Tags : NMPA

Henlius Reports NMPA’s Acceptance of NDA for HLX04 (biosimilar, bevacizumab)

Shots: NMPA has accepted the NDA of HLX04, based on the series of study data, including comparative pharmaceutical quality studies, comparative non-clinical studies & clinical studies. The NDA acceptance makes HLX04 the fourth product of Henlius that has received NMPA’s NDA acceptance & can be potentially used for the treatment of advanced/ metastatic or recurrent […]Read More

Innovent’s Sulinno (biosimilar, adalimumab) Receives NMPA’s Approval for Autoimmune Diseases

Shots: The NMPA has approved Sulinno for the treatment of RA, AS, and psoriasis in China. The approval of the Sulinno marks the expansion of Innovent’s portfolio in the non-oncology field Sulinno has similar clinical efficacy and safety to its reference product, Humira. The launch will provide Chinese patients with affordable adalimumab, bringing hope and […]Read More

Bayer Reports the NDA Submission to NMPA for Vericiguat to

Shots: The NDA submission was submitted to NMPA’s CDE and is based on P-III VICTORIA study, seeking regulatory approval of vericiguat in China In Oct’2014, Bayer and MSD signed a WW agreement for sGC modulators. The therapy is being jointly developed by both the companies as per the collaboration and has received the US FDA’s […]Read More

Henlius’ HLX02 Receives the NMPA’s Approval as the First Trastuzumab

Shots: On Aug 14, 2020, HLX02 (biosimilar, trastuzumab) received NMPA’s approval to treat HER2+ early BC, HER2+ m-BC and HER2+ m-gastric cancer. Additionally, On 27th July, HLX02 has received EC’s approval under the brand name Zercepac Henlius followed the NMPA and EMA’s biosimilar guidelines and has taken multiple head-to-head comparisons b/w HLX02 and the reference, […]Read More

Merck’s Keytruda Receives the NMPA’s Approval as a 2L Treatment

Shots: The approval is based on P-III KEYNOTE-181 study assessing Keytruda vs CT in previously treated patients with recurrent or metastatic ESCC whose tumors expressed PD-L1 (CPS ≥10) and  data from an extension of the global study in Chinese patients Results: Median OS (10.3 vs 6.7mos.), in Chinese patients: median OS (12.0 vs 5.4mos.). With […]Read More

Innovent Receives the NMPA’s Approval for Byvasda (biosimilar, bevacizumab) to

Shots: The NMPA has approved Byvasda for the treatment of patients with NSCLC and metastatic colorectal cancer. The approval follows TYVYT (sintilimab injection) approval, indicated to treat patients with Hodgkin’s lymphoma, granted in Dec’2018 The launch of Byvasda will provide Chinese patients with high-quality and relatively more affordable bevacizumab biosimilar injection In Jan’2020, Innovent granted […]Read More

AstraZeneca’s Bevespi Aerosphere (glycopyrronium/formoterol fumarate) Receives NMPA’s Approval for Patients

Shots: The NMPA’s approval is based on P-III PINNACLE 4 study assessing Bevespi Aerosphere (bid via a pMDI) vs its monotherapy components (glycopyrronium and formoterol fumarate) and PBO in patients with moderate to very severe COPD The P-III PINNACLE 4 study demonstrated improvement in lung function as measured by trough forced expiratory volume in one […]Read More

Henlius Receives NMPA’s IND Approval for its HLX13 (biosimilar, ipilimumab)

Shots: The approval follows the trials which involves assessing of HLX13 vs originator ipilimumab to evaluate its pharmacology, pharmacokinetics and toxicokinetics profiles, immunogenicity, and toxicity The study resulted in biosimilarity data in terms of in vivo and in vitro pharmacology, PK, toxicokinetics, immunogenicity and toxicity characteristics HLX13 is a recombinant anti-CTLA-4 fully human mAb injection […]Read More