CDE – Accestra Consulting https://www.accestra.com Your long term strategic partner for regulatory compliance. Wed, 03 Nov 2021 05:50:32 +0000 en-US hourly 1 https://wordpress.org/?v=6.5.5 https://www.accestra.com/wp-content/uploads/2019/03/cropped-accestra2-32x32.png CDE – Accestra Consulting https://www.accestra.com 32 32 New Guideline for Drug Master Filing (DMF) in China https://www.accestra.com/new-guidelines-china-dmf/ Thu, 28 Oct 2021 05:06:37 +0000 https://www.accestra.com/?p=4403

China DMF Inactive Number by CDE. Complete but not approved.

China DMF Active Number by CDE. Activated/Approved.

 

For Drug master filing (DMF) in China, there is a new guideline released by China’s NMPA (Formerly CFDA) in 2019 for the scope of active pharmaceutical ingredients (APIs), excipients and packaging materials. Similar to the systems of US DMF, Canadian DMF and EU CEP, the new guideline helps protect manufacturers from disclosing confidential information to their distributors and specifies a more direct route to communicating with China health authorities, e.g., Center for drug evaluation (CDE).

Applicants who already have US DMF, Canadian DMF and EU CEP will benefit from overlapping data, although they’re differences in local data requirements.

The new DMF filing system in China helps protect the supplier from disclosing unnecessary confidential data to the drug applicant which enables a direct path to exchange communication with China’s health authority namely Centre for drug evaluation (CDE).

What are inactive and active DMF numbers in China?

The applicant prepares China DMF dossier and file application to CDE for completeness review for allocation of DMF filing number with a status of “I” for “Inactive”.

Upon drug product registration, for example ANDA or new drug application; CDE will refer to the inactive DMF filing number and review the DMF dossier together with the drug dossier and then activate the DMF filing number shown as “A” for active. The “I” and “A” status will officially display on CDE database.

Steps to File DMF in China

The 7 steps for DMF filing process to obtain inactive and active DMF filing number is displayed in the flow graph above and correspondingly explained below:

The general steps for DMF filing include obtaining inactive and active filing number described below:
Step 1: Check material completeness to identify if the materials are generally complete.
Step 2: Conduct a more detailed data-gap analysis, providing guidance on supplementing missing data according to China CDE requirements.
Step 3: Prepare a DMF dossier in Chinese and file to CDE.
Step 4: CDE reviews dossier for completeness and feedback in 1 to 2 weeks.
Step 5: CDE issues the Inactive filing number in around 3-6 months counting from step 2 data gap analysis.
Step 6: CDE performs technical review. The queuing time at CDE may differ depending on the actual situation. It was slightly longer due to Covid-19 but now recovered back to normal processing times.
Step 7: CDE usually takes from start to finish 6-12 months for the technical review and will activate the DMF filing number If the finished product has already been approved.

Checklist for DMF filing in China

Costs & Timelines for DMF in China


China DMF Compared with US DMF, EU ASMF & CEP

 

Authorised Agent in China

Accestra Consulting has successfully helped overseas manufacturers to file drug master files (DMF) in China. We can be your trusted appointed agent by issuing us a letter of authorisation (LoA).

We would be more than happy to arrange a teleconference call you share an overview of the China DMF process, requirements, costs and timelines. Email us to arrange a date and time to call (Info@accestra.com).

Contact Accestra Consulting Group
]]> 2020 China Drug Evaluation Report – Part 2 https://www.accestra.com/2020-china-drug-evaluation-report-part-2/ Wed, 04 Aug 2021 22:40:14 +0000 https://www.accestra.com/?p=4210

Part 2. Chemical Drugs, Biological Products and Traditional Chinese Medicines

 

Table of contents

1. Chemical Drugs.
1.1. Application Overview.
1.2. Approval.
2. Biological Products.
2.1. Application Overview.
1.2. Approval.
3. Traditional Chinese Medicine.
3.1. Application Overview.
3.2. Approval.

 Despite severe challenges from the COVID-19 pandemic, the Center for Drug Evaluation (CDE) of China reviewed 8,606 drug applications in 2020 and approved many new drugs to help patients suffering from different diseases.

As a follow-up on part 1 of the Drug Evaluation Report 2020, part 2 gives an overview of drug applications and approvals respectively for chemical drugs, biological products, and traditional Chinese medicines.

1. Chemical Drugs

 

1.1 Application Overview

 
In 2020, CDE reviewed 6,778 chemical drug applications, including:
  • 1,086 Clinical Trial Applications (CTAs) for Investigational New Drugs (INDs) and confirmatory trials,
  • 163 New Drug Applications (NDAs),
  • 1,697 Abbreviated New Drug Applications (ANDA),
  • 1,136 consistency evaluations,
  • 2,248 supplementary applications.
 
Comparing to the previous year, the number of consistency evaluations has increased 103.22%
 
This is followed by CTAs (45.58%) and supplementary applications (23.72%).
 
View an overview of the chemical drug applications reviewed in 2020 below (Fig. 1).
 
TCM-Applications-Reviewed-2020
Fig. 1 Number of Chemical Drug Applications Reviewed in 2020
 

1.2. Approval

 
907 INDs, 115 NDAs, and 918 ANDAs were approved with an increase of 51.42%, 30.68%, and 15.33% respectively compared to the previous year.
 
The table below (Table. 1) gives an overview of the chemical drug applications approved in 2020.
Table 1. Overview of Chemical Drug Application Approvals in 2020

APPLICATION TYPE

NUMBER OF APPLICATIONS

APPROVAL (INCL. AFTER MATERIAL SUPPLEMENT)

NO APPROVAL SUGGESTED/NOT APPROVED

OTHERS*

TOTAL NUMBER
IND 907 39 14 960
Confirmatory Clinical Trial 108 11 7 126
NDA 115 3 45 163
ANDA 918 32 747 1,697
Supplementary Application 1,732 126 390 2,248
License Renewal of Imported Drugs 380 17 25 422
Consistency Evaluation 577 12 547 1,136
Re-Review N/A 26
Total 4,737 240 1,775 6,778

 

Others*: herein refers to the applications which were withdrawn by the applicants or pending for material supplement after technical review, similarly hereinafter.

 

1.2.1. IND Approval

 
Under the classification of IND application, the approval rate of 694 Class 1 Innovative New Drugs increased by 40.77% compared to 2019.
 
Based on the Active Pharmaceutical Ingredients (APIs) of these drugs, 298 categories were approved for Class 1 Drugs with an increase of 57.67% comparing to the previous year.
 
View the following diagram for a comparison of IND and Class 1 drug IND approvals between the last five years (Fig. 2).
IND-Approvals-2016-2020
Fig. 2 Number of IND and Class 1 Innovative New Drug IND Approvals from 2016 to 2020
 
Among the IND approvals of Class 1 drugs, the following shared a large proportion of 80.69%:
  • Anti-neoplastic,
  • anti-infective,
  • circulatory system,
  • endocrine system,
  • gastrointestinal,
  • autoimmune disease,
  • immunosuppressant drugs.
 
The diagram below (Fig. 3) shows the number of Class 1 drug IND approvals for each therapeutic field in 2020.
 
Biologics-IND-Approvals-2020
Fig. 3 Number of Class 1 Innovative New Drug IND Approvals for Each Therapeutic Field in 2020
 

1.2.2. NDA Approval

 
CDE approved 115 chemical drug NDAs in 2020, among which Class 1 Innovative New Drugs covered 14 drug categories.
 
View a comparison of NDA approvals between the last five years below (Fig. 4).
 
NDA-Approvals-2016 - 2020
Fig. 4 Number of NDA Approvals from 2016 to 2020
 

2. Biological Products

 

2.1 Application Overview

 
CDE reviewed a total of 1,410 Biologics License Applications (BLA) in 2020.
 

The number of reviewed IND applications and NDAs is given in the below table (Table 2) respectively for preventive and therapeutic biological products and in vitro diagnostics.

Table 2. Number of INDs and NDAs Reviewed for Biological Products in 2020

CLASSIFICATION

NUMBER OF INDs

NUMBER OF NDAs
Preventive Biological Product 27 9
Therapeutic Biological Product 537 108
In-vitro Diagnostics 0 1


The diagram below (Fig. 5) shows the number of BLAs reviewed for every application type.

 
BLAs-reviewed-2020
Fig. 5 Number of BLAs Reviewed in 2020
 

2.2 Approval

 
Among the reviewed BLAs, 500 INDs and 89 NDAs were approved with an increase of 60.26% and 20.27% respectively compared to the previous year.
 

The number of approvals for each application type is summarized in the table below (Table 3).

Table 3. Overview of BLA Approvals in 2020

APPLICATION TYPE

NUMBER OF APPLICATIONS

APPROVAL (INCL. AFTER MATERIAL SUPPLEMENT)

NO APPROVAL SUGGESTED/NOT APPROVED

OTHERS*

TOTAL NUMBER
Preventive IND 19 4 4 27
Therapeutic IND 481 45 11 537
Preventive NDA 7 0 2 9
Therapeutic NDA 81 1 26 108
In vitro Diagnostic NDA 1 0 0 1
Supplementary Application 551 22 102 675
License Renewal of Imported Drugs 45 0 4 49
Re-Review N/A N/A N/A 4
In Total 1,185 72 149 1,410
For a comparison of biologics IND and NDA approvals between the last five years, please see the diagram below (Fig. 6).
 
IND-NDA-Approvals-2016 - 2020
Fig. 6 Number of Biologics IND and NDA Approvals from 2016 to 2020
 

2.2.1. IND Approval

 
Under the classification of biologics IND application, 294 cancer drugs were approved in 2020 which covered 58.8% of the total amount. The diagram below (Fig. 7) shows the number of IND approvals for each therapeutic field of biological products in this year.
 
Biologics-IND-Approvals-2020
Fig. 7 Number of Biologics IND Approvals for Each Therapeutic Field in 2020
 

2.2.2. NDA Approval

 
Under the classification of biologics NDA, cancer, endocrine, and cardiovascular drugs shared a large proportion of 65.17% of the total amount approved in 2020. The diagram below (Fig. 8) shows the number of NDA approvals for each therapeutic field of biological products this year.
 
Biologics-NDA-Approvals-2020
Fig. 8 Number of Biologics NDA Approvals for Each Therapeutic Field in 2020
 

3. Traditional Chinese Medicines

 

3.1 Application Overview

 
CDE reviewed a total of 418 Traditional Chinese Medicine (TCM) applications in 2020, including 37 IND applications, 8 NDAs and 3 ANDAs. The diagram below (Fig. 9) shows the number of TCMs reviewed for each application type.
 
TCM-Applications-Reviewed-2020
Fig. 9 Number of TCM Applications Reviewed in 2020
 

3.2 Approval

 

Among the reviewed TCM applications, 28 INDs and 4 NDAs were approved by CDE. The number of approvals for each application type is summarized in the table below (Table 4).

Table 4. Overview of TCM Approvals in 2020

APPLICATION TYPE

NUMBER OF APPLICATIONS

Approval (incl. approval after material supplement)

No Approval Suggested / Not Approved

Others*

Total Number
IND 28 5 4 37
NDA 4 0 4 8
ANDA 0 2 1 3
Supplementary Application 220 42 65 327
License Renewal of Imported Drugs 17 6 4 27
Re-Review N/A 16
In Total 269 55 78 418

 

For a comparison of TCM IND and NDA approvals between the last five years, please see the diagram below (Fig. 10).
 
TCM-IND-NDA-Approvals-2016 - 2020
Fig. 10 Number of TCM IND and NDA Approvals from 2016 to 2020
 

3.2.1. IND Approval

 
Under the classification of IND applications, 28 TCMs of 10 therapeutic fields were approved in 2020.
 
Respiratory, orthopedic, and gastrointestinal drugs shared a large proportion of 53.57%.
 
The diagram below (Fig. 11) shows the number of IND approvals for each therapeutic field of TCMs this year.
 
TCM-IND-Approvals-2020
Fig. 11 Number of TCM IND Approvals for Each Therapeutic Field in 2020
Accestra Consulting Provides China Regulatory Affairs Outsourcing for:

  • Drugs/Pharmaceutical,
  • Food and Feed products for China NMPA (Formerly CFDA).
  • Regulatory approval including product registration for China Investigational New Drug (IND),
  • China New Drug Application (NDA),
  • China Drug Master File (DMF) for APIs,
  • Excipients and Packaging Materials,
  • ANDA,
  • eCTD submission and others.

Read part 1 of the 2020 Drug Evaluation Report.

Contact Accestra Consulting Group
]]> 2020 China Drug Evaluation Report – Part 1 https://www.accestra.com/2020-cde-report-part-one/ Wed, 28 Jul 2021 22:32:40 +0000 https://www.accestra.com/?p=4180

 

Table of contents

1. Summary.
2. Technical Review & Approval.
3. Reason For Application Rejections.
3.1 New Drug Application Rejections.
3.2 ANDA Rejections.
3.3 Supplementary Application Rejections.

3.4 Other Application Rejection.

In 2020, the Center for Drug Evaluation (CDE) of China reviewed and/or approved 11,582 drug registrations.

To summarize the accomplishments and failures of drug approvals, CDE released a China Drug Evaluation Report of the year.

Part 1 of the report gives an overview of drug approvals for:

  • All application types (incl. INDs, NDAs and ANDAs),
  • New drug approvals for hot topics in 2020,
  • Reasons for rejected applications.

1. China Drug Evaluation Report Summary

Under the impact of COVID-19 in 2020, the Center for Drug Evaluation (CDE) accelerated the drug review and approval process.
 
More drugs (incl. drug-device combinations) were reviewed and/or approved in 2020 than the previous year.
 
There were a total of 11,582 registrations (32.67% increase), among which 8,606 registrations required technical review and approval.
The others required only administrative approval. 4,882 registrations were also pending technical review.
 
For an overview of the registrations reviewed and/or approved (incl. rejections after technical review) in 2020, please see the table below (Table 1).

CATEGORY

REGISTRATION TYPE

NUMBER OF REGISTRATIONS
Drug Product Requires Technical Review 8,606
Only Administrative Approval 2,972
Drug-device Combination 4
Total Number 11,582
 
Among 8,606 registrations technically reviewed by CDE, there are:
  • 6,778 chemical drugs (25.33% increase year on year)
  • 418 traditional Chinese medicines (39.33% increase year on year),
  • 1,410 biological products (27.72% year on year).

View the diagram below (Fig. 1) for a comparison between the categories and the total number of registrations reviewed between 2016 and 2020.

Fig. 1 Comparison of Drug Registrations Reviewed from 2016 to 2020.

Fig. 1 Comparison of Drug Registrations Reviewed from 2016 to 2020.
(Note: There was no registration that required only administrative approval in 2016, i.e., all registrations required technical review & approval. From 2017, specific registrations could be approved without technical review under the new regulatory framework.)

2. Technical Review & Approval

Among 8,606 registrations technically reviewed by CDE, there are:
  • 1,561 Investigational New Drug (IND) applications (55.94% increase year on year ),
  • 289 New Drug Applications (7.04% increase year on year ),
  • 1,700 Abbreviated New Drug Applications (2.16% increase year on year).
 
View the diagram below (Fig. 2) for a comparison between the categories and the total number of applications reviewed between 2016 and 2020.

Fig. 2 Number of Applications Reviewed from 2016 to 2020. (Note: CDE has started to conduct quality and efficacy consistency evaluation of generic drugs since August 2017.)

 
Among these applications, 1,435 INDs, 208 NDAs, and 918 ANDAs were approved after technical review.
 
These approved NDAs covered a total of 92 drug categories. This includes 20 categories of domestic new drugs and 72 categories of imported new drugs.
 
The drug category of a chemical drug is referred to as the Active Pharmaceutical Ingredient (API) of the drug, whereas the drug category of a biological product or traditional Chinese medicine is referred to as the International Nonproprietary Name (INN) of the drug.
 
29 Categories of NDAs were chosen and given below (Table 2). This provides an overview of the new drugs approved for hot topics in 2020, such as COVID-19 vaccines and anti-neoplastic drugs.
 

Table 2. Overview of New Drug Approvals for Hot Topics in 2020.

NO.

TOPIC IN DRUG THERAPY

INDICATION

DRUG CATEGORY
1 COVID-19 Vaccines and other treatments SARS-CoV-2 COVID-19 Vaccine (Vero Cell) Inactivated
2 COVID-19 Vaccines and other treatments Acute Lung Injury (ALI) / Acute Respiratory Distress Syndrome (ARDS) Liahnhua Qingwen Tables/Capsules/Jinhua Qinggan Tables / Xuebijing Injection
3 COVID-19 Vaccines and other treatments Non-small Cell Lung Cancer Sivelestat Sodium Hydrate for Ijection
4 Anti-neoplastic Drugs Non-small Cell Lung Cancer Almonertinib Mesylate Tablets
5 Anti-neoplastic Drugs Pancreatic and Non-pancreatic Neuroendocrine Tumors Surufatinib Capsules
6 Anti-neoplastic Drugs Hodgkin Lymphoma and Anaplastic Large Cell Lymphoma Bretunximab Vedotin for Injection
7 Anti-neoplastic Drugs B-precursor Acute Lymphoblastic Leukaemia Blinatumomab for Injection
8 Anti-neoplastic Drugs Differentiate Thyroid Cancer Lenvatinib Mesylate Capsules
9 Anti-infective Drugs Chronic Hepatitis C Coblopasvir Hydrochloride Capsules
10 Anti-infective Drugs HIV-1 Pre-Exposure Prophylaxis Emtricitabine / Tenofovir Disoproxil Fumarate Tablets
11 Circulatory System Drugs Hereditary Angioedema Lanadelumab-flyo Injection
12 Circulatory System Drugs Transthyretin Amyloidosis Tafamidis Soft Capsules
13 Respiratory System Drugs Persistent Allergic Rhinitis Bencycloquidium Bromide Nasal Spray
14 Respiratory System Drugs Idiopathic Pulmonary Fibrosis (IPF)/Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD) Nintedanib Esylate Soft Capsules
15 Nervous System Drugs Huntington’s Disease Deutetrabenazine Tablets
16 Nervous System Drugs Stage 1 Symptomatic Polyneuropathy Tafamidis Meglumine Soft Capsules
17 Analgesics and Anesthetics Painless Gastroenteroscopy Ciprofol Injection
18 Dermatological and Otorhinolaryngological Drugs Neurotrophic Keratitis Cenegermin Eye Drops
19 Dermatological and Otorhinolaryngological Drugs Atopic Dermatitis Dupilumab Injection
20 Gastrointestinal Drug Ulcerative Colitis/Crohn’s Disease Vedolizumab for Injection
21 Surgical Drugs Malignant Hyperthermia Tacrolimus Granules
22 Surgical Drugs Pediatric Transplant Rejection Tacrolimus Granules
23 Rare Disease Drugs Mucopolysaccharidosis 1 Laronidase Concentrate for Injection
24 Rare Disease Drugs Mucopolysaccharidosis 2 Idursulfase-beta Injection
25 In Vivo Diagnostics In-vivo diagnosis of mycobaterium tuberculosis infection Recombinant ESAT-6:CFP-10 Fusion Protein
26 Preventive Biological Product (Vaccine) Influenza Influenza Vaccine, Live, Nasal, Freeze-dried
27 Traditional Chinese Medicine Type 2 Diabetes Mulberry Twig Alkaloids Tablets
28 Traditional Chinese Medicine Knee Osteoarthritis Jingu Zhitong Gel
29 Traditional Chinese Medicine Acute Bronchitis and Tracheitis Lianhua Qingke Tablets

 

3. Reasons for Application Rejections

367 Applications failed to get approved in 2020 because of:
  • Insufficient proof for drug safety,
  • Efficacy,
  • Quality control or delay in submitting the supplementary materials upon CDE’s requests.
 
The following reasons are identified from different perspectives of drug development and regulatory submission for INDs, NDAs, ANDAs, supplementary applications, and others.
 

3.1 New Drug Application Rejections

3.1.1. IND Application Rejections.

  1. Lack of pre-IND meeting
    Major data gaps were identified after IND applications were filed and couldn’t be supplemented in the given timeline.

  2. Insufficient data for clinical development justification.
    a. The IND-enabling (incl. pharmaceutical, nonclinical, preclinical) studies demonstrated that the drug efficacy was low and safety risk was high. The risk-benefit ratio was not suitable for first-in-human testing.
    b. The clinical development purpose did not comply with the principles of clinical trials.
    c. The IND-enabling studies were insufficient to start clinical trials.

  3. Insufficient data to enable clinical studies or control safety risks in humans.
    a. Major defects in the clinical trial protocol and insufficient risk control measures.
    b. Insufficient nonclinical data for combination therapy drugs.
    c. Insufficient data for each individual vaccine or different immunization procedures between the individual vaccines of a combination vaccine.

3.1.2. NDA Rejections

  1. Major defects in the research quality control and management system. Thus the submitted data couldn’t prove the safety, efficacy, and quality of the drug.

  2. Lack or regulatory compliance
    a. Inconsistent study drugs were used for different phases of clinical trials.
    b. Authenticity issues were identified in clinical data during on-site inspection/audit.

3.2. ANDA Rejections

  1. Unsuitable justification for generic development: The reference listed drug (RLD) which the generic compared to has been withdrawn from the market. A new drug with improved safety has been authorized for marketing in China.

  2. Insufficient data for quality consistency
    a. Product specification review and sample inspection did not follow the requirements, or major defects were identified in the analytical methods.
    b. The bioequivalence study demonstrated that the generic and RLD were not bioequivalent.
    c. Lack of compliance with technical requirements for generics (such as stability testing and choose of API starting materials).
    d. The APIs were not from legal sources.

3.3. Supplementary Application Rejections

  1. Insufficient data to justify the change to an approved drug.
    a. The submitted change had a major impact on the drug substance and caused substance change.
    b. The submitted change to the drug label/insert did not follow technical requirements for drafting the drug label/insert.

  2. The submitted data could not prove that the change to an approved drug had no impact on the drug safety, efficacy, and quality (such as insufficient reference literature and clinical data).

3.4. Other Application Rejection

  1. Biosimilars.
    a. Lack of similarity assessment or the choice of reference drug in the comparative study did not follow requirements.
    b. Insufficient nonclinical/preclinical data to enable clinical studies.

  2. Natural Medicines: The submitted data did not follow requirements for multi-regional clinical trials or the national guidelines for the review of natural medicines.

Accestra Consulting Provides China Regulatory Affairs Outsourcing for:

  • Drugs/Pharmaceutical,
  • Food and Feed products for China NMPA (Formerly CFDA).
  • Regulatory approval including product registration for China Investigational New Drug (IND),
  • China New Drug Application (NDA),
  • China Drug Master File (DMF) for APIs,
  • Excipients and Packaging Materials,
  • ANDA,
  • eCTD submission and others.
Contact Accestra Consulting Group
]]> China New Drug Application (NDA) Approvals in Q1 2020 https://www.accestra.com/china-new-drug-application-nda-approvals-in-q1-2020/ Sun, 26 Apr 2020 02:35:13 +0000 http://www.accestra.com/?p=2702 In the first quarter of 2020, the National Medical Products Administration (NMPA) approved a total of 11 new drugs including 6 imported drugs and 5 domestic drugs. Among them, domestic medicines also have a vaccine and a traditional Chinese medicine as the table below shows.

Note:
Here the NDAs are the drugs approved by NMPA in China for the first time, which includes NMEs (and compounds consisted of NME), biological products, traditional Chinese medicines and vaccines. The NMEs are mainly the category 1 and category 5.1 of chemical drugs. The biological products are mainly the category 1 and category 2 biologics, excluding biosimilars, new indications and new dosage forms.

The following is a brief introduction of some selected NDAs：

  • The first ADC drug approved in China

Roche’s Trastuzumab Emtansine injectable (Kadcyla®) was approved in China on January 21, 2020, becoming the first antibody-drug conjugated(ADC). Its indication is for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment. Kadcyla has been approved by FDA in May 2019, EMA in December 2019 and now also parallel approval of China.

  • The first approved traditional Chinese medicine for diabetes in recent 10 years

Mulberry Twig Alkaloids Tablet of Wehand was approved by NMPA on March 17, 2020. The main ingredient is twig alkaloids extracted from mulberry. This tablet is applied for the treatment of type 2 diabetes in combination of diet control. The phase III clinical trial has demonstrated the efficacy of the drug is similar with that of acarbose. Mulberry twig alkaloids tablet is the first new traditional Chinese medicine approved for diabetes in recent 10 years.

  • The first Chinese approved 3rd generation EGFR-TKI drug

Hansoh’s Almonertinib mesilate tablets obtained approval from NMPA on March 18, 2020 for the treatment of adult patients, who have progress with or after the treatment of EGFR-TKI and are confirmed with the presence of locally advanced or metastatic non-small cell lung cancer (NSCLC) positive for EGFR T790M mutation by detection. Almonertinib mesilate tablet is the third 3rdgeneration EGFR-TKI new drug in the world , and also the first 3rd generation EGFR-TKI drug in China.

Besides the above drugs, NMPA has approved another two clinical urgently needed overseas new drugs, namely Pfizer’s Tafamidis meglumine soft capsules and Takeda’s Vedolizumab for injection. In addition, the nasal freeze-dried influenza live vaccine of BCT is the first nasal spray influenza vaccine in China, and Atezolizumab injection of Roche is the second PD-L1 drug approved by NMPA.

This article is translated from Pharmcube.

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