Sihuan Pharma heart drug IND accepted in China

Leading China-based cardio-cerebral vascular drug firm Sihuan Pharmaceutical Holdings (HKEx: 0460) says that its application to register tylerdipine hydrochloride, the company's first innovative anti-hypertensive drug developed by its in-house R&D team, has been officially accepted by the Chinese State Food and Drug Administration (SFDA).

The application acceptance is an important step and significant achievement for the company and comes on top of its approval to conduct clinical trials for its internally developed anti-infective drug apapenem carbapenems earlier this year, the drugmaker notes.

Also plans to file IND in USA

Tylerdipine is an innovative patented calcium channel blocker for the treatment of hypertension and features a novel molecular structure and independent intellectual property right, the firm says. As the company's first international and innovative drug to apply for both domestic and overseas registration, Sihuan aims to file an Investigational New Drug application with the US Food and Drug Administration in 2012. The drug is expected to receive permission for clinical trial in China by the end of 2013.