The first phase clinical trial of a new class of Guizhou bailing chemical "tifentai"

On March 17, 2014, Guizhou bailing signed the technology development (entrustment) contract with Beijing bonoway Pharmaceutical Technology Development Co., Ltd the company is Party A and bonoway pharmaceutical is Party B The company will entrust bonoway pharmaceutical to carry out the phase I clinical trial of tifentai tablets and pay the technical service fee Bonoway pharmaceutical will accept the Commission and carry out this work The total amount of technical service fee is RMB 3.9 million four thousand two hundred and nineteen yuan (￥ 3904219) The tifentai project (original Y101) jointly developed by Guizhou bailing Group Pharmaceutical Co., Ltd and Key Laboratory of natural product chemistry, Chinese Academy of Sciences, Tianjin Pharmaceutical Research Institute, Chinese people's Liberation Army 302 hospital was on December 20, 2013 and 2014 On January 21, 2008, the company received the approval documents for clinical trials of APIs and preparations issued by the State Food and drug administration, and then carried out the preparations for clinical studies of tifentai project in accordance with the approval contents of the approval documents for clinical trials of drugs Guizhou bailing: Notice on the progress of "tifentai" project of new chemical medicine class I dated March 18, 2014; securities code: 002424; securities abbreviation: Guizhou bailing; Notice No.: 2014-041; notice on the progress of "tifentai" project of new chemical medicine class I of Guizhou bailing Group Pharmaceutical Co., Ltd 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 Guizhou bailing Group Pharmaceutical Co., Ltd (hereinafter referred to as "the company") and the Key Laboratory of natural product chemistry of Guizhou Academy of Sciences, Tianjin Pharmaceutical Research Institute, On December 20, 2013 and January 21, 2014, the tifentai project (formerly Y101) jointly developed by the third and second hospital of the people's Liberation Army received the approval for clinical trials of APIs and preparations issued by the State Food and drug administration, Therefore, the company has carried out all preparations for the clinical research of tifentai project in accordance with the approved contents of the approval document for clinical trials of drugs On March 17, 2014, the company signed the technology development (entrustment) contract with Beijing bonoway Pharmaceutical Technology Development Co., Ltd (hereinafter referred to as "bonoway pharmaceutical") The company is Party A and bonoway pharmaceutical is Party B The company will entrust bonoway pharmaceutical to carry out the phase I clinical trial of tifentai tablets and pay the technical service fee Bonoway pharmaceutical will accept the Commission and carry out this work The main contents of the contract are as follows: 1 Technical objectives: Party A entrusts Party B to complete the phase I clinical trial of tifentai tablets according to the time and funds agreed in the contract, obtain the research data and statistical results of phase I clinical trial of tifentai tablets, and submit the clinical summary report to Party A 2 Technical content: the pre clinical study has been completed and the clinical trial approval has been obtained Party B, entrusted by Party A, has completed the phase I clinical trial of the drug within the specified time through the strictly designed clinical trial scheme 3 Progress of technical services: on the premise that this Agreement comes into effect and Party A pays each sum of money to Party B on time: Party B shall complete the phase I clinical trial of tifentai tablets before June 30, 2015 4 Fees: Party A shall pay Party B technical service fees totaling three million nine hundred and four thousand two hundred and nineteen yuan (￥ 3904219) Both parties agree that Party A shall pay to Party B in the form of transfer, and Party B shall issue a formal full invoice within 10 working days after confirming the receipt of each period of payment from Party A according to the payment method agreed in the contract 5 Treatment of termination of clinical trial: in the performance of this contract, if the research and development fails or partially fails due to the technical difficulties that are difficult to overcome under the existing technical level and conditions, and one or both parties suffer losses, both parties shall bear the risk losses as follows: (1) in the process of performing this agreement, If the clinical trial cannot be completed according to the specified time and requirements due to the following reasons, both parties can negotiate according to the actual situation: ① force majeure occurs; ② the drug itself (such as poor clinical efficacy or poor safety) does not have the value of continuing research; ③ changes in national policies related to new drug development; ④ serious adverse events (2) in case of any of the above situations, both parties shall negotiate with the clinical unit to decide whether to terminate the test After the three parties negotiate and decide to terminate the clinical trial, they shall deal with it in the following ways: ① payment: Party A has paid Party B before the termination of the clinical trial, and Party B will not return it If the expenses incurred in the clinical supervision work exceed the expenses paid by Party A, Party A shall make up the excess after Party B provides the supporting materials Party A shall not pay Party B any further payment ② data: the ownership of all test data related to the project belongs to Party A 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 investment risk 1 The company's tifentai (original Y101) project has the potential risk of long clinical trial cycle The clinical research of the project will be carried out according to the approved clinical trial plan The research will be divided into multiple stages The company will timely disclose the information about 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 March 17, 2014