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 ...

Clinical Development and Approvals - The company received IND approval from the FDA for the first human Phase I clinical study of ABSK012 for advanced solid tumor patients in November 2023[1]. - The company has obtained nearly 28 IND or clinical trial approvals across multiple countries and regions, including three Phase III trials for pimicotinib in the US, Canada, and Europe[10]. - The company announced the preliminary results of the first human trial of the selective FGFR2/3 inhibitor ABSK061 in February 2024[12]. - The company has initiated the first human Phase I clinical trial for ABSK051 in China for the treatment of advanced solid tumors as of January 2024[46]. - ABSK012, a new generation FGFR4 inhibitor, demonstrated strong efficacy against both wild-type and mutant FGFR4 in preclinical studies[39]. - In April 2023, ABSK012 received Orphan Drug Designation (ODD) from the FDA for the treatment of STS[41]. - The company received orphan drug designation from the EMA for pimicotinib in January 2024, which will provide various incentives for development and market exclusivity[11]. Financial Performance - Revenue increased from zero in 2022 to RMB 19.06 million in 2023, primarily due to increased licensing fee income from a clinical candidate[20]. - Other income and gains rose from RMB 45.56 million in 2022 to RMB 87.38 million in 2023, driven by a RMB 30.5 million increase in bank interest income and a RMB 10.6 million increase in government subsidies[23]. - The company reported a pre-tax loss of RMB 431.58 million in 2023, an improvement from a loss of RMB 495.61 million in 2022[20]. - Total comprehensive loss for the year was RMB 399.78 million in 2023, compared to RMB 295.34 million in 2022[20]. - The company’s adjusted loss for the year was RMB 384.19 million in 2023, slightly improved from RMB 385.49 million in 2022[31]. - Cash and bank balances decreased from RMB 2,258.83 million in 2022 to RMB 1,971.49 million in 2023[22]. - Non-current assets decreased from RMB 81.83 million in 2022 to RMB 73.98 million in 2023, with a notable decline in right-of-use assets[22]. - The company reported a significant reduction in other expenses from RMB 41.3 million in 2022 to RMB 5.7 million in 2023, primarily due to fluctuations in exchange rates[35]. Research and Development - The company has a strong R&D team of approximately 218 employees, with over 71% holding advanced degrees, focusing on oncology[6]. - The company is advancing a robust pipeline of 16 promising candidates, with several entering late-stage clinical development[13]. - The company is focused on the continuous expansion and rapid advancement of various R&D pipelines[84]. - The management team includes experienced professionals with extensive backgrounds in pharmaceutical research and development[93][97]. - The company is investing in research and development, allocating $30 million towards new technologies aimed at enhancing product efficacy[100]. Strategic Partnerships and Collaborations - The company entered into a licensing agreement with Merck in December 2023, with total payments expected to reach $605.5 million, including upfront and milestone payments[4]. - The company received a non-refundable upfront payment of $70 million from Merck in February 2024 as part of the licensing agreement[5]. - The company aims to strengthen strategic partnerships with leading biopharmaceutical companies and academic institutions to accelerate innovation[14]. - The company has established a specialized business development team to identify and evaluate promising opportunities for strategic partnerships[3]. - The management team emphasized the importance of strategic partnerships, aiming to establish at least two new collaborations within the next year[100]. Market and Competitive Landscape - The company continues to face significant risks, including reliance on third-party licensors and the expectation of ongoing net losses in the foreseeable future[60]. - The company faces intense competition in the oncology market from existing products and candidates under development, which may impact its competitive position and the commercial success of its candidates[62]. - The business and financial outlook heavily depends on the success of clinical-stage and preclinical candidates; any significant delays in clinical development could adversely affect the company's performance[62]. Shareholder and Equity Information - The board of directors did not recommend a final dividend for the year ending December 31, 2023, consistent with the previous year[56]. - The beneficial ownership of the company is held by key executives, with Dr. Xu and Dr. Chen each holding 16.85% of the shares[81]. - As of December 31, 2023, the total number of shares issued by the company is 702,199,350 shares[118]. - The total number of unexercised stock options under the 2019 plan is 9,396,452 shares, representing approximately 1.34% of all issued shares[152]. - The total number of unexercised restricted share units under the 2019 plan is 21,847,000 shares, accounting for about 3.11% of all issued shares as of December 31, 2023[152]. Equity Incentive Plan - The 2019 equity incentive plan was approved on July 4, 2019, and aims to attract and retain qualified personnel, rewarding employees, directors, and consultants[129]. - The plan allows for various types of rewards, including stock options, share appreciation rights, and restricted shares[139]. - The board has the authority to determine the terms and conditions of the rewards, including the number of shares involved[136]. - The plan is effective for a period of ten years from the adoption date, with no further grants unless terminated early[130]. - The total number of stock options granted during the reporting period was 1,025,000[167]. Future Outlook - The company provided guidance for the next fiscal year, projecting revenue growth of 20% to $600 million[100]. - New product launches are expected to contribute an additional $50 million in revenue, with a focus on innovative healthcare solutions[100]. - Market expansion plans include entering three new international markets, which are projected to increase user base by 10%[100]. - The company is considering strategic acquisitions to bolster its market position, with a budget of $100 million earmarked for potential targets[100].

Drug Development and Clinical Trials - Pimicotinib received breakthrough therapy designation (BTD) from the FDA and priority medicine designation (PRIME) from EMA for the treatment of inoperable TGCT patients[16] - Objective response rates (ORR) for pimicotinib in TGCT patients reached 87.5% for the 50mg QD group and 66.7% for the 25mg QD group after one year of follow-up[18] - Irpagratinib demonstrated a 40.7% ORR in previously treated FGF19 overexpressing HCC patients in a recent study[8] - The company is conducting a Phase II trial of fexagratinib for locally advanced or metastatic urothelial carcinoma patients in China, with patient enrollment ongoing since November 2021[9] - The company is conducting global Phase III clinical trials for pimicotinib targeting TGCT in China, the US, and Europe, with approvals from both NMPA and FDA[16] - Irpagratinib's Phase II trial in combination with lenvatinib for advanced or unresectable HCC patients received approval from CDE in September 2023[7] - The company is advancing ABSK061, a next-generation selective FGFR2/3 inhibitor, in Phase I clinical trials for solid tumor patients in both China and the US[10] - The company is conducting a Phase I trial in Australia to evaluate the safety, tolerability, and PK/PD characteristics of ABSK043 in solid tumor patients[50] - The ORR for mUC patients with FGFR3 mutations treated with fexagratinib was confirmed at 30.7% (4/13), while the ORR for FGFR3 mutation patients was 44% (4/9) in the ongoing Phase II trial in mainland China[58] - The company received IND approval from the US FDA for the first human Phase I clinical study of ABSK012 in November 2023[38] - The company received approval from the National Medical Products Administration for a Phase II clinical trial of Pimicotinib in cGvHD patients in January 2023[104] - In June 2023, the first patient was dosed in the Phase II trial for cGvHD, and in July, the first patient was dosed in the Phase III trial for TGCT in the U.S.[106] - The European Medicines Agency approved Pimicotinib for a Phase III trial in TGCT patients in September 2023, marking a significant milestone for a CSF-1R inhibitor developed in China[106] - In November 2023, Pimicotinib was granted Orphan Drug Designation (ODD) by the EMA for the treatment of unresectable TGCT, which will provide various incentives including market exclusivity[124] - Irpagratinib received IND approval from the FDA in September 2023 for a Phase I clinical study evaluating its safety and pharmacokinetics in advanced solid tumor patients[116] - The Phase II clinical trial application for Irpagratinib in combination with Lenvatinib for liver cancer was accepted by the CDE in July 2023, following promising initial efficacy results[115] - ABSK051 received IND approval from the NMPA in November 2023 for a Phase I trial in patients with advanced solid tumors[120] - The clinical candidate ABK3376, a new generation EGFR inhibitor, is currently undergoing preclinical development after being licensed to a partner[121] - The company is conducting a Phase II trial of Irpagratinib in combination with Roche's anti-PD-L1 antibody for advanced HCC patients in mainland China[126] - ABSK121, a next-generation FGFR inhibitor, has shown strong efficacy against wild-type and mutant FGFR1-3 in preclinical studies, targeting patients with relapsed or progressed disease after initial FGFR inhibitor treatment[132] - The company is developing ABSK112, a next-generation EGFR exon 20 inhibitor, which shows superior activity against EGFR exon 20 mutations found in 3% to 5% of NSCLC patients[142] - The company is conducting a Phase Ib/II clinical trial in China for ABSK081 (mavorixafor) in combination with Junshi's toripalimab for TNBC patients, with patient enrollment completed[144] - The company has obtained nearly 28 IND or clinical trial approvals in various countries and regions, including three Phase III trials for pimicotinib in the US, Canada, and Europe[160] - In January 2024, the company completed the first dosing of ABSK051 in a Phase I clinical trial for advanced solid tumors in China[161] Financial Performance - The annual loss decreased from RMB 385.5 million in 2022 to RMB 384.2 million in 2023, attributed to increased R&D expenses and revenue growth[32] - The company received a total of up to $187.90 million in milestone payments for development and sales, along with a percentage of net sales royalties[29] - As of December 31, 2023, cash and bank balances amounted to RMB 1,971.5 million, a decrease of RMB 287.3 million from RMB 2,258.8 million as of December 31, 2022, primarily due to ongoing expansion and advancement of various R&D pipelines[40] - The financial cost decreased from RMB 2.69 million for the year ended December 31, 2022, to RMB 2.17 million for the year ended December 31, 2023, a reduction of RMB 0.52 million, mainly due to decreased lease interest payments[41] - The total assets less current liabilities amounted to RMB 2,006.2 million as of December 31, 2023, compared to RMB 2,381.996 million as of December 31, 2022[54] - The net asset value as of December 31, 2023, was RMB 1,981.1 million, down from RMB 2,346.4 million as of December 31, 2022[54] - The company reported a basic loss per share of RMB 0.667 for the year ended December 31, 2023, compared to RMB 0.798 for the year ended December 31, 2022[77] - The company’s pre-tax loss for the year was RMB 431,583,000, compared to RMB 495,606,000 in the previous year[77] - The total liabilities for the year 2023 were RMB 98,119,000, slightly up from RMB 97,585,000 in 2022[87] - The company has not declared or paid any dividends during the year[75] - The company recognized licensing revenue of RMB 19,060,000 during the reporting period[70] - The company achieved a gross profit of RMB 19.1 million, with no cost of sales reported[180] - The company experienced a total comprehensive loss of RMB 399.8 million for the year, compared to RMB 295.3 million in the previous year[172] - Research and development expenses amounted to RMB 433.7 million, an increase from RMB 378.7 million in the prior year[187] - Other income increased to RMB 87.4 million from RMB 45.6 million, driven by higher bank interest income and government subsidies[182] - The company’s net assets decreased to RMB 1,981.1 million from RMB 2,346.4 million year-over-year[173] - Cash and bank balances decreased to RMB 1,971,491 thousand in 2023 from RMB 2,258,827 thousand in 2022, representing a decline of approximately 12.7%[91] - The company reported a cash and cash equivalents balance of RMB 578,081 thousand in 2023, down from RMB 641,837 thousand in 2022, indicating a decrease of about 9.9%[91] - The company received an upfront payment of USD 70 million from Merck in February 2024 as part of a licensing agreement for pimicotinib, enhancing cash reserves for future development[169] Research and Development Focus - The company has developed a pipeline of 16 candidate drugs focused on oncology, with 10 in clinical stages since its establishment in 2016[89] - The R&D team consists of approximately 218 employees, with over 71% holding graduate degrees and about 20% holding PhDs, focusing on oncology[166] - R&D expenses (excluding share-based compensation) increased from RMB 313.6 million for the year ended December 31, 2022, to RMB 405.9 million for the year ended December 31, 2023, an increase of RMB 92.3 million, driven by the continuous expansion of R&D functions and the advancement of pipeline projects[42] - R&D expenses increased from RMB 378.7 million in 2022 to RMB 433.7 million in 2023, primarily due to an increase in third-party contract costs by RMB 47.2 million[189] - Total R&D expenses breakdown for 2023: Employee costs RMB 164.8 million, third-party contract costs RMB 230.8 million, and other costs RMB 38.1 million[190] - Administrative expenses decreased from RMB 118.4 million in 2022 to RMB 96.4 million in 2023, mainly due to a reduction in share-based payment expenses by RMB 27.8 million[190] - The company emphasizes the importance of R&D for maintaining competitiveness in the Chinese biopharmaceutical market, focusing on enhancing its product pipeline[157] Strategic Partnerships and Collaborations - The company entered into exclusive licensing agreements with Shanghai Elysium Pharmaceutical Technology Co., Ltd. and Merck KGaA, Darmstadt Germany[39] - The company entered into a licensing agreement with Merck in December 2023, granting exclusive commercialization rights for pimicotinib in Greater China, with total payments amounting to $605.5 million, including a $70 million upfront payment[149] - The company has established a specialized business development team to identify and evaluate promising opportunities for strategic partnerships and collaborations[148] - The board will continue to review the separation of the roles of Chairman and CEO at an appropriate time[199]