Monthly Report: New Drug Approvals in China | Nov. 2021

by Grace Wang Dec 15, 2021

Editor's Notes: New drugs in this article refer to

  • Innovative/improved new chemical drugs / biological products that have never been granted marketing authorization in or outside China;

  • Original/improved chemical drugs / biological products that have received marketing authorization outside China and are applying for marketing authorization in China;

  • First generic drugs in China*.

*"First generic drug in China" refers to the first generic drug developed by a Chinese company and approved by China National Medical Products Administration (NMPA) with marketing authorization.


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In Nov. 2021, China's NMPA approved seven new drugs, including three chemical drugs and four biological products.

1. Remimazolam Tosilate for Injection

1

Generic Name

Remimazolam Tosilate for Injection

2

Brand Name

Rui Bei Ning (瑞倍宁)

3

Registration Classification

Class 2.4 chemical drug

4

Application Type

New drug application (NDA)

5

Marketing Authorization Holder (MAH)

Jiangsu Hengrui Pharmaceutical Co., Ltd.

6

Approval Date

Nov. 12, 2021

7

Time from Application Acceptance to Approval

261 days

8

Priority Review

No

9

Target(s)

GABAA receptor

10

Indication(s)  

Indicated for procedural sedation during gastroscopy.

2. Olverembatinib Tablets

1

Generic Name

Olverembatinib Tablets

2

Brand Name

/

3

Registration Classification

Class 1 chemical drug

4

Application Type

NDA

5

MAH

Ascentage Pharma Group

6

Approval Date

Nov. 26, 2021

7

Time from Application Acceptance to Approval

397

8

Priority Review

Yes (qualified for conditional approval)

9

Target(s)

/

10

Indication(s)  

  • Indicated for the treatment of adult patients with tyrosine kinase inhibitor (TKI)-resistant chronic myeloid leukemia of chronic phase (CML-CP) or CML of accelerated-phase (CML-AP) harboring the T315I mutation.

  • Not recommended for newly-diagnosed CML patients.

3. Sodium Phosphates Powder

1

Generic Name

Sodium Phosphates Powder

2

Brand Name

/

3

Registration Classification

Class 2.2 chemical drug

4

Application Type

NDA

5

MAH

Sichuan Jewelland Pharmaceutical Co., Ltd.

6

Approval Date

Nov. 5

7

Time from Application Acceptance to Approval

1,733 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)  

Indicated for cleansing intestines before a colon X-ray test, colonoscopy, or surgery.

4. Toripalimab Injection

1

Generic Name

Toripalimab Injection

2

Brand Name

Tuo Yi (拓益)

3

Registration Classification

Class 2.2 therapeutic biological product

4

Application Type

Biologics License Application

5

MAH

Shanghai Junshi Biosciences Co., Ltd.

6

Approval Date

Nov. 26, 2021

7

Time from Application Acceptance to Approval

273 days

8

Priority Review

No

9

Target(s)

Programmed cell death protein 1 (PD-1)

10

Indication(s)  

Indicated for first-line treatment for patients with locally recurrent or metastatic nasopharyngeal carcinoma in combination with cisplatin and gemcitabine.

5. Envafolimab Injection

1

Generic Name

Envafolimab Injection

2

Brand Name

En Wei Da (恩维达)

3

Registration Classification

Class 1 therapeutic biological product

4

Application Type

BLA

5

MAH

Alphamab Oncology Co., Ltd.

6

Approval Date

Nov. 26, 2021

7

Time from Application Acceptance to Approval

326 days

8

Priority Review

Yes (qualified for conditional approval)

9

Target(s)

Programmed death-ligand 1 (PD-L1)

10

Indication(s)  

Indicated for the treatment of

  • microsatellite instability-high (MSI-H) advanced colorectal cancer;

  • MSI-H advanced gastric cancer that has failed the first-line standard treatment at least;

  • mismatch repair deficient (dMMR) advanced solid tumors that have failed the first-line standard treatment at least.

6. Bevacizumab Injection

1

Generic Name

Bevacizumab Injection

2

Brand Name

Pu Bei Xi (普贝希)

3

Registration Classification

Class 2 therapeutic biological product

4

Application Type

BLA

5

MAH

Bio-Thera Solutions, Ltd.

6

Approval Date

Nov. 19, 2021

7

Time from Application Acceptance to Approval

502 days

8

Priority Review

No

9

Target(s)

Vascular endothelial growth factor (VEGF)

10

Indication(s)  

  • Indicated for the treatment of patients with metastatic colorectal cancer (mCRC) in combination with fluorouracil-based chemotherapy.

  • Indicated for the first-line treatment of patients with unresectable, advanced, recurrent or metastatic non–squamous non–small cell lung cancer (NSCLC) in combination with platinum-based chemotherapy.

7. Bevacizumab Injection

1

Generic Name

Bevacizumab Injection

2

Brand Name

Bei An Ting (贝安汀)

3

Registration Classification

Class 2 therapeutic biological product

4

Application Type

BLA

5

MAH

Zhejiang Hisun Pharmaceutical Co., Ltd.

6

Approval Date

Nov. 26, 2021

7

Time from Application Acceptance to Approval

518 days

8

Priority Review

No

9

Target(s)

Vascular endothelial growth factor (VEGF)

10

Indication(s)  

  • Indicated for the treatment of patients with metastatic colorectal cancer (mCRC) in combination with fluorouracil-based chemotherapy.

  • Indicated for the first-line treatment of patients with unresectable, advanced, recurrent or metastatic non–squamous non–small cell lung cancer (NSCLC) in combination with platinum-based chemotherapy.

Welcome to contact BaiPharm if you need details of the approved drugs listed above or drug registration procedures in China.

We offer a full portfolio of China NMPA compliance consulting services. Our professionals have successfully carried out a great number of market entry projects of finished drugs, APIs, excipients and packaging materials.

Grace Wang
ChemLinked Regulatory Analyst & Editor
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