The APPA, if passed into law, puts an upper limit of 20 patents, but only of certain types of patents (see below), that can be asserted in a BPCIA litigation (the APPA does not affect ANDA litigations ...

Organon and Shanghai Henlius Biotech have announced that the European Medicines Agency (EMA) has validated a marketing ...

On March 5, 2025, the FDA cleared an investigational new drug application for CTD402, a CD7-targeted universal CAR T-cell ...

In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to two biosimilar candidates, including HLX11. The agreement covers ...

Shanghai Henlius Biotech and Organon (OGN) announced that the European Medicines Agency has validated the marketing authorization application ...

Henlius and Organon announced the European Medicines Agency validates filing for Perjeta® (pertuzumab) Biosimilar Candidate HLX11 ...

Introduction Biosimilar monoclonal antibodies (mAbs) are biologic drugs designed to be highly similar to already approved reference monoclonal ...

Monoclonal antibodies lead biosimilar approvals because of their large market size, well-defined regulatory pathways, and ...

SHANGHAI, March 19, 2025 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for HLX22, the ...

SHANGHAI, March 19, 2025 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for HLX22 ...

When combined with trastuzumab and chemotherapy, treatment with pembrolizumab was associated with a statistically significant improvement in PFS and OS compared with placebo. The conversion to ...