is committed to further strengthening its research and development platforms to maintain competitiveness in the biopharmaceutical industry[47]. - The company has committed to maintaining high standards of corporate governance to protect shareholder interests and enhance corporate value[68]. - The board consists of three executive directors, three non-executive directors, and three independent non-executive directors, ensuring a strong independent element[68]. - The company is actively monitoring regulatory developments, particularly with the U.S. FDA, to ensure compliance and expedite approvals[111]. - The company is exploring new markets and potential partnerships to expand its reach and enhance its product offerings[110]. - The company has implemented an equity incentive plan to align the interests of shareholders and management, adopted on August 31, 2021[111]. Financial Position and Cash Flow - As of June 30, 2023, the company's cash and bank balances were RMB 1,297.9 million, slightly down from RMB 1,298.7 million as of December 31, 2022[63]. - The net cash used in operating activities for the six months ended June 30, 2023, was RMB 219.8 million, an increase of RMB 107.9 million compared to RMB 111.9 million for the same period in 2022[61]. - The net cash generated from investing activities increased significantly to RMB 170.6 million, up from RMB 1.7 million in the previous year, marking an increase of RMB 172.3 million[61]. - The net cash generated from financing activities was RMB 189.3 million, compared to RMB 3.0 million used in the same period last year, indicating an increase of RMB 192.3 million[61]. - The company had a total of 300 employees as of June 30, 2023, with total salary costs amounting to RMB 92.0 million, an increase from RMB 78.4 million in the same period last year, reflecting a growth of approximately 17.9%[67]. - The company's lease liabilities amounted to RMB 142.7 million as of June 30, 2023[64]. - The company had no significant investments, acquisitions, or disposals of subsidiaries or joint ventures during the six months ended June 30, 2023[63]. Clinical Trials and Drug Development - JAB-3312, a second-generation SHP2 inhibitor, is in clinical development and has shown better efficacy and safety compared to the first-generation JAB-3068[22]. - JAB-3312 is actively recruiting patients for a trial in combination with Glecirasib for KRAS G12C mutated solid tumors, with over 100 patients targeted[23]. - Glecirasib's Phase I dose escalation for KRAS G12C mutation in NSCLC has been completed in China, with 800 mg QD identified as the RP2D[13]. - A Phase I/IIa trial for Glecirasib in STK 11 co-mutated NSCLC patients is ongoing in China, focusing on safety and preliminary efficacy[15]. - Glecirasib's key trial for KRAS G12C mutation in PDAC has been approved, with pilot expected to start in September 2023[18]. - Glecirasib's monotherapy in advanced colorectal cancer showed an overall response rate (ORR) of 33.3% and disease control rate (DCR) of 90.9%[19]. - In combination with cetuximab, Glecirasib demonstrated an ORR of 62.8% and DCR of 93% in colorectal cancer patients[19]. - JAB-8263 is a selective and highly active BET family protein small molecule inhibitor, with positive efficacy signals observed during dose escalation, and the recommended phase 2 dose (RP2D) is expected to be determined in the second half of 2023[27]. - JAB-2485, a selective Aurora A kinase inhibitor, is undergoing I/IIa global trials in the US and China, with the first patient dosed in January 2023[28]. - JAB-BX102, a humanized monoclonal antibody targeting CD73, has initiated I/IIa dose escalation and expansion trials, with RP2D expected in the first half of 2024[29]. Market and Competitive Landscape - Glecirasib has demonstrated favorable pharmacokinetic properties and tolerability compared to competitors' KRAS G12C inhibitors in preclinical studies[12]. - The company is developing innovative therapies, including small molecules and monoclonal antibodies, to address challenging drug targets[6]. - The company is developing a diverse pipeline targeting multiple key signaling pathways in cancer, with potential first-in-class or best-in-class candidates expected to enter the market[33]. - JAB-23400, an oral KRAS multi-inhibitor, shows significant anti-tumor effects in various cancer models and is expected to submit an IND application in the first half of 2024[34][36]. - JAB-30300, an oral small molecule for P53 Y220C mutations, demonstrated high binding affinity and tumor regression in multiple models, with an IND application anticipated in the second half of 2023[35][36]. - The company faced foreign exchange risks due to currency fluctuations, particularly with USD and HKD deposits[54]. - The company has entered into multiple foreign exchange contracts with banks to manage foreign currency risks related to USD to RMB[54].
加科思-B(01167) - 2023 - 中期业绩