Monthly Report: New Drug Approvals in China | October 2022

by Grace Wang Nov 03, 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 October 2022, China NMPA approved 17 new drugs, including 11 chemical drugs and 6 biological products.

  1. Hua Medicine's Dorzagliatin Tablets

  2. Hidragon Pharma's Lansoprazole Capsules

  3. Nanjing Haina Pharmaceutical's Levofolinic Acid Solution for Injection

  4. Changchun Haiyue Pharmaceutical's Esomeprazole Magnesium and Sodium Bicarbonate Capsules

  5. Haiscol's Ciprofol Injection

  6. Joincare's Tobramycin Inhalation Solution

  7. Pfizer's Tofacitinib Citrate Sustained-release Tablets

  8. Pfizer's Tofacitinib Citrate Tablets

  9. Eli Lilly's Selpercatinib Capsules

  10. Cabot Norit Nederland's Pharmaceutical Charcoal Granules for Suspension

  11. ViiV Healthcare's Dolutegravir Sodium and Rilpivirine Hydrochloride Tablets

  12. Shanghai Henlius Biotech's Serplulimab Injection

  13. JW Therapeutics' Relmacabtagene Autoleucel Injection

  14. MSD's Pembrolizumab Injection

  15. Eli Lilly's Ramucirumab Injection

  16. Kyowa Kirin's Mogamulizumab Injection

  17. Roche's Trastuzumab Injection

The approval details are as follows.

1. Dorzagliatin Tablets

1

Generic Name

Dorzagliatin Tablets

2

Brand Name

Hua Tang Ning (华堂宁)

3

Classification

Class 1 chemical drug

4

Application Type

New drug application (NDA)

5

Marketing   Authorization Holder (MAH)

Hua Medicine (Shanghai) Co., Ltd.

6

Approval Date

Oct. 9, 2022

7

Time from Application Acceptance to Approval

522 days

8

Priority Review

No

9

Target(s)

Glucokinase (GCK)

10

Indication(s)

For improving glycemic control in type 2 diabetes adult patients.

2. Lansoprazole Capsules

1

Generic Name

Lansoprazole Capsules

2

Brand Name

/

3

Classification

Class 2.2 chemical drug

4

Application Type

NDA

5

MAH

Hidragon Pharma

6

Approval Date

Oct. 9, 2022

7

Time from Application Acceptance to Approval

1,141 days

8

Priority Review

No

9

Target(s)

H+ K+ ATPase

10

Indication(s)

For treating gastric ulcer, duodenum ulcer, reflux esophagitis, and Zollinger-Ellison syndrome.

3. Levofolinic Acid Solution for Injection

1

Generic Name

Levofolinic Acid Solution for Injection

2

Brand Name

/

3

Classification

Class 2.2 chemical drug

4

Application Type

NDA

5

MAH

Nanjing Haina Pharmaceutical Co., Ltd.

6

Approval Date

Oct. 9, 2022

7

Time from Application Acceptance to Approval

1,299 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)

1. For offsetting the toxicity of antifol (e.g., methotrexate) in chemotherapy or when overused;

2. Used in combination with fluorouracil drugs in chemotherapy for treating gastric cancer and colorectal cancer.

4. Esomeprazole Magnesium and Sodium Bicarbonate Capsules

1

Generic Name

Esomeprazole Magnesium and Sodium Bicarbonate Capsules

2

Brand Name

Hai Yue Mei Ao (海悦美奥)

3

Classification

Class 2.3 chemical drug

4

Application Type

NDA

5

MAH

Changchun Haiyue Pharmaceutical Co., Ltd.

6

Approval Date

Oct. 9, 2022

7

Time from Application Acceptance to Approval

758 days

8

Priority Review

No

9

Target(s)

H+ K+ ATPase

10

Indication(s)

For treating gastroesophageal reflux, erosive reflux esophagitis, gastric ulcer, heartburn, and acid reflux.

 5. Ciprofol Injection

1

Generic Name

Ciprofol Injection

2

Brand Name

Si Shu Ning (思舒宁)

3

Classification

Class 2.4 chemical drug

4

Application Type

NDA

5

MAH

Liaoning Haisco Pharmaceutical Co., Ltd.

6

Approval Date

Oct. 14, 2022

7

Time from Application Acceptance to Approval

263 days

8

Priority Review

No

9

Target(s)

GABAA receptor

10

Indication(s)

Previously approved:

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

2. For the induction and maintenance of general anesthesia.

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

Newly approved on Oct. 14, 2022:

4. For sedation and anesthesia in gynecological outpatient procedures.

6. Tobramycin Inhalation Solution

1

Generic Name

Tobramycin Inhalation Solution

2

Brand Name

/

3

Classification

Class 2.4 chemical drug

4

Application Type

NDA

5

MAH

Joincare Pharmaceutical Group Industry Co., Ltd.

6

Approval Date

Oct. 14, 2022

7

Time from Application Acceptance to Approval

405 days

8

Priority Review

No

9

Target(s)

30S ribosomal subunit (pbp2)

10

Indication(s)

For controlling the infections and improving the symptoms of bronchiectasis caused by pulmonary Pseudomonas aeruginosa in adult patients.

7. Tofacitinib Citrate Sustained-release Tablets

1

Generic Name

Tofacitinib Citrate Sustained-release Tablets

2

Brand Name

Xeljanz XR

3

Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

Pfizer Inc.

6

Approval Date

Oct. 21, 2022

7

Time from Application Acceptance to Approval

285 days

8

Priority Review

No

9

Target(s)

Tyrosine-protein kinase JAK1;

Tyrosine-protein kinase JAK3

10

Indication(s)

Previously approved:

Ÿ   For the treatment of moderate-to-severe active rheumatoid arthritis (RA) in adult   patients who have had an inadequate response or intolerance to methotrexate.

Ÿ   Permitted to be used in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

Ÿ   Limitations of use: Not recommended to be used in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine.

Newly approved on Oct. 21, 2022:

For active psoriatic arthritis (PsA) patients who have inadequate response or intolerance to one or multiple anti-rheumatic drugs for improving symptoms.

8. Tofacitinib Citrate Tablets

1

Generic Name

Tofacitinib Citrate Tablets

2

Brand Name

Xeljanz (尚杰)

3

Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

Pfizer Europe MA EEIG

6

Approval Date

Oct. 14, 2022

7

Time from Application Acceptance to Approval

278 days

8

Priority Review

No

9

Target(s)

Tyrosine-protein kinase JAK1;

Tyrosine-protein kinase JAK3

10

Indication(s)

Previously approved:

Ÿ   For the treatment of moderate-to-severe active rheumatoid arthritis (RA) in adult patients who have had an inadequate response or intolerance to methotrexate.

Ÿ   Permitted to be used in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

Ÿ   Limitations of use: Not recommended to be used in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine.

Newly approved on Oct. 21, 2022:

For active psoriatic arthritis (PsA) patients who have  inadequate response or intolerance to one or multiple anti-rheumatic drugs for improving symptoms.

9. Selpercatinib Capsules

1

Generic Name

Selpercatinib Capsules

2

Brand Name

/

3

Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

Eli Lilly Nederland B.V.

6

Approval Date

Oct. 9, 2022

7

Time from Application Acceptance to Approval

325 days

8

Priority Review

No

9

Target(s)

Proto-oncogene tyrosine-protein kinase receptor Ret

10

Indication(s)

1. For treating adult and pediatric patients no younger than 12 years old who need systemic treatment for advanced or metastatic thyroid cancer with rearranged during transfection (RET) gene fusion.

2.  For treating adult and pediatric patients no younger than 12 years old who need systemic treatment and radioactive iodine treatment (if appropriate) for advanced or metastatic thyroid cancer with RET gene fusion.

3.  For treating patients who have locally advanced or metastatic non-small cell lung cancer (NSCLC) with RET gene fusion.

10. Pharmaceutical Charcoal Granules for Suspension

1

Generic Name

Pharmaceutical Charcoal Granules for Suspension

2

Brand Name

/

3

Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

Cabot Norit Nederland B.V.

6

Approval Date

Oct. 9, 2022

7

Time from Application Acceptance to Approval

331 days

8

Priority Review

Yes (pediatric drug)

9

Target(s)

/

10

Indication(s)

Indicated as an oral detoxification drug for treating acute poisoning or drug overdose.

11. Dolutegravir Sodium and Rilpivirine Hydrochloride Tablets

1

Generic Name

Dolutegravir Sodium and Rilpivirine Hydrochloride Tablets

2

Brand Name

/

3

Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

ViiV Healthcare BV

6

Approval Date

Oct. 21, 2022

7

Time from Application Acceptance to Approval

648 days

8

Priority Review

Yes (other situations for priority review)

9

Target(s)

/

10

Indication(s)

For treating human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months. The patients should have no history of treatment failure and no suspected/known resistance to non-nucleoside reverse transcriptase inhibitors (NNRTIs) or integrase inhibitors (INIs).

12. Serplulimab Injection

1

Generic Name

Serplulimab Injection

2

Brand Name

Han Si Zhuang (汉斯状)

3

Classification

Class 1 therapeutic biological product

4

Application Type

Biologics License Application (BLA)

5

MAH

Shanghai Henlius Biotech, Inc., a subsidiary of Fosun Pharma

6

Approval Date

Oct. 31, 2022

7

Time from Application Acceptance to Approval

404 days

8

Priority Review

No

9

Target(s)

Programmed cell death protein 1 (PD-1)

10

Indication(s)

Previously approved:

For treating unresectable or metastatic microsatellite instability-high (MSI-H) solid tumors that fail to respond to the standard therapy.

Newly approved on Oct. 31, 2022:

Indicated in combination with chemotherapy for treating locally advanced or metastatic NSCLC.

13. Relmacabtagene Autoleucel Injection

1

Generic Name

Relmacabtagene Autoleucel Injection

2

Brand Name

倍诺达 (Carteyva)

3

Classification

Class 2.2 therapeutic biological product

4

Application Type

BLA

5

MAH

JW Therapeutics (Shanghai) Co., Ltd.

6

Approval Date

Oct. 9, 2022

7

Time from Application Acceptance to Approval

212 days

8

Priority Review

Yes (for breakthrough therapy)

9

Target(s)

B-lymphocyte antigen CD19

10

Indication(s)

Previously approved:

For treating adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy. The applicable r/rLBCL includes diffuse large B-cell lymphoma (DLBCL), DLBCL transformed from follicular lymphoma, grade 3b follicular lymphoma, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphomas (HGBLs) with MYC and BCL2 and/or BCL6   rearrangements (so-called double/triple-hit lymphomas).

Newly approved on Oct. 9, 2022:

For treating relapsed or refractory follicular lymphoma (including histologic grade 1, 2, and 3a) after two or more lines of systemic treatment.

14. Pembrolizumab Injection

1

Generic Name

Pembrolizumab Injection

2

Brand Name

Keytruda (可瑞达)

3

Classification

Class 2.2 therapeutic biological product

4

Application Type

BLA, import

5

MAH

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

6

Approval Date

Oct. 9, 2022

7

Time from Application Acceptance to Approval

308 days

8

Priority Review

No

9

Target(s)

PD-1

10

Indication(s)

Previously approved:

For treating unresectable or metastatic melanoma after the failure of first-line treatment.

This indication is granted conditional marketing authorization in China based on the overall response rate (ORR) result of a single-arm clinical trial.

Whether this indication will receive full approval depends on the ongoing confirmatory clinical trial which explores whether the therapy can realize the long-term clinical value for patients in China.

Newly approved on Oct. 9, 2022:

Indicated as a single agent for hepatocellular carcinoma (HCC) patients who have been previously treated with sorafenib or oxaliplatin-containing chemotherapy.

15. Ramucirumab Injection

1

Generic Name

Ramucirumab Injection

2

Brand Name

Cyramza (希冉择)

3

Classification

Class 3.1 therapeutic biological product

4

Application Type

BLA, import

5

MAH

Eli Lilly and Company

6

Approval Date

Oct. 9, 2022

7

Time from Application Acceptance to Approval

403 days

8

Priority Review

No

9

Target(s)

Vascular endothelial growth factor receptor 2

10

Indication(s)

Previously approved:

In combination with paclitaxel for treating patients with advanced, gastric or gastro-esophageal junction adenocarcinoma with disease progression during or after prior fluropyrimidin- or platinum-containing chemotherapy.

Newly approved on Oct. 9, 2022:

For treating HCC patients who have an alpha fetoprotein (AFP) of ≥400 ng/Ml and have been treated with sorafenib.

16. Mogamulizumab Injection

1

Generic Name

Mogamulizumab Injection

2

Brand Name

Poteligeo (惠尔金)

3

Classification

Class 3.1 therapeutic biological product

4

Application Type

BLA, import

5

MAH

Kyowa Kirin Co., Ltd.

6

Approval Date

Oct. 14, 2022

7

Time from Application Acceptance to Approval

466 days

8

Priority Review

Yes (for conditional marketing authorization)

9

Target(s)

C-C chemokine receptor type 4 (CCR4)

10

Indication(s)

For treating adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.

17. Trastuzumab Injection (Subcutaneous Injection)

1

Generic Name

Trastuzumab Injection (Subcutaneous Injection)

2

Brand Name

Herceptin (赫赛汀)

3

Classification

Class 3.1 therapeutic biological product

4

Application Type

BLA, import

5

MAH

Roche Pharma (Schweiz) AG

6

Approval Date

Oct. 9, 2022

7

Time from Application Acceptance to Approval

527 days

8

Priority Review

No

9

Target(s)

human epidermal growth factor receptor 2 (HER2)

10

Indication(s)

Indicated in combination with chemotherapy for early-stage and metastatic breast cancer that is HER2-positive.  

Read More

Grace Wang
ChemLinked Regulatory Analyst
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