The production approval of the new drug xidaban

Sidabamide, a new class 1.1 drug of Shenzhen microcellular organism, has completed the on-site inspection, and its processing status was changed to "approved pending certification" on December 24, 2014, and it will be approved for market soon Sidabamide is the first drug to treat recurrent or refractory peripheral T-cell lymphoma (PTCL) in China PTCL is a rare and rapidly growing non-Hodgkin's lymphoma There are only three drugs to treat this disease in the world: folotyn of allos therapeuties (listed in the United States in 2009), istodax of new base medicine (listed in the United States in 2011) and bereodaq of spectrum pharmaceuticals (FDA in July 2014) Accelerated approval) At the same time, xidaban is the first drug approved for marketing in phase II clinical trials in China The results of phase II clinical trials of the drug showed that the objective remission rate of single drug treatment was 28%, which reached the predetermined target proposed by CDE The target was 26.5% and istodax 25% according to the objective remission rate of folotyn approved by FDA The domestic market is not able to meet the ambition of Shenzhen micro core As early as the early stage of development, Shenzhen micro core transferred the international market development right of xidaban to Huya biotechnology company of the United States with us $28 million, and is currently conducting phase I clinical trials in the United States About micro core bio micro core bio is a leading bio tech enterprise founded by a senior team of returning to the United States, specializing in the research and development of original small molecule drugs The original team and the local team have high scientific attainments in the biomedical research field, practical experience in innovative drug R & D and management, successful experience in establishing and managing enterprises in Europe and America, familiar with global drug management technology regulations and patent strategies, and familiar with the Chinese drug market The core technology to support the sustainable development of the company is the integrated drug innovation and early evaluation technology system based on chemical genomics that we independently build The platform system effectively integrates a number of modern technologies, including computer-aided drug design, drug and combinatorial chemistry, high-throughput and high-content drug screening, chemical genomics gene expression profile research, bioinformatics and chemical informatics data mining, which can effectively accelerate the research and development process of small molecule innovative drugs and reduce the risk of new drug development It is the development of clinical differences The important technology of chemical new drugs is also an important guarantee to support the future sustainable development of microchip biology According to the law of international new drug research and development and the current situation of China's pharmaceutical market, microchip biology has explored a way for the development of enterprises that can not only retain the rights and interests of Chinese products, but also implement patent authorization for international pharmaceutical companies, establish international clinical joint development and realize profits; at the same time, establish a business model of high-level cooperative research with multinational pharmaceutical enterprises Through this development strategy, the research and development of new drugs by micro core biology can not only be listed and sold in China as soon as possible, but also achieve the goal of China's original drugs entering the global market sales in the future through the mode of international clinical joint development This innovative development mode - realizing profits and development through patent authorization, cooperative research and final marketing of products - has changed the substantive defect of the lack of original drugs in Chinese local pharmaceutical enterprises, and created a precedent from "Chinese imitation" to "Chinese creation" Since its establishment, micro core biology has made breakthroughs in new drug research and development, intellectual property rights, business development and other aspects around the establishment of enterprise development strategy with patents and innovative drugs as the core competitiveness It has achieved the first in many industries and made positive contributions to China's innovative drug industry As a combination of independent innovation and cutting-edge platform technology, China's innovative drug company has attracted the attention of the industry and media since its establishment, and has been reported by many magazines and media including business week, time, natural biotechnology and so on He has been invited to make keynote speeches on new drug research and development at major conferences of international biomedical industry, laying a foundation for the influence of enterprises in domestic and international pharmaceutical fields Micro core biology has a complete ability from drug action target research to clinical candidate drug development and industrialization, and has successfully cultivated a rare technology and management team specialized in new chemical structure innovative drug development in China, which has become the guarantee for us to develop independent intellectual property rights as the core, for major diseases, with global patent protection and unique clinical effect Special innovative small molecule chemical drugs and core advantages of enterprise growth Micro core biology has been recognized by Shenzhen municipal government as the leading enterprise in independent innovation industry, intellectual property advantage enterprise and Shenzhen chemical innovation drug engineering technology center.