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RSS FeedPosted by Michael Wonder on 13 Jan 2023
COVID treatment molnupiravir to hit Chinese market on Friday
12 January 2023 - The COVID-19 treatment molnupiravir is expected to hit the Chinese market on Friday, after passing its ...
Posted by Michael Wonder on 12 Jan 2023
Pfizer's Paxlovid not included in China's national insurance
9 January 2023 - China will not include Pfizer’s COVID-19 treatment drug in a national reimbursement list that would have allowed ...
Posted by Michael Wonder on 03 Jan 2023
Legend Biotech announces acceptance of its new drug application for ciltacabtagene autoleucel in China
2 January 2023 - Legend Biotech announced today that China’s NMPA has formally accepted its new drug application for ciltacabtagene ...
Posted by Michael Wonder on 02 Jan 2023
BeiGene announces acceptance of twelfth regulatory submission in China for PD-1 inhibitor tislelizumab
30 December 2022 - Submission seeks marketing authorisation for first-line treatment of unresectable or metastatic hepatocellular carcinoma. ...
Posted by Michael Wonder on 02 Jan 2023
China CDE/NMPA recommends priority review for Nefecon for the treatment of primary IgA nephropathy
30 December 2022 - Calliditas Therapeutics' partner Everest Medicines today announced that the Center for Drug Evaluation of the China ...
Posted by Michael Wonder on 26 Dec 2022
BioArctic's partner Eisai initiates BLA submission of data for lecanemab in China
22 December 2022 - BioArctic's partner Eisai announced today that they have initiated submission of data for biologics license application ...
Posted by Michael Wonder on 28 Nov 2022
Ferinject approved in China for the treatment of iron deficiency in adult patients
28 November 2022 - China has the world’s largest iron deficiency anaemia population with estimated prevalence of 15%. ...
Posted by Michael Wonder on 28 Nov 2022
Lantheus announces the approval of Definity (perflutren lipid microsphere) by China’s NMPA
28 November 2022 - Definity is the leading diagnostic ultrasound enhancing agent for patients with suboptimal echocardiograms. ...
Posted by Michael Wonder on 22 Nov 2022
Junshi Biosciences announces approval of supplemental application for additional indications of adalimumab injection
22 November 2022 - Shanghai Junshi Biosciences announced today that the supplemental application for additional indications of adalimumab injection (UBP1211) for ...
Posted by Michael Wonder on 18 Nov 2022
Calliditas' partner Everest Medicine's new drug application for Nefecon is accepted by the China NMPA
15 November 2022 - Calliditas Therapeutics today announced that the Chinese regulatory authority NMPA has accepted Everest Medicines' new drug application ...
Posted by Michael Wonder on 02 Nov 2022
Henlius' novel anti-PD-1 mAb Hansizhuang (serplulimab) receives NMPA approval for the treatment of sqNSCLC
1 November 2022 - Shanghai Henlius Biotech announced that its first self-developed innovative anti-PD-1 monoclonal antibody Hansizhuang (serplulimab), in combination with ...
Posted by Michael Wonder on 21 Oct 2022
Akeso's ivonescimab granted breakthrough therapy designation by China NMPA for the treatment of advanced NSCLC
20 October 2022 - Akeso announced that the Center for Drug Evaluation of China NMPA has granted breakthrough therapy designation ...
Posted by Michael Wonder on 18 Oct 2022
CARsgen announces NDA acceptance of BCMA CAR T zevor-cel (CT053) by China NMPA
18 October 2022 - CARsgen Therapeutics announces that the NMPA of China has accepted the new drug application for zevorcabtagene autoleucel ...
Posted by Michael Wonder on 11 Oct 2022
The China NMPA approved Cyramza (ramucirumab) for the treatment in patients with hepatocellular carcinoma
9 October 2022 - Innovent Biologics is pleased to see that the NMPA of China has approved the supplemental new drug ...
Posted by Michael Wonder on 11 Oct 2022
JW Therapeutics announces NMPA approval of relmacabtagene autoleucel injection in patients with relapsed or refractory follicular lymphoma
11 October 2022 - JW Therapeutics announced that the NMPA of China has approved the supplemental new drug application for its ...