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RSS FeedPosted by Michael Wonder on 05 Jun 2023
Amarin Partner EddingPharm receives regulatory approval for Vascepa (icosapent ethyl) in Mainland China
1 June 2023 - Vascepa approved by the NMPA as an adjunct to diet to reduce triglyceride levels in adult patients ...
Posted by Michael Wonder on 05 Jun 2023
NMPA accepted Akeso's ebronucimab (PCSK9) marketing application in two cardiovascular indications
1 June 2023 - Akeso announced today that China's NMPA has accepted its new drug application for its fully human anti-PCSK9 ...
Posted by Michael Wonder on 02 Jun 2023
AD treatment Dupixent approved for use in China for young children
31 May 2023 - Sanofi announced on Tuesday that Dupixent, the world's first targeted biological agent for atopic dermatitis treatment, ...
Posted by Michael Wonder on 08 May 2023
BeiGene receives new approvals for Brukinsa (zanubrutinib) in China
6 May 2023 - Brukinsa is approved for first-line treatment for CLL/SLL and Waldenström's macroglobulinaemia in China and has multiple approved indications ...
Posted by Michael Wonder on 08 May 2023
Koselugo approved in China for paediatric patients with neurofibromatosis type 1 and plexiform neurofibromas
8 May 2023 - First and only approved treatment in China for rare and progressive genetic condition, which can result ...
Posted by Michael Wonder on 18 Apr 2023
HUTCHMED announces NDA acceptance in China for fruquintinib in second-line gastric cancer
18 April 2023 - HUTCHMED today announces that its new drug application for fruquintinib in combination with paclitaxel for the treatment ...
Posted by Michael Wonder on 23 Mar 2023
Calquence granted first regulatory approval in China for adults with previously treated mantle cell lymphoma
23 March 2023 - Across two clinical trials 82% overall response and 35% complete response rate were observed in Chinese ...
Posted by Michael Wonder on 15 Mar 2023
China National Medical Products Administration accepts regulatory submission for Nucala (mepolizumab) in severe eosinophilic asthma
14 March 2023 - GSK today announced that the China National Medical Products Administration has accepted for review a new drug ...
Posted by Michael Wonder on 13 Mar 2023
Haihe Biopharma announces gumarontinib receives approval from the NMPA of China for the treatment of locally advanced or metastatic NSCLC with MET exon 14 skipping mutation
8 March 2023 - Haihe Biopharma today announced that the NMPA of China has given conditional approval to gumarontinib, an oral ...
Posted by Michael Wonder on 10 Mar 2023
Astellas and Seagen announce China's National Medical Products Administration accepts biologics license application for enfortumab vedotin in certain patients with locally advanced or metastatic urothelial cancer
10 March 2023 - Clinical data submitted are consistent with global data and support enfortumab vedotin as a platinum-free option ...
Posted by Michael Wonder on 28 Feb 2023
CStone announces China’s NMPA has accepted the supplementary new drug application of sugemalimab as first-line treatment for patients with locally advanced or metastatic gastric/gastro-oesophageal junction adenocarcinoma
28 February 2023 - This supplementary new drug application was filed for the fourth indication for sugemalimab in China, following applications ...
Posted by Michael Wonder on 28 Feb 2023
Biologics license application for lecanemab designated for priority review by China NMPA
28 February 2023 - Eisai and Biogen announced today that the biologics license application for lecanemab (brand name in the US: ...
Posted by Michael Wonder on 24 Feb 2023
Enhertu approved in China for patients with HER2 positive metastatic breast cancer treated with one or more prior anti-HER2-based regimens
24 February 2023 - First approval for AstraZeneca and Daiichi Sankyo’s Enhertu in China. ...
Posted by Michael Wonder on 06 Feb 2023
China’s 2022 NRDL readout
7 February 2023 - Despite the twists and turns, 2022 turned out to be a banner year for National Reimbursement ...
Posted by Michael Wonder on 03 Feb 2023
Zai Lab announces NDA for sulbactam-durlobactam granted priority review by China’s NMPA
30 January 2023 - Zai Lab today announced that the Center for Drug Evaluation of China’s National Medical Products Administration has ...