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RSS FeedPosted by Michael Wonder on 03 Jan 2025
Innovent announces second new drug pplication of Dovbleron (taletrectinib adipate capsule, ROS1 inhibitor) was approved by China's National Medical Products Administration
2 January 2025 - Innovent Biologics today announced that China's National Medical Products Administration has approved the second new drug application ...
Posted by Michael Wonder on 19 Dec 2024
Lilly's Kisunla (donanemab-azbt) approved in China for the treatment of early symptomatic Alzheimer's disease
17 December 2024 - China is the fourth major market where Kisunla has received approval. ...
Posted by Michael Wonder on 05 Dec 2024
Kelun-Biotech’s TROP2 ADC sacituzumab tirumotecan approved for marketing by NMPA of China for second-line advanced or metastatic triple negative breast cancer
27 November 2024 - Sichuan Kelun-Biotech Biopharmaceutical announced that the Company received marketing authorisation in China from the NMPA for the ...
Posted by Michael Wonder on 14 Oct 2024
Enhertu approved in China as first HER2 directed therapy for patients with HER2 mutant metastatic non-small cell lung cancer
14 October 2024 - Approval based on DESTINY-Lung02 and DESTINY-Lung05 results which showed Enhertu demonstrated clinically meaningful efficacy in previously ...
Posted by Michael Wonder on 28 Sep 2024
Dupixent (dupilumab) approved in China as the first ever biologic medicine for patients with chronic obstructive pulmonary disease
27 September 2024 - Approval follows EU approval of Dupixent for adults with COPD with raised blood eosinophils, and is based ...
Posted by Michael Wonder on 24 Sep 2024
Japan's Ministry of Health, Labour and Welfare approves Padcev (enfortumab vedotin) with Keytruda (pembrolizumab) for first-line treatment of radically unresectable urothelial carcinoma
24 September 2024 - Approval based on the EV-302 trial where the treatment combination nearly doubled median overall survival and significantly ...
Posted by Michael Wonder on 29 Aug 2024
JW Therapeutics announces NMPA approval of the supplemental biological license application for Carteyva in adult patients with relapsed or refractory Mantle cell lymphoma
27 August 2024 - JW Therapeutics announced that the National Medical Products Administration of China has approved the supplemental Biological License ...
Posted by Michael Wonder on 20 Aug 2024
Fasenra approved in China for the treatment of severe eosinophilic asthma
20 August 2024 - Approval based on MIRACLE Phase 3 trial demonstrating a significant and clinically meaningful reduction in asthma ...
Posted by Michael Wonder on 20 Aug 2024
China’s NMPA approves Padcev (enfortumab vedotin) for treatment of locally advanced or metastatic urothelial cancer
20 August 2024 - Approval based on the global EV-301 and China EV-203 trials, where enfortumab vedotin significantly improved overall survival ...
Posted by Michael Wonder on 13 Aug 2024
Enhertu approved in China for patients with previously treated HER2 positive advanced or metastatic gastric cancer
13 August 2024 - Approval based on DESTINY-Gastric06 results which showed Enhertu demonstrated clinically meaningful efficacy in this setting. ...
Posted by Michael Wonder on 18 Jul 2024
Junshi Biosciences announces the acceptance of the supplemental new drug application for toripalimab combined with bevacizumab for the first-line treatment of advanced hepatocellular carcinoma
17 July 2024 - Shanghai Junshi Biosciences announced that the National Medical Products Administration has accepted for review the supplemental new ...
Posted by Michael Wonder on 16 Jul 2024
AusperBio receives breakthrough therapy designation for AHB-137 in chronic hepatitis B treatment
10 July 2024 - AHB-137 gains breakthrough therapy designation from the NMPA based on Phase 1/Phase2a clinical trial data demonstrating safety ...
Posted by Michael Wonder on 08 Jul 2024
Xpovio (selinexor) approved for new indication in DLBCL in China, bringing a new treatment option to patients in the country
5 July 2024 - Results from the registrational SEARCH study in China showed that the overall response rate among the ...
Posted by Michael Wonder on 04 Jul 2024
Gyre Therapeutics announces China’s NMPA approval of avatrombopag maleate tablets for the treatment of CLD associated thrombocytopenia
2 July 2024 - Gyre Therapeutics today announced that China’s National Medical Products Administration has approved Gyre Pharmaceuticals’ avatrombopag maleate tablets ...
Posted by Michael Wonder on 04 Jul 2024
Hutchmed announces NDA acceptance in China for tazemetostat for the treatment of relapsed or refractory follicular lymphoma with priority review status
4 July 2024 - - Hutchmed (China) today announces that the new drug application for tazemetostat for the treatment of ...