Tags : NMPA

Henlius Reports the NMPA’s Acceptance of IND for HLX14 (biosimilar,

Shots: The NMPA has accepted the IND for HLX14, a biosimilar referencing Prolia, indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture HLX14 is developed in harmony with biosimilar guidelines and was highly similar to the reference product in preclinical pharmacology, toxicology and PK studies Henlius has a robust biosimilar […]Read More

Sorrento’s Partner Mabpharm Files NDA to the NMPA for Infliximab

Shots: Mabpharm files Infliximab Biosimilar’s NDA to the NMPA based on the trial evaluating Infliximab Biosimilar vs Infliximab and has used CHO expression system which resulted in safety results and lower immunogenicity Sorrento plans to file BLA for Infliximab Biosimilar in the US by the end of 2020. Sorrento signed a worldwide license agreement with […]Read More

Zai Lab’s Zejula (niraparib) Receives NMPA’s Approval as Maintenance Therapy

Shots: Zejula (niraparib) is an oral once-daily poly (ADP-ribose) polymerase (PARP) inhibitor used as a maintenance therapy for adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy The NMPA approval of Zejula is novel product approved in Mainland China, has shown 73% […]Read More

AstraZeneca’s Triple Combination Regimen Receives NMPA’s Approval as the Maintenance

Shots: The approval follows PR designation and is based on P-III KRONOS study assessing budesonide/glycopyrronium/formoterol fumarate vs Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and PT009 (budesonide/formoterol fumarate, demonstrated significant improvement in FEV1 The approval marks the first NMPA approval for a fixed-dose triple-combination regimen in a pressurized metered-dose inhaler device which utilizes Aerosphere delivery technology Breztri Aerosphere […]Read More