Qilu Pharma's Risperidone Oral Soluble Film Breaks Market Deadlock: China’s First 2.2-Class Modified New Drug in a Billion-Dollar Therapeutic Area
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
Recently, the National Medical Products Administration（NMPA）The official website shows,Qilu Pharmaceutical Co., Ltd.Declared as a Class 2.2 modified new drugRisperidone Oral Soluble FilmApproved for marketing. This is the first approved product of its kind in China, and the sixth orally dissolving film drug launched by the company, used to treat bipolar disorder and schizophrenia.
Screenshot source: NMPA official website
Risperidone（Risperidone）A benzisoxazole derivative, it is a second-generation antipsychotic drug.(Atypical Antipsychotic Drugs)By antagonizing dopamine D2 receptors and 5-HT2A receptors, it modulates the balance of central neurotransmitters, effectively improving positive symptoms in patients with schizophrenia.(such as hallucinations, delusions)And negative symptoms(such as emotional apathy, social withdrawal)。
Screenshot source: Mosan Pharma Global Drug R&D Database
RisperidoneThe original research enterprise isJohnson & Johnson（Janssen）The company was initially listed in the EU in 1992 and entered the Chinese market in 1999. According to the Mosun Pharmaceutical Database, the Chinese hospital market in the past three years...RisperidoneSales exceeded 1 billion yuan each, with cumulative sales breaking through 12.1 billion yuan.
Source of Screenshot: Mosun Medicine National Hospital Sales (All-Terminal) Database
In terms of market share,Qilu PharmaceuticalThe highest proportion, reaching 28.53%,Xi'an JanssenFollowing closely with 20.72%. This timeQilu PharmaceuticalLaunch of Improved New Drug Expected to Further Expand Its Presence inRisperidoneMarket share.
Source of Screenshot: Mosun Medicine National Hospital Sales (All-Terminal) Database
And the current market size of antipsychotic drugs in hospitals in China is about 9 billion yuan,Risperidone TabletsAndRisperidone Orally Disintegrating TabletsRanking TOP5 and TOP7 in this market, respectively.
Screenshot source: Mosentropy Medicine National Hospital Sales (All Terminals) Database
The medication dilemma for patients with mental illnesses has long existed. According to data from the World Health Organization in 2022, more than 1 billion people worldwide suffer from mental disorders, including approximately 23 million with schizophrenia, and over 6.4 million patients in China.
Screenshot source: Mosentropy Medical Epidemiology Database
RisperidoneAs one of the largest prescribed drugs for schizophrenia globally, multiple formulations have been approved in China, including oral solution, tablets, orally disintegrating tablets, and injectable microspheres.
Screenshot source: Mosentropy Medicine China Drug Approval Database
Qilu PharmaceuticalInRisperidoneOutstanding performance in the field, currently approvedRisperidone Tablets、Risperidone Orally Disintegrating Tablets、Risperidone Oral Soluble Film3 products, includingRisperidone Oral Soluble FilmForThe First in China to be Approved，Risperidone Orally Disintegrating TabletsForFirst in China to Pass the Review。
Risperidone Oral Soluble FilmAlsoQilu PharmaceuticalThe sixth orally disintegrating film drug to be listed. Previously, the company has successfully launchedAripiprazole Orally Disintegrating Film、Olanzapine Orally Disintegrating Film、Memantine Hydrochloride Oral Soluble Film、Montelukast Sodium Oral Soluble Film、Tadalafil Orally Disintegrating FilmFive products, including [product names], have been launched into the market.
Screenshot source: Mosentropy China Drug Evaluation Database
Notably, last year, there were widespread rumors in the industry that orally dissolving films were difficult to get approved, and modified new drugs were even more hopeless.HaiscoAndAquestiveJointly declared Class 5.1Riluzole Oral FilmWithdrawal of Application,Lipin PharmaceuticalClass 2.2Donepezil Hydrochloride Oral Soluble FilmRejected, these two incidents once made the industry lose confidence.
Since the beginning of this year,Jiangsu HechenAndJiangsu HengruiTheOndansetron Oral Soluble FilmSuccessively replicated,Qilu PharmaceuticalTheRisperidone Oral Soluble FilmIt has also been approved for marketing, breaking the rumor that oral dissolving films are difficult to get approved, and drawing renewed market attention.
ButQiluThisRisperidone Oral Soluble FilmThe approval process was challenging: clinical trial application submitted in 2014, followed by a suspension of the trial and expiration of the approval. In 2022, the project was restarted and a clinical trial application was filed under Category 2.2. An application for marketing authorization was submitted in November of the same year, supplementary materials were submitted in December 2023, and final approval was granted in July 2025. According to the review timeline, the project took nearly three years, far exceeding the typical approval timeframe for a standard marketing application.(Median 18 months)。
Image source: Susan Law Research Society
As an emerging dosage form in China in recent years, oral soluble films have high technical barriers, expensive production equipment, and large initial investments, but their market performance is remarkable: only a few years after their introduction, the existing seven varieties have created a market scale exceeding 300 million yuan, among which...QiluAndHengruiCombined, they account for 99% of the market share, indicating vast room for development. If the transition pathway from oral formulations to orally dissolving films can truly be established, more companies will undoubtedly enter the market in the future. This market is worth our continued attention!
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