Pemetrexed

As one of the core varieties of antimetabolite antineoplastic drugs, pemetrexed exerts its antitumor effect by disrupting the normal folate-dependent metabolic process in cells and inhibiting cell replication. It is often clinically combined with platinum drugs for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (non-squamous) and malignant pleural mesothelioma, and can also be used for maintenance treatment and subsequent line treatment of non-small cell lung cancer. It is one of the core drugs in the whole-course management of patients with advanced lung cancer, and the covered population is mainly middle-aged and elderly lung cancer patients.

The peak of the global pemetrexed market size once exceeded 2.5 billion US dollars, and the annual sales in the Chinese market are stable at more than 4 billion yuan. Since the expiration of the core patent, generic drugs have rapidly replaced the original research drugs. At present, the share of generic drugs in the domestic market has exceeded 85%. After the implementation of centralized volume-based procurement, the price of preparations has dropped by more than 90%, which directly drives the continuous expansion of upstream API demand. In recent years, the annual demand for domestic pemetrexed APIs has maintained an annual growth rate of about 15%, and the competition pattern is concentrated in leading characteristic API enterprises in Jiangsu, Shandong and other regions.

The original research enterprise of pemetrexed is Eli Lilly and Company, and the original trade name is "Alimta". Its Chinese compound patent expired in 2017, and the preparation patent expired in 2021. The main dosage form approved for the original research is pemetrexed disodium for injection, with common specifications of 0.2g and 0.5g. It 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, more than 30 domestic enterprises in China have obtained A status for their pemetrexed disodium APIs through CDE registration, and more than 20 other enterprises have obtained marketing approval for pemetrexed disodium for injection preparations, among which many have passed the quality and efficacy consistency evaluation of generic drugs. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of pemetrexed impurity reference standards, which can fully cover the qualitative and quantitative research needs of process impurities and degradation impurities. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can provide stable and reliable material basis support for the registration and declaration and quality research of API and preparation enterprises.