Shanghai Xinxing has completely stopped production and carried out self inspection and accepted the verification of relevant departments
-
Last Update: 2019-02-11
-
Source: Internet
-
Author: User
Search more information of high quality chemicals, good prices and reliable suppliers, visit
www.echemi.com
Recently, the general office of the national health and Health Commission issued the notice on suspending the use of human immunoglobulin for intravenous injection of relevant batch numbers of Shanghai Xinxing Pharmaceutical Co., Ltd (gwdy [2019] No 4) According to the notice, the national health and Health Commission received a report from the health and Health Commission of Jiangxi Province, and the CDC of the health and Health Commission of Jiangxi Province tested the HIV antibody of Shanghai Xinxing Pharmaceutical Co., Ltd (hereinafter referred to as "Shanghai Xinxing") injected with human immunoglobulin (batch No.: 20180610z) Shanghai Xinxing is a holding subsidiary of China Pharmaceutical and Health Industry Co., Ltd (hereinafter referred to as "the company"), the company attaches great importance to this event, immediately establishes a special working group, and quickly sends personnel to Shanghai Xinxing for on-site supervision The information is as follows: 1 Human immunoglobulin is a blood product prepared from human plasma, which is mainly used for the treatment of critical infection and immunodeficiency patients This batch of human immunoglobulin (batch No.: 20180610z) was batch signed by Shanghai food and Drug Inspection Institute on October 12, 2018, with a total of 12226 bottles, specification of 5%, 2.5g/50ml/bottle, shelf life to June 8, 2021 2、 Current progress (1) on February 6, 2019, the national health and Health Commission issued the response to the issues related to "positive injection of human immunoglobulin AIDS antibody": the working group has been dispatched to local areas for guidance at the first time, and experts have been convened to analyze and judge the relevant issues According to the relevant international literature reports, combined with the characteristics of the production process of inactivated virus and the pH value of the product and other factors, experts believe that the risk of HIV infection in patients using the drug is very low (2) On February 6, 2019, the State Food and Drug Administration announced the preliminary investigation of emerging related products in Shanghai: the nucleic acid test of HIV, hepatitis B and C carried out by Shanghai for the involved batches of intravenous injection of human immunoglobulin was negative; the nucleic acid test of HIV in Jiangxi was negative 3、 At present, the company holds 51% equity of Shanghai Xinxing, which was included in the scope of consolidated statements of Listed Companies in June 2018 The company has no guarantee for Shanghai Xinxing (1) Financial data as of the end of September 2018, the total assets of Shanghai Xinxing consolidated accounting for 384 million yuan, accounting for 1.5% of the company's total assets; the total net assets of 361 million yuan, accounting for 3.6% of the company's total net assets; from January to September 2018, Shanghai Xinxing consolidated accounting for 153 million yuan, accounting for 0.69% of the company's total operating revenue; and the net profit of 7, 1.83 million yuan, the net profit attributable to its parent company is 36.63 million yuan, accounting for 2.95% of the total net profit attributable to shareholders of the listed company (2) Product composition the main product income composition of Shanghai Xinxing from January to September 2018 is as follows: unit: 10000 yuan to sum up, Shanghai Xinxing's business scale and profit account for a small proportion in the company, with little impact on the company 4、 The company's response measures (I) the company's first time requirements after learning the news: 1 Shanghai Xinxing informs relevant units to stop selling, using, sealing and recalling the batch of products in question, and at the same time conduct a comprehensive inventory of the use of the batch of products in question 2 Shanghai Xinxing has stopped production in an all-round way, and has comprehensively checked the possible problems in the raw material source, production and quality control process of the batch of products in question Once any violation is found, the company will seriously investigate the responsibility of relevant personnel 3 Shanghai Xinxing shall immediately carry out self inspection and fully cooperate with the inspection work of relevant departments to ensure the authenticity and integrity of the original records of production and quality control (2) The company set up a special working group to immediately enter Shanghai Xinxing, understand the specific situation and carry out on-site supervision 5、 As of the disclosure date of this announcement, the on-site inspection work of relevant departments and the self inspection work of Shanghai Xinxing are still in progress If there is further follow-up progress, the company will make an announcement in time Please refer to the information and announcement released by the company on the official website (www.meheco Com), the legal information disclosure media and the website of Shanghai Stock Exchange (www.sse Com CN) 6、 At present, Shanghai Xinxing has stopped production in an all-round way to carry out self inspection and accept the verification of relevant departments, and the time to resume production is still uncertain We sincerely invite investors to invest rationally and pay attention to investment risks It is hereby announced Board of directors of China Pharmaceutical Health Industry Co., Ltd February 11, 2019
This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only.
This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of
the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed
description of the concern or complaint, to
service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content
will be removed immediately.