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



© All rights reserved. Collaborate with us:
Related Post
Moderna To Collaborate With Harbour BioMed On Nucleic Acid-Based Cancer Therapies
CDC Warns Of “Tripledemic” Winter Amid Rising Flu And RSV Cases
Eli Lilly and BI Notch Clinical Win for Kidney Disease Drug
Repairing Genetic Mutations in Neurological Diseases with RNA Targeting Strategy
AstraZeneca Thailand Wins Two ACES Awards 2022: “Industry Champions of the Year” and “Community Initiative”
Mabwell Announces the U.S. FDA approval of 9MW3011 (FIC) for IND
Novartis Shifts Gear To Phase 3 For Anti-Malaria Drug
Moving Past Animal Models with Better Data for Drug Discovery
IonOpticks ushers in a new age of proteomics with Aurora Frontier
Korea Ginseng Corp.: As an adaptogenic herb, Korean red ginseng boosts the human immune response
New Orleans, USA
Hong Kong, China
7th Asia Microbiome Conference
Taipei, Taiwan
Scroll to Top

Create an account with us now to say goodbye to all the pop-ups!