the new drug of the subsidiary of fosun pharma obtains the approval in clinical trials
on april 9, 2016, shanghai fosun pharmaceutical (group) ltd. (“fosun pharma”) released its announcement that 0.7-mg-packed dutasteride/tamsulosin (fixed-dose combination) sustained-release capsule and its api—dutasteride (collectively called “this new drug”) manufactured by its subsidiary chongqing pharmaceutical research institute co., ltd. (“cpri”) has obtained the approval of clinical trials from china food and drug administration (“cfda”).
this new drug, registration category 3 chemicals independently designed by fosun pharma, applies well to benign prostatic hyperplasia (bph, enlarged prostrate). as of march 2016, fosun pharma group currently has invested approximately rmb 48 million yuan in research and development of this new drug (0.7 mg and 0.9 mag packs).
it is reported that currently there is no such capsule available in china (excluding hong kong, taiwan and macao). according to the materials of ims midastm (provided by ims health, which the global leading provider of the professional information and strategic consulting service in the health and medicine industry), the 2015 global sales of this capsule had soared to usd 400 million or so. fosun pharma’s announcement, however, indicated a relevant risk that, in accordance with the state regulations governing new drug r&d, application for production of this new drug can be submitted only if the clinical trials have been conducted.
fosun pharma always takes innovation as the driving force of its corporate development and continued optimize its pharmaceutical r&d system that integrates imitation and innovation. in recent years, fosun pharma has continuously increased its r&d investment, thus having formed the international r&d layout and the comparatively stronger r&d capacity. at present, fosun pharma has nearly 900 research staff and has built the interactively integrated development system by laying out its business operation in shanghai, chongqing, taiwan and san francisco the us and continued to increase its investment on the four major r&d platforms, thus having created the high-efficient r&d platform in such fields as small molecule chemical innovation drugs, large molecular biosimilars, high-value generic drugs and characteristic preparation technology, etc.
about shanghai fosun pharmaceutical (group) co., ltd.
shanghai fosun pharmaceutical (group) co., ltd. (“fosun pharma”) is a leading healthcare company in china, which was established in 1994 and was listed on shanghai stock exchange and on the main board of the stock exchange of hong kong limited in august 1998 and october 2012, respectively (stock code: 600196-sh,02196-hk). fosun pharma's operations strategically cover several important segments of the healthcare industry value-chain, including: pharmaceutical manufacturing and r&d, pharmaceutical distribution and retail, healthcare services, diagnostic products and medical devices. fosun pharma maintains a highly capable international r&d team in addition to its national recognized enterprise technology centre, with a continuous focus on research and development in therapeutic areas such as metabolism and alimentary tract, cardiovascular system, central nervous system, anti-tumor, immune regulation and anti-infection. with its commitment to innovation for good health and creating a better future, fosun pharma will adhere to its development strategy - “organic growth, coupled with m&a and integration”, and engage itself to becoming a world-class enterprise in the global mainstream medical industry. for more information, please visit www.fosunpharma.com.