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

by Grace Wang Nov 08, 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 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.

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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

1

Generic Name

Clopidogrel Bisulfate and Aspirin Tablets

2

Brand Name

/

3

Registration Classification

Class 5.1 chemical drug

4

Application Type

Drug import

5

MAH

Sanofi K.K.

6

Approval Date

Oct. 11, 2021

7

Time from Application Acceptance to Approval

557 days

8

Priority Review

No

9

Target(s)

Prostaglandin-Endoperoxide Synthase 2 (PTGS2); P2Y purinoceptor 12 (P2RY12)

10

Indication(s)  

Indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndrome who have already been taking both clopidogrel hydrogen sulfate and acetylsalicylic acid (aspirin).6

11

Notes

Innovative new drug imported to China

6. Bezafibrate Sustained-release Tablets

1

Generic Name

Bezafibrate Sustained-release Tablets

2

Brand Name

/

3

Registration Classification

Class 3 chemical drug

4

Application Type

Marketing authorization

5

MAH

Jiangsu Tasly Diyi Pharmaceutical Co., Ltd.

6

Approval Date

Marketing authorization

7

Time from Application Acceptance to Approval

661 days

8

Priority Review

No

9

Target(s)

Ÿ     Cytochrome P450 1A1 (CYP1A1);

Ÿ     Cytochrome P450 2C8 (CYP2C8);

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

Ÿ     Peroxisome Proliferator Activated Receptor Alpha (PPARA);

Ÿ     Peroxisome Proliferator Activated Receptor Delta (PPARD);

Ÿ     Peroxisome Proliferator Activated Receptor Gamma (PPARG);

Ÿ     Solute carrier organic anion transporter family member 1B1 (SLCO1B1);

Ÿ     Peroxisome proliferator activated receptor (PPAR);

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

Ÿ     Retinoid X Receptor Alpha (RXRA);

Ÿ     Retinoic acid receptor RXR-beta (RXRB);

Ÿ   Retinoic acid receptor RXR-gamma (RXRG)

10

Indication(s)  

The drug is indicated for

Ÿ     lipid metabolism disorders after the failure of food therapy, exercise enhancement, weight loss and other methods to control the lipid metabolism disorders.

Ÿ     lipid metabolism disorders that is induced by primary diseases (e.g. diabetes) and still exists after appropriate therapy for the primary diseases.

11

Notes

First generic drug in China

7. Succinylated Gelatin, Multiple Electrolytes and Sodium Acetate Injection

1

Generic Name

Succinylated Gelatin, Multiple Electrolytes and Sodium Acetate Injection

2

Brand Name

/

3

Registration Classification

Class 3 chemical drug

4

Application Type

Marketing authorization

5

MAH

B. Braun Medical (Suzhou) Co., Ltd.

6

Approval Date

Oct. 13, 2021

7

Time from Application Acceptance to Approval

1,009 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)  

As a colloidal volume substitute for

- prophylaxis and treatment of absolute and relative hypovolemia (e.g. following shock due to hemorrhage, trauma, perioperative blood losses, burns, or sepsis);

- prophylaxis of hypotension (e.g. in connection with induction of epidural or spinal anesthesia).

- hemodilution;

- extra-corporeal circulation (heart-lung   machine, hemodialysis).7

11

Notes

First generic drug in China

8. Colistimethate Sodium for Injection

1

Generic Name

Colistimethate Sodium for Injection

2

Brand Name

/

3

Registration Classification

Class 3 chemical drug

4

Application Type

Marketing authorization

5

MAH

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

6

Approval Date

Oct. 13, 2021

7

Time from Application Acceptance to Approval

1,386 days

8

Priority Review

Yes (Reason: major special project or major research & development plan)

9

Target(s)

Outer membrane protein

10

Indication(s)  

  • Indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli.

  • Not indicated for infections due to Proteus or Neisseria.

  • The drug has proven clinically effective in treatment of infections due to Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Acinetobacter baumannii.

  • The drug can be used in the initiate therapy in serious infections that are suspected to be caused by gram-negative organisms and in the initial treatment of infections due to susceptible gram-negative pathogenic bacilli.

11

Notes

First generic drug in China

9. Regadenoson Injection

1

Generic Name

Regadenoson Injection

2

Brand Name

/

3

Registration Classification

Class 3 chemical drug

4

Application Type

Marketing authorization

5

MAH

Nanjing Heron Pharmaceutical Science and Technology Co., Ltd.

6

Approval Date

Oct. 28, 2021

7

Time from Application Acceptance to Approval

478 days

8

Priority Review

No

9

Target(s)

Adenosine A2a Receptor (ADORA2A)

10

Indication(s)  

Indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.8

11

Notes

First generic drug in China

10. Daratumumab Injection (Subcutaneous Injection)

1

Generic Name

Daratumumab Injection (Subcutaneous Injection)

2

Brand Name

兆珂速/DARZALEX FASPRO

3

Registration Classification

Class 2.2 therapeutic biological product

4

Application Type

Drug import

5

MAH

Janssen-Cilag International NV

6

Approval Date

Oct. 11, 2021

7

Time from Application Acceptance to Approval

324 days

8

Priority Review

Yes (Reason: innovative/improved new drug which is in urgent clinical need for preventing or treating severe infectious diseases or rare diseases)

9

Target(s)

CD38 Molecule

10

Indication(s)  

  • DARZALEX FASPRO is indicated for the treatment of adult patients with endogenous light chain (AL) amyloidosis.

  • DARZALEX FASPRO is indicated for the treatment of adult patients whose atopic dermatitis is insufficiently controlled by topical prescription drugs, or such drugs are not recommended for the case.

  • DARZALEX FASPRO is optional to be used in combination with topical corticosteroid.

11

Notes

Improved new drug imported to China

11. Insulin Degludec and Liraglutide Injection

1

Generic Name

Insulin Degludec and Liraglutide Injection

2

Brand Name

Xultophy

3

Registration Classification

Class 3.1 therapeutic biological product

4

Application Type

Drug import

5

MAH

Novo Nordisk

6

Approval Date

Oct. 28, 2021

7

Time from Application Acceptance to Approval

384 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)  

Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

11

Notes

Biological products that are manufactured outside China and imported to China

If you need details of the approved drugs listed above or drug registration procedures in China, welcome to send an email to contact@chemlinked.com.

Grace Wang
ChemLinked Regulatory Analyst
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