U.S. FDA Grants Market Approval for Beihai Biotech’s New Drug BEIZRAY
October 28, 2024, Zhuhai Beihai Biotech Co., Ltd. ("Beihai Biotech") announced that its innovative cancer drug, BH009 (marketed as BEIZRAY), has received approval from the U.S. Food and Drug Administration (FDA). BEIZRAY is indicated for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer. Beihai Biotech holds full global intellectual property rights to BEIZRAY.
About BEIZRAY
BEIZRAY is the first clinically validated, improved formulation of docetaxel to show significant clinical advantages in nearly three decades. As a mainstay treatment for various solid tumors, docetaxel has been widely used in the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer. However, existing docetaxel formulations contain polysorbate 80, an emulsifying agent linked to severe hypersensitivity and fluid retention, resulting in black box warnings on all current docetaxel products. BEIZRAY eliminates polysorbate 80 from its formulation, removing the associated risk of severe allergic reactions and significantly improving clinical safety. Clinical trials showed that BEIZRAY substantially reduces the typical hematologic toxicity of docetaxel, offering an improved risk-benefit profile for patients with advanced cancers. Presented at the 2023 and 2024 American Society of Clinical Oncology (ASCO) Annual Meetings, BEIZRAY’s clinical results have garnered recognition within the international academic community. With its innovative formulation of docetaxel, BEIZRAY offers significant advancements in clinical safety, efficacy, and overall patient experience.
Dr. Qun Sun, Founder and Chairman of Beihai Biotech, on BEIZRAY’s U.S. Approval
“We’re thrilled to announce BEIZRAY’s approval for the United States market, marking a pivotal step for Beihai Biotech and our molecular targeting delivery platform’s global reach. As the first improved docetaxel formulation with significant clinical advantages to be approved in the U.S., BEIZRAY highlights our dedication to innovation and our capability to develop original therapies. We are excited about the future of our pipeline, particularly in PDC products, and look forward to bringing further innovative cancer treatments to patients worldwide,” said Dr. Qun Sun, Founder and Chairman of Beihai Biotech.
Beihai Biotech Reaches Commercialization Milestone, Accelerates Path to Profitability
Beihai Biotech is actively expanding BEIZRAY’s reach into the U.S., Canada, the European Union, and key emerging markets to deliver this high-quality, innovative oncology treatment to patients worldwide. Beihai Biotech anticipates significant commercial value as BEIZRAY continues its rollout across global markets.It expects this growth to drive a crucial inflection point toward profitability, generating substantial revenue to support future R&D and market development initiatives. This growth trajectory will expedite the company’s progress toward achieving a sustainable balance between revenue and expenses, marking a new phase in Beihai Biotech’s development.
