Neurodawn Pharmaceutical Co., Ltd. announced that its self‑developed Category 1 chemical drug, Y‑3 for Injection (generic name: Lobemilast), has had its New Drug Application (NDA) officially accepted by China’s National Medical Products Administration (NMPA) for the treatment of Acute Ischemic Stroke (AIS).
Regulatory Milestone
Item
Details
NDA Acceptance Date
11 Dec 2025
Agency
NMPA (China)
Product
Y‑3 for Injection (Lobemilast)
Drug Class
Category 1 chemical drug (innovative small molecule)
Preclinical: favorable tolerability; Phase II data pending
Reduced risk of off‑target effects vs. single‑target agents
Dosing
IV injection; early intervention post‑stroke
Potential for emergency‑room administration
Pipeline Extension
Being explored for post‑stroke depression and anxiety prevention
Expands beyond acute treatment
R&D Investment
2023: RMB 57.6 M; 2024: RMB 91 M; H1 2025: RMB 52.8 M
Rapidly accelerating spend
Market Opportunity
Metric
Value
Context
China AIS Incidence
~ 2.0 million new cases annually (2024)
<10% receive thrombolysis; high unmet need for neuroprotectants
China Stroke Care Market
¥18 billion (≈ US$2.5 B)
Dominated by thrombolytics (alteplase) and antiplatelets
Neuroprotectant Gap
No approved neuroprotectants in China; global pipeline limited
Lobemilast could be first‑in‑class if approved
Peak Sales Forecast
¥2.5‑3.5 billion (≈ US$350‑490 M) by 2032
Assumes 30% share of eligible AIS patients not receiving thrombolysis
Global Expansion Potential
Pathway validated in Western models; potential US/EU partnering
PSD95‑nNOS/MPO mechanism aligns with global neuroprotection research
Strategic Implications
For Neurodawn: NDA acceptance validates 12‑year R&D effort and positions the company as a leader in CNS innovation; next‑generation pipeline includes oral formulations and combination therapy candidates.
For Patients: If approved, Lobemilast offers neuroprotection beyond the 4.5‑hour thrombolysis window, potentially reducing disability in ischemic stroke patients.
For Investors: Neurodawn reportedly planning Hong Kong IPO in 2026; NDA acceptance strengthens pre‑IPO valuation and signals regulatory confidence.
Forward‑Looking Statements This brief contains forward‑looking statements regarding Lobemilast’s NDA review timeline, market penetration, and clinical development for post‑stroke psychiatric symptoms. Actual results may differ due to regulatory delays, competitive responses, or unforeseen safety signals.-Fineline Info & Tech
By Fineline Cube 