Monthly Report: New Drug Approvals in China | April 2022

by Grace Wang May 12, 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 April 2022, China NMPA approved 23 new drugs, including 20 chemical drugs and 3 biological products.

1. Abrocitinib Tablets

1

Generic Name

Abrocitinib Tablets

2

Brand Name

CIBINQO (希必可)

3

Registration Classification

Class 1 chemical drug

4

Application Type

New drug application (NDA), import

5

Marketing Authorization   Holder (MAH)

Pfizer Inc.

6

Approval Date

April 13, 2022

7

Time from Application Acceptance to Approval

421 days

8

Priority Review

Yes (pediatric drug)

9

Target(s)

Tyrosine-protein kinase JAK1

10

Indication(s)

CIBINQO is indicated for treating moderate-to-severe atopic dermatitis (including relieving pruritus) in patients no younger than 12 who receive inadequate therapeutic response from topical therapies or for whom those therapies are inappropriate. The drug can be used with or without topical therapies.

2. Tegoprazan Tablet

1

Generic Name

Tegoprazan Tablets

2

Brand Name

Tai Xin Zan (泰欣赞)

3

Registration Classification

Class 1 chemical drug

4

Application Type

NDA

5

MAH

Luoxin Pharmaceutical Co., Ltd.

6

Approval Date

April 13, 2022

7

Time from Application Acceptance to Approval

449 days

8

Priority Review

No

9

Target(s)

H+ K+ ATPase

10

Indication(s)

Tai Xin Zan is indicated for treating reflux esophagitis.

3. Lorlatinib Tablets

1

Generic Name

Lorlatinib Tablets

2

Brand Name

LORBRENA

3

Registration Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

Pfizer Inc.

6

Approval Date

April 29, 2022

7

Time from Application Acceptance to Approval

287 days

8

Priority Review

Yes (qualified for conditional approval)

9

Target(s)

ALK; Ros1 tyrosine kinase receptor

10

Indication(s)

LORBRENA is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) positive in patients who have received one or more ALK-tyrosine kinase inhibitor (TKI) therapies.

4. Pemigatinib Tablets

1

Generic Name

Pemigatinib Tablets

2

Brand Name

Pemazyre (达伯坦)

3

Registration Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

Innovent Biologics (Suzhou) Co., Ltd.

6

Approval Date

April 6, 2022

7

Time from Application Acceptance to Approval

260 days

8

Priority Review

Yes (qualified for conditional approval)

9

Target(s)

Fibroblast Growth Factor 1 (FGF1)

Fibroblast Growth Factor 2 (FGF2)

Fibroblast Growth Factor 3 (FGF3)

10

Indication(s)

Pemazyre is indicated for the treatment of adults who have experienced at least one prior systemic therapy and are confirmed by test that they have unresectable locally advanced or metastatic cholangiocarcinoma with fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.

5. Larotrectinib Sulfate Capsules

1

Generic Name

Larotrectinib Sulfate Capsules

2

Brand Name

VITRAKVI (维泰凯)

3

Registration Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

Bayer AG

6

Approval Date

April 13, 2022

7

Time from Application Acceptance to Approval

323 days

8

Priority Review

Yes (qualified for conditional approval)

9

Target(s)

Neurotrophic Receptor Tyrosine Kinase 1 (NTRK1)

10

Indication(s)

VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that:

-        have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion;

-        are locally advanced, metastatic, or where surgical resection is likely to result in severe complications, and

-        have no satisfactory treatment alternatives.

6. Beclometasone Dipropionate, Formoterol Fumarate, and Glycopyrrolate Inhalation Aerosol

1

Generic Name

Beclometasone Dipropionate, Formoterol Fumarate, and Glycopyrrolate Inhalation Aerosol

2

Brand Name

/

3

Registration Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

Chiesi Farmaceutici S.p.A.

6

Approval Date

April 15, 2022

7

Time from Application Acceptance to Approval

530 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)

This drug is indicated for the treatment of chronic obstructive pulmonary disease (COPD) and asthma in adult patients.

7. Irinotecan Hydrochloride Liposome Injection

1

Generic Name

Irinotecan Hydrochloride Liposome Injection

2

Brand Name

ONIVYDE

3

Registration Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

Les Laboratoires Servier

6

Approval Date

April 15, 2022

7

Time from Application Acceptance to Approval

659 days

8

Priority Review

No

9

Target(s)

DNA topoisomerase 1 (TOP1)

10

Indication(s)

ONIVYDE, in combination with 5-Fluorouracil (5FU) and folinic acid (LV), is indicated for metastatic pancreatic cancer after gemcitabine therapy.

8. Procarbazine Hydrochloride Capsules

1

Generic Name

Procarbazine Hydrochloride Capsules

2

Brand Name

Matulane

3

Registration Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

Leadiant GmbH

6

Approval Date

April 21, 2022

7

Time from Application Acceptance to Approval

708 days

8

Priority Review

No

9

Target(s)

deoxyribonucleic acid (DNA)

10

Indication(s)

Matulane is indicated for the treatment of advanced Hodgkin's disease.

9. Tetrofosmin and Stannous Chloride for Injection

1

Generic Name

Tetrofosmin and Stannous Chloride for Injection

2

Brand Name

MYOVIEW

3

Registration Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

GE Healthcare AS

6

Approval Date

April 6, 2022

7

Time from Application Acceptance to Approval

750 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)

MYOVIEW is a kit for the preparation of technetium Tc99m tetrofosmin injection, a radioactive diagnostic drug. Two doses of the injection are used for the myocardial perfusion imaging under rest and pharmacologic stress conditions to reflect changes of myocardial blood flow and perfusion in patients with known or suspected coronary artery disease.

10. Anlotinib Hydrochloride Capsules

1

Generic Name

Anlotinib Hydrochloride Capsules

2

Brand Name

FOCUS V (福可维)

3

Registration Classification

Class 2.4 chemical drug

4

Application Type

NDA

5

MAH

Chai Tai Tianqing Pharmaceutical Group Co., Ltd. (CTTQ Co., Ltd.)

6

Approval Date

April 13, 2022

7

Time from Application Acceptance to Approval

336 days

8

Priority Review

No

9

Target(s)

Vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), platelet-derived growth factor receptors (PDGFR), and c-kit.

10

Indication(s)

Approved previously:

  • 1. FOCUS V is indicated for the treatment of locally advanced or metastatic NSCLC in patients with disease progression or relapse after   receiving at least two types of systemic chemotherapies. For patients with gene mutation of epidermal growth factor receptor (EGFR) or being ALK-positive, they should have disease progression after receiving the corresponding standard targeted drug therapy before using FOCUS V, and disease progression or relapse after at least two systemic chemotherapies.

  • 2. FOCUS V is indicated for the treatment of acinar soft tissue sarcoma (ASPS), clear cell sarcoma (CCS), and other advanced soft   tissue sarcoma in patients who have disease progression or relapse after receiving at least the anthracycline chemotherapy.

  • 3. FOCUS V is indicated for the treatment of small cell lung cancer (SCLC) in patients who have disease progression or relapse after receiving at least two types of chemotherapies. The indication received conditional approval based on the results of the Phase II clinical trial involving 119 such patients. Full approval depends on the ongoing confirmatory trials to prove FOCUS V's clinical benefit in patient group.

  • 4. FOCUS V is indicated for the treatment of patients with unresectable medullary thyroid cancer that is locally advanced or metastatic with clinical symptoms or clear disease progression. This indication received conditional approval based on the results of the Phase IIB clinical trial involving 91 patients with advanced medullary thyroid cancer. Full approval depends on the ongoing confirmatory trials to prove FOCUS V's clinical benefit in patient group.

Approved on April 13, 2022:

  • 5. FOCUS V is indicated for the treatment of inoperable radioactive iodine-refractory differentiated thyroid cancer (RAIR-DTC) that is locally advanced or metastatic.

11. Tofacitinib Citrate Tablets

1

Generic Name

Tofacitinib Citrate Tablets

2

Brand Name

Xeljanz (尚杰)

3

Registration Classification

Class 2.4 chemical drug

4

Application Type

NDA, import

5

MAH

Pfizer Europe MA EEIG

6

Approval Date

April 15, 2022

7

Time from Application Acceptance to Approval

440 days

8

Priority Review

No

9

Target(s)

Janus kinase (JAK);

Tyrosine-protein kinase JAK1 (JAK1);

Tyrosine-protein kinase JAK3 (JAK3).

10

Indication(s)

  • Xeljanz is indicated for the treatment of moderate-to-severe active rheumatoid arthritis (RA) in adult patients who have had an inadequate response or intolerance to methotrexate.  

  • Xeljanz can be used in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs).

  • Limitations of use: Xeljanz is not recommended to be used in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine.

12. Upadacitinib Sustained-release Tablets

1

Generic Name

Upadacitinib Sustained-release Tablets

2

Brand Name

RINVOQ (瑞福)

3

Registration Classification

Class 2.4 chemical drug

4

Application Type

NDA, import

5

MAH

AbbVie Ireland NL B.V.

6

Approval Date

April 6, 2022

7

Time from Application Acceptance to Approval

440 days

8

Priority Review

No

9

Target(s)

Tyrosine-protein kinase JAK1

10

Indication(s)

Approved previously:

  • 1. RINVOQ is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients no younger than 12 years old.

  • 2. RINVOQ is indicated for the treatment of moderate-to-severe active rheumatoid arthritis in adult patients who have had an inadequate response or intolerance to one or more TNF blockers.

Approved on April 6:

  • 3. RINVOQ is indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or intolerance to one or more DMARDs.

13. Posaconazole Enteric-coated Tablets

1

Generic Name

Posaconazole Enteric-coated Tablets

2

Brand Name

Noxafil (诺科飞)

3

Registration Classification

Class 2.4 chemical drug

4

Application Type

NDA, import

5

MAH

Merck Sharp & Dohme Ltd

6

Approval Date

April 6, 2022

7

Time from   Application Acceptance to Approval

470 days

8

Priority Review

No

9

Target(s)

Lanosterol 14-alpha demethylase (CYP51A1)

10

Indication(s)

Noxafil is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy.

14. Dehydrated Alcohol Injection

1

Generic Name

Dehydrated Alcohol Injection

2

Brand Name

/

3

Registration Classification

Class 2.4 chemical drug

4

Application Type

NDA, import

5

MAH

Guorui Pharmaceutical Co., Ltd. (Parent company: Sinopharm)

6

Approval Date

April 29, 2022

7

Time from Application Acceptance to Approval

601 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)

The dehydrated alcohol injection is indicated for reducing the volume of simple kidney cysts (diameter 5-10cm) with symptoms or imaging changes of compressing obstruction, and needing therapeutic intervention. The injection should be used after comprehensive evaluations by experienced medical specialists.

15. Tofacitinib Citrate Extended-release Tablets 

1

Generic Name

Tofacitinib Citrate Extended-release Tablets

2

Brand Name

/

3

Registration Classification

Class 3 chemical drug

4

Application Type

Abbreviated new drug application (ANDA)

5

MAH

Qilu Pharmaceutical Co., Ltd.

6

Approval Date

April 21, 2022

7

Time from   Application Acceptance to Approval

600 days

8

Priority Review

No

9

Target(s)

Janus kinase (JAK);

Tyrosine-protein kinase JAK1 (JAK1);

Tyrosine-protein kinase JAK3 (JAK3).

10

Indication(s)

  • The drug is indicated for the treatment of moderate-to-severe active rheumatoid arthritis (RA) in adult patients who have had an inadequate response or intolerance to methotrexate.

  • The drug can be used in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs).

  • Limitations of use: the drug is not recommended to be used in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine.

11

Notes

First generic in China

16. Midazolam Hydrochloride Oral Solution

1

Generic Name

Midazolam Hydrochloride Oral Solution

2

Brand Name

/

3

Registration Classification

Class 3 chemical drug

4

Application Type

ANDA

5

MAH

Jiangsu Nhwa Pharmaceutical Co., Ltd.

6

Approval Date

April 15, 2022

7

Time from Application Acceptance to Approval

679 days

8

Priority Review

Yes (pediatric drug)

9

Target(s)

Benzodiazepine receptor (BZR)

10

Indication(s)

The drug is indicated for

  • diagnosis or therapy for pediatric patients;

  • sedation, anxiety reduction, and anterograde amnesia before endoscopy and anesthesia induction.  

11

Notes

First generic in China

17. Levofolinic Acid Injection

1

Generic Name

Levofolinic Acid Injection

2

Brand Name

/

3

Registration Classification

Class 3 chemical drug

4

Application Type

ANDA

5

MAH

Nanjing Healthnice Pharmaceutical Technology Co., Ltd.

6

Approval Date

April 29, 2022

7

Time from Application Acceptance to Approval

1,344 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)

The drug is indicted for

  • diminishing the toxicity and counteract the action of folic acid antagonist (e.g., methotrexate) therapy and overdose;

  • the chemotherapy with 5-fluorouracil for stomach and colon cancers.

11

Notes

First generic in China

18. Sodium Nitroprusside Injection

1

Generic Name

Sodium Nitroprusside Injection

2

Brand Name

/

3

Registration Classification

Class 3 chemical drug

4

Application Type

ANDA

5

MAH

Hainan Poly Pharm Co., Ltd.

6

Approval Date

April 15, 2022

7

Time from Application Acceptance to Approval

774 days

8

Priority Review

No

9

Target(s)

Natriuretic Peptide Receptor 1 (NPR1)

10

Indication(s)

The drug is indicated for

  • the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crisis;

  • controlling hypotension in order to reduce bleeding during surgery;

  • the treatment of acute congestive heart failure.

11

Notes

First generic in China

19. Medium and Long Chain Fat Emulsion, Amino Acids (16) and Glucose (36%) Injection

1

Generic Name

Medium and Long Chain Fat Emulsion, Amino Acids (16) and Glucose (36%) Injection

2

Brand Name

/

3

Registration Classification

Class 3 chemical drug

4

Application Type

ANDA

5

MAH

Kelun Industry Group

6

Approval Date

April 13, 2022

7

Time from Application Acceptance to Approval

1,074 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)

The drug is indicated for providing nutrition to moderate-to-severe catabolic patients no younger than two years old with functional deficiency or inability to receive nutrients through mouth or intestine.

11

Notes

First generic in China

20. Medium and Long Chain Fat Emulsion, Amino Acids (16) and Glucose (30%) Injection

1

Generic Name

Medium and Long Chain Fat Emulsion, Amino Acids (16) and Glucose (30%) Injection

2

Brand Name

/

3

Registration Classification

Class 3 chemical drug

4

Application Type

ANDA

5

MAH

Kelun Industry Group

6

Approval Date

April 13, 2022

7

Time from Application Acceptance to Approval

563 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)

The drug is indicated for providing nutrition to moderate-to-severe catabolic patients at or over two years old with functional deficiency or inability to receive nutrients through mouth or intestine.

11

Notes

First generic in China

21. Tislelizumab Injection

1

Generic Name

Tislelizumab Injection

2

Brand Name

Bai Ze An (百泽安)

3

Registration Classification

Class 2.2 biological product

4

Application Type

Biologics License Application (BLA)

5

MAH

BeiGene (Shanghai) Biotechnology Co., Ltd.

6

Approval Date

April 13, 2022

7

Time from Application Acceptance to Approval

274 days

8

Priority Review

No

9

Target(s)

Programmed cell death protein 1 (PD-1)

10

Indication(s)

  • 1.   On December 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.

  • 2.   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.

  • 3. 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.

  • 4. 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.

  • 5.   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.

  • 6. 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.

  • 7. 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.

  • 8. On April 13, 2022, the drug received full approval for the treatment of esophageal squamous cell carcinoma (ESCC) that is unresectable, relapsed, locally advanced or metastatic after prior systemic treatment.

22. Blinatumomab for Injection

1

Generic Name

Blinatumomab for Injection

2

Brand Name

BLINCYTO (倍利妥)

3

Registration Classification

Class 3.1 biological product

4

Application Type

BLA, import

5

MAH

Amgen Inc.

6

Approval Date

April 29, 2022

7

Time from Application Acceptance to Approval

392 days

8

Priority Review

Yes (pediatric drug)

9

Target(s)

B-lymphocyte antigen CD19;

Myeloid cell surface antigen CD33.

10

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Approved previously:

  • BLINCYTO is indicated for treating relapsed or refractory precursor B-cell ALL in adult patients.

Approved on April 29, 2022:

  • BLINCYTO is indicated for treating relapsed or refractory precursor B-cell acute lymphoblastic leukemia (ALL) in pediatric patients.

23. Omalizumab for Injection

1

Generic Name

Omalizumab for Injection

2

Brand Name

Xolair (茁乐)

3

Registration Classification

Class 3.1 biological product

4

Application Type

BLA, import

5

MAH

Novartis Europharm Limited

6

Approval Date

April 13, 2022

7

Time from Application Acceptance to Approval

449 days

8

Priority Review

/

9

Target(s)

Immunoglobulin E (IgE)

10

Indication(s)

Approved previously:

  • Xolair is indicated for the treatment of adult and pediatric patients no younger than six years old with moderate-to-severe allergic asthma.

Approved on April 13, 2022:

  • Xolair is indicated for the treatment of chronic spontaneous urticaria in adult and adolescents no younger than 12 years old who remain symptomatic after H1 antihistamine treatment.

RELATED:

Grace Wang
ChemLinked Regulatory Analyst
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