Leucogen

As a commonly used clinical drug in the field of leukocyte elevation therapy, Leucogen is a cysteine derivative leukopoietic drug. Its mechanism of action is to bind with proteins in the alkaline environment of the duodenum to form soluble substances, which are rapidly absorbed by the intestinal tract to enhance the proliferation and differentiation capacity of the bone marrow hematopoietic system and promote the production of leukocytes and platelets. Clinically, it is mainly used for the prevention and treatment of leukopenia and thrombocytopenia caused by tumor radiotherapy and chemotherapy, and can also be used for adjuvant treatment of diseases related to insufficient bone marrow hematopoietic function such as aplastic anemia. The applicable population includes tumor patients receiving radiotherapy and chemotherapy, patients with chronic diseases who take drugs that may affect hematopoietic function for a long time, and elderly people with primary hematopoietic hypofunction.

At present, the domestic market size of Leucogen preparations is stably above 1.2 billion yuan, with a compound annual growth rate of around 7% in the past three years, and the demand is highly rigid. As the original research patent of Leucogen has long expired, the domestic market is dominated by generic drugs, the overall competitive landscape is concentrated, and the top three enterprises account for more than 90% of the preparation market share. After the implementation of the volume-based procurement policy, the terminal price of Leucogen tablets has dropped by more than 40%, which has further expanded its accessibility in primary clinical settings and driven the continuous rise in demand for active pharmaceutical ingredients.

The original research enterprise of Leucogen is Japan's Yoshitomi Pharmaceutical Co., Ltd., with the original brand name "Leucogen", and the core compound patent expired globally in 1999. The mainstream dosage form approved in China is tablet, with main specifications of 10mg and 20mg. Among them, the 20mg specification of the original preparation and multiple domestic generic drugs have been included in the National Reference Preparation Catalog. In terms of domestic API registration, there are currently 4 enterprises whose Leucogen APIs have obtained A-status registration numbers through the approval of the Center for Drug Evaluation (CDE). All the approved preparation varieties are oral tablets, and more than 20 enterprises have obtained domestic marketing approval for Leucogen tablets. (Data as of September 2024, please refer to the official CDE website for the latest information)

In response to the demand for quality research of Leucogen APIs and preparation R&D, CATO can provide a full set of impurity reference standards for this API. Most products are available from stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can provide stable and reliable material basis support for enterprises' impurity research, quality control and registration declaration work.