Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 24 Jun 2021
China's first CAR-T cell therapy approved Fosun Kite axicabtagene ciloleucel (FKC876)
24 June 2021 - The first CAR-T cell therapy approved by NMPA: opening a new era of cell therapy in China. ...
Posted by Michael Wonder on 24 Jun 2021
Lynparza approved in China for the treatment of BRCA mutated metastatic castration resistant prostate cancer
24 June 2021 - First PARP inhibitor approved in China in advanced prostate cancer. ...
Posted by Michael Wonder on 23 Jun 2021
Orpathys approved in China for patients with lung cancer and MET gene alterations
23 June 2021 - First-in-class approval in China in this setting and first regulatory approval for the oral, potent and ...
Posted by Michael Wonder on 21 Jun 2021
BeiGene announces China NMPA approval of Brukinsa (zanubrutinib) for the treatment of patients with relapsed or refractory Waldenström’s macroglobulinaemia
18 June 2021 - Third approval for Brukinsa in China and second approval in Waldenström’s macroglobulinaemia worldwide. ...
Posted by Michael Wonder on 19 Jun 2021
HutchMed announces NMPA approval of surufatinib (Sulanda in China) for advanced pancreatic neuroendocrine tumours
18 June 2021 - Second new drug application approved for Sulanda in China. ...
Posted by Michael Wonder on 09 Jun 2021
BeiGene announces acceptance of a supplemental biologics license application in China for tislelizumab in microsatellite instability-high or mismatch repair-deficient solid tumours
7 June 2021 -BeiGene today announced that the Center for Drug Evaluation of the China NMPA has accepted a supplemental ...
Posted by Michael Wonder on 10 May 2021
China NMPA approves PARP inhibitor pamiparib for patients with previously treated advanced ovarian cancer
7 May 2021 - This marks the first approval of pamiparib and the third BeiGene discovered medicine to receive regulatory approval. ...
Posted by Michael Wonder on 19 Apr 2021
Citrine Medicine and Sinopharm Group announce strategic partnership to broaden and accelerate access to rare disease drugs in China
19 April 2021 - Citrine Medicine and Sinopharm Group today announced a strategic partnership to accelerate the commercialisation of rare ...
Posted by Michael Wonder on 14 Apr 2021
Tagrisso approved in China in early lung cancer
14 April 2021 - Approval based on unprecedented results from the ADAURA Phase III trial where Tagrisso reduced the risk ...
Posted by Michael Wonder on 13 Apr 2021
Qilian International announces inclusion of 16 products into China's National Reimbursement Drugs List
13 April 2021 - Qilian International today announced that 16 of its products have been included in the latest version of ...
Posted by Michael Wonder on 13 Apr 2021
NMPA approves toripalimab in patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neo-adjuvant or adjuvant platinum-containing chemotherapy
12 April 2021 - Third indication approved for toripalimab in China. ...
Posted by Michael Wonder on 05 Apr 2021
BeyondSpring announces submission of new drug application to U.S. FDA and China NMPA for plinabulin and G-CSF combination for the prevention of chemotherapy-induced neutropenia
31 March 2021 - Applications are supported by positive PROTECTIVE-2 Phase 3 data demonstrating that plinabulin in combination with G-CSF offers ...