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

by Grace Wang Dec 15, 2021

Editor's Note: New drug approvals in China cover drugs under the following categories:

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

  • 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 or biosimilars in China.

- "First generic drug/biosimilar in China" refers to the first generic drug/biosimilar developed by Chinese companies and approved by National Medical Products Administration (NMPA) while its original version hasn't received marketing authorization in China.

-  Technically, generic drugs/biosimilars are not new innovative/improved drugs according to Chinese drug regulations. Yet, first generics/biosimilars are still included in this article because they are "new" in the Chinese market.

Perhaps you'd like to know

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
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