The China’s Center for Drug Evaluation (CDE) website has signaled that GlaxoSmithKline’s (GSK; NYSE: GSK) Blenrep (belantamab mafodotin) and Star Pharmaceutical Ltd.’s topiramate oral solution are on track to receive priority review statuses in China.
Blenrep: An Antibody-Drug Conjugate for Multiple Myeloma
Blenrep is an innovative antibody drug conjugate (ADC) that targets B-cell maturation antigen (BCMA) with a monoclonal antibody linked to the cytotoxic agent auristatin F via a non-cleavable linker. The drug’s development involved licensing technology from Seagen Inc., and Kyowa Kirin Group. Blenrep has been approved for marketing in Hong Kong, Israel, and Singapore as a monotherapy and was awarded Breakthrough Therapy Designation (BTD) in mainland China in September 2024. The priority review status for Blenrep is based on its BTD status and is indicated for use in combination with bortezomib and dexamethasone for multiple myeloma patients who have received at least one prior treatment.
Topiramate Oral Solution: A New Option for Epilepsy and Migraines
Topiramate is an antiepileptic drug that stabilizes electrical activity in the brain, reducing the likelihood of epileptic seizures. In China, no oral solution of topiramate has been approved, with only capsules or tablets available. Azurity Pharmaceuticals, Inc., based in the US, received FDA approval for its topiramate oral solution in 2021. Star Pharmaceutical’s topiramate oral solution has been granted priority review status as it aligns with the category of “New varieties, dosage forms, and specifications of pediatric drugs that meet the physiological characteristics of children.” The drug’s indications include monotherapy for epilepsy, epilepsy adjuvant therapy, and migraine treatment.-Fineline Info & Tech
