Roche(RHHBY.US)“obinutuzumab” submits the first listing application for a non-oncology indication in China

LootboxPhobia · 2026-04-03T13:46:08+00:00

Roche's Ocrelizumab Injection for New Indications has been accepted for review, primarily for the treatment of primary nephrotic syndrome in patients aged 2 and above, and has been included in priority review. The drug has been approved overseas for the treatment of various diseases and was first launched domestically in 2021.

LootboxPhobia

2026-04-03 13:46:08

Abstract generation in progress

Zhitong Finance APP learned that on April 2, the CDE website published an announcement that a new indication approval application for Roche (RHHBY.US) obinutuzumab injection has been accepted for review. Based on the drug’s research progress and its regulatory classification, the Insight database speculates that the indication applied for this time is for the treatment of patients with primary nephrotic syndrome aged 2 years and older. This indication was included in the CDE’s priority review this February.

Screenshot source: CDE website

Obinutuzumab is a humanized monoclonal antibody targeting CD20. Overseas, the drug has already been approved for the treatment of chronic lymphocytic leukemia / small lymphocytic lymphoma, follicular lymphoma, and lupus nephritis. In China, obinutuzumab was first approved for marketing in June 2021, and is used in combination with chemotherapy for adult patients with follicular lymphoma. In 2025, obinutuzumab’s global sales reached $1.19 billion.

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