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: [email protected]
Related Post
R&D
Advancements in Alzheimer’s Disease Drug Innovation and Funding Programs in 2024
2024-07-04
FDA Greenlights Eli Lilly’s Groundbreaking Alzheimer’s Drug Kisunla for Early Symptomatic Treatment
2024-07-04
Eli Lilly and OpenAI Team Up to Combat Drug-Resistant Pathogens
2024-07-02
LATEST
Wistar and Accelerated Biosciences Partner to Develop Novel hTSCs Platform for Immunotherapies
2024-07-15
Accelerated Bio and Pluristyx Generate Clinical-Grade Induced Pluripotent Stem Cells from Reprogrammed Human Trophoblast Stem Cells
2024-07-12
Novo Nordisk and PT Bio Farma Agree to Enhance Insulin Production for Diabetes Patients in Indonesia
2024-07-12
Alzheimer’s Drug LEQEMBI Approved for Treatment in Hong Kong
2024-07-12
Foreseen Biotech Strikes $1.03B Deal with Ipsen for First-in-Class ADC
2024-07-12
Synthetic Biology’s Innovator Dr. John Cumbers – Addressing Inefficiencies in Biopharma and Economic Sustainability
2024-07-11
Delivering Affordable Biologic Medicines Worldwide: An Interview with Tanvex Chairman and CEO, Henry Chen
2024-07-11
EVENT
Scroll to Top