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]

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]

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香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部分內容所產生或因依 賴該等內容而引致的任何損失承擔任何責任。 Abbisko Cayman Limited 和譽開曼有限責任公司 （於開曼群島註冊成立的有限公司） （股份代號：2256） 截至2024年6月30日止六個月的中期業績公告 和譽開曼有限責任公司（「本公司」）董事會（「董事會」）欣然宣佈本公司及其附屬 公司（「本集團」或「我們」）截至2024年6月30日止六個月（「報告期」）的未經審核 簡明綜合中期業績連同2023年相應期間的比較數字。 業務摘要 於2024年至今，我們在各個方面都取得了重大進展： 進一步推進我們的臨床階段資產 Pimicotinib (ABSK021) • 我們完成pimicotinib針對腱鞘巨細胞瘤（「TGCT」）的全球多中心III期臨床試 驗的患者入組，該試驗於中國、加拿大、美國及歐洲開展。Pimicotinib獲中 華人民共和國國家藥品監督管理局（「NMPA」）及美國食品藥品監督管理局 （「FDA」）授予突破性療法認定（「BTD ...

[Table_Industry] [Table_Finance1] 公司盈利预测及估值 2022 2023 2024E 2025E 2026E 收入、其他收入及收益 （百万元） 46 106 562 636 687 增长率 yoy% 130% 430% 13% 8% 净利润（百万元） -496 -432 2 29 60 增长率 yoy% -13% -101% 1056% 107% 每股收益（元） -0.72 -0.63 0.00 0.04 0.09 每股现金流量 -0.85 -0.12 0.10 0.15 0.20 净资产收益率 -21% -22% 0% 1% 2% P/E -4.2 -4.8 828.9 71.7 34.6 P/B 0.9 1.0 0.9 0.7 0.6 备注：每股指标按照最新股本数全面摊薄；注：股价截至 2024.8.1 [Table_Profit] 基本状况 总股本(百万股) 686 流通股本(百万股) 686 市价(港元) 3.0 市值(百万港元) 2059 流通市值(百万港元) 2059 和誉医药(2256.HK)/医药生 物证券研究报告/公司深度报告 2024 年 08 月 01 ...