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Pharma Network January 19 - Recently, Yantai University Molecular Pharmacology and Drug Evaluation Ministry of Education key laboratory research team presided over the development of innovative micro-ball preparation - Risinto ® (injection of lipe ketone micro-ball (II.) was approved by the State Drug Administration for listing.
the drug is used to treat acute and chronic schizophrenia and other types of psychotic conditions with obvious positive and obvious negative symptoms, can alleviate the emotional symptoms associated with schizophrenia.
xinto® for injection with slow-release micro-ball preparation, is China's first independent research and development, global registration, with independent intellectual property rights of innovative micro-ball preparations.
It is understood that the research and development of new high-end preparations is regarded by many industry experts as the only way and frontier for the innovation and development of China's pharmaceutical industry, which is determined by the clinical advantages of high-end preparations, the value of pharmaceutical economics and the national drug safety strategy.
high-end complex preparations, such as liposomes, microspheres, etc., often have obvious clinical advantages, such as better effectiveness and safety, to meet unsymuted clinical needs.
the same time, injection micro-ball preparation is a complex preparation, its research and development, production difficulties, high technical barriers, the technology was previously mainly mastered by several foreign enterprises.
The Guidelines for the Development of the Pharmaceutical Industry, jointly issued by the Ministry of Industry and Information Technology, the National Development and Reform Commission, the Ministry of Science and Technology, the Ministry of Commerce, the National Health and Family Planning Commission and the former State Food and Drug Administration in 2016, clearly focus on the development of high-end formulations, including micro-balls, and the development of high-end preparation industrialization technologies.
Based on Yantai University and Green leaf pharmaceutical "production, research and development" cooperation integrated platform, Yantai University pharmacy teachers as the core backbone of the research and development team after years of efforts, one after another to break through the technical barriers of new high-end preparations, to create the world's leading new long-acting preparation technology platform, around the needs of patients, in the field of cancer, central nervous system and other major diseases have been deeply laid out.
Rehinto® research and development work by Yantai University Molecular Pharmacology and Drug Evaluation Ministry of Education key laboratory Professor Sun Kaoxiang in the green leaf pharmaceutical overall chair, Liu Wanhui, Professor Tian Jingwei and other key members to complete the project's research and development.
According to Wang Hongbo, dean of Yantai University's School of Pharmacy, the results of the project are also the result of synergetic innovations led by Yantai University, in collaboration with six organizations, including Greenleaf Pharmaceutical Group, Shanghai Pharmaceutical Research Institute of the Chinese Academy of Sciences, Institute of Pharmacy of the Chinese Academy of Medical Sciences, and China Pharmaceutical University.
is a chronic and serious mental disorder that affects more than 20 million people worldwide and is a mental illness that our country focuses on.
This approved listing of Risinto® every two weeks intramuscular injection, has a clear clinical advantage, can avoid the risk of oral administration of drugs missed or overdose, can significantly improve oral antipsychotic drugs in patients with schizophrenia prevalence of drug compliance.
Because of its obvious therapeutic advantages, ® was included in the priority review process by the Drug Review Center of the State Drug Administration in December 2019, enabling patients with schizophrenia in China to benefit from this new treatment program at an early time.
in order to benefit more patients around the world as quickly as possible, Risinto ®'s global registration filing process is also being carried out simultaneously, and is now in the application phase for new drugs in the United States and conducting key clinical studies in Europe.
patents for this product have been granted in China, the United States, Europe, Japan, Korea, Russia, Canada and Australia until 2032.
(Reporter Zhao Qiuli Fengfan, correspondent Yan Jiansheng Wang Aiping)