Incident: Recently, the company released its 2023 Annual Report and 2024 Quarterly Report. In 2023, the company achieved revenue of 705 million yuan, a year-on-year increase of 54.86%; in Q1 2024, the company achieved revenue of 162 million yuan, an increase of 4.30% over the previous year. Net profit attributable to shareholders of listed companies was -119 million yuan, and net profit attributable to shareholders of listed companies after deducting non-recurring profit and loss was -123 million yuan.
The global promotion of BAT1806 (tocilizumab) has been successful. On April 26, the company voluntarily disclosed that it had received a notice from the European Medicines Agency (“EMA”), and BAT1806 received a positive opinion from the EMA Commission for Human Medicines (“CHMP”). The CHMP recommended that the European Commission approve the listing of BAT1806. BAT1806 (tocilizumab) was approved for marketing by China's National Drug Administration in January 2023. It is the first tocilizumab biosimilar drug approved domestically, and the world's first tocilizumab biosimilar. In September 2023, BAT1806 was approved for marketing by the US FDA. It is the first monoclonal antibody drug independently developed and produced by a local Chinese pharmaceutical company and approved for marketing by the US FDA. It is also the first toclonal antibiotic similar drug approved by the US FDA.
The R&D pipeline has entered the harvest period. As of December 31, 2023, the company has received marketing approval from the State Drug Administration for marketing of 3 products, including: galerizumab (adalimumab), purbecil (bevacizumab), and schirelli (tocilizumab); 2 products have received FDA approval: TOFIDANCE (tocilizumab) and Avzivi (bevacizumab). Meanwhile, tocilizumab injections and bevacizumab injections have submitted marketing applications to EMA. In addition, the company has submitted a marketing license application for 1 product (BAT2094 batifiban) to the State Drug Administration, and 6 products are in phase III clinical research.
Investment advice: The company adheres to an innovation-driven development strategy and is committed to developing a new generation of innovative drugs and biosimilar drugs to treat tumors, autoimmune diseases, cardiovascular diseases and other major diseases that endanger human life or health. We expect the company to achieve revenue of 1,22/16.48/2,060 billion yuan in 2024-2026, maintaining the “gain” rating.
Risk warning: risk of changes in industry policies, risk of new drug development, risk of uncertain marketing of products under development, risk of poor progress in internationalization, risk of market competition, etc.