In this section, we will outline various methods for keeping track of new drug updates in China.:
1. Approval Information of Drugs
This section will explain how to obtain the latest updates from the Chinese National Medical Products Administration (NMPA) website, including information on new drug approvals.
| Drug search page |
On the drug search page, you can enter the name of a drug (either in Chinese or English) to view the list of approved domestic and imported drugs. For full details about a specific approval, click the product link.
| Drug list |
| Details |
2. IND Updates of New Drugs
Here we will explain how to search for updates on new drug Investigational New Drug Applications (INDs) in China.
Where to find the NEW DRUG IND data
| Navigation bar |
We can find that information on the China Center for Drug Evaluation (CDE) website. Please select the 受理品种信息 option on the navigation bar. The new IND updates are available for you here.
You can search for specific products by entering the product name in the 药品名称 field or the company name in the 企业名称 field, then clicking the 查询 button.
| IND list |
3. IND Approval Data of New Drugs
This section will discuss the process for obtaining Investigational New Drug (IND) approval in China.
| Navigation bar |
We can find that information on the China Center for Drug Evaluation (CDE) website. Select the 临床试验默示许可 option from the navigation bar. The new IND approval updates are available here for you.
You can search for specific products by entering their names in the dialog and then clicking the 查询 button.
| IND approval list |
4. Priority Reviews List of New Drugs
Here, we explain how to obtain the list of new drug priority reviews in China.
| Navigation bar |
We can find that information on the China Center for Drug Evaluation (CDE) website. Click on the 优先审评公示 link in the navigation bar. The latest priority review updates are available here for you.
You can search for specific products by entering their names in the dialog and clicking the 查询 button.
| Priority reviews list |
5. Breakthrough Design List of New Drugs
In this section, we will explain how to obtain the latest list of breakthrough drug designs in China.
| Navigation bar |
To find that information, visit the China Center for Drug Evaluation (CDE) website. Click on the 突破性治疗公示 link in the navigation menu. The updates on the new breakthrough design are available for you here.
You can search for specific products by entering their names in the dialog box and clicking the 查询 button.
| BTD list |
6. Clinical Trials Information of New Drugs
In this section, we provide information on where to find new drug clinical trial data in China.
| Chinaclinicaltrials |
We can find this information on the China clinical trials website by simply entering the product and starting the search. For instance, here are the search results for HSK31679.
| Search results for HSK31679 |
When we access the results of the first NASH trial, all details are displayed clearly.
| Details |
7. Patents of New Drugs
We provide details on where to find patent information for new drugs in China.
| PatentHomePage |
To find that information, visit the patent information website. Select the "专利信息公示" (Patent information publicity), enter the product name, and click search. For example, here are the search results for "奥拉帕利" (Olaparib).
| PatentSearchPage |
PatentSearchResult
|
8. Press Releases of Public Companies
Here, we present a new method to discover the latest press releases of China-listed companies beyond their official websites.
| StockInfoHomepage |
Now, let's navigate to the homepage of 巨潮. Simply input the stock code and initiate the search. For example, entering '688235, 6160, or BJSZ' will lead you to Beigene.
| Beigene Result |
9. Labels and Review Packages of New Drugs
In this section, we will explain where to find new drug labels and review packages in China.
| Navigation bar |
For more information, visit the China Center for Drug Evaluation (CDE) website. Click on '上市药品信息' in the navigation bar to access updates on new drug approvals.
You can search for specific products by entering their names in the dialog and then clicking the 查询 button.
The review package, known as the上市技术审评报告, along with the drug labels, referred to as 说明书, are provided below.
| Review package and label |
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