[PharmaEssentia] Announcement that the Company's Taichung Plant has received GMP certification from the Drug Administration of Vietnam (DAV)
PharmaEssentia's Taichung plant achieved GMP certification from Vietnam's DAV, clearing a key hurdle for the marketing approval of its PV drug BESREMi in Vietnam.
📋 Article Processing Timeline
- 📰 Published: April 22, 2026 at 09:00
- 🔍 Collected: April 23, 2026 at 08:00 (23h 0m after Published)
- 🤖 AI Analyzed: April 23, 2026 at 12:33 (4h 32m after Collected)
1. Date of occurrence: 2026/04/22
2. Name or code of the new drug: BESREMi (Ropeginterferon alfa-2b, i.e., P1101)
3. Indication: For the treatment of adult patients with Polycythemia Vera (PV)
4. Planned R&D stages: Review of marketing authorization application in Vietnam
5. Current R&D stage:
(1) The Company's Taichung plant has been recognized as compliant with Good Manufacturing Practice (GMP) by the Drug Administration of Vietnam (DAV).
(4) Accumulated R&D expenses incurred: Considering future marketing strategies and to protect the rights of the company and investors, this will temporarily not be disclosed.
6. Next R&D stage:
Review of the marketing authorization application in Vietnam.
(1) Estimated completion time: Subject to DAV's review process and official notification.
7. Market status:
PV is a myeloproliferative neoplasm (MPN). Patients have a high risk of cardiovascular complications... According to market research, there are about 15,000 PV patients in Vietnam. Current treatments include phlebotomy, Hydroxyurea (HU), interferons, and JAK2 inhibitors.
8. Other matters to be specified:
(1) The company applied for the Vietnam marketing authorization for Ropeginterferon alfa-2b on April 1, 2025.
(2) Ropeginterferon alfa-2b is an innovative new-generation long-acting interferon developed and manufactured in-house. It has been approved in about 50 countries globally, including major markets like the US, Japan, China, and the EU.
9. New drug development takes a long time, involves high costs, and does not guarantee success. Investors should evaluate risks carefully.
2. Name or code of the new drug: BESREMi (Ropeginterferon alfa-2b, i.e., P1101)
3. Indication: For the treatment of adult patients with Polycythemia Vera (PV)
4. Planned R&D stages: Review of marketing authorization application in Vietnam
5. Current R&D stage:
(1) The Company's Taichung plant has been recognized as compliant with Good Manufacturing Practice (GMP) by the Drug Administration of Vietnam (DAV).
(4) Accumulated R&D expenses incurred: Considering future marketing strategies and to protect the rights of the company and investors, this will temporarily not be disclosed.
6. Next R&D stage:
Review of the marketing authorization application in Vietnam.
(1) Estimated completion time: Subject to DAV's review process and official notification.
7. Market status:
PV is a myeloproliferative neoplasm (MPN). Patients have a high risk of cardiovascular complications... According to market research, there are about 15,000 PV patients in Vietnam. Current treatments include phlebotomy, Hydroxyurea (HU), interferons, and JAK2 inhibitors.
8. Other matters to be specified:
(1) The company applied for the Vietnam marketing authorization for Ropeginterferon alfa-2b on April 1, 2025.
(2) Ropeginterferon alfa-2b is an innovative new-generation long-acting interferon developed and manufactured in-house. It has been approved in about 50 countries globally, including major markets like the US, Japan, China, and the EU.
9. New drug development takes a long time, involves high costs, and does not guarantee success. Investors should evaluate risks carefully.