Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced NMPA clearance to initiate a Phase I clinical trial evaluating SHR-2524 injection in combination with bevacizumab as first-line treatment for advanced hepatocellular carcinoma (HCC). The Category 2.1 and 2.3 modified therapeutic biological product represents a novel subcutaneous formulation with no similar products currently available domestically or internationally, positioning Hengrui to address the largest liver cancer market globally with improved patient convenience and compliance.
Regulatory Milestone
Item
Detail
Agency
National Medical Products Administration (NMPA)
Approval Type
Phase I clinical trial authorization (IND)
Product
SHR-2524 injection
Drug Class
Category 2.1 and 2.3 modified therapeutic biological product
Potential for improved patient convenience, reduced infusion center burden, enhanced compliance
HCC Market Context:
China Burden: 400,000+ annual cases; 50% of global HCC incidence; hepatitis B-driven etiology
Standard of Care: Atezolizumab + bevacizumab (IMbrave150 regimen) dominates first-line; subcutaneous alternatives limited
Unmet Need: IV infusion requirements limit access in community settings; subcutaneous enables broader distribution
Competitive Landscape
Product
Developer
Mechanism/Class
Route
China Status
SHR-2524 Differentiation
Avastin (bevacizumab)
Roche
Anti-VEGF mAb
IV
Approved (HCC)
Subcutaneous formulation convenience
Tecentriq + Avastin
Roche
PD-L1 + anti-VEGF
IV
Approved (1L HCC)
Potential subcutaneous alternative to IV combination
Sintilimab + bevacizumab
Innovent
PD-1 + anti-VEGF
IV
Approved (1L HCC)
Formulation innovation vs. standard IV
Hengrui
SHR-2524
Modified biologic (undisclosed target)
Subcutaneous
Phase I-ready
First subcutaneous formulation in class; potential for combination versatility
Development Outlook
Phase
Timeline
Objectives
Phase I
2026-2027
PK/PD characterization; safety/tolerability of subcutaneous route; preliminary efficacy signals
Phase II
2027-2028
Expansion in HCC; biomarker stratification; combination optimization
Phase III
2028-2030
Head-to-head vs. standard of care (atezo/bev); China NDA filing
Global Strategy
2029+
U.S./EU IND potential; subcutaneous formulation may support 505(b)(2) pathway
Forward‑Looking Statements This brief contains forward‑looking statements regarding clinical development timelines, formulation advantages, and competitive positioning for SHR-2524 in hepatocellular carcinoma. Actual results may differ due to target/mechanism disclosure timing, subcutaneous bioavailability challenges, and competitive dynamics in the HCC immunotherapy market.-Fineline Info & Tech
By Fineline Cube