Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 03 Jul 2024
China’s National Medical Products Administration Approves Xtandi (enzalutamide) in metastatic hormone sensitive prostate cancer
2 July 2024 - Approval marks Xtandi’s third indication for advanced prostate cancer in China. ...
Posted by Michael Wonder on 01 Jul 2024
Leqembi (lecanemab) for the treatment of Alzheimer’s disease launched in China
27 June 2024 - China is the third country to launch Leqembi following the United States and Japan. ...
Posted by Michael Wonder on 26 Jun 2024
Tagrisso with the addition of chemotherapy approved in China as first-line treatment for patients with EGFR-mutated advanced lung cancer
26 June 2024 - Approval based on FLAURA2 results which showed Tagrisso plus chemotherapy reduced the risk of disease progression ...
Posted by Michael Wonder on 20 Jun 2024
Golidocitinib approved in China as first in class JAK1 only inhibitor for the treatment of relapsed or refractory peripheral T-cell lymphoma
19 June 2024 - Golidocitinib is a first-in-class Janus kinase 1 only inhibitor approved for the treatment of relapsed/refractory PTCL based ...