
Pharmaceutical R&D Manufacturer

On July 28, 2025, Hengrui reached an agreement with GSK to grant GSK the global exclusive rights (excluding mainland China, Hong Kong SAR, Macao SAR, and Taiwan region) for the HRS-9821 project and the exclusive option for global exclusive licenses of up to 11 projects (excluding mainland China, Hong Kong SAR, Macao SAR, and Taiwan region) on a paid basis.
(1) HRS-9821 Project Information
HRS-9821 is a potential best-in-class PDE3/4 inhibitor currently in clinical development for the treatment of chronic obstructive pulmonary disease (COPD) as an add-on maintenance therapy, regardless of prior treatment regimens. The drug has demonstrated potent PDE3 and PDE4 inhibitory effects in early clinical and preclinical studies, enhancing bronchodilation and anti-inflammatory actions while offering opportunities for the development of a convenient dry powder inhaler (DPI) formulation. For more information on HRS-9821, please refer to the announcement disclosed on the Shanghai Stock Exchange website, titled "Hengrui Medicine's Announcement on Receiving Clinical Trial Approval Notice for Drug" (Announcement No.: Interim 2025-100).
(II) Other Project Information
The other 11 projects involve innovative drugs in various therapeutic fields such as oncology, respiratory, autoimmune, and inflammation, and are currently all in the preclinical research stage. Hengrui will lead the development of these projects, at the latest until the completion of Phase I clinical trials including data from overseas participants.
GSK is a global biopharmaceutical company headquartered in London, UK, and listed on the London Stock Exchange and New York Stock Exchange (Stock Code: GSK).
Licensor: Jiangsu Hengrui Medicine Co., Ltd.
Licensee: GlaxoSmithKlineIntellectualProperty(No.3)Limited and GlaxoSmithKlineIntellectualProperty(No.4)Limited
(1) Scope of License
According to the agreement, Hengrui will grant GSKThe global exclusive licensing rights (excluding mainland China, Hong Kong SAR, Macao SAR, and Taiwan region) for PDE3/4 inhibitor HRS-9821.
Apart from HRS-9821, the agreement also includes the collaborative development of up to 11 projects, each with its own financial structure. Hengrui will lead the R&D of these projects until the completion of Phase I clinical trials, including data from overseas participants. GSK will have the exclusive option to further develop and commercialize each project globally (excluding mainland China, Hong Kong SAR, Macao SAR, and Taiwan region) by the time Phase I clinical trials are completed at the latest, as well as certain project substitution rights.
(II) Financial Terms
1. Upfront Payment: GSK will pay Hengrui an upfront payment of 500 million US dollars.
2. Option Exercise Fee and Milestone Payments: If all options are exercised and all milestones are achieved, Hengrui will be eligible to receive a potential total amount of approximately USD 12 billion in future milestone payments based on successful development, registration, and sales.*。
3. Sales Commission: Hengrui will have the right to charge GSK a tiered sales commission (excluding mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region, and Taiwan region).
*The payments for future milestones based on successful development as agreed in the contract are subject to certain conditions. The final option exercise fee and milestone payment amounts remain uncertain.
(III) Term of the Agreement
The license rights granted by Hengrui to the HRS-9821 project will take effect after obtaining all applicable antitrust approvals. Unless the contract stipulates early termination, this agreement will remain in effect until the royalty term for each project expires in each licensed country.
Previously,On July 9, Merck announced that it would acquire Verona Pharma, a biotech company in the respiratory field, for $10 billion, obtaining the COPD drug Ohtuvayre (Ensifentrine). Through this acquisition, Merck will obtain Verona Pharma's chronic obstructive pulmonary disease drug Ohtuvayre (a dual-target inhibitor of PDE3 and PDE4). The U.S. Food and Drug Administration (FDA) just approved the drug in June of last year for the maintenance treatment of adult chronic obstructive pulmonary disease.This medication is the first novel inhaled mechanism drug for treating COPD in over 20 years.According to the World Health Organization's forecast, COPD is expected to become the third leading cause of death worldwide by 2030; it is projected that over 5.4 million people will die from COPD by 2060. The market is huge. Ensifentrine is a dual-target inhibitor targeting phosphodiesterase-3 (PDE3) and phosphodiesterase-4 (PDE4), with an affinity for PDE3 that is 3,440 times greater than for PDE4.