01

Guidelines for Real-world Data 

On August 3, CDE issued the Guidelines for Real-world Data Used to Generate Real-world Evidence (Draft for Comments).

 

 

As a supplement to the Guidelines for Drug Development and Review Supported by Real-world Evidence (Trial Implementation), the guidelines will provide specific requirements and guiding suggestions for real-world data from the perspectives of the definition, source, evaluation, governance, standards, security compliance, quality assurance, applicability, etc. of real-world data to help sponsors better carry out data governance, evaluate the applicability of RWD, and make full preparations for the generation of effective RWE. (Click here to view details)

02

The New Round of Adjustment for Medical Insurance Catalog Is Coming

The second batch of nationally procured drugs, respiratory drugs for COVID-19, and drugs added for more than 5 provinces all have the opportunity to be included in the new round of national medical insurance catalog.

 

 

On August 3, the National Healthcare Security Administration issued the Work Plan for the 2020 National Medical Insurance Drug Catalog Adjustment (Draft for Comments) to determine the scope of the new round of medical insurance drug transfers.

According to the document, the adjustment results of the drug catalog and the new version of the drug catalog will be announced from November to December 2020, and the management and implementation requirements will be clarified at the same time. (Click here to view details)

03

Clinical trials for the mRNA Vaccine against COVID-19 Have Been Started 

On August 5, Fosun Pharma and BIONTECH jointly announced that after the MRNA vaccine (BNT162B1) against COVID-19 is approved by National Medical Products Administration for clinical trials, up to now, 72 subjects have received the BNT162B1 vaccine.

 

 

If the vaccine is licensed for sale in the future, Fosun Pharma will exclusively commercialize the vaccine against COVID-19 developed based on the BIONTECH MRNA technology platform in mainland China and Hong Kong, Macao and Taiwan. (Click here to view details)

04

Hengrui PD-L1 Was Approved for Clinical Use 

On August 5, Hengrui Pharmaceutical  issued an announcement that SHR-1316 injection has received the Approval Notice on Drug Clinical Trial reviewed and issued by the National Medical Products Administration, and announced that the company will carry out clinical trials for limited-phase small cell lung cancer in the near future.

SHR-1316 can help get rid of the immunosuppressive effect mediated by PD-L1, enhance the function of killer T cells, and play a role in mobilizing the body's immune system to eliminate tumor cells in the body.

SHR-1316 is a product independently developed by Hengrui Pharmaceutical. The INSIGHT database shows that currently, Hengrui Pharmaceutical has carried out multiple SHR-1316 clinical trials in China. (Click here to view details)

05

New Study: Vitamin D Does Not Prevent Depression 

Due to the many limitations of the existing antidepressants and anti-anxiety drugs, and the difficulties in the R&D of new drug molecules, many researchers have shifted their attention to new treatments with antidepressant and anti-anxiety potential, such as vitamin D.

 

 

In recent years, there have been more and more studies on vitamin D, and many of them have revealed the antidepressant effect of vitamin D. However, these studies have many limitations.

Recently, a study published in JAMA came to the conclusion that vitamin D cannot prevent depression. (Click here to view details)

06

Complement Inhibitors Urgently Need to Be Developed 

Complement is a serum protein that has enzymatic activity after activation and can mediate immunological response and inflammatory reaction. Studies related to complement have shown that existing drugs that inhibit the complement system can help treat critically ill patients.

In order to determine whether the disorders of complement or coagulation system could affect disease, scientists found that a history of macular degeneration and coagulation disorders was associated with a higher morbidity and mortality of SARS-COV-2 in a retrospective observational study.

 

 

The results could provide important insights into the pathophysiology of COVID-19, and illuminate the role of complement and coagulation pathways in determining clinical outcomes in patients with SARS-COV-2 infection. The study findings have been published in the Nature Medicine. (Click here to view details)

07

A total of 70 drug specifications have not been approved. 

On August 5, the CDE published the draft for comments of the Catalogue of Reference Preparations for Chemical Generic Drugs (batch 32), including 81 reference preparations, of which 8 drug specifications not approved are disclosed.

 

 

On January 10, 2020, the CDE published the draft for comments of the list of batch 25 and 26 of the Catalogue of Reference Preparations for Chemical Generic Drugs, in which the list of reference preparations not passing the review were disclosed for the first time, including 29 drug specifications in total. A total of 70 drug specifications have not been approved up to now.

INSIGHT Database has sorted up the reference preparations not approved that have been by disclosed by the CDE and the corresponding reasons for reference in the industry. (Click here to view details)