Clinical Trials and Drug Development - Abbisko Cayman Limited completed patient enrollment for the global Phase III clinical trial of pimicotinib targeting tenosynovial giant cell tumor (TGCT) with over 94 patients enrolled, exceeding the initial target of 90 patients[6] - Irpagratinib demonstrated a 40.7% objective response rate (ORR) in treated FGF19+ HCC patients during the Ib trial, with good tolerability reported[8] - The ORR for irpagratinib combined with atezolizumab in FGF19+ HCC patients was reported at 50% during the latest II phase clinical trial[8] - Fexagratinib showed an ORR of 30.7% in mUC patients with FGFR3 mutations, with a 44% ORR specifically in FGFR3 mutated patients[10] - The company is conducting Phase I clinical trials for ABSK061 in China and the US, with an ORR of 37.5% observed in patients with FGFR alterations[14] - The company announced a collaboration with Shanghai Eli Lilly Pharmaceutical Technology Co., Ltd. for a Phase II clinical trial combining ABSK043 with vorolanib for advanced NSCLC patients[13] - The company has initiated a Phase II clinical trial of pimicotinib for cGvHD patients in China, with the first patient dosed in June 2023[37] - The global Phase III MANEUVER trial for pimicotinib has enrolled 94 patients, exceeding the initial target of 90, with over half of the participants from Europe and North America[37] - The company is conducting a Phase II trial of fexagratinib for locally advanced or metastatic urothelial carcinoma patients with FGFR2/3 mutations in China[43] - ABSK043 is being developed as a highly selective small molecule PD-L1 inhibitor, aiming to address the limitations of antibody-based immunotherapy[44] - The Phase I trial of ABSK043 in Australia is nearing completion, with a reported ORR of 27.3% in 11 evaluable patients at a dose of 1,000mg twice daily[45] - ABSK061 has shown an ORR of 37.5% in 8 patients with FGFR-activated solid tumors at doses of 75mg twice daily and 150mg once daily[46] - ABSK112 received clinical research approvals from NMPA and FDA in July and October 2023, respectively, with the first patient dosed for NSCLC in February 2024[51] - ABSK051 has received IND approval from NMPA for a Phase I trial in advanced solid tumors, with the first patient dosed in January 2024[56] - ABSK012 was granted ODD by the FDA in April 2023 for soft tissue sarcoma and received IND approval for a Phase I trial in advanced solid tumors in November 2023[57] - The company is conducting a Phase I trial of ABSK081 in combination with a monoclonal antibody for triple-negative breast cancer, with patient enrollment completed[53] - The company is exploring the potential of ABSK061 for treating achondroplasia, with ongoing preclinical development[46] - ABSK121 is currently in a Phase I trial in both China and the US, with the first patient dosed in June 2023[47] Financial Performance - The company achieved a revenue of RMB 497.3 million (USD 70 million) for the six months ended June 30, 2024, primarily due to the upfront payment from Merck[22] - The profit for the same period was RMB 206.8 million, a significant increase of RMB 415.4 million compared to a loss of RMB 208.6 million for the six months ended June 30, 2023[24] - The increase in net profit is primarily attributed to higher revenue and other income, partially offset by increased R&D expenses[25] - Revenue increased from RMB 19.1 million for the six months ended June 30, 2023, to RMB 497.3 million for the six months ended June 30, 2024, primarily due to an upfront payment received from Merck[76] - Other income and gains rose from RMB 37.7 million to RMB 48.5 million, mainly driven by an increase in bank interest income of RMB 18.7 million, partially offset by a decrease in government subsidies[76] - Profit before tax was RMB 285.5 million, with a tax expense of RMB 78.7 million, resulting in a net profit of RMB 206.8 million for the period[80] - The company reported a total comprehensive income of RMB 216.9 million, compared to a loss of RMB 140.1 million in the previous period[80] - Adjusted profit for the period, excluding share-based compensation costs, was RMB 215.4 million, compared to a loss of RMB 182.9 million in the prior period[81] Research and Development - Research and development expenses increased to RMB 215.1 million for the six months ended June 30, 2024, up from RMB 204.6 million for the same period in 2023[23] - R&D expenses increased from RMB 189.0 million for the six months ended June 30, 2023, to RMB 209.3 million for the six months ending June 30, 2024, representing a growth of 10.8%[25] - Employee costs for R&D increased to RMB 85.3 million from RMB 81.9 million, reflecting the company's investment in talent[78] - The company has a pipeline of 16 drug candidates, with 10 currently in clinical stages, focusing on oncology and precision medicine[30] - The company emphasizes ongoing investment in R&D to push scientific boundaries and provide breakthrough solutions to urgent medical challenges[72] Licensing and Collaborations - The company received a first payment of $70 million from Merck for an exclusive license agreement allowing Merck to commercialize products containing pimicotinib in Greater China[6] - The company has entered into an exclusive licensing agreement with Merck, receiving an upfront payment of USD 70 million, with potential total payments reaching USD 605.5 million[20] - A licensing agreement with Merck was established in December 2023, granting Merck exclusive commercialization rights for pimicotinib in China, Hong Kong, Macau, and Taiwan, with an upfront payment of $70 million expected in February 2024[37] - The company is committed to strengthening strategic partnerships with leading biopharmaceutical companies and academic institutions to accelerate innovation and maximize value from collaborations[71] Share Repurchase and Capital Management - The company repurchased 18,571,000 shares for a total amount of HKD 56.3 million, reducing the total issued shares by 2.25% to 686,366,350 shares[22] - The company repurchased a total of 700,000 shares at a total cost of approximately HKD 2,257,250 between July 2 and July 4, 2024[66] - Following the cancellation of 15,833,000 repurchased shares, the total number of issued shares decreased to 686,366,350[66] - During the reporting period, the company repurchased a total of 18,571,000 shares at a total cost of HKD 56,318,840[90] - The company did not declare an interim dividend for the six months ended June 30, 2024, consistent with the previous year[93] Corporate Governance and Compliance - The company is committed to maintaining high standards of corporate governance and has adhered to all applicable codes during the reporting period[99] - The company has established a timeline for the expected utilization of unutilized proceeds, with most allocations planned for December 31, 2024[102] - The company will comply with the relevant regulations regarding the granting of awards to connected persons[151] Shareholder Information - The company’s directors and senior management collectively hold 16.46% of the shares, totaling 115,550,487 shares[104] - LAV GP III, L.P. and LAV Corporate GP, Ltd. each hold 41,854,060 shares, representing 5.96% of total shares[110] - 施毅 holds 70,361,790 shares, accounting for 10.02% of total shares[110] - Qiming Venture Partners VI, L.P. has 47,323,020 shares, which is 6.74% of total shares[110] - Temasek Holdings (Private) Limited owns 23,307,460 shares, representing 3.32% of total shares[110] - Morgan Stanley & Co. International plc holds 52,486,000 shares (7.47%) and has a short position of 21,108,000 shares (3.01%) [116] - The total number of shares issued as of June 30, 2024, is 702,199,350[112] Equity Incentive Plans - The 2019 Equity Incentive Plan is valid for ten years from its adoption date, with approximately 5 years remaining as of June 30, 2024[118] - The plan does not involve the issuance of additional shares post-IPO[117] - The total number of ordinary shares that may be issued under the 2019 plan is capped at 8,360,280 shares, adjusted to 83,602,800 shares post-stock split[128] - The management has the authority to propose amendments to the 2019 plan and select employees eligible for rewards[122] - The types of rewards under the 2019 plan include stock options, share appreciation rights, and restricted shares[124] - The total number of restricted share units available for grant under the 2019 plan is 20,562,241 shares as of January 1, 2024[128] - The company has established a standard performance evaluation system for employees to assess their contributions to the group[139] Utilization of Proceeds - 19.7% of the net proceeds, equating to HKD 329.78 million, is allocated for ongoing and future R&D, including core candidate products[102] - 32.6% of the net proceeds, or HKD 545.72 million, is designated for R&D related to Fexagratinib (ABSK091, AZD4547) with an expected utilization date of December 31, 2024[102] - 28.0% of the net proceeds, amounting to HKD 468.72 million, is planned for funding other clinical-stage products, with HKD 119.62 million utilized during the reporting period[102] - The company plans to allocate 6.3% of the net proceeds, or HKD 105.46 million, for constructing a production facility in Shanghai, with HKD 60.93 million remaining unutilized as of June 30, 2024[102] - The total unutilized net proceeds as of June 30, 2024, amount to HKD 795.54 million[102]
和誉(02256) - 2024 - 中期财报