Member Profile
PharmaEssentia Corporation
藥華醫藥以原創性長效型蛋白質藥物研發定點 PEGylation 技術平台及高難度小分子合成藥物技術等為基礎，製造出更優質的一系列突破性新藥產品，幫助病患對抗血液腫瘤、慢性肝炎感染、惡性皮膚病以及某些嚴重的癌症。PEGylation為將蛋白質藥物與長鏈高分子PEG (polyethylene glycol) 結合在一起的技術，目的為延長蛋白質藥物在人體血液內維持有效濃度的時間，使藥物具有最長藥效和最單純化合物的優勢。Ropeginterferon alfa-2b是以前述平台所製成的幾近單一化合物高純度的蛋白質新藥，形成一個化學上穩定且單一成分的新一代PEG長效型α干擾素藥物；Ropeginterferon alfa-2b以治療真性紅血球增生症 (Polycythemia Vera ，PV) 已於2019年2月取得歐洲藥物管理局 (EMA) 的上市許可、2020年5月取得台灣衛福部 (TFDA) 的上市許可、2021年10月取得韓國的上市許可、2021年11月取得美國食品藥物管理局 (FDA) 的上市許可、2023年3月取得日本的上市許可。
Product Pipelines
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Company Milestones
| 2017 | PharmaEssentia approves EMA’s PAI (Pre-Approval Inspection) for PV. |
| 2018 | The data of P1101 (Ropeginterferon alfa-2b) for PV in Phase III shows superiority in Durable Response for HU patients. |
| 2018 | PharmaEssentia Taipei Laboratory received GMP Certificate approved from EMA. |
| 2018 | PharmaEssentia Taichung manufacturing site received GMP Certificate approved from TFDA and EMA. |
| 2019 | The Marketing Authorization For Ropeginterferon alfa-2b (Besremi) is granted by EMA. |
| 2020 | The marketing authorization for Ropeginterferon alfa-2b for treatment of Polycythemia Vera (PV) was granted by TFDA. |
| 2020 | The marketing authorization for Ropeginterferon alfa-2b for treatment of Polycythemia Vera (PV) was granted in Switzerland. |
| 2021 | The marketing authorization for Ropeginterferon alfa-2b for treatment of Polycythemia Vera (PV) was granted in Israel. |
| 2021 | The marketing authorization for Ropeginterferon alfa-2b for treatment of Polycythemia Vera (PV) was granted in Korea. |
| 2021 | The marketing authorization for Ropeginterferon alfa-2b for treatment of Polycythemia Vera (PV) was granted by U.S FDA. |