Former CDE Chief Scientist Dr. Gang Wang Joins Junshi Biosciences to Build World-Class Quality Management System

On August 19, 2019, Junshi Biosciences, a leading domestic pioneer in biopharmaceutical innovation, announced the appointment of Dr. Wang Gang as Senior Vice President of Industrial Affairs and Chief Quality Officer, with full responsibility for production quality and related operations at Junshi Biosciences.

Dr. Wang Gang

Dr. Wang Gang has dedicated over three decades to the pharmaceutical industry, with more than 20 years of experience in the regulatory, manufacturing, and compliance sectors for biological products, including cell and gene therapies. His expertise encompasses cGMP (Current Good Manufacturing Practice) compliance, product review, manufacturing, pre-approval inspections, and cGMP compliance inspections. He previously held positions at the former China Food and Drug Administration (CFDA) and the U.S. Food and Drug Administration (FDA), serving as Chief Scientist responsible for compliance and inspections at the CFDA’s Center for Drug Evaluation (CDE), and as Assistant Director of the FDA’s China Office.

After many years of service in government regulatory agencies, Dr. Wang Gang transitioned to the corporate sector. Prior to joining Junshi Biosciences, he served as Vice President of the Quality Department at WuXi Biologics (Shanghai), where he was responsible for quality and global regulatory affairs.

“Junshi Biosciences is an outstanding domestic innovative pharmaceutical company currently in a phase of rapid development, with continuous optimization and improvement across all segments of its industry chain,” stated Dr. Wang Gang. “Quality is the top priority for any enterprise. Only by ensuring the safety, efficacy, and quality reliability of pharmaceutical products can we ultimately benefit patients. Throughout the entire product lifecycle—including drug research and development, clinical trials, commercial manufacturing, and post-marketing surveillance—operations must be strictly controlled under a robust quality assurance system. As Junshi Biosciences rapidly expands its production capacity, it is essential to establish a world-class production quality management system to ensure that product quality remains stable and consistently compliant with cGMP standards. This is precisely what I aim to achieve.”

As a leading pioneer in biopharmaceutical innovation in China, Junshi Biosciences has always prioritized production quality management as a core corporate strategy. Whether for approved products gaining new indications or the future commercialization of new products, meeting market demand requires robust production capacity, and a world-class production quality system ensures the sustainable expansion of such capacity.

To date, Junshi Biosciences has 19 products in its R&D pipeline, including 17 innovative drugs and two biosimilars, all of which are gradually moving toward commercialization. The most advanced asset, the anti-PD-1 monoclonal antibody toripalimab (brand name: Tuoyi), was approved for marketing last year for the indication of melanoma. Meanwhile, more than 30 clinical trials covering 14 tumor types are being conducted in China, the United States, and other Asian countries, with plans to submit marketing applications for one to two new indications each year.

The rapid pace of R&D and the swift growth in market demand have placed higher requirements on production capacity. Junshi Biosciences is accelerating the commissioning of its production facilities and currently operates two manufacturing bases: one in Wujiang, Suzhou, and the other in Lingang, Shanghai. The Wujiang production base is the first monoclonal antibody manufacturing facility in China whose single-use production system has passed the NMPA GMP inspection, with a capacity of 3,000 liters. The Lingang, Shanghai production base, under construction, is built in accordance with international cGMP standards. Its Phase I project alone has a planned capacity of 30,000 liters and is scheduled to commence phased commercial production by the end of this year.

Junshi Biosciences Shanghai Lingang Production Base

Dr. Wang Gang Joins Junshi Biosciences to Lead the Development of an Internationally Aligned Production Quality Management System, Addressing Growing Capacity Needs and Global Market Expansion

Dr. Wang Gang has a clear vision and plan for joining Junshi Biosciences. The company’s high standards for production and quality management have also made him acutely aware of the significant responsibilities he bears. He will focus on ensuring continuous cGMP compliance, launching new production lines, building teams, and establishing quality systems. He revealed that upon joining Junshi Biosciences, he will shoulder four major objectives:

First, prioritize quality by continuously ensuring the stability and improvement of product quality during the commercial production of existing products, thereby maintaining consistent compliance with cGMP quality standards. Second, focus on production launch by ensuring the successful completion, validation, and commissioning of the production lines at the Shanghai Lingang manufacturing base, smoothly obtaining cGMP certification from regulatory authorities in major countries worldwide, and guaranteeing the company’s subsequent large-scale production capabilities. Third, establish an internationally standardized production quality management system to prepare for expanding products into overseas markets. Currently, Junshi Biosciences’ self-developed anti-PD-1 monoclonal antibody and anti-BTLA monoclonal antibody are undergoing clinical trials in multiple countries and regions abroad. Fourth, emphasize talent development by leveraging accumulated industry experience to cultivate a top-tier professional quality team for Junshi Biosciences within China’s burgeoning biopharmaceutical sector, providing the strongest support for the continuous improvement of the enterprise’s production quality system.

Dr. Wang Gang stated, “Junshi Biosciences positions itself as a world-class biopharmaceutical enterprise. Its emphasis on production and quality management systems has demonstrated the global vision of Chinese companies. I hope to help domestic enterprises elevate their biopharmaceutical production and quality systems to international standards, expand into global markets, and become world-leading innovators in novel drug development.”

“China’s innovative biologics hold immense potential. Supported by Chinese government policies and the speed of Chinese manufacturing, we are confident in our ability to build an innovative pharmaceutical enterprise that is fast, excellent, and strong,” stated Dr. Li Ning, CEO of Junshi Biosciences. “We believe that the addition of Dr. Wang Gang will have a profound impact on and significantly drive Junshi Biosciences’ comprehensive quality management. With his support, we look forward to elevating our production and quality systems to new heights, accelerating our international expansion with greater efficiency, and delivering superior quality to reward the trust placed in us by patients worldwide.”

Junshi Biosciences (NEEQ: 833330, HKEX: 01877) was founded in December 2012 by a team of graduates from prestigious universities in China and the United States, with extensive experience in cross-border technology transfer and industrialization.

Junshi Biosciences is primarily dedicated to the development of therapeutic antibodies, focusing on the research, development, and industrialization of innovative monoclonal antibody drugs and other therapeutic protein drugs. The company boasts a robust pipeline of products in development, comprising 17 innovative drugs and two biosimilars. Junshi Biosciences is the first Chinese company to receive marketing approval from the National Medical Products Administration (NMPA) for an anti-PD-1 monoclonal antibody. It is also the first domestic company to obtain NMPA approval for Investigational New Drug (IND) applications for anti-PCSK9 and anti-BLyS monoclonal antibodies. Furthermore, it has secured the world’s first IND approval from the U.S. Food and Drug Administration (FDA) for an anti-BTLA blocking antibody for cancer treatment. Currently, Junshi Biosciences employs over 1,000 people worldwide, with operations in San Francisco and Maryland in the United States, and Shanghai, Suzhou, Beijing, and Guangzhou in China.