Complex Formulation
Complex Formulation
The group has clarified the two-pronged approach of independent research and development and BD introduction, fully promoting the dual-wheel drive strategy of innovative drugs and complex preparations with high barriers, and continuously building an innovative high-barrier complex preparation research and development technology platform represented by the ante inhalation preparation nanocrystals. The existing inhalation preparation platform has become the enterprise with the most complete dosage forms, the most pipelines, and the widest layout in China.
Inhalation formulation platform
Inhalation formulations are defined by the FDA as complex formulations with high barriers to research and approval. The technical barriers for inhalation formulations are extremely high, and the market has been dominated by only a few pharmaceutical companies for many years, with a huge addressable market space. Many inhalation formulations are listed in China's "Encouraged Generic Drug List", including drugs that are considered to be in short supply in China.
Since 2013, we have been focusing on inhalation formulations and are one of the leading Chinese companies in the field of inhalation formulations. This is evidenced by the monetization of our comprehensive inhalation product portfolio and representative product, Shutanlin ®. Shutanlin ® the first inhalation product in China approved under the new registration classification issued by the National Medical Products Administration. As of 2023, the company has launched 8 varieties and 12 product specifications, among which the small size of budesonide for inhalation is exclusively produced domestically by the company. Our research and development drugs cover all forms of inhalation formulations, with a total of 82 related patents in the field of inhalation formulations, of which 54 are authorized valid patents. We have international leading research and development capabilities, a comprehensive dosage form, integrated medicine and equipment, and a high-capacity industrial chain layout, and the ability to solve the problem of low accessibility for Chinese patients. Based on the inhalation preparation platform, we seek to further expand the unmet clinical needs of inhalation preparations in the treatment of respiratory system diseases, and develop drugs for the treatment of idiopathic pulmonary fibrosis, infections and other lung diseases. Specifically, we have rich research and development experience in inhalation preparations such as inhalation powders, inhalation solutions, and inhalation aerosols.
Microsphere platform
Sustained-release microsphere injections are currently an important direction for innovative research and development of international sustained-release formulations, with broad market space. Sustained-release microspheres can continuously release encapsulated drugs in the patient's blood for several weeks to months. Its advantages include: (i) reducing the number of doses and improving patient compliance, (ii) improving bioavailability and stability by providing long-term or controlled drug delivery, and (iii) being able to target drugs to specific sites. The production technology of microsphere injections is relatively difficult, and due to the difficulty in controlling parameters such as encapsulation rate, particle size, and uniformity of microspheres, it has become the biggest barrier to monetization production. We are one of the earliest companies in China to achieve monetization of sustained-release microsphere injection products. As of June 30, 2022, we are one of the three Chinese companies that have developed and monetized sustained-release microsphere injection products. Our long-lasting microsphere technology platform comprehensively masters the microsphere research and mass production technology system, is a national research center, and has built a rich pipeline around sustained-release microsphere injection.
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