China approved its first homegrown CD20 antibody in August
Danni Yin ·09/19/2022
China NMPA Approval Tracker


In August, China saw the approval of only one new molecular entity (NME), Sinocelltech’s CD20 antibody ripertamab (SCT400). Another two homegrown companies, Zelgen and Alphamab, gained new indications and dosing regimens for their self-developed products as well.


China’s first homegrown CD20 therapy gains approval


SinoCellTech’s second biological drug ripertamab (SCT400) gained its first clearance in China for the treatment of newly diagnosed CD20-positive diffuse large B-cell non-Hodgkin's lymphoma (DLBCL).


This is China’s first homegrown CD20 therapy. Before its approval, Roche’s MabThera (rituximab) and Gazyva (obinutuzumab) and Novartis’s Kesimpta (ofatumumab) had demonstrated efficacies in the CD20 area.


Other homegrown CD20 competitors include BioRay’s HS006 (zuberitamab), Mabworks Biotech’s MIL62 and marketed rituximab biosimilars developed by Innovent Biologics and Henlius Biotech.


Ripertamab’s approval was supported by data from a pivotal registration Phase III clinical trial published in the July 2022 issue of Hematological Oncology.


The results showed that the ripertamab-CHOP group reaches 94.5% in primary endpoint IRC-assessed ORRs and 94.1% in the rituximab-CHOP group, with no significant difference between the two.


The company said ripertamab in combination with CHOP is non-inferior to the rituximab-CHOP regimen for the treatment of DLBCL and that they expect the drug to be a cost-effective alternative to rituximab for treating DLBCL.


In addition, Zelgen Biopharmaceuticals gained its core product, Zepsun (donafenib), for the treatment of locally advanced/metastatic radioactive iodine-refractory differentiated thyroid cancer (RAIR-DTC). Alphamab Oncology extends the use of subcutaneous PD-L1 antibody Enweida (envafolimab) to a 300 mg dose every two weeks.


In the import drugs space, Boehringer Ingelheim and Eli Lilly gained approval for Jardiance (empagliflozin), a treatment for reducing the risk of cardiovascular death or hospitalization due to heart failure. Roche's entrectinib gained a new indication for the treatment of ROS1-positive advanced NSCLC as well.



NDA submissions and other notable filings


There were several August NDA submissions worth keeping an eye on as well.


Roche filed the world’s first NDA application for C5 recycling antibody crovalimab and was granted priority review. The application was based on a Chinese phase III clinical trial (COMMODORE 3 study) for paroxysmal nocturnal hemoglobinuria.


The company also announced a NDA acceptance of Vabysmo (faricimab) from NMPA. The drug is a bispecific antibody targeting VEGF-A and ANG-2 for the treatment of wet age-related macular degeneration and diabetic macular edema.


Astellas Pharma submitted its first application for Smyraf (peficitinib), a treatment for rheumatoid arthritis patients with inadequate response or intolerance to MTX. The drug may become China's sixth JAK inhibitor.


Also, BioRay submitted its first application for HS006, China's first homegrown CD20 monoclonal antibody.


PD-1 antibodies remained hot in August too. BeiGene submitted its 11th application for Baize'an (tislelizumab), a drug developed for previously untreated advanced or metastatic esophageal squamous cell carcinoma (ESCC). Henlius likewise announced NMPA acceptance of Hansizhuang (serplulimab) for the same indication.



(Edited by Justin Fischer)

Keywords: first homegrown CD20 antibody August China
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