Guizhou bailing anti hepatitis a new drug tifentai Y101 obtained clinical approval

Tefentai tablet is a kind of new chemical medicine against hepatitis B, and it is a major new drug creation project in the 12th Five Year Plan, Guizhou bailing has undertaken a total of 30 million yuan of pre clinical research and related patent technology transfer fees for the tifentai project At the same time, it is clearly agreed that the project patents, new drug certificates and production approval documents obtained shall be owned by the company The project has repeatedly obtained national key new drug projects and local special support funds in Guizhou Province from project initiation to research and development According to the public data, compared with the main anti hepatitis B virus varieties interferon and the existing chemical antiviral drugs, tefentai has the characteristics of strong virus inhibition effect, less adverse reactions, weak symptom rebound after drug withdrawal, and strong liver protection effect The experiment shows that it has significant protective effect on the damaged liver tissue, and the symptoms of liver transaminase increase after use are obvious To alleviate Guizhou bailing: announcement date of approval for clinical trial of new chemical drug "tifentai" December 21, 2013 securities code: 002424 securities abbreviation: Guizhou bailing Announcement No.: 2013-094 Guizhou bailing Enterprise Group Pharmaceutical Co., Ltd announcement date of approval for new chemical drug "tifentai" The company and its directors, supervisors and senior managers guarantee that the contents of the announcement are true, accurate and complete, and that there are no false records, misleading statements or major omissions in the announcement On December 20, 2013, Guizhou bailing Group Pharmaceutical Co., Ltd (hereinafter referred to as "the company") received the notice of approval opinions issued by the State Food and drug administration The company, together with the natural product chemistry Key Laboratory of the Chinese Academy of Sciences in Guizhou Province and Tianjin Pharmaceutical Research Institute, Tifentai (original Y101), which was jointly developed by the third and second hospital of the Chinese people's Liberation Army, obtained the approval for clinical trials of drugs: it was agreed that the preparation of this product should be used for phase I clinical trials Relevant information is as follows: drug name: tifentai; approval No.: 2013l02491; dosage form: API; application items: new drug registration classification: chemical drug class 1.1 after obtaining phase I clinical trial approval, The company will organize cooperative R & D units to carry out clinical trials as soon as possible in accordance with the requirements of national clinical trials Risk tip: in view of the complexity, risk and uncertainty of new drug development, the development of tiffingtai (Y101) project has a long cycle and large investment, and each stage of research has a risk The company will timely perform the obligation of information disclosure, and invite investors to pay attention to the risk of investment 1 The company's tifentai (original Y101) project has the potential risk of long clinical experiment period The clinical research of the project will be conducted according to the approved clinical experiment scheme The research will be divided into multiple stages The company will timely disclose the information of the cycle time, and there are risks and major uncertainties in each stage; 2 The company's tifentai (original Y101) project may not obtain the new drug certificate and drug production approval It is hereby announced Board of directors of Guizhou bailing Group Pharmaceutical Co., Ltd December 20, 2013 Recently, we have made some preliminary understanding of the specific anti HBV mechanism of Guizhou bailing's new anti HBV drug, horseshoe gold derivative Y101 (tefentai) Mechanism of anti HBV: 1 Directly interfere with the synthesis of HBV DNA; 2 Synthesize antigens on the surface of HBV so that the human immune mechanism can recognize and eliminate them; 3 Summary of other mechanisms (involving confidentiality temporarily not disclosed): Y101 (tefentai) anti HBV is multi-target, and some drugs commonly used at present are single target This is the first advantage of Y101 as a new anti HBV drug: multi target anti HBV Thanks to the multi-target mechanism, Y101 (tefentai) has gained a major feature in the anti hepatitis B virus test at present, that is, the virus inhibition effect is very good, the symptom rebound phenomenon is weak after drug withdrawal, and it does not need long-term continuous medication, which is the second advantage that can be expected Interferon and nucleoside need to be used for a long time, especially the latter The third advantage is that the bioavailability is up to 64%, which can be used orally, which is relative to interferon and therapeutic vaccine The fourth advantage is that the completed pharmacological and toxicological tests show less adverse reactions and less damage to normal cells This is not surprising, because the common people of horseshoe gold, the original medicine of Y101, have been using it for a long time They haven't heard of any special side effects In Taiwan, some people even use it to grind powder to cure colds The fifth advantage is that as mentioned above, Y101 (tefentai) has a strong liver protection effect in addition to anti-virus Experiments show that Y101 has a significant protective effect on the damaged liver tissue After using Y101, the symptoms of elevated liver transaminase are significantly relieved One of the most popular new anti HBV drugs in foreign countries is rep 9, which is produced by replicor company Rep 9 also has some similar characteristics First, it is also multi-target Rep 9 can inhibit two important viral proteins in the process of hepatitis B virus replication: neuraminidase and erythroagglutinin The antiviral effect of rep 9 is also relatively broad-spectrum, and it is effective for 12 kinds of viruses, including influenza, hepatitis B and C, HIV, RSV and herpes However, Y101 and its original drug, horseshoe gold, have shown some broad-spectrum characteristics in the past practice Finally, it should be noted that the above words do not mean that Y101 has been a successful new generation of anti hepatitis B drugs, and the development process of new drugs is still relatively long, which must be completed However, it is gratifying that at present, Guizhou bailing has made important progress in the research and development of Y101, a new class of anti hepatitis B drugs, and has completed its clinical application At the same time, all the pre bed studies have also applied to the national drug regulatory department for clinical trials Although the process is long, it does not exclude that the national policy is expected to make the product enter the market ahead of time At present, from the information obtained by Y101 (tefentai) and some characteristics that have been understood, there are some common features, or potential, of the next generation of new anti HBV drugs.