by LI Kewen

For innovative drug companies, Shanghai's main strength lies in the concentration of its biopharma ecosystem, said Li Xin, executive director and senior vice president of government affairs at Shanghai Junshi Biosciences.

At the "Shanghai 2035: Answers for the Future" roundtable's biopharma session, Li said that in Zhangjiang, early scientific ideas can quickly connect with expertise across technology, clinical development, regulatory affairs, capital and commercialization. This efficiency is particularly important for early-stage innovation, she said, and is not easily replicated by capital alone.

Shanghai Junshi Biosciences is one of the city's homegrown innovative drug companies with international ambitions. Its pipeline covers oncology, autoimmune diseases, metabolic disorders and infectious diseases. Li said local government support has been relatively responsive, with policies introduced quickly and regular channels for companies to raise operational challenges.

However, she noted that taking innovative drugs global remains complex at every stage. Companies need to factor in overseas regulatory requirements early in development, build capabilities in global multicenter clinical trials and Good Clinical Practice (GCP) compliance, and meet chemistry, manufacturing and controls (CMC) and quality standards. Registration processes require passing overseas inspections, while commercialization depends on understanding local reimbursement systems, physician practices, patient needs and competitive dynamics.

Junshi began recruiting international talent early and established its own manufacturing base to support integrated R&D and production. Its Covid-19 neutralizing antibody Etesevimab received emergency-use authorization in more than 15 countries and regions, while toripalimab became one of the first China-developed PD-1 therapies approved in the United States.

Li said international partnerships can provide both capital and operational experience, while also helping improve global recognition of China's drug development capabilities.

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.