Monthly Report: New Drug Approvals in China | July 2022

by Grace Wang Aug 05, 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 a Chinese company and approved by China National Medical Products Administration (NMPA) with marketing authorization.

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In July 2022, China NMPA approved 10 new drugs, including 8 chemical drugs and 2 biological products. Among the drugs, Genuine Biotech's Azvudine Tablets is the first homegrown oral drug to get NMPA's approval for COVID-19 treatment.

  1. Genuine Biotech's Azvudine Tablets

  2. Haisco Pharmaceutical's Ciprofol Injection

  3. Yichang Humanwell Pharmaceutical's Remimazolam Besylate for Injection

  4. Xiamen LP Pharmaceutical's Clonidine Hydrochloride Sustained-release Tablets

  5. Anbison Lab's Carbamazepine Sustained-release Tablets (II)

  6. G1 Therapeutics' Trilaciclib for Injection

  7. Roche's Entrectinib Capsules

  8. Toray Industries' Beraprost Sodium Sustained-Release Tablets

  9. Lepu Biopharma's Pucotenlimab Injection

  10. Eli Lilly's Ixekizumab Injection

1. Azvudine Tablets

1

Generic Name

Azvudine Tablets

2

Brand Name

/

3

Registration Classification

Class 2.4 chemical drug

4

Application Type

New drug application (NDA)

5

Marketing 

Authorization Holder (MAH)

Genuine Biotech Co., Ltd.

6

Approval Date

July 25, 2022

7

Time from Application Acceptance to Approval

/

8

Special Approval

Yes

9

Target(s)

Nucleoside reverse transcriptase;

Viral infectivity factor (Vif)

10

Indication(s)

Previously approved:

1.  Indicated to be used with nucleoside reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs) for the treatment of HIV-1-infected adult patients with high viral loads.

Newly approved on July 25, 2022:

2.  Indicated for treating adult patients with COVID-19 pneumonia.

2. Ciprofol Injection

1

Generic Name

Ciprofol Injection

2

Brand Name

Si Shu Ning (思舒宁)

3

Registration Classification

Class 2.4 chemical drug

4

Application Type

NDA

5

MAH

Haisco Pharmaceutical Group

6

Approval Date

July 13, 2022

7

Time from Application Acceptance to Approval

230 days

8

Priority Review

No

9

Target(s)

GABAA receptor

10

Indication(s)

Previously approved:

1.  Indicated for sedation and anesthesia in non-tracheal-incubation   surgeries/operations.

2.  Indicated for the induction and maintenance of general anesthesia.

Newly approved on July 13, 2022:

3.  Indicated for sedation for patients in intensive care units (ICUs).

3. Remimazolam Besylate for Injection

1

Generic Name

Remimazolam Besylate for Injection

2

Brand Name

Rui Ma (锐马)

3

Registration   Classification

Class 2.4 chemical drug

4

Application Type

NDA

5

MAH

Yichang Humanwell Pharmaceutical Co., Ltd.

6

Approval Date

July 22, 2022

7

Time from Application Acceptance to Approval

244 days

8

Priority Review

No

9

Target(s)

GABAA receptor

10

Indication(s)

Indicated for sedation in colonoscopy and bronchoscopy for invasive procedures.

4. Clonidine Hydrochloride Sustained-release Tablets

1

Generic Name

Clonidine Hydrochloride Sustained-release Tablets

2

Brand Name

/

3

Registration   Classification

Class 3 chemical drug

4

Application Type

Abbreviated new drug application (ANDA)

5

MAH

Xiamen LP Pharmaceutical Co., Ltd.

6

Approval Date

July 4, 2022

7

Time from Application Acceptance to Approval

433 days

8

Priority Review

Yes (pediatric drug)

9

Target(s)

Alpha 2 adrenoceptor

10

Indication(s)

The drug is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as a monotherapy or an adjunctive therapy to stimulant medications.  

11

Notes

First generic in China

5. Carbamazepine Sustained-release Tablets (II)

1

Generic Name

Carbamazepine Sustained-release Tablets (II)

2

Brand Name

/

3

Registration Classification

Class 3 chemical drug

4

Application Type

ANDA

5

MAH

Anbison Lab

6

Approval Date

July 22, 2022

7

Time from Application Acceptance to Approval

908 days

8

Priority Review

No

9

Target(s)

Sodium channel

10

Indication(s)

1.  The drug is indicated for treating epilepsy. It is highly effective for complex partial seizures and secondary seizures, and also effective for primary generalized seizures, simple partial seizures, and mixed seizures.

2.  The drug is indicated for relieving trigeminal neuralgia and glossopharyngeal neuralgia, and preventing/treating bipolar manic depression and central partial diabetes insipidus.

11

Notes

First generic in China

6. Trilaciclib for Injection

1

Generic Name

Trilaciclib for Injection

2

Brand Name

Cosela

3

Registration Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

G1 Therapeutics, Inc.

6

Approval Date

July 13, 2022

7

Time from Application Acceptance to Approval

223 days

8

Priority Review

Yes (conditional approval)

9

Target(s)

Cyclin-dependent kinase 4 (CDK4)

Cyclin-dependent kinase 6 (CDK6)

10

Indication(s)

The drug is indicated to decrease the incidence of chemotherapy-induced myelosuppression in patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC).

7. Entrectinib Capsules

1

Generic Name

Entrectinib Capsules

2

Brand Name

ROZLYTREK

3

Registration Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

Roche (China) Investment Co., Ltd.

6

Approval Date

July 29, 2022

7

Time from Application Acceptance to Approval

270 days

8

Priority Review

Yes  (conditional approval)

9

Target(s)

ALK tyrosine kinase receptor

Ros1 tyrosine kinase receptor

Neurotrophic receptor tyrosine kinase 1 (NTRK1)

BDNF/NT-3 growth factors receptor (TrkB)

NT-3 growth factor receptor (NTRK3)

10

Indication(s)

The drug is indicated for treating NTRK gene fusion-positive solid tumors that is locally advanced or metastatic.  

8. Beraprost Sodium Sustained-Release Tablets

1

Generic Name

Beraprost Sodium Sustained-Release Tablets

2

Brand Name

Dorner

3

Registration Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

Toray Industries, Inc.

6

Approval Date

July 29, 2022

7

Time from Application Acceptance to Approval

816 days

8

Priority Review

No

9

Target(s)

Prostacyclin receptor (PTGIR)

10

Indication(s)

Indicated for improving symptoms including ulcers, intermittent claudication, pain, and feeling of coldness.

9. Pucotenlimab Injection

1

Generic Name

Pucotenlimab Injection

2

Brand Name

Pu You Heng (普佑恒)

3

Registration   Classification

Class 1 therapeutic biological product

4

Application Type

Biologics License Application (BLA)

5

MAH

Lepu Biopharma Co., Ltd.

6

Approval Date

July 22, 2022

7

Time from Application Acceptance to Approval

266 days

8

Priority Review

Yes (conditional approval)

9

Target(s)

Programmed cell death protein 1 (PD-1)

10

Indication(s)

Indicated for treating advanced solid tumors that are microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) in patients who have failed at least the first-line systemic treatment.

10. Ixekizumab Injection

1

Generic Name

Ixekizumab Injection

2

Brand Name

TALTZ (拓咨)

3

Registration   Classification

Class 3.1 therapeutic biological product

4

Application Type

BLA, import

5

MAH

Eli Lilly and Company

6

Approval Date

July 29, 2022

7

Time from Application Acceptance to Approval

306 days

8

Priority Review

No

9

Target(s)

Interleukin-17A (IL17A)

10

Indication(s)

Indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

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Grace Wang
ChemLinked Regulatory Analyst
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