GSK has entered into agreements with Hengrui Pharma, a Lianyungang, China-based bio/pharmaceutical company, to develop up to 12 medicines across several therapeutic areas (respiratory, immunology & inflammation, and oncology) in a deal worth up to $12.5-billion ($500 million upfront and $12 billion in milestone payments).  

The agreements include an exclusive worldwide license (excluding mainland China, Hong Kong, Macau, and Taiwan) for a PDE3/4 inhibitor (HRS-9821) in clinical development for the treatment of chronic obstructive pulmonary disease (COPD) as an add-on maintenance treatment, irrespective of background therapy. The addition of HRS-9821 supports GSK’s goal to treat patients across the spectrum of COPD by including those who face continued dyspnea (shortness of breath) or who are unlikely to receive inhaled corticosteroids or biologics, based on their disease profile. HRS-9821 has demonstrated PDE3 and PDE4 inhibition, leading to increased bronchodilation and anti-inflammatory effects in early clinical and preclinical studies, according to information from GSK. In addition, HRS-9821 holds the opportunity to be delivered in a dry-powder inhaler formulation that strategically fits GSK’s inhaled respiratory portfolio.  

The agreements also include a scaled collaboration to generate up to 11 programs in addition to HRS-9821, each with its own financial structure. Hengrui Pharma will lead the development of these program up to completion of Phase I trials, including patients outside of China. GSK will have the exclusive option 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, as well as certain program substitution rights. 

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 Pharma is approximately $12 billion if all programs are optioned and all milestones are achieved. In addition, Hengrui Pharma will be eligible to receive tiered royalties on global product net sales (excluding mainland China, Hong Kong, Macau, and Taiwan).

Hengrui Pharma is an innovator drug company based in China. It has a global R&D team that includes 14 R&D centers and more than 5,500 professionals, Hengrui Pharma’s therapeutic areas of focus include oncology, metabolic and cardiovascular diseases, immunological and respiratory diseases, and neuroscience. The company has commercialized 23 new molecular entity drugs and four other innovative drugs in China. 

Source: GSK