Monthly Report: New Drug Approvals in China | Dec 2021

by Grace Wang Jan 07, 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 Dec 2021, China's NMPA approved 11 new drugs, including 7 chemical drugs and 4 biological products.

1. Omadacycline Tablets

1

Generic Name

Omadacycline Tablets

2

Brand Name

NUZYRA®

3

Registration Classification

Class 1 chemical drug

4

Application Type

New drug application (NDA)

5

MAH

Zai Lab Limited

6

Approval Date

Dec. 16, 2021

7

Time from Application Acceptance to Approval

661 days

8

Priority Review

Yes (innovative drug)

9

Target(s)

/

10

Indication(s)

1. Community-acquired bacterial pneumonia (CABP);

2. Acute bacterial skin/skin structure infections (ABSSSIs).

2. Omadacycline for Injection

1

Generic Name

Omadacycline for Injection

2

Brand Name

NUZYRA®

3

Registration Classification

Class 1 chemical drug

4

Application Type

NDA

5

MAH

Zai Lab Limited

6

Approval Date

Dec. 16, 2021

7

Time from Application Acceptance to Approval

661 days

8

Priority Review

Yes (innovative drug)

9

Target(s)

/

10

Indication(s)

1. Community-acquired bacterial pneumonia (CABP);

2. Acute bacterial skin/skin structure infections (ABSSSIs).

3. Almonertinib Mesilate Tablets

1

Generic Name

Almonertinib Mesilate Tablets

2

Brand Name

Ameile® (阿美乐)

3

Registration Classification

Class 2.4 chemical drug

4

Application Type

NDA

5

MAH

Jiangsu Hansoh Pharmaceutical Group Co., Ltd.

6

Approval Date

Dec. 16, 2021

7

Time from Application Acceptance to Approval

208 days

8

Priority Review

Yes (Breakthrough Therapy Designation)

9

Target(s)

Receptor tyrosine kinases (RTKs)

10

Indication(s)

1. Indicated for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are EGFR 790 mutation-positive and have disease progression during or after a prior epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) therapy. This indication was approved on March 18, 2020.

2. Indicated for the first-line treatment for locally advanced or metastatic NSCLC adult patients with EGFR exon 19 deficiency or exon 21 L858R mutation. This indication was approved this time.

4. Ciprofol Injection

1

Generic Name

Ciprofol Injection

2

Brand Name

/

3

Registration Classification

Class 2.4 chemical drug

4

Application Type

NDA

5

MAH

Liaoning Haisco Pharmaceutical Co., Ltd.

6

Approval Date

Dec. 10, 2021

7

Time from Application Acceptance to Approval

305 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)

1. Sedation in gastrointestinal endoscopy. This indication was approved on Aug. 12, 2021.

2. Sedation in bronchoscopy. This indication was approved this time.

5. Selinexor Tablets

1

Generic Name

Selinexor Tablets

2

Brand Name

XPOVIO®

3

Registration Classification

Class 5.1 chemical drug

4

Application Type

NDA

5

MAH

Antengene Corporation Limited

6

Approval Date

Dec. 16, 2021

7

Time from Application Acceptance to Approval

316 days

8

Priority Review

Yes (conditional approval)

9

Target(s)

Exportin-1 (XPO1)

10

Indication(s)

In combination with dexamethasone for the treatment of relapsing or refractory multiple myeloma patients who have received prior therapy and whose disease is refractory to at least one proteasome inhibitors, at least one immunomodulatory agents, and at least one anti‐CD38 monoclonal antibody.

6. Dronedarone Hydrochloride Tablets

1

Generic Name

Dronedarone Hydrochloride Tablets

2

Brand Name

MULTAQ®

3

Registration   Classification

Class 5.1 chemical drug

4

Application Type

Import

5

MAH

Sanofi (China) Investment Co., Ltd.

6

Approval Date

Dec. 22, 2021

7

Time from   Application Acceptance to Approval

316 days

8

Priority Review

No

9

Target(s)

Sodium channel; adrenergic receptor; calcium channel; potassium channel.

10

Indication(s)

Dronedaroneis an anti-arrhythmia drug indicated to reduce the risk of hospitalization for patients with atrial fibrillation (AF) or atrial flutter (AFL).

It is also indicated for patients with recent paroxysmal AF/AFL and cardiovascular risk factors, and patients can restore a normal sinus rhythm or heart rhythm.

7. Isavuconazonium Sulfate Capsules

1

Generic Name

Isavuconazonium Sulfate Capsules

2

Brand Name

Cresemba® (康新博)

3

Registration Classification

Class 5.1 chemical drug

4

Application Type

Import

5

MAH

Basilea Pharmaceutica Deutschland GmbH

6

Approval Date

Dec. 16, 2021

7

Time from Application Acceptance to Approval

517 days

8

Priority Review

No

9

Target(s)

Lanosterol 14-alpha demethylase (CYP51A1)

10

Indication(s)

Cresemba is a new antifungal drug indicated for adult patients for the treatment of invasive mucormycosis.

8. Sugemalimab Injection

1

Generic Name

Sugemalimab Injection

2

Brand Name

Cejemly (择捷美)

3

Registration Classification

Class 1 therapeutic biological product

4

Application Type

Biologics License Application (BLA)

5

MAH

CStone Pharmaceuticals

6

Approval Date

Dec. 22, 2021

7

Time from Application Acceptance to Approval

392 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)

  1. In combination with Pemetrexed and Carboplatin, the drug is indicated for the first-line treatment of non-small cell lung cancer (NSCLC) that is EGFR mutation-negative, ALK-negative, metastatic, and non-squamous.

  2. In combination with Paclitaxel and Carboplatin, the drug is indicated for the first-line treatment of metastatic squamous NSCLC.

9. Camrelizumab for Injection

1

Generic Name

Camrelizumab for Injection

2

Brand Name

AiRuiKa™ (艾瑞卡)

3

Registration Classification

Class 2.2 therapeutic biological product

4

Application Type

BLA

5

MAH

Suzhou Shengdiya Bipharmaceutical Co., Ltd.

6

Approval Date

Dec. 10, 2021

7

Time from Application Acceptance to Approval

392

8

Priority Review

No

9

Target(s)

Programmed cell death protein 1 (PD-1)

10

Indication(s)

  1. Camrelizumab is indicated for the treatment of relapsing or refractory classic Hodgkin lymphoma (HL) in patients who have received at least second-line chemotherapy. This indication is granted conditional approval based on the objective response rate (ORR) and response duration in a single-arm clinical trial. The full approval will depend on the ongoing randomized controlled trial to prove that the Camrelizumab has more clinical benefit than the standard therapy.

  2. In combination with Paclitaxel and Carboplatin, Camrelizumab is indicated for the first-line treatment of unresectable esophageal squamous cell carcinoma that is locally advanced, relapsing or metastatic.

10. Ofatumumab Injection

1

Generic Name

Ofatumumab Injection 

2

Brand Name

Kesimpta®

3

Registration Classification

Class 3.1 therapeutic biological product

4

Application Type

Import

5

MAH

Novartis

6

Approval Date

Dec. 22, 2021

7

Time from Application Acceptance to Approval

405

8

Priority Review

Yes (other qualified conditions)

9

Target(s)

/

10

Indication(s)

Indicated for treating adult patients with relapsing multiple sclerosis (RMS), including clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and secondary progressive multiple sclerosis (SPMS).

11. Siltuximab for Injection

1

Generic Name

Siltuximab for Injection

2

Brand Name

Sylvant (萨温珂)

3

Registration Classification

Class 3.1 therapeutic biological product

4

Application Type

Import

5

MAH

EUSA Pharma (Netherlands) B.V.

6

Approval Date

Dec. 2, 2021

7

Time from Application Acceptance to Approval

303 days

8

Priority Review

Yes (other qualified conditions)

9

Target(s)

Interleukin-6 receptor subunit alpha (IL6R);

heat shock protein.

10

Indication(s)

Indicated for the treatment of multicentric Castleman's disease (MCD) in adult patients who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.

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Grace Wang
ChemLinked Regulatory Analyst
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