Limaprost

Peripheral neuropathy and microcirculation disturbance are common complications in patients with chronic diseases such as diabetes and lumbar spinal stenosis. Traditional circulation-improving drugs often have the limitations of single action target and slow onset of effect. Limaprost, as a synthetic prostaglandin E1 derivative, belongs to prostacyclin class antiplatelet and circulation-improving drugs. By selectively binding to prostaglandin receptors, it can not only dilate blood vessels and increase peripheral circulation blood flow, but also inhibit platelet aggregation and reduce the risk of thrombosis. At present, it is clinically mainly used to improve limb pain and numbness caused by lumbar spinal stenosis, as well as ischemic symptoms associated with thromboangiitis obliterans, and is widely used in elderly patients with chronic diseases complicated with microcirculation lesions.

The number of patients with lumbar spinal stenosis in China exceeds 20 million, and patients with diabetes complicated with peripheral vascular disease account for 20% to 30% of the total diabetic population. The huge patient base promotes the continuous expansion of the limaprost market. Data show that the domestic market size of limaprost preparations has exceeded 1.2 billion yuan in 2023, and the compound annual growth rate in the past three years has remained above 18%. At present, the original research products still dominate the market, and the application progress of domestic generic drugs is relatively slow. With the increasing clinical attention to the treatment of microcirculation disturbance, the substitution space of generic drugs is very considerable.

The original research enterprise of limaprost is Ono Pharmaceutical Co., Ltd. of Japan, and the original research trade name is "OPALMON® (奥脉明)". Its core compound patent in Japan expired in 2013, and the core preparation patent in China expired in 2022. The original marketed dosage form is tablet with a specification of 5μg, which has been included in the China Listed Medicines Catalogue as the reference preparation. As of November 2024, 6 domestic enterprises have completed the registration of limaprost API in CDE (status A). The approved and marketed preparations include the imported original research product and the generic drug products of 3 domestic enterprises. (Data as of November 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for limaprost API, fully covering synthetic process impurities, degradation impurities and enantiomers. All products meet the relevant regulatory requirements of the Chinese Pharmacopoeia and FDA, and most products support spot supply. Spot orders placed before 16:00 can be shipped on the same day, which can fully meet the full-process R&D needs of pharmaceutical enterprises such as consistency evaluation, quality research and stability study.