Drug Development and Clinical Trials - Glecirasib (JAB-21822) NDA submitted for ≥2L NSCLC treatment, received priority review qualification in May 2024[2] - JAB-3312 (SHP2 inhibitor) entered Phase III registration trial, marking it as the first SHP2 inhibitor to do so globally[3] - JAB-8263 (BET inhibitor) II phase trial expected to start in H2 2024, showing promising safety and efficacy signals in myelofibrosis patients[4] - JAB-30355 (p53 Y220C activator) IND approved by FDA and CDE, with patient recruitment actively ongoing in China and the US[4] - JAB-2485 (Aurora A kinase inhibitor) global trial initiated, with encouraging clinical efficacy signals observed[4] - IND approvals received for JAB-BX300 (anti-LIF monoclonal antibody), JAB-26766 (PARP7 inhibitor), and JAB-24114 (glutamine-related metabolic enzyme inhibitor)[5] - Glecirasib's clinical activity and safety results in pancreatic cancer patients presented at ASCO GI 2024[3] - Glecirasib's breakthrough therapy designation for ≥2L PDAC granted by the FDA in April 2024[3] - JAB-8263 showed a 56.5% spleen volume reduction in myelofibrosis patients after over a year of treatment[4] - JAB-3312 demonstrated good efficacy and safety in patients, with the first patient initiated in the Phase III trial in China[3] - JAB-23E73, a novel oral pan-KRAS inhibitor, is expected to complete IND applications with CDE and the US FDA in June and August 2024, respectively[6] - The clinical candidate JAB-BX400 is anticipated to be nominated in the second half of 2024 after showing effectiveness in preclinical studies[6] - The company aims to initiate Phase II POC trials for JAB-8263 in the second half of 2024 targeting specific biomarker-positive tumors[10] - IND approval for JAB-30355 was received from the US FDA in March 2024, with further approvals from CDE in June 2024[10] - Glecirasib (JAB-21822) has shown a clinical overall response rate (cORR) of 47.9% in patients with KRAS G12C mutation NSCLC, with a disease control rate (DCR) of 86.3% and a median progression-free survival (mPFS) of 8.2 months[14] - The NDA for Glecirasib as a monotherapy for ≥2L NSCLC was submitted to CDE in May 2024 and received priority review designation[14] - The combination therapy of Glecirasib and JAB-3312 for 1L NSCLC has shown an overall response rate (ORR) of 64.7% and a DCR of 93.1%, with a mPFS of 12.2 months[15] - The first patient in the Phase III trial for Glecirasib combined with JAB-3312 was enrolled in August 2024, marking it as the first SHP2 inhibitor to enter Phase III registration trials globally[15] - Glecirasib is the first KRAS G12C inhibitor to enter ≥2L pancreatic cancer registration trials, with the first patient enrolled in October 2023[17] - The clinical results for Glecirasib in ≥2L NSCLC were first reported at the 2024 ASCO annual meeting, highlighting its efficacy compared to FDA-approved KRAS G12C inhibitors[14] - Glecirasib has been granted orphan drug designation by the FDA for pancreatic cancer in April 2024, indicating its potential in treating this indication[17] - The combination of Glecirasib and cetuximab for treating ≥3L CRC patients has received CDE approval for a Phase III trial design in May 2024[17] - The company has initiated a Phase II pivotal study for Glecirasib in China for patients with KRAS G12C mutation in PDAC, with significant progress reported in patient recruitment[17] - The safety and efficacy data for Glecirasib combined with JAB-3312 were presented at the 2024 ASCO oral abstract session, demonstrating controllable safety and good efficacy[15] - Glecirasib demonstrated an overall response rate (ORR) of 52.6% (10/19) and a disease control rate (DCR) of 84.2% (16/19) in a study involving patients with KRAS G12C mutations across various cancer types[18] - In a clinical trial for advanced colorectal cancer (CRC) in China, glecirasib as a monotherapy showed an ORR of 33.3% (11/33) and a DCR of 90.9% (30/33) with a median progression-free survival (mPFS) of 6.9 months[19] - The combination of glecirasib with cetuximab in advanced CRC patients resulted in an ORR of 62.8% (27/43) and a DCR of 93% (40/43), although mPFS data is still pending[19] - Glecirasib is the most advanced KRAS G12C inhibitor in terms of patient recruitment and data publication among all clinical-stage KRAS G12C inhibitors globally[18] - JAB-3312, a second-generation SHP2 inhibitor, has shown promising preclinical results with an IC50 value of 0.7-3.0 nM and has received orphan drug designation for esophageal cancer treatment in the U.S.[22] - JAB-8263, a potent BET family protein inhibitor, demonstrated significant efficacy signals in solid tumors and hematological malignancies, with a total symptom score improvement and a spleen volume reduction of 56.5% in one patient[24] - JAB-2485, an Aurora kinase A inhibitor, is currently in I/IIa global trials, showing encouraging clinical efficacy signals, including disease stabilization in a patient treated for over a year[25] - JAB-30355 is a potent oral small molecule p53 activator targeting p53 Y220C mutations, showing 2-3 times the efficacy of registered drugs in preclinical studies[26] - JAB-30355's IND application was approved by the FDA in March 2024, with the first patient dosed in China in July 2024[26] - JAB-BX102, a humanized monoclonal antibody targeting CD73, has completed dose escalation in a Phase I/IIa trial for advanced solid tumors[27] - JAB-BX300's IND application was approved in June 2023, targeting KRAS-driven tumors by reducing M2 macrophages and activating NK and cytotoxic T cells[28] - JAB-26766, an oral PARP7 inhibitor, received IND approval for a Phase I/IIa trial in June 2023, showing significant tumor suppression in various models[28] - JAB-24114, a prodrug of DON, has IND approval for a Phase I/IIa trial, enhancing T cell function while blocking tumor nutrition[29] - JAB-23E73, a novel oral pan-KRAS inhibitor, has shown significant anti-tumor effects in preclinical studies and IND applications submitted in June and August 2024[30] - JAB-22000, a selective KRAS G12D inhibitor, is in preclinical development with multiple patent applications filed[31] - The iADC project utilizes STING agonists as payloads, aiming to enhance anti-tumor immunity and convert "cold" tumors into "hot" tumors[32] - JAB-BX400, an iADC candidate, shows less than 1% release of free payload in plasma after 48 hours, indicating improved plasma stability compared to competitors[34] - The clinical candidate JAB-BX400 is expected to be nominated in the second half of 2024, with ongoing development of additional iADC candidates targeting TAA[34] Financial Performance - R&D expenses decreased by RMB 22.0 million or 11.1% to RMB 176.8 million for the six months ending June 30, 2024, primarily due to reduced costs of raw materials and employee expenses[7] - Administrative expenses decreased by RMB 2.5 million or 10.5% to RMB 21.2 million for the six months ending June 30, 2024, mainly due to lower administrative staff costs and professional service fees[7] - Loss for the reporting period increased to RMB 169.1 million for the six months ending June 30, 2024, compared to the loss for the same period in 2023[7] - For the six months ended June 30, 2024, the company reported no revenue, compared to RMB 40.3 million for the same period in 2023, which was related to a terminated collaboration agreement with AbbVie[43] - The cost of revenue for the six months ended June 30, 2024, was zero, while it was RMB 37.9 million for the same period in 2023, associated with the SHP2 inhibitor under the same terminated agreement[44] - Gross profit decreased from RMB 2.4 million for the six months ended June 30, 2023, to zero for the same period in 2024[45] - Other income increased significantly from RMB 0.8 million in the first half of 2023 to RMB 7.5 million in the first half of 2024, primarily due to increased government grants related to R&D projects[46] - Net other income decreased from RMB 34.7 million for the six months ended June 30, 2023, to RMB 4.7 million for the same period in 2024, mainly due to a reduction in foreign exchange gains[47] - The adjusted loss for the six months ended June 30, 2024, was RMB (163,459) thousand, compared to RMB (158,338) thousand for the same period in 2023, reflecting an increase in loss of approximately 3.4%[53] - The net cash used in operating activities for the six months ended June 30, 2024, was RMB 180.4 million, a decrease of RMB 39.4 million compared to RMB 219.8 million for the same period in 2023[56] - The net cash generated from investing activities for the six months ended June 30, 2024, was RMB 43.7 million, a significant decrease of RMB 126.9 million from RMB 170.6 million in the same period of 2023[57] - The net cash generated from financing activities for the six months ended June 30, 2024, was RMB 25.8 million, down RMB 163.5 million from RMB 189.3 million in the same period of 2023[58] - As of June 30, 2024, the company's cash and bank balances were RMB 1,060.2 million, a decrease from RMB 1,147.8 million as of December 31, 2023, primarily due to cash used in operating activities[58] - The company had no significant investments, acquisitions, or disposals of subsidiaries, associates, or joint ventures during the six months ended June 30, 2024[58] - The company recorded a net current asset value of RMB 899.5 million as of June 30, 2024, a decrease from RMB 963.3 million as of December 31, 2023, indicating a reduction of RMB 63.8 million[61] - The total number of employees as of June 30, 2024, was 298, with total salary costs amounting to RMB 79.7 million, down from RMB 92.0 million for the same period in 2023[62] - The company did not recommend an interim dividend for the six months ending June 30, 2024, consistent with the previous period[63] - The company repurchased a total of 2,335,200 shares at a total cost of HKD 3,849,042 during the reporting period[66] - The net proceeds from the global offering amounted to approximately HKD 1,421.8 million, with RMB 121.8 million utilized as of June 30, 2024[67] - 25% of the net proceeds, amounting to RMB 300.6 million, is allocated for clinical trials and registration preparations for JAB-3068[68] - 18% of the net proceeds, totaling RMB 213.0 million, is designated for the registration clinical trials of JAB-3312 and JAB-21822[68] - 10% of the net proceeds, equivalent to RMB 118.3 million, is allocated for ongoing and planned clinical trials[68] - 22% of the net proceeds, amounting to RMB 254.6 million, is for the clinical development of JAB-21822, including registration trials[68] - 9% of the net proceeds, totaling RMB 107.3 million, is designated for the discovery and development of new candidate drugs[68] - The company plans to utilize the remaining unutilized proceeds by the end of 2025[67] - The audit committee reviewed the interim results and confirmed compliance with applicable accounting principles and standards[65] - The net proceeds from the fundraising activities amounted to approximately RMB 139.1 million, with an expected utilization by the end of 2025[70] - The proportion of net proceeds allocated for the clinical development of glecirasib increased from RMB 254.6 million to RMB 454.6 million, primarily for registration clinical trials and NDA preparation[69] - The net proceeds for ongoing and planned early drug discovery and development increased from RMB 107.3 million to RMB 207.9 million, focusing on projects like JAB-23E73, JAB-30355, JAB-26766, and iADC[69] - The company reported a total revenue of RMB 40.3 million for the six months ended June 30, 2024, compared to RMB 37.9 million for the same period in 2023[76] - The operating loss for the six months ended June 30, 2024, was RMB 185.9 million, slightly higher than the loss of RMB 184.6 million in the same period of 2023[76] - The net loss attributable to the company's owners for the period was RMB 169.1 million, consistent with the loss of RMB 166.3 million in the previous year[76] - The company reported a net financial income of RMB 16.8 million for the six months ended June 30, 2024, compared to RMB 18.3 million in the previous year[76] - The total comprehensive loss for the period was RMB 169.3 million, compared to 166.2 million in the same period of 2023[77] - Total assets decreased from RMB 1,460,481 thousand as of December 31, 2023, to RMB 1,312,762 thousand as of June 30, 2024, representing a decline of approximately 10.1%[78] - Non-current assets totaled RMB 233,496 thousand as of June 30, 2024, down from RMB 292,071 thousand as of December 31, 2023, a decrease of about 20.0%[78] - Current assets decreased from RMB 1,168,410 thousand to RMB 1,079,266 thousand, reflecting a decline of approximately 7.6%[78] - The total equity attributable to owners decreased from RMB 1,073,371 thousand to RMB 906,544 thousand, a reduction of about 15.5%[78] - The total liabilities increased from RMB 387,110 thousand to RMB 406,218 thousand, an increase of approximately 4.0%[80] - Revenue for the six months ended June 30, 2024, was RMB 0, compared to RMB 40,335 thousand for the same period in 2023, indicating a significant decline in income[88] - Employee benefit expenses decreased from RMB 92,033 thousand in the first half of 2023 to RMB 79,702 thousand in the first half of 2024, a reduction of approximately 17.0%[91] - Testing expenses decreased from RMB 97,776 thousand to RMB 77,291 thousand, reflecting a decline of about 21.0%[91] - The company reported a cumulative loss of RMB (3,362,852) thousand as of June 30, 2024, compared to RMB (3,193,799) thousand as of December 31, 2023, indicating an increase in losses[78] - Long-term bank deposits were reduced to zero as of June 30, 2024, from RMB 50,013 thousand as of December 31, 2023, indicating a complete withdrawal of long-term deposits[78] - The company reported a basic loss per share of RMB 0.22 for the six months ended June 30, 2024, consistent with the loss per share for the same period in 2023[96] - The total loss attributable to the company's owners for the six months ended June 30, 2024, was RMB 169,053 thousand, compared to RMB 166,281 thousand for the same period in 2023[96] - The company has not declared or recommended any dividends for the six months ended June 30, 2024, remaining at zero as in the previous year[98] - As of June 30, 2024, the company's cash and cash equivalents amounted to RMB 361,808 thousand, down from RMB 469,155 thousand as of December 31, 2023[100] - The company has a redeemable liability of RMB 105,592 thousand as of June 30, 2024, an increase from RMB 58,817 thousand as of December 31, 2023[101] - The company’s non-current assets include investments in preferred shares of associates totaling RMB 11,053 thousand as of June 30, 2024, slightly down from RMB 11,339 thousand at the end of 2023[99] - The company has no estimated taxable profits for federal and state corporate income taxes in the U.S. for the six months ended June 30, 2024[94] - The company’s subsidiaries in mainland China benefit from a reduced corporate income tax rate of 15% due to their qualification as high-tech enterprises[95] - The company’s cash and bank balances decreased from RMB 1,147,847 thousand as of December 31, 2023, to RMB 1,060,201 thousand as of June 30, 2024[100] - The company has short-term bank loans of RMB 63,806 thousand as of June 30, 2024, down from RMB 73,616 thousand as of December 31, 2023[103] Strategic Initiatives and Partnerships
加科思-B(01167) - 2024 - 中期业绩