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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]

智通财经APP讯，和誉-B(02256)发布公告，公司附属公司上海和誉生物医药科技有限公司(和誉医药)宣布，其在2024年欧洲肿瘤学会靶向抗癌治疗大会(ESMO靶向抗癌治疗大会，“ESMO TAT”)上以口头报告形式发布其新一代FGFR2/3高选择性抑制剂ABSK061的首次人体临床研究资料。 作为全球范围内首个进入临床试验的选择性FGFR2/3抑制剂，ABSK061在晚期实体瘤患者的剂量爬坡试验中，高磷血症等副作用与此前泛FGFR抑制剂相比有明显改善。含有FGFR基因改变的肺癌、胃癌等多个病人产生应答。这个结果也为ABSK061将来在软骨发育不全症等其他疾病的开发，奠定了良好的基础。 ...

Financial Performance - Revenue increased from RMB 0 to RMB 19.1 million for the six months ended June 30, 2023, primarily due to licensing fee income received from Eli Lilly[18]. - The company reported a loss of RMB 208.6 million for the six months ended June 30, 2023, a decrease of RMB 13.0 million from a loss of RMB 221.6 million for the same period in 2022, attributed to the combined effects of increased R&D expenses and revenue growth[50]. - Other income and gains increased from RMB 11.7 million to RMB 37.7 million for the six months ended June 30, 2023, primarily due to increased bank interest income and government subsidies[35]. - Administrative expenses (excluding share-based compensation costs) rose from RMB 32.9 million to RMB 35.7 million for the six months ended June 30, 2023, an increase of RMB 2.8 million, mainly due to an increase in employee benefits from non-R&D related functions[39]. - R&D expenses increased from RMB 159.0 million for the six months ended June 30, 2022, to RMB 204.6 million for the six months ended June 30, 2023, an increase of RMB 45.6 million, mainly due to the advancement of pipeline projects and expansion of R&D functions[35]. - The adjusted loss for the period was RMB 182.9 million for the six months ended June 30, 2023, compared to RMB 164.0 million for the same period in 2022[109]. - As of June 30, 2023, cash and bank balances amounted to RMB 2,102.4 million (approximately USD 291.0 million), a decrease of RMB 156.4 million from RMB 2,258.8 million as of December 31, 2022, primarily due to increased R&D activities and operational expenses[48]. Research and Development - Pimicotinib demonstrated a 77.4% objective response rate (ORR) in the 50mg group for advanced tenosynovial giant cell tumor (TGCT) patients, with a median treatment duration of 9.3 months[25]. - Pimicotinib received Breakthrough Therapy Designation (BTD) from the FDA in January 2023 for the treatment of inoperable TGCT patients[10]. - The company is conducting a global Phase III clinical trial for Pimicotinib targeting TGCT with approximately 100 participants planned across 50 centers[9]. - In June 2023, Pimicotinib was approved by the National Medical Products Administration (NMPA) to initiate a Phase II clinical study for first-line treatment of advanced pancreatic cancer[12]. - Pimicotinib was granted Priority Medicines (PRIME) designation by the European Medicines Agency (EMA) for the treatment of inoperable TGCT patients in June 2023[26]. - The company is advancing preclinical candidates including ABSK051, a small molecule CD73 inhibitor, and ABSK012, a next-generation small molecule FGFR4 inhibitor[17]. - The company completed the first patient dosing in a randomized, double-blind, placebo-controlled Phase III study of Pimicotinib in April 2023[24]. - The company is focused on enhancing its clinical-stage assets, particularly Pimicotinib, which has shown high activity and selectivity as a CSF-1R small molecule inhibitor[23]. - The company plans to evaluate the safety and efficacy of Pimicotinib in combination with standard chemotherapy and immunotherapy for advanced pancreatic cancer[12]. - The company is conducting a Phase 1b clinical trial for Irpagratinib in advanced hepatocellular carcinoma, with data to be disclosed at the ESMO 2023 conference in October[28]. - The company has initiated a Phase I clinical trial for ABSK112 targeting non-small cell lung cancer, following FDA approval in July 2023[30]. - The company is conducting a Phase I clinical trial of ABSK061 in solid tumor patients in both China and the US, having received IND approval[86]. - ABSK121, a next-generation FGFR inhibitor, received clinical trial approval in February 2023 and is set to begin trials for advanced solid tumor patients in China[92]. - Irpagratinib has demonstrated a 22% ORR in patients with FGF19+ hepatocellular carcinoma (HCC) in early Phase I results[64]. - Fexagratinib, a selective FGFR inhibitor, has shown a 33% response rate in FGFR2 amplified gastroesophageal cancer patients in previous trials[67]. - Fexagratinib's preliminary efficacy results show an objective response rate (ORR) of 30.7% for mUC patients with FGFR3 mutations, consistent with previous trials[84]. - Fexagratinib demonstrated a good safety profile with no reported grade 4 or higher adverse reactions at a dose of 80mg twice daily in Chinese patients[84]. - The Phase II trial application for Irpagratinib was accepted in July 2023, following excellent initial results in monotherapy for liver cancer[80]. - The company is exploring additional dosing levels for Irpagratinib to identify the optimal dose for expansion[79]. Corporate Governance and Shareholder Information - The company has a total of 118,116,676 shares held by Dr. Xu, Dr. Chen, and Dr. Yu, representing 16.82% of the equity[133]. - The company is committed to maintaining high standards of corporate governance to protect shareholder interests and enhance corporate value[144]. - The board will continue to review and consider separating the roles of Chairman and CEO at an appropriate time[139]. - The company has a total of HKD 1,674.00 million in net proceeds from the IPO, with HKD 1,182.56 million remaining unutilized as of June 30, 2023[132]. - The net proceeds from the global offering amounted to approximately HKD 1,674 million after deducting underwriting commissions and other estimated expenses[146]. - As of June 30, 2023, the total number of shares issued by the company was 702,199,350[149]. - LAV GP III, L.P. and LAV Corporate GP, Ltd. each hold 51,454,060 shares, representing 7.33% of the total shares[151]. - The largest shareholder, 施毅, holds 75,143,790 shares, accounting for 10.70% of the total shares[151]. - Temasek Holdings (Private) Limited holds 52,734,460 shares, which is 7.51% of the total shares[151]. - The company has not declared an interim dividend for the six months ended June 30, 2023, consistent with the previous year[139]. - As of June 30, 2023, the company had no significant acquisitions or disposals of subsidiaries, associates, or joint ventures during the reporting period[140]. - The board of directors has confirmed compliance with the standard code of conduct for securities trading during the reporting period[131]. IPO Proceeds Allocation - The company plans to allocate 19.7% of the net proceeds from the IPO (approximately HKD 329.78 million) for ongoing and future R&D, including the core product Irpagratinib (ABSK011) clinical trials and commercialization, with expected full utilization by December 31, 2023[132]. - A total of 32.6% of the net proceeds (approximately HKD 545.72 million) will be used for clinical trials and commercialization of the product Fexagratinib (ABSK091, AZD4547), with full utilization expected by December 31, 2023[132]. - The company has allocated 28.0% of the net proceeds (approximately HKD 468.72 million) for other clinical stage products and pipeline candidates, with expected full utilization by December 31, 2024[132]. Equity Incentive Plan - The 2019 equity incentive plan was approved on July 4, 2019, and is valid for ten years, with approximately 6 years remaining as of June 30, 2023[159]. - The 2019 plan aims to attract and retain qualified personnel and reward employees, directors, and consultants[158]. - The company has not issued any additional shares under the 2019 plan since its listing on the stock exchange[158]. - The total number of stock options granted under the 2019 plan is capped, and no further stock options can be granted after the listing date[171]. - The management has the authority to adjust the vesting schedule of stock options granted under the 2019 plan[162]. - The maximum number of ordinary shares that may be issued under the 2019 plan is subject to shareholder approval[171]. - The management can propose amendments to the 2019 plan and select eligible participants for rewards[188]. - The rewards granted under the 2019 plan must be formalized through agreements between the company and eligible participants[189]. - The management is responsible for determining the terms and conditions of any rewards granted to employees[188]. - The company must comply with applicable laws regarding the payment of withholding taxes on shares issued upon the exercise of options[167]. - As of June 30, 2023, no share appreciation rights or equivalent dividend rights were granted under the 2019 plan[197]. - The weighted average closing price of shares prior to the exercise of options under the 2019 plan was HKD 3.04[199]. - The exercise prices for different batches of options are RMB 0.01, RMB 1.34, and RMB 1.45[199]. - 20%, 30%, and 50% of the options will vest on the first, second, and third anniversaries of the grant date, respectively[199].

感谢大家参加本次会议,会议即将开始,请稍后。感谢大家参加本次会议,会议即将开始,请稍后。 这次会议是中国国际资产合作组织CICC的闭门会议只有邀请客人可以参加不需要CICC和评论员签署的允许任何组织或人员不得删除、翻载、複制、複制、複制、複制、複制、複制、複制、複制、複制、複制、複制、複制、複制、複制、複制、複制、複制、複制、複制、複制、複制、複制、複制、複制、複制、複制、複制、複制、� 潜在的Basin-class CSF1-R1-Z ABS-K021获得了FDA CBE以及EMA在内的这个Breakthrough的多项认证或者是这个优先药物资格那用于TBCP的国际三期临床也完成了中美首例患者的给药另外呢公司的FGFR41-Z与口服的PDR11-Z临床数据也将在接下来的ISMO会议上有更新的临床进展 临床比例方面都取得了稳步的推进另外财务状况也是非常稳健OK 首先介绍一下中晚期的临床管线第一个我要讲的是我们的ABS-K021 Pimicotinib这个项目获得了中美欧三级突破性疗法的认定 在早期管轻方面我们有新一代的EGFR-X20移植剂已经获得了美国FDA和MDP的批件这是针对肺癌的疫情实验马上就会进行A ...

Financial Performance - Total comprehensive loss attributable to equity holders of the parent was RMB (140,133) thousand for the six months ended June 30, 2023, compared to RMB (107,985) thousand for the same period in 2022 [2]. - Adjusted loss for the period was RMB (182,883) thousand for the six months ended June 30, 2023, compared to RMB (164,039) thousand for the same period in 2022 [7]. - The net loss for the six months ended June 30, 2023, was RMB 208.6 million, a decrease of RMB 13.0 million from RMB 221.6 million for the same period in 2022 [71]. - For the six months ended June 30, 2023, the company reported a loss attributable to equity holders of RMB 208,592,000, compared to a loss of RMB 221,605,000 for the same period in 2022 [142]. - The company experienced a net loss of RMB 208.59 million for the six months ended June 30, 2023, compared to a net loss of RMB 221.61 million for the same period in 2022, reflecting a decrease in administrative expenses [99]. Research and Development - Research and development expenses increased from RMB 159.0 million for the six months ended June 30, 2022, to RMB 204.6 million for the six months ended June 30, 2023, primarily due to an increase in third-party contract costs of RMB 38.8 million as clinical trials advanced [4]. - R&D expenses (excluding share-based compensation) increased from RMB 124.4 million to RMB 189.0 million, driven by the advancement of pipeline projects and expansion of R&D functions [72]. - Research and development expenses (excluding depreciation and amortization) increased to RMB 198,023,000 in the first half of 2023, up from RMB 152,769,000 in the same period of 2022, representing a growth of approximately 29.5% [8]. - The company aims to discover and develop differentiated therapies in oncology and other fields to address significant unmet medical needs in China and globally [149]. - The company has a pipeline of 16 drug candidates, including 8 in clinical stages, focused on small molecule oncology therapies [178]. Clinical Trials and Drug Development - The company completed the first patient dosing in a Phase III study of Pimicotinib in April 2023, evaluating its efficacy and safety in treating TGCT patients [36]. - Pimicotinib received priority medicine designation from the European Medicines Agency in June 2023 for the treatment of inoperable TGCT patients [37]. - Pimicotinib received Breakthrough Therapy Designation (BTD) from the FDA in January 2023 for the treatment of inoperable TGCT patients, based on Phase Ib trial results [154]. - The clinical pipeline includes Pimicotinib, which is currently in a global Phase III trial for TGCT, with approximately 100 participants planned across 50 centers, including 30 in China [153]. - The company plans to initiate a Phase I clinical trial for ABSK121 in China for treating advanced solid tumors [63]. - Irpagratinib's Phase II clinical trial application was accepted in July 2023, following promising initial results in advanced HCC patients [161]. - Fexagratinib demonstrated a 31.3% response rate in a clinical trial for advanced urothelial carcinoma, comparable to the approved FGFR inhibitor erdafitinib [164]. - The company has initiated a Phase I trial for ABSK043, a selective PD-L1 inhibitor, with the first patient dosed in September 2022 [169]. - ABSK061 is a highly selective FGFR2/3 inhibitor showing potential for improved safety and efficacy in treating various cancers [170]. - ABSK121 targets both wild-type and mutant FGFRs, showing strong efficacy in preclinical studies, potentially benefiting patients with FGFR mutations [171]. - The company has received IND approval for ABSK061 for solid tumors in both China and the US, with trials ongoing [197]. - The company is exploring higher dosing regimens for Irpagratinib, with ongoing patient enrollment for 320mg and 160mg twice daily [186]. - The company has completed patient enrollment for the daily 180mg group in the Irpagratinib trial, demonstrating promising safety and pharmacokinetic profiles [186]. - The company acknowledges the uncertainty in successfully developing and commercializing several of its drug candidates, including ABSK011 and ABSK112 [188][200]. Financial Position - Cash and bank balances as of June 30, 2023, were RMB 2,102.4 million (approximately USD 291.0 million), a decrease of RMB 156.4 million from RMB 2,258.8 million as of December 31, 2022, mainly due to increased R&D expenditures [9]. - The debt-to-asset ratio as of June 30, 2023, was 4.93%, down from 5.75% as of December 31, 2022 [10]. - The company’s total equity as of June 30, 2023, was RMB 2,231,965,000, down from RMB 2,346,389,000 as of December 31, 2022 [105]. - The company’s total liabilities decreased from RMB 45,575,000 as of December 31, 2022, to RMB 40,776,000 as of June 30, 2023 [102][104]. - The company’s total liabilities included other payables and accrued expenses, which are unsecured and interest-free, reflecting a stable financial position [128]. - As of June 30, 2023, the company's total liabilities decreased to RMB 75,088 thousand from RMB 97,585 thousand as of December 31, 2022, representing a reduction of approximately 23% [148]. Revenue and Income - Revenue increased from RMB 0 to RMB 19.1 million for the six months ended June 30, 2023, primarily due to licensing fee income received from Elysium [48]. - The company reported a one-time licensing revenue of RMB 19,060,000 for the six months ended June 30, 2023, generated from an exclusive licensing agreement with Shanghai Eli Lilly Pharmaceutical Technology Co., Ltd. [113]. - Other income increased from RMB 11.74 million for the six months ended June 30, 2022, to RMB 37.7 million for the same period in 2023, primarily due to increased bank interest income and government subsidies [93]. Administrative Expenses - Administrative expenses for the six months ended June 30, 2023, were RMB (45,729) thousand, compared to RMB (55,848) thousand for the same period in 2022 [8]. - Administrative expenses (excluding share-based compensation) rose from RMB 32.9 million to RMB 35.7 million, attributed to an increase in employee benefits due to a higher number of non-research-related staff [51]. - The company did not declare or pay any dividends for the six months ended June 30, 2023, consistent with the previous year [120]. - As of June 30, 2023, the company had no impairment losses recognized for the six months ended June 30, 2023, similar to the previous year [124].

Research and Development - Research and development expenses increased from RMB 176.3 million in 2021 to RMB 313.6 million in 2022, a growth of 78%[6] - R&D expenses (excluding share-based compensation) increased from RMB 176.3 million in 2021 to RMB 313.6 million in 2022[46] - R&D expenses increased from RMB 226.1 million for the year ended December 31, 2021, to RMB 378.7 million for the year ended December 31, 2022, an increase of RMB 152.6 million due to the advancement of pipeline projects[63] - Research and development expenses increased to RMB 378.7 million in 2022 from RMB 226.1 million in 2021, reflecting a significant investment in clinical trials and drug development[158] - The R&D team consists of approximately 200 employees, with over 68% holding postgraduate degrees and about 21% holding PhDs[174] Clinical Trials and Approvals - Pimicotinib received Breakthrough Therapy Designation (BTD) from the National Medical Products Administration for the treatment of unresectable TGCT, based on preliminary trial results[7] - The company is conducting a Phase II trial of Fexagratinib for patients with locally advanced or metastatic urothelial carcinoma with FGFR2/3 mutations, with patient enrollment ongoing since November 2021[8] - The company received FDA approval for the clinical trial of ABSK121, initiating a Phase I trial for the treatment of advanced solid tumors[9] - The company achieved significant progress with Pimicotinib, which received approval for a Phase III clinical study in October 2022 and was granted Breakthrough Therapy Designation by the FDA in January 2023[47][48] - The company is conducting simultaneous Ib phase trials for Pimicotinib in the US and China, with patient enrollment completed for specific dosing regimens[69] - Fexagratinib received orphan drug designation from the FDA for treating gastric cancer and is being tested for other solid tumors[76] - The company has a pipeline of 15 oncology drug candidates, with ongoing clinical trials and regulatory approvals[84] - The company completed patient enrollment for the first case in the Phase II trial of Fexagratinib combined with Tislelizumab in November 2022[125] - The company is conducting a Phase I trial for ABSK043 in Australia to evaluate its safety and PK/PD characteristics in solid tumor patients[100] - The company has received IND approval for ABSK061 in both mainland China and the US for treating solid tumor patients[118] - The company initiated the first patient enrollment for the Phase II clinical trial of ABSK121, a next-generation FGFR inhibitor, in November 2022, which targets both wild-type and mutant FGFR1-3[141] Financial Performance - Revenue for the year ended December 31, 2022, was zero, compared to RMB 22.7 million for the year ended December 31, 2021, due to a lack of licensing fee prepayments from a clinical candidate[41] - Loss for the year decreased from RMB 1,810.0 million for the year ended December 31, 2021, to RMB 495.6 million for the year ended December 31, 2022, mainly due to the impact of various factors including increased R&D expenses[43] - Loss for the year (excluding non-IFRS adjustments) was RMB 385.5 million for the year ended December 31, 2022, compared to RMB 195.7 million for the year ended December 31, 2021[46] - The company reported a pre-tax loss of RMB 495.6 million for the year ended December 31, 2022, compared to a pre-tax loss of RMB 1.81 billion in 2021, indicating an improvement in financial performance[158] - The company is eligible to receive up to $258 million in payments based on specified clinical and commercialization milestones from its collaboration with Eli Lilly[36] - The company expects to receive up to $187.90 million in upfront, development, and sales milestone payments from the exclusive licensing agreement with Elysium[106] Administrative and Other Expenses - Administrative expenses decreased from RMB 124.8 million for the year ended December 31, 2021, to RMB 118.4 million for the year ended December 31, 2022, primarily due to the absence of IPO-related expenses[42] - Administrative expenses (excluding share-based compensation) decreased to RMB 73.4 million in 2022 from RMB 84.7 million in 2021[44] - Employee costs rose by RMB 56.0 million to RMB 167.9 million, while third-party contract costs increased by RMB 87.6 million to RMB 183.5 million[164] - Financial costs rose from RMB 1.0 million in 2021 to RMB 2.7 million in 2022, primarily due to increased interest expenses on lease liabilities[165] Collaborations and Partnerships - The company established multiple collaboration agreements in 2022 to develop new treatment options for patients with unmet medical needs[4] - The collaboration with Elysium Pharmaceuticals for the licensing of ABSK3376, a fourth-generation EGFR-TKI, was recently established[35] - The company is expanding its global licensing options with Elysium under agreed terms and conditions[10] - A global collaboration agreement with Eli Lilly was established for the discovery and development of a novel molecule targeting an undisclosed target[102] - The company has entered into a global collaboration agreement with Eli Lilly in January 2022 to discover and develop novel small molecule drugs targeting unmet medical needs, with potential milestone payments of up to $258 million[146] Market Strategy and Future Plans - The company aims to strengthen its business through external partnerships and collaborations[23] - The company aims to enhance its global presence by expanding its business and media footprint into other geographical regions[38] - The company aims to address significant unmet medical needs in oncology and other fields through the discovery and development of differentiated therapies[108] - The company aims to expand its pipeline through innovative projects focusing on first-in-class or best-in-class therapies to meet critical unmet medical needs in China and globally[155] - The company anticipates that the COVID-19 pandemic will not have a significant long-term impact on its overall clinical development plans, despite challenges faced in 2022[156] Asset and Liability Management - As of December 31, 2022, cash and bank balances were RMB 2,258.8 million, a decrease of RMB 286.7 million from RMB 2,545.5 million as of December 31, 2021, primarily due to ongoing R&D pipeline expansion[62] - Non-current assets increased from RMB 73,150 thousand in 2021 to RMB 81,832 thousand in 2022, representing an increase of approximately 11.5%[1] - Current assets decreased from RMB 2,581,389 thousand in 2021 to RMB 2,407,717 thousand in 2022, a decline of about 6.7%[1] - Total liabilities increased from RMB 73,538 thousand in 2021 to RMB 107,553 thousand in 2022, marking an increase of approximately 46.2%[1] - Total equity decreased from RMB 2,536,059 thousand in 2021 to RMB 2,346,389 thousand in 2022, a decline of about 7.5%[1] - The debt-to-asset ratio increased to 6% as of December 31, 2022, compared to 4% in the previous year[170]