Approval for clinical trial of olanzapine fluoxetine capsule

Zhejiang Jinhua Kangenbei biopharmaceutical Co., Ltd., a holding subsidiary of Zhejiang Kangenbei Pharmaceutical Co., Ltd., received the approval document for clinical trial of olanzapine fluoxetine capsule approved and issued by the State Food and drug administration Examination and approval conclusion: after examination, the product conforms to the relevant provisions of new drug examination and approval, and agrees to carry out clinical trials The approval of the product experiment will bring another new profit point to the company and will have a positive impact on the stock price Kangenbei: announcement date of approval for clinical trials of olanzapine fluoxetine capsule, subsidiary: 2016-04-28 securities abbreviation: Kangenbei securities code: 600572 No.: 2016-057 Zhejiang Kangenbei Pharmaceutical Co., Ltd The board of directors and all directors of the company guarantee that there are no false records, misleading statements or major omissions in the contents of the announcement, and They shall be jointly and severally liable for the authenticity, accuracy and completeness of their contents Recently, Zhejiang Jinhua Kangenbei biopharmaceutical Co., Ltd (hereinafter referred to as "Jinhua Kangenbei"), a holding subsidiary of Zhejiang Kangenbei Pharmaceutical Co., Ltd (hereinafter referred to as "the company"), received the approval for clinical trials of ornipine fluoxetine capsules approved and issued by the State Food and drug administration The relevant information is hereby announced as follows: 1 Main contents of clinical trial approval document (1) olanzapine fluoxetine capsule 1 Drug name: Olanzapine fluoxetine capsule 2 Approval document No.: 2016l02328 3 Dosage form: capsule 4 Specification: 6mg / 25mg 5 Application items: domestic drug registration 6 Registration classification: chemical medicine category 3.2 7 Applicant: Zhejiang Jinhua Kangenbei biopharmaceutical Co., Ltd and Shandong chengchuang Pharmaceutical Technology Development Co., Ltd 8 Examination and approval conclusion: after examination, the product complies with the relevant provisions of new drug examination and approval, and agrees to carry out clinical trials (II) olanzapine fluoxetine capsule 1 Drug name: Olanzapine fluoxetine capsule 2 Approval No.: 2016l03994 3 Dosage form: capsule 4 Specification: 3mg / 25mg 5 Application items: domestic drug registration 6 Registration classification: category 3.2 of original chemicals 7 Applicant: Zhejiang Jinhua Kangenbei biopharmaceutical Co., Ltd and Shandong chengchuang Pharmaceutical Technology Development Co., Ltd (III) olanzapine fluoxetine capsule 1 Drug name: Olanzapine fluoxetine capsule 2 Approval No.: 2016l03996 3 Dosage form: capsule 4 Specification: 12mg / 25mg 5 Application items: domestic drug registration 6 Registration classification: original chemical drug category 3.2 7 Applicant: Zhejiang Jinhua Kangenbei biopharmaceutical Co., Ltd and Shandong chengchuang Pharmaceutical Technology Development Co., Ltd 2 Research and development of the new drug Olanzapine fluoxetine capsule is a compound preparation, mainly composed of olanzapine and fluoxetine hydrochloride Olanzapine is a non typical antipsychotic drug Fluoxetine hydrochloride is a selective serotonin reuptake inhibitor (SSRI) It is mainly used in the acute treatment of bipolar I-related depression and refractory depression (i.e as an emergency treatment for depression patients who have developed resistance to other drugs) The combination of olanzapine and fluoxetine can produce synergistic effect Compared with olanzapine or fluoxetine alone, the combination of olanzapine and fluoxetine can increase the release of norepinephrine and dopamine in the prefrontal cortex, increase the 5-hydroxytryptamine, and increase the antidepressant ability A large number of clinical trials have proved that olanzapine fluoxetine capsule is effective and safe in the treatment of bipolar depression and refractory depression The product was developed by Lilly company of the United States and approved by FDA of the United States in 2004 The product is named "Symbyax" The product is not listed in China and is in the stage of research and development in China The olanzapine fluoxetine capsules developed by Jinhua Kangenbei refer to the products of Lilly company, the original manufacturer, whose prescription composition, types and dosage of excipients are basically the same as those of the original foreign manufacturer, so as to ensure that the efficacy of the products is the same as that of the original foreign products Olanzapine fluoxetine capsule is a product jointly developed by Jinhua Kangenbei and Shandong chengchuang Pharmaceutical Technology Development Co., Ltd the product's note was submitted by Jinhua Kangenbei and Shandong chengchuang Pharmaceutical Technology Development Co., Ltd in May 2014 The application was approved and issued by the State Food and Drug Administration in February 2016 The property right of the product belongs to Jinhua Kangenbei Up to now, Jinhua Kangenbei has invested about 2.7 million yuan in research and development of the product Jinhua Kangenbei will carry out the clinical trial in strict accordance with the requirements of the above clinical trial approval documents, and submit the clinical trial report and relevant documents to the State Food and drug administration after the completion of the clinical trial, and apply for the production registration approval documents III other relevant information: since 2013, there have been 6 domestic enterprises (including 1 application number of Jinhua Kangenbei) that have obtained the approval for clinical trial of olanzapine fluoxetine hydrochloride capsule or olanzapine fluoxetine capsule, a new class 3.2 chemical medicine, and no company has applied for production In addition, the clinical application of olanzapine fluoxetine hydrochloride capsule or olanzapine fluoxetine capsule, a new class 3.2 chemical drug from 6 enterprises, is in the review stage (including 2 application numbers of Zhejiang Jinhua Kangenbei) In addition, 3 enterprises obtained the clinical approval documents of olanzapine fluoxetine hydrochloride capsule or olanzapine fluoxetine capsules (I), (II) and (III) According to the clinical procurement data of 360 sample hospitals in 22 cities / regions of China Pharmaceutical Association, the clinical procurement amount of antidepressant sample hospitals in 2015 was 1.004 billion yuan, an increase of 7.31% year on year In 2015, there were 4 kinds of sales exceeding 100 million yuan: escitalopram, sertraline, venlafaxine and paroxetine In 2015, the clinical purchase of escitalopram, which ranked first in sales, was 207 million yuan, a year-on-year increase of 22.95%, accounting for 20.62% of the total sales of antidepressant drugs in 2015 2013-2015 clinical purchase data of antidepressant preparations in sample hospital of China Pharmaceutical Association 2013-2014-2015 sales volume of antidepressant preparations (RMB 100 million) 831.9.35-10.04 Growth rate: 12.56%, 7.31% 1 Sales volume of escitalopram (100 million yuan) 1.18, 1.68, 2.07 Growth rate - 42.92% 22.95% 2 Sales volume of sertraline (100 million yuan) 1.27-1.29-1.47 Growth rate - 1.10% 14.66% 3 Sales volume of venlafaxine (100 million yuan) 1.01-1.25-1.44 Growth rate - 23.84% 15.19% 4 Paroxetine sales (100 million yuan) 1.81-1.49-1.42 The growth rate is - 17.49% - 4.78% for new drug research and development of pharmaceutical products, including clinical trials and the long period from registration and application to industrial production There are many links, and there are many uncertain factors such as technology, capital and approval The company will pay close attention to the R & D of related products and the change of market conditions At the same time, please pay attention to the investment risk The company will timely perform the obligation of information disclosure according to the actual progress of drug research and development It is hereby announced Board of directors of Zhejiang Kangenbei Pharmaceutical Co., Ltd April 28, 2016