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RSS FeedPosted by Michael Wonder on 13 May 2024
Zai Lab announces approval of Augtyro (repotrectinib) for patients with ROS1 positive NSCLC by China’s NMPA
12 May 2024 - The approval is based on the pivotal TRIDENT-1 trial, in which Augtyro achieved a high response ...
Posted by Michael Wonder on 28 Mar 2024
China's National Medical Products Administration accepts Astellas and Pfizer's supplemental biologics license application for enfortumab vedotin with Keytruda (pembrolizumab) for first-line treatment of advanced bladder cancer
28 March 2024 - Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival vs platinum-containing ...
Posted by Michael Wonder on 04 Mar 2024
NMPA approves the NDA for CARsgen's BCMA CAR-T therapy zevorcabtagene autoleucel for relapsed or refractory multiple myeloma
1 March 2024 - CARsgen Therapeutics announces that today the National Medical Products Administration of China has approved the new drug ...
Posted by Michael Wonder on 11 Jan 2024
Nucala (mepolizumab) approved in China for use in severe asthma with an eosinophilic phenotype
10 January 2024 - Approval based on a separate Phase 3 trial among Chinese patients reinforcing mepolizumab’s efficacy and safety ...
Posted by Michael Wonder on 10 Jan 2024
Leqembi approved for the treatment of Alzheimer's disease in China
9 January 2024 - BioArctic's partner Eisai announced today that Leqembi (lecanemab-irmb) has been approved in China as a treatment for ...
Posted by Michael Wonder on 02 Jan 2024
Beyfortus approved in China for the prevention of RSV disease in infants
2 January 2024 - First and only RSV preventive option authorised for use in China ...
Posted by Michael Wonder on 22 Dec 2023
Takeda announces China NMPA approval of Livtencity (maribavir) for the treatment of adults with post-transplant cytomegalovirus refractory to prior therapies
21 December 2023 - Approval based on Phase 3 TAK-620-303 SOLSTICE study demonstrating maribavir was superior to conventional therapies at week ...
Posted by Michael Wonder on 21 Dec 2023
RemeGen announces continued inclusion of telitacicept and disitamab vedotin in China National Reimbursement Drug List, ensuring continuous accessibility of innovative drugs for more patients
18 December 2023 - RemeGen has recently confirmed that under the 2023 simple renewal mechanism of China National Healthcare Security ...
Posted by Michael Wonder on 18 Dec 2023
AnHeart Therapeutics and Innovent Announce China’s NMPA has granted taletrectinib (ROS1 inhibitor) priority review designation
18 December 2023 -AnHeart Therapeutics and Innovent Biologics today announced the Center for Drug Evaluation of China’s National Medical Products ...
Posted by Michael Wonder on 18 Dec 2023
Zai Lab announces the first listing of Vyvgart (efgartigimod alfa) and other updates in China’s National Reimbursement Drug List
12 December 2023 - Zai Lab today announced that the 2023 National Reimbursement Drug List (NRDL) released by China’s National Healthcare ...
Posted by Michael Wonder on 14 Dec 2023
Antengene announces inclusion of Xpovio (selinexor) in 2023 China's National Reimbursement Drug List
13 December 2023 - Antengene today announced that Xpovio (selinexor) has been added to the National Reimbursement Drug List (2023 Version) ...
Posted by Michael Wonder on 13 Dec 2023
Hutchmed announces continued inclusion of Elunate (fruquintinib) and Sulanda (surufatinib) in the National Reimbursement Drug List in China at current terms
12 December 2023 - Hutchmed today announces that under the 2023 simple renewal mechanism of the China National Healthcare Security Administration, ...
Posted by Michael Wonder on 11 Dec 2023
CStone announces NMPA approval of sugemalimab as first-line treatment for oesophageal squamous cell carcinoma
8 December 2023 - This marks the 13th new drug application approval obtained by CStone and sugemalimab's fourth indication approved in ...
Posted by Michael Wonder on 20 Nov 2023
Apollomics announces the first approval of vebreltinib for MET exon 14 skip non-small-cell lung cancer
16 November 2023 - Compelling clinical data serving as basis of this approval supports continued development of vebreltinib for the rest ...
Posted by Michael Wonder on 14 Nov 2023
Imfinzi plus chemotherapy approved in China as first immunotherapy regimen for patients with locally advanced or metastatic biliary tract cancer
14 November 2023 - Approval based on results from TOPAZ-1 global Phase 3 trial and a Chinese patient cohort which ...