Qilu Pharma's Tadalafil Oral Soluble Film Set to Become China's First Approved Product of Its Kind

On January 24, according to the NMPA website, Qilu Pharmaceutical's Class 2.2 modified new drug, Tadalafil Oral Soluble Film, has entered the administrative approval stage and is expected to be approved for marketing in the near future, becoming the first of its kind in China.

Source: NMPA Official Website

Tadalafil Tablets are used to treat erectile dysfunction (ED) and the symptoms and signs of benign prostatic hyperplasia (BPH) in combination. The drug was initially developed and marketed by LillyICOS (a joint venture between Eli Lilly and ICOS) and United Therapeutics. It is an orally active phosphodiesterase 5 (PDE5) inhibitor.

According to the Insight database, there are currently four types of tadalafil formulations in China, including regular tablets, chewable tablets, suspensions, and oral soluble films. Apart from regular tablets, no other formulations have been approved yet. However, the oral soluble film is the most mainstream modified new drug formulation under development, with four companies in China already developing it. Qilu Pharmaceutical was the first to file for marketing approval in March 2020, while Hengrui filed a year and a half later. Baili Pharmaceutical and Lipharma are also in clinical development. Among similar drugs, Kelun Pharmaceuticals has also developed an oral soluble film for sildenafil and submitted a marketing application.

Development Status of Tadalafil Oral Soluble Film in China

From Insight database (http://db.dxy.cn/v5/home/)

Oral Fast-Dissolving Film is a new type of oral preparation, made by processing drugs with suitable film-forming materials into a film-like formulation. Once placed in the mouth, it adheres to the administration site, is not easily expelled, and disperses quickly, reducing instances of patient non-compliance with medication. For drugs with systemic effects, the active substance can be directly absorbed through the oral mucosa, avoiding the first-pass effect.

In the context of fierce competition among generic drugs in China and the combination of centralized procurement, exploring modified new drugs that are more suitable for patients might be a good choice. According to the Insight database, Qilu Pharmaceutical's modified chemical new drugs focus on the oral soluble film field, with a predominance of neurological drugs, for which patients particularly need a more compliant method of administration.

Currently, Qilu Pharmaceutical has 8 orally dissolving film products in clinical development. Among them, the Olanzapine Orally Dissolving Film and Montelukast Sodium Orally Dissolving Film were successively approved in the first quarter of 2021. The Tadalafil Orally Dissolving Film is also about to be approved, while the Aripiprazole Orally Dissolving Film and Memantine Hydrochloride Orally Dissolving Film have already been submitted for market approval. Public information shows that the company owns a self-built production workshop for orally dissolving film drugs, with competitive production capacity in China.

While laying out orally dissolving film formulations, Qilu also conducted multi-formulation development on some ingredients. For example, Olanzapine was simultaneously approved for tablet, orally disintegrating tablet, and orally dissolving film; Montelukast was developed into chewable tablets and orally dissolving film; Tadalafil was also concurrently developed into tablet and orally dissolving film.

Looking at the new innovative drug applications over the past five years, Qilu Pharmaceutical's innovative drugs have also entered a period of rapid growth, with 10 new drug projects filed in 2021 alone.

Trend of New Drug Clinical Applications by Qilu Pharmaceutical in the Past Five Years

Qilu Pharmaceutical's First Clinical New Drug Project Application in 2021

From Insight Database (http://db.dxy.cn/v5/home/)