Class 1.1 new drug PA-824 of Xingtai pharmaceutical, a subsidiary of Fosun Pharmaceutical, was accepted

The board of directors and all directors of Shanghai Fosun Pharmaceutical (Group) Co., Ltd guarantee that there are no false records, misleading statements or major omissions in the announcement about the acceptance of drug clinical trial application by the holding subsidiary, and assume individual and joint liabilities for the authenticity, accuracy and integrity of the contents I overview Recently, Shanghai Xingtai Pharmaceutical Technology Co., Ltd (hereinafter referred to as "Shanghai Xingtai"), a holding subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd (hereinafter referred to as "the company"), received the notice on acceptance of drug registration application from Shanghai food and Drug Administration (hereinafter referred to as "Shanghai food and Drug Administration"), and Shanghai Fosun Pharmaceutical Industry Development Co., Ltd The clinical research application of PA-824 tablets (acceptance No.: cxhl1600091 Shanghai, cxhl1600092 Shanghai) and their APIs (acceptance No.: cxhl1600090 Shanghai) (hereinafter collectively referred to as "the new drug") developed by Shanghai Xingtai has been accepted by Shanghai food and drug administration 2 Basic information of the new drug 1 Drug name: PA-824 acceptance No.: cxhl1600091 Shanghai dosage form: preparation: tablet specification: 100mg application items: new drug application: chemical drugs 1.1 application stage: clinical application: Fosun Pharmaceutical industry, Shanghai Xingtai Conclusion: the application materials meet the requirements of relevant regulations and are accepted 2 Drug name: PA-824 Acceptance Number: cxhl1600092 Hu dosage form: preparation: tablet Specification: 200mg Application items: new drug application: chemical drugs 1 Class 1 Application stage: clinical application Applicant: Fosun Pharmaceutical industry, Shanghai Xingtai Conclusion: the application materials meet the requirements of relevant regulations, and shall be accepted 3 Drug name: PA-824 Acceptance Number: cxhl1600090 Dosage form: non preparation: API Application items: new drug application: chemical drug class 1.1 Application stage: clinical application: Fosun Pharmaceutical industry, Shanghai Xingtai Conclusion: the application materials meet the requirements of relevant regulations and are accepted 3 The research of the new drug was accepted On March 9, 2016, the first clinical trial application submitted by Fosun Pharmaceutical Industry and Shanghai Xingtai to Shanghai food and drug administration was accepted The new drug can inhibit Mycobacterium tuberculosis mainly by inhibiting the double action mechanism of bacterial protein synthesis and cell wall mycotic acid synthesis The antibacterial activity is better than isoniazid, and it is better for sensitive TB and rifampicin resistant TB; it has potential efficacy for isolated MDR-TB, and may shorten the treatment cycle, and has no cross resistance with the anti TB drugs currently used in the clinical bed As of the date of this announcement, no similar drugs with independent intellectual property rights have been listed in China (excluding Hong Kong, Macao and Taiwan) As of February 2016, the company and its holding subsidiaries / units have invested about 14 million yuan in research and development of the new drug at this stage IV risk indicates that although the clinical research of the new drug is expected to be good, according to the experience of new drug research and development at home and abroad, there are certain risks in new drug research and development, for example, the phase I, phase II and / or phase III clinical trials may be terminated due to safety and / or effectiveness According to the regulatory requirements for new drug research and development in China, a series of clinical studies on the new drug should be carried out and approved by the national drug review department before it can be put on the market New drug research and development is a long-term work, there are many uncertain factors, please pay attention to the investment risk of investors It is hereby announced Board of directors of Shanghai Fosun Pharmaceutical (Group) Co., Ltd March 29, 2016