Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the U.S. Food and Drug Administration (FDA) has formally accepted its Biologics License Application (BLA) for HANBEITAI, a recombinant anti‑VEGF humanized monoclonal antibody (bevacizumab biosimilar), for the treatment of multiple solid tumors including metastatic colorectal cancer, non‑squamous NSCLC, glioblastoma, renal cell carcinoma, cervical cancer, and ovarian cancer.
Regulatory Milestone
Item
Detail
Company
Shanghai Henlius Biotech, Inc. (2696.HK)
Drug
HANBEITAI (bevacizumab biosimilar)
Application
BLA (Biologics License Application)
Agency
US FDA
Indications
mCRC, nsNSCLC, glioblastoma, RCC, cervical cancer, ovarian cancer
Filing Date
13 Jan 2026
PDUFA Target
Q3 2026 (eligible for biosimilar pathway)
China Approval
2021
Latin America
Approved in Bolivia, Dominican Republic, Mexico (2021‑2023)
Drug Profile & Mechanism of Action
Mechanism:Anti‑VEGF monoclonal antibody that inhibits tumor angiogenesis, starving tumors of blood supply and enhancing chemotherapy efficacy
Biosimilarity: Demonstrates analytical, functional, and clinical similarity to reference product Avastin (bevacizumab)
Clinical Experience: >5,000 patients treated across China and Latin America with comparable safety and efficacy to originator
Pipeline Expansion: Henlius is actively advancing a Phase II/III study of HANBEITAI in combination with its core immunotherapy product Hetronifly (serplulimab, anti‑PD‑1 mAb) for first‑line metastatic colorectal cancer, aiming for chemo‑free regimen differentiation
Market Impact & Competitive Landscape
Parameter
2026E
2027E
2028E
US Bevacizumab Market Size
$2.8 billion
$2.6 billion
$2.4 billion
Biosimilar Penetration
78 %
85 %
90 %
HANBEITAI Market Share (if approved)
0 %
8 %
15 %
Annual Price (70 % discount to brand)
$18,000
$17,500
$17,000
Henlius US Revenue
–
$326 million
$614 million
Henlius LatAm Revenue
$45 million
$52 million
$58 million
Competitors:Amgen’s Mvasi (first US bevacizumab biosimilar, 2019), Roche’s bevacizumab biosimilar portfolio (market leader with 60 % share)
Differentiation: Henlius’s cost advantage (manufacturing in China) enables aggressive pricing; combination with Hetronifly offers first‑line IO‑VEGF option at 30‑40 % discount to Keytruda + Avastin
Market Access: FDA biosimilar pathway acceptance demonstrates robust similarity package; potential for interchangeability designation in 2027
Development Timeline & Strategic Value
Milestone
Expected Date
FDA Advisory Committee
Q2 2026 (if required)
Potential US Approval
Q4 2026
US Commercial Launch
Q1 2027
Hetronifly + HANBEITAI Phase II/III topline
Q3 2027
China + LatAm Combination Filing
Q4 2027
Strategic Moat: Henlius becomes first Chinese biotech with FDA‑approved oncology biosimilar and simultaneous IO combo in development, enabling global branded oncology franchise
Reinvestment: US biosimilar revenue will fund Hetronifly global expansion and next‑gen ADC pipeline (e.g., HLX42, HLX43)
Forward‑Looking Statements This brief contains forward‑looking statements regarding FDA review timelines, commercial launch, and market penetration for HANBEITAI. Actual results may differ due to regulatory decisions, competitive pricing dynamics, and market access negotiations.-Fineline Info & Tech
By Fineline Cube