Qilu Pharmaceutical's Class 2.2 New Drug Montelukast Sodium Oral Film Receives First-in-China Approval

On March 11, the official website of the National Medical Products Administration (NMPA) announced that Qilu Pharmaceutical’s Class 2.2 new drug application for “Montelukast Sodium Orally Disintegrating Films” had been approved for market launch, marking the first approval of this dosage form in China.

Montelukast sodium, a potent and selective leukotriene receptor antagonist developed by Merck & Co. (brand name: Singulair), specifically inhibits cysteinyl leukotriene receptors in the airways, thereby improving airway inflammation and effectively controlling asthma symptoms.

According to the Insight database, three dosage forms of the originator drug have currently been approved in China, including conventional tablets, chewable tablets, and granules, with generic versions approved for all three. All three dosage forms were included in the national centralized volume-based procurement (VBP) program; notably, Qilu Pharmaceutical’s Montelukast Sodium Chewable Tablets were successfully selected in the third round of VBP. The Montelukast Sodium Oral Dissolving Film recently approved for Qilu is the first of its kind in China, holding promise for expanding into new markets beyond the VBP framework.

Oral Fast-Dissolving Films are a novel type of oral dosage form. These film-like preparations are manufactured by processing active pharmaceutical ingredients with suitable film-forming materials. Upon placement in the mouth, they adhere to the administration site, are difficult to expel, and rapidly disperse, thereby reducing patient non-compliance with medication. For drugs intended for systemic effects, the active substances can be directly absorbed through the oral mucosa, avoiding the first-pass effect. They are particularly suitable for pediatric and geriatric patients.

Public data shows that the sales revenue of montelukast in domestic public medical institutions approached 3 billion yuan in 2019. With the launch of the new dosage form, orally disintegrating film, it is expected to open up new markets by providing patients with a novel and convenient method of medication administration.

According to the Insight database, Qilu Pharmaceutical currently has multiple orally disintegrating film products in development. Its olanzapine orally disintegrating film was approved in January this year. In addition, tadalafil, aripiprazole, and memantine hydrochloride orally disintegrating films have been submitted for marketing approval. The montelukast sodium orally disintegrating film approved this time is the second orally disintegrating film product approved for Qilu Pharmaceutical.

Given the intense competition among generic drugs in China, exploring improved new drugs that are better suited for patients may be a viable option.