Good news: Puli Pharmaceutical's five hundred and five (b) (two) boron neutron innovative drug - inj

12 days ago
9

【 Good news 】 Puli Pharmaceutical's five hundred and five (b) (two) innovative boron neutron drug - boron [tenB] Fallon for injection has been approved for clinical trials in China. 【 Good news 】 Puli Pharmaceutical's five hundred and five (b) (two) innovative boron neutron drug - boron [tenB] Fallon for injection has been approved for clinical trials in China. Recently, Hainan Puli Pharmaceutical Co., Ltd. received the drug clinical trial approval notice for boron [tenB] Fallon for injection issued by the National Medical Products Administration, marking a new milestone in Puli Pharmaceutical's research on BNCT boron neutron innovative drugs. Boron [tenB] Fallon for injection is an innovative five hundred and five (b) (two) drug developed by Hainan Puli Pharmaceutical Co., Ltd., mainly used for boron neutron capture therapy (BNCT). BNCT is a new high-end radiation therapy method and one of the most advanced tumor treatment methods internationally, known as the "fifth therapy" for tumor treatment. Boron [tenB] Fallon (BPA) is a drug used for BNCT and, together with BNCT equipment, forms the entire BNCT treatment system. Boron neutron capture therapy (BNCT) is a radiation therapy that uses secondary particles produced by the nuclear reaction between neutrons and boron elements in tumors to destroy cancer cells. Targeted boron drugs gather around cancer cells and, triggered by neutrons, carry out "targeted blasting" to kill cancer cells at the cellular scale. Compared with other treatment methods, BNCT has high biological lethality, high biological targeting, achieves cell level precision, and has minimal damage to normal cells. Only one-two treatments (less than one hour each time) are needed, which is much lower than other radiation treatments (ten-thirty times) and chemotherapy (four-eight courses, each course lasting twenty-one days). Its high safety, short treatment duration, significant therapeutic effect, and high barriers have attracted countries such as the United States and Japan to accelerate their layout. Previously, China's first accelerator boron neutron capture treatment experimental device of the spallation neutron source of the Institute of High Energy Physics of the Chinese Academy of Sciences was reported by CCTV News as a "thirteenth Five Year Plan" achievement parade project. The injection grade boron [tenB] falen independently developed by Puli Pharmaceutical uses boron ten isotopes with an abundance of ninety-nine% or higher, ensuring the quality and stability of the product from the source. High abundance BPA can also ensure that the boron concentration in tumors reaches the required level for treatment, ensuring efficacy while reducing adverse reactions such as kidney damage and providing higher safety guarantees for patients. Puli Pharmaceutical relies on Anhui Puli API Factory and Hainan Puli Formulation Workshop to have the ability to produce BPA in large quantities, providing solid support for clinical research and subsequent commercialization. In this project, Puli Pharmaceutical and Guoke Neutron Medical Technology Co., Ltd. work together to undertake the research and development of boron drugs and neutron therapy equipment, respectively, and jointly promote the comprehensive implementation and localization process of BNCT, a high-end radiation therapy. In addition, as early as two thousand twenty-one, Puli Pharmaceuticals and the Institute of High Energy Physics of the Chinese Academy of Sciences established Beijing Puli Biomedical Technology Co., Ltd., which focuses on innovative research and development of boron drugs. This clinical study will be conducted based on the BNCT treatment center of Dongguan People's Hospital. Believe in the joint efforts of Puli Pharmaceutical, Guoke Neutron, and Dongguan People's Hospital teams

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