Zydus & Beihai Biotech sign an exclusive deal to commercialize BEIZRAY in US market

New Delhi: Zydus Lifesciences, a global innovation driven healthcare company announced that its wholly owned subsidiary, Zydus Lifesciences Global FZE has entered into an exclusive licensing, supply and commercialization agreement with Zhuhai Beihai Biotech Co., Ltd for BEIZRAY (Albumin Solubilized 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 commercialization 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 solubilized 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 23^rd 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.

Speaking on the development, President and Chief Executive Officer of Zydus Pharmaceuticals (USA) Inc., Punit Patel said, “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, commented “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”

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.