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]
和誉(02256) - 2023 - 年度业绩