by CHEN Yang
Shanghai should encourage innovative drug companies to develop systematic global capabilities, said Wang Yan, board secretary of Shanghai Henlius Biotech, at the "Shanghai 2035: Answers for the Future" biopharma roundtable.
Founded in Zhangjiang in 2010, Shanghai Henlius Biotech has grown into a biopharmaceutical company with more than 4,000 employees. By the end of 2025, ten of its products had been approved in more than 60 markets, reaching over one million patients worldwide. The company has built overseas experience across clinical development, regulatory filings and commercialization partnerships.
Wang said expanding overseas remains complex. Henlius initially focused on biosimilars and entered the European Union, where regulatory pathways are relatively well established. It later moved toward the United States, where pricing mechanisms for innovative drugs are more market-driven. In 2026, the company began developing its own commercial strategy in the U.S. market.
The company has undergone three inspections by the U.S. Food and Drug Administration, all without deficiencies. Each inspection required extensive preparation and addressed different aspects of compliance, Wang said, adding that the process helps companies build internationally aligned quality systems.
On the debate over licensing early-stage assets overseas, Wang said such deals reflect growing global recognition of China's biopharma research. At the same time, she noted that companies will need to strengthen their ability to capture long-term value from pipelines, including through overseas clinical development and commercialization.
She added that policy support could help companies move beyond early licensing toward broader global operations, with the aim of building stronger intellectual property portfolios and international presence.
Editor's note: "Shanghai 2035: Answers for the Future" is a multimedia series produced by the Shanghai Municipal Government Information Office and Jiemian News. The project explores the city's long-term development across key sectors through documentaries, expert roundtables and interviews. The biopharma chapter examines how Shanghai is developing its drug innovation ecosystem, with a focus on clinical resources, commercialization pathways and global expansion.
