Venetoclax

In the clinical treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), the emergence of the BCL-2 target has addressed the limitations of traditional chemotherapy. As the world's first approved selective B-cell lymphoma-2 (BCL-2) inhibitor, venetoclax specifically binds to the BCL-2 protein to restore the apoptosis pathway of tumor cells, overcoming the pain points of high drug resistance and severe adverse reactions associated with traditional treatment regimens. At present, this drug has been approved for the treatment of adult patients with chronic lymphocytic leukemia and small lymphocytic lymphoma, as well as in combination with azacitidine, decitabine or low-dose cytarabine for the treatment of newly diagnosed elderly patients with acute myeloid leukemia or adult patients who cannot tolerate intensive induction chemotherapy, providing the possibility of long-term survival for patients with relapsed and refractory hematological malignancies.

The global market size of venetoclax had exceeded USD 2.5 billion in 2023, with a compound annual growth rate of over 18%. The core growth drivers are the approval of new indications such as acute myeloid leukemia and the increase in clinical drug penetration. In terms of the Chinese market, due to the large patient base of hematological malignancies and the gradual improvement in the accessibility of targeted drugs, the in-hospital sales of venetoclax exceeded RMB 1.5 billion in 2023, with a growth rate of over 40%. Currently, the original research product occupies the vast majority of the market share. As the core patents expire successively, more than 10 domestic enterprises have laid out the research and development of generic drugs. The launch of generic drugs in the next 2-3 years is expected to further reduce the medication burden of patients, with significant market expansion potential.

Venetoclax was jointly developed by AbbVie and Roche as the original research enterprises, with the trade name Venclexta®. Its core compound patent in the United States will expire in 2026, and the compound patent in China will expire in 2027. The main currently approved dosage form is tablet, with specifications including 10mg, 50mg and 100mg. The original research product has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also a reference preparation recognized by the FDA. Up to now, one enterprise in China has obtained the A-status registration for venetoclax API after passing the review and public announcement of the CDE, and the original preparation as well as 3 domestic generic drugs have been approved for marketing. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for venetoclax API, covering all path impurities including those generated in the synthesis process and degradation products, which can meet the full-process needs of pharmaceutical enterprises from API R&D to generic drug consistency evaluation. Most products are in stock. For in-stock orders placed before 16:00, delivery can be made on the same day. All products comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. The structures of relevant impurities have been confirmed by multi-dimensional techniques such as NMR, MS and HPLC, and a complete analysis report can be provided along with the goods.