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]

Investment Rating - The report gives a "Buy" rating for the company, marking its first coverage [6]. Core Views - The company focuses on differentiated small molecule drug development, with its core asset, Pimicotinib, expected to be commercialized soon [6][12]. - The company achieved its first annual profit in 2024, with a net profit of 28.3 million yuan and total revenue of 504 million yuan, primarily from licensing agreements [6][23]. - The company has a robust pipeline with 19 oncology products, 12 of which are in clinical development [6][12]. Summary by Sections Section 1: Commitment to Differentiated Small Molecule Development - The company is dedicated to developing differentiated small molecule therapies for oncology, with 12 clinical candidates in its pipeline [12]. - The management team has extensive experience in drug development, enhancing the company's innovation capabilities [18]. - A stock repurchase plan of up to 200 million HKD is set to start in 2025, reflecting management's confidence in future growth [21]. - The company reported its first annual profit in 2024, with a strong cash reserve of 1.959 billion yuan [23]. - The core product, Pimicotinib, is expected to submit applications for market approval in China and the U.S. in 2025 [26]. Section 2: CSF-1R Pimicotinib for TGCT - Pimicotinib has reached the primary endpoint in its Phase 3 trial for treating TGCT, with plans to submit market applications in 2025 [30][32]. - The drug shows promising efficacy and safety in treating chronic graft-versus-host disease (cGvHD) in its Phase 2 trials [38][44]. Section 3: FGFR Small Molecule Inhibitors - The company has a multi-faceted approach to FGFR inhibitors, with ABSK011 entering pivotal Phase 2/3 trials for liver cancer [7]. - ABSK061, the first FGFR2/3 inhibitor in clinical trials, is expected to advance in 2025 for various indications [7]. Section 4: Oral PD-L1 Inhibitor ABSK043 - The global PD-(L)1 market is projected to exceed 50 billion USD in 2024, with the company exploring the potential of its oral PD-L1 inhibitor [4]. Section 5: Early Pipeline and Dual-Antibody ADC Platform - The company maintains a rich early-stage pipeline, which is crucial for its long-term growth [7].

Investment Rating - The report gives a "Buy" rating for the company, marking its first coverage [6]. Core Views - The company focuses on differentiated small molecule drug development, with its core asset, Pimicotinib, expected to be commercialized soon [6][12]. - The company achieved its first annual profit in 2024, with a net profit of 28.3 million yuan and total revenue of 504 million yuan, primarily from licensing agreements [6][23]. - The company has a robust pipeline with 19 oncology products, 12 of which are in clinical development, and has established partnerships with major pharmaceutical companies [6][12]. Summary by Sections Section 1: Commitment to Differentiated Small Molecule Development - The company is dedicated to developing differentiated small molecule therapies for oncology, with 12 clinical candidates in its pipeline [12]. - The management team has extensive experience in drug development, enhancing the company's innovation capabilities [19]. - A stock buyback plan of up to 200 million HKD is set to start in 2025, reflecting management's confidence in future growth [21]. - The company reported its first annual profit in 2024, with a cash reserve of 1.959 billion yuan [23]. - The core product, Pimicotinib, is expected to submit applications for market approval in China and the U.S. in 2025 [28]. Section 2: Pimicotinib for TGCT - Pimicotinib has reached the primary endpoint in its Phase 3 trial for treating TGCT and is expected to submit market applications in 2025 [30][33]. - The drug shows promising efficacy and safety in treating cGvHD, with a complete Phase 2 data disclosure expected in 2025 [39][45]. Section 3: FGFR Small Molecule Inhibitors - The company is advancing its FGFR4 inhibitor, ABSK011, into pivotal Phase 2/3 trials for liver cancer [7]. - ABSK061, a FGFR2/3 inhibitor, is set to enter clinical trials for achondroplasia in 2025 [7]. Section 4: Oral PD-L1 Inhibitor Development - The global PD-(L)1 market is projected to exceed 50 billion USD in 2024, with the company exploring the potential of its oral PD-L1 inhibitor [4]. Section 5: Early Pipeline and Dual-Antibody ADC Platform - The company maintains a rich early-stage pipeline, which is crucial for its long-term growth [7].

Core Insights - The core reason for He Yu-B's (02256) first full-year profitability in 2024 is the successful collaboration with Merck on its core product Pimicotinib (ABSK021), which included a $70 million upfront payment and an $85 million option fee for global commercialization [1][2][3] - The partnership has generated over $150 million in cash for He Yu-B, providing substantial financial support for future R&D projects [1][3] - Pimicotinib is recognized as a potential blockbuster drug with significant global commercialization prospects, particularly in treating TGCT and other indications [2][3] Group 1: Financial Performance and Collaborations - He Yu-B achieved profitability in 2024 due to innovative capabilities and successful business development (BD) transactions, resulting in strong cash flow [1][3] - The collaboration with Merck is expected to yield additional milestone payments totaling up to $606 million, excluding double-digit net sales royalties [1][3] - The management's confidence in the company's future is reflected in stock buyback initiatives, which have positively impacted stock prices [4][5] Group 2: Product Development and Market Potential - Pimicotinib is the first Chinese-developed CSF-1R inhibitor to enter global Phase III clinical trials, with breakthrough therapy designations from multiple regulatory agencies [2][3] - The drug demonstrated a 54% objective response rate (ORR) in clinical trials, significantly outperforming the placebo group [3] - He Yu-B's pipeline includes 19 candidate drugs targeting various cancer pathways, with several having the potential to be first-in-class (FIC) or best-in-class (BIC) [4][6] Group 3: Future Prospects and Market Trends - The global liver cancer market is projected to reach approximately $5.3 billion by 2029, with immunotherapy expected to capture a significant share [6] - He Yu-B's other candidate, Ipagotene (ABSK011), is positioned to become a leading FIC/BIC drug due to its efficacy and safety profile [6][7] - The company is actively participating in major conferences to showcase its innovative research, indicating strong market interest and potential for future BD opportunities [7][8]

Core Viewpoint - The company is showcasing its innovative drug development progress at the AACR annual meeting, emphasizing the importance of reliable clinical results for intrinsic value in the growing innovative drug sector [1][2]. Group 1: Clinical Research and Development - The company will present four new preclinical research results at the AACR conference, including the EGFR Exon20ins inhibitor ABSK112, PRMT5*MTA inhibitor ABSK131, and KRAS inhibitor [1]. - ABSK112 has demonstrated superior brain penetration, selectivity against wild-type EGFR, and a broader mutation coverage in preclinical studies, indicating its potential as a next-generation drug for non-small cell lung cancer (NSCLC) [2][3]. - ABSK131 targets the PRMT5 gene, which is associated with synthetic lethality in tumors lacking the MTAP gene, showing promise as a novel cancer treatment strategy [3]. Group 2: Financial Performance - In 2024, the company achieved approximately 504 million yuan in revenue, a significant year-on-year increase of 2544%, successfully turning a profit [1]. - The strong revenue growth and expected cash flow support the company's innovative research and development efforts, with 451 million yuan allocated for R&D during the reporting period [1]. Group 3: Market Position and Future Prospects - The company has established a competitive pipeline of 15 candidate drugs focusing on precision oncology and immunotherapy, with several candidates showing "best-in-class" or "first-in-class" potential [3]. - The stock price reached a peak of 8.98 HKD on March 28, marking the highest level since the second half of 2022, indicating the market's recognition of the company's intrinsic value [4].

Investment Rating - The report initiates coverage with a "Buy" rating and sets a target price of HKD 11.50, indicating a potential upside of 43% from the current price of HKD 8.02 [5][6]. Core Insights - The company has demonstrated outstanding capabilities in small molecule innovative drug development, particularly in oncology, with a pipeline consisting of 16 major candidates, including 10 in clinical stages [11][12]. - The global product Pimicotinib has shown excellent clinical data and is nearing commercialization, with a reported objective response rate (ORR) of 54.0% in a key clinical trial [3][22]. - The innovative drug Ipazagratinib is being developed for advanced liver cancer with promising early clinical results, indicating a significant market opportunity [4][33]. - The company is expected to experience rapid growth, with projected revenues of RMB 650 million, RMB 680 million, and RMB 730 million for 2025, 2026, and 2027 respectively [5][46]. Company Overview - The company focuses on discovering and developing innovative small molecule therapies for oncology, having established a robust pipeline since its inception in 2016 [8][11]. - The research team comprises approximately 221 professionals, with a significant portion holding advanced degrees, underscoring the company's strong R&D capabilities [39][40]. Financial Overview - The company is projected to achieve revenues of RMB 504 million in 2024, a substantial increase from RMB 19 million in 2023, marking a significant turnaround with a net profit of RMB 28 million expected for 2024 [46][47]. - The financial forecasts indicate continued growth, with revenues from Pimicotinib expected to reach RMB 110 million by 2026 and RMB 450 million by 2028 [47]. Industry Context - The report highlights the increasing support for innovative drug policies in China, which is expected to enhance the market potential for new drugs [15][16]. - The Chinese innovative drug sector is witnessing a surge in international licensing agreements, with 96 agreements totaling USD 856 billion in 2023, indicating a strong competitive advantage for domestic companies [16].

Investment Rating - The report maintains a "Buy" rating for the company, with a target price of HKD 9.12, indicating an expected upside of over 20% from the current price of HKD 7.52 [6]. Core Insights - The company reported a total revenue of HKD 504 million for 2024, representing a year-on-year increase of 2544%, primarily due to a USD 70 million upfront payment from Merck. The net profit for 2024 was HKD 28.3 million, up 107% year-on-year [1]. - The clinical trial results for ABSK021 in the treatment of TGCT in the Phase III MANEUVER study were positive, achieving a 54.0% overall response rate (ORR) compared to 3.2% in the placebo group, with significant improvements in key secondary endpoints [2]. - The company is advancing its clinical trials for ABSK011, which has received approval for a Phase III registration trial, targeting advanced or unresectable HCC patients [4]. - The market for ACH (Achondroplasia) presents unmet medical needs, with a global incidence of 1 in 17,000 to 28,000 live births, indicating a significant patient population for potential treatments [5]. Summary by Sections Financial Performance - The company expects revenues of HKD 630 million in 2025, with an upward revision of 2026 revenues from HKD 617 million to HKD 684 million. The projected net profits for 2025 and 2026 are HKD 45 million and HKD 68 million, respectively, with an expected net profit of HKD 98 million in 2027 [6]. Clinical Development - ABSK021 has shown excellent efficacy and safety in its Phase III trials for TGCT, with a low rate of treatment-related adverse events and no evidence of cholestatic liver toxicity [2]. - The Phase II trial results for ABSK021 in cGvHD showed an overall response rate of 57.7%, with significant responses observed across various affected organs [3]. Market Potential - The report highlights the potential of FGFR2/3 inhibitors like ABSK061 in treating ACH, with a significant market opportunity given the prevalence of the condition and the limited current treatment options [5].

Investment Rating - The report maintains a "Buy" rating for the company, with a target price of HKD 9.12, indicating an expected upside of over 20% from the current price of HKD 7.52 [6]. Core Insights - The company reported a total revenue of HKD 504 million for 2024, representing a year-on-year increase of 2544%, primarily due to a USD 70 million upfront payment from Merck. The net profit for 2024 was HKD 28.3 million, up 107% year-on-year [1]. - The clinical trial results for ABSK021 in the treatment of TGCT were outstanding, with a 54% overall response rate (ORR) in the 50mg QD dosage group, significantly outperforming the placebo group [2]. - The company is advancing its clinical trials for ABSK011, which has received approval for a Phase III registration trial, showing promising results in earlier phases with an ORR of 44.8% [4]. - The market for ACH (Achondroplasia) presents significant unmet medical needs, with a global incidence rate of 1 in 17,000 to 28,000 live births, indicating a substantial patient population for potential treatments [5]. Summary by Sections Financial Performance - The company expects revenues of HKD 630 million in 2025, with an upward revision of 2026 revenues from HKD 617 million to HKD 684 million, and projected revenues of HKD 634 million in 2027 [6]. Clinical Development - ABSK021 has shown excellent efficacy and safety in its Phase III trial for TGCT, with a 25-week ORR of 54% and a low rate of treatment-related adverse events [2][3]. - The ongoing Phase II trial for ABSK021 in cGvHD has reported an overall ORR of 57.7%, with promising results across various affected organs [3]. Market Potential - The global market for ACH treatments is expanding, with existing therapies showing significant sales growth, indicating a robust opportunity for the company's FGFR2/3 inhibitor, ABSK061 [5].

Investment Rating - The report maintains a "Buy" rating for the company, with a target price of HKD 9.12, indicating an expected relative return of over 20% within six months [6]. Core Insights - The company reported a total revenue of HKD 504 million for 2024, a significant increase of 2544% year-on-year, primarily due to a USD 70 million upfront payment from Merck. The net profit for 2024 was HKD 28.3 million, reflecting a year-on-year growth of 107% [1]. - The clinical trial results for ABSK021 in the treatment of TGCT in Phase III were positive, achieving a 54.0% overall response rate (ORR) compared to 3.2% in the placebo group, with significant improvements in key secondary endpoints [2]. - The company is advancing its clinical trials for ABSK011, which has received approval for Phase III registration trials, showing promising results in earlier phases with an ORR of 44.8% in HCC patients [4]. Summary by Sections Financial Performance - The company expects revenues of HKD 630 million in 2025, with an upward revision of 2026 revenues from HKD 617 million to HKD 684 million, and projected revenues of HKD 634 million in 2027. The net profit estimates for 2025 and 2026 have been adjusted to HKD 45 million and HKD 68 million, respectively, with a forecast of HKD 98 million for 2027 [6]. Clinical Development - ABSK021 has shown excellent efficacy and safety in its Phase III clinical trials for TGCT, with a low rate of treatment-related adverse events and no evidence of cholestatic liver toxicity [2]. - The company is also progressing with ABSK011, which has received approval for Phase III trials, targeting advanced or unresectable HCC patients [4]. Market Potential - The ACH indication presents a significant unmet medical need, with a global prevalence of approximately 360,000 affected individuals. The report highlights the potential of FGFR2/3 inhibitors like ABSK061 in addressing this need [5].

Clinical Trials and Drug Development - The global Phase III MANEUVER study for pimicotinib in treating TGCT patients reported a 54.0% objective response rate (ORR) at 25 weeks, compared to 3.2% in the placebo group (p<0.0001) [4] - The long-term results of the Phase Ib study for pimicotinib in TGCT patients showed an ORR of 85.0% with a median treatment duration of 20.67 months as of June 30, 2024 [5] - Preliminary results from the Phase II study for pimicotinib in treating cGvHD patients indicated an ORR of 64% in a subgroup receiving 20mg QD treatment [6] - The FGFR4 inhibitor irpagratinib received approval from China's CDE to initiate a registration clinical study for treating advanced or unresectable HCC patients [7] - The oral PD-L1 inhibitor ABSK043 demonstrated an ORR of 20.4% in a Phase I study, with 33.3% in NSCLC patients and 41.7% in high PD-L1 expressing NSCLC patients [8] - The initial human data for FGFR2/3 inhibitor ABSK061 showed an ORR of 37.5% in patients with advanced solid tumors [9] - The company completed the first patient dosing in a Phase II study combining ABSK061 with ABSK043 for treating solid tumors [10] - ABK3376 (AST2303), a new generation EGFR inhibitor, received approval for a Phase I study in China for NSCLC patients with EGFR-C797S mutation, in collaboration with Elys [14] - ABSK131, a selective PRMT5-MTA complex inhibitor, received IND approval from the FDA in December 2024, with preclinical results presented at the EORTC-NCI-AACR conference in October 2024 [14] - The company is conducting a Phase I trial of ABSK112 for NSCLC, with the first patient dosed in February 2024 [53] - The company is conducting Phase I studies for ABSK121 in advanced solid tumors in both China and the U.S. [51] - The company is exploring various combination therapies for ABSK043 and ABSK061 to enhance treatment efficacy [42][45] Financial Performance - The company achieved a revenue of RMB 504.0 million (approximately USD 70.0 million from Merck licensing and USD 1.0 million from milestone payments from Elys) for the year ended December 31, 2024, marking a significant increase of 2,544% compared to RMB 19.1 million in 2023 [15][16][20] - The company recorded a profit of RMB 28.3 million for the year, a turnaround from a loss of RMB 431.6 million in the previous year, representing a 107% improvement [15][19] - Research and development expenses increased to RMB 451.4 million from RMB 433.7 million in 2023, reflecting a 4% rise due to advancements in pipeline projects [15][20] - As of December 31, 2024, the company had cash and bank balances of RMB 1,959.2 million, slightly down by 1% from RMB 1,971.5 million in 2023 [15][16] - The company reported a total comprehensive income of RMB 50,919 thousand for the year, a significant improvement from a comprehensive loss of RMB 399,777 thousand in 2023 [74] - Total revenue for the year ended December 31, 2024, increased to RMB 503.99 million from RMB 19.06 million in 2023, representing a growth of approximately 2541% [89] - The company recorded a one-time licensing revenue of RMB 504.0 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 [89] - The company maintained a strong cash position with current assets totaling RMB 2,020,434 thousand as of December 31, 2024, slightly down from RMB 2,041,402 thousand in 2023 [75] - The company reported a basic earnings per share of RMB 0.0446 for 2024, compared to a loss of RMB 0.6660 for 2023, indicating a significant recovery in profitability [108] Shareholder Actions and Corporate Governance - The company repurchased and canceled 22,594,000 shares, accounting for 3.22% of the total shares issued as of January 1, 2024, with a total expenditure of HKD 68.7 million [15] - The company plans to enhance shareholder value through share buybacks and has a strong commitment to advancing its research and development initiatives [15][20] - The company has established a strategic partnership with Elysium for ABK3376, potentially receiving up to $187.9 million in payments, including milestone payments [65] - A licensing agreement with Merck for the CSF-1R inhibitor pimicotinib could yield up to $605.5 million, including an upfront payment of $70 million received in February 2024 [66] - The company has a robust pipeline consisting of 19 drug candidates, with 12 currently in clinical development, focusing on oncology and precision medicine [22][23] - The company maintains a high level of corporate governance and has complied with all applicable codes during the reporting period [126] Strategic Focus and Future Plans - The company aims to address unmet medical needs in oncology and other fields through innovative therapies, with a strategic focus on expanding indications beyond oncology [22] - The company plans to accelerate the transition to a new and sustainable model to support ongoing and future innovative drug development [72] - The company is committed to advancing its pipeline and clinical stage assets while actively exploring and establishing empowering partnerships [73] - The company plans to reduce the allocation of net proceeds by HKD 432 million originally intended for the development of fexagratinib, focusing instead on the next-generation FGFR inhibitor ABSK061 [137] - The company will reallocate HKD 273.64 million for other clinical-stage products, including ABSK021 and ABSK043, to accelerate their clinical progress [137] Management Changes - The company appointed Ms. Xu Haiyin as an independent non-executive director effective February 28, 2025, while Mr. Wang Lei resigned from the same position [72] - Dr. Chen will resign as an executive director and chief scientific officer effective March 3, 2025, due to other commitments, with no claims against the company [152] - Dr. Ji Jing has been appointed as an executive director effective March 3, 2025, with a term until the next annual general meeting [161] - The company believes that the change in executive directors will not have a significant adverse impact on operations [154]