By Fineline Cube 
China‑based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (HKG: 1276, SHA: 600276) announced that the China National Medical Products Administration (NMPA) has approved an open‑label, multicenter Phase 1b/2 clinical trial of its novel antibody‑drug conjugate (ADC) SHR‑A2009 in combination with existing anti‑tumor therapies for patients with advanced solid tumors.
What Is SHR‑A2009?
- Target – Human epidermal growth factor receptor‑3 (HER3) expressed on the surface of many solid‑tumor cells.
- Mechanism – The ADC binds HER3, is internalized, and delivers a cytotoxic payload via lysosomal hydrolysis, selectively killing HER3‑positive tumor cells.
- Innovation – No other HER3‑targeted ADC has received global marketing approval, positioning SHR‑A2009 as a first‑in‑class candidate.
Regulatory Milestone
- NMPA Clearance – The agency approved the initiation of a Phase 1b/2 study, allowing Hengrui to evaluate safety, tolerability, and preliminary efficacy in a real‑world, combination‑therapy setting.
- Trial Design – Open‑label, multicenter, enrolling patients with advanced solid tumors who are receiving standard anti‑tumor regimens.
Investment & Development
- R&D Spend – The cumulative research and development investment for SHR‑A2009 has reached ≈ RMB 197.74 million (≈ US$ 28 million).
- Pipeline Positioning – This investment underscores Hengrui’s commitment to expanding its ADC portfolio and to addressing unmet needs in oncology.
Market Implications
- Competitive Landscape – By targeting HER3, SHR‑A2009 fills a therapeutic niche where most ADCs focus on HER2, EGFR, or CD33.
- Strategic Advantage – Early‑phase data will guide dose‑optimization and potential combination partners, enhancing Hengrui’s positioning in the global ADC market.-Fineline Info & Tech