The NMPA Breakthrough Therapy Designation was based on results from the Phase 2 TRUST trial of ROS1 fusion-positive NSCLC patients treated with taletrectinib, a new generation of potent ROS1 inhibitors
BBL will gain Viatris’ global biosimilars business whose revenues are estimated to be USD 1 billion next year, along with its portfolio of in-licensed biosimilar assets
On track to complete the BLA submission in the first half of 2022
The companies will continue with their exclusive agreements, including commercialization of their current portfolio
Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward
The company’s platform technology works like a compression algorithm for molecular testing and has applications in healthcare, pharmaceuticals, agriculture, animal husbandry, food safety, synthetic biology, and molecular biology research
Trastuzumab is monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancer and metastatic gastric cancers
The deepCDR engine combines deep sequencing and deep learning methods with a proprietary mammalian display process to select from a wide range of antibodies and rapidly identify candidates with the highest possible affinity and developability profiles
The company will manufacture a cancer immunotherapy product from 2022
The platform’s technology works as a compression algorithm for molecular testing
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