On November 10, 2023, Baekje Shenzhou (NASDAQ: BGNE; Hong Kong Stock Exchange: 06160.HK; Shanghai Stock Exchange: 688235. SH) announced its US stock performance report and A-share performance report for the third quarter of 2023.
According to the A-share performance report, Baiji Shenzhou achieved a total operating revenue of 5.624 billion yuan in the third quarter, a year-on-year increase of 111.5%. Thanks to strong demand for core products, product revenue maintained a high growth rate this quarter, reaching 4.287 billion yuan, a year-on-year increase of 79.2%.
In the first three quarters of 2023, the total operating revenue of Baekje Shenzhou was 12.875 billion yuan, an increase of 87.4% year-on-year. In the first three quarters, the product revenue of Baekje Shenzhou exceeded the 10 billion mark for the first time, reaching 10.984 billion yuan, a year-on-year increase of 81%, significantly exceeding the full year product revenue of last year.
Zebutinib has significant global sales, with overseas revenue exceeding 80%
As the first innovative drug approved by Baekje Shenzhou in the international market, this year, Baekje&Co; Reg; Global sales have achieved continuous month on month growth, with overseas revenue accounting for over 80% in the third quarter. Zebutinib's global sales in the third quarter reached 2.571 billion yuan, a year-on-year increase of approximately 130%. Among them, the sales revenue in the United States reached 1.937 billion yuan, an increase of more than double compared to 740 million yuan in the same period last year. In China, Zebutinib's sales reached 344 million yuan, compared to 270 million yuan in the same period last year.
Currently, Zebutinib has been approved in over 65 markets and has established a wide range of clinical development layouts worldwide. In addition, Baekje Shenzhou has submitted a new indication marketing license application for the treatment of follicular lymphoma (FL) with Zebutenib combined with Otuzumab to the US FDA and has been accepted. The FDA is expected to make a decision on this application in March 2024. Zebutinib has received positive feedback from the European Medicines Agency (EMA) Committee on Human Medicines (CHMP) regarding this marketing approval application.
Zebutinib's continuous success in the international market not only reflects the differentiated competitiveness of Baekje's self-developed products, but also proves the correctness and strong execution ability of its independent global commercial layout. At present, Baekje Shenzhou has a commercialization team of over 500 people overseas, with main personnel recruited locally, covering mainstream markets such as North America and Europe, truly achieving global "localization".
PD-1 goes to sea with "zero breakthrough", accelerating global layout to benefit patients
In addition, another core self-developed product of Baekje Shenzhou, PD-1 Antibody Baekzean& Reg; Tirelizumab was first approved in the European Union for second-line treatment of adult patients with esophageal squamous cell carcinoma (ESCC), achieving a "zero breakthrough" in the PD-1 field.
At the same time, Baekje is accelerating the global registration plan for tirelizumab. In the United States, the FDA is reviewing the application for a new drug marketing license to treat second-line ESCC with tirelizumab, and is expected to approve the application within 2023 or the first half of 2024. In addition, EMA is reviewing the marketing license application for the combination of tirelizumab and chemotherapy for first-line and second-line treatment of metastatic non-small cell lung cancer (NSCLC), and it is expected that EMA will approve this application in the first half of 2024. In 2024, Baekje will also submit marketing approval applications in the United States, the European Union, Japan, and China, further expanding the global layout of tirizumab.
In China, the market share of tirizumab continues to increase, with sales reaching 1.046 billion yuan in the third quarter, compared to 879 million yuan in the same period last year. So far, over 750000 patients have received treatment with tirelizumab. At present, 11 indications of tirelizumab have been approved by the China National Drug Administration, of which 9 indications have been included in the national medical insurance drug catalog.
The financial report shows that Baekje Shenzhou has entered the next wave of research and development, and is fully advancing towards "first in class" or "best in class". At present, Baekje Shenzhou has a rich global R&D pipeline reserve, with a total of 23 development projects and over 60 preclinical projects under research. (Yan Yun)