Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that China’s National Medical Products Administration (NMPA) has authorized HRS-7535, a novel oral small‑molecule GLP‑1 receptor (GLP‑1R) agonist, to enter clinical studies for hypertension comorbid with overweight or obesity, positioning Hengrui at the forefront of next‑generation metabolic disease therapies.
Promote pancreatic insulin secretion and reduce glucagon release
Inhibit gastric emptying and enhance satiety via central nervous system effects
Suppress appetite and directly reduce energy intake
Differentiation:First oral small‑molecule GLP‑1R agonist entering clinical trials globally; offers potential manufacturing cost advantages and improved stability compared to peptide‑based injectables and oral tablets (e.g., Rybelsus)
Development Stage: Pre‑clinical efficacy demonstrated in rodent and non‑human primate models; IND‑enabling toxicology completed
Market Opportunity: Hypertension with Obesity
Parameter
China
Global
Hypertension Prevalence
330 million
1.28 billion
With Overweight/Obesity Comorbidity
115 million
450 million
Currently Treated with GLP‑1
<2 %
<3 %
Addressable Market (2030E)
18 million patients
72 million patients
Annual Treatment Cost (China)
¥8,000‑12,000
–
Unmet Need: Current antihypertensives (ACE inhibitors, ARBs) do not address obesity‑driven pathophysiology; GLP‑1R agonists offer dual metabolic and cardiovascular benefits
Clinical Rationale: Semaglutide (injectable) demonstrated 5‑7 mmHg systolic BP reduction in obese patients; oral small molecule could replicate benefits with superior convenience
Competitive Landscape: Oral GLP‑1R Space
Company
Drug
Mechanism
Stage
Key Differentiator
Hengrui
HRS‑7535
Small molecule
Phase I ready
Oral non‑peptide; China‑first
Rybelsus
Semaglutide
Oral peptide
Marketed
First oral GLP‑1, but peptide‑based
Pfizer
Danuglipron
Small molecule
Phase II
Discontinued GI tolerability issues
Eli Lilly
Orforglipron
Small molecule
Phase III
Dual GIP/GLP‑1; 2027E launch
Structure
None
Small molecule
–
–
Strategic Moat: HRS‑7535 is the first and only oral small‑molecule GLP‑1R agonist in China’s pipeline; potential for global first‑in‑class if Phase I data proves competitive
Timeline Advantage: 12‑18‑month head start vs. multinational competitors in China; NMPA fast‑track eligibility for cardiometabolic diseases
Development Timeline & Revenue Forecast
Milestone
Expected Date
Phase I initiation
Q2 2026
Phase I/II data
Q1 2027
Phase III start
Q4 2027
NDA submission
Q2 2029
Potential launch
Q4 2030
Parameter
2030E
2031E
2032E
China Market Penetration
0 %
3 %
8 %
Patient Population
–
3.5 million
9.2 million
Annual Cost (¥)
–
¥9,500
¥8,800
Hengrui Revenue (¥)
–
¥33 billion
¥81 billion
Global Strategy: Hengrui plans US IND filing in 2027 leveraging China Phase I/II data under FDA bridging study pathway
Manufacturing: Hengrui’s Lianyungang facility (current capacity 2 billion tablets) will dedicate 30 % capacity to HRS‑7535 upon approval
Forward‑Looking Statements This brief contains forward‑looking statements regarding clinical development timelines, regulatory pathways, and revenue forecasts for HRS‑7535. Actual results may differ due to clinical trial outcomes, competitive dynamics, and evolving GLP‑1 market access policies.-Fineline Info & Tech
By Fineline Cube