Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that trastuzumab rezetecan (SHR-A1811), its HER2-targeted antibody-drug conjugate (ADC), has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of NMPA for first-line locally advanced or metastatic NSCLC with HER2 (ERBB2) activating mutations. This marks the eighth BTD for the in-house developed ADC, which has rapidly accumulated breakthrough designations across seven additional indications since its initial NSCLC approval in May 2025.
Breast cancer, NSCLC (2L+), colorectal cancer, gastric/GEJ adenocarcinoma, biliary tract cancer, primary peritoneal cancer, cervical cancer
First Approval
May 2025 – HER2-mutant NSCLC (≥1 prior systemic therapy)
BTD Portfolio Expansion
Indication
BTD Status
Strategic Value
First-line HER2+ NSCLC
New (8th BTD)
Front-line positioning vs. chemotherapy; largest addressable population
Breast cancer
BTD granted
Competing with trastuzumab deruxtecan (Enhertu) in HER2+ and HER2-low
Colorectal cancer
BTD granted
First HER2 ADC with BTD in this indication; filing under NMPA review
Gastric/GEJ adenocarcinoma
BTD granted
High HER2 prevalence; established HER2 therapy (trastuzumab) precedent
Biliary tract cancer
BTD granted
Orphan indication; limited treatment options
Primary peritoneal cancer
BTD granted
Rare gynecologic malignancy; unmet need
Cervical cancer
BTD granted
HPV-related; potential combination with immunotherapy
Second-line+ HER2+ NSCLC
Approved May 2025
First approved indication; foundation for first-line expansion
Strategic Positioning & Market Context
Factor
Strategic Analysis
HER2-Mutant NSCLC Prevalence
~2-4% of NSCLC patients (~20,000-40,000 annual cases in China); no approved HER2-targeted therapies in first-line globally
BTD Strategic Value
Accelerated development and review (6-12 month timeline compression); priority CDE consultation; conditional approval pathway eligibility
Hengrui ADC Platform Validation
Eight BTDs across solid tumors demonstrates broad mechanism applicability and regulatory confidence in SHR-A1811’s efficacy and safety profile
Competitive Landscape
Trastuzumab deruxtecan (Enhertu, AstraZeneca/Daiichi) leads globally; Hengrui’s domestic manufacturing and pricing positions for China market leadership and emerging market expansion
First-Line Opportunity
Front-line positioning (vs. second-line approval) captures treatment-naïve patients before chemotherapy resistance; premium pricing and volume potential
Development & Commercial Outlook
Priority
Execution Plan
Timeline
First-Line NSCLC
Phase III registrational trial; BTD-enabled accelerated pathway
2026-2027
NRDL Inclusion
Reimbursement negotiation for approved 2L+ indication; 1L+ filing preparation
2026
Global Expansion
Ex-China partnership discussions; FDA/EMA IND submissions
2026-2027
Pipeline Synergies
Combination studies with Hengrui’s PD-1 inhibitors (SHR-1210) and angiogenesis inhibitors
2026+
Forward‑Looking Statements This brief contains forward‑looking statements regarding trastuzumab rezetecan first-line NSCLC approval timelines, BTD-enabled commercial acceleration, and competitive positioning vs. trastuzumab deruxtecan. Actual results may differ due to Phase III trial outcomes, pricing pressure from national procurement programs, and global partnership negotiation results.-Fineline Info & Tech
By Fineline Cube