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]
和誉(02256) - 2022 - 年度财报