-
Garsorasib Tablets Approved with Conditions for Marketing by China NMPA
2025-02-19
Recently, the Class 1 innovative drug Garsorasib Tablets (trade name: 安方宁) of Shanghai Chia-tai Tianqing Pharmaceutical Technology Development Co. Ltd. is approved with conditions for marketing through the priority review and approval procedure by NMPA in China.
-
Zorifertinib Hydrochloride Tablets Approved for Marketing by China NMPA
2025-02-19
Recently, the Class 1 innovative drug Zorifertinib Hydrochloride Tablets (trade name: 泽瑞尼) of Alpha Biopharma (Jiangsu) Co., Ltd. is approved for marketing by China NMPA.
-
NMPA Announcement on the Applicability of ICH Guideline M12: Drug Interaction Studies and Its Q&A Document (No. 130, 2024)
2025-02-19
To keep pace with the international technical standards for drug registration, NMPA has decided after research to apply ICH Guideline M12: Drug Interaction Studies and its Q&A document (hereinafter referred to as the M12 Guidelines and its Q&A document).
-
NMPA Announcement on the Applicability of ICH Guideline E11A: Pediatric Extrapolation (No. 139, 2024)
2025-02-19
To keep pace with the international technical standards for drug registration, NMPA has decided after research to apply ICH Guideline E11A: Pediatric Extrapolation (hereinafter referred to as the E11A Guidelines).
-
Ebronucimab Injection Approved for Marketing by China NMPA
2025-02-19
Recently, the Ebronucimab Injection (trade name: 伊喜宁) of Kangrong Dongfang (Guangdong) Pharmaceutical Co., Ltd. is approved for marketing by China NMPA.
-
Iparomlimab and Tuvonralimab Injection Approved with Conditions for Marketing by China NMPA
2025-02-19
Recently, the Iparomlimab and Tuvonralimab Injection (trade name: 齐倍安) of Qilu Pharmaceuticals Co., Ltd. is approved for marketing with conditions by China NMPA. It is indicated for the treatment of recurrent or refractory cervix carcinoma patients who progressed on or after platinum-based chemotherapy.
