Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that SHR‑1826, an antibody‑drug conjugate (ADC) targeting c‑Met, has been granted Breakthrough Therapy Designation (BTD) by China’s Center for Drug Evaluation (CDE) for the treatment of locally advanced or metastatic non‑squamous NSCLC patients with high c‑Met overexpression who have progressed after prior systemic therapy.
Monotherapy for c‑Met overexpressed (2‑3+, ≥50%), driver‑gene‑negative, advanced nsq‑NSCLC post ≥1 prior therapy
Designation Date
10 Jan 2026
Next Steps
Priority review pathway; potential NDA submission in Q4 2026
Drug Profile & Mechanism
Mechanism of Action: SHR‑1826 is an ADC that binds to c‑Met on tumor cell surfaces, internalizes, and releases a cytotoxic payload, leading to targeted cell death while sparing normal tissue
Target Population:c‑Met overexpression (2‑3+, ≥50%) occurs in ~5‑7 % of NSCLC cases; typically associated with poor prognosis and resistance to EGFR‑TKIs and immunotherapy
Differentiation: Designed for high specificity and stable linker technology to minimize off‑target toxicity; addresses unmet need in driver‑gene‑negative population lacking targeted options
Global Benchmark: AbbVie’s Emerlis (telisotuzumab vedotin, ABBV‑399) received FDA accelerated approval in May 2025 for similar indication, validating the c‑Met ADC approach
Market Opportunity & Patient Landscape
Parameter
China
Global
NSCLC New Cases Annually
800,000
2,200,000
c‑Met High Overexpression (≥50%)
40,000‑56,000
110,000‑154,000
Driver‑Gene‑Negative Subset
24,000‑34,000
66,000‑92,000
2L+ Treatment‑Eligible
~17,000
~46,000
Addressable Market Value (2030E)
¥2.5 billion
$1.8 billion
Unmet Need: Current 2L+ options (chemo, immunotherapy) offer ORR <15 % and mPFS ~3 months in c‑Met overexpressed NSCLC
Pricing Benchmark: Emerlis US pricing: $18,000/month; Hengrui expected to price SHR‑1826 at ¥80,000‑100,000/month in China
Competitive Landscape: c‑Met ADCs
Drug
Company
Status
Approval Region
Key Efficacy (ORR)
Emerlis (telisotuzumab vedotin)
AbbVie
Accelerated approval
US (May 2025)
32 %
SHR‑1826
Hengrui
Breakthrough designation (China)
China (pending)
TBD (Phase II data expected Q3 2026)
RC108
RemeGen
Phase II
China
28 % (preliminary)
ABBV‑514
AbbVie
Phase I
Global
Early stage
Strategic Moat: BTD provides 6‑month expedited review and positions SHR‑1826 as first‑to‑market c‑Met ADC in China, ahead of AbbVie’s potential China filing
Global Expansion: Hengrui planning US IND filing in H1 2027, leveraging China BTD and Phase II data for FDA fast‑track eligibility
Development Timeline & Revenue Forecast
Milestone
Expected Timeline
Phase II completion
Q3 2026
NDA submission
Q4 2026
China approval
Q2 2027 (via BTD pathway)
US IND filing
H1 2027
Global launch
2028‑2029
Parameter
2027E
2028E
2029E
China Market Penetration
0 %
12 %
25 %
Patient Volume
–
2,040
4,250
Annual Cost (¥)
–
¥90,000
¥85,000
Hengrui China Revenue (¥)
–
¥1.84 billion
¥3.61 billion
Pipeline Synergy: SHR‑1826 complements Hengrui’s SHR‑1701 (PD‑L1/TGF‑β bispecific) and SHR‑0302 (JAK1 inhibitor), creating a comprehensive NSCLC portfolio
Manufacturing: Hengrui’s Nanjing ADC facility (capacity 5,000 L) ready for commercial production; additional $50 M investment planned for expansion
Forward‑Looking Statements This brief contains forward‑looking statements regarding clinical development timelines, regulatory pathways, and revenue forecasts for SHR‑1826. Actual results may differ due to clinical trial outcomes, competitive dynamics, and evolving c‑Met biomarker diagnostic standards.-Fineline Info & Tech
By Fineline Cube