China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that its mitoxantrone hydrochloride liposome has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for neuromyelitis optica spectrum disorders (NMOSD). This follows the product’s initial approval in January this year for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL).
Drug Overview
The mitoxantrone hydrochloride liposome utilizes liposome technology as a carrier, which offers advantages such as reduced peak drug concentration, decreased myocardial distribution, and minimized toxic and side effects. These features enhance the efficacy and safety profile of mitoxantrone.
NMOSD Treatment Landscape
NMOSD, a high-recurrence and high-disability autoimmune disease of the central nervous system, was included on China’s rare disease list in May 2018. Other NMOSD drugs under development in China include Harbour Bio’s anti-FcRn antibody batoclimab (HBM9161), Hengrui Medicine’s SHR1459, Ascentage’s Bcl-2 inhibitor lisaftoclax, InnoCare’s Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib, and Shanghai Pharma’s anti-CD20 monoclonal antibody. Viela Bio’s inebilizumab, licensed to Hansoh Pharma for China, and Roche’s satralizumab were approved for marketing in China in March 2022 and May 2021, respectively.-Fineline Info & Tech
