Blog
RSS FeedPosted by Michael Wonder on 09 Sep 2021
Merck’s Keytruda (pembrolizumab) approved in China in combination with chemotherapy for first-line treatment of patients with locally advanced unresectable or metastatic oesophageal or gastro-oesophageal junction carcinoma
7 September 2021 - Keytruda is now approved for eight indications across five different types of cancer in China. ...
Posted by Michael Wonder on 06 Sep 2021
JW Therapeutics announces NMPA approval of relmacabtagene autoleucel injection in China
6 September 2021 - The first CAR-T product independently developed in China and approved as a Category 1 biologics product, and ...
Posted by Michael Wonder on 05 Sep 2021
CStone announces China's NMPA has accepted its new drug application for sugemalimab in the treatment of stage III NSCLC
2 September 2021 - Sugemalimab becomes the world’s first anti-PD-1/PD-L1 monoclonal antibody to significantly improve progression-free survival in patients with stage ...
Posted by Michael Wonder on 31 Aug 2021
Ligand’s Partner Gloria Biosciences receives approval in China for zimberelimab for the treatment of recurrent or refractory classical Hodgkin’s lymphoma
31 August 2021 - First regulatory approval of an OmniAb derived antibody. ...
Posted by Michael Wonder on 24 Aug 2021
BeiGene announces acceptance of a supplemental biologics license application in China for tislelizumab in nasopharyngeal cancer
22 August 2021 - BeiGene today announced that the Center for Drug Evaluation of the China National Medical Products Administration ...
Posted by Michael Wonder on 18 Aug 2021
BeiGene and EUSA Pharma announce China NMPA approval of Qarziba (dinutuximab beta) for patients with high risk neuroblastoma
17 August 2021 - BeiGene and EUSA Pharma today announced that the China National Medical Products Administration has granted Qarziba (dinutuximab ...
Posted by Michael Wonder on 17 Aug 2021
Novartis secures new approval in China for Cosentyx (secukinumab) in paediatric psoriasis
17 August 2021 - China NMPA approval reinforces that Cosentyx (secukinumab) is safe and effective for children and adults with psoriasis. ...
Posted by Michael Wonder on 13 Aug 2021
GC Pharma announces GreenGene F approval in China for the treatment of haemophilia A
12 August 2021 - GreenGene F now approved in China, provides more haemophilia A patients access to proven therapy. ...
Posted by Michael Wonder on 05 Aug 2021
New drug application for penpulimab monoclonal antibody (PD-1) for third-line treatment of metastatic nasopharyngeal carcinoma accepted by NMPA
5 August 2021 - Akeso announced that the new drug application of penpulimab (AK105) for third-line treatment of metastatic nasopharyngeal ...
Posted by Michael Wonder on 22 Jul 2021
RareStone announces submission of new drug application of Wakix (pitolisant) for narcolepsy with and without cataplexy in China
21 July 2021 - Application is supported by data used in the Wakix EMA and the U.S. FDA approvals. ...
Posted by Michael Wonder on 21 Jul 2021
Sorrento announces its partner Mabpharm has received marketing approval in China for infliximab biobetter
20 July 2021 - Sorrento to exclusively market the product outside of China including US, Japan and Europe. ...
Posted by Michael Wonder on 19 Jul 2021
Imfinzi approved in China for the treatment of extensive-stage small cell lung cancer
19 July 2021 - Only PD-1/PD-L1 immunotherapy to demonstrate both a significant survival benefit and improved response rate in combination ...
Posted by Michael Wonder on 08 Jul 2021
BeiGene announces acceptance of a supplemental biologics license application in China for tislelizumab in oesophageal squamous cell carcinoma
7 July 2021 - BeiGene today announced that the Center for Drug Evaluation of the China National Medical Products Administration ...
Posted by Michael Wonder on 08 Jul 2021
Y-mAbs announces NMPA submission of BLA for Danyelza (naxitamab-gqgk) in China
6 July 2021 - Y-mAbs Therapeutics today announced that SciClone Pharmaceuticals has submitted the biologics license application for Danyelza (naxitamab-gqgk) for ...
Posted by Michael Wonder on 29 Jun 2021
Innovent announces the China NMPA approval of Tyvyt (sintilimab injection) in combination with Byvasda (bevacizumab biosimilar injection) as first-line therapy for people with hepatocellular carcinoma
28 June 2021 - Innovent Biologics today announced that the National Medical Products Administration of China has approved the supplemental ...