Blog
RSS FeedPosted by Michael Wonder on 25 Jul 2022
Policy updates on access to and affordability of innovative medicines in China
22 July 2022 - In China, efforts to qualify innovative medical products for reimbursement used to be subject to substantial delays ...
Posted by Michael Wonder on 19 Jul 2022
Ascentage Pharma and Innovent announce the China NMPA accepted and granted priority review designation to a new drug application for olverembatinib for the treatment of drug resistant CML
19 July 2022 - Ascentage Pharma and Innovent Biologics today announce that the Center for Drug Evaluation of China's NMPA ...
Posted by Michael Wonder on 17 Jul 2022
China CDE grants breakthrough therapy designation to Neurophth's NR082 in Leber's hereditary optic neuropathy
15 July 2022 - Neurophth Therapeutics today announced that the Center for Drug Evaluation of China National Medical Products Administration has ...
Posted by Michael Wonder on 14 Jul 2022
Zai Lab announces acceptance by China’s NMPA of the BLA for efgartigimod for patients with generalised myasthenia gravis
13 July 2022 - Efgartigimod alfa injection is the first accepted BLA submission of an FcRn antagonist for generalised myasthenia gravis ...
Posted by Michael Wonder on 10 Jul 2022
Prices and clinical benefit of national price negotiated anti-cancer medicines in China
8 July 2022 - High prices of anticancer medicines have increased the economic burden for both patients and health insurance systems. ...
Posted by Michael Wonder on 30 Jun 2022
Akeso's cadonilimab (PD-1/CTLA-4), the first dual immune checkpoint inhibitor to treat cancer, approved for marketing in China
29 June 2022 - Globally first dual immune checkpoint inhibitor bi-specific antibody approved for marketing. ...
Posted by Michael Wonder on 28 Jun 2022
Innovent and Lilly jointly announce the approval of Tyvyt (sintilimab) by China NMPA in combination with chemotherapy as first-line treatment of advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma
26 June 2022 - Innovent Biologics and Eli Lilly announced that the NMPA of China has approved the supplemental new drug ...
Posted by Michael Wonder on 23 Jun 2022
Innovent and Lilly jointly announce the approval of Tyvyt (sintilimab injection) by China NMPA in combination with chemotherapy as first-line treatment for oesophageal squamous cell carcinoma
20 June 2022 - Innovent Biologics and Eli Lilly today announced that the Center for Drug Evaluation of China's National ...
Posted by Michael Wonder on 14 Jun 2022
FDA’s treatment of China developed drugs spurs demands for multiregional clinical trials
14 June 2022 - China’s ambition to become a leader in the biopharma industry has been clear in the last ...
Posted by Michael Wonder on 12 Jun 2022
Zai Lab announces breakthrough therapy designations granted for repotrectinib in China
10 June 2022 - Breakthrough therapy designations granted for ROS1 positive non-small-cell lung cancer patients pretreated with one prior line of ...
Posted by Michael Wonder on 10 Jun 2022
Everest Medicines announces approval of Trodelvy in China for second-line metastatic triple negative breast cancer
10 June 2022 - Everest plans to launch commercial sales of Trodelvy in China in Q4, 2022. ...
Posted by Michael Wonder on 08 Jun 2022
CStone and Pfizer announce NMPA approval of sugemalimab in patients with unresectable stage III non-small cell lung cancer
6 June 2022 - Sugemalimab became the first anti-PD-1/PD-L1 monoclonal antibody approved for stage III NSCLC following concurrent or sequential chemoradiotherapy. ...
Posted by Michael Wonder on 02 May 2022
U.S. FDA declines to approve two more China tested drugs
2 May 2022 - The U.S. FDA declined to approve two China tested cancer treatments on Monday, raising concerns over ...
Posted by Michael Wonder on 18 Apr 2022
China NMPA approves tislelizumab for patients with second-line oesophageal squamous cell carcinoma
15 April 2022 - Tislelizumab is now approved for eight indications in China. ...
Posted by Michael Wonder on 07 Apr 2022
Innovent announces the approval of Pemazyre (pemigatinib) by the NMPA for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement as confirmed by a validated diagnostic test that have progressed after at least one prior line of systemic therapy
6 April 2022 - Innovent Biologics announced that the National Medical Products Administration has approved Pemazyre (pemigatinib) for the treatment of ...