Gan & Lee Pharmaceuticals (SHA: 603087) and its European subsidiary Gan & Lee Europe announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending approval for two insulin biosimilars: Bysumlog (insulin lispro) and Dazparda (insulin aspart). Upon European Commission (EC) ratification, the products will be marketed across EU member states plus Iceland, Liechtenstein, and Norway, providing biosimilar alternatives to Eli Lilly’s Humalog and Novo Nordisk’s NovoRapid.
Regulatory Milestone
Item
Detail
Company
Gan & Lee Pharmaceuticals (SHA: 603087) + Gan & Lee Europe
Commercialization and sales in Europe + specified regions
Gan & Lee Responsibilities
Manufacturing supply and related matters
Strategic Value
Leverages Sandoz’s established European diabetes market access and payer relationships
Strategic Implications
Biosimilar Market Entry: Bysumlog and Dazparda will be among the first insulin biosimilars in the EU, targeting the € 2 billion+ European rapid‑acting insulin market dominated by originators.
Pricing Pressure: Biosimilar entry is expected to drive 20–40% price reductions, improving patient access while capturing market share from Lilly and Novo Nordisk.
China‑EU Biopharma Export: CHMP positive opinion validates Gan & Lee’s manufacturing quality and regulatory capabilities, supporting broader global biosimilar expansion.
Sandoz Partnership Synergy: Collaboration with Europe’s leading generics/biosimilars player de‑risks commercial execution and accelerates formulary access across diverse reimbursement systems.
Automatic substitution policies in multiple EU states; cost‑containment pressure on national health systems
Gan & Lee Positioning
First Chinese insulin manufacturer to achieve EMA positive opinion; establishes quality benchmark for domestic biopharma
Competitive Dynamics
Mylan/Viatris, Biocon, and others advancing insulin biosimilars; Gan & Lee/Sandoz combination provides strong competitive positioning
Forward‑Looking Statements This brief contains forward‑looking statements regarding EC final approval timelines, commercial launch dates, and market share capture. Actual results may differ due to risks including originator pricing responses, automatic substitution policy variations, and manufacturing supply consistency.-Fineline Info & Tech
By Fineline Cube 