Author:Qingfeng Pharmaceutical Group
Posted Time:2025-03-21 00:00
On March 21, Qingfeng Pharmaceutical’s subsidiary, Kvvit Pharmaceuticals, obtained NMPA approval to market the first domestically developed generic piracetam oral suspension.
Clinical Advantages
Pirampanel Oral Suspension is indicated for adults and children aged 4 years and older to treat partial-onset seizures—whether simple or complex. It represents Qingfeng Pharmaceutical’s first oral suspension formulation. The formulation is a semi-solid jelly at rest; with just a 5-second shake it turns into a pourable liquid. Its highly dispersed and uniform consistency allows for accurate dose titration, making it ideal for children, elderly patients, and individuals with swallowing difficulties. Unlike most anti-epileptic drugs that require twice-daily dosing, this piracetam suspension only needs to be administered once a day at bedtime, improving medication adherence.
Market Outlook
The Pirampanel Oral Suspension, with its clear clinical benefits, offers significant market potential. In March 2021, Perampanel was added to China’s “Second Batch of Encouraged Generic Drugs.” In March 2023, China’s revised Clinical Diagnosis and Treatment Guidelines for Epilepsy recognized Perampanel as a first-line therapy for newly diagnosed focal seizures and recommended it for both multiple seizure types and epilepsy syndromes. According to Eisai’s financial report, Perampanel achieved global sales of approximately RMB 1.86 billion (~USD 300 million) in 2022. Since its introduction to China in 2019, inpatient hospital sales have surpassed RMB 100 million.
On April 14, 2023, the NMPA, along with the Ministry of Public Security and the National Health Commission, reclassified Perampanel as a Class II psychotropic controlled substance.
The company’s R&D, manufacturing, and supply teams overcame a number of key challenges—including BE trial design, production-line upgrade, and controlled-substance audits—to achieve final approval.
Qingfeng Welcomes a New Member to Its CNS Family
The central nervous system (CNS) is one of the key therapeutic fields in Qingfeng Pharmaceutical’s pipeline. In recent years, Qingfeng has made significant investments in this therapeutic field. The approval of Qingfeng Pharmaceutical’s Pirampanel Oral Suspension further strengthens the company’s CNS portfolio, offering epilepsy patients a new treatment option and a more comprehensive therapeutic solution.
Qingfeng is currently developing nearly 20 anti-epileptic drug specifications across multiple dosage forms—including oral solids, oral liquids, and injectables—establishing a diverse domestic product offering in this therapeutic field.
Looking ahead, Qingfeng Pharmaceutical Group will remain committed to addressing clinical needs through research-driven innovation, with the goal of delivering more clinically valuable therapies for patients throughout the world.
