Beijing News (Reporter Wang Kala) On November 4, the Insight database of Dingxiangyuan showed that Qilu Pharmaceutical Co., Ltd. announced the submission of a new improved drug, Risperidone Oral Soluble Film, for market approval to treat schizophrenia or bipolar disorder, etc. In terms of improved new drugs, Qilu Pharmaceutical, which mainly focuses on oral soluble films, has already brought five oral soluble film products to the market.
According to the official website of Qilu Pharmaceutical, the company initiated the development of Risperidone Oral Soluble Film in 2013, marking the first step in the research and development of oral soluble film drugs. In terms of product layout for oral soluble films, Qilu Pharmaceutical prioritizes drugs with clear clinical advantages, such as psychiatric medications, pediatric drugs, and treatments for erectile dysfunction, aiming to create a differentiated pipeline of oral soluble film products. For these types of drugs, oral soluble film formulations often demonstrate better patient compliance. However, drugs with unpleasant taste, particularly high dosage, or unique absorption and metabolism characteristics are not suitable for development into oral soluble film formulations.
According to Frost & Sullivan data, the overall growth of China's modified new drug market has been relatively fast, increasing from a market size of 261.4 billion yuan in 2016 to 389.7 billion yuan in 2021, and it is expected to exceed the 400 billion yuan mark in 2022. Compared with innovative drugs that have entirely new targets and structures, modified new drugs, which are based on known active ingredients,Clinical DevelopmentCycleGreatlyShorten,Has become one of the hot directions in current new drug research and development.Oral dissolving films are one of the细分 categories, with a relatively favorable competitive landscape, especially offering significant advantages in terms of improved compliance. However, there are numerous challenges in the development process of oral dissolving film formulations, such as optimizing taste-masking methods, selecting film-forming materials and packaging materials, and choosing scalable production equipment and industrialization processes.
Qilu Pharmaceutical stated that the biggest challenge in the development of oral soluble film products lies in scaled-up production. Due to differences in production equipment and process parameters, the small-scale trial processes developed in laboratories often cannot be directly linearly scaled up. The research and development team consulted a large number of relevant domestic and international references, innovated through exploration, and successfully identified the rules for process transformation between different scales of products. They established a stable and controllable scaled-up production process, achieving steady production of commercial products across multiple varieties. Qilu Pharmaceutical has built China's largest capacity, most highly automated commercial production line for oral soluble films.
In 2021 and 2022, Qilu Pharmaceutical entered the harvest period for its orally dissolving film products. Among the multiple orally dissolving film products submitted for approval, Aripiprazole Orally Dissolving Film, Olanzapine Orally Dissolving Film, Memantine Hydrochloride Orally Dissolving Film, Montelukast Sodium Orally Dissolving Film, and Tadalafil Orally Dissolving Film were approved for marketing. Risperidone Orally Dissolving Film was recently submitted for market approval. According to the Dingxiangyuan Insight database, Qilu Pharmaceutical's Escitalopram Oxalate Orally Dissolving Film has been approved for clinical trials, while Oseltamivir Orally Dissolving Film is still in the clinical application stage. Currently, in the niche field of orally dissolving films, there are only 25 Class 2 modified new drugs of orally dissolving films in China, and Qilu Pharmaceutical alone boasts 8 projects, clearly taking the leading position.
Apart from Qilu Pharmaceutical, Zhejiang Heze Pharmaceutical, Sichuan Baili Pharmaceutical, and Lipharma each have three orally dissolving film products. Hengrui Medicine, Hansoh Pharmaceutical, Kelun Pharmaceuticals, and Shanghai Pharmaceuticals, among others, are also actively involved in this field.
As a well-established pharmaceutical company, Qilu Pharmaceutical's strength in the generic drug field is undeniable. The number of its products that have passed the consistency evaluation ranks among the top, and it has also drawn significant attention in multiple rounds of bulk procurement, especially in the seventh national bulk procurement where Qilu Pharmaceutical had the highest number of selected products. In terms of innovative drugs, Qilu Pharmaceutical has made numerous strategic moves. Its self-developed innovative drug, Irukaclue tablets, is a novel ALK/ROS1 inhibitor. It can inhibit the activity of ALK kinase in wild-type and different fusion types, as well as the resistance mutations of ALK (anaplastic lymphoma kinase) inhibitors, while effectively suppressing the activity of ROS1 kinase in different fusion types. Qilu Pharmaceutical submitted the marketing registration application for this drug in July of last year, and the industry expects the drug to be approved in the second half of this year. Once approved, Irukaclue tablets will become Qilu Pharmaceutical's first Class 1 new drug.
In addition, the Insight database of Dingxiangyuan shows that Qilu Pharmaceutical has five innovative biologics currently in Phase III clinical trials, including two monoclonal antibodies, two fusion proteins, and one monoclonal antibody combination product. Among them, four are anti-cancer drugs, and one is for chemotherapy-induced thrombocytopenia. According to the official website of Qilu Pharmaceutical, within the next few years, over ten drugs will enter Phase II/III clinical trials in the field of cutting-edge innovative drug research worldwide. In particular, several blockbuster drugs and biopharmaceutical projects are expected to be launched.
Proofread by Baoqing Liu