GemPharmatech’s Weekly News Digest

1. Pfizer CD3/BCMA Dual Antibody Proposed for Priority Review

March 18 

Pfizer's CD3/BCMA dual antibody Elranatamab(PF-06863135, trade name Elrexfio) was proposed to be included in the priority review for thetreatment of relapsed or refractory multiple myeloma (R/R MM) with at least three previoustreatments (including a proteasome inhibitor, an immunomodulator and an anti-CD38monoclonal antibody). myeloma (R/R MM) in adult patients.

2. Novel Oral Antihypertensive Drug Gets FDA Approval for Marketing

March 19 

The FDA revealed that Aprocitentan (trade name Tryvio) developed by Idorsia was approved for marketing for the treatment of patients with refractory hypertension.

3. The first Chinese-made IL-5 monoclonal antibody entered phase III

March 21 

ClinicalTrials.gov showed SSGJ-610, an IL-5 monoclonal antibodydeveloped by 3S Guojian Pharmaceutical, initiated Phase III clinical trials, becoming the firstdomestic IL-5 monoclonal antibody to enter the Phase III stage.

4. European Commission Recommends Approval of Novo Nordisk's Weekly Insulin Formulation Icodec

March 21 

Novo Nordisk announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Awiqli (once-weekly basal insulin icodec) for the treatment of diabetes in adults.

Reference: PHARMCUBE