Tot Biopharmaceutical International Co., Ltd (HKG: 1875) has announced the termination of the Phase III clinical study for its HER2-targeted antibody-drug conjugate (ADC) TAA013. The decision was made due to significant changes in the market competitive landscape for the drug target and technology.
Rational Resource Allocation and Strategic Transformation
The China-based firm noted that TAA013 is not expected to meet its early planning and forecast potential marketing value. As a result, the company has decided to re-allocate resources to the research and development of other product pipeline candidates and to support the sales of on-market products. Additionally, Tot Bio will focus on the development of its CDMO business, marking a strategic transformation for the company.
Ensuring Care for Trial Participants
Tot Bio will ensure that existing trial participants receive suitable treatment regimens to maintain their health and well-being.
Market Context and Competitive Landscape
Multiple HER2-targeted ADCs are already on the market, including Roche’s Kadcyla (trastuzumab emtansine), AstraZeneca/Daiichi Sankyo’s fam-trastuzumab deruxtecan, and RemeGen’s disitamab vedotin. Several other HER2-targeted ADCs are under development in China, such as Zhejiang Medicine’s ARX788, Hengrui Medicine’s SHR-A1811, CSPC’s DP303c, Kelun Pharma’s A166, and Bio-Thera Solutions’ BAT8010.-Fineline Info & Tech
