Roche's CD20 Monoclonal Antibody Gazyva Nominated for Priority Review in China

On December 13, the CDE website indicated that Roche’s second-generation anti-CD20 monoclonal antibody obinutuzumab (brand name Gazyva®) had been proposed for inclusion in the priority review and approval program in China. As an upgraded version of Roche’s rituximab, Gazyva achieved a 40% increase in sales in 2018.

The core patent for Roche’s blockbuster product MabThera (rituximab) has expired, and its global revenue declined by 8% in 2018 due to the impact of biosimilars. Gazyva, regarded as an upgraded version of MabThera, represents Roche’s strategy to counteract erosion of its CD20 market share. In 2018, Gazyva achieved global sales of CHF 390 million, a year-on-year increase of 40%. Analysts had previously predicted that the drug would generate over USD 3 billion in revenue by 2022.

Gazyva is the successor to Rituxan, a blockbuster drug from Genentech, a Roche subsidiary. In 2013, the FDA approved Gazyva in combination with chlorambucil as a first-line treatment for chronic lymphocytic leukemia (CLL). It was subsequently approved for use in combination with chemotherapy for the treatment of follicular lymphoma (FL) and advanced FL, as well as in combination with Imbruvica for the treatment of CLL/small lymphocytic lymphoma (SLL).

Insight database shows that Roche’s Gazyva (GA101) has two international multicenter Phase III clinical trials currently underway in China:

First, in non-Hodgkin lymphoma (NHL), a comparison was made between GA101 maintenance therapy following GA101 plus chemotherapy and rituximab maintenance therapy following rituximab plus chemotherapy (Registration No. CTR20130805). The actual number of enrolled patients was 1,401 overall, including 58 from China.

Second, to compare the efficacy of GA101 combined with chemotherapy (CHOP) versus rituximab combined with chemotherapy (CHOP) in previously untreated patients with CD20-positive diffuse large B-cell lymphoma (DLBCL). The actual number of enrolled participants was 1,418 overall, including 253 from China. This clinical trial has been completed.

The domestic development of rituximab has clearly entered a red ocean. Henlius’ rituximab biosimilar was approved for marketing in February and successfully included in the 2019 National Reimbursement Drug List, with its current price at only 60% of that of the originator product; consequently, the market share of the originator is bound to be squeezed. Meanwhile, Innovent Biologics’ marketing application for rituximab has been included in the priority review program, with approval expected in 2020. In addition, there are five other candidates currently in Phase III clinical trials.

Roche’s rituximab faces pressure from all sides; the launch of Gazyva at this time aims to enter the Chinese market before a wave of domestically produced rituximab products receives dense regulatory approvals, thereby securing Roche’s position in the CD20 field in China.

On September 18, 2019, based on the outstanding data from the Phase II clinical NOBILITY trial, the FDA granted Breakthrough Therapy Designation to its CD20 antibody Gazyva for the treatment of adult lupus nephritis. It is understood that the FDA has not yet approved any drugs for the treatment of lupus nephritis, and Gazyva is expected to fill this gap.

It is believed that with the continuous expansion of Gazyva’s indications, it is poised to become Roche’s next core product in the future.