Qilu Pharmaceutical's Olanzapine Orally Disintegrating Film Nears NMPA Approval as a Class 2.2 New Drug

Source: PharmCube Info

Recently, the marketing application for olanzapine orally disintegrating film submitted by Qilu Pharmaceutical as a Class 2.2 chemical drug (acceptance numbers: JXHS1800028, CXHS1900029) is in the "under review" stage and is expected to receive approval from the National Medical Products Administration (NMPA) in the near future. This will make Qilu Pharmaceutical the second company to obtain approval for this dosage form, following Jiangsu Hansoh Pharmaceutical.

Olanzapine (brand name: Zyprexa), originally developed by Eli Lilly, was first launched in China in 1998 for the treatment of schizophrenia, moderate-to-severe manic episodes, and bipolar disorder.

Both of Qilu Pharmaceutical’s olanzapine tablets and orally disintegrating tablets have passed the consistency evaluation. Its olanzapine tablets were included in the expanded “4+7” volume-based procurement program at a price of RMB 2.48 per tablet, while its olanzapine orally disintegrating tablets were listed in the third batch of centralized procurement at RMB 6.3 per tablet. The recent approval of its olanzapine oral fast-dissolving film marks another blockbuster product in its strategic layout for the central nervous system (CNS) therapeutic area.

The approval of Qilu’s olanzapine orally disintegrating film formulation was based on a bioequivalence study comparing this product with the reference listed drug, olanzapine orally disintegrating tablets (Zyprexa, 5 mg; manufactured by Catalent UK Swindon Zydis Ltd.), administered orally under fasting and fed conditions in healthy adult subjects (Clinical Trial Registration Number: CTR20190536).

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Oral Fast-Dissolving Films (OFDF) are a novel drug delivery system in which a specific dose of the active ingredients of chemical drugs or traditional Chinese medicine extracts is immobilized on thin films made from modified starch and colloids. Resembling postage stamps in size, shape, and thickness, OFDFs offer advantages such as small volume, light weight, ease of administration, and avoidance of the first-pass effect, making them particularly suitable for children, the elderly, and patients with dysphagia.