By Fineline Cube 
Jiangsu Hengrui Pharmaceutical Co., Ltd (SHA: 600276, HKG: 1276) announced that China’s National Medical Products Administration (NMPA) approved clinical trials for four pipeline assets: SHR‑A1811 (SC), RSS0343, HRS9531, and HRS‑1780, spanning oncology, respiratory, metabolic, and cardiovascular diseases.
Clinical Trial Approvals Overview
| Product | Formulation | Mechanism | Indication | Stage |
|---|---|---|---|---|
| SHR‑A1811 (SC) | Subcutaneous injection | HER2 ADC | Advanced solid tumors | Clinical trial |
| RSS0343 | Oral tablet | Novel anti‑inflammatory small molecule | Chronic rhinosinusitis without polyps, COPD | Clinical trial |
| HRS9531 | Injection | GIPR/GLP‑1R dual agonist | MASH | Clinical trial |
| HRS‑1780 | Oral tablet | Mineralocorticoid receptor antagonist | Heart failure (LVEF ≥40%) | Clinical trial |
Individual Asset Profiles
SHR‑A1811 (SC)
- Background: IV formulation approved in China (May 2025) for HER2‑mutant NSCLC
- Innovation: First subcutaneous HER2 ADC for solid tumors; maintains efficacy with improved convenience
- Market: Global HER2 ADC market $7 billion; SC route addresses outpatient treatment demand
RSS0343
- Novelty: First‑in‑class oral anti‑inflammatory; no approved global/China equivalents for chronic rhinosinusitis without polyps or COPD
- Mechanism: Potent, highly selective Class 1 small molecule with strong preclinical efficacy
- Market: COPD affects >100 million in China; rhinosinusitis market ¥5 billion
HRS9531
- Mechanism: GIPR/GLP‑1R dual agonist; regulates glucose/lipid metabolism, suppresses appetite
- Indication: MASH (Metabolic Dysfunction‑Associated Steatohepatitis)
- Differentiation: Expected to improve hepatic lipid accumulation, reduce inflammation/fibrosis
- Market: Global MASH market projected $35 billion by 2030; China MASH prevalence >30 million
HRS‑1780
- Mechanism: Mineralocorticoid receptor antagonist for heart failure with LVEF ≥40%
- Market: HFpEF affects ~50% of 6 million heart failure patients in China; complements existing ARNI/SGLT2i standards
- Competition: Differentiated from finerenone (non‑steroidal MRA) with improved selectivity profile
Strategic Implications
- For Hengrui: Four parallel pipeline advancements demonstrate R&D breadth; RSS0343’s first‑in‑class status and HRS9531’s MASH entry position company in high‑growth markets; builds on SHR‑A1811’s commercial success.
- For Investors: Validates ¥3‑4 billion annual R&D investment (2023‑2025); multiple shots on goal reduce pipeline risk; potential for global out‑licensing of ADC and metabolic assets.
- For Market: Strengthens China’s innovation pipeline in respiratory and metabolic diseases; MASH and HFpEF programs address massive unmet needs with aging population.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical trial timelines, market size estimates, and competitive positioning. Actual results may differ due to regulatory feedback, clinical risks, or competitive responses.-Fineline Info & Tech