Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 06 Jun 2024
Ivonescimab in combination with chemotherapy approved in China by NMPA for 2L+ EGFRm NSCLC based on HARMONi-A clinical trial: positive trend observed in overall survival towards ivonescimab plus chemotherapy
31 May 2024 - Separate and distinct from HARMONi-2 announcement, HARMONi-A showed clinically meaningful and statistically significant benefit: progression-free survival hazard ...
Posted 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 ...