Monthly Report: New Drug Approvals in China | May 2022

by Grace Wang Jun 07, 2022

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

  • 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; and

  • 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.

In May 2022, China NMPA approved 12 new drugs, including 10 chemical drugs and 2 biological products.

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1. Vericiguat Tablets

1

Generic Name

Vericiguat Tablets

2

Brand Name

Verquvo (唯可同)

3

Registration Classification

Class 1 chemical drug

4

Application Type

New Drug Application (NDA), import

5

Marketing Authorization   Holder (MAH)

Bayer AG

6

Approval Date

May 20, 2022

7

Time from Application Acceptance to Approval

628 days

8

Priority Review

Yes (innovative/improved drug that is urgently needed in clinical settings, in shortage, and can prevent diseases such as major   infectious diseases and rare diseases.

9

Target(s)

Guanylate cyclase

10

Indication(s)

This drug is indicated to reduce the risk of heart failure (HF) hospitalization or need for intravenous (IV) diuretics in adults who were recently hospitalized due to HF and whose conditions have been stabilized (with less than 45% ejection fraction) after IV treatment.

2. Rivaroxaban Granules

1

Generic Name

Rivaroxaban Granules

2

Brand Name

XARELTO (拜瑞妥)

3

Registration Classification

Class 2.2 and Class 2.4 chemical drug

4

Application Type

NDA, import

5

MAH

Bayer AG

6

Approval Date

May 7, 2022

7

Time from Application Acceptance to Approval

581 days

8

Priority Review

Yes (pediatric drug)

9

Target(s)

Coagulation Factor X (F10)

10

Indication(s)

This drug is indicated for the treatment of venous thromboembolism (VTE) and the reduction in the risk of recurrent VTE in pediatric patients from full-term infants to less than 18-year-old adolescents who have started receiving standard anticoagulant treatment.

3. Fenofibric Acid Tablets

1

Generic Name

Fenofibric Acid Tablets

2

Brand Name

/

3

Registration Classification

Class 3 chemical drug

4

Application Type

Abbreviated New Drug Application (ANDA)

5

MAH

Changchun Haiyue Pharmaceutical Co., Ltd.

6

Approval Date

May 13, 2022

7

Time from Application Acceptance to Approval

577 days

8

Priority Review

No

9

Target(s)

Peroxisome proliferator-activated receptor alpha (PPARA)

10

Indication(s)

On the basis of a diet, this drug is indicated for

1. reducing the triglyceride (TG) in hypertriglyceridemia (≥500mg/dL) adult patients;

2. the treatment of adult patients with primary hypercholesterolemia (PH) or mixed dyslipidemia.

12

Notes

First generic in China

4. Deferasirox Tablets

1

Generic Name

Deferasirox Tablets

2

Brand Name

/

3

Registration Classification

Class 3 chemical drug

4

Application Type

ANDA

5

MAH

Jiangsu Hansoh Pharmaceutical Group Co., Ltd.

6

Approval Date

May 13, 2022

7

Time from Application Acceptance to Approval

532 days

8

Priority Review

No

9

Target(s)

Ferritin

10

Indication(s)

This drug is indicated for

1. the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients no younger than 2 years old.

2. the treatment of chronic iron overload in patients no less than 10 years old with non-transfusion-dependent thalassemia (NTDT) syndromes.

12

Notes

First generic in China

5. Vigabatrin Powder for Oral Solution

1

Generic Name

Vigabatrin Powder for Oral Solution

2

Brand Name

/

3

Registration Classification

Class 3 chemical drug

4

Application Type

ANDA

5

MAH

Easton Biopharmaceuticals Co., Ltd.

6

Approval Date

May 13, 2022

7

Time from Application Acceptance to Approval

722 days

8

Priority Review

No

9

Target(s)

4-aminobutyrate aminotransferase GabT

10

Indication(s)

This drug is indicated

1. as an adjuvant treatment for patients who do not adequately respond to other anti-seizure drugs, especially who have complex partial seizures.

2. for the treatment of West syndrome (infantile spasm) in infants.

12

Notes

First generic in China

6. Hemofiltration Replacement Fluid of Sodium Bicarbonate

1

Generic Name

Hemofiltration Replacement Fluid of Sodium Bicarbonate

2

Brand Name

/

3

Registration Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

Gambro Lundia AB

6

Approval Date

May 20, 2022

7

Time from Application Acceptance to Approval

963 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)

This drug is indicated as displacement fluid for the treatment of acute kidney injury (AKI) during continuous renal replacement therapy (CRRT).

7. Omega-3-acid Ethyl Ester 90 Soft Capsules

1

Generic Name

Omega-3-acid Ethyl Ester 90 Soft Capsules

2

Brand Name

/

3

Registration Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

Abbott Laboratories Trading (Shanghai) Co., Ltd.

6

Approval Date

May 7, 2022

7

Time from Application Acceptance to Approval

683 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)

  • The drug is indicated for the treatment of endogenous hypertriglyceridemia, and can be an adjuvant treatment to a diet that doesn't have satisfactory effect:

  • The drug, as a single agent, can treat type IV familial dyslipidemia, and can be used in combination with statins to treat type II b/Ⅲ hyperlipidemia when triglyceride is inadequately controlled.

8. Letermovir Injection

1

Generic Name

Letermovir Injection

2

Brand Name

PREVYMIS

3

Registration Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

Merck Sharp & Dohme B.V.

6

Approval Date

May 13, 2022

7

Time from Application Acceptance to Approval

538 days

8

Priority Review

No

9

Target(s)

Terminase, large subunit

10

Indication(s)

The drug is indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).

9. Lamivudine and Dolutegravir Sodium Tablets

1

Generic Name

Lamivudine and Dolutegravir Sodium Tablets

2

Brand Name

DOVATO

3

Registration Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

ViiV Healthcare B.V.

6

Approval Date

May 7, 2022

7

Time from Application Acceptance to Approval

287 days

8

Priority Review

No

9

Target(s)

DNA polymerase;

In HIV;

HIV-1 Reverse Transcriptase;

Nucleoside reverse transcriptase.

10

Indication(s)

This drug is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and no known substitutions associated with resistance to the individual components of the drug.

10. Cyclosporine Ophthalmic Emulsion

1

Generic Name

Cyclosporine Ophthalmic Emulsion

2

Brand Name

VERKAZIA

3

Registration Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

Santen Pharmaceutical Co., Ltd.

6

Approval Date

May 7, 2022

7

Time from Application Acceptance to Approval

371 days

8

Priority Review

Yes

9

Target(s)

/

10

Indication(s)

This drug is indicated for the treatment of vernal keratoconjunctivitis (VKC) in children (≥ 4 years old) and adolescents.

11. Human Papillomavirus (Types 16,18) Vaccine, Adsorbed

1

Generic Name

Human Papillomavirus (Types 16,18) Vaccine, Adsorbed

2

Brand Name

CERVARIX (希瑞适)

3

Registration Classification

Class 3.1 biological product

4

Application Type

Biologics License Application (BLA)

5

MAH

GlaxoSmithKline Biologicals S.A.

6

Approval Date

May   13, 2022

7

Time from Application Acceptance to Approval

439 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)

The vaccine is recommended to be used on females at 9-45 years old for the prevention of following diseases induced by Human Papillomavirus (HPV) types 16 and 18:

1. cervical cancer;

2. Level 2/3 cervical intra-epithelial neoplasia (CIN 2/3) and adenocarcinoma in situ (AIS);

3. Level 1 cervical intra-epithelial neoplasia (CIN1).

12. Conbercept Ophthalmic Injection

1

Generic Name

Conbercept Ophthalmic Injection

2

Brand Name

Lang Mu (朗沐)

3

Registration Classification

Class 2.2 biological product

4

Application Type

BLA

5

MAH

Kanghong Pharmaceutical Co., Ltd.

6

Approval Date

May 7, 2022

7

Time from Application Acceptance to Approval

459 days

8

Priority Review

No

9

Target(s)

Vascular endothelial growth factor receptor (VEGFR)

10

Indication(s)

The drug is indicated for the treatment of

1. neovascular age-related macular degeneration (nAMD);

2. visual impairment caused by choroidal neovascularization secondary to pathologic myopia (mCNV);

3. visual impairment caused by diabetic macular edema (DME);

4. visual impairment secondary to renal vein occlusion (RVO).

* The first three are previously approve indications; the fourth is the indication newly approved on May 7, 2022.


Grace Wang
ChemLinked Regulatory Analyst
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