Revenue and Financial Performance - Revenue for the year ended December 31, 2024, reached RMB 980.7 million, a year-on-year increase of 342% primarily due to Takeda Pharmaceutical's option payments and strong sales of Olverembatin (耐立克®) [4] - The company recorded a loss of RMB 405.7 million for the year ended December 31, 2024, a decrease of RMB 520.0 million or 56.2% from a loss of RMB 925.7 million for the previous year [8] - The gross profit for the year ended December 31, 2024, was RMB 951,565,000, compared to RMB 191,441,000 in 2023, indicating a substantial increase in profitability [68] - The total comprehensive loss for the year ended December 31, 2024, was RMB 398.7 million, a significant reduction of RMB 500.8 million or 55.7% from RMB 899.5 million for the year ended December 31, 2023 [107][119] - The company's cash and bank balances as of December 31, 2024, were RMB 1,261.2 million, an increase of RMB 167.4 million or 15.3% from RMB 1,093.8 million as of December 31, 2023 [9] - The company reported a foreign exchange gain of RMB 6,949,000 for the year, compared to a gain of RMB 26,259,000 in 2023 [70] - The basic loss per share for 2024 was RMB 1.34, based on a weighted average of 302,062,104 shares, compared to a loss of RMB 3.28 per share in 2023 with 282,299,269 shares [96] Research and Development - Research and development expenses increased by RMB 240.3 million or 34.0% to RMB 947.2 million for the year ended December 31, 2024, due to increased clinical research costs [7] - The company is conducting ten registration clinical trials, with two already approved by the FDA [5] - The company has a pipeline of 6 clinical-stage small molecule candidates as of December 31, 2024 [21] - The company is developing therapies targeting traditionally "undruggable" proteins associated with tumorigenesis, such as PROTACs [21] - Clinical trials for CLL/SLL, AML, and MDS are ongoing, with registration trials for NSCLC and ovarian cancer also in progress [23] - The company is actively involved in clinical research and development, participating in major oncology conferences such as AACR and ASCO [188] Product Development and Regulatory Approvals - The new drug application (NDA) for Lisaftoclax (APG-2575) in China was accepted and included in the priority review process [5] - Lisaftoclax's NDA for treating relapsed/refractory CLL and SLL was accepted for priority review by the NMPA in November 2024, marking it as the second NDA submission globally for a Bcl-2 inhibitor [18] - The company plans to launch Lisaftoclax in China in 2025, pending regulatory approval, and aims to seek approvals in multiple countries [18] - Aorebatin has received three indications for Chronic Myeloid Leukemia (CML) approval in China, with reimbursement expected to start in early 2025 [143] - The company aims to seek FDA approval for a Phase III clinical trial targeting newly diagnosed Ph+ ALL patients [31] Sales and Market Expansion - Sales revenue of Olverembatin (耐立克®) in China for 2024 amounted to RMB 241.0 million, representing a year-on-year growth of 52% [4] - For the year ending December 31, 2024, sales revenue of Nairike® (Aorebatin) in China reached RMB 241.0 million, an increase of RMB 82.0 million or 52% compared to RMB 159.0 million for the year ending December 31, 2023 [12] - As of December 31, 2024, the number of hospitals and DTP pharmacies with access to Nairike® (Aorebatin) reached 734, representing an 86% increase compared to December 31, 2023 [12] - Nairike has been included in the National Medical Insurance Drug List in China since January 2025, enhancing affordability and accessibility for patients [24] - The company aims to maximize the value of its pipeline products through global collaborations with leading biotech and pharmaceutical companies [65] Strategic Partnerships and Collaborations - The company has established collaborations with leading biotech and pharmaceutical companies, including AstraZeneca and Merck [20] - The company has entered into an exclusive option agreement with Takeda Pharmaceuticals for the research, development, import, export, manufacturing, use, commercialization, and development of Nilotinib, dated June 14, 2024 [190] - The company aims to seek strategic partnerships to maximize the potential of its product portfolio, leveraging strong relationships with key opinion leaders and collaborations with leading biotech and pharmaceutical companies [145] Employee and Corporate Governance - As of December 31, 2024, the company has 567 full-time employees, with 71.8% (407 employees) in R&D, 16.4% (93 employees) in commercial roles, and 11.8% (67 employees) in administrative functions [138] - The company has implemented various employee incentive plans, including pre-IPO and post-IPO share option plans, and restricted share unit plans [140] - The company expresses gratitude to shareholders, management, employees, business partners, and customers for their support and contributions [186] - The company is committed to maintaining compliance with corporate governance codes as per the listing rules [189] Financial Position and Investments - The company’s equity increased to RMB 274,162,000 as of December 31, 2024, compared to RMB 70,632,000 in 2023, reflecting a significant improvement in financial health [72] - The company has confirmed compliance with the standard code of conduct and securities trading code during the reporting period [147] - The company reported non-current assets totaling RMB 1,095,832 thousand in 2024, slightly up from RMB 1,091,422 thousand in 2023 [82] - The company has made slight adjustments to the planned allocation due to exchange rate fluctuations following the placements [166]
亚盛医药(06855) - 2024 - 年度业绩