August 2023 Global Innovative Drug Report

Our August 2023 drug report offers an in-depth look into the pharmaceutical industry’s recent innovations, diving deep into individual drug analyses. Within, you’ll find details on each drug’s profile, R&D status, active patents, mechanisms of action, clinical trials, competitive dynamics, and more.

This report consists of four parts:

1. August new drug approvals

2. New drug analysis 

3. Global drugs under Expedited Review Pathway

4. Analysis of selected ERP drugs 

Report Overview

1.) August Drug Approvals

In August 2023, a total of nine drugs received global approval. This included three monoclonal antibodies, two bispecific antibodies, two small molecule drugs (SMDs), one RNA vaccine, and one aptamer drug conjugate.

2.) New Drug Analysis

This report features in-depth analyses of five newly approved drugs, including a thorough examination of Avacincaptad pegol.

Avacincaptad pegol treats the severe eye condition known as geographic atrophy. It aims to delay vision deterioration by preventing the immune system from damaging eye cells.

3.) Global Drugs Under Expedited Review Pathway

What’s more, 56 drugs were placed on ERP in August, including 35 orphan drug designations, nine with fast track status, four targeting rare pediatric diseases, three under breakthrough therapy designation, three with priority reviews, two receiving accelerated approvals, and one granted conditional marketing approval.

4.) Analysis of Selected ERP Drugs 

This report also highlights five ERP drugs for detailed analysis. Focusing on Savolitinib — a receptor tyrosine kinase inhibitor targeting the mesenchymal-epithelial transition factor (MET), here’s what we uncovered:

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