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

by Grace Wang Nov 08, 2021

Editor's Note: New drug approvals in China covers 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 has not got 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 Oct. 2021, China's NMPA granted 11 new drug approvals1:

1. Chiglitazar Sodium Tablets

1

Generic Name

Chiglitazar Sodium Tablets2

2

Brand Name

双洛平/Bilessglu

3

Registration Classification

Class 1 chemical drug

4

Application Type

Marketing authorization

5

Marketing Authorization Holder (MAH)

Chengdu Chipscreen Pharmaceutical Co., Ltd.

6

Approval Date

Oct. 20, 2021

7

Time from Application Acceptance to Approval

748 days

8

Priority Review

No

9

Target(s)

Peroxisome Proliferator Activated Receptor Gamma (PPARG); Peroxisome Proliferator Activated Receptor Alpha (PPARA)

10

Indication(s)

Chiglitazar Sodium Tablets as a single agent is indicated as an adjunct to diet and exercise to improve glycemic control of adults with type 2 diabetes mellitus.3

11

Notes

Innovative new drug in China

2. Polymeric Micellar Paclitaxel for Injection

1

Generic Name

Polymeric Micellar Paclitaxel for Injection

2

Brand Name

/

3

Registration Classification

Class 2.2 chemical drug

4

Application Type

Marketing authorization

5

MAH

Shanghai Yizhong Biotechnology Co., Ltd.

6

Approval Date

Oct. 28, 2021

7

Time from Application Acceptance to Approval

820 days

8

Priority Review

No

9

Target(s)

Ÿ     Cytochrome P450 2C8 (CYP2C8);

Ÿ     Microtubule-associated protein 2 (MAP2);

Ÿ     Bile salt export pump (ABCB11);

Ÿ     Microtubule Associated Protein Tau (MAPT);

Ÿ     Multidrug resistance-associated protein 1 (ABCC1);

Ÿ     Tubulin beta-1 chain (TUBB1);

Ÿ     Cytochrome P450 1B1 (CYP1B1);

Ÿ     Canalicular multispecific organic anion transporter 1 (ABCC2);

Ÿ     ATP Binding Cassette Subfamily G Member 2 (ABCG2);

Ÿ     BCL2 Apoptosis Regulator (BCL2);

Ÿ     Cytochrome P450 Family 19 Subfamily A Member 1 (CYP19A1);

Ÿ     Microtubule-associated protein 4 (MAP4);

Ÿ     Nuclear receptor subfamily 1 group I member 2 (NR1I2);

Ÿ     Solute carrier organic anion transporter family   member 1B3 (SLCO1B3);

Ÿ     Tubulin;

Ÿ     Cytochrome P450 2C9 (CYP2C9);

Ÿ     Cytochrome P450 Family 3 Subfamily A Member 4 (CYP3A4);

Ÿ     Cytochrome P450 Family 3 Subfamily A Member 5 (CYP3A5);

Ÿ     Cytochrome P450 Family 3 Subfamily A Member 7 (CYP3A7);

Ÿ   Multidrug resistance protein 1 (MRP1).

10

Indication(s)

The drug, in combination with platinum, is indicated for the first-line treatment for patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) that is EGFR mutation-negative and ALK-negative.4

11

Notes

Improved new drug in China

3. Cefotaxime Sodium and Tazobactam Sodium for Injection

1

Generic Name

Cefotaxime Sodium and Tazobactam Sodium for Injection

2

Brand Name

/

3

Registration Classification

Class 2.3 chemical drug

4

Application Type

Marketing authorization

5

MAH

Nanjing Youke Pharmaceutical Co., Ltd.

6

Approval Date

Oct. 20, 2021

7

Time from Application Acceptance to Approval

952 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)  

Indicated for patients with moderate-to-severe infections who are resistant and sensitive to cefotaxime. The infection can be lower respiratory tract infections (LSTIs), urinary tract infections (UTIs), gynecological infections, bacteremia/septicemia, skin and/or soft tissue   infections (SSTIs), abdominal infections, central nervous system infections, etc.5

11

Notes

Improved new drug in China

4. Vonoprazan Fumarate Tablets

1

Generic Name

Vonoprazan Fumarate Tablets

2

Brand Name

沃克/VOCINTI

3

Registration Classification

Class 5.1 chemical drug

4

Application Type

Drug import

5

MAH

Takeda Pharmaceutical Company Limited

6

Approval Date

Oct. 13, 2021

7

Time from Application Acceptance to Approval

525 days

8

Priority Review

No

9

Target(s)

Potassium-transporting ATPase alpha chain 1 (ATP4A);

H+ K+ ATPase

10

Indication(s)  

Indicated for treating reflux esophagitis.

11

Notes

Improved new drug imported to China

5. Clopidogrel Bisulfate and Aspirin Tablets

Grace Wang
ChemLinked Regulatory Analyst
+ FOLLOW
Copyright: unless otherwise stated all contents of this website are ©2021 - REACH24H Consulting Group - All Rights Reserved - For permission to use any content on this site, please contact cleditor@chemlinked.com