Alvotech ehf., of Iceland, and an independent sister company of U.S. pharmaceutical firm Alvogen Group Inc., recently joined hands with China's Changchun High & New Technology Industries Group Inc. to develop, manufacture and commercialize Alvotech's biosimilars in the Asian country. The collaboration will see a new joint venture with manufacturing capabilities in China's Jilin province, which will be equally funded by both companies.
HONG KONG – Japan's Ministry of Health, Labour and Welfare gave the nod to Blincyto (blinatumomab) for use in relapsed or refractory B-cell acute lymphoblastic leukemia (ALL), marking the bispecific T-cell engager's entry into the Asian market, following approvals in the U.S., all members of the EU and European Economic Area, Canada and Australia.
HONG KONG – The recent M&A deal between Japan's 237-year-old Takeda Pharmaceutical Co. Ltd. and Irish firm Shire plc has attracted massive attention, not just because of the mammoth size of the deal but also the tug of war among the Japanese company's shareholders, a group of which made a failed attempt to block the deal during Takeda's general meeting earlier this year.
Alvotech ehf., of Iceland, and an independent sister company of U.S. pharmaceutical firm Alvogen Group Inc., recently joined hands with China's Changchun High & New Technology Industries Group Inc. to develop, manufacture and commercialize Alvotech's biosimilars in the Asian country. The collaboration will see a new joint venture with manufacturing capabilities in China's Jilin province, which will be equally funded by both companies.
HONG KONG – Japan's Ministry of Health, Labour and Welfare gave the nod to Blincyto (blinatumomab) for use in relapsed or refractory B-cell acute lymphoblastic leukemia (ALL), marking the bispecific T-cell engager's entry into the Asian market, following approvals in the U.S., all members of the EU and European Economic Area, Canada and Australia.
HONG KONG – The recent M&A deal between Japan's 237-year-old Takeda Pharmaceutical Co. Ltd. and Irish firm Shire plc has attracted massive attention, not just because of the mammoth size of the deal but also the tug of war among the Japanese company's shareholders, a group of which made a failed attempt to block the deal during Takeda's general meeting earlier this year. (See BioWorld, May 8, 2018.)
HONG KONG – China's Zhejiang Hisun Pharmaceutical Co. Ltd. said results of two key phase III trials for HS-25, a cholesterol absorption inhibitor that targets hyperlipoproteinemia, showed both met the standard 12-week descent rate of low-density lipoprotein cholesterol (LDL-C), while adverse drug reactions were minor. In the next one to two months, the company is expected to apply to the National Medical Products Administration (NMPA), China's FDA, for marketing clearance.
HONG KONG – China's Zhejiang Hisun Pharmaceutical Co. Ltd. said results of two key phase III trials for HS-25, a cholesterol absorption inhibitor that targets hyperlipoproteinemia, showed both met the standard 12-week descent rate of low-density lipoprotein cholesterol (LDL-C), while adverse drug reactions were minor. In the next one to two months, the company is expected to apply to the National Medical Products Administration (NMPA), China's FDA, for marketing clearance.
HONG KONG – Shanghai-based Fosun Kite Biotechnology Co. Ltd. was granted approval from China's National Medical Products Administration (NMPA) to advance its gene therapy candidate, FKC-876, to clinical trials.
HONG KONG – China has seen a busy month of drug approvals, from Lenvima (lenvatinib, Eisai Co. Ltd. and Merck & Co. Inc.) on Sept. 5 to Elunate (fruquintinib, Hutchison China Meditech Ltd.) and Soliris (eculizumab, Alexion Pharmaceuticals Inc.) on Sept. 6. More notably, the three drugs, all accepted under the priority review pathway, were granted marketing approval in about a year.
