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The China Food and Drug Administration (CFDA) has accepted Sihuan Pharmaceutical’s application for clinical trial approval for its Pirotinib, a Category 1.1 innovative oncology drug developed by the company’s drug R&D team.

By developing Pirotinib, Sihuan Pharma has demonstrated its capability for the oncology products market. The company holds the largest cardio-cerebral vascular (CCV) drug franchise in China’s prescription market.

The new drug is a second generation (pan-HER) inhibitor intended to treat patients with lung and breast cancer.

Preclinical studies of Pirotinib showed that the drug has unique profiles in pharmacology, pharmacokinetics and toxicology, and features a developable property.

In order to offer unique advantages of Pirotinib, the company’s scientific research team is currently evaluating the project for a possibility of filing an application in the US Food and Drug Administration (FDA).

In addition, the company has already submitted applications for international patent rights for Pirotinib and has also entered the actual assessment in China, Japan, the US and Europe.

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By GlobalData

Sihuan Pharmaceutical chairman and CEO Che Fengsheng said according to statistics from MENET, the oncology drug market is one of the largest drug markets in China with a market scale exceeding RMB 66.7bn ($10.9bn) at the end of 2012.

"Lung cancer is the top tumour disease in China, while breast cancer ranks sixth, with mortality rate increasing in recent years."

"Lung cancer is the top tumour disease in China, while breast cancer ranks sixth, with mortality rate increasing in recent years," Fengsheng said.

"Pirotinib, as a unique innovative drug designed to cure lung cancer and breast cancer featuring competitive rates of efficacy, has strong market potential."

The company expects Pirotinib to provide physicians and patients better treatment options as well as help consolidate the company’s diversified product lines and drive its sustainable growth.

Sihuan’s existing products comprise the top five medical therapeutic areas in China: cardio-cerebral vascular system, central nervous system, metabolism, oncology and anti-infectives.

The company’s major products including Kelinao, Oudimei, Yuanzhijiu, Yeoduojia, GM1 and Chuanqing are widely used in the treatment of several cardio-cerebral vascular diseases.

Image: A CT scan showing a cancerous tumor in the left lung. Photo: courtesy of Mrug.