Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that two investigational drugs — SHR‑1139 Injection, an IL‑23p19/IL‑36R bispecific antibody, and HRS‑5346 Tablets, an oral small‑molecule Lp(a) inhibitor — have been approved by China’s National Medical Products Administration (NMPA) to initiate clinical trials, advancing a dual‑pathway immunology asset and a first‑in‑class cardiovascular candidate with no similar drugs approved for marketing in China or internationally to date.
Regulatory Milestone
| Item | SHR‑1139 Injection | HRS‑5346 Tablets |
|---|---|---|
| Modality | IL‑23p19/IL‑36R bispecific antibody (injectable) | Oral small‑molecule Lp(a) inhibitor |
| Agency | NMPA (China) | NMPA (China) |
| Clearance | Approved to initiate clinical trials | Approved to initiate Phase III clinical trial |
| Current Indication | Palmoplantar pustulosis | Reducing risk of major adverse cardiovascular events (MACE) in adults with confirmed atherosclerotic cardiovascular disease (ASCVD) or elevated risk of a first CV event, with elevated lipoprotein(a) |
| Prior Clearances | Psoriasis; ulcerative colitis; pyoderma gangrenosum | – |
| Competitive Status | Dual‑pathway approach in inflammation | No similar drugs approved for marketing in China or worldwide |
Drug Profile – SHR‑1139 (Immunology & Inflammation)
- Molecule: IL‑23p19/IL‑36R bispecific antibody — a dual‑targeting biologic administered by injection.
- Mechanism: Simultaneously blocks two inflammatory pathways — IL‑23 and IL‑36R — which may provide more comprehensive and durable inflammation control than single‑pathway biologics.
- Newest Indication: Cleared for clinical trials in palmoplantar pustulosis, a chronic, difficult‑to‑treat neutrophilic skin disease.
- Expansion Track Record: Previously cleared for clinical trials in psoriasis, ulcerative colitis, and pyoderma gangrenosum, building a multi‑indication inflammation portfolio on one bispecific platform.
Drug Profile – HRS‑5346 (Cardiovascular & Metabolic)
- Molecule: Oral small‑molecule inhibitor of lipoprotein(a) [Lp(a)], a genetically determined lipid risk factor not addressed by existing lipid‑lowering therapies.
- Trial Phase: Approved to initiate a Phase III clinical trial — entering late‑stage development directly for a cardiovascular outcomes setting.
- Target Population: Adults with confirmed ASCVD or elevated risk of a first cardiovascular event who have elevated Lp(a).
- Endpoint: Reduction of the risk of major adverse cardiovascular events (MACE).
- Innovation: No similar drugs have been approved for marketing in China or internationally to date, positioning HRS‑5346 as a potential first‑to‑market oral Lp(a) inhibitor.
Market Impact & Outlook
- Pipeline Breadth: The twin clearances showcase Hengrui’s ability to advance biologics and small molecules in parallel across immunology and cardiometabolic disease — two of the largest therapeutic franchises in China’s innovative drug market.
- Lp(a) Race: Elevated Lp(a) affects a substantial share of the population and is a recognized residual cardiovascular risk factor with no approved therapies; an oral Phase III‑ready inhibitor would give Hengrui a differentiated position in the global race to drug Lp(a), alongside injectable competitors in development.
- Bispecific Inflammation Strategy: SHR‑1139’s expansion into palmoplantar pustulosis — following psoriasis, ulcerative colitis, and pyoderma gangrenosum — reflects a platform strategy of testing dual IL‑23/IL‑36R blockade across neutrophil‑ and IL‑23‑driven inflammatory diseases.
- Commercial Positioning: Both assets address conditions with significant unmet need in China, reinforcing Hengrui’s transition toward first‑in‑class and best‑in‑class innovative therapies from its dual Shanghai and Hong Kong listings.
- Watchpoints: Phase III design and enrollment pace for HRS‑5346, SHR‑1139’s indication prioritization, and competitive developments in the global Lp(a) and bispecific inflammation spaces will shape the programs’ trajectories.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the clinical development of SHR‑1139 Injection and HRS‑5346 Tablets, trial progression and outcomes, and potential regulatory approvals. Actual results may differ due to risks including clinical trial execution, safety and efficacy findings, regulatory review outcomes, and competitive developments in the Lp(a) inhibitor and bispecific antibody fields.-Fineline Info & Tech
