Monthly Report: New Drug Approvals in China | March 2022

by Grace Wang Apr 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 March 2022, China NMPA approved 23 new drugs, including 15 chemical drugs and 8 biological products.

1. Ensartinib Hydrochloride Capsules

1

Generic Name

Ensartinib Hydrochloride Capsules

2

Brand Name

Bei Mei Na (贝美纳)

3

Registration Classification

Class 2.4 chemical drug

4

Application Type

New drug application (NDA)

5

Marketing Authorization Holder (MAH)

Betta Pharmaceuticals Co., Ltd.

6

Approval Date

March 18, 2022

7

Time from  Application Acceptance to Approval

246 days

8

Priority Review

Yes (reason: meeting other conditions for priority review)

9

Target(s)

ALK;  Ros1 tyrosine kinase receptor.

10

Indication(s)

Approved on March 18, 2022:

Indicated for the first-line treatment of patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) that is locally advanced or metastatic.

Approved on November 19, 2020:

Indicated for the treatment of patients with ALK-positive NSCLC that is locally advanced or metastatic with progression after prior crizotinib therapy or resistance to the crizotinib.

2. 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

March 11, 2022

7

Time from Application Acceptance to Approval

250 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)

Approved on March 11, 2022:

Indicated for the induction and maintenance of general anesthesia.

Approved on July 20, 2020:

Indicated for sedation during colonoscopy.

3. Rivaroxaban Tablets

1

Generic Name

Rivaroxaban Tablets

2

Brand Name

Xarelto

3

Registration Classification

Class 2.4 chemical drug

4

Application Type

NDA

5

MAH

Bayer AG

6

Approval Date

March 11, 2022

7

Time from Application Acceptance to Approval

558 days

8

Priority Review

No

9

Target(s)

Coagulation Factor X (F10)

10

Indication(s)

Approved on March 11, 2022:

  • Indicated for treating and preventing the relapse of venous thromboembolism (VTE) at least five days after the first-line treatment for non-oral anticoagulant(s) in children and adolescents no more than 18 years old and weighing more than 30kg.

Approved previously:

  • Indicated for preventing VTE in adult patients after elective hip/knee arthroplasty.

  • Indicated for treating DVT and pulmonary embolism (PE) in adult patients.

  • Indicated for reducing the relapse risk of DVT and/or PE in adult patients who face the risk continuously at least six months after the first-line treatment.

  • Indicated for reducing the risks of apoplexy and systemic embolism in adult patients with non-valvular atrial fibrillation who have one or multiple risk factors (e.g., congestive heart failure, hypertension, age ≥75, diabetes, and the history of apoplexy or transient ischemic attack). *Rivaroxaban has limited data to prove the efficacy of lowering the risk of apoplexy and systemic embolism in comparison with warfarin when the patient's condition is well controlled under the warfarin therapy.

4. Duvelisib Capsules

1

Generic Name

Duvelisib Capsules

2

Brand Name

Copiktra

3

Registration Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

CSPC Pharmaceutical Group Co., Ltd.

6

Approval Date

March 18, 2022

7

Time from Application   Acceptance to Approval

329 days

8

Priority Review

Yes (reason: qualified for conditional approval)

9

Target(s)

/

10

Indication(s)

Indicated for treating patients with relapsed or refractory follicular lymphoma (FL) after at least two systemic treatments.

5. Pralsetinib Capsules

1

Generic Name

Pralsetinib Capsules

2

Brand Name

GAVRETO (普吉华)

3

Registration Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

Blueprint Medicines Corporation

6

Approval Date

March 11, 2022

7

Time from Application Acceptance to Approval

329 days

8

Priority Review

Yes (reason: breakthrough therapy)

9

Target(s)

Proto-oncogene tyrosine-protein kinase receptor Ret (RET)

10

Indication(s)

  • Indicated for the treatment of adult and pediatric patients ≥12 years old with advanced or metastatic medullary thyroid cancer who require systemic therapy and are difficult to be cured by radioactive iodine (if the radioactive iodine therapy is applicable).

  • Indicated for the treatment for adult patients with metastatic RET fusion-positive NSCLC after prior platinum-based chemotherapy.

6. Brigatinib Tablets

1

Generic Name

Brigatinib Tablets

2

Brand Name

Alunbrig (安伯瑞)

3

Registration Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

Takeda Pharmaceutical Co., Ltd.

6

Approval Date

March 24, 2022

7

Time from Application Acceptance to Approval

425 days

8

Priority Review

No

9

Target(s)

ALK tyrosine kinase receptor (ALK);

Epidermal growth factor receptor (EGFR);

Proto-oncogene tyrosine-protein kinase ROS (ROS1);

Ros1 tyrosine kinase receptor.

10

Indication(s)

Indicated as a single agent for the treatment of patients with ALK-positive NSCLC that is locally advanced or metastatic.

7. Trametinib Tablets

1

Generic Name

Trametinib Tablets

2

Brand Name

Mekinist (迈吉宁)

3

Registration Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

Novartis Europharm Limited

6

Approval Date

March 24, 2022

7

Time from Application Acceptance to Approval

197 days

8

Priority Review

Yes (reason: qualified for conditional approval)

9

Target(s)

Dual specificity mitogen-activated protein kinase kinase 1 (MAP2K1);

Dual specificity mitogen-activated protein kinase kinase 2 (MAP2K2).

10

Indication(s)

Approved on March 24, 2022:

  • Indicated in combination with dabrafenib mesylate for the treatment for patients with metastatic BRAF V600 mutation-positive NSCLC.

Approved previously:

  • Indicated in combination with dabrafenib mesylate for the treatment of BRAF V600 mutation-positive melanoma that is unresectable or metastatic.

  • Indicated in combination with dabrafenib mesylate for the adjuvant treatment of patients with BRAF V600 mutation-positive melanoma following complete resection.

8. Dabrafenib Mesylate Capsules

1

Generic Name

Dabrafenib Mesylate Capsules

2

Brand Name

Tafinlar (泰菲乐)

3

Registration Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

Novartis Europharm Limited

6

Approval Date

March 24, 2022

7

Time from Application Acceptance to Approval

197 days

8

Priority Review

No

9

Target(s)

Serine/threonine-protein kinase B-raf (BRAF)

10

Indication(s)

Approved on March 24, 2022:

Indicated in combination with trametinib for the treatment of patients with metastatic NSCLC with BRAF V600 mutation.

Approved previously:

  • Indicated in combination with trametinib for the treatment of BRAF V600 mutation-positive melanoma that is unresectable or metastatic.

  • Indicated in combination with trametinib for the adjuvant treatment of patients with BRAF V600 mutation-positive melanoma following complete resection.

9. Upadacitinib Sustained-release Tablets

1

Generic Name

Upadacitinib Sustained-release Tablets

2

Brand Name

RINVOQ (瑞福)

3

Registration Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

AbbVie Deutschland GmbH & Co. KG

6

Approval Date

March 24, 2022

7

Time from Application Acceptance to Approval

445 days

8

Priority Review

No

9

Target(s)

Tyrosine-protein kinase JAK1

10

Indication(s)

Indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers.

10. Nitric Oxide for Inhalation

1

Generic Name

Nitric Oxide for Inhalation

2

Brand Name

INOmax

3

Registration Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

INO Therapeutics LLC

6

Approval Date

March 11, 2022

7

Time from Application Acceptance to Approval

787 days

8

Priority Review

Yes (reason: for rare disease)

9

Target(s)

/

10

Indication(s)

As a vasodilator, the drug is indicated for improving the oxygenation and reducing the need for extracorporeal membrane oxygenation of neonates (>34 weeks' gestation) with hypoxic respiratory failure associated with clinical or   echocardiographic evidence of pulmonary hypertension in conjunction with ventilation and other appropriate agents.

11. Articaine Hydrochloride and Epinephrine Tartrate Injection

1

Generic Name

Articaine Hydrochloride and Epinephrine Tartrate Injection

2

Brand Name

Primacaine Adrenaline (必兰)

3

Registration Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

Produits Dentaires Pierre Rolland

6

Approval Date

March 24, 2022

7

Time from Application Acceptance to Approval

544 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)

Indicated for local dental anesthesia, especially in surgery involving osteotomy and mucosal incision.

12. Hemofiltration Replacement Fluid of Sodium Bicarbonate and Phosphate

1

Generic Name

Hemofiltration Replacement Fluid of Sodium Bicarbonate and Phosphate

2

Brand Name

/

3

Registration Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

Gambro Lundia AB

6

Approval Date

March 11, 2022

7

Time from Application Acceptance to Approval

858 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)

Indicated as a replacement fluid for the treatment of acute kidney failure during continuous renal replacement therapy (CRRT).

13. Cyproheptadine Hydrochloride Oral Solution

1

Generic Name

Cyproheptadine Hydrochloride Oral Solution

2

Brand Name

/

3

Registration Classification

Class 3 chemical drug

4

Application Type

Abbreviated new drug application (ANDA)

5

MAH

Chengji Pharma Co., Ltd.

6

Approval Date

March 24, 2022

7

Time from Application Acceptance to Approval

623 days

8

Priority Review

No

9

Target(s)

Histamine receptor

10

Indication(s)

Indicated for the treatment of

  • Perennial and seasonal allergic rhinitis;

  • Vasomotor rhinitis;

  • Allergic conjunctivitis due to inhalant allergens and foods;

  • Mild, uncomplicated allergic skin manifestations of urticaria and angioedema;

  • Amelioration of allergic reactions to blood or plasma

  • Cold urticarial;

  • Dermatographism;

  • As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.

11

Notes

First generic drug in China

14. Miglitol Orally-disintegrating Tablets

1

Generic Name

Miglitol Orally-disintegrating Tablets

2

Brand Name

/

3

Registration Classification

Class 3 chemical drug

4

Application Type

ANDA

5

MAH

Zhejiang Medicine Co., Ltd.

6

Approval Date

March 11, 2022

7

Time from Application Acceptance to Approval

626 days

8

Priority Review

No

9

Target(s)

Lysosomal alpha-glucosidase;

Neutral alpha-glucosidase C;

Maltase-glucoamylase, intestinal.

10

Indication(s)

Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

11

Notes

First generic drug in China

15. Methacholine Chloride for Inhalation

1

Generic Name

Methacholine Chloride for Inhalation

2

Brand Name

/

3

Registration Classification

Class 3 chemical drug

4

Application Type

ANDA

5

MAH

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

6

Approval Date

March 24, 2022

7

Time from Application Acceptance to Approval

732 days

8

Priority Review

No

9

Target(s)

muscarinic acetylcholine receptors (mAChRs)

10

Indication(s)

Indicated for the diagnosis of bronchial airway hyperreactivity in adults and pediatric patients five years of age and older who do not have clinically apparent asthma.

11

Notes

First generic drug in China

16. Serplulimab Injection

1

Generic Name

Serplulimab Injection

2

Brand Name

Han Si Zhuang (汉斯状)

3

Registration Classification

Class 1 therapeutic biological product

4

Application Type

Biologics License Application (BLA)

5

MAH

Shanghai Henlius Biotech, Inc. (Parent company: Fosun Pharma)

6

Approval Date

March 24, 2022

7

Time from Application Acceptance to Approval

333 days

8

Priority Review

Yes (reason: qualified for conditional approval)

9

Target(s)

Programmed cell death protein 1 (PD-1)

10

Indication(s)

Indicated for the treatment of unresectable or metastatic microsatellite instability-high (MSI-H) solid tumors that fail to respond to the standard therapy.

17. Adalimumab Injection

1

Generic Name

Adalimumab Injection

2

Brand Name

Jun Mai Kang (君迈康)

3

Registration Classification

Class 2 therapeutic biological product

4

Application Type

BLA

5

MAH

Shanghai Junshi Biosciences Co., Ltd.

6

Approval Date

March 3, 2022

7

Time from Application Acceptance to Approval

839 days

8

Priority Review

No

9

Target(s)

tumor necrosis factor (TNF)

10

Indication(s)

  • Used in combination with methotrexate for inhibiting the progression of structural damage and improving physical function of adult patients with moderately to severely active rheumatoid arthritis who don't respond to methotrexate and other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

  • Indicated for the treatment of adult patients with active ankylosing spondylitis who don't respond to standard treatments.

  • Indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who require systemic therapy or phototherapy, and don't respond to systemic therapies (including cyclosporine, methotrexate, and photochemotherapy). The drug should only be administered to patients who will be closely monitored and have regular follow-up visits with physicians.

18. Porcine Fibrin Sealant Kit

1

Generic Name

Porcine Fibrin Sealant Kit

2

Brand Name

Bei Xiu Jiao (倍绣胶)

3

Registration Classification

Class 2.2 biological product

4

Application Type

BLA

5

MAH

Guangzhou Bioseal Biotech Co., Ltd.

6

Approval Date

March 24, 2022

7

Time from Application Acceptance to Approval

545 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)

Indicated for preventing wounds fromexuding liquids, small vein bleeding, and tissue adhesion during surgery.

19. Atezolizumab Injection

1

Generic Name

Atezolizumab Injection

2

Brand Name

Tecentriq (泰圣奇)

3

Registration Classification

Class 2.2 therapeutic biological product

4

Application Type

BLA, import

5

MAH

F. Hoffmann-La Roche Ltd.

6

Approval Date

March 18, 2022

7

Time from Application Acceptance to Approval

259 days

8

Priority Review

No

9

Target(s)

Programmed death-ligand 1 (PD-L1)

10

Indication(s)

The drug, in combination with carboplatin and etoposide, is indicated for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).

20. 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

Application Type

BLA

5

MAH

BeiGene (Shanghai) Biotechnology Co., Ltd.

6

Approval Date

March 11, 2022

7

Time from Application Acceptance to Approval

277 days

8

Priority Review

Yes (reason: qualified for conditional approval)

9

Target(s)

Programmed cell death protein 1 (PD-1)

10

Indication(s)

Approved on March 11, 2022:

  • The drug received the conditional approval for the treatment of locally advanced, unresectable or metastatic, microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) solid tumors after prior treatment.

Approved on January 5, 2022:

  • The drug received the full approval for being used in the second-line or third-line treatment for NSCLC patients who have disease progression after platinum chemotherapy.

Approved on June 22, 2021:

  • The drug received the full approval for being used with pemetrexed and platinum chemotherapy in the first-line treatment for NSCLC that are EGFR-negative, ALK-negative and unresectable by surgery.

Approved on June 22, 2021:

  • The drug received a conditional approval for treating hepatocellular carcinoma (HCC) patients who have received at least one type of systemic therapy.

Approved on January 18, 2021:

  • The drug received the full approval to be used in combination with paclitaxel and platinum in the first-line treatment for patients with advanced squamous non-small cell lung cancer (NSCLC) that is unresectable by surgery.

Approved on April 13, 2020:

  • The drug received a conditional approval for urothelial cancer (UC) and small lymphocytic lymphoma (SLL) patients with high PD-L1 expression, prior failure of platinum chemotherapy, and disease progression within 12 months after the neoadjuvant or adjuvant chemotherapy.

Approved on Dec. 31, 2019:

  • The drug received a conditional approval for the second-line treatment for relapsed or refractory classic Hodgkin lymphoma (cHL) patients who have received at least the second-line chemotherapy.

21. Ramucirumab Injection

1

Generic Name

Ramucirumab Injection

2

Brand Name

Cyramza (希冉择)

3

Registration Classification

Class 3.1 therapeutic biological product

4

Application Type

BLA, import

5

MAH

Eli Lilly and Company

6

Approval Date

March 18, 2022

7

Time from Application Acceptance to Approval

419 days

8

Priority Review

No

9

Target(s)

Vascular endothelial growth factor receptor 2 (KDR);

Vascular endothelial growth factor A (VEGFA);

Vascular endothelial growth factor C (VEGFC)

Vascular endothelial growth factor D (VEGFD).

10

Indication(s)

The drug, in combination with paclitaxel, is indicated for the treatment of patients with advanced, gastric or gastro-esophageal junction adenocarcinoma with disease progression during or after prior fluropyrimidin- or platinum-containing chemotherapy.

22. Emapalumab Injection

1

Generic Name

Emapalumab Injection

2

Brand Name

GAMIFANT

3

Registration Classification

Class 3.1 therapeutic biological product

4

Application Type

BLA, import

5

MAH

Swedish Orphan Biovitrum

6

Approval Date

March 11, 2022

7

Time from Application Acceptance to Approval

453 days

8

Priority Review

Yes (reason: qualified for conditional approval)

9

Target(s)

Interferon gamma (IFNG)

10

Indication(s)

Indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy.

23. Inebilizumab Injection

1

Generic Name

Inebilizumab Injection

2

Brand Name

UPLIZNA (昕越)

3

Registration Classification

Class 3.1 therapeutic biological product

4

Application Type

BLA, import

5

MAH

Viela Bio, Inc.

6

Approval Date

March 11, 2022

7

Time from   Application Acceptance to Approval

510 days

8

Priority Review

No

9

Target(s)

B-lymphocyte antigen CD19

10

Indication(s)

Indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

RELATED:

Grace Wang
ChemLinked Regulatory Analyst
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