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].
和誉-B(02256) - 2023 - 中期财报