Is there a big difference whether Ensartinib is a domestic or imported drug?

Ensartinib is manufactured by Betta Pharmaceuticals Co., Ltd. Ltd.), it is mainly used to treat ALK-positive non-small cell lung cancer (NSCLC). Betta Pharmaceuticals was founded in 2003 and is headquartered in Hangzhou, Zhejiang. It is a national high-tech enterprise focusing on the research and development of innovative drugs with independent intellectual property rights and integrating R&D, production and marketing. The company has new drug research and development centers in Beijing and Hangzhou, and a production base in Yuhang Economic and Technological Development Zone, Hangzhou City, Zhejiang Province.

Ensartinib was approved for marketing by China's National Medical Products Administration (NMPA) at the end of 2020, becoming the first domestically approved ALK inhibitor. The drug has shown good efficacy in clinical studies, especially in ALKpositiveNSCLC patients, which can significantly improve the objective response rate (ORR) and progression-free survival (PFS). In addition, ensartinib has good penetration into brain metastases and is suitable for patients with a variety of ALK mutation types.

Betta Pharmaceuticals adopts a multi-functional modular design and layout for the production of ensartinib. The API workshop can also meet the company's R&D and production needs for 1.1 new drugs. The company has built an innovative drug industrialization base in Shengzhou Economic Development Zone, Zhejiang Province, with an estimated annual production capacity of over 40 tons of innovative APIs. The construction of this project is aimed at meeting the company's manufacturing needs for new products and improving production capacity.

In general, ensartinib is independently developed and produced by Betta PharmaceuticalsALKInhibitors have strong competitiveness in the domestic market. Its research and development and production are all completed by domestic companies, reflecting the independent research and development capabilities of Chinese pharmaceutical companies in the field of innovative drugs. With the improvement of production capacity and market expansion, ensartinib is expected to provide effective treatment options for more patients with ALK positive NSCLC.

Reference materials:https://www.drugs.com/