Breakthrough Clinical Results
Hengrui Pharma and GSK have entered into agreements to co-develop up to 12 innovative medicines across respiratory, immunology & inflammation, and oncology. The deal includes an exclusive worldwide license for Hengrui's HRS-9821, a potential best-in-class PDE3/4 inhibitor for COPD, for GSK. GSK will pay $500 million upfront, with potential milestone payments totaling approximately $12 billion. Hengrui will lead development up to Phase I, after which GSK has the option to further develop and commercialize the remaining 11 programs globally (excluding mainland China, Hong Kong, Macau, and Taiwan). This collaboration leverages Hengrui's early discovery capabilities and GSK's global clinical network and commercial expertise.
Key Highlights
- GSK to pay $500 million upfront for the collaboration.
- Exclusive worldwide license for HRS-9821 (PDE3/4 inhibitor for COPD) granted to GSK.
- Up to 11 additional programs to be co-developed, with GSK having options to further develop and commercialize.
- Potential total value of future milestone payments could reach approximately $12 billion.
Incidence and Prevalence
Latest Global COPD Epidemiology Estimates
Prevalence
The World Health Organization predicts that COPD will become the third leading cause of mortality and the fifth cause of disability in 2020 worldwide. Recent studies show significant variation in prevalence across regions and populations:
- A 2023 study from rural southwest China found that COPD prevalence increased from 8.7% to 12.8% between 2011 and 2021
- A 2024 study in China reported COPD prevalence was estimated at 12.8% for males and 5.7% for females over 50 years of age in 2020-2021
- The most recent epidemiological data from 2023 shows a 2% COPD prevalence (95% CI: 1.45, 2.55) in a rural Bangladesh population, with significant difference between males (2.7%) and females (1.2%)
- In a 2016 study of Chinese greenhouse farmers, the overall prevalence was 17.5%
- A 2016 Moroccan study found an overall prevalence of 12.6% for stage 1 or higher COPD and 7.9% for GOLD stage 2 or higher
- A 2007 New Zealand study reported GOLD-defined, age-adjusted prevalence for adults aged ≥40 years was 14.2%
- A 2017 Latin American study found COPD prevalence according to GOLD-2013 was 20.1%
Risk Factors and Demographic Patterns
The lifetime risk of physician-diagnosed COPD at age 80 years was estimated at 27.6% in a large North American population study. This risk varies significantly by demographics:
- Higher in men than women (29.7% vs 25.6%)
- Higher in individuals of lower socioeconomic status (32.1% vs 23.0%)
- Higher in rural settings than urban settings (32.4% vs 26.7%)
Studies consistently show that men, ethnic minorities, and those with lower educational level, lower income, or lower socioeconomic position have a higher prevalence of COPD.
Disease Burden and Mortality
- India contributes significantly to global COPD mortality with rates of 102.3/100,000 and 6,740,000 DALYs out of a world total of 27,756,000 DALYs
- From 1990 to 2019, the age-standardized mortality rate (ASMR) of COPD attributed to particulate matter decreased globally by 61.80%
- In Taiwan, COPD mortality has been steadily increasing since 2009
Future Projections
A 2018 French study projected a steady increase in crude COPD prevalence among subjects aged ≥45 years from 2005 (84.51‰) to 2025 (projected prevalence: 95.76‰, +0.56‰/yr), with:
- A 4-fold increase in the prevalence of GOLD grade 3-4 cases
- A 23% relative increase in women
- A 21% relative increase in subjects ≥75 years
Challenges
- Underdiagnosis remains a significant issue, with one study showing 52.1% of COPD cases were undiagnosed
- The economic burden of COPD has been increasing, with one study showing a 1.9-fold increase in economic costs over a decade (2011-2021)
- Inadequate treatment remains a concern, with one study finding 50% of COPD exacerbation cases received inadequate management
Economic Burden
Economic Burden of Treating COPD in USA and Europe
Global Impact
The macroeconomic burden of COPD will cost the world economy INT$4.326 trillion (uncertainty interval 3.327-5.516; at constant 2017 prices) in 2020-50, equivalent to a yearly tax of 0.111% on global GDP.
United States
The USA faces one of the largest economic burdens from COPD, accounting for INT$1.037 trillion (uncertainty interval 0.868-1.175). According to a 2016 cross-sectional population-based survey, the annual direct costs of COPD in the USA were $9,981 per patient, the highest among 12 countries studied. A more recent 2021 systematic review reported even higher figures, with annual per patient direct medical cost reaching $10,367 and hospitalization cost at $6,852.
In the USA, inpatient hospitalizations and home oxygen therapy were identified as key drivers of direct costs. The total societal costs per patient were $30,826, showing the highest burden among studied countries. Additionally, 52% of COPD patients in the USA were completely prevented from working due to their condition.
A 2017 cost-effectiveness study examining UMEC/VI treatment for moderate to very severe COPD found it was associated with lower lifetime medical costs ($82,344) compared to tiotropium ($88,822), open dual LAMA + LABA treatment ($114,442), and no long-acting bronchodilator ($86,751).
European Countries
In Europe, annual direct expenditures for COPD treatment per patient ranged from €530 in France to €3,238 in Spain (based on a 1998/99 survey).
Spain has been studied extensively, with a significant proportion of the economic burden associated with inpatient hospitalization (€2,708), accounting for almost 84% of the total direct cost. The total societal cost of COPD in Spain was estimated at €3,538 per patient per year, with indirect costs amounting to €300 per patient.
Spanish research also demonstrated that patients with severe COPD were associated with considerably higher total societal costs than patients with mild disease (€9,850 versus €1,316 per patient). A recent analysis of the Salford Lung Study in COPD applied to Spain showed potential annual savings of €353,623 when substituting usual care with fluticasone furoate/vilanterol 92/22 mcg.
Common Patterns
A 2023 systematic review confirmed that COPD generates substantial costs for health systems, mainly related to moderate to severe stages and the exacerbations and complications. The highest costs reported across multiple studies corresponded to hospitalizations and associated pharmacological treatment.
The review also highlighted the importance of loss of productivity and premature retirement as the main generators of indirect costs. A consistent pattern across countries showed greater costs among those with increased burden of COPD (symptoms, health status and more severe disease) and a greater number of comorbidities.
Drug used in other indications
HRS-9821 Clinical Trials Beyond COPD
After thorough review, no information is available regarding HRS-9821 being trialed for indications other than Chronic Obstructive Pulmonary Disease (COPD). The compound HRS-9821 does not appear in any of the available clinical trial data.
Similarly, there is no data available on intervention models, dosing regimens, or administration protocols for HRS-9821 in any therapeutic areas, including both COPD and non-COPD indications.
The absence of information extends to the compound's mechanism of action that might support its investigation across multiple therapeutic areas.
While other compounds for COPD treatment such as ZD-0892, indacaterol, olodaterol, statins, and Duaklir have been documented in clinical research, HRS-9821 is not mentioned among these established or investigational treatments.
Without clinical trial data, it is not possible to determine whether HRS-9821 is being investigated for additional indications beyond COPD or what intervention models might be employed in such trials.