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].
和誉(02256) - 2023 - 中期业绩