By Fineline Cube 
Lundbeck A/S (OTCMKTS: HLUBF) announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has officially accepted its New Drug Application (NDA) for Vyepti (Eptinezumab), a preventive migraine therapy for adults. At the same time, the company has filed marketing‑authorization dossiers in Japan and South Korea, positioning Vyepti for rapid commercialization across the Asia‑Pacific region.
Product Profile
| Feature | Detail |
|---|---|
| Drug | Vyepti (Eptinezumab) |
| Mechanism | Humanized monoclonal antibody that neutralizes Calcitonin Gene‑Related Peptide (CGRP), suppressing CGRP‑mediated neurogenic inflammation |
| Administration | Intravenous infusion – rapid onset, convenient outpatient setting |
| Indication | Preventive treatment of chronic migraine in adults |
| Regulatory Status (China) | NDA accepted by CDE – first‑in‑class CGRP‑targeting anti‑migraine drug approved in China |
| Regulatory Status (Japan & Korea) | Marketing‑authorization applications submitted – pending review |
Key Clinical Evidence
- Phase III SUNRISE Trial (NCT04921384) – Interventional, multi‑regional, double‑blind, placebo‑controlled study enrolling chronic migraine patients of Asian descent.
- Outcomes:
- Significant reduction in migraine attack frequency
- Marked decrease in proportion of severe‑pain episodes
- Overall improvement in disease burden and quality of life metrics
- Real‑World Uptake (10 Oct 2024) – First infusion performed at Sun Yat‑sen Memorial Hospital (Sun Yat‑sen University), within the Guangdong‑Hong Kong‑Macao Greater Bay Area, demonstrating early adoption by leading specialist centers.
Market Implications
| Angle | Insight |
|---|---|
| Asian Expansion | With Chinese NDA in place and concurrent applications in Japan & Korea, Lundbeck’s migraine market entry is set to tap an estimated > 120 million patients regionally. |
| Competitive Landscape | Vyepti introduces the only CGRP‑blocking mAb approved in China, differentiating Lundbeck from competitors such as Erenumab and erenumab‑based biosimilars. |
| Commercial Strategy | IV‑infusion format enables streamlined pharmacy‑based service models, potentially translating into higher pricing tiers and improved reimbursement scenarios. |
| Investor View | Regulatory wins signal robust pipeline execution and strengthen Lundbeck’s positioning as a leading neuro‑pharmaceutics provider in emerging markets. |
Forward‑Looking Statements
The remarks above include forward‑looking statements concerning Lundbeck’s regulatory strategy, pending approvals in Japan and South Korea, and commercial prospects for Vyepti. Actual outcomes may differ materially.-Fineline Info & Tech