Klus Pharma Inc., a subsidiary of Sichuan Kelun Pharmaceutical Co. in the US, got go-ahead from the US Food and Drug Administration, FDA, to carry out the clinical trial of its anti-cancer injection.
Last month, Klus Pharma applied to FDA for the clinical trial of A166 for injection, said Kelun Pharma in a statement today. A166 is a drug targeted at specific gene HER2 and can treat malignant tumor such as breast cancer and gastric cancer. With a better degree of safety and tolerance, A166 performs better curative effect in anti-tumor capacity compared with similar drugs.
At present, Kadcyla (T-DM1) developed by the Swiss company Roche Holding AG is the only anti-cancer drug targeted at HER2 which has been put into market around the world. It was approved by FDA in 2013 and its global sales volume in last year registered USD965 million.
As of now, Klus Pharma has invested around CNY32 million (USD5 million) in the research and development of A166 for injection. Under the relevant laws, the company needs to regularly report the test results to FDA after carrying out the clinical trial and only by passing the examination and onsite inspection can the company sell the drug to the public, the statement added.
Established in 1996, Kelun Pharmaceutical is China’s leading injection and infusion products manufacturer. It set up Klus Pharma in New Jersey, the US in 2014, which focuses on research and development of bio-pharmaceutical and global business development.
Source: yicaiglobal.com
