Roche's Second-Generation CD20 Monoclonal Antibody Obinutuzumab (Gazyva®), the 'Next-Gen Rituximab,' Nears Approval in China

On May 30, the Insight intelligence monitoring system indicated that Roche's second-generation CD20 monoclonal antibody Obinutuzumab (trade name: Gazyva^®）has entered the administrative approval stage and is expected to be approved shortly. As a next-generation successor to Roche's rituximab, Gazyva has achieved consistent year-on-year sales growth since its market launch, with sales reaching $677 million in 2020.

Obinutuzumab is the next-generation successor to the blockbuster drug Rituximab, developed by Genentech, a member of the Roche Group, and also targets CD20. In 2013, the FDA approved it in combination with chlorambucil as a first-line treatment for chronic lymphocytic leukemia (CLL). Subsequently, it has been approved in combination with chemotherapy for the treatment of follicular lymphoma (FL) and advanced FL, and in combination with Imbruvica for the treatment of CLL/small lymphocytic lymphoma (SLL).

As is well known, the core patents for Roche’s blockbuster drug MabThera (rituximab) have expired, and its sales have begun to decline due to the impact of biosimilars. Gazyva has long been regarded as a next-generation version of MabThera and serves as Roche’s strategic response to the erosion of its CD20 market share. In 2019, its global sales reached $550 million, a year-on-year increase of 39%. Analysts once predicted that the drug would generate over $3 billion in revenue by 2022.

From the Insight Database (http://db.dxy.cn/v5/home/)

The R&D landscape for rituximab in China has clearly entered a highly competitive "red ocean." Currently, the rituximab biosimilars from Henlius and Innovent Biologics have both received marketing approval and been successfully included in the National Reimbursement Drug List (NRDL). With the latest winning bid prices dropping to as low as 45% of the originator's price, the originator's market share is inevitably set to be eroded.

Competitive Landscape of Rituximab in China

From the Insight Database (http://db.dxy.cn/v5/home/)

Roche's rituximab faces mounting competition on multiple fronts. The approval of obinutuzumab will enable its launch in the Chinese market amid a wave of approvals for China-made rituximab, thereby securing Roche's position in China's CD20 market.

The Insight database shows that Roche's obinutuzumab was submitted for marketing approval in September 2019, included in the priority review and approval program in December of the same year, and currently has multiple indications under clinical development.

From the Insight Database (http://db.dxy.cn/v5/home/)

On September 18, 2019, based on compelling data from the Phase II NOBILITY clinical trial, the FDA granted Breakthrough Therapy Designation to its CD20 antibody Gazyva for the treatment of adult lupus nephritis. It was not until January 22, 2021, that the first approved drug for this indication, voclosporin (brand name: LUPKYNIS), became available. Given that a substantial unmet medical need persists, Gazyva is poised to fill this therapeutic gap.

Note: The original text has been abridged.