Financial Performance - In 2021, the company achieved a revenue of RMB 76,325 thousand, a 239.36% increase from RMB 22,491 thousand in 2020, with RMB 53,690 thousand coming from CDMO/CMO business[9] - The operating loss for 2021 was RMB 259,700 thousand, a 10% improvement from the operating loss of RMB 288,672 thousand in 2020[17] - The net loss for 2021 was RMB 261,216 thousand, which is a 9% decrease from the net loss of RMB 288,498 thousand in 2020[17] - The adjusted net loss for 2021 was RMB 255,920 thousand, a decrease of RMB 16,746 thousand compared to the adjusted net loss of RMB 272,666 thousand in 2020[22] - The adjusted EBITDA for 2021 was RMB 219,215 thousand, down RMB 19,663 thousand from RMB 238,878 thousand in 2020[22] - CDMO and CMO service revenue for 2021 reached RMB 53,690 thousand, up RMB 47,267 thousand from RMB 6,423 thousand in 2020[23][26] - The company's general and administrative expenses increased to RMB 56,336 thousand in 2021 from RMB 46,855 thousand in 2020, an increase of RMB 9,481 thousand[30] - The total assets as of December 31, 2021, were RMB 710,263 thousand, compared to RMB 641,183 thousand as of December 31, 2020[39] - The net assets decreased to RMB 335,091 thousand as of December 31, 2021, down RMB 247,266 thousand from RMB 582,357 thousand in 2020[38] - The total liabilities increased significantly to RMB 375,172 thousand in 2021 from RMB 58,826 thousand in 2020[39] Research and Development - Research and development expenses for 2021 were RMB 214,699 thousand, a decrease of 8.72% from RMB 235,196 thousand in 2020, primarily due to the completion of Phase III clinical trials for TAB008[9] - R&D expenses for 2021 were RMB 214,699 thousand, a 9% decrease from RMB 235,196 thousand in 2020[17] - The global R&D center, with a total construction area of 25,000 square meters, was initiated on November 9, 2021, to enhance innovative drug development capabilities[12] - The company has accelerated the development of its one-stop innovative drug CDMO business, providing effective solutions for new drug development[12] - The company is focusing on antibody drug development, with several products in various stages of clinical trials, including TAA013 for HER2-positive breast cancer[59] Product Development and Launches - The company’s first self-developed biopharmaceutical, TAB008 (Bevacizumab Injection), was approved for market launch, establishing exclusive promotion partnerships in China and commercialization agreements in emerging overseas markets[9] - The company successfully launched TOZ309 (Temozolomide Capsules) and TOM218 (Medroxyprogesterone Acetate Oral Suspension), with promotional collaborations established for both products in the Chinese market[10] - Three products were successfully approved for market launch in 2021: TAB008 (Bevacizumab injection) on November 30, TOZ309 (Temozolomide capsules) in May, and TOM218 (Medroxyprogesterone acetate oral suspension) in May[57][63][65] - TAB008, a biosimilar to Avastin, targets multiple high-incidence cancers and had global sales of $6.09 billion in 2020, with an expected market size in China nearing RMB 10 billion by 2030[62] - TOZ309 is a generic version of Temodar, used as a first-line treatment for newly diagnosed and recurrent glioblastoma, offering stronger efficacy and fewer side effects compared to conventional chemotherapy[63] - TOM218 is the first high-concentration oral suspension of Medroxyprogesterone acetate approved in China, aimed at improving the condition of patients with cancer and AIDS-related cachexia[65] Strategic Partnerships and Collaborations - The company has formed a strategic partnership with Borui Biopharmaceuticals to strengthen its one-stop CDMO service platform[12] - The company has established a global strategic cooperation with HAPLOMED for the joint development of innovative antibody drugs targeting tumor diseases[58] - The company signed an exclusive promotion agreement with Jiangxi Jixin Pharmaceutical to enhance market penetration for TOZ309 and TAB008, achieving 90% provincial coverage for national procurement[70] - The company is collaborating with Sinovac Biotech to commercialize the product Puxintin in overseas markets, aligning with the Belt and Road Initiative[71] Market Outlook and Growth - The Chinese oncology drug market was valued at USD 28.6 billion in 2020 and is projected to grow to USD 60.3 billion by 2025, with a CAGR of 16.1%[55] - The CDMO/CMO market in China is projected to grow at a compound annual growth rate (CAGR) of 30.0% from 2021 to 2025, with expected revenue of CNY 123.5 billion by 2025[74] - The ADC drug market is anticipated to reach USD 16.4 billion globally by 2026, with TAA013 being one of the three HER2-positive breast cancer drugs in Phase III trials[74] Corporate Governance - The board consists of nine members, including two executive directors, four non-executive directors, and three independent non-executive directors as of December 31, 2021[133] - The company has adopted the corporate governance code as a basis for its governance practices, ensuring compliance with all applicable provisions[133] - The company has established a strict set of guidelines for employees regarding the handling of unpublished price-sensitive information[133] - The board believes that high standards of corporate governance are essential for protecting shareholder interests and enhancing corporate value[133] - The company has implemented internal and external training for senior management and employees to ensure compliance with governance policies[133] Risk Management - The company faces significant risks, including substantial net losses and cash flow issues, as well as potential impacts from infectious disease outbreaks on business operations and clinical research[195] - The company has established a risk governance framework to identify, assess, and monitor key risks, including strategic and financial risks[174] - The company has implemented multiple risk management procedures and guidelines to address potential risks in key business processes[177] Sustainability and ESG - The establishment of a strategic and ESG committee by the board aims to integrate environmental, social, and governance factors with the company's strategy for sustainable development[94] - The company recognizes the importance of environmental policies for sustainable growth and has established a strategic and ESG committee to enhance corporate governance[196] - The company emphasizes the importance of evaluating its environmental and social impacts, aligning with international and local ESG trends[158]
东曜药业(01875) - 2021 - 年度财报