Monthly Report: New Drug Approvals in China | March 2023

by Grace Wang Apr 07, 2023

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: the first generic chemical drug developed by a Chinese company and approved by China National Medical Products Administration (NMPA) with marketing authorization. The definition of “first generic drug” is commonly used in the Chinese pharma industry but not written in Chinese regulations.


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In Mar. 2023, China NMPA approved 15 new drugs, all of which are chemical drugs.

1. Raynovent’s Leritrelvir Tablets

2. Shanghai Haihe Biopharma’s Glumetinib Tablets

3. IPSEN PHARMA’s Triptorelin Pamoate for Injection

4. AstraZeneca’s Acalabrutinib Capsules (CALQUENCE)

5. Nobelpharma’s Sirolimus Gel (HYFTOR)

6. EVEREST MEDICINES’ Eravacycline Hydrochloride for Injection

7. Medac’s Methotrexate Injection (Prefilled)

8. Jiangsu Hengrui Pharmaceuticals’ Dexmedetomidine Hydrochloride Nasal Spray

9. Eli Lilly’s Baricitinib Tablets (OLUMIANT)

10. Bayer’s Darolutamide Tablets (NUBEQA)

11. Huaxia Shengsheng Pharmaceutical’s Linezolid and Sodium Chloride Injection (first generic)

12. Hunan Kelun Pharmaceutical’s Cefoxitin Sodium for Injection and Glucose Injection (first generic)

13. Xi'an Gelan Xintong Pharmaceutical’s Fosphenytoin Sodium Concentrated Solution for Injection (first generic)

14. Hainan Herui Pharmaceutical’s Mesalazine Enteric-coated Sustained-release Capsules (first generic)

15. Zhongrun Pharmaceutical’s Peramivir Injection (first generic)

The details are as follows.

1.  Leritrelvir Tablets

1

Generic Name

Leritrelvir Tablets

2

Brand Name

Le Rui Ling (乐睿灵)

3

Classification

Class 1 chemical drug

4

Application Type

New drug application (NDA), domestic

5

Marketing Authorization Holder (MAH)

Guangdong Raynovent Biotech Co., Ltd.

6

Approval Date

23/03/2023

7

Time from Application Acceptance to Approval

Not revealed

8

Priority Review

Yes (conditional approval)

9

Target(s)

3CL protease

10

Indication(s)

For treating adult patients with mild-to-moderate COVID-19 infection.

2. Glumetinib Tablets

1

Generic Name

Glumetinib Tablets

2

Brand Name

Hai Yi Tan (海益坦)

3

Classification

Class 1 chemical drug

4

Application Type

NDA, domestic

5

MAH

Shanghai Haihe Biopharma R&D Institute Co., Ltd.

6

Approval Date

07/03/2023

7

Time from Application Acceptance to Approval

375 days

8

Priority Review

Yes (breakthrough therapy)

9

Target(s)

Hepatocyte growth factor receptor (c-Met)

10

Indication(s)

For the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition factor (MET) exon 14 skipping.

3. Triptorelin Pamoate for Injection

1

Generic Name

Triptorelin Pamoate for Injection

2

Brand Name

/

3

Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

IPSEN PHARMA

6

Approval Date

07/03/2023

7

Time from Application Acceptance to Approval

207 days

8

Priority Review

Yes (reason not revealed)

9

Target(s)

Gonadotropin-releasing hormone receptor (GnRH receptor)

10

Indication(s)

For the treatment of locally advanced or metastatic prostate cancer.

4. Acalabrutinib Capsules

1

Generic Name

Acalabrutinib Capsules

2

Brand Name

CALQUENCE (康可期)

3

Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

AstraZeneca Pty Ltd

6

Approval Date

21/03/2023

7

Time from Application Acceptance to Approval

440 days

8

Priority Review

No

9

Target(s)

Tyrosine-protein kinase BTK

10

Indication(s)

For the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

5. Sirolimus Gel

1

Generic Name

Sirolimus Gel

2

Brand Name

HYFTOR

3

Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

Nobelpharma Co., Ltd.

6

Approval Date

28/03/2023

7

Time from Application Acceptance to Approval

1,251 days

8

Priority Review

Yes (rare disease)

9

Target(s)

Mammalian target of rapamycin complex 1 (FKBP1A);

Peptidyl-prolyl cis-trans isomerase FKBP1A (mTORC1)

10

Indication(s)

For the treatment of facial angiofibroma associated with tuberous sclerosis in adults and pediatric patients 6 years of age and older.

6. Eravacycline Hydrochloride for Injection

1

Generic Name

Eravacycline Hydrochloride for Injection

2

Brand Name

Yi Jia (依嘉)

3

Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

EVEREST MEDICINES (SINGAPORE) PTE. LTD.

6

Approval Date

15/03/2023

7

Time from Application Acceptance to Approval

723 days

8

Priority Review

No

9

Target(s)

30S ribosomal subunit

10

Indication(s)

For the treatment of complicated intraabdominal infections (cIAI) caused by susceptible microorganisms: Escherichia colis, Klebsiella pneumoniae, Citrobacter freundii, Enterobacter cloacae, Klebsiella oxytoca, Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus, Streptococcus anginosus group, Clostridium perfringens, Bacteroides species, and Parabacteroides distasonis in patients 18 years or older.

7. Methotrexate Injection (Prefilled)

1

Generic Name

Methotrexate Injection (Prefilled)

2

Brand Name

/

3

Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

medac Gesellschaft für klinische Spezialpräparate mbH

6

Approval Date

24/03/2023

7

Time from Application Acceptance to Approval

470 days

8

Priority Review

Yes (reason not revealed yet)

9

Target(s)

Dihydrofolate Reductase (DHFR)

10

Indication(s)

For the treatment of severe recalcitrant disabling psoriasis, which is not adequately responsive to standard treatments.

8. Dexmedetomidine Hydrochloride Nasal Spray

1

Generic Name

Dexmedetomidine Hydrochloride Nasal Spray

2

Brand Name

/

3

Classification

Class 2.2 chemical drug

4

Application Type

NDA, domestic

5

MAH

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

6

Approval Date

15/03/2023

7

Time from Application Acceptance to Approval

532 days

8

Priority Review

No

9

Target(s)

Alpha-2 adrenergic receptor (ADRA2)

10

Indication(s)

For sedation/anti-anxiety treatment for adult patients before procedures.

9. Baricitinib Tablets

1

Generic Name

Baricitinib Tablets

2

Brand Name

OLUMIANT (艾乐明)

3

Classification

Class 2.4 chemical drug

4

Application Type

NDA, import

5

MAH

Eli Lilly Nederland B.V.

6

Approval Date

24/03/2023

7

Time from Application Acceptance to Approval

438 days

8

Priority Review

No

9

Target(s)

Tyrosine-protein kinase JAK1;

Tyrosine-protein kinase JAK2

10

Indication(s)

Previously approved:

For the treatment of adult patients with moderate-to-severe active rheumatoid arthritis who had inadequate response or intolerance to one or more anti-rheumatic medicines for improving the condition.

Newly approved on Mar. 24, 2023:

For the treatment of adult patients with severe alopecia areata.

10. Darolutamide Tablets

1

Generic Name

Darolutamide Tablets

2

Brand Name

NUBEQA (诺倍戈)

3

Classification

Class 2.4 chemical drug

4

Application Type

NDA, import

5

MAH

Bayer HealthCare Pharmaceuticals Inc.

6

Approval Date

15/03/2023

7

Time from Application Acceptance to Approval

325 days

8

Priority Review

No

9

Target(s)

Androgen receptor

10

Indication(s)

Previously approved:

For the treatment of adult patients with non-metastatic castration resistant prostate cancer (nmCRPC);

Newly approved on Mar. 15, 2023:

For the treatment of metastatic hormone-sensitive prostate cancer (mHSPC).

11. Linezolid and Sodium Chloride Injection

1

Generic Name

Linezolid and Sodium Chloride Injection

2

Brand Name

/

3

Classification

Class 3 chemical drug

4

Application Type

Abbreviated new drug application (ANDA), domestic

5

MAH

Huaxia Shengsheng Pharmaceutical (Beijing) Co., Ltd.

6

Approval Date

24/03/2023

7

Time from Application Acceptance to Approval

554 days

8

Priority Review

No

9

Target(s)

Monoamine Oxidase A

10

Indication(s)

1. For the treatment of nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates) or Streptococcus pneumoniae.

2. For the treatment of community-acquired pneumonia caused by Streptococcus pneumoniae, including cases with concurrent bacteremia, or Staphylococcus aureus (methicillin-susceptible isolates only).

3. For the treatment of complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis, caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, or Streptococcus agalactiae. Linezolid has not been studied in the treatment of decubitus ulcers.

4. For the treatment of vancomycin-resistant Enterococcus faecium infections, including cases with concurrent bacteremia.

11

Note

First generic drug in China

12. Cefoxitin Sodium for Injection and Glucose Injection

1

Generic Name

Cefoxitin Sodium for Injection and Glucose Injection

2

Brand Name

/

3

Classification

Class 3 chemical drug

4

Application Type

ANDA, domestic

5

MAH

Hunan Kelun Pharmaceutical Co., Ltd.

6

Approval Date

24/03/2023

7

Time from Application Acceptance to Approval

421 days

8

Priority Review

No

9

Target(s)

Monoamine Oxidase A

10

Indication(s)

For mixed infections caused by aerobic and anaerobic bacteria, and infections caused by sensitive β-lactamase-producing bacteria.

11

Note

First generic drug in China

13. Fosphenytoin Sodium Concentrated Solution for Injection

1

Generic Name

Fosphenytoin Sodium Concentrated Solution for Injection

2

Brand Name

/

3

Classification

Class 3 chemical drug

4

Application Type

ANDA, domestic

5

MAH

Xi'an Gelan Xintong Pharmaceutical Co., Ltd.

6

Approval Date

15/03/2023

7

Time from Application Acceptance to Approval

587 days

8

Priority Review

No

9

Target(s)

Sodium channel

10

Indication(s)

1. For the prevention and treatment of seizures occurring in the perioperative period or during neurosurgery.

2. For the treatment of generalized tonic-clonic status epilepticus.

11

Note

First generic drug in China

14. Mesalazine Enteric-coated Sustained-release Capsules

1

Generic Name

Mesalazine Enteric-coated Sustained-release Capsules

2

Brand Name

/

3

Classification

Class 3 chemical drug

4

Application Type

ANDA, domestic

5

MAH

Hainan Herui Pharmaceutical Co., Ltd.

6

Approval Date

15/03/2023

7

Time from Application Acceptance to Approval

618 days

8

Priority Review

No

9

Target(s)

Serine/threonine-protein phosphatase 2A (PP2A)

10

Indication(s)

For the maintenance of remission of ulcerative colitis in adults.

11

Note

First generic drug in China

15. Peramivir Injection

1

Generic Name

Peramivir Injection

2

Brand Name

/

3

Classification

Class 3 chemical drug

4

Application Type

ANDA, domestic

5

MAH

Zhongrun Pharmaceutical (Group) Co., Ltd.

6

Approval Date

24/03/2023

7

Time from Application Acceptance to Approval

777 days

8

Priority Review

No

9

Target(s)

Exo-alpha-sialidase

10

Indication(s)

For the treatment of influenza A and influenza B.

11

Note

First generic drug in China

Please contact BaiPharm if you need more details of drug approvals in China.

Read More

Grace Wang
ChemLinked Regulatory Analyst & Editor
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