Guizhou bailing: Notice on the progress of research and development project of new drug GZ50 of antitumor and chemotherapeutic drug 1.1

Securities code: 002424 securities abbreviation: Guizhou bailing Announcement No.: 2016-009 Guizhou bailing Enterprise Group Pharmaceutical Co., Ltd announcement on the progress of the research and development project of new drug GZ50 of anti-tumor drug 1.1 The company and all members of the board of directors guarantee the authenticity, accuracy and integrity of the announcement, announcement There is no false record, misleading statement or major omission Risk tip: in view of the complexity, risk and uncertainty of drug research and development, each stage of research is risky, and the company will timely perform the obligation of information disclosure, and investors are invited to pay attention to the investment risk 1 This research project has the possibility risk of failing to achieve the research objectives; 2 This R & D progress will not have a significant impact on the company's current operation Guizhou bailing Group Pharmaceutical Co., Ltd (hereinafter referred to as "the company" or "Guizhou bailing") and West China Hospital of Sichuan University (National Key Laboratory of biological therapy) (hereinafter referred to as "Party B 1") and Key Laboratory of natural product chemistry of Chinese Academy of Sciences of Guizhou Province (hereinafter referred to as "Party B 1") on September 9, 2015 2) sign the technology development (cooperation) contract (hereinafter referred to as the "contract") The contract partner will jointly participate in the research and development project of "research and development of anti-tumor drug 1.1 candidate drug GZ50" For relevant announcements, please refer to securities times, China Securities Journal and cninfo (http:// the information disclosure media designated by the company on September 10, 2015 Recently, the company and Party B 1 and Party B 2 made the first research summary on the research and development of anti-tumor drug 1.1 new drug GZ50 project, and now the relevant information is announced as follows: 1 The contents of the research meeting summary 1 Guizhou bailing actively invested in the development of GZ50 project Guizhou Bailing is a listed company in Shenzhen Stock Exchange, with a market value of nearly 400 in 2015 Billion yuan, ranking among the top listed pharmaceutical companies in China Now, it has become the largest leading enterprise of Miao medicine in China, with national technology center and National Postdoctoral research station Guizhou bailing has long been rooted in ethnic minority areas, collating and absorbing the essence of national folk medicine, combining modern medicine technology research and development technology, using the leading international drug research methods, adhering to the traditional pharmacology inspiration and developing original innovative new drugs Now, many new original drugs are being carried out in pre clinical and clinical research The company has enough confidence and strength to invest in the development of GZ50 project 2 Party B 1 reports on the current research results of GZ50, which is a reversible colchicine site microtubule inhibitor modified by natural products to obtain a new chemical skeleton At present, paclitaxel is the first-line drug in the market of microtubule target, and it is used in a variety of tumor indications in clinical treatment The latest FDA approved microtubule drugs: ixabepilone, cabazittaxel, erbulin mesalate In addition, ca4-p (phase 3), mpc6827 (phase 2) and other small molecular compounds were used in clinical experiments The idea of GZ50 is to replace the quinoxaline skeleton of mpc6827 with natural skeleton The in vitro activity of GZ50 was higher than that of paclitaxel In different tumor strains, IC50 was 1-10 nm The effect of GZ50 on MCF-7 / ADR, A2780 / T and HCT / T was very good IC50 was all in 1-30 nm Different from mpc6827, GZ50 is a reversible microtubule inhibitor, so its toxicity will be much smaller At present, GZ50 citrate is used for administration to make common intravenous preparations GZ50 citrate has a very good antitumor effect in six models of colon cancer C26, lung cancer H460, breast cancer MCF-7 and MCF-7 / ADR, ovarian cancer a2780s and A2780 / T its activity is higher than paclitaxel, and its toxicity is lower than paclitaxel and mpc-6827 tissue distribution experiment It is found that GZ50 has a good lung accumulation effect 3 Wei Yuquan, academician of the Chinese Academy of Sciences (director of the State Key Laboratory of Biotherapy, Sichuan University), attended the meeting and put forward his guidance Wei Yuquan pointed out that the GZ50 project suggested that the indications could be breast cancer lung metastasis model It was important to check whether the model had small molecule targeted drugs, and if so, how to establish advantages In addition, microtubule drugs are currently used for spinal cord loss (such as paclitaxel), whether GZ50 is considered For the selection of preparations, ordinary preparations are preferred 4 Party B 2 put forward suggestions on the research and development of GZ50, focusing on the selection and optimization of the synthesis process route of GZ50 API, impurity control, pilot scale-up, preparation and property inspection of various salts, patent application and other issues, hoping to prepare GZ50 samples with purity of about 99.5% Some constructive suggestions are put forward for other work 5 Party A and Party B 1 have basically determined that the domestic clinical application of GZ50 and the drug clinical trial application (ind) of the US Food and Drug Administration (FDA) should be carried out at the same time on the basis of the communication opinions on the domestic and foreign dual application and the doctor's entry of the postdoctoral research workstation Therefore, the pre clinical research data should be prepared according to two sets of data In order to better promote the development of the project, strengthen personnel training Both parties agree that Sichuan University postdoctoral mobile station will introduce a doctor to Guizhou bailing postdoctoral research station to carry out the research work of GZ50 project, and train qualified Guizhou bailing researchers to study for master's degree and doctor's degree in engineering 2、 The results show that GZ50 is a new reversible microtubule inhibitor with a new chemical framework It has very good antitumor effect, higher activity than paclitaxel and lower toxicity than paclitaxel It has very good drug-forming ability 2 It has preliminarily determined the treatment indications of GZ50, and it is suggested to select breast cancer, ovarian cancer and lung metastasis of breast cancer 3 It has preliminarily determined the drug dosage form of GZ50, and the powder injection preparation is preferred 4 It is basically determined that the pre clinical study of GZ50 will be applied for both domestic and foreign clinical trials; 5 The next work is agreed 3、 Later main research work plan 1 Party A is responsible for the coordination and application of GZ50 project 2 Party B 1 is responsible for the research of GZ50 preparation and pharmacology and toxicology The preparation and quality research of 5 batches of intravenous preparations, official pharmacodynamics experiment of GZ50 and long-term toxicity pre test of rats were completed 3 Party B shall perfect the patent application of GZ50 as soon as possible Based on the existing route, a batch of products were synthesized The solubility and stability of GZ50 were studied At the same time, provide the synthesis raw materials and intermediates of GZ50, and give them to Party B 2 to carry out the API research 4 Party B 2 is responsible for the pharmaceutical research of GZ50 API Optimization and scale-up tests were carried out on the synthesis process of GZ50 API, and the preparation of 5 batches of API pilot samples, quality research, impurity research, physical and chemical properties of the pilot samples, and API influencing factors test were completed 5 According to the drug review reform plan, the three parties work together to make GZ50 enter the domestic clinical research stage in 18 months It is hereby announced Board of directors of Guizhou bailing Group Pharmaceutical Co., Ltd January 15, 2016