Bio‑Thera Solutions (SHA: 688177) submitted a New Drug Application (NDA) to China’s National Medical Products Administration (NMPA) for Velasitaximab injection (BAT5906), a recombinant humanized anti‑VEGF‑A165 monoclonal antibody, for the treatment of neovascular (wet) age‑related macular degeneration (nAMD).
Regulatory Milestone
Item
Details
Submission Date
19 Dec 2025
Agency
NMPA (China)
Product
Velasitaximab injection (BAT5906)
Indication
Neovascular (wet) AMD
Innovation
Independently developed IgG1‑type full‑length antibody (149 kDa)
Mechanism
Binds VEGF‑A165, blocking angiogenesis and endothelial cell proliferation
Drug Profile & Preclinical Data
Attribute
BAT5906
Competitive Landscape
Antibody Type
Recombinant humanized IgG1, 149 kDa
Similar to aflibercept (Eylea) and ranibizumab (Lucentis)
For Bio‑Thera:NDA submission validates antibody platform beyond biosimilars; VEGF‑A165 selectivity positions for differentiated marketing; potential for global expansion if China data supports US/EU filings.
For Patients:Oral not available; injectable offers alternative to existing anti‑VEGF agents; cost‑effective option could improve access in tier‑2/3 cities.
For Market:First domestic VEGF‑A165 antibody challenges multinational dominance; NRDL negotiation likely in 2026; biosimilar pressure on Eylea/Lucentis creates pricing headroom.
Forward‑Looking Statements This brief contains forward‑looking statements regarding BAT5906’s regulatory review timeline, market penetration, and competitive positioning. Actual results may differ due to NMPA feedback, clinical risks, or competitive responses.-Fineline Info & Tech
By Fineline Cube 