GENE ONLINE|News &
Opinion
Blog

Innovent Biologics Bags Chinese Approval for Fourth Monoclonal Antibody

by Rajaneesh K. Gopinath
Share To

By Rajaneesh K. Gopinath, Ph.D.

On October 9th, Innovent Biologics, Inc. and Eli Lilly announced that their recombinant human/murine chimeric monoclonal antibody Halpryza (rituximab injection) had been approved by China’s National Medical Products Administration (NMPA). The drug has been approved for three indications, namely, diffuse large b cell lymphoma (DLBCL), follicular lymphoma (FL), and chronic lymphocytic leukemia (CLL).

Rituximab binds to the CD20 antigen expressed widely on the surface of B lymphocytes and mediates complement-dependent cytotoxicity (CDC) and antibody-dependent cellular cytotoxicity (ADCC). The drug will eliminate both normal and malignant B cells and is therefore used to treat diseases characterized by overactive or dysfunctional B cells.

 

Rituximab Biosimilars

Rituximab was the first monoclonal antibody to be used in the treatment of cancer. Originally developed by Genentech (Roche) as Rituxan®, the drug was FDA approved in 1997. In 2000, Rituxan® was imported into China under the trade name MabThera® for the treatment of Non-Hodgkin’s Lymphoma (NHL). Once its patent was expired, two biosimilars have currently entered the US market. Teva and Celltrion’s Truxima was the first biosimilar to be FDA approved in November 2018, while Pfizer’s Ruxience received approval in July 2019. Amgen and Allergan had also submitted BLA for their biosimilar candidate ABP 798 to the FDA last year.

Meanwhile, China approved the country’s first-ever rituximab biosimilar, HLX01, developed by Shanghai Henlius Biotech, Inc. in February 2019. It was primarily approved for the treatment of non-Hodgkin lymphoma. Co-developed by Innovent and Eli Lilly, Halpryza has now received approval in China for three indications. This is the Innovent’s fourth monoclonal antibody drug approved by the NMPA after Tyvyt (sintilimab injection), Byvasda (bevacizumab injection), and Sulinno (adalimumab injection).

 

High Market Value

Since the drug is prescribed for several indications, the rituximab biosimilar market is expected to grow rapidly and can reach billions, especially in countries like China that have a huge population.

“Halpryza (rituximab injection) is another example of our success with the National Major New Drug Innovation and Development Projects and the fourth monoclonal antibody drug approved by the NMPA following Tyvyt (sintilimab injection), Byvasda (bevacizumab injection), and Sulinno (adalimumab injection). We hope to bring this high-quality drugs to more patients in need in China as soon as possible,” said Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent.

Dr. Li Wang, Senior VP of Lilly China and Head of Lilly China Drug Development and Medical Affairs Center, stated: “We’re excited that Lilly and Innovent strategic collaboration has reached another success. Lymphoma is one of the malignant tumors with rapid growing incidence. However, the survival rate is also relatively higher than other tumor types when having appropriate treatment. The approval of HALPRYZA® (rituximab injection) will bring a new option to Chinese Lymphoma patients, help them to improve quality of life & prolong their survivals.”

Related Article: China Approves Avastin’s New Indication

References
  1. http://innoventbio.com/en/#/news/218

 

©www.geneonline.com All rights reserved. Collaborate with us: service@geneonlineasia.com
Related Post
Eli Lilly Caps Insulin At $35 A Month, Widening Access For Americans
2023-03-02
Investigate the Current Status of Rivaroxaban Generic Drug Application in China
2023-03-01
Avian Flu H5N1: Fear Over Potential Spread Among Humans and What We Should Know
2023-02-15
LATEST
Novartis’ CDK4/6 Inhibitor Meets Phase 3 Endpoints In Breast Cancer
2023-03-28
BD and A*STAR collaborate to Advance Ultra-High Dimensional Analysis in Flow Cytometry for Immunology Research
2023-03-28
Vertex and CRISPR Collaborate Again with $330 Million Diabetes Gene Editing Deal
2023-03-28
Amway Applauded by Frost & Sullivan for Capitalizing on Innovative Competitive Strategies to Drive Differentiation in Its Home Water Treatment Solution in APAC
2023-03-28
BJ Bioscience Announces Clinical Collaboration with MSD to Evaluate BJ-001 in Combination with KEYTRUDA® (pembrolizumab)
2023-03-27
35% Of Better Therapeutics’ Staff to be Cut to Extend the Company’s Runway
2023-03-27
Pharming’s Joenja Racks Up FDA Approval For Rare Primary Immunodeficiency
2023-03-27
Scroll to Top