Product Pipeline and Development - Olverembatinib (耐立克°) and APG-2575 Lisaftoclax are key products under development[1] - APG-115 is a novel oral small molecule MDM2-p53 inhibitor in the company's pipeline[4] - APG-1252 is a novel small molecule drug targeting Bcl-2/Bcl-xL proteins to restore apoptosis[4] - APG-1387 is a novel small molecule IAP inhibitor being developed by the company[4] - APG-2449 is a third-generation inhibitor targeting FAK, ROS1, and ALK kinases[4] - APG-5918 is a highly potent oral selective EED inhibitor in development[4] - The company's pipeline includes multiple novel small molecule inhibitors targeting various cancer pathways[4] - Key therapeutic areas include leukemia (CML, ALL, AML) and lymphoma (Bcl-2/Bcl-xL)[4][5] - The company's third-generation BCR-ABL inhibitor, HQP1351, is designed to overcome drug resistance caused by BCR-ABL kinase mutations, including the T315I mutation[7] - The company's product HQP1351 is aimed at addressing drug resistance in BCR-ABL kinase mutations, particularly the T315I mutation[7] - The company has 6 small molecule candidates in clinical development, with 40+ Phase I/II trials ongoing in China, the US, Australia, and Europe[18] - The company's lead asset, Olverembatinib, is the first and only third-generation BCR-ABL1 inhibitor approved in China for T315I-mutated CML patients[18] - Olverembatinib received 4 FDA orphan drug designations and 1 fast-track designation for CML, AML, ALL, and GIST, as well as an EMA orphan drug designation for CML[23] - Olverembatinib was included in the 2024 NCCN CML treatment guidelines and recommended by the CSCO CML and Ph+ ALL treatment guidelines[23] - Olverembatinib was included in China's National Reimbursement Drug List in January 2023, significantly improving patient accessibility[23] - Nailike® (Olverembatinib) was approved for marketing in Macau, China in July 2024, targeting TKI-resistant CML patients with or without T315I mutation[24] - Nailike® was included in the 2024 CSCO Guidelines for Hematologic Malignancies in May 2024 and the 2024 NCCN CML Guidelines in December 2023[24] - The company disclosed updated 1-year follow-up data for Nailike® in CML and Ph+ ALL at EHA 2024, showing sustained clinical efficacy and good tolerability[24] - Nailike® demonstrated significant efficacy and safety in SDH-deficient GIST patients at ASCO 2024, marking its third consecutive year of presentation at ASCO[25] - The company plans to continue Phase III trials for Nailike® in CML (POLARIS-2), Ph+ ALL (POLARIS-1), and SDH-deficient GIST (POLARIS-3) in 2024[26] - Lisaftoclax (APG-2575) is expected to submit an NDA for CLL/SLL in China in 2024, potentially becoming the second global and first Chinese Bcl-2 inhibitor for this indication[27] - Over 1,000 patients, including more than 400 CLL/SLL patients, have been treated with Lisaftoclax (APG-2575) as of June 30, 2024[27] - Lisaftoclax (APG-2575) received FDA orphan drug designations for FL, WM, CLL, MM, and AML[27] - A Phase III trial (GLORA-4) for Lisaftoclax combined with azacitidine in high-risk MDS patients is underway in China[27] - A global Phase III trial (GLORA) for Lisaftoclax combined with BTK inhibitors in CLL/SLL patients previously treated with BTK inhibitors is ongoing[28] - Lisaftoclax (APG-2575) combined with pomalidomide and dexamethasone showed an ORR of 70.4% in 27 evaluable r/r MM patients, with 10 PR, 7 VGPR, and 2 CR cases[29] - Lisaftoclax (APG-2575) monotherapy or combination therapy in newly diagnosed AML patients showed an ORR of 64.1% and a CRc rate of 51.3% in 39 patients[29] - The company plans to submit a new drug application for Lisaftoclax (APG-2575) for the treatment of r/r CLL/SLL in China in 2024[30] - Alrizomadlin (APG-115) has received six orphan drug designations from the FDA, including for soft tissue sarcoma, gastric cancer, AML, retinoblastoma, melanoma, and neuroblastoma[31] - Alrizomadlin (APG-115) demonstrated promising antitumor activity and tolerability in progressive salivary gland cancer, particularly adenoid cystic carcinoma[32] - Pelcitoclax (APG-1252) has shown preliminary antitumor activity in heavily pretreated patients and is being studied in combination with osimertinib for EGFR-mutated NSCLC[34][35] - APG-5918, an EED inhibitor, has shown potential in improving hemoglobin deficiency in preclinical models of CKD-induced anemia[36] - The company is conducting a multicenter, open-label Phase I trial of APG-5918 in advanced solid tumors or lymphomas[36] - Lisaftoclax (APG-2575) is being studied in global Ib/II trials for WM patients in combination with BTK inhibitors[29] - Alrizomadlin (APG-115) is being evaluated in multiple clinical trials in combination with immune therapies or chemotherapy for solid and hematologic tumors[31][32] - APG-5918 showed preclinical progress in improving hemoglobin deficiency in CKD-induced anemia models at EHA 2024[37] - APG-5918 demonstrated synergistic tumor growth inhibition with alrizomadlin in prostate cancer models at AACR 2024[37] - APG-2449 showed preliminary efficacy in NSCLC patients, including those resistant to 2nd-gen ALK TKIs, at ASCO 2024[38] - APG-2449 exhibited tumor metastasis inhibition and enhanced PLD's antitumor effects in epithelial ovarian cancer at AACR 2024[38] Financial Performance and Reporting - Revenue increased by RMB 681.0 million or 477.2% to RMB 823.7 million for the six months ended June 30, 2024, compared to RMB 142.7 million for the same period in 2023[13] - Other income and gains increased by RMB 0.3 million or 1.8% to RMB 17.3 million for the six months ended June 30, 2024, primarily due to increased bank interest income[13] - Sales and distribution expenses increased by RMB 6.3 million or 7.6% to RMB 89.6 million for the six months ended June 30, 2024, driven by commercialization of Olverembatinib (HQP1351) and other products[13] - R&D expenses increased by RMB 134.3 million or 43.4% to RMB 444.1 million for the six months ended June 30, 2024, mainly due to increased internal R&D spending[13] - Net income increased by RMB 565.1 million to RMB 162.8 million for the six months ended June 30, 2024, compared to a loss of RMB 402.3 million for the same period in 2023[13] - Cash and bank balances stood at RMB 1,100.3 million as of June 30, 2024, an increase of RMB 6.5 million or 0.6% compared to December 31, 2023[13] - Olverembatinib (HQP1351) achieved cumulative sales of RMB 489.7 million since its launch in November 2021, with sales in the first half of 2024 increasing by 120% compared to the second half of 2023[14] - The company received USD 100.0 million in July 2024 from Takeda Pharmaceuticals under an exclusive option agreement for Olverembatinib, with potential milestone payments and royalties up to USD 1.2 billion[14] - The company successfully issued and allotted 24,307,322 shares to Takeda Pharmaceuticals in June 2024, raising USD 75.0 million (approximately HKD 585.77 million)[14] - Revenue for the six months ended June 30, 2024, increased to RMB 823.7 million, up 477.2% from RMB 142.7 million in the same period in 2023[48][49][50] - Net profit for the six months ended June 30, 2024, was RMB 162.8 million, compared to a net loss of RMB 402.3 million in the same period in 2023[48][49] - R&D expenses for the six months ended June 30, 2024, increased to RMB 444.1 million, up from RMB 309.8 million in the same period in 2023[48][49] - The company received a $100 million option payment related to the exclusive option agreement with Takeda Pharmaceutical for the global rights to develop and commercialize Olverembatinib (耐立克®), excluding China, Hong Kong, Macau, and Taiwan[46] - The company is eligible to receive up to $1.2 billion in option exercise fees and additional potential milestone payments, as well as double-digit percentage royalties on annual net sales from the Takeda agreement[46] - Sales and distribution expenses increased by RMB 6.3 million or 7.6% to RMB 89.6 million, driven by the commercialization of Olverembatinib and other products[53] - R&D expenses increased by RMB 134.3 million or 43.4% to RMB 444.1 million, primarily due to higher internal R&D costs[54] - Administrative expenses decreased by RMB 4.3 million or 4.7% to RMB 87.0 million, mainly due to reduced labor and operational costs at the Suzhou base[56] - Financing costs decreased by RMB 18.6 million or 35.3% to RMB 34.1 million, primarily due to lower interest on bank borrowings[58] - Other expenses increased by RMB 2.9 million or 69.0% to RMB 7.1 million, mainly due to higher charitable donations[59] - The company's profit increased by RMB 565.1 million from a loss of RMB 402.3 million to a profit of RMB 162.8 million[60] - Net cash outflow from operating activities was RMB 354.4 million, a decrease from RMB 368.5 million in the previous period[61] - Net cash outflow from investing activities was RMB 131.3 million, including RMB 16.5 million for property, plant, and equipment[62] - Net cash inflow from financing activities was RMB 396.9 million, including RMB 532.0 million from the 2024 share subscription[62] - The company's current ratio improved to 1.8 from 1.4, and the quick ratio also improved to 1.8 from 1.4[63] - The company's cash and bank balances remained stable at RMB 1,100.3 million as of June 30, 2024, compared to RMB 1,093.8 million as of December 31, 2023[70] - The company's total current assets amounted to RMB 1,963.8 million, including cash and bank balances of RMB 1,100.3 million, inventory of RMB 10.7 million, and trade receivables of RMB 743.5 million as of June 30, 2024[70] - The company's total current liabilities were RMB 1,065.4 million, including trade payables of RMB 83.1 million, other payables and accrued expenses of RMB 215.2 million, and borrowings of RMB 729.5 million as of June 30, 2024[70] - The company's total non-current liabilities were RMB 1,265.3 million, including long-term borrowings of RMB 970.6 million and deferred revenue of RMB 233.4 million as of June 30, 2024[70] - The company has 574 full-time employees, with 70.9% (407 employees) engaged in R&D and laboratory work as of June 30, 2024[71] - Employee benefit expenses increased to RMB 218.9 million for the six months ended June 30, 2024, compared to RMB 201.2 million for the same period in 2023[71] - The company has 520 authorized patents globally, including 367 overseas patents, as of June 30, 2024[73] - The company plans to advance six differentiated clinical-stage product candidates to the next clinical stage and seek global NDA approvals[73] - The company aims to strengthen its global intellectual property portfolio and seek strategic partnerships with global biotech and pharmaceutical companies[73] - The company did not recommend an interim dividend for the six months ended June 30, 2024[74] - The company's unaudited condensed consolidated financial statements for the six months ended June 30, 2024, were reviewed by Ernst & Young and the Audit Committee, which found them to be in compliance with applicable accounting standards[161] - The company's interim financial information for 2024 shows revenue of RMB 823.746 million, a decrease of RMB 15.059 million compared to the previous year[169] - The company reported a net profit attributable to ordinary equity holders of RMB 162.826 million for the six months ended June 30, 2024, compared to a net loss of RMB 402.349 million in the same period last year[169] - Earnings per share for the six months ended June 30, 2024, were RMB 0.56, compared to a loss per share of RMB 1.47 in the same period last year[169] - The company reported a net profit of RMB 162,826 thousand for the first half of 2024, compared to a net loss of RMB 402,349 thousand in the same period of 2023[170] - Total comprehensive income for the first half of 2024 was RMB 165,095 thousand, a significant improvement from a loss of RMB 362,569 thousand in the first half of 2023[170] - The company's total assets as of June 30, 2024, were RMB 1,963,839 thousand, a 46.1% increase from RMB 1,344,178 thousand as of December 31, 2023[171] - Total equity increased to RMB 776,439 thousand as of June 30, 2024, from RMB 70,632 thousand as of December 31, 2023, representing a 999.5% increase[172] - Non-current liabilities decreased to RMB 1,265,281 thousand as of June 30, 2024, from RMB 1,495,588 thousand as of December 31, 2023, a 15.4% reduction[172] - The company's financial assets measured at fair value through profit or loss decreased to RMB 1,458 thousand as of June 30, 2024, from RMB 1,951 thousand as of December 31, 2023[171] - Contract liabilities decreased to RMB 233,423 thousand as of June 30, 2024, from RMB 251,189 thousand as of December 31, 2023[172] - Interest-bearing bank and other borrowings decreased to RMB 970,555 thousand as of June 30, 2024, from RMB 1,179,191 thousand as of December 31, 2023, a 17.7% reduction[172] - Deferred tax liabilities decreased to RMB 5,849 thousand as of June 30, 2024, from RMB 10,549 thousand as of December 31, 2023[172] - The company's cash and cash equivalents decreased to RMB 882,198 thousand as of June 30, 2024, from RMB 905,815 thousand as of December 31, 2023[171] - Net profit for the period reached RMB 163,001 thousand, compared to a net loss of RMB 402,351 thousand in the same period last year[173] - Total equity increased to RMB 776,439 thousand as of June 30, 2024, up from RMB 600,178 thousand as of June 30, 2023[173] - Cash and cash equivalents decreased by RMB 88,763 thousand, ending at RMB 952,434 thousand as of June 30, 2024[174] - Operating cash outflow was RMB 354,391 thousand, slightly lower than the previous year's outflow of RMB 368,464 thousand[174] - Financing activities generated a net cash inflow of RMB 396,906 thousand, primarily from the issuance of shares amounting to RMB 533,940 thousand[174] - Investment activities resulted in a net cash outflow of RMB 131,278 thousand, mainly due to investments in property, plant, and equipment, and joint ventures[174] - The company's total cash and bank balances stood at RMB 1,100,314 thousand as of June 30, 2024, down from RMB 1,581,600 thousand in the previous year[174] - The company issued ordinary shares worth RMB 533,940 thousand during the period, contributing to the increase in share capital and share premium[173] - Exchange rate fluctuations resulted in a gain of RMB 2,269 thousand, positively impacting the company's comprehensive income[173] - The company's accumulated losses decreased to RMB 5,202,121 thousand as of June 30, 2024, from RMB 5,365,122 thousand at the beginning of the year[173] - Revenue from external customers in Mainland China increased to RMB 145.33 million in the first half of 2024, up from RMB 142.70 million in the same period in 2023[179] - Revenue from Switzerland, a new market, contributed RMB 678.42 million in the first half of 2024, compared to zero in the same period in 2023[179] - Total revenue for the first half of 2024 reached RMB 823.75 million, a significant increase from RMB 142.70 million in the first half of 2023[179] - Non-current assets in Mainland China slightly decreased to RMB 1,083.22 million as of June 30, 2024, from RMB 1,
亚盛医药-B(06855) - 2024 - 中期财报