The Ministry of Science and Technology issued a fine, two listed medical device companies | '中枪'!
Medical Network October 26th The Ministry of Science and Technology first published 6 'rare' tickets, related to human genetic resources. Huada Gene, Shanghai Huashan Hospital, WuXi PharmaTech, AstraZeneca and other 6 companies or institutions were punished.
On October 24, the official website of the Ministry of Science and Technology of the People's Republic of China published six administrative penalties. The time for the punishment was displayed on September 7, 2015, October 21, 2016, July 31, 2018, July 12, 2018. day.
Some media reported that this is the first time the Ministry of Science and Technology has publicized such punishment.
Today, according to the news, relevant personnel of the Ministry of Science and Technology have confirmed to them that the six tickets are the first publicity of the Ministry of Science and Technology.
Opened six tickets, the companies or institutions that were punished include: Shenzhen Huada Gene Technology Service Co., Ltd., Huashan Hospital affiliated to Fudan University, Suzhou Wuming Kangde New Drug Development Co., Ltd., Xiamen Aide Bio medicine Technology Co., Ltd., AstraZeneca Investment (China) Co., Ltd., Kunyu Ruicheng Pharmaceutical R&D (Beijing) Co., Ltd.
There are several provisions in the six companies or institutions that violate the Interim Measures for the Administration of Human Genetic Resources.
It should be noted that two of the six companies that have been punished are medical instruments Related enterprise.
The punishment book shows that in the investigation of the international research cooperation on the large-scale case-control study of Chinese women with unipolar depression, Huashan hospital Shenzhen Huada Gene Technology Service Co., Ltd. (abbreviation: Huada Technology) conducted an international cooperation study on human genetic resources in China with the University of Oxford without permission. Huashan Hospital and Huada Technology will pass some human genetic resources information online without permission. Exiting.
Article 4 of the Interim Measures for the Administration of Human Genetic Resources stipulates that the State shall implement a declaration and registration system for important genetic families and genetic resources of specific regions; without permission, no unit or individual may collect, collect, trade, export, exit or otherwise The form is provided externally.
On September 7, 2015, the Ministry of Science and Technology made a decision on punishment, requiring Huashan Hospital and Shenzhen Huada Gene Technology Service Co., Ltd. to immediately stop the aforementioned research work; destroy all unearthed genetic resources materials and related research data in the aforementioned research work; The hospital and Huada Gene are involved in the international cooperation of China's human genetic resources, and carry out rectification.
The penalty book shows that Xiamen Aide has received 30 samples of AstraZeneca Investment (China) Co., Ltd. without permission, and is intended to be used for kit development activities. It is also found that AstraZeneca will be approved without permission. The remaining samples were transferred to Xiamen Aide Biomedical Technology Co., Ltd. and Kunyu Ruicheng Pharmaceutical R&D (Beijing) Co., Ltd. to carry out research activities beyond the scope of examination and approval.
On July 12, 2018, the Ministry of Science and Technology made a penalty decision to warn Xiamen Aide, AstraZeneca; confiscated and destroyed illegal use of human genetic resources materials.
At the same time, the punishment for AstraZeneca also includes the abolition of the two administrative licenses of the National Science and Technology Legislation [2015] No. 83, [2016] No. 837; the acceptance of AstraZeneca from the date of the delivery of this decision involves Chinese humans. Applications for international cooperation activities on genetic resources shall be accepted after rectification and acceptance.
The 'Xiamen Aide' shown in the punishment book is the listed machinery enterprise Aide Bio, the full name of Xiamen Aide Biomedical Technology Co., Ltd.
On August 2, 2017, Aide Bio officially landed on A shares. Start a business The board has become another listed company in the field of genetic diagnosis after the successful listing of the Chinese gene, and some media called it the 'tumor gene detection bully'.
However, Ed Bio is called another 'unicorn' in the field of genetic diagnosis. On August 20 last year, Xinhua News Agency also made a special report on it.
In addition, the 'Shenzhen Huada Gene Technology Service Co., Ltd.' will be directly punished and called 'Hua Da Gene'.
According to the previous prospectus of Huada Gene, 'Shenzhen Huada Gene Technology Service Co., Ltd.' is referred to as 'Hua Da Technology' and is a first-class subsidiary of Shenzhen Huada Gene Co., Ltd. (the listed 'Hua Da Gene'). The main business includes biotechnology research and development, biotechnology services, purchase and sale of reagents (technical services), etc. Huada Gene holds 90.9091% of Huada Technology.
The ticket issued in 2015 has been three years since today, and the Huada Gene has enough time to rectify it. The daily economic news report confirmed this statement.
Today (October 25) afternoon, according to the "Daily Economic News" report, Huada Gene related people responded to it, saying that after receiving the administrative punishment in 2015, the company attached great importance to this matter and quickly advanced it. The rectification work has been re-regulated and comprehensively rectified for the qualification requirements, cooperation process and effect evaluation of relevant cooperation.
The above-mentioned person said that after verification and on-site inspection, the Ministry of Science and Technology has approved the company to resume international cooperation on human genetic resources.
