The "Innovative Medicine Brother" of Baiji Shenzhou delivered a good transcript in the third quarter.
On November 10th, Baekje Shenzhou (BGNE. NS; 06160. HK; 688235. SH) released its third quarter report for 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%. Among them, the product revenue was 4.287 billion yuan, a year-on-year increase of 79.2%, accounting for 76% of the total revenue. In the third quarter, the net profit attributable to the parent company was 1.341 billion yuan, which was converted from loss to profit. The non net loss attributable to the parent company was 1.282 billion yuan.
In the first three quarters, the total operating revenue of Baekje Shenzhou was 12.875 billion yuan, an increase of 87.4% year-on-year. The product revenue in the first three quarters was 10.984 billion yuan, surpassing 10 billion yuan for the first time, an increase of 81% year-on-year, exceeding the full year product revenue of last year. In the first three quarters, the net loss attributable to the parent company narrowed to 3.878 billion yuan, while the net loss attributable to the parent company was 6.783 billion yuan.
Baekje Shenzhou stated that the revenue growth in the third quarter was mainly due to the continuous sales growth of its self-developed product BTK inhibitor Zebutinib globally and PD-1 tumor drug Tirelizumab in China, as well as the sales growth of Anjin authorized products in China.
Specifically, Zebutinib's global sales in the third quarter reached 2.571 billion yuan, with sales in the United States reaching 1.937 billion yuan, more than double the same period last year's 740 million yuan. In China, Zebutinib's sales reached 344 million yuan, up from 270 million yuan in the same period last year, an increase of 27%.
It is worth mentioning that Zebtini's overseas revenue accounted for over 80% in the third quarter. Zebutinib is the "first domestically produced new cancer drug to go to sea" and has been approved with multiple indications in over 65 markets, including the United States, China, the European Union, the United Kingdom, Canada, Australia, South Korea, and Switzerland. 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.
Tirelizumab is another star product under the umbrella of Baekje Shenzhou, which has previously been approved in the European Union for second-line treatment of adult patients with esophageal squamous cell carcinoma (ESCC), achieving a "zero breakthrough" in the domestic PD-1 market. In China, 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 drug's sales revenue in China in the third quarter was 1.046 billion yuan, compared to 879 million yuan in the same period last year, a year-on-year increase of nearly 19%. Adding in 1.836 billion yuan in the first half of the year, domestic sales exceeded 2.8 billion yuan.
In addition to the European Union, Baekje is also accelerating the global listing process of 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.
As of the close of the 10th, the Baekje Shenzhou A-share fell 1.6% to 148.88 yuan, while the Hong Kong stock fell 0.17% to 117 Hong Kong dollars.