Today (February 18th), Zhuhai Beihai Biotechnology Co., Ltd. (referred to as "Beihai Biotechnology") announced that it has reached a significant strategic cooperation with Zydus Lifesciences, granting its new drug BEIBRAY (docetaxel BH009) exclusive commercialization rights in the US market. The news pointed out that BEIZRA is the first improved new drug in China to successfully achieve authorization for export to the United States in recent years.

According to the terms of the agreement, Beihai Biotechnology will be responsible for the production and supply of BEIBRAY, while Zydus Pharmaceuticals, a US subsidiary of Zydus, will be responsible for the commercialization of the product in the United States. Beihai Biotechnology will receive a down payment of $15 million (to be paid after the agreement is signed) and $10 million (to be paid after the first product delivery), as well as multiple sales milestone payments and high double-digit profit sharing.

According to a press release from Beihai Biotechnology, BEIBRAY is the first modified new drug of docetaxel that has been clinically validated and has significant clinical advantages in nearly 30 years since its launch. As one of the cornerstone drugs for tumor treatment, docetaxel is widely used in clinical treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric cancer, head and neck squamous cell carcinoma and other common solid tumors. According to IQVIA MAT data for December 2024, the annual usage of docetaxel injection in the US market is approximately 531000 units.

BEIZRAY was approved by the FDA for marketing in October 2024, and is used for the treatment of breast cancer, non-small cell lung cancer, head and neck squamous cell cancer, and prostate cancer. The drug does not contain Tween 80 or other synthetic solubilizers such as cyclodextrin, significantly improving the clinical safety of the drug. In clinical trials, BEIZARY significantly reduced the specific blood toxicity of docetaxel, overall improved the clinical benefit risk ratio of the drug, and provided better treatment options for advanced solid tumor patients.

Dr. Sun Qun, founder and chairman of Beihai Biotechnology, stated that Beizeray is the first clinically validated and clinically advantageous modified new drug of docetaxel. Beizeray's global value has been internationally recognized, confirming Beihai Biotechnology's differentiated research and development strategy guided by clinical practice. The collaboration with Zydus will accelerate the benefits of this innovative therapy to patients worldwide. Beihai Biotechnology is excited about Zvdus' outstanding position in this field and looks forward to deeper cooperation in the future to benefit more patients.

Beihai Biotechnology is an innovative biopharmaceutical company dedicated to developing innovative cancer drugs that meet the unmet clinical needs centered on patients. The company has a molecular targeted delivery technology platform and a PDC coupled drug technology platform, and has laid out more than 10 differentiated innovative drug development pipelines. Multiple new drug projects have entered the clinical stage, and 11 new drug clinical trial licenses (IND) have been obtained in China and the United States.

Source: https://pharm.jgvogel.cn/c1488744.shtml