Baigo Pharmaceuticals Secures National 'Major New Drug Creation' Project Support with Five High-End Generic Oral Solid Dosage Forms

Recently, the Medical and Health Science and Technology Development Research Center of the National Health and Family Planning Commission officially issued the “Notice on the 2017 Annual Project Topics for the National Science and Technology Major Project on ‘Major New Drug Innovation’” (hereinafter referred to as the “Notice”) to enterprises that had received project approval support.

Five generic drug projects from Baiyang Pharmaceutical have been approved for support under the National Major Project for New Drug Innovation and Development during the 13th Five-Year Plan period, marking Baiyang Pharmaceutical’s entry into the internationalization of Chinese generic drugs. This signifies that the company’s R&D and manufacturing capabilities for high-end generic drugs are now at the industry’s forefront.

In recent years, the Chinese government has frequently introduced favorable policies to support research and innovation in generic drugs. Notably, on January 23, 2018, the Second Meeting of the Central Committee for Comprehensively Deepening Reforms reviewed and approved the “Several Opinions on Reforming and Improving Policies for the Supply, Assurance, and Use of Generic Drugs.” These opinions explicitly call for reforming and enhancing policies related to the supply assurance and use of generic drugs, promoting R&D and innovation in this sector, improving product quality and therapeutic efficacy, strengthening pharmaceutical supply capabilities, and better meeting the medication needs of the general public.

The Notice, which aligns with numerous favorable national policies for generic drug development, explicitly prioritizes the concentrated breakthrough of ten key common technologies in pharmaceutical formulations—including improved novel dosage form technologies, hot-melt extrusion (HME) technology, and 3D printing technology—for application in the manufacturing of 39 types of high-end oral solid dosage forms. It aims to develop drugs with high efficacy, low side effects, and affordable prices for major diseases, while simultaneously building a national technological innovation system for pharmaceuticals. This system will provide technical support for innovative drug R&D and explore and establish new models and mechanisms for innovative drug development that are effective and suited to China’s national conditions. The plan aims to secure U.S. FDA Abbreviated New Drug Application (ANDA) approvals for 33 products, five New Drug Applications (NDAs), and one approval from the Australian Therapeutic Goods Administration (TGA) by the end of 2020.

As favorable national policies continue to emerge and the domestic generic drug market environment evolves, Chinese pharmaceutical companies are ushering in a new round of development opportunities centered on R&D capabilities as their core competitive advantage. For Chinese pharmaceutical enterprises, bringing an innovative drug to market typically requires 10–12 years and an investment of approximately USD 1–2 billion. Since the vast majority of Chinese pharmaceutical companies do not yet possess such capabilities, most have been pursuing a strategy that combines imitation with innovation, primarily focusing on the production of low- to mid-end generic drugs. On the other hand, many high-end Chinese pharmaceutical companies, represented by Baiyang Pharmaceutical, have gradually forged a development path centered on advanced technology R&D and have successfully expanded into international markets.

As one of the pharmaceutical companies undertaking major national projects during the 13th Five-Year Plan period, Baiyang Pharmaceutical had five of its international research products for high-end oral solid dosage forms selected. These specifically include Metformin Hydrochloride Extended-Release Tablets, Duloxetine Hydrochloride Enteric-Coated Capsules, Glipizide Controlled-Release Tablets, Nifedipine Controlled-Release Tablets, and Carbamazepine Controlled-Release Tablets. This selection not only signifies that these products have been designated as national strategic varieties, but also that their research teams have been integrated into the national-level research cohort.

Lei Jifeng, a director at Baiyang Pharmaceutical, stated: “The research projects submitted by Baiyang Pharmaceutical underwent rigorous multi-round reviews by experts from the National Health and Family Planning Commission (NHFPC) and the Ministry of Science and Technology (MOST), as well as multiple defense presentations. They were found to meet the requirements of the National 13th Five-Year Plan’s Major Science and Technology Special Project on ‘Major New Drug Development.’ As a result, the NHFPC designated Baiyang Pharmaceutical as one of the pharmaceutical companies undertaking major national projects under the 13th Five-Year Plan. It is the only pharmaceutical company in Qingdao with selected projects and one of only three such enterprises in Shandong Province. Notably, as a newly established pharmaceutical company, having five products approved in a single application is a first in China.”

Currently, the company possesses corresponding technical platforms, featuring manufacturing processes suitable for the production of sustained- and controlled-release formulations, as well as advanced production equipment. Its infrastructure complies with domestic and international EHS (Environment, Health, and Safety) requirements and has reached an internationally advanced level. A high-standard quality management system has been established in accordance with the new Chinese GMP requirements and U.S. GMP standards. The company passed the domestic new GMP certification in June 2015 and achieved a zero-defect outcome in the U.S. FDA cGMP inspection in October 2016. Furthermore, to implement this special project, Baiyang Pharmaceutical has established a research and development team led by experts and primarily composed of individuals holding doctoral and master’s degrees.

As the only pharmaceutical company in Qingdao selected for this research initiative, Baiyang Pharmaceutical projects that by 2025, five of its products will generate RMB 1 billion in sales revenue, with profits reaching RMB 400 million and national tax contributions exceeding RMB 150 million, thereby injecting new momentum into Qingdao’s economic development. Meanwhile, Baiyang Pharmaceutical aims to establish a new benchmark for advanced pharmaceutical manufacturing in Qingdao, setting fresh standards in the research and development, production, sales, and internationalization of generic drugs for pharmaceutical enterprises in Jimo City, Qingdao City, Shandong Province, and across China.

Looking ahead, Baiyang Pharmaceutical will leverage its inclusion in the National 13th Five-Year Plan’s Major Science and Technology Project for “Significant New Drug Development” as an opportunity to continue focusing on the research, development, and production of high-end generic drugs, aligning with international best practices in R&D and manufacturing. The company also aims to achieve simultaneous market launches in both China and the United States, thereby enabling more high-end generic drugs to bear the “Made in China” label.