Tags : 3

Henlius Receives NMPA’s IND Approval for its HLX13 (biosimilar, ipilimumab)

Shots: The approval follows the trials which involves assessing of HLX13 vs originator ipilimumab to evaluate its pharmacology, pharmacokinetics and toxicokinetics profiles, immunogenicity, and toxicity The study resulted in biosimilarity data in terms of in vivo and in vitro pharmacology, PK, toxicokinetics, immunogenicity and toxicity characteristics HLX13 is a recombinant anti-CTLA-4 fully human mAb injection […]Read More

Merck’s Keytruda(pembrolizumab) Receives 5 Approvals from PMDA, Japan across 3

Shots: •      Out of 5 approvals three are for NSCLC patients, one for Melanoma and one for Microsatellite Instability-High (MSI-H) solid tumor patients •      Keytruda got approved as monotherapy in 1L PD-L1 positive NSCLC patients based on Keynote-042, one in 1L non-squamous patients in combination with pemetrexed and PT-CT based on keynote-189 and another for […]Read More