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Crovalimab Injection Approved for Marketing by China NMPA
2024-02-07
Recently, the Crovalimab Injection (trade name: 派圣凯/Piasky) of Roche Pharma (Schweiz) AG was approved for marketing by China NMPA through the priority review and approval procedures. It is indicated for use in adults and adolescents (≥12 years old) with paroxysmal nocturnal hemoglobinuria who have not received complement inhibitor therapy.
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Tegileridine Fumarate Injection Approved for Marketing by China NMPA
2024-01-31
Recently, the Category 1 innovative product Tegileridine Fumarate Injection (trade name: 艾苏特) of Jiangsu Hengrui Pharmaceuticals Co., Ltd. was approved for marketing by China NMPA. It is indicated for moderate to severe pain after abdominal surgery.
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Ganagliflozin Proline Tablets Approved for Marketing by China NMPA
2024-01-19
Recently, the Category 1 innovative product Ganagliflozin Proline Tablets (trade name: 惠优静) of Jilin Huisheng Biopharmaceutical Co,. Ltd. was approved for marketing by China NMPA.
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Lecanemab Injection Approved for Marketing by China NMPA
2024-01-09
Recently, the Lecanemab Injection (trade name: 乐意保/Leqembi) of Eisai Inc. was approved for marketing by China NMPA through the priority review and approval procedures. It is indicated for the treatment of mild cognitive impairment and dementia caused by Alzheimer's disease.
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Dimdazenil Capsules Approved for Marketing by China NMPA
2023-11-29
Recently, the Category 1 innovative drug Dimdazenil Capsules of Zhejiang Jingxin Pharmaceutical Co., Ltd. was approved for marketing by China NMPA. This drug is indicated for short-term treatment for insomnia patients.
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Atilotrelvir Tablets/Ritonavir Tablets Approved with Conditions
2023-11-24
Recently, the Category 1 innovative drug Atilotrelvir Tablets/Ritonavir Tablets (co-packaged) (Chinese trade name: 泰中定) of Fujian Guangsheng Zhonglin Biotechnology Co., Ltd. was approved with conditions by China NMPA through the emergency review and approval procedure in accordance with the relevant provisions of special review and approval prescribed in the Drug Administration Law.