GlaxoSmithKline has struck a landmark $12.5 billion licensing agreement with Chinese pharmaceutical company Jiangsu Hengrui Pharmaceuticals, securing exclusive global rights to develop up to 12 innovative medicines in a deal that highlights China's expanding role in global drug development.
The agreement centers on HRS-9821, a potential best-in-class PDE3/4 inhibitor currently in clinical development for treating chronic obstructive pulmonary disease (COPD) as an add-on maintenance treatment. GSK will receive worldwide rights to the drug, excluding mainland China, Taiwan, Hong Kong, and Macau.
COPD Treatment with Novel Mechanism
HRS-9821 has demonstrated potent PDE3 and PDE4 inhibition in early clinical and preclinical studies, leading to increased bronchodilation and anti-inflammatory effects. The drug is designed to treat patients across the widest spectrum of COPD, including those who face continued dyspnoea (shortness of breath) or who are unlikely to receive inhaled corticosteroids or biologics based on their disease profile.
The compound offers the opportunity for a convenient dry-powder inhaler (DPI) formulation that strategically fits GSK's established inhaled portfolio, according to the companies.
Scaled Collaboration Model
Beyond HRS-9821, the agreement includes a pioneering scaled collaboration to generate up to 11 additional programs across respiratory, immunology, inflammation, and oncology therapeutic areas. Under this structure, Hengrui will lead development of these programs through completion of Phase I trials, including patients outside of China.
GSK will have exclusive options to further develop and commercialize each program worldwide (excluding mainland China, Hong Kong, Macau, and Taiwan) at the end of Phase I or earlier at GSK's election, along with certain program substitution rights.
Financial Structure
GSK will pay $500 million in upfront fees across the agreements, including for the license of the PDE3/4 program. The potential total value of future success-based development, regulatory, and commercial milestone payments to Hengrui is approximately $12 billion if all programs are optioned and all milestones are achieved. Additionally, Hengrui will be eligible to receive tiered royalties on global product net sales from the excluded territories.
Strategic Significance
"This strategic collaboration with GSK marks yet another significant milestone in Hengrui's globalisation journey and our mission to innovate and deliver higher-quality, cutting-edge therapies for patients worldwide," said Frank Jiang, Executive Vice President and Chief Strategy Officer of Hengrui Pharma.
Tony Wood, Chief Scientific Officer at GSK, emphasized the strategic value: "This deal reflects our strategic investment in programmes that address validated targets, increasing the likelihood of success, and with the option to advance those assets with the greatest potential for patient impact."
The collaboration leverages GSK's therapy area expertise, clinical development capabilities, and global commercial scale alongside Hengrui's early discovery engine, platform technologies, and extensive preclinical pipeline. The license to HRS-9821 remains subject to customary conditions, including applicable regulatory agency clearances under the Hart-Scott-Rodino Act in the United States.
Hengrui, established in Lianyungang in 1997, has built a global R&D network including 14 R&D centers and more than 5,500 professionals. The company has commercialized 23 new molecular entity drugs and 4 other innovative drugs in China to date.