Monthly Report: New Drug Approvals in China | April 2023

by Grace Wang May 10, 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 Apr. 2023, China NMPA approved 13 new drugs, among which 11 are chemical drugs while 2 are biological products. 

1. AstraZeneca’s Selumetinib Hydrogen Sulfate Capsules

2. Novartis’ Ruxolitinib Phosphate Tablets

3. Janssen-Cilag’s Esketamine Hydrochloride Nasal Spray

4. Hengrui Pharma’s Pyrotinib Maleate Tablets

5. InnoCare Pharma’s Orelabrutinib Tablets

6. Livzon Pharma’s Ilaprazole Sodium for Injection

7. BeiGene’s Zanubrutinib Capsules

8. Nhwa Pharma’s Oliceridine Fumarate Injection

9. Heze Pharma’s Desmopressin Acetate Oral Solution

10. Beijing Baiao Pharma’s Omeprazole and Sodium Bicarbonate Capsules (II)

11. Tianjin Jinyao Pharma’s Diflucortolone Valerate Cream

12. Pfizer’s 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

13. Lanzhou Institute of Biological Products’ 3-valent Rotavirus Gene Recombination Vaccine 

The approval details are as follows.

1.  Selumetinib Hydrogen Sulfate Capsules

1

Generic Name

Selumetinib Hydrogen Sulfate Capsules

2

Brand Name

KOSELUG/科赛优

3

Classification

Class 5.1 chemical drug

4

Application Type

New drug application (NDA), import

5

Marketing Authorization Holder (MAH)

ASTRAZENECA UK LIMITED

6

Approval Date

28/04/2023

7

Time from Application Acceptance to Approval

319 days

8

Priority Review

Yes (pediatric use)

9

Target(s)

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

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

10

Indication(s)

For treating children 3 years of age and older with neurofibromatosis type 1 (NF1) and symptomatic and inoperable plexiform neurofibromas (PN).

2. Ruxolitinib Phosphate Tablets

1

Generic Name

Ruxolitinib Phosphate Tablets

2

Brand Name

Jakavi/捷恪卫

3

Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

Novartis Pharma Schweiz AG

6

Approval Date

11/04/2023

7

Time from Application Acceptance to Approval

319 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 intermediate or high-risk primary myelofibrosis (PMF), also known as chronic idiopathic myelofibrosis, post-polycythemia vera myelofibrosis (PPV-MF), and essential thrombocythemia myelofibrosis (PET-MF) in adult patients with disease-related symptoms, especially splenomegaly.

 

Newly approved:

For the treatment of steroid-refractory acute graft-versus-host disease (aGVHD) in patients 12 years and older who have inadequate response to glucocorticoid or other systemic therapies.

3. Esketamine Hydrochloride Nasal Spray

1

Generic Name

Esketamine Hydrochloride Nasal Spray

2

Brand Name

/

3

Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

Janssen-Cilag International NV

6

Approval Date

17/04/2023

7

Time from Application Acceptance to Approval

445 days

8

Priority Review

No

9

Target(s)

N-Methyl-D-Aspartate receptor (NMDAR)

10

Indication(s)

Indicated, in conjunction with an oral antidepressant, for the treatment of depressive symptoms in adults who have major depressive disorder (MDD) with acute suicidal ideation or behavior.

4. Pyrotinib Maleate Tablets

1

Generic Name

Pyrotinib Maleate Tablets

2

Brand Name

艾瑞妮 (Ai Rui Ni)

3

Classification

Class 2.4 chemical drug

4

Application Type

NDA, domestic

5

MAH

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

6

Approval Date

17/04/2023

7

Time from Application Acceptance to Approval

190 days

8

Priority Review

Yes (breakthrough therapy)

9

Target(s)

Epidermal growth factor receptor (EGFR);

Receptor tyrosine-protein kinase erbB-2 (HER2)

10

Indication(s)

Previously approved:

1. Conditional approval: In combination with capecitabine for the treatment of HER2-positive, relapsed or metastatic breast cancer in patients with/without prior trastuzumab therapy. Patients should receive anthracycline or taxane chemotherapy therapy before using pyrotinib.

2. As a neoadjuvant therapy, in combination with trastuzumab and docetaxel, for HER2-positive, primary or locally advanced breast cancer patients.

Newly approved:

3. Indicated, in combination with trastuzumab and docetaxel, for the treatment of HER2-postive, relapsed or metastatic breast cancer patients who have not received anti-HER2 therapy in the advanced stage.

5. Orelabrutinib Tablets

1

Generic Name

Orelabrutinib Tablets

2

Brand Name

宜诺凯 (Yi Nuo Kai)

3

Classification

Class 2.4 chemical drug

4

Application Type

NDA, import

5

MAH

InnoCare Pharma Limited

6

Approval Date

17/04/2023

7

Time from Application Acceptance to Approval

245 days

8

Priority Review

Yes (conditional approval)

9

Target(s)

Tyrosine-protein kinase BTK

10

Indication(s)

Previously approved:

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

2. For the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) in adult patients who have received at least one therapy.

Newly approved:

3. For the treatment of relapsed/refractory marginal zone lymphoma (MZL).

6. Ilaprazole Sodium for Injection

1

Generic Name

Ilaprazole Sodium for Injection

2

Brand Name

壹丽安 (Yi Li An)

3

Classification

Class 2.4 chemical drug

4

Application Type

NDA, domestic

5

MAH

Livzon Pharmaceutical Group Inc.

6

Approval Date

28/04/2023

7

Time from Application Acceptance to Approval

283 days

8

Priority Review

No

9

Target(s)

H+ K+ ATPase

10

Indication(s)

For the treatment of peptic ulcer and reflux esophagitis.

7. Zanubrutinib Capsules

1

Generic Name

Zanubrutinib Capsules

2

Brand Name

百悦泽/BRUKINSA

3

Classification

Class 2.4 chemical drug

4

Application Type

NDA, domestic

5

MAH

BeiGene (Suzhou) Biotech Co., Ltd.

6

Approval Date

28/04/2023

7

Time from Application Acceptance to Approval

455 days

8

Priority Review

No

9

Target(s)

Tyrosine-protein kinase BTK

10

Indication(s)

Previously approved:

1. For the treatment of mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL) in adult patients who have received at least one therapy.

2. For the treatment of waldenstrom macroglobulinemia (WM) in adult patients who have received at least one therapy.

Newly approved:

3. For the treatment of newly diagnosed (not treated before) CLL/SLL in adult patients;

4. For the treatment of newly diagnosed (not treated before) WM patients.

8. Oliceridine Fumarate Injection

1

Generic Name

Oliceridine Fumarate Injection

2

Brand Name

/

3

Classification

Class 3 chemical drug

4

Application Type

Abbreviated new drug application (ANDA), domestic

5

MAH

Jiangsu Nhwa Pharmaceutical Co., Ltd.

6

Approval Date

28/04/2023

7

Time from Application Acceptance to Approval

392 days

8

Priority Review

No

9

Target(s)

Mu-type opioid receptor (OPRM1)

10

Indication(s)

Indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.

11

Note

First generic in China

9. Desmopressin Acetate Oral Solution

1

Generic Name

Desmopressin Acetate Oral Solution

2

Brand Name

/

3

Classification

Class 3 chemical drug

4

Application Type

ANDA, domestic

5

MAH

Heze Pharmaceutical Co., Ltd.

6

Approval Date

28/04/2023

7

Time from Application Acceptance to Approval

462 days

8

Priority Review

No

9

Target(s)

Vasopressin receptor

10

Indication(s)

1. For the treatment of central diabetes insipidus.

2. For the treatment of primary nocturnal enuresis in patients (over 5 years of age) normal urine concentrating ability.

11

Note

First generic in China

10. Omeprazole and Sodium Bicarbonate Capsules (II)

1

Generic Name

Omeprazole and Sodium Bicarbonate Capsules(II)

2

Brand Name

/

3

Classification

Class 3 chemical drug

4

Application Type

ANDA, domestic

5

MAH

Beijing Baiao Pharmaceuticals Co., Ltd.

6

Approval Date

04/04/2023

7

Time from Application Acceptance to Approval

467 days

8

Priority Review

No

9

Target(s)

H+ K+ ATPase

10

Indication(s)

Indicated in adults for the:

1. short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

2. short-term treatment (4 to 8 weeks) of active benign gastric ulcer.

3. treatment of heartburn and other symptoms associated with GERD for up to 4 weeks.

4. short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD which has been diagnosed by endoscopy in adults.

5. maintenance of healing of EE due to acid-mediated GERD. Controlled studies do not extend beyond 12 months.

11

Note

First generic in China

11. Diflucortolone Valerate Cream

1

Generic Name

Diflucortolone Valerate Cream

2

Brand Name

/

3

Classification

Class 3 chemical drug

4

Application Type

ANDA, domestic

5

MAH

Tianjin Jinyao Pharmaceutical Co., Ltd.

6

Approval Date

28/04/2023

7

Time from Application Acceptance to Approval

850 days

8

Priority Review

No

9

Target(s)

Glucocorticoid receptor (GR)

10

Indication(s)

For the treatment of eczema, allergic contact dermatitis, neurodermatitis, psoriasis, seborrheic dermatitis, diaper rash, and heat rash.

11

Note

First generic in China

12. 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

1

Generic Name

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

2

Brand Name

沛儿13/Prevenar 13

3

Classification

Class 3.1 prophylactic biological product

4

Application Type

Biologics License Application (BLA), import

5

MAH

Pfizer Europe MA EEIG

6

Approval Date

17/04/2023

7

Time from Application Acceptance to Approval

782 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)

Prevenar 13 is used for active immunization in infants and young children to prevent invasive diseases (including Bacteremic pneumonia, meningitis, sepsis, bacterimia, etc.) caused by serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, or 23F of Streptococcus pneumoniae.

Pneumococcus is the most common cause of invasive diseases, pneumonia, and upper respiratory tract infections.

Prevenar 13 can only provide prevention against the pneumococcal serotypes contained in the vaccine, but cannot prevent invasive diseases, pneumonia, or otitis media caused by serotypes or microorganisms not contained in this product.

 13. 3-valent Rotavirus Gene Recombination Vaccine

1

Generic Name

3-valent Rotavirus Gene Recombination Vaccine

2

Brand Name

/

3

Classification

Class 1 biological product

4

Application Type

BLA, domestic

5

MAH

Lanzhou Institute of Biological Products Co., Ltd.

6

Approval Date

17/04/2023

7

Time from Application Acceptance to Approval

2,342 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)

For the prevention of rotavirus gastroenteritis in infants and young children caused by rotavirus.

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

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