Recently, Zhejiang CDMO Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Hangzhou BIO-SINCERITY Pharmaceutical Technology Co., Ltd. (301096.SZ), received marketing authorisation from the National Medical Products Administration (NMPA) for its Class 2.2 improved new chemical entity, Levetiracetam Sustained-release Granules, under approval number National Drug Approval Number H20260050. This is BIO-SINCERITY’s first approved modified new drug, marking a milestone breakthrough for the company in the field of modified new drug research and development.

    The approval of this formulation has further expanded the range of clinical dosage forms available for levetiracetam, providing new treatment options for relevant patients, whilst also demonstrating BIO-SINCERITY’s ongoing expertise and innovative capabilities in the field of improved new drug development.

New dosage form approved to meet the need for differentiated clinical treatment

Epilepsy is a common chronic neurological disorder characterised primarily by recurrent epileptic seizures. Patients typically require ongoing, standardised treatment, and some need to take antiepileptic drugs over the long term; consequently, drug efficacy, safety, ease of administration and treatment adherence are all important considerations in clinical practice.

Levetiracetam is an antiepileptic drug belonging to the pyrrolidone class. The exact mechanism of its antiepileptic action has not yet been fully elucidated; however, current research suggests that its effect may be related to its binding to synaptic vesicle protein 2A (SV2A) in the central nervous system. By regulating synaptic vesicle release and neurotransmitter transmission, it inhibits abnormal excessive neuronal discharge, thereby reducing the frequency of epileptic seizures. This drug demonstrates good efficacy and safety, with favourable pharmacokinetic properties, and is a first-line treatment for epilepsy both in China and internationally.

At present, levetiracetam is available in a variety of dosage forms for clinical use, including standard tablets, oral solutions, injectables and sustained-release tablets. The levetiracetam sustained-release granules recently approved for Zhejiang CDMO Pharmaceutical represent a formulation improvement based on the known active ingredient, combining the characteristics of sustained-release delivery with the granule dosage form.

According to relevant research data, the prevalence of dysphagia among the elderly in China is approximately 66 per cent, whilst the incidence of dysphagia among children with epilepsy is approximately 72.3 per cent; the medication needs of these specific patient groups have long remained inadequately met. Levetiracetam sustained-release granules consist of multiple individual units, facilitating dose adjustment and making them more suitable for children and elderly patients with dysphagia. An advanced coating technology is used to apply a modified layer to the exterior of the individual units, resulting in a pleasant taste that is readily accepted by patients.

This product is bioequivalent to levetiracetam sustained-release tablets and, whilst ensuring therapeutic efficacy, offers the following clinical advantages: it is easier to swallow than sustained-release tablets; it is more portable than oral solutions and contains no preservatives; and, compared with conventional formulations, it reduces the frequency of dosing, allowing for once-daily administration. Furthermore, this formulation is characterised by reduced fluctuations in plasma drug concentrations, good reproducibility of absorption, minimal inter-individual variability and absorption that is unaffected by food. It can effectively improve patient adherence to treatment, providing a more convenient and stable therapeutic option for epilepsy patients requiring long-term medication.

Focusing on long-term treatment and expanding the range of antiepileptic drug formulations

Epilepsy is a common neurological disorder; there are over 9 million people with epilepsy in China, all of whom require long-term medication. Levetiracetam is a first-line treatment for epilepsy; it has a large market presence and continues to enjoy strong clinical demand. As a Category 2.2 improved new drug, this product involves a high technical threshold for research and development. Compared with the fiercely competitive environment of centralised procurement for standard formulations, this product is expected to have favourable market prospects in the field of anti-epileptic treatment, thanks to its high technical barriers and a relatively favourable competitive landscape.

Meanwhile, various dosage forms of levetiracetam—including tablets, sustained-release tablets, oral solutions and concentrated solutions for injection—have been included in the *National Essential Medicines List (2026 Edition)*, which will come into effect on 1 September 2026.

Adhering to a clinical value-driven approach to advance the research and development of improved new drugs

As BIO-SINCERITY’s first approved modified new drug, the successful launch of levetiracetam sustained-release granules represents a significant achievement in the company’s development of its sustained- and controlled-release formulation technology platform, and has also provided valuable R&D and regulatory experience for the advancement of the company’s future pipeline of modified new drugs.

BIO-SINCERITY and its subsidiary, Zhejiang CDMO Pharmaceutical, will continue to focus on the treatment of central nervous system disorders, remaining steadfastly guided by patients’ clinical needs whilst continuously advancing the research, development and commercialisation of improved new drugs and innovative formulations. Looking ahead, the company will continue to draw on its robust R&D capabilities and commercialisation infrastructure to provide the clinical community with a wider range of safe, effective and convenient treatment options, thereby helping to enhance patients’ treatment experience and quality of life.