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

by Grace Wang Sep 14, 2021

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 a Chinese company and approved by China National Medical Products Administration (NMPA) with marketing authorization.


In Aug. 2021, China NMPA granted 11 new drug approvals:

1.  Tislelizumab Injection

1

Generic Name

Tislelizumab Injection

2

Brand Name

Bai Ze An (百泽安)

3

Registration Classification

Class 2.2 therapeutic biological product

4

Marketing   Authorization Holder (MAH)

Boehringer Ingelheim Biopharmaceuticals China Ltd. and Guangzhou BeiGene Biopharmaceuticals Co., Ltd.

5

Approval Date

Aug. 12, 2021

6

Time from Application Acceptance to Approval

74 days

7

Priority Review

No

8

Conditional Approval

Yes (supplemental application for new indication)

9

Target

PD-1

10

Indication(s)  

Treating patients with relapsed/refractory classical Hodgkin's lymphoma (cHL) who have received at least two prior systemic chemotherapies.

2. Apremilast Tablet

1

Generic Name

Apremilast Tablet

2

Brand Name

OTEZLA (欧泰乐)

3

Registration Classification

Class 5.1 chemical drug

4

MAH

Amgen Inc.

5

Approval Date

Aug. 16, 2021

6

Time from Application Acceptance to Approval

196 days

7

Priority Review

Yes (other qualified situations)

8

Target

PDE4

9

Indication(s)  

Psoriasis.

3. Nivolumab Injection

1

Generic Name

Nivolumab Injection

2

Brand Name

OPDIVO (欧狄沃)

3

Registration Classification

Class 2.2 therapeutic biological product

4

MAH

Bristol-Myers Squibb Pharma EEIG

5

Approval Date

Aug. 30, 2021

6

Time from Application Acceptance to Approval

239 days

7

Priority Review

No

8

Target

PD-1

9

Indication(s)  

Ÿ   Non-Small Cell Lung Cancer

OPDIVO as a monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with progression after platinum-based chemotherapy or with intolerance to another chemotherapy, and with no EGFR or ALK genomic tumor aberrations.

Ÿ   Squamous Cell Carcinoma of the Head and Neck

OPDIVO as a monotherapy is indicated for the treatment of PD-L1 positive (1% tumor cells with positive PD-L1 expression) patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

4. Triptorelin Pamoate for Injection

1

Generic Name

Triptorelin Pamoate for Injection

2

Brand Name

/

3

Registration Classification

Class 5.1 chemical drug

4

MAH

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

5

Approval Date

Aug. 5, 2021

6

Time from Application Acceptance to Approval

366 days

7

Priority Review

No

8

Target

GNRHR

9

Indication(s)  

Locally advanced or metastatic prostate cancer.

5. Penpulimab Injection

1

Generic Name

Penpulimab Injection

2

Brand Name

An Ni Ke (安尼可)

3

Registration   Classification

Class 1 therapeutic biologic product

4

MAH

CTTQ Akeso (Shanghai) Biomedical Technology Co., Ltd.

5

Approval Date

Aug. 5, 2021

6

Time from Application Acceptance to Approval

441 days

7

Priority Review

No

8

Target

PD-1

9

Indication(s)  

/

6. Teneligliptin Hydrobromide Tablets

1

Generic Name

Teneligliptin Hydrobromide Tablets

2

Brand Name

TENELIA (泰里安)

3

Registration   Classification

Class 5.1 chemical drug

4

MAH

Mitsubishi Tanabe Pharma Corporation

5

Approval Date

Aug. 5, 2021

6

Time from Application Acceptance to Approval

680 days

7

Priority Review

No

8

Target

DPP4

9

Indication(s)  

Type-2 diabetes.

7. Ozagrel Trometamol Concentrated Solution for Injection

1

Generic Name

Ozagrel Trometamol Concentrated Solution for Injection

2

Brand Name

/

3

Registration Classification

Class 2.1 chemical drug

4

MAH

Wuhan Hengxinyuan Pharmaceutical Co., Ltd.

5

Approval Date

Aug. 16, 2021

6

Time from Application Acceptance to Approval

1,156 days

7

Priority Review

No

8

Target

TBXAS1

9

Indication(s)  

/

8. Recombinant Coagulation Factor VIII for Injection

1

Generic Name

Recombinant Coagulation Factor VIII for Injection

2

Brand Name

GreenGene F (绿茵芷)

3

Registration Classification

Class 3.1 therapeutic biological product

4

MAH

Green Cross Corporation

5

Approval Date

Aug. 11, 2021

6

Time from Application Acceptance to Approval

728 days

7

Priority Review & Approval

Yes (rare disease)

8

Target

Coagulation Factor X

9

Indication(s)  

Ÿ   GreenGene F is a recombinant antihemophilic factor for the on-demand treatment and control of bleeding episodes for adults and children (aged 0-16) with Hemophilia A.

Ÿ   Perioperative management of bleeding of adults and children (aged 0-16) with Hemophilia A.

Ÿ   Routine prophylaxis to reduce the frequency of bleeding episodes and joint injuries in children (this indication is based on results of clinical trials outside of China without collecting data to from Chinese kids).

Ÿ   NOT indicated for Von Willebrand disease (VWD).

9. Dinutuximab beta Injection

1

Generic Name

Dinutuximab beta Injection

2

Brand Name

Qarziba (凯泽百)

3

Registration Classification

Class 3.1 therapeutic biological product

4

MAH

EUSA Pharma (Netherlands) B.V.

5

Approval Date

Aug. 17, 2021

6

Time from Application Acceptance to Approval

39 days

7

Priority Review & Approval

Yes (other qualified situations)

8

Target

GD2

9

Indication(s)  

Ÿ   Indicated for treating patients (≥12 months) with high-risk neuroblastoma, and the patients' condition should meet the following descriptions: the patients had received prior neoadjuvant chemotherapy and experienced at least partial remission; after that, they received myeloid   therapy and stem cell transplantation (SCT) therapy.

Ÿ   Indicted for patients (≥12 months) with relapsed or refractory neuroblastoma with or without residual foci.

Ÿ   Proper measures should be taken to stabilize the activity or progression of neuroblastoma before the treatment of relapsed neuroblastoma.

Ÿ   Dinutuximab beta Injection should be used with Interleukin-2 (IL-2) on patients who have not reached full   recovery after the first-line therapy for relapsed/refractory diseases.

10. Zimberelimab Injection

1

Generic Name

Zimberelimab Injection

2

Brand Name

誉妥 (Pinyin: Yu Tuo)

3

Registration   Classification

Class 1 therapeutic biological product

4

MAH

Guangzhou Gloria Biosciences Co., Ltd.

5

Approval Date

Aug. 30, 2021

6

Time from Application Acceptance to Approval

542 days

7

Priority Review

No

8

Target

Programmed cell death protein 1 (PD-1)

9

Indication(s)  

For the treatment of adult patients with relapsed or   refractory classic Hodgkin lymphoma (cHL) after at least two prior systemic chemotherapies

11. Sildenafil Citrate Tablets

1

Generic Name

Sildenafil Citrate Tablets

2

Brand Name

/

3

Registration   Classification

Class 5.2 chemical drug

4

MAH

Aurobindo Pharma Limited

5

Approval Date

Aug. 30, 2021

6

Time from Application Acceptance to Approval

966 days

7

Priority Review

No

8

Target

Phosphodiesterase 5A (PDE5A)

9

Indication(s)  

Sildenafil Citrate Tablets are a phosphodiesterase type 5 inhibitor (PDE5 inhibitor) or the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening.

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.

Know more about drug classifications by reading the articles below:


Grace Wang
ChemLinked Regulatory Analyst & Editor
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