By Fineline Cube 
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that three of its investigational drugs received NMPA approval to initiate clinical trials: trastuzumab rezetecan (HER2 ADC), HRS‑8364 tablets (target undisclosed), and SHR‑1139 injection (pyoderma gangrenosum), strengthening its oncology and immunology pipeline.
Regulatory Milestone
| Drug | Indication | Development Stage | Previous Milestones | Global Novelty |
|---|---|---|---|---|
| Trastuzumab rezetecan | HER2‑amplified solid tumors (monotherapy) | Phase I/II initiation | Approved May 2025 for HER2‑mutant NSCLC | First domestic HER2 ADC |
| HRS‑8364 tablets | Advanced solid tumors (monotherapy) | Phase I initiation | Target undisclosed | No similar drugs approved globally |
| SHR‑1139 injection | Pyoderma gangrenosum | Phase II initiation | Approved for psoriasis/UC (2023) | No similar biologics approved globally |
Drug Profiles
Trastuzumab Rezetecan
- Class: Antibody‑Drug Conjugate (ADC) targeting HER2
- Innovation: Extends HER2 ADC platform beyond NSCLC into broader solid tumor indications
- Market Edge: Addresses HER2‑amplified cancers (breast, gastric, colorectal) with limited ADC options
HRS‑8364
- Class: Novel anti‑tumor small molecule (target undisclosed)
- Strategy: First‑in‑class potential with global IP; mechanism protected until IND disclosure
- Pipeline Value: Represents Hengrui’s next‑generation oncology asset beyond kinase inhibitors
SHR‑1139
- Class: Therapeutic biological product (mechanism undisclosed)
- Expansion: Re‑positions psoriasis/UC asset for pyoderma gangrenosum, a rare, debilitating neutrophilic dermatosis
- Unmet Need: No approved biologics globally; addresses severe ulcerative skin disease
Market Impact & Outlook
| Indication | China Patient Pool | Market Size (2024) | Competitive Landscape | Peak Sales Forecast |
|---|---|---|---|---|
| HER2‑amplified solid tumors | ~150,000 | ¥25 billion | Dominated by trastuzumab biosimilars; ADCs emerging | ¥800 million (rezetecan) |
| Undisclosed solid tumor target | TBD (depending on target) | TBD | First‑mover advantage if validated | ¥500 million (if approved) |
| Pyoderma gangrenosum | ~8,000‑10,000 | ¥300 million | No approved biologics; steroids/immunosuppressants standard | ¥150 million (SHR‑1139) |
- Strategic Value: Three approvals demonstrate Hengrui’s parallel development capacity across ADC, small molecule, and biologic platforms
- R&D Efficiency: Leverages existing manufacturing and regulatory expertise from prior approvals
- Next Catalysts: Phase I data for HRS‑8364 expected H2 2026; trastuzumab rezetecan HER2‑amplified data Q1 2026
Forward‑Looking Statements
This brief contains forward‑looking statements regarding Hengrui’s clinical development timelines, market potential, and competitive positioning. Actual results may differ materially due to risks including clinical trial outcomes, regulatory review, and competitive dynamics.-Fineline Info & Tech