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The integration and development of private enterprises and taiwan-funded enterprises in suzhou achieved fruitful results


Recently, the state food and drug administration (CFDA) officially approved two suzhou enterprises - Taiwan enterprise TOT BIOPHARM and private enterprise suzhou pioneer pharmaceutical co., LTD. For a chemical 1.1 new drug MAH registration application. This marks the official landing of MAH system in jiangsu province, TOT BIOPHARM and the development of pharmaceutical cooperation in the new drug became the first MAH pilot variety in jiangsu province, and also became a successful case of the integration and development of suzhou private enterprises and Taiwan enterprises.  

The MAH system refers to the management mode that separates the marketing license from the production license. Under this mechanism, the production and research and development of drugs will no longer be tied together, and repeated investment and construction will be avoided through professional division of labor, thus saving the cost of drug development and accelerating the speed of drug innovation.  

Suzhou pioneer pharmaceutical co., LTD., founded in 2009, is a high-tech innovative enterprise committed to the early development of anti-cancer drugs. Since its establishment, the company has been funded by the national 12th five-year plan "major new drug innovation and innovation", the innovation fund for small and medium-sized enterprises of the Ministry of Science and Technology, the science and technology support plan of jiangsu province (social development), the science and technology plan of suzhou city and the special project for leading talents in innovation and entrepreneurship of gusu. It was successfully launched on the new three board last September.  

TOT BIOPHARM is a high-tech enterprise specializing in the development, production and marketing of anti-tumor new drugs. The company's products involve monoclonal antibodies and antibody-conjugated drugs, oncolytic virus products and special dosage forms of anticancer drugs. The company invested in the construction of the second phase of anti-antibody drug production base last year, which will become one of the largest industrialization bases in the domestic biopharmaceutical industry.  

Based on the strong r&d and industrialization strength of TOT BIOPHARM, in November last year, the two enterprises signed an agreement to develop a chemical 1.1 new drug product research, development and production commissioned by TOT BIOPHARM, and actively explore and practice the MAH system pilot work. The approval of MAH registration application of the two enterprises will not only push the enterprises to make further progress towards innovative achievements, but also play a good demonstration role for the biomedical industry in jiangsu province and promote the implementation of MAH pilot work in jiangsu province.