Baiji Shenzhou Releases Q3 2023 Financial Report: Robust Growth Driven by Key Products

On November 10th, Baiji Shenzhou announced its Q3 2023 financial report, showcasing impressive performance in both the US stock market and A-share market. The company's total revenue for the first three quarters of 2023 reached $1.824 billion, representing a remarkable year-on-year growth of 87.4%. In Q3 alone, the total revenue amounted to $781 million, marking a staggering increase of 102%. The global product revenue surged to $595 million, a growth of 70% compared to the same period last year.

Key Products Driving Growth:
Increased Production and Accelerated Clinical Development

The highlight of Baiji Shenzhou's Q3 2023 financial report lies in its product revenue. Baiyuzhe (Zebutinib Capsules), the company's first innovative drug to receive international market approval, achieved sales revenue of CNY 2.571 billion in Q3 alone, representing a remarkable year-on-year growth of 130%. Notably, the US market contributed CNY 1.937 billion to the revenue, compared to CNY 740 million in the same period last year.

According to the financial report, Zebutinib's sales growth in the US can be attributed to an increase in its market share for approved indications. Additionally, Baiji Shenzhou's Suzhou facility has received FDA approval as another manufacturing site. In the Chinese market, Baiyuzhe has steadily increased its sales revenue, with three indications already included in the National Medical Insurance Catalog.

Currently, Zebutinib has obtained approvals in over 65 markets, particularly in the United States, China, the European Union, Canada, and Australia, for the treatment of adult patients with CLL or SLL. Furthermore, Baiji Shenzhou has successfully submitted a new indication application for the use of Zebutinib in combination with rituximab for the treatment of FL to the US FDA. The decision on this application is expected in March 2024. The application has also received positive opinions from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

Another core self-developed product, BaiZe'an (Tislelizumab, a PD-1 antibody), has also demonstrated impressive performance. In China, Tislelizumab achieved sales revenue of CNY 1.046 billion in Q3, compared to CNY 879 million in the same period last year. Currently, Tislelizumab has obtained NMPA approval for 11 indications, with nine of them included in the National Medical Insurance Catalog.

Similar to Zebutinib, Tislelizumab's global registration plan is progressing rapidly. The financial report reveals that Tislelizumab has received approval in the European Union for the treatment of adult patients with ESCC in the second-line setting, marking a breakthrough in the PD-1 field. In the United States, Baiji Shenzhou has also submitted an application for this indication, with the FDA expected to make a decision in 2023 or the first half of 2024. Baiji Shenzhou plans to submit marketing authorization applications for Tislelizumab in the United States, the European Union, Japan, and China in 2024, further expanding its global footprint.

Focus on Two Key Therapeutic Areas:
     Empowering Robust Product Pipelines

In addition to the two core products, Baiji Shenzhou has strategically focused on the fields of hematological malignancies and solid tumors, building a rich product pipeline.

In the field of hematological malignancies, the company has initiated global clinical trials for "best-in-class" sonrotoclax (a BCL2 inhibitor) for the treatment of relapsed or refractory Waldenstrom's macroglobulinemia, with the potential for global registration. Furthermore, Baiji Shenzhou plans to initiate a pivotal global trial in Q4 this year, investigating the combination of Zebutinib and sonrotoclax for first-line treatment of CLL patients. Meanwhile, the company continues to advance other projects in its pipeline.

In the field of solid tumors, Baiji Shenzhou has established a comprehensive immune-oncology pipeline centered around Tislelizumab, targeting key solid tumors such as lung cancer, upper gastrointestinal cancer, and colorectal cancer.

Currently, Baiji Shenzhou is accelerating the expansion of indications for Zebutinib and Tislelizumab, as well as driving their global market access. Additionally, the company possesses 23 development projects and over 60 preclinical projects. With a focus on innovation and the acceleration of globalization, Baiji Shenzhou is poised for further success in the future.