Revenue Growth - Revenue increased from RMB 279 million for the year ended December 31, 2021, to RMB 2,097 million for the year ended December 31, 2022, representing a growth of 651.6%[2] - Total revenue for the year ended December 31, 2022, was RMB 209,711 thousand, a significant increase from RMB 27,910 thousand in 2021, representing a growth of approximately 651%[50] - The company reported a total revenue of RMB 1.5 billion for the fiscal year 2022, representing a year-over-year growth of 25%[124] - The company projects a revenue guidance of RMB 1.8 billion for the fiscal year 2023, reflecting an anticipated growth of 20%[124] Income and Expenses - Other income decreased from RMB 681 million for the year ended December 31, 2021, to RMB 670 million for the year ended December 31, 2022, a decline of 60.1%[3] - Sales and distribution expenses rose significantly from RMB 477 million for the year ended December 31, 2021, to RMB 1,574 million for the year ended December 31, 2022, an increase of 230.0%[3] - Administrative expenses increased from RMB 1,435 million for the year ended December 31, 2021, to RMB 1,706 million for the year ended December 31, 2022, an increase of 18.9%[3] - The company incurred a net loss of RMB 882.924 million for 2022, compared to a net loss of RMB 782.424 million in 2021, reflecting ongoing investment in R&D[34] - The total comprehensive loss for the year ended December 31, 2022, was RMB 821.4 million, compared to RMB 813.7 million for the year ended December 31, 2021[70] Research and Development - R&D expenses decreased slightly from RMB 7,665 million for the year ended December 31, 2021, to RMB 7,431 million for the year ended December 31, 2022, a reduction of 3.1%[3] - The company is conducting over 40 I/II clinical trials globally, showcasing its robust clinical development pipeline[7] - The product pipeline includes nine clinical-stage small molecule candidates targeting various cancers and diseases[8] - The company aims to advance eight differentiated clinical product candidates to the next clinical stage and apply for NDA globally[95] - The company is committed to enhancing its R&D capabilities to develop innovative therapies that address unmet medical needs and improve patient health[96] Product Development and Market Access - The cumulative sales of the core product, Nairike® (Orebatinib), reached RMB 1,824 million since its launch in November 2021[4] - Nairike® was included in the 2022 National Medical Insurance Drug List, enhancing its market access[4] - The new drug application for Nairike® to treat chronic myeloid leukemia (CML) patients was accepted and prioritized for review in July 2022[4] - The important investigational drug, Lisaftoclax (APG-2575), demonstrated a 98% overall response rate (ORR) in combination therapy for relapsed/refractory CLL/SLL patients[5] - Nairike® (Orebatinib) received FDA orphan drug designation for the treatment of gastrointestinal stromal tumors (GIST) in September 2022[11] Financial Position - Total assets decreased to RMB 3.829 billion in 2022 from RMB 4.439 billion in 2021, while total liabilities increased to RMB 2.428 billion from RMB 1.705 billion[37][38] - The company’s cash and bank balances decreased to RMB 1.492 billion in 2022 from RMB 1.744 billion in 2021, indicating a reduction in liquidity[37] - The current ratio decreased from 5.2 in 2021 to 1.9 in 2022, and the quick ratio also decreased from 5.2 to 1.8 during the same period[83] - As of December 31, 2022, the company had bank loans amounting to RMB 1,775.5 million and lease liabilities of RMB 17.2 million[85] Strategic Partnerships and Collaborations - The company has established global partnerships with leading biotech and pharmaceutical companies and academic institutions to enhance its R&D capabilities[7] - A collaboration with Tanner Pharma Group was established in July 2022 to launch a Named Patient Program for Olverembatinib in over 130 countries[31] - The company plans to actively seek strategic partnerships with global biotech and pharmaceutical companies to capitalize on commercialization opportunities in the global drug market[95] Regulatory and Compliance - The company has adopted corporate governance principles in accordance with the listing rules and has confirmed compliance with the standard code during the reporting period[97] - The company is committed to maintaining compliance with international financial reporting standards, ensuring transparency and accuracy in its financial disclosures[123] Employee and Management - As of December 31, 2022, the company had a total of 580 full-time employees, with 67.6% (392 employees) in R&D, 19.5% (113 employees) in commercial roles, and 12.9% (75 employees) in administrative functions[93] - Employee benefits expenses for the years ending December 31, 2021, and 2022 were RMB 388.2 million and RMB 427.6 million, respectively, reflecting an increase of approximately 10.5%[93] - The senior management team consists of 157 senior employees with an average of 15 to 20 years of experience in the biotechnology industry[93] Future Outlook - The company is developing several new drugs, including APG-115, a novel oral MDM2-p53 inhibitor, and APG-1252, a selective Bcl-2/Bcl-xL inhibitor aimed at restoring apoptosis[121] - The company is exploring strategic acquisitions to bolster its portfolio and enhance its competitive edge in the biopharmaceutical market[122] - The company has reported a robust pipeline with several candidates targeting critical pathways in cancer treatment, reflecting its commitment to innovation[121]
亚盛医药(06855) - 2022 - 年度业绩