According to statistics, the NMPA approved the marketing of 13 Class 1 new drugs and 17 biological products in the 17 years from 2001 to 2017. The number of innovative drugs approved was pitifully small.
The State Council of China issued the important document the Opinions on the Reform of Review and Approval System for Drugs and Medical Devices (No. 44) in Aug. 2015 to accelerate innovative drug review and approval and conduct the pilot program of Marketing Authorization Holder (MAH) System and other policy reforms, which officially began the era of Chinese innovative drugs.
The drug regulator reform and capital catalysis revolutionized the marketing situation of Chinese-produced new drugs in 2018 where the NMPA approved the marketing of 9 Chinese-produced Class 1 new drugs. As a result, 2018 is called the first year of the era of Chinese innovative drugs.
A total of 20 Chinese-produced Class 1 new drugs have been marketed since 2018, involving hot areas such as oncology, liver disease, and diabetes.
Then, what are the specific proportions of chemical drugs and biological drugs in those 20 new drugs? What are the areas of their indications? Which pharmaceutical enterprise has the largest number? How are their performances after marketing? Which drugs have entered the national reimbursement drug list (NRDL) of China? What are the future trends?
Chinese-produced Class 1 New Drugs Marketed Since 2018
S/N | Pharmaceutical product name | Trade name | Registration class | Developed by | Target | Indication | Time of first approval |
1 | Recombinant Cytokine Gene-derived Protein Injection | Novaferon | Therapeutic biological products 1 | Genova Inc. | / | HBeAg-positive chronic hepatitis B | Apr. 2018 |
2 | Anlotinib Hydrochloride Capsules | FOCUS V | Chemical drugs 1 | Chia Tai Tianqing | Tyrosine kinase inhibitor of multi-targets | NSCLC 3L, SCLC 3L, soft tissue sarcoma 2L | May 2018 |
3 | Albuvirtide for Injection | Aikening | Chemical drugs 1 | Frontier Biotechnologies | HIV-1 | HIV-1 infection with HIV-1 virus replication after the treatment with other multiple antiretroviral drugs | May 2018 |
4 | Danoprevir Sodium Tablets | Ganovo | Chemical drugs 1 | Ascletis | New-generation NS3/4A protease inhibitor | Untreated non-cirrhotic genotype 1b chronic hepatitis C | June 2018 |
5 | Pyrotinib Maleate Tablets | Airuini | Chemical drugs 1 | Hengrui Medicine | Pan-ErbB receptor tyrosine kinase inhibitor | HER2-positive advanced breast cancer | Aug. 2018 |
6 | Fruqui... Read More
Previous:
Advarra Acquires IRB Company, Inc.
Related News
Marketing Strategies for CROs and CDMOs
Saher Haider September 3, 2025 You may like
Orforglipron
Tempered glass suction cup hanger, glass deep processing handling lifting suction cup, glass 90 degree flip suction crane
Vacuum suction cup hanger steel plate high temperature aluminum plate suction cup titanium plate and other metal plate suction cup under 30 tons
Supply nitrile rubber suction cup HFG-200 vacuum suction cup spreader high temperature suction cup
3 tons of aluminum plate vacuum suction cup hanger can set high quality plate suction cup hanger
Get alerted on the PharmaSources E-Newsletter and Pharma Sources Insight E-Compilation! Subscribe
Note: You can unsubscribe from the alerts at any time. Get alerted on the PharmaSources E-Newsletter and Pharma Sources Insight E-Compilation! Subscribe
Note: You can unsubscribe from the alerts at any time. Most popular
The Rise of Biosimilars: Regulatory Pathways and Market Outlook
Nurah Ekhlaque
Sep 19, 2025
Digitalization in Procurement: From AI Forecasting to Blockchain Traceability
Saher Haider
Sep 19, 2025
Methodology Validation in Chinese Pharmacopoeia 2025: How to Report Accuracy and Precision
Xing Xing
Sep 12, 2025
|










(All Rights Reserved)