By Fineline Cube 
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that China’s National Medical Products Administration (NMPA) has granted approval for clinical trials of two independently developed biologics: SHR‑3045 injection for rheumatoid arthritis (RA) and SHR‑1139 injection for ulcerative colitis (UC). The approvals mark the first step toward bringing these innovative therapies to patients in China and potentially beyond.
What Are SHR‑3045 and SHR‑1139?
- SHR‑3045 is designed to inhibit the function of key immune cells that drive inflammation in RA, aiming to suppress joint swelling, pain, and functional decline.
- SHR‑1139 seeks to combine anti‑inflammatory action with preservation of the intestinal epithelial barrier, offering a dual mechanism that could improve mucosal healing and reduce flare‑ups in UC.
Both agents are therapeutic biologics produced under Hengrui’s proprietary platform, and no comparable drugs have been approved for marketing in either domestic or international markets.
Strategic Significance
- Clinical Development: The NMPA approvals allow Hengrui to initiate Phase I/II studies, potentially accelerating the timeline for a global launch.
- Portfolio Diversification: Adding RA and UC indications expands Hengrui’s presence in the rapidly growing immune‑inflammatory disease sector, which is projected to exceed US$12 billion by 2030.
- Regulatory Momentum: Successful trials could pave the way for subsequent approvals in the U.S. and EU, positioning Hengrui as a key contender in the biologics arena.
Next Steps
Hengrui plans to commence Phase I safety studies for SHR‑3045 and SHR‑1139 in the next quarter. The company will also engage with key opinion leaders and patient advocacy groups to refine trial designs and ensure robust data collection. If early results are favorable, Hengrui aims to pursue accelerated approval pathways in China and seek regulatory submissions in other major markets by 2028.-Fineline Info & Tech