Indian pharmaceutical firm Zydus Lifesciences has announced that its wholly owned subsidiary, Zydus Lifesciences Global FZE has entered into an exclusive licensing, supply and commercialisation agreement with China's Zhuhai Beihai Biotech Co., for BEIZRAY (Albumin Solubilised Docetaxel Injection), a 505(B)(2) product for the US market.
Under the terms of this agreement, Beihai Biotech will be responsible for the manufacturing and supply of the product. Zydus will be responsible for commercialisation of the product in the US.
Beihai Biotech shall receive upfront payments, sales targets-based milestone payments and a share of BEIZRAY’s net profits earned in the US as per the terms of the agreement.
BEIZRAY is the first clinically validated, improved formulation of Docetaxel without synthetic excipients like Polysorbate-80 or Sulfobutyl Ether Cyclodextrin. It is solubilised in human-derived Albumin leading to a reduction in adverse events associated with synthetic excipients.
The NDA for BEIZRAY got approved in the USA on 23rd of October 2024. BEIZRAY is indicated for the treatment of Breast Cancer, Non-small Cell Lung Cancer, Prostate Cancer, Gastric Adenocarcinoma, and Head and Neck Cancer.
The Docetaxel Injection market provides access to an annual volume uptake of approximately 531,000 units in the USA market as per the IQVIA MAT December 2024.
