Prestige Biopharma Ltd. is mounting efforts to rise rank through the industry with a two-pronged strategy of becoming a global cancer antibody drug developer and contract development and manufacturing organization.
Mabwell (Shanghai) Bioscience Co. Ltd. has received clearance by China’s National Medical Products Administration (NMPA) for its clinical trial application for 9MW-2921 for advanced solid tumors.
Hangzhou Qihan Biotech Co. Ltd. has received clinical trial clearance from China’s National Medical Products Administration (NMPA) for QN-019a for CD19-positive relapsed/refractory aggressive B-cell non-Hodgkin lymphoma.
Viiv Healthcare Group’s long-acting therapies to treat human immunodeficiency virus (HIV), including cabotegravir as an oral tablet and as an injectable, have been approved by China’s NMPA, expanding the company’s presence in the sector and giving HIV patients in the country a new treatment option.
China’s NMPA approved Daiichi Sankyo Co. Ltd. and Astrazeneca plc’s Enhertu (fam-trastuzumab deruxtecan) as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer.
Another collaboration between two biopharmaceutical companies in the Asia-Pacific region is adding fuel to an already heated fire for antibody-drug conjugate (ADC) development worldwide. Suzhou, China-headquartered Genequantum Healthcare Co. Ltd. and South Korea’s Aimedbio Inc. recently announced extending an existing partnership to jointly develop five ADC investigative drugs.
On the heels of a licensing deal last week, Genequantum Healthcare Co. Ltd. has struck another deal, this time out-licensing its conjugation technology to Inxmed Co. Ltd. to support development of next-generation targeted antibody-drug conjugates (ADCs).
Shineco Inc.’s subsidiary Changzhou Biowin Pharma received marketing approval from China’s NMPA for its test device that can complete a diagnosis of acute myocardial infarction in five minutes. The five-minute cardiac test relies on a combination of three major cardiac markers that can detect cardiac troponin I, myoglobin and heart fatty acid binding protein in a single test.
Lifetech Scientific Corp.’s fully degradable iron-based absorbable coronary scaffold showed its safety and efficacy to treat non-complex coronary lesions that have not been previously treated with an interventional device during a three-year, first-in-humans trial.
China’s NMPA approved Daiichi Sankyo Co. Ltd. and Astrazeneca plc’s Enhertu (fam-trastuzumab deruxtecan) as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer.