China News Service, March 25 (Reporter Zhang Ni) 2023 is regarded by the industry as the first year for domestic innovative drugs to "go overseas". This year, domestic pharmaceutical companies have continued to increase their overseas projects, and even set a new record for down payments.

　　In the overseas market, opportunities and risks coexist. In 2023, some people will be happy and some will be sad? This can be seen from the performance results announced by major companies one after another.

  Data map: Panoramic view of Suzhou Biomedical Industrial Park. Photo courtesy of Suzhou Biomedical Industrial Park

Who makes the profit when innovative drugs go overseas?

　　In late February, BeiGene announced its fourth quarter and full-year U.S. stock performance reports for 2023, as well as its 2023 A-share performance report. The US stock performance report shows that total revenue in the fourth quarter of 2023 was US$634.4 million, and total revenue for the year was US$2.5 billion, compared with US$380.1 million and US$1.4 billion in the same period last year.

　　It is worth noting that BeiGene’s financial report shows that the BTK inhibitor zanubrutinib (trade name: Baiyuez) it developed has performed well. Including overseas markets, global sales of zanubrutinib will reach US$1.3 billion in 2023, a year-on-year increase of 129%.

　　In the same February, Junshi Biotech disclosed its 2023 annual performance report. During the reporting period, the company achieved operating income of RMB 1.54 billion, a year-on-year increase of 5.96%. Last year, Junshi's PD-1 toripalimab injection (trade name: Tuoyi) was approved for nasopharyngeal cancer indications in the United States. The performance report described Tuoyi's performance as "sales revenue continues to grow."

　　Innovent Biologics also recently announced its results, saying that sales in 2023 will reach RMB 6.206 billion, a year-on-year increase of 36.2%. Product revenue for the year was 5.728 billion yuan, a year-on-year increase of 38.4%. Its performance announcement also mentioned that sintilimab injection (trade name: Tyvyt) continues to maintain strong sales performance and a solid market leadership position.

　　Looking at Chi-Med Pharmaceuticals, which had original new drugs approved in the United States last year, its full-year revenue in 2023 increased by 97% to US$838 million, with net income of US$101 million. Its independently developed drug, fruquintinib (US trade name: FRUZAQLA), obtained the first US Food and Drug Administration (FDA) approval and achieved market sales of US$15.1 million in the US.

　　However, the "going global" of innovative drugs also faces uncertainties. Yifan Pharmaceuticals previously released a performance forecast for 2023, predicting a loss of 382 million yuan to 650 million yuan in 2023, compared with a profit of 191 million yuan in the same period last year.

　　Its notice mentioned that in 2023, F-627 (ibegastine α injection) independently developed by the company's holding subsidiary Yiyi Biotech has been successfully approved in China and the United States. However, major changes have occurred in the global market competition pattern and competitive situation. Changes (an increase in the number of competing products and a decrease in the price of competing products) will have an adverse impact. It is expected that the future recoverable amount will be less than expected, resulting in impairment. The final impairment amount will be determined by the evaluation agency and accounting firm hired by the company after evaluation and audit.

Some companies' losses have narrowed, and their "cash burning" has taken effect?

　　In addition to the sales data of various pharmaceutical companies in 2023, another point worthy of attention is that the losses of some companies that have continued to "burn money" in research and development have narrowed.

　　For example, BeiGene, known as the "King of R&D Investment", has R&D expenses rising to US$1.7786 billion in 2023, accounting for the majority of operating expenses. Although BeiGene will still be at a loss in 2023, its annual loss has narrowed significantly year-on-year. According to outside analysis, the company is only "one step away" from turning losses into profits.

  Screenshot from BeiGene performance report

　　BeiGene also emphasized that the United States was the company's highest revenue market in the fourth quarter and full year of 2023. The market's total revenue was US$313.2 million and US$1.1 billion respectively, compared with US$155.4 million and US$502.6 million respectively in the same period last year. Dollar.

　　Innovent Biologics lost RMB 1.028 billion during the year, a 52.8% decrease from RMB 2.179 billion in 2022. However, unlike BeiGene, Innovent’s R&D expenditure in 2023 will be approximately 2.23 billion yuan, which is significantly reduced from 2.87 billion yuan in 2022.

　　Junshi Biotech said that during the reporting period, operating losses, total losses and other indicators decreased compared with the same period last year. This was mainly because the company strengthened various expense control while increasing operating income, optimized resource allocation, and focused on R&D pipelines with greater potential.

  Data map: Photo by Zheng Yingying, Zhangjiang·China Medicine Valley Biomedical Innovation Exchange Center

Keywords for 2024: new releases

　　Win or lose, in 2024, innovative drugs that have been written into the government work report may usher in a new round of outbreak.

　　For enterprises, continuing to work on research and development and promoting "new innovation" have become the main tasks.

　　Just in the middle of this month, BeiGene announced that the U.S. Food and Drug Administration (FDA) has approved tislelizumab (Chinese trade name: TEVIMBRA; English trade name: TEVIMBRA) as a monotherapy for past patients. Adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after systemic chemotherapy (without PD-1/L1 inhibitors).

　　Innovent Biologics stated in its annual results announcement that the innovative lung cancer targeted drugs fluzerecet (KRAS G12C) and talatinib (ROS1) are expected to be approved for marketing in 2024.

　　Data from multiple professional platforms also show that China Pharmaceutical BD (Business Development) transactions will have a “good start” at the beginning of 2024.

　　Of course, some multinational pharmaceutical giants have also keenly sensed opportunities.

　　In February this year, AstraZeneca officially announced that Shanghai has become its fifth global strategic center, and simultaneously released the "Shanghai Biopharmaceutical Innovation Enterprise 2024 Cooperation Overseas Plan." It is said that the plan will help 30 outstanding Shanghai companies go overseas and continue to promote cross-border cooperation and exchanges in pharmaceutical innovation.

　　As AstraZeneca's global CEO Suboko said, China plays a vital role in the global healthcare industry, not only taking a leading position in innovation, but also playing a key role in the global research and development and production of important drugs. .

　　However, for Chinese pharmaceutical companies, the road to “going overseas” for innovative drugs is long and difficult. How can enterprises overcome "acclimatization"? How to prevent competitors from attacking overseas? How to truly increase revenue and profits? There is still a long exploration process ahead. (over)