The Development Center for Medical Science and Technology (DCMST) of National Health and Family Planning Commission (NHFPC) distributed the Notice on 2017 Projects to Be Initiated as Major Special Scientific and Technological Projects under Major New Drug Innovation and Manufacturing Program the other day to companies that have obtained support for initiation of projects. BAHEAL Pharmaceutical, a high-end manufacturer of generics in China, of the BAHEAL Pharmaceutical Group, has five generics projects available that have been granted the support for initiation of special projects on the innovation and manufacturing of major new drugs under the 13^th Five-year Plan of the state and has become one of the globalized generics producers in China, which also implies that BAHEAL Pharmaceutical has become a leading player across the industry in terms of the capacity in innovation and manufacturing of high-end generics and that the pharmaceutical accompanies in China are also embracing a new epoch that focuses on technology as a core competitiveness.

China’s Generic Drugs Aligned with the International Market, Drawing Much Attention to Its Innovation, Manufacturing and Preparation of New Drugs

Favorable policies have been formulated by the state one after another in recent years with regard to the R&D and innovation of generic drugs. On January 23, 2018, at the 2^nd meeting of the Central Leading Group for Comprehensively Deepening Reform, the Opinions on the Reform and Improvement of the Supply as well as the Policy for the Use of Generic Drugs was considered and adopted, in which it is expressly stated that efforts will be made to improve the supply as well as the policy for the use of generic drugs, facilitate their R&D and innovation and improve their quality and effectiveness so as to further guarantee the supply of drugs and better meet the demand of the general public for drugs.

With constantly positive dividend of state policies and evolving domestic market environment for generic drugs, pharmaceutical companies in China are also greeting a new round of opportunities to grow with the research and development of technologies as the core competencies. As far as the Chinese pharmaceutical companies are concerned, it typically takes 10 to 12 years for an innovative drug to access the market with an investment of nearly USD 800 million. Most Chinese pharmaceutical companies, due to the lack of such strengths, have been combining generics with innovations, with manufacturing focused on mid- and low-end generics. While on the other hand, a large number of high-end pharmaceutical companies, represented by BAHEAL Pharmaceutical, have gradually found out a development approach with the research and development of high-end technologies at the center and have succeeded in accessing the international arena.

Five of the high-end oral solid preparations as products under international research, namely, Metformin Hydrochloride Sustained Release Tablets, Duloxetine Hydrochloride Enteric Capsule, Glipizide Controlled Release Tablets, Nifedipine Controlled Release Tablets and carbamazepine controlled release tablets, from BAHEAL Pharmaceutical, one of the pharmaceutical companies undertaking major projects of the state during the 13^th Five-year Plan Period, were included. This indicates not only that these products have been incorporated as national strategic varieties, but that the research team has also been listed among national teams.

Qingdao BAHEAL Pharmaceutical Co., Ltd.

BAHEAL Pharmaceutical Concentrates on High-end Generics Aligned with International Standards

“Following strict reviews by several groups of experts from National Health and Family Planning Commission (NHFPC) and the Ministry of Science and Technology as well as several Q&As, the projects applied by BAHEAL Pharmaceutical meet the requirements for major scientific and technological projects for ‘Innovation and Manufacturing of Major New Drugs’ during the 13^th Five-year Plan Period of the state. BAHEAL Pharmaceutical has been identified by NHFPC as one of the pharmaceutical companies undertaking major projects during the 13^th Five-year Plan Period of the state. It is the only company in Qingdao and one of the three companies in Shandong Province with projects included. It is the first time a new pharmaceutical manufacturer in China has five products approved at a time,” said Mr. LEI Jifeng, Chairman of the company.

Presently BAHEAL Pharmaceutical is equipped with technology platform as well as the processes and advanced equipment necessary for the manufacturing of controlled-release preparations, and its infrastructures also meet the EHS requirements in and out of China and are in line with top international standards. High-caliber quality management system has been established in accordance with the requirements of the latest version of GMP and the GMP in the United States. The company succeeded in the certification of the latest version of GMP at home in June 2015 and went through certification of cGMP from FDA of the United States with zero finding in October 2016. Meanwhile a R&D team, with experts as project leaders and doctors and masters as members, has also been established at BAHEAL Pharmaceutical for the fulfillment of the research project.

As the only pharmaceutical company in Qingdao with projects approved, BAHEAL Pharmaceutical estimates that, by 2025, these five products will generate a sales income of RMB 1 billion, a profit of RMB 400 million and national revenue of RMB 150 million, which will inject brand-new impetus for the economic development of the city. In the meantime, BAHEAL Pharmaceutical will also make a new business card of advanced pharmaceutical manufacturing in Qingdao, creating a new benchmark for manufacturers in Jimo, Qingdao, Shandong Province and even in China in the R&D, manufacturing, marketing and globalization of generic drugs.

In the future, BAHEAL Pharmaceutical will also take this event as an opportunity to remain focused on the R&D and manufacturing of high-end generic drugs in compliance with the top international standards for the R&D and manufacturing of such drugs. Meanwhile moves will be taken to achieve synchronized marketing on the Chinese and American markets and enable more and more high-end generic drugs to be attached with the label “Made in China”.