approval for clinical trial on tuberculosis drug of fosun pharma’s controlling subsidiaries
[3 december 2016, hong kong] on 2 december 2016, as stated in the a share announcement of shanghai fosun pharmaceutical (group) co., ltd. (“fosun pharma”, stock code: 600196.sh, 02196.hk), shanghai suntech pharmaceutical co., ltd. and shanghai fosun pharmaceutical industrial development co., ltd, its controlling subsidiaries, have received approval from the china food and drug administration in relation to clinical trial on pa-824 api preparations (pa-824 tablets and pa-824 api, hereinafter collectively referred to as the “new drug”).
the new drug is used for treatment of tuberculosis by inhibition of mycobacterium tuberculosis primarily through a double action of inhibiting syntheses of bacterial protein and cell wall mycolic acid. the antibacterial activity of the new drug is higher than isoniazid, notably for sensitive mycobacterium tuberculosis and rifampicin-resistant mycobacterium tuberculosis. it also shows a potential efficacy for isolated mdr-tb and a possibility to shorten the treatment cycle without any cross-resistance with anti-tuberculosis drugs currently in clinical use.
currently, no comparable drugs with the same target with the new drug and independent intellectual property rights have been launched in china (except hong kong, macau and taiwan). as of october 2016, fosun pharma group has invested research and development expenses of approximately rmb19 million in the new drug at the current stage.
relevant risks were also indicated in the announcement of fosun pharma. pursuant to the regulatory requirements for the research and development of relevant new drugs in china, the sale of new drug is still subject to a series of clinical trials and the examination and approval from national drug evaluation authorities.
fosun pharma always regards independent innovation as essential to its corporate development and continuously optimizes its pharmaceutical r&d system that integrates imitation and manufacture. in recent years, fosun pharma has been increasing investment in r&d and gained competitive edge in internationalized r&d capability. up to now, the company and its holding subsidiaries have a staff of nearly 900 in its r&d team, spreading over shanghai, chongqing, taipei and san francisco, forming a systematic research system by interacting and integrating with each other. the company continues to raise investment in its four major platforms, aiming to establish highly-effective r&d platforms covering small-molecular drugs, large-molecule bio-similars, high-value generic drugs and specialized pharmaceutical technology.