Monthly Report: New Drug Approvals in China | February 2022

by Grace Wang Mar 11, 2022

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 Chinese companies and approved by China National Medical Products Administration (NMPA). Technically, generic drugs are not innovative/improved drugs according to Chinese drug regulations. Yet, first generics are still included in this article because they are new in the Chinese market.

In February 2022, China NMPA approved 16 new drugs, including 12 chemical drugs and 4 biological products. Among the newly approved drugs, Pfizer's Paxlovid is the first foreign drug against COVID-19 to receive marketing authorization in China. [Read More]

1. Nirmatrelvir/Ritonavir Tablets

1

Generic Name

Nirmatrelvir/Ritonavir Tablets

2

Brand Name

Paxlovid

3

Registration Classification

Class 5.1 chemical drug

4

Application Type

New drug application (NDA)

5

Marketing Authorization Holder (MAH)

Pfizer Inc.

6

Approval Date

Feb. 11, 2022

7

Time from Application Acceptance to Approval

/

8

Priority Review

/

9

Target(s)

/

10

Indication(s)  

For treating mild-to-moderate COVID-19 pneumonia in adult patients with a high risk of developing into severe conditions. The high risk may be advanced age, or with a severe disease such as chronic kidney disease, diabetes, cardiovascular disease, or chronic pneumonia.

2. Montmorillonite Suspension

1

Generic Name

Montmorillonite Suspension

2

Brand Name

/

3

Registration Classification

Class 5.1 chemical drug

4

Application Type

NDA

5

MAH

Beaufour-Ipsen (Tianjin) Pharmaceutical Co., Ltd.

6

Approval Date

Feb. 24, 2022

7

Time from Application Acceptance to Approval

232 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)  

  • For treating chronic or acute diarrhea in adult and pediatric patients.

  • As an adjuvant treatment for pains caused by esophagus, stomach, or duodenum disease.

  • NOT indicated as an antispasmodic drug.

3. Yttrium [Y-90] Resin Microspheres

1

Generic Name

Yttrium [Y-90] Resin Microspheres

2

Brand Name

SIR-Spheres

3

Registration Classification

Class 5.1 chemical drug

4

Application Type

NDA

5

MAH

Grandpharma (China) Co., Ltd.

6

Approval Date

Feb. 9, 2022

7

Time from Application Acceptance to Approval

430 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)  

For treating colon cancer that has spread to the liver and can't be surgically removed after failure of the standard treatment.

4. Ivosidenib Tablets

1

Generic Name

Ivosidenib Tablets

2

Brand Name

Tibsovo (拓舒沃)

3

Registration Classification

Class 5.1 chemical drug

4

Application Type

NDA

5

MAH

Servier Pharmaceuticals LLC

6

Approval Date

Feb. 9, 2022

7

Time from Application Acceptance to Approval

180 days

8

Priority Review

Yes (qualified for conditional approval)

9

Target(s)

Isocitrate dehydrogenase [NADP] cytoplasmic (IDH1)

10

Indication(s)  

For treating patient adults with relapsed or refractory acute myeloid leukemia (R/R AML) with an IDH1 mutation.

5. Everolimus Tablets

1

Generic Name

Everolimus Tablets

2

Brand Name

Afinitor (飞尼妥)

3

Registration Classification

Class 5.1 chemical drug

4

Application Type

Supplemental application for adding a new indication

5

MAH

Novartis Pharma Schweiz AG

6

Approval Date

Feb. 9, 2022

7

Time from Application Acceptance to Approval

282 days

8

Priority Review

No

9

Target(s)

mammalian target of rapamycin (mTOR) complex 1;

serine/threonine-protein kinase mTOR.

10

Indication(s)  

Approved on Feb. 9, 2022:

  • Indicated for treating postmenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer, after failure of treatment with letrozole or anastrozole.

Approved previously:

  • Indicated for treating adult patients with pancreas-originated neuroendocrine tumors (NET) which is well-differentiated (which means medium or highly differentiated), progressive, unresectable, and locally advanced/metastatic.

  • For treating adult patients with NET of gastrointestinal or lung origin. The NET should be unresectable, locally advanced/metastatic, well-differentiated, progressive, and non-functional.

  • For treating adult patients with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib.

  • For treating adult and pediatric patients with tuberous sclerosis complex (TSC)-associated subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be resected.

  • For treating adult patients with TSC-associated renal angiomyolipoma (AML) that does not require immediate surgery.

6. Upadacitinib Extended-release Tablets

1

Generic Name

Upadacitinib Extended-release Tablets

2

Brand Name

RINVOQ

3

Registration Classification

Class 2.4 chemical drug

4

Application Type

NDA

5

MAH

Abbvie Pharmaceutical Trading (Shanghai) Co., Ltd.

6

Approval Date

Feb. 24, 2022

7

Time from Application Acceptance to Approval

417 days

8

Priority Review

Yes (pediatric drug)

9

Target(s)

Tyrosine-protein kinase JAK1

10

Indication(s)  

For the systemic treatment for patients at the age of 12 or older with moderate-to-severe atopic dermatitis.

7. Ciprofol Injection

1

Generic Name

Ciprofol Injection

2

Brand Name

思舒宁 (Si Shu Ning)

3

Registration Classification

Class 2.4 chemical drug

4

Application Type

NDA

5

MAH

Haisco Pharmaceutical Group

6

Approval Date

Feb. 24, 2022

7

Time from Application Acceptance to Approval

242 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)  

For sedation during digestive endoscopy.

8. Tadalafil Oral Soluble Film

1

Generic Name

Tadalafil Oral Soluble Film

2

Brand Name

/

3

Registration Classification

Class 2.4 chemical drug

4

Application Type

NDA

5

MAH

Qilu Pharmaceutical Co., Ltd.

6

Approval Date

Feb. 9, 2022

7

Time from Application Acceptance to Approval

691 days

8

Priority Review

No

9

Target(s)

cGMP-specific 3',5'-cyclic phosphodiesterase (PDE5A)

10

Indication(s)  

For treating erection dysfunction (ED) and benign prostatic hyperplasia (BPH).

9. Levornidazole Dispersible Tablets

1

Generic Name

Levornidazole Dispersible Tablets

2

Brand Name

/

3

Registration Classification

Class 2.2 chemical drug

4

Application Type

NDA

5

MAH

Hunan Mingrui Pharmaceutical Co., Ltd.  

6

Approval Date

NDA

7

Time from Application Acceptance to Approval

248 days

8

Priority Review

No

9

Target(s)

deoxyribonucleic acid (DNA)

10

Indication(s)  

For treating oral infections (periodontitis, periapical inflammation, and pericoronitis), trichomonas vaginitis, and other infections caused by trichomonas in the genitourinary tract or sensitive anaerobic bacteria (Bacteroides fragilis, Bacteroides disiens, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus, Clostridia, Eubacterium, Peptococcus & Peptostreptococcus, Helicobacter pylori, Bacteroides melaninogenicus, Fusobacterium, Capnocytophaga, Porphyromonas gingivalis, etc.)

10. Ondansetron Oral Soluble Pellicles

1

Generic Name

Ondansetron Oral Soluble Pellicles

2

Brand Name

/

3

Registration Classification

Class 3 chemical drug

4

Application Type

Abbreviated new drug application (ANDA)

5

MAH

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

6

Approval Date

Feb. 9, 2022

7

Time from Application Acceptance to Approval

1,427 days

8

Priority Review

Yes (meeting the consistency evaluation criteria)

9

Target(s)

5-Hydroxytryptamine 3 receptor (5-HT3)

10

Indication(s)  

For preventing nausea and vomiting caused by highly and moderately emetogenic chemotherapy, radiotherapy, and surgery.

11

Notes

First generic in China

11. Amlodipine Besilate and Losartan Potassium Tablets (II)

1

Generic Name

Amlodipine Besilate and Losartan Potassium Tablets (II)

2

Brand Name

/

3

Registration Classification

Class 3 chemical drug

4

Application Type

ANDA

5

MAH

Beijing Hanmi Pharmaceutical Co., Ltd.

6

Approval Date

Feb. 9, 2022

7

Time from Application Acceptance to Approval

880 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)  

For treating primary hypertension patients whose blood pressure can't be controlled by a single agent.

11

Notes

First generic in China

12. Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution

1

Generic Name

Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution

2

Brand Name

/

3

Registration Classification

Class 3 chemical drug

4

Application Type

ANDA

5

MAH

Jumpcan Pharmaceutical Co., Ltd.

6

Approval Date

Feb. 9, 2022

7

Time from Application Acceptance to Approval

581 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)  

For cleansing the colon of adults before colonoscopy or other operations entailing colon-cleansing.

11

Notes

First generic in China

13. Rituximab Injection

1

Generic Name

Rituximab Injection

2

Brand  Name

汉利康 (Han Li Kang)

3

Registration Classification

Class 2.2 therapeutic biological   product

4

Application Type

Biologics License Application (BLA)

5

MAH

Shanghai Henlius Biotech, Inc.

6

Approval Date

Feb. 28, 2022

7

Time from Application Acceptance to Approval

426 days

8

Priority Review

No

9

Target(s)

B-lymphocyte ligand

10

Indication(s)  

Approved on Feb. 28, 2022:

  • The drug is indicated in combination with methotrexate for treating adult patients with moderate-to-severe rheumatoid arthritis (RA) for which one or more than one TNF-αinhibitors are ineffective.

Approved previously:

  • For treating relapsed/drug-resistant follicular center lymphoma (type B, C, and D of B-cell Non-Hodgkin lymphoma).

  • For patients with CD20-positive follicular Non-Hodgkin lymphoma (NHL) of III-IV phase and without prior treatments, the drug should be used with chemotherapy.

  • For patients with CD20-positive diffuse large B cell lymphoma (DLBCL), the drug should be used for eight courses of combination therapy with the CHOP chemotherapy which includes cyclophosphamide, doxorubicin hydrochloride (hydroxydaunorubicin), vincristine sulfate (Oncovin), and prednisone.

  • Indicated in single-agent maintenance therapy for patients with follicular lymphoma (FL) who have achieved full or partial recovery after the first-line treatment of combination therapy with MabThera (Rituximab).

  • In combination with fludarabine and cyclophosphamide, the drug is indicated for patients with untreated, relapsed or refractory chronic lymphocytic leukemia (CLL).

14. Belimumab Powder for Concentrate for Solution for Infusion

1

Generic Name

Belimumab Powder for Concentrate for Solution for Infusion

2

Brand Name

BENLYSTA (倍力腾)

3

Registration Classification

Class 2.2 therapeutic biological product

4

Application Type

BLA

5

MAH

GlaxoSmithKline (Ireland) Limited

6

Approval Date

Feb. 9, 2022

7

Time from Application Acceptance to Approval

357 days

8

Priority Review

No

9

Target(s)

B-lymphocyte ligand

10

Indication(s)  

In combination with routine treatment, the drug is indicated for adult patients with active systemic lupus nephritis (SLE) and positive self-antibodies who have high disease activities (e.g., having positive anti-dsDNA antibodies, being hypocomplementemic, with the SELENA-SLEDAI score≥8) while receiving the routine treatment.

15. Dupilumab Injection

1

Generic Name

Dupilumab Injection

2

Brand Name

Dupixent (达必妥)

3

Registration Classification

Class 3.1 therapeutic biological product

4

Application Type

BLA

5

MAH

Sanofi-Aventis Groupe

6

Approval Date

Feb. 24, 2022

7

Time from Application Acceptance to Approval

284 days

8

Priority Review

Yes (other situations that meet the conditions for priority review)

9

Target(s)

Interleukin-13 receptor; interleukin 4 receptor (IL4R)

10

Indication(s)  

The drug is indicated for treating pediatric (≥6 and<12 years old) and adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The drug can be used with or without topical corticosteroids.

16. Influenza Vaccine (Split Virion), Inactivated, Quadrivalent

1

Generic Name

Influenza Vaccine (Split Virion), Inactivated, Quadrivalent

2

Brand Name

/

3

Registration Classification

Class 3.2 therapeutic biological product

4

Application Type

BLA

5

MAH

Hualan Biological Vaccine Co., Ltd.

6

Approval Date

Feb. 9, 2022

7

Time from Application Acceptance to Approval

258 days

8

Priority Review

Yes (vaccine urgently needed for  disease prevention and control)

9

Target(s)

/

10

Indication(s)  

Approved on Feb. 9, 2022:

  • For providing immunization against four influenza virus strains to prevent influenza in pediatric patients at the age of six months to three years.

Approved previously:

  • For providing immunization against four influenza virus strains to prevent influenza in patients who are three years old or older. The vaccine is especially recommended to people susceptible to complications, such as children, the elderly, the infirm, and those in influenza-active areas.

RELATED:


Grace Wang
ChemLinked Regulatory Analyst
+ FOLLOW
Copyright: unless otherwise stated all contents of this website are ©2022 - REACH24H Consulting Group - All Rights Reserved - For permission to use any content on this site, please contact cleditor@chemlinked.com