ABSK081 項目進展 於2021年11月，我們的合作夥伴X4宣佈其已完成III期臨床試驗的患者入組。積 極的頂線結果於2022年11月披露。 在中國內地，我們正在中國進行ABSK081(mavorixafor)聯合君實的特瑞普利單抗 治療TNBC患者的Ib/II期臨床試驗。我們於2021年7月完成首例患者給藥。患者入 組工作已完成。 臨床前開發階段候選藥物 ABSK051是一種小分子CD73抑制劑，現正開發用於治療包括肺癌、胰腺癌及其 他癌症在內的各種腫瘤。其在抑制可溶性及表面表達的CD73活性方面表現出強勁 效力。其亦在各種動物模型中顯示出強大的體內功效。我們目前正在進行臨床前 開發研究。 ABSK112是下一代EGFR外顯子20抑制劑，對野生型EGFR具有更高的選擇性及 入腦性。有3%至5%的NSCLC患者會發生EGFR外顯子20變異，該變異對目前可 用的第一代、第二代及第三代EGFR抑制劑具有耐藥性。由於對野生型EGFR的選 擇性有限，目前針對該等變異的臨床化合物的治療窗口有限。在臨床試驗中，增 加選擇性將可能導致更好的靶向調節及療效。於多項細胞試驗中，ABSK112表現 出對EGFR外顯子20變異 ...

Clinical Development - Abbisko Cayman Limited established a global early-stage research collaboration with Eli Lilly in January 2022, potentially earning up to $258 million in milestone payments and tiered royalties based on sales[5]. - The company is conducting an Ib phase trial for ABSK011 in China for patients with FGF19-overexpressing liver cancer, with patient enrollment ongoing for both 180mg and 160mg groups[6]. - ABSK091 (AZD4547) is in a phase II trial in China for patients with locally advanced or metastatic urothelial carcinoma, with the first patient dosed in November 2021[7]. - ABSK021 has been designated as a breakthrough therapy for the treatment of inoperable tenosynovial giant cell tumors (TGCT) in China, with preliminary trial results expected in the second half of 2022[9]. - The company has received IND approval for ABSK061 to conduct a phase I clinical trial for solid tumor patients in both China and the US, with the first patient dosed in June 2022[12]. - The company is advancing clinical trials for ABSK043 in Australia, assessing its safety and tolerability in solid tumor patients[11]. - ABSK081 is undergoing an Ib/II phase trial in China for triple-negative breast cancer patients, with patient enrollment currently ongoing[10]. - The collaboration with Roche for ABSK011 in a phase II trial for advanced HCC patients is also in progress, with patient enrollment ongoing since January 2022[6]. - ABSK011 is a selective small molecule FGFR4 inhibitor currently undergoing clinical trials in China for advanced HCC, with approximately 30% of global HCC patients overexpressing FGF19/FGFR4[25]. - The Ib phase trial for ABSK011 has completed patient enrollment for the 180mg group and expanded to 320mg and 160mg twice daily groups due to excellent safety and PK/PD characteristics observed in the Ia phase trial[26]. - The BISCAY trial for ABSK091 (AZD4547) showed a 31.3% response rate in advanced urothelial carcinoma patients, comparable to the approved FGFR inhibitor erdafitinib with a 32.2% response rate[29]. - ABSK091 has received orphan drug designation from the FDA for gastric cancer treatment, with plans to explore other solid tumors[30]. - ABSK021 has been designated as a breakthrough therapy for inoperable TGCT based on preliminary results from the ongoing Ib phase trial in China[32]. - ABSK081 (mavorixafor) is the only orally bioavailable CXCR4 modulator in clinical development globally, with ongoing trials in combination with other therapies for TNBC patients[34]. - ABSK043 is a small molecule PD-L1 inhibitor currently in I phase trials in Australia and China, with IND approval received for malignant tumor patients[37]. - ABSK061 is a selective FGFR2/3 inhibitor with IND approval for I phase trials in solid tumor patients in China and the US, with the first patient dosed in June 2022[41]. - ABSK121 is a next-generation small molecule FGFR inhibitor showing strong efficacy against wild-type and mutant FGFR1-3, with IND submission expected in 2022[42]. - ABSK051 is a small molecule CD73 inhibitor currently in preclinical development for various cancers, demonstrating strong efficacy in animal models[42]. - ABSK071 is a next-generation KRAS-G12C inhibitor selected as a preclinical candidate, targeting approximately 30% of lung cancer patients with KRAS mutations[44]. - The company has received IND approval for a combination therapy trial involving ABSK091 and an anti-PD-1 antibody, with patient enrollment expected to start soon[46]. - The company has obtained 13 IND or clinical trial approvals across four countries and regions, including trials in the US and Australia[52]. Financial Performance - As of June 30, 2022, cash and bank balances were RMB 2,496.6 million (approximately USD 372.0 million), a decrease of RMB 48.9 million from RMB 2,545.5 million as of December 31, 2021, primarily due to R&D expenditures and business operations[16]. - Other income and gains increased from RMB 10.0 million for the six months ended June 30, 2021, to RMB 11.7 million for the six months ended June 30, 2022, mainly due to increased bank interest income and government subsidies[16]. - R&D expenses rose significantly from RMB 79.6 million for the six months ended June 30, 2021, to RMB 159.0 million for the six months ended June 30, 2022, an increase of RMB 79.4 million, driven by the expansion of R&D functions and pipeline project advancements[16]. - Administrative expenses increased from RMB 40.8 million for the six months ended June 30, 2021, to RMB 55.8 million for the six months ended June 30, 2022, an increase of RMB 15.0 million, primarily due to the expansion of non-R&D related staff[17]. - The net loss for the six months ended June 30, 2022, was RMB 221.6 million, a decrease from RMB 377.2 million for the same period in 2021, mainly due to increased R&D expenses and the impact of convertible redeemable preferred shares fair value losses[17]. - R&D expenses (excluding share-based compensation costs) increased from RMB 72.1 million for the six months ended June 30, 2021, to RMB 124.4 million for the six months ended June 30, 2022, an increase of RMB 52.3 million[19]. - The company experienced a pre-tax loss of RMB 221.61 million in the first half of 2022, an improvement from a loss of RMB 377.22 million in the same period of 2021[60]. - The company reported a financial cost of RMB 1,400 thousand, a substantial increase from RMB 60 thousand in the previous year[193]. - The company incurred share-based payment expenses of RMB 57,566 thousand, up from RMB 13,273 thousand, marking a 333.5% increase[193]. - The company’s foreign exchange differences resulted in a net gain of RMB 17,047 thousand, compared to a gain of RMB 336 thousand in the previous year[193]. - Total revenue for the six months ended June 30, 2022, was RMB 11,740,000, compared to RMB 9,972,000 for the same period in 2021, representing a growth of approximately 17.7%[189]. - The company reported a pre-tax loss of RMB (221,605,000), an improvement from a loss of RMB (377,217,000) in the previous year, indicating a reduction in losses by approximately 41.3%[189]. - The net cash and bank balances as of June 30, 2022, were RMB 2,496,576,000, slightly down from RMB 2,545,513,000 at the end of 2021[190]. - Total assets less current liabilities amounted to RMB 2,521,903,000, compared to RMB 2,581,001,000 at the end of 2021, showing a decrease of approximately 2.3%[190]. - The company's equity attributable to ordinary shareholders decreased to RMB 2,481,585,000 from RMB 2,536,059,000, reflecting a decline of about 2.1%[190]. - The basic and diluted loss per share for the period was RMB 0.32, down from RMB 3.80 in the same period last year, indicating a significant improvement in loss per share[189]. - Other comprehensive income for the period included a foreign exchange gain of RMB 113,620,000, compared to a gain of RMB 20,942,000 in the previous year, representing a substantial increase[189]. - The company’s total liabilities as of June 30, 2022, were RMB 118,456,000, compared to RMB 117,618,000 at the end of 2021, indicating a slight increase[190]. Research and Development Strategy - Abbisko's strategic focus includes expanding its clinical pipeline and enhancing its research capabilities through partnerships and innovative drug development[5]. - The company aims to discover and develop differentiated therapies in oncology and other fields to address significant unmet medical needs in China and globally[22]. - The product pipeline includes various candidates targeting multiple cancer types, with several in critical clinical trials[24]. - The company is strategically expanding its R&D capabilities and product pipeline to enhance its market position in the biopharmaceutical industry[23]. - The company plans to continue investing in R&D to drive future growth and innovation, as evidenced by the significant increase in R&D expenses[189]. - The company aims to continue advancing high-quality clinical-stage compounds and developing preclinical candidates to meet urgent medical needs[55]. - The company has a pipeline of 15 candidate drugs, including six in clinical stages, focusing on small molecule precision oncology and immunotherapy[23]. Shareholder Information - As of June 30, 2022, Dr. Xu Yaochang holds 23.45% of the company's shares, totaling 164,581,300 shares[90]. - The board believes that having the same individual serve as both Chairman and CEO can facilitate effective execution of strategic initiatives[84]. - The company plans to review the separation of the roles of Chairman and CEO at an appropriate time[85]. - As of June 30, 2022, the total number of shares issued by the company was 701,774,350[96]. - LAV GP III, L.P. and LAV Corporate GP, Ltd. each hold 51,454,060 shares, representing 7.33% of the total shares[95]. - Dr. Shi holds 75,143,790 shares, accounting for 10.71% of the total shares[95]. - Qiming Venture Partners VI, L.P. holds 47,323,020 shares, which is 6.74% of the total shares[95]. - Temasek Holdings (Private) Limited holds 52,734,460 shares, representing 7.51% of the total shares[95]. - The Hong Kong Central Securities Trust Company Limited holds 37,054,800 shares, accounting for 5.28% of the total shares[95]. - The total shares held by 恒泰信託（香港）有限公司 is 75,239,210, representing 10.72% of the total shares[95]. - Elbrus Investments Pte. Ltd. directly owns 46,508,460 shares, which is 6.63% of the total shares[100]. - The company has a significant concentration of ownership among major shareholders, with the top three shareholders holding over 24% of the total shares[95]. - The company is subject to disclosure requirements under the Securities and Futures Ordinance regarding shareholdings and interests[94]. Equity Incentive Plans - The 2019 equity incentive plan was approved on July 4, 2019, and aims to attract and retain qualified personnel, rewarding employees, directors, and consultants[103]. - The total number of ordinary shares that may be issued under all rewards is capped at 8,360,280 shares, adjusted to 83,602,800 shares after the share split[114]. - As of June 30, 2022, the total number of ordinary shares involved in unexercised options and restricted share units under the 2019 plan was 67,075,503 shares and 16,527,297 shares, respectively[114]. - The 2019 plan is valid for ten years from the adoption date, with no further options or awards granted unless terminated early[104]. - The management of the 2019 plan includes the board of directors and a designated senior officer or committee, with the authority to select participants and determine reward amounts[105]. - The rewards under the 2019 plan include stock options, share appreciation rights, equivalent dividend rights, restricted shares, and restricted share units[109]. - The plan allows for the issuance of shares upon exercise of rewards, with payment terms determined by the board based on specific circumstances[111]. - The plan prohibits the transfer of rewards unless approved by management, ensuring control over the incentive structure[113]. - The company has established trusts for managing the ordinary share equity incentive plan, ensuring proper governance and management of shares issued under the plan[115]. - As of June 30, 2022, a total of 29,072,780 stock options were granted but not exercised, representing approximately 4.14% of all issued shares[119]. - The exercise price of all stock options granted under the 2019 plan ranges from RMB 0.10 to RMB 2.38 per share[119]. - As of June 30, 2022, a total of 38,002,723 restricted share units were granted but not exercised, accounting for about 5.42% of all issued shares[119]. - The company has adopted a post-IPO restricted share unit plan as of September 16, 2021, which does not involve stock options and is not subject to the provisions of Chapter 17 of the listing rules[120]. - The purpose of the post-IPO restricted share unit plan is to align the interests of eligible individuals with the group's long-term growth and profitability through share ownership and dividends[123]. - The rewards under the post-IPO restricted share unit plan can be granted in the form of shares or cash equivalent to the sale price of the reward shares[124]. - The board has the discretion to grant rewards to selected participants, with specific conditions and vesting dates outlined in the reward letter[125]. - The total number of shares granted under the post-IPO restricted share unit plan is subject to limits set by shareholders[128]. - The company must comply with applicable securities laws and regulations when granting rewards under the plan[128]. - The board may not grant any rewards if it would lead to violations of applicable securities laws or regulations[128]. - The total number of shares that can be granted under the post-IPO restricted share unit plan is capped at 10% of the company's issued share capital, amounting to 4,872,343 shares (adjusted to 48,723,430 shares post-split)[130]. - The board may determine the vesting criteria and conditions for the rewards during the effective period of the post-IPO restricted share unit plan[135]. - In the event of a merger or privatization, the board has the discretion to accelerate the vesting date of the rewards[136]. - Any unvested rewards will be forfeited or repurchased upon termination of employment, unless otherwise decided by the board[139]. - Adjustments to the number of unexercised restricted share units will be made in case of stock splits or consolidations to avoid dilution of benefits[137]. - The company must issue shares or transfer necessary funds to the trustee within 30 business days from the grant date to fulfill the rewards[132]. - The trustee is required to sell any non-cash distributions related to the trust holdings, with net proceeds treated as income for the plan[138]. - Selected participants have no rights to dividends or voting until the rewards are vested[131]. - The company must provide necessary funds for the trustee to purchase shares at market price to fulfill additional rewards[138]. - The total number of shares granted under the plan cannot exceed the specified limit without shareholder approval[130]. - As of June 30, 2022, no restricted share units have been granted or agreed to be granted under the post-IPO restricted share unit plan[145]. - The maximum number of shares that may be issued under the post-IPO share option plan is capped at 10% of the issued share capital as of the date of shareholder approval, equating to 4,872,343 shares (adjusted to 48,723,430 shares post-split), representing approximately 6.94% of the total issued shares[150]. - The post-IPO share option plan does not set any performance targets that must be achieved prior to the exercise of options[152]. - The subscription price for shares acquired through the exercise of options will not be less than the higher of the closing price on the date of grant or the average closing price over the five trading days preceding the grant[155]. - Any options granted to related parties must be approved by independent non-executive directors, and if the total number of shares issued exceeds 0.1% of the issued shares or the total value exceeds HKD 5 million, further grants require shareholder approval[157]. - The company will issue stock options through a letter detailing the number of shares, subscription price, and acceptance deadline, which must be within 28 days of the offer date[159]. - Stock options will be considered granted and accepted upon receipt of a signed acceptance letter and payment of 1 HKD or its equivalent[160]. - The company will not offer stock options during specific blackout periods, including the time leading up to the announcement of financial results[161]. - Stock options will automatically expire upon the earliest occurrence of several conditions, including the expiration of the option period or the commencement of liquidation[164]. - Holders of unexercised stock options will not have rights to dividends or voting[166]. - Adjustments to stock options will be made in the event of changes to the company's capital structure, ensuring that the proportion of shares held remains consistent[167]. - In the event of a takeover offer, the company will strive to extend the offer to all option holders under the same terms[169]. - Option holders may choose to exercise their options within 21 days following a voluntary liquidation resolution[171]. - Shares issued upon exercising options will be subject to the company's articles of association and will enjoy equal rights with other shares issued on the same date[172]. - The company granted 1,700,000 stock options to employees on June 1, 2022, with an exercise price of HKD 4.000 per share[180]. - The stock options have a validity period of 10 years from the grant date, with 25% vesting on June 1 of each year from 2023 to 2026[181]. - The closing price of the shares on the grant date was HKD 4.000, which is the highest of the specified valuation methods[181]. - The company established a committee composed of directors and senior management to manage the stock option plan[178]. - Any amendments to the stock option plan require shareholder approval, especially if they affect the rights of existing participants[175]. - The remaining term of the stock option plan is approximately 9.5 years[179]. - The company has not disclosed any significant events post-reporting period that require shareholder attention[184]. - The stock options granted do not exceed individual limits, and no options were granted to suppliers of goods and services[183]. - The company must comply with the relevant regulations when granting stock options to connected persons[176]. - The stock option plan can be terminated by the company or the board at any time, but previously granted options remain valid[177].

Financial Performance - Revenue increased from zero for the year ended December 31, 2020, to RMB 22.7 million for the year ended December 31, 2021, mainly attributed to royalties from a clinical candidate[10]. - Other income and gains rose from RMB 18.8 million for the year ended December 31, 2020, to RMB 43.6 million for the year ended December 31, 2021, driven by increased bank interest income, government subsidies, investment gains from the sale of associates, and foreign exchange gains[10]. - The net loss for the year increased from RMB 706.6 million for the year ended December 31, 2020, to RMB 1,810.0 million for the year ended December 31, 2021, marking an increase of 156%[12]. - The company reported a pre-tax loss of RMB 1.81 billion for 2021, compared to a loss of RMB 706.64 million in 2020[70]. - The company has incurred substantial net losses since its inception and expects to continue doing so in the foreseeable future[119]. Cash and Bank Balances - As of December 31, 2021, cash and bank balances amounted to RMB 2,545.5 million (approximately USD 400.5 million), an increase of RMB 1,927.7 million compared to RMB 617.8 million as of December 31, 2020, primarily due to funds raised from the D round financing and the IPO[10]. - Cash and bank balances as of December 31, 2021, were RMB 2,545.5 million, compared to RMB 617.8 million as of December 31, 2020, reflecting a significant increase of 312%[15]. Research and Development (R&D) - R&D expenses increased from RMB 132.7 million for the year ended December 31, 2020, to RMB 226.1 million for the year ended December 31, 2021, representing a growth of 70%[11]. - The company has built a pipeline consisting of 14 small molecule oncology projects, with 6 currently in clinical stages[20]. - The company aims to continue advancing high-quality clinical-stage compounds and expanding its pipeline with innovative projects to address unmet medical needs[7]. - The company plans to submit IND applications for multiple projects currently in the IND filing stage within the year[5]. - The company has obtained 11 IND or clinical trial approvals across four countries and regions, including trials in the US and Australia[60]. Clinical Trials and Pipeline Development - The company achieved significant progress in its pipeline, with multiple clinical-stage candidates entering key phases of clinical trials, including ABSK011, ABSK091, ABSK021, and ABSK081[5]. - Two preclinical candidates have entered Phase I studies, with ABSK043 undergoing a dose escalation trial in Australia and ABSK061 receiving IND approval from the FDA and NMPA[5]. - The company is conducting Phase Ib trials for ABSK021 in the US and mainland China, with the first patient dosed in August 2021 and the first patient in the TGCT group dosed in December 2021[23]. - The company received IND approval for the clinical trial of ABSK011 in combination with an anti-PD-L1 antibody for advanced HCC patients in China[21]. - The company is developing ABSK011, a selective FGFR4 inhibitor for treating advanced hepatocellular carcinoma (HCC), with approximately 30% of global HCC patients overexpressing the FGF19/FGFR4 pathway[35]. Strategic Partnerships and Collaborations - A licensing agreement was established with a partner for the development and commercialization of ABSK021 in Greater China, with total upfront and milestone payments amounting to USD 270.5 million[6]. - The company established a global early-stage research collaboration with Eli Lilly, potentially earning up to $258 million in milestone payments and tiered royalties based on sales[16]. - The company is actively exploring strategic partnerships to enhance its internal R&D capabilities and maximize the commercial value of its projects[6]. Administrative and Operational Expenses - Administrative expenses rose from RMB 21.2 million for the year ended December 31, 2020, to RMB 124.8 million for the year ended December 31, 2021, an increase of 487%[11]. - R&D expenditures for the years ended December 31, 2020, and 2021, were RMB 132.7 million and RMB 226.1 million, respectively, indicating a significant increase in investment[56]. Employee and Management Structure - As of December 31, 2021, the R&D team consists of approximately 111 employees, with 80% holding graduate degrees and 30% holding PhDs, reflecting strong clinical development experience[56]. - The company had 160 employees as of December 31, 2021, with 40.6% in research roles[83][84]. - The management team includes experienced professionals with extensive backgrounds in pharmaceutical research and development[89][90][93][94][95]. Shareholder Information - The total number of shares issued by the company as of December 31, 2021, was 702,578,350 shares[140]. - Major shareholders include LAV GP III, L.P. and LAV Corporate GP, Ltd., each holding 51,454,060 shares, representing 7.32% of total shares[147]. - The largest shareholder, Shi Yi, holds 75,143,790 shares, accounting for 10.70% of total shares[147]. Future Outlook and Challenges - The company aims to advance existing projects while exploring new technologies and areas with unmet medical needs to enhance its product pipeline[68]. - The company continues to face significant competition in the oncology market, which may impact its market position and financial performance[119]. - The company relies on several third-party licensors for some clinical development activities, which poses a risk to its operations[119].