The Fc fusion protein injection of recombinant human immunoglobulin ε and γ, a new class 1 new drug of Jingfeng pharmaceutical biological products, has obtained the clinical approval

The company and all members of the board of directors guarantee that the contents of the announcement are true, accurate and complete without any false record, misleading statement or major omission I Basic Information On August 2, 2012, Hunan Jingfeng Pharmaceutical Co., Ltd (hereinafter referred to as "the company"), a joint-stock subsidiary (50%) of Shanghai Kexin Biomedical Technology Co., Ltd (hereinafter referred to as "Kexin pharmaceutical") independently developed recombinant human immunoglobulin ε and γ fusion protein injection (hereinafter referred to as "fusion protein AAFP") applied for clinical trial research and was accepted（ Acceptance No.: cxsl200062 Shanghai) On January 4, 2016, Kexin pharmaceutical received the approval for clinical trials of drugs (approval No.: 2015l05266) approved and issued by the State Food and drug administration II Product introduction AAFP is a kind of innovative medicine for biological products developed by Kexin medicine for more than ten years Its dosage form is injection, specification: 20mg / 4ml It is a class 1 innovative medicine for biological products for treatment, with complete independent intellectual property rights At present, it has obtained patent authorization from the United States, Japan, Australia and China, and it is a project funded by national major special project "major new drug creation" The fusion protein AAFP is an innovative product jointly developed by scientists at home and abroad of new medicine It can block the activation and degranulation of cells and treat allergic diseases caused by allergens from the source through delicate molecular design and regulation of cell signal pathway Its innovative molecular structure is the first in the world At present, there is no similar drug approved for clinical application aiming at the target of AAFP Therefore, the fusion protein AAFP is a completely innovative variety from molecular structure to mechanism of action, which has an indicator significance for the development of China's biopharmaceutical industry The fusion protein AAFP project has completed a large number of preclinical pharmacological and toxicological tests based on animals (mice, monkeys, etc.), the results show that the fusion protein AAFP has an effective therapeutic effect on allergic diseases caused by allergens, and a large number of toxicological tests show that the fusion protein AAFP has good safety and tolerance The national food and Drug Administration approved the AAFP project to enter human clinical trials, which will greatly promote the implementation of the project Kexin pharmaceutical will strictly implement the requirements of the current clinical trial specifications, organize domestic excellent clinical research team, steadily promote clinical trials, and promote the early approval of the recombinant fusion protein AAFP for the treatment of allergic diseases Allergic disease is a kind of diseases caused by allergens With the development of industrialization and the change of environment and climate, the incidence of allergic diseases is increasing year by year According to the statistics of literature, the incidence of allergic asthma in developed areas has reached 5-10%, and allergic rhinitis even more than 20% However, there is a lack of drugs that can treat allergic diseases Most of the current drugs are aimed at the treatment of allergic symptoms, rather than the root cause of allergy The fusion protein AAFP is targeted at allergens induced cell activation, which prevents cells from releasing inflammatory mediators leading to allergic diseases from the source, thus "root" treating allergic diseases, with significant scientific advanced nature, which is suitable for allergens caused by allergens Allergic asthma will be the first indication in the upcoming clinical trials Therefore, the development of AAFP will be a good news for the majority of allergic asthma patients, which has great clinical value At the same time, Kexin medicine will timely carry out research on other indications (such as allergic rhinitis), and actively expand the indications of AAFP to benefit the majority of patients Phase I clinical trial will be carried out after the drug obtains the clinical approval Therefore, the clinical approval of the above products will not have a significant impact on the company's recent performance 3 The risk indicates that although a large number of preclinical research data prove the effectiveness and safety of AAFP, there are still great uncertainties in the future clinical research as a class 1 biological innovative drug Whether the fusion protein AAFP can be used in clinical needs to be evaluated by a large number of human clinical trials Based on scientific attitude and in accordance with the requirements of laws and regulations, Kexin pharmaceutical will strictly implement the current clinical trial specifications, strengthen risk control, and steadily promote the clinical trial of AAFP At the same time, it will also draw the attention of investors to the inherent risks in the development of class 1 biological drugs The validity period of the above clinical approval is 3 years If it is not implemented within the time limit, the approval will be automatically abolished Kexin pharmaceutical will actively carry out clinical experimental research in accordance with the provisions of the measures for the administration of drug registration and the measures for the administration of the quality of drug clinical trials The progress and results of this study are uncertain The company will timely perform the obligation of information disclosure for the follow-up progress of the above-mentioned projects We sincerely invite investors to make prudent decisions and pay attention to investment risks It is hereby announced that the board of directors of Hunan Jingfeng Pharmaceutical Co., Ltd dated January 5, 2016