Tags : Henlius

Weekly Snapshot

PharmaShots Weekly Snapshot (March 09-13, 2020)

1. I-Mab to Initiate the Development of TJM2 for Treating Cytokine Release Syndrome Associated with COVID-19 Published: Mar 13, 2020 | Tags: I-Mab, Initiate, Development, TJM2, Treating, Cytokine Release Syndrome, COVID-19 2. EMD Serono and Pfizer to Terminate P-III JAVELIN Head and Neck 100 Study Evaluating Bavencio + CRT for Squamous Cell Carcinoma of the Head […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshot (November 04-08, 2019)

1. Triumvira’s TAC01-CD19 Receives FDA’s Fast Track Designation for R/R Diffuse Large B-Cell Lymphoma Published: Nov 07, 2019 | Tags: Triumvira, TAC01-CD19, Receives, FDA, Fast Track Designation, R/R, Diffuse Large B-Cell Lymphoma 2. Janssen Reports Submission of MAA to EMA for its Investigational Ebola Vaccine Regimen to Prevent Ebola Virus Disease Published: Nov 07, 2019 | Tags: […]Read More

Pharma

Henlius and Ascentage Pharma Collaborate to Evaluate the Combination Therapy

Shots: The companies collaborated to conduct the clinical studies of a dual regimen consisting of Ascentage’s APG-2575 and Henlius’s HLX01 (biosimilar, rituximab) for the treatment of chronic lymphocytic leukemia in the People’s Republic of China The teams from both the companies will explore the clinical utility of the dual regimen aiming to demonstrate a synergistic […]Read More

Biosimilars Regulatory

Henlius Reports EMA’s Acceptance of Marketing Authorization Application for HLX02

Shots: The acceptance follows P-III study demonstrating bio-similarity data between HLX02 and reference product trastuzumab sourced from EU in 649 patients with HER2+ m-breast cancer and P-I study resulting equivalence in PK & safety studies b/w HLX02 and reference trastuzumab sourced from both EU and China In Jun’18, Henlius granted exclusive commercialization rights of HLX02 […]Read More