▲August 1-2, 2025 China Pharmaceutical Industry Expo ClickFreeReportNameOn July 28, the NMPA issued a drug approval document, and Qilu Pharmaceutical's Risperidone Oral Soluble Film was successfully approved for marketing, becoming the first approved Risperidone Oral Soluble Film formulation in China.Qilu's Risperidone Oral Soluble FilmThe 2.2 class改良型上市 was approved. Since last year, there have been rumors in the industry that oral soluble films could no longer be approved, and改良型 ones were even less likely to be approved.Last year, first the 5.1 class Riluzole Oral Film application submitted by Haisi Science in collaboration with Aquestive was withdrawn, then the 2.2 class Donepezil Hydrochloride Oral Soluble Film by Lipharma was rejected, which once made the industry lose confidence in the future of oral soluble films.But this year, first Jiangsu Hengrui and Jiangsu Chenhe successfully copied Ondansetron Oral Soluble Film, followed by the modification of Qilu Pharmaceutical.The approval of Risperidone Oral Soluble Film has broken the rumors that oral soluble films cannot be approved, and this innovative dosage form seems to have gained popularity again.The controversy surrounding this Risperidone Oral Soluble Film is also significant.The WeChat Official Account "Susan Law Research Society" mentioned that the orally dissolving filmThe product has been launched overseas, and it was listed in Germany on June 7, 2010. The holder is Hexal Aktiengesellschaft.Can overseas listed companies still apply for改良型新药 classification 2.2?The approval process for Qilu Pharmaceutical's risperidone oral soluble film was quite challenging. It was first submitted for clinical trials in 2014, but the trials were later suspended, leading to the expiration of the clinical trial approval. In 2022, it was reactivated and submitted for clinical trials as a Category 2.2 drug, and an application for marketing authorization was submitted in November 2022.Image source: Susan Law Research SocietyQilu Risperidone Oral Soluble Film was submitted for marketing approval under Category 2.2 in November 2022, received a supplementary request in September 2023, submitted the supplementary data in December 2023, and was finally approved in July 2025. According to the review timeline, this project has exceeded the typical marketing application approval period (median of 18 months), taking nearly three years.July 1st,CDE Adds Two Categories of General Technical Issues for Improved New Drugs, Mentioning Whether a Previously Approved but Later Withdrawn Product Can Be Submitted as an Improved New Drug – The Response Says Yes, If There Is Clinical Demand.It happens that, according toThe WeChat Official Account "Susan Law Research Society" stated,The Risperidone Oral Soluble Film that was launched overseas has been withdrawn from the market, which means thatNot long after CDE issued the technical answers,Risperidone Oral Soluble Film Has Been Approved.This also raises another question: Is the approval of risperidone oral soluble film because this product was not the first to be marketed in China? It has been launched in Germany, and has the "clear clinical advantage" required for an improved new drug already been proven?There are concerns in the industry that if this is indeed the case, the path of converting oral dosage forms into orally dissolving films may not have been truly successful in China.Another perspective within the industry speculates that the path cannot be impassable based on Qilu Pharmaceutical's strategic layout.Qilu Pharmaceutical is a pioneer in the oral soluble film formulation in China. Of the seven oral soluble films approved in China, six belong to Qilu Pharmaceutical, all of which were launched as improved new drugs. It is impossible for them to be unaware of the approval mechanism for the market launch of oral soluble films.Meanwhile, Qilu Pharmaceutical launched another improved orodispersible film in July last year.Brexpiprazole Orally Disintegrating Film.
Brexpiprazole, originally developed by Otsuka Pharmaceutical, has only been marketed in tablet form. In China, several companies have already laid out plans for改良口溶膜 (improved orally dissolving film) formulations of brexpiprazole tablets. Nine companies have already submitted applications for marketing approval, including Qilu Pharmaceutical Co., Ltd.If the company hasn't communicated well with CDE, would so many companies submit applications at the same time?Orally dissolving films are a new dosage form that has only emerged in China in recent years. This form has high technical barriers, requires expensive production equipment, and demands significant investment. However, in terms of market growth, this new dosage form has only been around for a few years, with a total of only seven varieties, yet it already holds a market value of over 300 million yuan, indicating considerable potential. Among this, Qilu Pharmaceutical and Hengrui account for 99% of the market.If the path to reformulate oral dosage forms into orally dissolving films is successfully established, the number of companies entering the market is bound to increase in the future.Whether everyone can approve or notRisperidone Oral Soluble FilmThis special case, just lookApproval Status of Brexpiprazole Oral Soluble Film.Reference:Susan Law Research Society Screenshot and Data Source: Mesentech PharmaceuticalsTomorrow, the Suzhou International Expo Center is set to grandly open!
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