AbbVie Submits NDA for Venetoclax, the World’s First Bcl-2 Inhibitor, in China

Original: Vernacular Chinese

On January 13, AbbVie’s marketing application for venetoclax tablets in China was accepted by the Center for Drug Evaluation (CDE).

Venetoclax is an oral B-cell lymphoma-2 (Bcl-2) inhibitor jointly developed by AbbVie and Roche. It first received FDA approval on April 11, 2016, becoming the first FDA-approved drug targeting Bcl-2. In 2018, the drug’s sales reached $344 million. EvaluatePharma predicted that its sales would reach $1.4 billion in 2020.

Currently, the approved indications for venetoclax include: 1) second-line treatment of chronic lymphocytic leukemia with chromosome 17p deletion abnormality; 2) second-line treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma in combination with rituximab; 3) first-line treatment of acute myeloid leukemia unsuitable for standard induction therapy in combination with azacitidine/decitabine/cytarabine.

Source: PharmaCube NextPharma

Bcl-2 plays a crucial role in apoptosis and is the predominant oncogene in most hematologic malignancies. Currently, venetoclax has been approved in China for clinical trials in relapsed or refractory chronic lymphocytic leukemia with 17p deletion, acute myeloid leukemia, and multiple myeloma.

Companies developing Bcl-2 inhibitors in China include Ascentage Pharma (APG-1252, APG-2575) and BeiGene (BGB-11417).