Innovent Biologics Bags Chinese Approval for Fourth Monoclonal Antibody

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

Author

Rajaneesh K. Gopinath