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]

和誉-B20250102 摘要 Q&A 请介绍一下合力公司在 2023 年和 2024 年的主要进展情况。 从 2023 年到 2024 年，合力公司在多个方面取得了显著进展。首先，关于平美替 尼项目，我们在 2023 年 3 月底完成了患者入组，并在同年 11 月获得了数据读出， 主要临床终点 ORR 达到 54%，相比竞品的 40%表现优异。此外，平美替尼的第二 个适应症 GPSD 也在去年 12 月初于 F 会议上进行了口头报告，显示出 64%的有效 性。尽管部分患者尚未完全达到临床终点，但预计最终 OA 可能会超过 64%。安 全性方面，无论是 TTCT 还是 GPSD 适应症的数据均表现良好。 合力公司与默克的合作情况如何？ 在 2023 年 12 月，合力公司与默克签订了一项许可协议，当时获得了 7,000 万美 元的首付款。预计到 2025 年，该合作将有很大概率继续推进，并可能带来更多 海外首付款。 • 2023 年，合力公司平美替尼项目主要临床终点 ORR 达 54%，显著高于竞品； 第二个适应症 GPSD 有效性达 64%，安全性数据良好，预计未来将带来可 观收益。 • 2023 年 12 ...

Investment Rating - The report assigns a positive investment rating to the company, indicating a favorable outlook for its future performance [2]. Core Viewpoints - The approval of the clinical trial for the selective FGFR4 inhibitor, Ipagotene (ABSK011), represents a significant opportunity in the treatment of hepatocellular carcinoma (HCC), a market with limited effective drugs available [2]. - The company has demonstrated strong early clinical data for Ipagotene, with a 50% overall response rate (ORR) in patients previously treated with immune checkpoint inhibitors [2]. - The research and development (R&D) team, consisting of approximately 221 professionals, is focused on oncology, with a significant portion holding advanced degrees, indicating a strong foundation for innovation [2]. - The company has established a partnership with Merck, granting exclusive commercialization rights for Pimicotinib and related products in several regions, with a total agreement value of $605.5 million [2]. Summary by Sections Clinical Development - The approved clinical trial is a multi-center, randomized, double-blind study assessing the efficacy and safety of Ipagotene combined with best supportive care (BSC) versus placebo plus BSC in advanced or unresectable HCC patients with FGF19 overexpression [2]. - Approximately 30% of global HCC patients exhibit FGF19 overexpression, highlighting the need for targeted therapies in this area [2]. R&D and Innovation - The company has developed a pipeline of 16 oncology-focused drug candidates, with 10 currently in clinical stages, showcasing its commitment to advancing cancer treatment [2]. - The leadership team, including Dr. Xu Yaochang, Dr. Yu Hongping, and Dr. Chen Zhui, has a proven track record in successfully commercializing drug projects, enhancing the company's competitive edge in small molecule drug development [2]. Market Potential - The report emphasizes the significant market potential for Ipagotene in treating HCC, particularly given the lack of effective therapies for late-stage liver cancer patients [2]. - The company's innovative approach and efficient R&D processes position it well for future growth in the oncology sector, with the current valuation seen as undervalued [2].

Investment Rating - The report maintains a "Buy" rating for the company, expecting a relative increase of over 15% in stock price compared to the benchmark index within the next 6 to 12 months [2][8]. Core Insights - The report highlights the successful results of the global Phase III clinical trial for Pimicotinib, a small molecule inhibitor for treating tenosynovial giant cell tumors (TGCT), which is expected to lead to a market application submission [1][2]. - The company anticipates significant revenue growth, projecting total revenue to increase from 46 million in 2023 to 562 million in 2024, representing a year-over-year growth rate of 134% [2][5]. - The net profit is expected to turn positive in 2024, with projections of 2 million, and further increasing to 28 million by 2025 [2][5]. Financial Projections - Total Revenue (in million): - 2023A: 46 - 2024E: 562 - 2025E: 639 - 2026E: 689 - Year-over-Year Growth Rate: - 2023A: -31% - 2024E: 134% - 2025E: 428% - 2026E: 8% [2][5]. - Net Profit (in million): - 2023A: -496 - 2024E: -432 - 2025E: 2 - 2026E: 28 [2][5]. - Earnings Per Share (in yuan): - 2023A: -0.73 - 2024E: -0.64 - 2025E: 0.00 - 2026E: 0.04 [2][5]. - Price-to-Earnings (P/E) Ratio: - 2023A: -5.6 - 2024E: -6.4 - 2025E: 1359.5 - 2026E: 99.4 [2][5]. Market Position and Competitive Advantage - The report indicates that Pimicotinib has shown significant efficacy and safety in clinical trials, with a notable overall response rate (ORR) of 54.0% compared to the placebo group [1][2]. - The company has established a licensing agreement with Merck for Pimicotinib, which is expected to enhance cash flow and open up overseas markets [1][2]. - The report emphasizes the competitive edge of Pimicotinib over similar products in the market, particularly in terms of safety and efficacy [1][2].

Investment Rating - The investment rating for the company is "Buy" (maintained) [1][2] Core Views - The report highlights the excellent results from the Phase III clinical trial of Pimicotinib (ABSK021) for the indication of tenosynovial giant cell tumor, indicating strong efficacy and safety [1] - The company has entered into an exclusive licensing agreement with Merck for Pimicotinib, which is expected to enhance commercialization prospects [2] - Revenue forecasts for 2024 and 2025 have been revised upwards to 547 million and 636 million CNY respectively, with a projected net profit of 3 million and 28 million CNY for the same years [2] Summary by Sections Clinical Trial Results - The Phase III trial of Pimicotinib showed an overall response rate (ORR) of 54.0% compared to 3.2% in the placebo group, with a best ORR of 85.0% and a median treatment duration of 20 months [1] - The drug demonstrated good tolerability with a low rate of treatment discontinuation due to adverse events [1] Financial Projections - The company's revenue estimates for 2024 and 2025 have been increased significantly due to the promising trial results and the licensing agreement with Merck [2] - The projected net profit for 2026 is estimated at 1.3 million CNY [2] Pipeline Development - The report mentions ongoing clinical trials for other drug candidates, including ABSK011 and ABSK043, indicating a robust pipeline and continued research and development efforts [1]

Abbisko Cayman Limited 和譽開曼有限責任公司 股份代號 : 2256 （於開曼群島註冊成立的有限公司） 2024 中期報告 目錄 | --- | --- | |----------------------------------|-------| | | | | 公司資料 | 2 | | 業務摘要 | 4 | | 財務摘要 | 8 | | 管理層討論及分析 | 10 | | 其他資料 | 27 | | 中期簡明綜合損益及其他全面收益表 | 61 | | 中期簡明綜合財務狀況表 | 62 | | 中期簡明綜合權益變動表 | 63 | | 中期簡明綜合現金流量表 | 65 | | 中期簡明綜合財務資料附註 | 67 | 公司資料 | --- | --- | |---------------------------------|-----------------------------------------------| | | | | 董事會 | | | 執行董事 | | | 徐耀昌博士 （主席） | | | 喻紅平博士 | | | 陳椎博士 | | | 非執行董事 | | | 唐艷旻女士 ...

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