Almonertinib

Targeted therapy for EGFR-mutant non-small cell lung cancer (NSCLC) has long been confronted with the clinical pain point of resistance to first- and second-generation drugs. Aumolertinib, as a third-generation EGFR tyrosine kinase inhibitor independently developed in China, can highly selectively inhibit EGFR sensitive mutations and T790M resistance mutation, while reducing the inhibitory effect on wild-type EGFR, which greatly reduces adverse reactions such as rash and diarrhea. At present, its indications cover the first-line treatment of adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletion or exon 21 (L858R) substitution mutation, as well as adult patients with locally advanced or metastatic NSCLC who have progressed on prior EGFR-TKI treatment and are positive for T790M mutation, providing a treatment option that better fits the clinical needs of the local population for Chinese NSCLC patients.

In 2023, the domestic market size of third-generation EGFR-TKIs has exceeded 14 billion yuan. With its differentiated clinical safety advantages, aumolertinib's market share has continued to rise. In the first half of 2024, its market share in the public medical institution segment of third-generation EGFR-TKIs was approximately 22%, second only to osimertinib. At present, 3 domestic enterprises have submitted marketing applications for generic aumolertinib. As core patents expire successively, future market competition will gradually shift to competition in cost control and supply chain stability.The original research enterprise of aumolertinib is Jiangsu Hansoh Pharmaceutical Group Co., Ltd., with the trade name Ameile. Its core compound patent will expire in October 2028, and its formulation patent will expire in July 2031. The currently approved and marketed dosage form is tablet, with specifications including 55mg and 110mg, which has been included in the *Catalogue of Chemical Reference Preparations (38th Batch)* issued by the National Medical Products Administration. In terms of domestic API registration, currently only Hansoh Pharmaceutical's aumolertinib API has been approved for marketing (registration number: Y20190003389), and no aumolertinib API from other enterprises has been registered through the CDE.(Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of aumolertinib impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the various R&D and production quality control needs of API enterprises, including quality research, impurity profile analysis, and generic drug consistency evaluation.

（数据截至2025年6月，最新请以CDE官网为准）

CATO/佳途科技可提供阿美替尼全套杂质标准品，大部分产品现货供应，现货产品16:00前下单当天发货，所有产品均符合中国药典、FDA等多法规体系合规要求，能够充分满足原料药企业的质量研究、杂质谱分析及仿制药一致性评价等各类研发与生产质控需求。