Shanghai Tianci International Pharmaceuticals Co., Ltd. and Beijing Yadong Biopharmaceutical Co., Ltd. signed the cooperation agreement on Marketing Authorization Holder (MAH) of 198 drugs today. A large number of drugs with bright market prospects and high technological level will be produced in Zhangjiang.

MAH System Reform Helps Shanghai Medical Research Enjoy Leapfrog Development in Transformation More than 200 Drugs Will Be Produced in Zhangjiang

News from Chinanews Shanghai on April 20 (Reporter Chen Jing) On April 20, Shanghai Tianci International Pharmaceuticals Co., Ltd. (hereinafter referred to as Tianci International) and Beijing Yadong Biopharmaceutical Co., Ltd. signed the cooperation agreement on Marketing Authorization Holder (MAH) of 198 drugs, including 36 exclusive varieties in China. A large number of drugs with bright market prospects and high technological level will be produced in Zhangjiang, which has enabled Shanghai medicine, having achieved fruitful results in biomedical research for many years but transformed few achievements, to take a big step forward in the process of industrial transformation.

It is known that for a long time, Shanghai has been the "front-runner" of China's pharmaceutical industry. Although it has strong scientific research capacity, it is difficult to transform its achievements. Shanghai has high land cost and scarce resources. For R&D institutions, it is almost impossible to realize industrialized production of new pharmaceutical technologies locally in Shanghai, so technological achievements in Shanghai pharmaceutical industry seriously outflow.

Shanghai has been selected as the pilot area for the reform of drug licensing holder (MAH) system. It is reported that the drug Marketing Authorization Holder (MAH) system is an important measure for the deep reform of national drug laws and regulations, which has changed the binding mode between drug approval number and manufacturing enterprises. As one of the pilot provinces and municipalities of the first batch of drug Marketing Authorization Holder (MAH) system in China, Shanghai will break the bottleneck of the original development and achieve new breakthroughs in the pharmaceutical industry.

Li Hanpu, Chairman of Tianci International Pharmaceuticals Co., Ltd., said, “Its most significant advantage is that not only drug manufacturers, but also R&D institutions and researchers can become the holders of drug marketing authorizations. This means that when the R&D side develops a new drug, it is no longer necessary to struggle for the establishment of a factory, as the appropriate pharmaceutical enterprises can be directly entrusted for production, which saves a lot of money and social resources. At the same time, it greatly encourages drug R & D personnel, enhances their passion for new drug R & D, and addresses the "last mile" from drug R &D to the transformation of achievements.”

Chi Wangzhou, the deputy general manager of Shanghai Tianci International Pharmaceuticals Co., Ltd., said that the innovative industry model created by Tianci International will integrate the research and development, production and sales of biomedicine into a whole industry chain platform, and create a "flexible, open and giving" sharing platform. This innovative model based on MAH system aims to share production capacity and solve the last mile problem of achievement transformation.

As far as Shanghai is concerned, under the cooperation agreement on Marketing Authorization Holder (MAH) of 198 drugs, the pharmaceutical industry has achieved a large number of technological achievements, which has changed the situation of outflow of pharmaceutical research achievements in Shanghai to a certain extent. In terms of the partners, the MAH system has also brought them benefits. Fu Jianjia, general manager of Beijing Yadong Biopharmaceutical Co., Ltd., said that the cooperation under the MAH system has also eased the pressure of production in their transition process.

Zhangjiang is the innovation highland of China's biomedicine industry. It has gathered high-level technology, projects and talents in the field of medicine all over the world. At present, the proportion of Zhangjiang biomedical industry in Shanghai is nearly 1/3. In 2017, the output value of Zhangjiang biomedical industry reached 63.3 billion yuan.

Zhang Ling, the deputy director of Administrative Committee of Zhangjiang Hi-Tech Park, said that at present, 11 enterprises and 16 varieties have participated in the pilot project. The pilot enterprises in Zhangjiang account for 69% of the city and 92% of the New District; and the pilot varieties account for 64% of the city and 84% of the New District. Today, 198 drugs of Tianci International Pharmaceuticals will be produced in Zhangjiang through MAH system, which has also promoted and deepened the pilot, promotion and deepening of the MAH system in Shanghai's pharmaceutical industry.

It is found that Tianci International's Base for Transformation of Tianci International Biomedical Achievements in Zhangjiang Hi-Tech Park will soon be completed and put into operation. The 198 products signed will become the first production varieties of the base, which will also become an important milestone in its development process.