Clinical Development and Trials - In 2024, Abbisko achieved a significant milestone with six encouraging clinical data results, including a global multicenter Phase III trial for Pimicotinib showing an objective response rate (ORR) of 54%[10] - Pimicotinib's ongoing Phase II study for chronic graft-versus-host disease (cGvHD) reported an ORR of 64%, indicating strong safety and tolerability[12] - Irpagratinib demonstrated an ORR of 44.8% in advanced hepatocellular carcinoma (HCC) patients and 50% when combined with atezolizumab, showing improved outcomes over current therapies[12] - Four new drug clinical trials (INDs) were approved in 2024, including ABSK131 by the FDA and ABSK043 in combination therapies by the NMPA[14] - ABSK043 showed an ORR of 20.4% across various cancers, with better efficacy in PD-L1 high-expressing non-small cell lung cancer (NSCLC) patients[18] - ABSK061 reported a positive ORR of 37.5% in its first human trial, demonstrating its potential as a selective FGFR inhibitor[18] - The company is advancing the clinical development of ABSK141 and submitted IND applications for ABSK131 and ABSK061 in December 2024[15] - Pimicotinib achieved a 54.0% overall response rate (ORR) in the global Phase III MANEUVER study for TGCT, compared to 3.2% in the placebo group (p<0.0001)[34] - In the Phase Ib study for TGCT, the best ORR for 42 patients treated with 50mg of pimicotinib was 85.0%, with a median treatment duration of 20.67 months[35] - The preliminary Phase II study for cGvHD showed an ORR of 64% for patients treated with 20mg QD of pimicotinib, indicating potential for improved efficacy over time[36] - Irpagratinib (ABSK011) received approval from China's CDE to conduct a registrational clinical study for treating advanced or unresectable HCC with FGF19 overexpression[37] - In a Phase I study, Irpagratinib at 220mg BID achieved an ORR of 44.8% in FGF19+ advanced HCC patients, with a median progression-free survival (mPFS) of 5.5 months[38] - The combination of Irpagratinib and atezolizumab in a Phase II study showed an ORR of 50% in FGF19+ advanced HCC patients[40] - The oral PD-L1 inhibitor ABSK043 demonstrated an ORR of 20.4% in 49 evaluable patients, with a higher ORR of 33.3% in NSCLC patients who had not received prior immunotherapy[41] - ABSK061 showed a 37.5% ORR in a Phase I trial for advanced solid tumors, with promising initial results[43] - The company submitted an IND application for ABSK061 to treat ACH to China's NMPA[45] - ABSK131 received IND approval from the FDA and the company submitted an IND application to China's NMPA, indicating progress in its clinical development[50] - The Phase III MANEUVER study enrolled 94 patients, exceeding the initial target of 90, with over half of the participants from Europe and North America[63] - Initial Phase II results for Pimicotinib in treating cGvHD showed a 64% ORR among patients receiving 20mg QD treatment[65] - Irpagratinib (ABSK011) is being developed for advanced HCC patients, with approximately 30% of global HCC patients expressing FGF19/FGFR4[67] - The company is conducting a Phase II clinical study of Pimicotinib in combination with chemotherapy for advanced pancreatic cancer patients in China[60] - The company is actively pursuing the development of Irpagratinib as a monotherapy and in combination treatments for HCC[67] - The company has received orphan drug designation for Pimicotinib from the EMA for treating TGCT[60] - Irpagratinib monotherapy showed an ORR of 44.8%, mDoR of 7.4 months, and mPFS of 5.5 months in previously treated FGF19+ advanced HCC patients[68] - Irpagratinib combined with atezolizumab achieved an ORR of 50% in FGF19+ advanced HCC patients in a Phase II trial[70] - ABSK043 demonstrated an ORR of 20.4% in 49 evaluable patients, with 33.3% ORR in untreated NSCLC patients[75] - In PD-L1 high expressing NSCLC patients, ABSK043 showed an ORR of 41.7%[75] - Fexagratinib achieved a confirmed ORR of 30.7% in FGFR3 mutated mUC patients[84] - ABSK061 showed a promising ORR of 37.5% in advanced solid tumor patients with FGFR activation changes[79] - The company is conducting a Phase I trial of ABSK121 for advanced solid tumors in China and the US[86] - The company is exploring various combination therapies for ABSK043 and ABSK061 to enhance efficacy[76][80] - The company received ODD designation from the FDA for irpagratinib for HCC treatment[69] - ABSK112 received IND approval from both China's NMPA and the US FDA in July and October 2023, respectively, with the first patient dosed in February 2024[88][89] - Mavorixafor (ABSK081) is the only orally bioavailable CXCR4 modulator in global clinical development, with market approval for treating WHIM syndrome patients aged 12 and older obtained from the US FDA in April 2024[90][91] - ABSK051, a small molecule CD73 inhibitor, is currently undergoing Phase I trials in China, with the first patient dosed in January 2024[93][94] - ABSK012 received IND approval for a Phase I clinical trial in advanced solid tumors from the US FDA in November 2023, and was granted orphan drug designation for soft tissue sarcoma in April 2023[95][96] - ABSK131, a selective PRMT5-MTA complex inhibitor, had its latest preclinical research results presented at the EORTC-NCI-AACR conference in October 2024, with IND approval from the US FDA expected in December 2024[97][98] - ABK3376 (AST2303), an EGFR-C797S inhibitor, received IND approval for a Phase I study in NSCLC patients with the EGFR-C797S mutation from China's NMPA in September 2024[101][102] Financial Performance - The financial performance in 2024 reflects significant advancements in R&D capabilities and a commitment to addressing unmet medical needs globally[9] - The company achieved a revenue of RMB 504.0 million for the year ended December 31, 2024, primarily from licensing income received from Merck, amounting to RMB 497.3 million (USD 70.0 million) and milestone payments from Shanghai Eli Lilly Pharmaceutical Technology Co., Ltd. of RMB 6.7 million (USD 1.0 million)[25] - The company recorded a profit of RMB 28.3 million for the year, a significant turnaround from a loss of RMB 431.6 million in the previous year, representing a 107% improvement[28] - Research and development expenses increased to RMB 451.4 million, up RMB 17.7 million from RMB 433.7 million in the previous year, primarily due to advancements in pipeline projects[30] - The company repurchased and canceled a total of 22,594,000 shares, representing 3.22% of the total shares issued as of January 1, 2024, for a total amount of HKD 68.7 million[25] - As of December 31, 2024, the company had cash and bank balances of RMB 1,959.2 million, slightly down from RMB 1,971.5 million in the previous year, reflecting increased spending on R&D and share buybacks[25] - The company plans to accelerate the development of clinical assets, including the NDA submission for pimicotinib for TGCT treatment and the initiation of registration clinical trials for irpagratinib for HCC treatment[24] - The company aims to explore and establish strategic partnerships to maximize the potential of its rich pipeline[24] - The company believes its stock is undervalued in the market, leading to the share buyback initiative[20] - The company expressed confidence in its strong R&D engine and clinical development platform as the foundation for future growth and success[21] - The company is committed to providing innovative therapies for global patients and will continue to uphold its mission in the coming years[21] - The company achieved a revenue of RMB 503,992,000 for the year ended December 31, 2024, compared to RMB 19,060,000 in 2023, representing a significant increase[118] - The one-time licensing revenue for the year amounted to RMB 504 million, with RMB 497.3 million generated from an exclusive licensing agreement with Merck and RMB 6.7 million from an agreement with Eli Lilly[139] - Interest income increased by RMB 23.6 million to RMB 89.1 million in 2024, compared to RMB 65.5 million in 2023[143] - Total other income and gains rose to RMB 104.09 million in 2024, up from RMB 87.38 million in 2023, primarily due to the increase in interest income[143] - The company recorded government subsidies of RMB 13.2 million in 2024, down from RMB 21.2 million in 2023, with no unmet conditions related to the subsidies received during the year[143] - The company operates in a single reportable segment focused on the development of innovative drugs, with no further segment analysis provided[134] - The company has adopted revised international financial reporting standards, impacting the presentation of financial statements[122] - The company has not yet applied new and revised international financial reporting standards that have been issued but are not yet effective, planning to adopt them when they come into effect[125] - The company’s research and development expenses are expensed as incurred unless specific criteria for capitalization are met[127] - The company uses incremental borrowing rates to measure lease liabilities, reflecting the rates that would be paid to borrow funds in similar economic environments[133] - R&D expenses increased from RMB 433.7 million in 2023 to RMB 451.4 million in 2024, a rise of RMB 17.7 million, primarily due to an increase in third-party contract costs by RMB 5.1 million[144] - Administrative expenses decreased from RMB 96.4 million in 2023 to RMB 74.2 million in 2024, a reduction of RMB 22.2 million, mainly due to decreased share-based payment expenses and third-party consulting service costs[146] - Other expenses decreased from RMB 5.7 million in 2023 to RMB 2.9 million in 2024, a decline of RMB 2.8 million, attributed to reduced foreign exchange losses[147] - Financial costs decreased from RMB 2.2 million in 2023 to RMB 1.6 million in 2024, primarily due to a reduction in lease liability interest[148] - The company reported a profit attributable to equity holders of RMB 28.3 million in 2024, compared to a loss of RMB 431.6 million in 2023[160] - The weighted average number of ordinary shares for basic earnings per share calculation was 633,992,967 in 2024, down from 647,226,272 in 2023[160] - Cash and bank balances decreased slightly from RMB 1,971.5 million in 2023 to RMB 1,959.2 million in 2024[164] - Cash and cash equivalents amounted to RMB 289.5 million in 2024, down from RMB 578.1 million in 2023[164] - The company had prepaid supplier amounts of RMB 9.1 million in 2024, down from RMB 21.3 million in 2023[163] - The company did not declare or pay any dividends for the year ended December 31, 2024, consistent with 2023[157] - The total other payables and accrued expenses increased to RMB 124,425 thousand in 2024 from RMB 98,119 thousand in 2023, representing a growth of approximately 27%[167] - The adjusted profit for 2024 was RMB 49,041 thousand, a significant improvement from a loss of RMB 384,185 thousand in 2023[171] - Research and development expenses for 2024 were RMB 451,376 thousand, compared to RMB 433,736 thousand in 2023, indicating an increase of about 4%[171] - The cash and bank balance as of December 31, 2024, was RMB 1,959.2 million, slightly down by 0.6% from RMB 1,971.5 million in 2023[174] - The debt-to-asset ratio increased to 7% in 2024 from 6% in 2023, reflecting a rise in financial leverage[175] - The company reported no significant acquisitions or disposals of subsidiaries, associates, or joint ventures during the reporting period[176] - There are no major future investment or capital asset plans disclosed in the report[177] - The company had no bank loans or other borrowings as of December 31, 2024[179] - There were no significant contingent liabilities reported as of December 31, 2024[180] - The company did not have any assets pledged as collateral as of December 31, 2024[181] Leadership and Strategic Direction - Dr. Yu Hongping, co-founder of the group, has held various leadership roles since 2016, including Chief Scientific Officer as of March 2022[188] - Dr. Ji Jing joined the group as Chief Medical Officer in February 2021 and was appointed Executive Director in March 2025, overseeing clinical development and regulatory strategies[192] - Dr. Sun Piaoyang has been a board member of Jiangsu Hengrui Medicine Co., Ltd. since April 1997, contributing to strategic decision-making[195] - Mr. Sun Hongbin was appointed as an independent non-executive director in September 2021, bringing over 23 years of financial and auditing experience to the board[198] - The company has a strong leadership team with extensive experience in pharmaceutical research and development, clinical trials, and corporate governance[190] - The group aims to expand its market presence and enhance product offerings through strategic partnerships and acquisitions[198] - Future product development will focus on innovative therapies and technologies to meet evolving healthcare needs[192] - The company is committed to maintaining high standards in clinical research and regulatory compliance to support its growth strategy[192] - The leadership team emphasizes collaboration and knowledge sharing to drive the company's strategic initiatives[190] - The group is actively exploring new markets to leverage growth opportunities and enhance shareholder value[198]
和誉-B(02256) - 2024 - 年度财报