On June 21st, the National Medical Products Administration (NMPA), to which the Center for Drug Evaluation (CDE) is affiliated, issued the China Drug Evaluation Report 2020.1
This part 1 of the article collects key numbers from the report to inform global pharmaceutical companies of the drug approvals in China last year and the approval tendency in the past few years.
1. Review & Approval of Drug Registration Applications
In 2020, CDE completed the review of 11,582 registration applications (including four applications for drug-device combination products) for Traditional Chinese medicines (TCM), chemical drugs and biological products, an increase of 32.67% from 2019.
Among all applications, 8,606 were required for technical review (5,674 of them needed both technical review and administrative approval), a growth of 26,24% from 2019. Another 2,972 applications were for administrative approval only (without technical review).
The number of applications which were under review or pending for review has dropped from the peak of nearly 22,000 in Sept. 2015 to 4,882 by the end of 2020 (excluding the pending applications due to incomplete or flawed application materials).
Among the 8,606 applications subject to technical review, 6,778 of them were chemical drug applications, a growth of 25.22% from 2019; 418 of them were TCM applications, increasing by 39.33% from 2019; 1,410 of them were biological product application, up by 27.72 %. Chemical drug applications accounted for 78.76% of all applications which have completed the technical review.
In 2020, CDE reviewed and approved
1,435 Investigational New Drug (IND) applications, increasing by 54.97% from 2019;
208 New Drug Applications (NDAs), growing by 26.83%；
918 Abbreviated New Drug Applications (ANDAs);
577 applications for consistency evaluation of generic drug's quality and efficacy, rising by 121.92% from 2019.
CDE also reviewed and approved NDAs for 20 innovator drugs and 72 overseas-manufactured original drugs (including those with new indications).
1.1 Traditional Chinese Medicine
In 2020, CDE completed reviewing 418 TCM applications, including 37 IND applications, 8 NDAs and 3 ANDAs. Among all the reviewed TCM applications, 28 IND applications and 4 NDAs were approved. The overview of approvals for TCM registrations in 2020 are shown in Table 1.
Notes for tables in the article: "Others" refers to the situation that applicants voluntarily withdraw the application, or CDE has completed reviewing the application and is waiting for the applicant to submit supplemental documents for registration, etc.
1.2 Chemical Drug
Last year, CDE completed the review of 6,778 chemical drug applications, including
163 NDA applications, among which 115 applications for 14 chemical drug products were approved;
1,697 ANDA applications, among which 918 got approved and the approval rate grew by 15.33% from 2019;
960 IND applications, among which 907 got approved. Among the reviewed IND applications, 694 (for 298 Class 1 innovative new chemical drug products) got approved. Compared with 2019, the approved IND applications increased by 40.77% and the drug products involved in the applications by 57.67%.
Among the approved 694 IND applications for Class 1 innovative new chemical drugs, 80.69% are for drugs that are anti-neoplastic, anti-infective, or for treating circulatory system, endocrine system, digestive system, rheumatism and immune system diseases.
1.3 Biological Product
In 2020, CDE completed the review of 1,410 biological product applications, including
27 IND applications for prophylactic biologics;
537 IND applications for therapeutic biologics (a 58.88% increase from 2019);
9 NDA applications for prophylactic biologics;
108 NDAs for therapeutic biologics;
1 NDA for in vitro diagnostic devices (IVD).
In all the reviewed biologic applications, CDE approved
500 IND applications, a 60.26% growth from 2019,
- including 19 for prophylactic biologics and 481 for therapeutic ones (the latter had a 63.61% growth).
89 NDAs with a 20.27% year-over-year (YoY) growth,
- including 7 prophylactic NDAs, 81 therapeutic NDAs (19.12% growth) and 1 NDA for IVD.
The approvals for biological product applications in 2020 are shown in the table below.
Notes for Fig. 8 and Fig. 9: Prophylactic vaccines and IVDs are recorded as a general category without specifying their indications.
2. Acceptance of Drug Registration Applications
2.1 Innovative new Drugs and Original Drugs
In 2020, CDE accepted 1,062 applications for 597 Class 1 innovative new drugs, a YoY growth of 51.71%.
The applications include
1,008 IND applications (for 559 drug products), increasing by 49.78% from 2019;
54 NDAs (for 38 drug products), a YoY growth of 100%.
The accepted Class 1 innovator drug applications include 14 for TCMs, 752 for chemical drugs and 296 for biological products. In terms of the countries/regions of the manufacturers, 843 of the accepted applications were for domestically-manufactured drugs and 219 for overseas-manufactured ones.
2.2 Traditional Chinese Medicine
CDE accepted 471 TCM applications, including 22 IND applications, 6 NDAs and 1 ANDA. The overview of accepted TCM applications are shown below.
Among the 14 applications for innovative TCM, there were 9 IND applications for 9 drug products and 5 NDAs for 5 drug products.
2.3 Chemical Drug
CDE accepted 7,901 applications for chemical drugs, including
946 IND applications (36.61% YoY growth),
191 NDAs (46.92% YoY growth),
1,125 ANDAs (7.45% YoY growth) and
914 consistency evaluations (11.95% YoY decrease).
CDE accepted 752 chemical drug applications for 360 Class 1 innovator chemical drug products, a 31.24% growth from 2019. The accepted chemical drug applications include 721 IND applications (30.62% YoY growth) for 339 drug products and 31 NDAs (47.62% YoY growth) for 21 drug products.
CDE also accepted 160 chemical drug applications under drug registration Class 5.1, increasing by 1.91% from 2019, including 53 IND applications (confirmatory trial) and 107 NDAs.
In the applications for 360 Class 1 innovative chemical drugs, 258 applications are for products produced in China and 102 are for those manufactured overseas.
2.4 Biological Product
CDE accepted 1,867 biological product registration applications. These applications include
580 IND applications (25 prophylactic and 555 therapeutic ones), increasing by 87.1% from 2019;
126 NDAs (7 prophylactic, 117 therapeutic and 2 for IVDs), a YoY rise of 1.62%.
CDE accepted 296 Class 1 innovative biological product applications (covering 223 drug products), with an YoY increase of 113.07%. The 296 applications include
5 for prophylactic biological products and 291 for therapeutic ones;
278 for IND applications (for 211 biologics), a 129.75% increase from 2019 and biologic NDAs (for 12 drug products) grew by 200%.
3. Priority Review
Priority review (PR) is one of China's four expedited programs for drug registration. Two main improvements have been made for the PR scope and process under the Administrative Measures for Drug Registration (hereinafter referred to as the Measures) taking effect in 2020.
One improvement is to cover more drugs in the following categories:
Drugs with distinct clinical value;
Drugs urgently needed in clinical settings;
Drugs for preventing and treating major infectious diseases;
Rare disease drugs;
Drugs granted Breakthrough Therapy Designation (BTD);
Drugs granted Conditional Approval (CA).
The other progress is the review time for drug registration applications becomes less. The review time for applications with PR designation is 130 workdays, much shorter than the 200 workdays for other normal applications. In particular, the priority review time for rare disease drugs sold in overseas markets with urgent clinical needs is even shorter–only 70 workdays.
Numbers about PR designations:
Among the applications that granted PR designation according to the criteria before the Measures came out:
Parallel applications account for 44% (64/144);
New drugs with substantial clinical value account for 20%;
Re-applications for drug products after supplementing necessary materials according to the generic drug consistency evaluation criteria decrease from 7.9% in 2019 to 4.2% in 2020.
Among the applications claiming PR designation according to the criteria in the Measures:
Approved drugs which are qualified for conditional approval account for 36% (27/75);
Innovator drugs and pediatric drugs take 28% (21/75).
4. Significant Therapeutic Areas of Drug Products Approved in 2020
Vaccines and Therapeutic Drugs Against Covid-19
1.Inactivated virus Covid-19 vaccines (Vero Cell)
Prophylactic for SARS-CoV-2 (aged over 18)
2. Three traditional Chinese medicines
a. Jinhua Qinggan Granule
b. Lianhua Qingwen Capsule/Granule
c. Xuebijing Injection
a & b. Mild Covid-19 cases
c. Server, critical cases and Inflammation
3. Sivelestat Sodium Hydrate for Injection
Acute Lung Injury (ALI)/Acute Respiratory Distress Syndrome (ARDS)
1. Imatinib Mesylate tablets
During or after EGFR-TKI treatment
2. Sulfatinib Capsules
3. Brentuximab Vedotin for Injection
Hodgkin Lymphoma and Anaplastic Large Cell Lymphoma
4. Blinatumomab for Injection
B-precursor Acute Lymphocytic Leukemia
5. Lenvatinib Mesylate Capsules
Differentiated Thyroid Cancer
1. Coblopasvir Hydrochloride Capsules
Chronic Hepatitis C virus
2. Emtricitabine and Tenofovir Disoproxil Fumarate Tablet
Prophylactic for HIV
Circulatory System Drugs
1. Lanadelumab-flyo Tablet
Prophylactic for Hereditary Angioedema (aged over 12)
2. Tafamidis Soft Capsules
Respiratory System Drugs
1. Bencycloquidium Bromide Nasal Spray
Persistent Allergic Rhinitis
2. Nintedanib Esylate Soft Capsules
Systemic Sclerosis-associated interstitial lung disease (SSc-ILD) and Progressive Fibrosing ILD
Nervous System Drugs
1. Deutetrabenazine Tablets
2. Tafamidis Meglumine Soft Capsule
Analgesics and Anaesthetics
Dermatological and Otorhinolaryngological Drugs
1. Cenegermin Eye Drops
2. Dupilumab Injection
Digestive System Drugs
1. Vedolizumab for Injection
Crohn's Disease and Ulcerative Colitis
1. Dantrolene Sodium for Injection
2. Tacrolimus Granules
Prevent Transplant Rejection
Rare Diseases Drugs
1. Laronidase Concentrate Solution for Injection
2. Idursulfase-beta Injection
In Vivo Diagnostics
1.Recombinant EAST-6; CFP-10 Fusion Protein
In-vivo Diagnosis of Mycobaterium Tuberculosis Infection
Prophylactic Biological Products (Vaccines)
1.Influnenza Vaccine (Nasal Spray, Freeze-dried, Live Attenuated)
Influenza (aged 3-17)
Traditional Chinese Medicine (New)
1. Mulberry Twig Total Alkaloid Tablets
Type 2 Diabetes
2.Jingu Zhitong Gel
3.Lianhua Qingke Tablets
Acute Bronchitis and Tracheitis