Zydus Lifesciences partners with Zhuhai Beihai Biotech for BEIZRAY commercialisation in the US

Zydus Lifesciences has announced that its wholly owned subsidiary, Zydus Lifesciences Global FZE, has entered into an exclusive licensing, supply, and commercialisation agreement with Zhuhai Beihai Biotech Co., Ltd for BEIZRAY (Albumin Solubilized Docetaxel Injection) in the US market. BEIZRAY is a 505(B)(2) product, approved for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.

Under the agreement, Beihai Biotech will be responsible for manufacturing and supplying the product, while Zydus will oversee its commercialisation in the US. Beihai Biotech will receive upfront payments, milestone-based sales payments, and a share of BEIZRAY’s net profits in the US.

BEIZRAY is the first clinically validated, improved formulation of Docetaxel that does not contain synthetic excipients such as Polysorbate-80 or Sulfobutyl Ether Cyclodextrin. Instead, it is solubilized in human-derived Albumin, reducing adverse events associated with synthetic excipients. The product received NDA approval in the US on 23 October 2024.

Punit Patel, President and Chief Executive Officer of Zydus Pharmaceuticals (USA) Inc., stated, “We are pleased to partner with Beihai Biotech for the commercialization of this complex drug product in the US market. The partnership will provide impetus to our strategic focus on high unmet need therapy area, as well as our stated purpose of delivering much-needed medicines to more patients in the country. We are certain that by pooling our resources and knowledge, we will be able to empower more patients and help them lead a better quality of life.”

Dr Qun Sun, Founder and Chairman of Zhuhai Beihai Biotech Co. Ltd, said, “The launch of BEIZRAY, the first improved Docetaxel formulation with significant clinical advantages, in the USA provides patients with an important treatment alternative for these extremely challenging conditions. We are excited about Zydus’ top position in this field and anticipate further collaborations in the future. Beihai Biotech is committed to deliver innovative and high-quality medicine for all patients through this collaboration.”

According to IQVIA MAT data from December 2024, the Docetaxel Injection market in the US has an annual volume uptake of approximately 531,000 units.