Qilu Pharmaceutical's 'Drug Transformation': From Pills to 'Stamps'—China's First Risperidone Orally Disintegrating Film Approved for Mental Disorders!

Have you ever heard of "oral postage stamps"?

This is an innovative drug dosage form, typically made by dissolving or dispersing the medication in a film-forming material to create a thin film preparation with a thickness ranging from 12 to 100 micrometers. Its shape, size, and thickness are similar to a postage stamp, featuring a "melts-in-the-mouth" characteristic. The pharmaceutical industry refers to this type of thin film preparation as an orally disintegrating film, which is used in the treatment of various diseases.

Recently, a new orally dissolving film drug has been approved in the field of mental illness treatment: Risperidone Orally Dissolving Film from Qilu Pharmaceutical Co., Ltd. received approval from the National Medical Products Administration (NMPA) for the treatment of schizophrenia.

Public information shows that risperidone is a second-generation antipsychotic drug (atypical antipsychotic drug), which regulates the balance of central neurotransmitters by antagonizing dopamine D2 receptors and 5-HT2A receptors. It is commonly used for manic episodes in bipolar disorder and can effectively improve positive symptoms (such as hallucinations and delusions) and negative symptoms (such as emotional apathy and social withdrawal) in patients with schizophrenia.

It is worth mentioning that this new drug from Qilu Pharmaceutical is the first approved risperidone orally dissolving film formulation in China, effectively filling the gap in the niche market for such formulations. It also serves as a microcosm of Qilu Pharmaceutical's accelerated market expansion in recent years.

Multiple Products Launched, Aiming at the Billion-Dollar Neurological System Drug Market

Qilu Pharmaceutical is no stranger to the development of risperidone.

Before the orally dissolving film formulation, the company had already received approvals for products such as risperidone tablets and orally disintegrating risperidone tablets. Among these, the orally disintegrating risperidone tablets were the first in China to pass the quality evaluation and are currently performing well in the market. According to the [Pharmaceutical Full-Terminal Sales Analysis System] by Yaozhi Data, sales of risperidone in the Chinese market reached nearly 700 million yuan in 2024. Of this, the orally disintegrating tablets developed by Qilu Pharmaceutical Co., Ltd. accounted for the largest share, reaching 27%.

Zooming out, Qilu Pharmaceutical has not only focused on the Risperidone variety for mental illnesses. Also, in July this year, among the drug approval information released by the National Medical Products Administration, there was Qilu Pharmaceutical's Olanzapine for Injection, which can also be used to treat schizophrenia.

In addition to injectable olanzapine, Qilu Pharmaceutical also offers various formulations of olanzapine products, including olanzapine tablets, orally disintegrating olanzapine tablets, and olanzapine oral soluble films. Data from Menet shows that Qilu Pharmaceutical ranked as the TOP2 company in the olanzapine market in Q1 2025, with its market share surpassing 20% for the first time.

It is not difficult to see that Qilu Pharmaceutical is keen to focus on specific varieties and pursue a comprehensive layout by enriching drug dosage forms and other means. This is clearly aimed at capturing a demand-prominent and large-scale track.

According to WHO data, 1 billion people worldwide suffer from mental disorders, including approximately 60 million with bipolar disorder and about 23 million with schizophrenia. Incomplete statistics indicate that the number of schizophrenia patients in China exceeds 6.4 million, and the number of bipolar disorder patients reaches 1.1 million, jointly supporting a central nervous system drug market with sales exceeding 100 billion yuan.

Based on this, one of Qilu Pharmaceutical's strategies for gaining market share is to cover diverse needs through multiple varieties and dosage forms. Even if a single product does not have an absolute competitive advantage, moving forward in all categories should still open up significant market space.

As for the recently approved risperidone oral soluble film, this single product actually holds significant application value, potentially helping Qilu Pharmaceutical establish a strong foothold in the field of psychiatric disorders and continue to enhance its market competitiveness.

Why Was Qilu Pharmaceutical's Risperidone Oral Soluble Film Approved?

In fact, compared with other dosage forms, orally dissolving films may be more suitable for the treatment needs of mental illnesses, mainly because they address...Poor patient complianceMarket Pain Points。

It is understood that patients with mental illnesses have long faced medication challenges, specifically manifesting as resistance to taking medication (e.g., hiding or spitting out pills), swallowing difficulties, and challenges in dose control. The core advantage of orally dissolving films lies in their ability to address the issue of poor patient compliance to a certain extent.

As mentioned earlier, oral soluble films, as a thin film formulation, are more convenient to take compared to traditional formulations. They can quickly disperse and dissolve without water, and they take effect rapidly. At the same time, they have the advantages of compact appearance, portability, and accurate dosing. Therefore, the market has a positive outlook on the application prospects of oral soluble films.

According to research statistics from Baijian Strategy (DIResearch), the global oral soluble film market sales reached 2.74 billion yuan in 2023, and it is expected to reach 5.48 billion yuan by 2030, with a compound annual growth rate (CAGR) of 10.41% from 2023 to 2030.

Qilu Pharmaceutical has taken the lead in filling the gap in China's risperidone market with the missing orally dissolving film formulation, gaining at least a first-mover advantage in the commercial aspect.

Moreover, in both the risperidone and orally dissolving film fields, the company already has accumulated technical and sales experience at the product level. It is expected that Qilu Pharmaceutical has high commercial expectations for its new drug.

It is reported that Qilu Pharmaceutical has been laying out the development of orally dissolving film formulations since 2013, with its research and production levels both at the forefront in China.InRisperidone Oral Soluble FilmPreviously, Qilu Pharmaceutical had five orally disintegrating films approved for marketing: Aripiprazole Orally Disintegrating Film, Olanzapine Orally Disintegrating Film, Memantine Orally Disintegrating Film, Montelukast Sodium Orally Disintegrating Film, and Tadalafil Orally Disintegrating Film.

Overall, the product has broad application prospects, and Qilu Pharmaceutical Co., Ltd. has also accumulated rich experience.Risperidone Oral Soluble Film This New DrugPositive factors for approval.

In addition, there is also the issue of a time node.

Public information shows that risperidone oral soluble film was approved for marketing in Germany on June 7, 2020, and is held by Hexal Aktiengesellschaft. Consequently, Qilu Pharmaceutical's risperidone oral soluble film did not meet the definition of a Category 2 drug in China (i.e., an innovative modified new drug that has not been marketed both domestically and overseas), which extended the timeline for the new drug application, acceptance, and approval process (according to the review timeline, this project exceeded the conventional time limit for market application approval (median of 18 months), taking nearly three years).

In recent years, with the withdrawal of the 5.1 class Riluzole Oral Film application jointly filed by Haisco and Aquestive, and the rejection of Lipharma's 2.2 class Donepezil Hydrochloride Orally Disintegrating Film, the industry once believed that it would be very difficult for orally disintegrating film products under development, especially modified drugs, to gain marketing approval.

But eventually, the silence was broken.

According to the latest public information, Hexal Aktiengesellschaft voluntarily withdrew multiple batches of drugs between the end of 2024 and July 2025, including Levetiracetam Tablets, Irbesartan Hydrochlorothiazide Tablets, Rivaroxaban Tablets, etc. Risperidone Orally Disintegrating Film was also among the products withdrawn from the market in this round.

Perhaps it is also based on this that Qilu Pharmaceutical's Risperidone Oral Soluble Film has gained an opportunity to enter the market. After the product's launch, more pharmaceutical companies are expected to recognize the market gap and accelerate the development of similar drugs. Driven by competition, Qilu Pharmaceutical’s product portfolio may become even more diverse.

Conclusion

From the launch of Risperidone Oral Soluble Film, one can see a methodology behind Qilu Pharmaceutical's market expansion: finding its own differentiated advantages within a diversified product portfolio, focusing on product commercialization synergy, and covering a broader range of market demands.

Of course, such a "casting a wide net" model is not very suitable for small and medium-sized pharmaceutical companies. Industry leaders occupy a volume advantage, have ample resources, and are accordingly more willing to take risks.

It is reported that in recent years, Qilu Pharmaceutical has continued to maintain high-intensity R&D investment. In 2023, the R&D expenditure was 4.43 billion yuan, a year-on-year increase of 13.9%, accounting for 11.4% of the annual sales revenue. In 2024, the R&D investment was 4.38 billion yuan, accounting for about 11% of sales revenue. Based on such R&D intensity, the company currently has more than 300 products and over 400 specifications on the market, covering diseases in the fields of oncology, cardiovascular and cerebrovascular, anti-infection, psychiatric system, and nervous system.

In addition, according to the data from Pharma Intelligence, from 2017 to the first half of 2025, Qilu Pharmaceutical Co., Ltd. has passed or is deemed to have passed the consistency evaluation for a total of 206 varieties (deduplicated by drug + group + registration type + year), ranking first in the industry.

As new drugs continue to be launched, the pace of Qilu Pharmaceutical's progress is expected to accelerate even further.

Source: Medical Research Society

       Title: Qilu Pharmaceutical's "Drug Transformation": From Tablets to "Stamps," Mental Illness Treatment Welcomes "First Approval"!