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Medical Network News, March 11 On March 8, the State Drug Administration's government service portal updated the "Notice of Publication of Non-Registration Approval", Hangzhou Anxu Biotechnology Co.
, Ltd.
(abbreviated as "Anxu Bio") key product—— Human immunodeficiency virus antibody/hepatitis C virus antibody/hepatitis B virus surface antigen/Treponema pallidum antibody combined detection kit (immunochromatographic method) will be officially granted non-registration approval.
, Ltd.
(abbreviated as "Anxu Bio") key product—— Human immunodeficiency virus antibody/hepatitis C virus antibody/hepatitis B virus surface antigen/Treponema pallidum antibody combined detection kit (immunochromatographic method) will be officially granted non-registration approval.
In fact, in January this year, the National Medical Products Administration issued the " Announcement on the Authenticity Issues in the Supervision and Random Inspection of Medical Device Clinical Trials in 2020 ", clearly identifying that Anxu Biologics has multiple clinical trials in this monitoring kit product.
For authenticity issues, penalties will be imposed in accordance with the "Administrative Licensing Law of the People's Republic of China" and the "Administrative Measures for In Vitro Diagnostic Reagent Registration".
For authenticity issues, penalties will be imposed in accordance with the "Administrative Licensing Law of the People's Republic of China" and the "Administrative Measures for In Vitro Diagnostic Reagent Registration".
Since 2015, the national drug regulatory authority has strictly implemented the "four strictest" spirit and promulgated a number of regulations and policies aimed at strengthening the management of clinical trials of medical devices, focusing on monitoring the authenticity, accuracy, and integrity of clinical trial data to ensure Traceability of the research process.
Industry analysis pointed out that today's clinical trials should not have a fluke mentality, and conducting clinical trials in a true and compliant manner is the policy "red line" for products to successfully obtain regulatory approval.
Industry analysis pointed out that today's clinical trials should not have a fluke mentality, and conducting clinical trials in a true and compliant manner is the policy "red line" for products to successfully obtain regulatory approval.
Pre-IPO product "explosive thunder"
Clinical data cannot be traced
In order to strengthen the supervision and management of clinical trials of medical devices, the National Medical Products Administration conducted a random inspection of clinical trial supervision on 10 medical device registration application projects under review in November 2020, involving 27 clinical trial institutions.
The State Food and Drug Administration found that the human immunodeficiency virus antibody/hepatitis C virus antibody/hepatitis B virus surface antigen/Treponema pallidum antibody combined detection kit (immunochromatographic method) produced by Hangzhou Anxu Biotechnology Co.
, Ltd.
( Acceptance number: CSZ2000162) In the clinical trials carried out by the First Affiliated Hospital of Zhejiang University School of Medicine, the time and location of the electronic photographs kept by medical institutions were inconsistent with the actual time and location of the clinical trial, and the clinical trial data could not be traced to the source.
, Ltd.
( Acceptance number: CSZ2000162) In the clinical trials carried out by the First Affiliated Hospital of Zhejiang University School of Medicine, the time and location of the electronic photographs kept by medical institutions were inconsistent with the actual time and location of the clinical trial, and the clinical trial data could not be traced to the source.
After the occurrence of falsified clinical data, the State Food and Drug Administration, in accordance with the "Administrative Licensing Law of the People's Republic of China" and "In Vitro Diagnostic Reagent Registration Management Measures", made a decision not to register the registration application, and from the date of non-registration The registration application for this project will not be accepted again within one year from the beginning; at the same time, Zhejiang Provincial Drug Administration is instructed to effectively fulfill the territorial supervision responsibility of Hangzhou Anxu Biotechnology Co.
, Ltd.
and related clinical trial institutions, and investigate and deal with it in accordance with laws and regulations.
, Ltd.
and related clinical trial institutions, and investigate and deal with it in accordance with laws and regulations.
It is worth noting that Anxu Bio is a listed company on the Science and Technology Innovation Board.
It is reported that on June 2, 2020, Anxu Biosciences Innovation Board listing application was accepted, and plans to raise 459 million yuan; On November 3, 2020, Anxu Biotechnology passed the listing committee meeting; December 30, 2020, submitted Sci-tech Innovation Board registration.
It is reported that on June 2, 2020, Anxu Biosciences Innovation Board listing application was accepted, and plans to raise 459 million yuan; On November 3, 2020, Anxu Biotechnology passed the listing committee meeting; December 30, 2020, submitted Sci-tech Innovation Board registration.
The prospectus of Anxu Biology shows that its main POCT reagents and instruments cover 8 categories, including drug testing series and infectious disease detection series.
The product sales are mainly for export.
From 2017 to 2019, Anxu Biology’s overseas revenue was 1.
04.
100 million yuan, 154 million yuan, 195 million yuan.
The product sales are mainly for export.
From 2017 to 2019, Anxu Biology’s overseas revenue was 1.
04.
100 million yuan, 154 million yuan, 195 million yuan.
Anxu Biological Prospectus
In fact, the market segment in which Anxu Biology is in fierce competition.
The main domestic competitors include Oriental Biology, Wanfu Biology, Jidan Biology, and Mingde Biology.
In comparison, because Anxu Biotech still has a big gap with the leading companies in terms of product variety, production scale and technology development , it is urgent to use the capital market to help the development of the company.
However, at the critical moment of the company's listing, important products under research exploded, causing the industry to worry about the future prospects of the company's IPO.
The main domestic competitors include Oriental Biology, Wanfu Biology, Jidan Biology, and Mingde Biology.
In comparison, because Anxu Biotech still has a big gap with the leading companies in terms of product variety, production scale and technology development , it is urgent to use the capital market to help the development of the company.
However, at the critical moment of the company's listing, important products under research exploded, causing the industry to worry about the future prospects of the company's IPO.
Anxu Biotech previously stated publicly that this fraud incident was mainly caused by problems in medical institutions.
The company commissioned the First Affiliated Hospital of Zhejiang University School of Medicine to conduct clinical trials.
The main responsibility for the problems found in random inspections was the medical institution, and the company was also a victim of the incident.
.
The company commissioned the First Affiliated Hospital of Zhejiang University School of Medicine to conduct clinical trials.
The main responsibility for the problems found in random inspections was the medical institution, and the company was also a victim of the incident.
.
However, this statement obviously cannot be quelled.
Market analysis believes that, in accordance with the requirements of the new version of the "Quality Management Regulations for Drug Clinical Trials" (GCP), it is clear that the sponsor, as the ultimate responsible party for the quality and reliability of clinical trials, needs to establish a quality management system, conduct quality management based on risks, and strengthen quality assurance and Quality control, the establishment of an independent data monitoring committee, and the implementation of risk assessment-based inspections and audits, etc.
, corporate responsibility is the core subject in the full-cycle quality management of clinical trials.
Market analysis believes that, in accordance with the requirements of the new version of the "Quality Management Regulations for Drug Clinical Trials" (GCP), it is clear that the sponsor, as the ultimate responsible party for the quality and reliability of clinical trials, needs to establish a quality management system, conduct quality management based on risks, and strengthen quality assurance and Quality control, the establishment of an independent data monitoring committee, and the implementation of risk assessment-based inspections and audits, etc.
, corporate responsibility is the core subject in the full-cycle quality management of clinical trials.
Resolutely implement the "four strictest"
Quality supervision of clinical trials
The establishment of a comprehensive quality assurance system by the subjects of clinical trials is the cornerstone of ensuring the high-quality completion of the project.
Resolutely implement the "four strictest" spirit, effectively improve the quality of clinical trials of medical devices, promote the improvement of clinical trials, strengthen the sense of responsibility of clinical trial investigators, ensure the authenticity, accuracy and completeness of clinical trial data, and ensure the research process Traceability has been the focus of the work of the drug regulatory authority for many years.
Resolutely implement the "four strictest" spirit, effectively improve the quality of clinical trials of medical devices, promote the improvement of clinical trials, strengthen the sense of responsibility of clinical trial investigators, ensure the authenticity, accuracy and completeness of clinical trial data, and ensure the research process Traceability has been the focus of the work of the drug regulatory authority for many years.
On March 10, the Shanxi Provincial Food and Drug Administration issued the "Notice on Carrying out the Supervision and Inspection of Drug Clinical Trial Institutions", and decided to conduct supervision and inspection of drug clinical trial institutions in the province, aiming to strengthen the supervision and management of drug clinical trials in the province.
The status of drug clinical trials carried out by drug clinical trial institutions.
The status of drug clinical trials carried out by drug clinical trial institutions.
Prior to this, Heilongjiang, Shandong, Sichuan and other provinces have successively issued notices to strengthen the record management of drug clinical trial institutions, and greatly improve the level of clinical trial supervision; Beijing, Tianjin, and Hebei Drug Administration jointly formulated the "Beijing-Tianjin-Hebei Drug The Standards for the First Supervision and Inspection of Clinical Trial Institutions after Filing (Draft for Soliciting Opinions)" requires that clinical trial institutions have "defect items" that do not meet the requirements for immediate correction.
Clinical experts pointed out that in terms of authenticity, all parties involved in clinical trials should respect life, respect their duties and regulations, and resolutely not fabricate clinical trial data; ensure that clinical trial data is traceable; ensure that trial products are used correctly; Serious adverse events, product defects, and banned treatments related to trial products; ensure the quality of data in the registration application materials, etc.
In terms of compliance issues, members of the clinical trial project team should undergo strict training and authorization, and be proficient in the specific requirements of relevant laws, pharmnet.
com.
cn/" target="_blank">regulations and plans.
The entire project implementation process should have mature standard operating procedures (SOP) as guidelines.
com.
cn/" target="_blank">regulations and plans.
The entire project implementation process should have mature standard operating procedures (SOP) as guidelines.
In order to punish the criminal acts of falsifying the application materials for drug and device registration in accordance with the law, the top-level policies have been continuously upgraded.
In 2017, the Supreme People’s Court and the Supreme People’s Procuratorate issued the "Interpretation on Several Issues Concerning the Application of Laws in the Handling of Criminal Cases of Falsification of Registration Application Materials for Drugs and Medical Devices".
Drug clinical trial data that affect the results of drug safety and effectiveness evaluation shall be punished as "intentionally providing false certification documents", and the maximum sentence may be five years.
In 2017, the Supreme People’s Court and the Supreme People’s Procuratorate issued the "Interpretation on Several Issues Concerning the Application of Laws in the Handling of Criminal Cases of Falsification of Registration Application Materials for Drugs and Medical Devices".
Drug clinical trial data that affect the results of drug safety and effectiveness evaluation shall be punished as "intentionally providing false certification documents", and the maximum sentence may be five years.
Not long ago, China Judgment Documents.
com published a criminal judgment issued by the People’s Court of Putuo District, Shanghai.
An employee of Ienkang Clinical Medical Research (Beijing) Co.
, Ltd.
, in order to accelerate the promotion of Bristol-Myers Squibb (China) Investment Co.
, Ltd.
The project entrusted to manage it forged the official seal of the ethical review agency, which was illegally used to obtain an administrative license from the China Human Genetic Resources Management Office, and was eventually sentenced for the crime of forging the seal of a public institution.
com published a criminal judgment issued by the People’s Court of Putuo District, Shanghai.
An employee of Ienkang Clinical Medical Research (Beijing) Co.
, Ltd.
, in order to accelerate the promotion of Bristol-Myers Squibb (China) Investment Co.
, Ltd.
The project entrusted to manage it forged the official seal of the ethical review agency, which was illegally used to obtain an administrative license from the China Human Genetic Resources Management Office, and was eventually sentenced for the crime of forging the seal of a public institution.
After several years of heavy supervision of clinical trials, data quality has been highly valued by the entire industry chain, and the regulatory authorities have also received widespread praise for their "zero tolerance" for data quality issues.
The industry generally believes that only by truly consolidating the authenticity, completeness, and standardization of clinical data, can it be possible to create a real sense of scientific research and technological innovation of pharmaceutical equipment, effectively guarantee the safety, effectiveness, and controllable quality of listed drugs , and fundamentally improve China The international competitiveness of the pharmaceutical industry.
The industry generally believes that only by truly consolidating the authenticity, completeness, and standardization of clinical data, can it be possible to create a real sense of scientific research and technological innovation of pharmaceutical equipment, effectively guarantee the safety, effectiveness, and controllable quality of listed drugs , and fundamentally improve China The international competitiveness of the pharmaceutical industry.
Medical Network News, March 11 On March 8, the State Drug Administration's government service portal updated the "Notice of Publication of Non-Registration Approval", Hangzhou Anxu Biotechnology Co.
, Ltd.
(abbreviated as "Anxu Bio") key product—— Human immunodeficiency virus antibody/hepatitis C virus antibody/hepatitis B virus surface antigen/Treponema pallidum antibody combined detection kit (immunochromatographic method) will be officially granted non-registration approval.
, Ltd.
(abbreviated as "Anxu Bio") key product—— Human immunodeficiency virus antibody/hepatitis C virus antibody/hepatitis B virus surface antigen/Treponema pallidum antibody combined detection kit (immunochromatographic method) will be officially granted non-registration approval.
In fact, in January this year, the National Medical Products Administration issued the " Announcement on the Authenticity Issues in the Supervision and Random Inspection of Medical Device Clinical Trials in 2020 ", clearly identifying that Anxu Biologics has multiple clinical trials in this monitoring kit product.
For authenticity issues, penalties will be imposed in accordance with the "Administrative Licensing Law of the People's Republic of China" and the "Administrative Measures for In Vitro Diagnostic Reagent Registration".
For authenticity issues, penalties will be imposed in accordance with the "Administrative Licensing Law of the People's Republic of China" and the "Administrative Measures for In Vitro Diagnostic Reagent Registration".
Since 2015, the national drug regulatory authority has strictly implemented the "four strictest" spirit and promulgated a number of regulations and policies aimed at strengthening the management of clinical trials of medical devices, focusing on monitoring the authenticity, accuracy, and integrity of clinical trial data to ensure Traceability of the research process.
Industry analysis pointed out that today's clinical trials should not have a fluke mentality, and conducting clinical trials in a true and compliant manner is the policy "red line" for products to successfully obtain regulatory approval.
Industry analysis pointed out that today's clinical trials should not have a fluke mentality, and conducting clinical trials in a true and compliant manner is the policy "red line" for products to successfully obtain regulatory approval.
Pre- IPO product "explosive thunder"
Clinical data cannot be traced
In order to strengthen the supervision and management of clinical trials of medical devices, the National Medical Products Administration conducted a random inspection of clinical trial supervision on 10 medical device registration application projects under review in November 2020, involving 27 clinical trial institutions.
The State Food and Drug Administration found that the human immunodeficiency virus antibody/hepatitis C virus antibody/hepatitis B virus surface antigen/Treponema pallidum antibody combined detection kit (immunochromatographic method) produced by Hangzhou Anxu Biotechnology Co.
, Ltd.
( Acceptance number: CSZ2000162) In the clinical trials carried out by the First Affiliated Hospital of Zhejiang University School of Medicine, the time and location of the electronic photographs kept by medical institutions were inconsistent with the actual time and location of the clinical trial, and the clinical trial data could not be traced to the source.
, Ltd.
( Acceptance number: CSZ2000162) In the clinical trials carried out by the First Affiliated Hospital of Zhejiang University School of Medicine, the time and location of the electronic photographs kept by medical institutions were inconsistent with the actual time and location of the clinical trial, and the clinical trial data could not be traced to the source.
After the occurrence of falsified clinical data, the State Food and Drug Administration, in accordance with the "Administrative Licensing Law of the People's Republic of China" and "In Vitro Diagnostic Reagent Registration Management Measures", made a decision not to register the registration application, and from the date of non-registration The registration application for this project will not be accepted again within one year from the beginning; at the same time, Zhejiang Provincial Drug Administration is instructed to effectively fulfill the territorial supervision responsibility of Hangzhou Anxu Biotechnology Co.
, Ltd.
and related clinical trial institutions, and investigate and deal with it in accordance with laws and regulations.
, Ltd.
and related clinical trial institutions, and investigate and deal with it in accordance with laws and regulations.
It is worth noting that Anxu Bio is a listed company on the Science and Technology Innovation Board.
It is reported that on June 2, 2020, Anxu Biosciences Innovation Board listing application was accepted, and plans to raise 459 million yuan; On November 3, 2020, Anxu Biotechnology passed the listing committee meeting; December 30, 2020, submitted Sci-tech Innovation Board registration.
It is reported that on June 2, 2020, Anxu Biosciences Innovation Board listing application was accepted, and plans to raise 459 million yuan; On November 3, 2020, Anxu Biotechnology passed the listing committee meeting; December 30, 2020, submitted Sci-tech Innovation Board registration.
The prospectus of Anxu Biology shows that its main POCT reagents and instruments cover 8 categories, including drug testing series and infectious disease detection series.
The product sales are mainly for export.
From 2017 to 2019, Anxu Biology’s overseas revenue was 1.
04.
100 million yuan, 154 million yuan, 195 million yuan.
The product sales are mainly for export.
From 2017 to 2019, Anxu Biology’s overseas revenue was 1.
04.
100 million yuan, 154 million yuan, 195 million yuan.
Anxu Biological Prospectus
In fact, the market segment in which Anxu Biology is in fierce competition.
The main domestic competitors include Oriental Biology, Wanfu Biology, Jidan Biology, and Mingde Biology.
In comparison, because Anxu Biotech still has a big gap with the leading companies in terms of product variety, production scale and technology development , it is urgent to use the capital market to help the development of the company.
However, at the critical moment of the company's listing, important products under research exploded, causing the industry to worry about the future prospects of the company's IPO.
The main domestic competitors include Oriental Biology, Wanfu Biology, Jidan Biology, and Mingde Biology.
In comparison, because Anxu Biotech still has a big gap with the leading companies in terms of product variety, production scale and technology development , it is urgent to use the capital market to help the development of the company.
However, at the critical moment of the company's listing, important products under research exploded, causing the industry to worry about the future prospects of the company's IPO.
Anxu Biotech previously stated publicly that this fraud incident was mainly caused by problems in medical institutions.
The company commissioned the First Affiliated Hospital of Zhejiang University School of Medicine to conduct clinical trials.
The main responsibility for the problems found in random inspections was the medical institution, and the company was also a victim of the incident.
.
The company commissioned the First Affiliated Hospital of Zhejiang University School of Medicine to conduct clinical trials.
The main responsibility for the problems found in random inspections was the medical institution, and the company was also a victim of the incident.
.
However, this statement obviously cannot be quelled.
Market analysis believes that, in accordance with the requirements of the new version of the "Quality Management Regulations for Drug Clinical Trials" (GCP), it is clear that the sponsor, as the ultimate responsible party for the quality and reliability of clinical trials, needs to establish a quality management system, conduct quality management based on risks, and strengthen quality assurance and Quality control, the establishment of an independent data monitoring committee, and the implementation of risk assessment-based inspections and audits, etc.
, corporate responsibility is the core subject in the full-cycle quality management of clinical trials.
Market analysis believes that, in accordance with the requirements of the new version of the "Quality Management Regulations for Drug Clinical Trials" (GCP), it is clear that the sponsor, as the ultimate responsible party for the quality and reliability of clinical trials, needs to establish a quality management system, conduct quality management based on risks, and strengthen quality assurance and Quality control, the establishment of an independent data monitoring committee, and the implementation of risk assessment-based inspections and audits, etc.
, corporate responsibility is the core subject in the full-cycle quality management of clinical trials.
Resolutely implement the "four strictest"
Quality supervision of clinical trials
The establishment of a comprehensive quality assurance system by the subjects of clinical trials is the cornerstone of ensuring the high-quality completion of the project.
Resolutely implement the "four strictest" spirit, effectively improve the quality of clinical trials of medical devices, promote the improvement of clinical trials, strengthen the sense of responsibility of clinical trial investigators, ensure the authenticity, accuracy and completeness of clinical trial data, and ensure the research process Traceability has been the focus of the work of the drug regulatory authority for many years.
Resolutely implement the "four strictest" spirit, effectively improve the quality of clinical trials of medical devices, promote the improvement of clinical trials, strengthen the sense of responsibility of clinical trial investigators, ensure the authenticity, accuracy and completeness of clinical trial data, and ensure the research process Traceability has been the focus of the work of the drug regulatory authority for many years.
On March 10, the Shanxi Provincial Food and Drug Administration issued the "Notice on Carrying out the Supervision and Inspection of Drug Clinical Trial Institutions", and decided to conduct supervision and inspection of drug clinical trial institutions in the province, aiming to strengthen the supervision and management of drug clinical trials in the province.
The status of drug clinical trials carried out by drug clinical trial institutions.
The status of drug clinical trials carried out by drug clinical trial institutions.
Prior to this, Heilongjiang, Shandong, Sichuan and other provinces have successively issued notices to strengthen the record management of drug clinical trial institutions, and greatly improve the level of clinical trial supervision; Beijing, Tianjin, and Hebei Drug Administration jointly formulated the "Beijing-Tianjin-Hebei Drug The Standards for the First Supervision and Inspection of Clinical Trial Institutions after Filing (Draft for Soliciting Opinions)" requires that clinical trial institutions have "defect items" that do not meet the requirements for immediate correction.
Clinical experts pointed out that in terms of authenticity, all parties involved in clinical trials should respect life, respect their duties and regulations, and resolutely not fabricate clinical trial data; ensure that clinical trial data is traceable; ensure that trial products are used correctly; Serious adverse events, product defects, and banned treatments related to trial products; ensure the quality of data in the registration application materials, etc.
In terms of compliance issues, members of the clinical trial project team should undergo strict training and authorization, and be proficient in the specific requirements of relevant laws, pharmnet.
com.
cn/" target="_blank">regulations and plans.
The entire project implementation process should have mature standard operating procedures (SOP) as guidelines.
com.
cn/" target="_blank">regulations and plans.
The entire project implementation process should have mature standard operating procedures (SOP) as guidelines.
In order to punish the criminal acts of falsifying the application materials for drug and device registration in accordance with the law, the top-level policies have been continuously upgraded.
In 2017, the Supreme People’s Court and the Supreme People’s Procuratorate issued the "Interpretation on Several Issues Concerning the Application of Laws in the Handling of Criminal Cases of Falsification of Registration Application Materials for Drugs and Medical Devices".
Drug clinical trial data that affect the results of drug safety and effectiveness evaluation shall be punished as "intentionally providing false certification documents", and the maximum sentence may be five years.
In 2017, the Supreme People’s Court and the Supreme People’s Procuratorate issued the "Interpretation on Several Issues Concerning the Application of Laws in the Handling of Criminal Cases of Falsification of Registration Application Materials for Drugs and Medical Devices".
Drug clinical trial data that affect the results of drug safety and effectiveness evaluation shall be punished as "intentionally providing false certification documents", and the maximum sentence may be five years.
Not long ago, China Judgment Documents.
com published a criminal judgment issued by the People’s Court of Putuo District, Shanghai.
An employee of Ienkang Clinical Medical Research (Beijing) Co.
, Ltd.
, in order to accelerate the promotion of Bristol-Myers Squibb (China) Investment Co.
, Ltd.
The project entrusted to manage it forged the official seal of the ethical review agency, which was illegally used to obtain an administrative license from the China Human Genetic Resources Management Office, and was eventually sentenced for the crime of forging the seal of a public institution.
com published a criminal judgment issued by the People’s Court of Putuo District, Shanghai.
An employee of Ienkang Clinical Medical Research (Beijing) Co.
, Ltd.
, in order to accelerate the promotion of Bristol-Myers Squibb (China) Investment Co.
, Ltd.
The project entrusted to manage it forged the official seal of the ethical review agency, which was illegally used to obtain an administrative license from the China Human Genetic Resources Management Office, and was eventually sentenced for the crime of forging the seal of a public institution.
After several years of heavy supervision of clinical trials, data quality has been highly valued by the entire industry chain, and the regulatory authorities have also received widespread praise for their "zero tolerance" for data quality issues.
The industry generally believes that only by truly consolidating the authenticity, completeness, and standardization of clinical data, can it be possible to create a real sense of scientific research and technological innovation of pharmaceutical equipment, effectively guarantee the safety, effectiveness, and controllable quality of listed drugs , and fundamentally improve China The international competitiveness of the pharmaceutical industry.
The industry generally believes that only by truly consolidating the authenticity, completeness, and standardization of clinical data, can it be possible to create a real sense of scientific research and technological innovation of pharmaceutical equipment, effectively guarantee the safety, effectiveness, and controllable quality of listed drugs , and fundamentally improve China The international competitiveness of the pharmaceutical industry.
Medical Network News, March 11 On March 8, the State Drug Administration's government service portal updated the "Notice of Publication of Non-Registration Approval", Hangzhou Anxu Biotechnology Co.
, Ltd.
(abbreviated as "Anxu Bio") key product—— Human immunodeficiency virus antibody/hepatitis C virus antibody/hepatitis B virus surface antigen/Treponema pallidum antibody combined detection kit (immunochromatographic method) will be officially granted non-registration approval.
, Ltd.
(abbreviated as "Anxu Bio") key product—— Human immunodeficiency virus antibody/hepatitis C virus antibody/hepatitis B virus surface antigen/Treponema pallidum antibody combined detection kit (immunochromatographic method) will be officially granted non-registration approval.
In fact, in January this year, the National Medical Products Administration issued the " Announcement on the Authenticity Issues in the Supervision and Random Inspection of Medical Device Clinical Trials in 2020 ", clearly identifying that Anxu Biologics has multiple clinical trials in this monitoring kit product.
For authenticity issues, penalties will be imposed in accordance with the "Administrative Licensing Law of the People's Republic of China" and the "Administrative Measures for In Vitro Diagnostic Reagent Registration".
Medical equipment medical equipment medical equipmentFor authenticity issues, penalties will be imposed in accordance with the "Administrative Licensing Law of the People's Republic of China" and the "Administrative Measures for In Vitro Diagnostic Reagent Registration".
Since 2015, the national drug regulatory authority has strictly implemented the "four strictest" spirit and promulgated a number of regulations and policies aimed at strengthening the management of clinical trials of medical devices, focusing on monitoring the authenticity, accuracy, and integrity of clinical trial data to ensure Traceability of the research process.
Industry analysis pointed out that today's clinical trials should not have a fluke mentality, and conducting clinical trials in a true and compliant manner is the policy "red line" for products to successfully obtain regulatory approval.
Industry analysis pointed out that today's clinical trials should not have a fluke mentality, and conducting clinical trials in a true and compliant manner is the policy "red line" for products to successfully obtain regulatory approval.
Pre- IPO product "explosive thunder"
Pre- IPO product "explosive thunder" Clinical data cannot be traced
Clinical data cannot be traced In order to strengthen the supervision and management of clinical trials of medical devices, the National Medical Products Administration conducted a random inspection of clinical trial supervision on 10 medical device registration application projects under review in November 2020, involving 27 clinical trial institutions.
The State Food and Drug Administration found that the human immunodeficiency virus antibody/hepatitis C virus antibody/hepatitis B virus surface antigen/Treponema pallidum antibody combined detection kit (immunochromatographic method) produced by Hangzhou Anxu Biotechnology Co.
, Ltd.
( Acceptance number: CSZ2000162) In the clinical trials carried out by the First Affiliated Hospital of Zhejiang University School of Medicine, the time and location of the electronic photographs kept by medical institutions were inconsistent with the actual time and location of the clinical trial, and the clinical trial data could not be traced to the source.
, Ltd.
( Acceptance number: CSZ2000162) In the clinical trials carried out by the First Affiliated Hospital of Zhejiang University School of Medicine, the time and location of the electronic photographs kept by medical institutions were inconsistent with the actual time and location of the clinical trial, and the clinical trial data could not be traced to the source.
After the occurrence of falsified clinical data, the State Food and Drug Administration, in accordance with the "Administrative Licensing Law of the People's Republic of China" and "In Vitro Diagnostic Reagent Registration Management Measures", made a decision not to register the registration application, and from the date of non-registration The registration application for this project will not be accepted again within one year from the beginning; at the same time, Zhejiang Provincial Drug Administration is instructed to effectively fulfill the territorial supervision responsibility of Hangzhou Anxu Biotechnology Co.
, Ltd.
and related clinical trial institutions, and investigate and deal with it in accordance with laws and regulations.
, Ltd.
and related clinical trial institutions, and investigate and deal with it in accordance with laws and regulations.
It is worth noting that Anxu Bio is a listed company on the Science and Technology Innovation Board.
It is reported that on June 2, 2020, Anxu Biosciences Innovation Board listing application was accepted, and plans to raise 459 million yuan; On November 3, 2020, Anxu Biotechnology passed the listing committee meeting; December 30, 2020, submitted Sci-tech Innovation Board registration.
It is reported that on June 2, 2020, Anxu Biosciences Innovation Board listing application was accepted, and plans to raise 459 million yuan; On November 3, 2020, Anxu Biotechnology passed the listing committee meeting; December 30, 2020, submitted Sci-tech Innovation Board registration.
The prospectus of Anxu Biology shows that its main POCT reagents and instruments cover 8 categories, including drug testing series and infectious disease detection series.
The product sales are mainly for export.
From 2017 to 2019, Anxu Biology’s overseas revenue was 1.
04.
100 million yuan, 154 million yuan, 195 million yuan.
The product sales are mainly for export.
From 2017 to 2019, Anxu Biology’s overseas revenue was 1.
04.
100 million yuan, 154 million yuan, 195 million yuan.
Anxu Biological Prospectus
In fact, the market segment in which Anxu Biology is in fierce competition.
The main domestic competitors include Oriental Biology, Wanfu Biology, Jidan Biology, and Mingde Biology.
In comparison, because Anxu Biotech still has a big gap with the leading companies in terms of product variety, production scale and technology development , it is urgent to use the capital market to help the development of the company.
However, at the critical moment of the company's listing, important products under research exploded, causing the industry to worry about the future prospects of the company's IPO.
Enterprise business enterpriseThe main domestic competitors include Oriental Biology, Wanfu Biology, Jidan Biology, and Mingde Biology.
In comparison, because Anxu Biotech still has a big gap with the leading companies in terms of product variety, production scale and technology development , it is urgent to use the capital market to help the development of the company.
However, at the critical moment of the company's listing, important products under research exploded, causing the industry to worry about the future prospects of the company's IPO.
Anxu Biotech previously stated publicly that this fraud incident was mainly caused by problems in medical institutions.
The company commissioned the First Affiliated Hospital of Zhejiang University School of Medicine to conduct clinical trials.
The main responsibility for the problems found in random inspections was the medical institution, and the company was also a victim of the incident.
.
Hospital hospital hospitalThe company commissioned the First Affiliated Hospital of Zhejiang University School of Medicine to conduct clinical trials.
The main responsibility for the problems found in random inspections was the medical institution, and the company was also a victim of the incident.
.
However, this statement obviously cannot be quelled.
Market analysis believes that, in accordance with the requirements of the new version of the "Quality Management Regulations for Drug Clinical Trials" (GCP), it is clear that the sponsor, as the ultimate responsible party for the quality and reliability of clinical trials, needs to establish a quality management system, conduct quality management based on risks, and strengthen quality assurance and Quality control, the establishment of an independent data monitoring committee, and the implementation of risk assessment-based inspections and audits, etc.
, corporate responsibility is the core subject in the full-cycle quality management of clinical trials.
Market analysis believes that, in accordance with the requirements of the new version of the "Quality Management Regulations for Drug Clinical Trials" (GCP), it is clear that the sponsor, as the ultimate responsible party for the quality and reliability of clinical trials, needs to establish a quality management system, conduct quality management based on risks, and strengthen quality assurance and Quality control, the establishment of an independent data monitoring committee, and the implementation of risk assessment-based inspections and audits, etc.
, corporate responsibility is the core subject in the full-cycle quality management of clinical trials.
Resolutely implement the "four strictest"
Resolutely implement the "four strictest" Quality supervision of clinical trials
Quality supervision of clinical trials The establishment of a comprehensive quality assurance system by the subjects of clinical trials is the cornerstone of ensuring the high-quality completion of the project.
Resolutely implement the "four strictest" spirit, effectively improve the quality of clinical trials of medical devices, promote the improvement of clinical trials, strengthen the sense of responsibility of clinical trial investigators, ensure the authenticity, accuracy and completeness of clinical trial data, and ensure the research process Traceability has been the focus of the work of the drug regulatory authority for many years.
Resolutely implement the "four strictest" spirit, effectively improve the quality of clinical trials of medical devices, promote the improvement of clinical trials, strengthen the sense of responsibility of clinical trial investigators, ensure the authenticity, accuracy and completeness of clinical trial data, and ensure the research process Traceability has been the focus of the work of the drug regulatory authority for many years.
On March 10, the Shanxi Provincial Food and Drug Administration issued the "Notice on Carrying out the Supervision and Inspection of Drug Clinical Trial Institutions", and decided to conduct supervision and inspection of drug clinical trial institutions in the province, aiming to strengthen the supervision and management of drug clinical trials in the province.
The status of drug clinical trials carried out by drug clinical trial institutions.
The status of drug clinical trials carried out by drug clinical trial institutions.
Prior to this, Heilongjiang, Shandong, Sichuan and other provinces have successively issued notices to strengthen the record management of drug clinical trial institutions, and greatly improve the level of clinical trial supervision; Beijing, Tianjin, and Hebei Drug Administration jointly formulated the "Beijing-Tianjin-Hebei Drug The Standards for the First Supervision and Inspection of Clinical Trial Institutions after Filing (Draft for Soliciting Opinions)" requires that clinical trial institutions have "defect items" that do not meet the requirements for immediate correction.
Clinical experts pointed out that in terms of authenticity, all parties involved in clinical trials should respect life, respect their duties and regulations, and resolutely not fabricate clinical trial data; ensure that clinical trial data is traceable; ensure that trial products are used correctly; Serious adverse events, product defects, and banned treatments related to trial products; ensure the quality of data in the registration application materials, etc.
In terms of compliance issues, members of the clinical trial project team should undergo strict training and authorization, and be proficient in the specific requirements of relevant laws, pharmnet.
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The entire project implementation process should have mature standard operating procedures (SOP) as guidelines.
pharmnet. com.
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The entire project implementation process should have mature standard operating procedures (SOP) as guidelines.
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In order to punish the criminal acts of falsifying the application materials for drug and device registration in accordance with the law, the top-level policies have been continuously upgraded.
In 2017, the Supreme People’s Court and the Supreme People’s Procuratorate issued the "Interpretation on Several Issues Concerning the Application of Laws in the Handling of Criminal Cases of Falsification of Registration Application Materials for Drugs and Medical Devices".
Drug clinical trial data that affect the results of drug safety and effectiveness evaluation shall be punished as "intentionally providing false certification documents", and the maximum sentence may be five years.
In 2017, the Supreme People’s Court and the Supreme People’s Procuratorate issued the "Interpretation on Several Issues Concerning the Application of Laws in the Handling of Criminal Cases of Falsification of Registration Application Materials for Drugs and Medical Devices".
Drug clinical trial data that affect the results of drug safety and effectiveness evaluation shall be punished as "intentionally providing false certification documents", and the maximum sentence may be five years.
Not long ago, China Judgment Documents.
com published a criminal judgment issued by the People’s Court of Putuo District, Shanghai.
An employee of Ienkang Clinical Medical Research (Beijing) Co.
, Ltd.
, in order to accelerate the promotion of Bristol-Myers Squibb (China) Investment Co.
, Ltd.
The project entrusted to manage it forged the official seal of the ethical review agency, which was illegally used to obtain an administrative license from the China Human Genetic Resources Management Office, and was eventually sentenced for the crime of forging the seal of a public institution.
com published a criminal judgment issued by the People’s Court of Putuo District, Shanghai.
An employee of Ienkang Clinical Medical Research (Beijing) Co.
, Ltd.
, in order to accelerate the promotion of Bristol-Myers Squibb (China) Investment Co.
, Ltd.
The project entrusted to manage it forged the official seal of the ethical review agency, which was illegally used to obtain an administrative license from the China Human Genetic Resources Management Office, and was eventually sentenced for the crime of forging the seal of a public institution.
After several years of heavy supervision of clinical trials, data quality has been highly valued by the entire industry chain, and the regulatory authorities have also received widespread praise for their "zero tolerance" for data quality issues.
The industry generally believes that only by truly consolidating the authenticity, completeness, and standardization of clinical data, can it be possible to create a real sense of scientific research and technological innovation of pharmaceutical equipment, effectively guarantee the safety, effectiveness, and controllable quality of listed drugs , and fundamentally improve China The international competitiveness of the pharmaceutical industry.
Medicine, medicine, medicine The industry generally believes that only by truly consolidating the authenticity, completeness, and standardization of clinical data, can it be possible to create a real sense of scientific research and technological innovation of pharmaceutical equipment, effectively guarantee the safety, effectiveness, and controllable quality of listed drugs , and fundamentally improve China The international competitiveness of the pharmaceutical industry.
