Monthly Report: New Drug Approvals in China | September 2022

by Grace Wang Oct 08, 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 September 2022, China NMPA approved 16 new drugs, including 12 chemical drugs and 4 biological products.

  1. Nanjing Biosnwill Medical's Edaravone Sublingual Tablet

  2. AstraZeneca's Dapagliflozin Tablets

  3. Bayer's Rivaroxaban Tablets

  4. AstraZeneca's Olaparib Tablets

  5. Yichang Humanwell Pharmaceutical's Clobazam Tablets

  6. Jiangxi Yiyou Pharmaceutical's Bromhexine Hydrochloride Granules

  7. Qilu Pharmaceutical's Aprepitant Injection

  8. Hainan Poly Pharm's Terlipressin Injection

  9. Inner Mongolia Baiyi Pharmaceutical's Compound Vitamins (13) for Injection

  10. Staidson's Polyethylene Glycol Electrolytes Oral Solution

  11. Staidson's Polyethylene Glycol Electrolytes Powder

  12. Kelun Pharmaceutical's Ceftriaxone Sodium for Injection and Sodium Chloride Injection

  13. CStone Pharmaceuticals' Sugemalimab Injection

  14. Lepu Biopharma's Pucotenlimab Injection

  15. Shanghai Junshi Biosciences' Toripalimab Injection

  16. Novartis' Omalizumab Injection

The approval details are as follows.

1. Edaravone Sublingual Tablet

1

Generic Name

Edaravone Sublingual Tablet

2

Brand Name

/

3

Classification

Class 2.2 chemical drug

4

Application Type

New drug application (NDA)

5

Marketing   Authorization Holder (MAH)

Nanjing Biosnwill Medical Co., Ltd.

6

Approval Date

Sept. 19, 2022

7

Time from Application Acceptance to Approval

422 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)

Indicated for inhibiting the progression of dysfunctions caused by amyotrophic lateral sclerosis (ALS).

2. Dapagliflozin Tablets

1

Generic Name

Dapagliflozin Tablets

2

Brand Name

FORXIGA (安达唐)

3

Classification

Class 2.4 chemical drug

4

Application Type

NDA, import

5

MAH

AstraZeneca AB

6

Approval Date

Sept. 2, 2022

7

Time from Application Acceptance to Approval

584 days

8

Priority Review

No

9

Target(s)

Sodium/glucose cotransporter 2 (SLC5A2)

10

Indication(s)

Previously approved:

Indicated ① as a single therapy / ② in combination with metformin hydrochloride / ③ in   combination with insulin, all combined with diet and exercise to improve glycemic control for adults having type 2 diabetes mellitus.

Limitation of use:

Not recommended for treating type 1 diabetes mellitus or diabetic ketoacidosis.

Newly approved on Sept. 2, 2022:

Indicated for reducing the risk of end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease (CKD) at risk of   progression.

3. Rivaroxaban Tablets

1

Generic Name

Rivaroxaban Tablets

2

Brand Name

Xarelto (拜瑞妥)

3

Classification

Class 2.4 chemical drug

4

Application Type

NDA, import

5

MAH

Bayer AG

6

Approval Date

Sept. 2, 2022

7

Time from Application Acceptance to Approval

624 days

8

Priority Review

No

9

Target(s)

Coagulation Factor X

10

Indication(s)

Previously approved:

   1. Indicated for preventing venous thromboembolism (VTE) in adult patients who are going to receive elective hip/knee joint replacement surgery.

   2.  Indicated for treating deep vein thrombosis (DVT) in adult patients, and reducing the risk of recurrence of DVT and/or pulmonary embolism (PE) after acute DVT.

   3.  Indicated for reducing the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation and one or more risk factors (e.g., congestive heart failure, hypertension, ≥ 75 years old, diabetes, history of stroke or transient ischemic attack).

Newly approved on Sept. 2, 2022:

   4.  Indicated for reducing the risk of major thrombotic vascular events (cardiovascular-disease-induced death, myocardial infarction, ischemic stroke, major amputation, and acute limb ischemia) for peripheral artery disease (PAD) patients who have recently received a lower extremity revascularization procedure (surgery or therapeutic intervention).

4. Olaparib Tablets

1

Generic Name

Olaparib Tablets

2

Brand Name

LYNPARZA (利普卓)

3

Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

AstraZeneca AB

6

Approval Date

Sept. 19, 2022

7

Time from Application Acceptance to Approval

257 days

8

Priority Review

No

9

Target(s)

Poly (ADP-Ribose) Polymerase 1 (PARP);

Poly (ADP-Ribose) Polymerase 2 (PARP2);

Protein mono-ADP-ribosyltransferase PARP3

10

Indication(s)

   1. Indicated for the maintenance treatment of germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer in adult patients who are in complete or partial response to first-line platinum-based chemotherapy.

   2.  Indicated for the maintenance treatment of platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in adult patients who are in complete or partial response to platinum-based chemotherapy.

5. Clobazam Tablets

1

Generic Name

Clobazam Tablets

2

Brand Name

/

3

Classification

Class 3 chemical drug

4

Application Type

Abbreviated new drug application (ANDA)

5

MAH

Yichang Humanwell Pharmaceutical Co., Ltd.

6

Approval Date

Sept. 19, 2022

7

Time from Application Acceptance to Approval

187 days

8

Priority Review

Yes (pediatric drug)

9

Target(s)

Benzodiazepine receptor (BZR);

GABAA receptor (GABAAR)

10

Indication(s)

Indicated in combination therapy for treating seizures in patients no younger than two years old with Lennox-Gastaut syndrome (LGS).

11

Notes

First generic drug in China

6. Bromhexine Hydrochloride Granules

1

Generic Name

Bromhexine Hydrochloride Granules

2

Brand Name

/

3

Classification

Class 3 chemical drug

4

Application Type

ANDA

5

MAH

Jiangxi Yiyou Pharmaceutical Co., Ltd.

6

Approval Date

Sept. 19, 2022

7

Time from Application Acceptance to Approval

551 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)

Indicated for treating acute and chronic bronchitis, asthma, bronchiectasis, and pneumoconiosis in patients whose viscid phlegm is difficult to be expectorated.

11

Notes

First generic drug in China

7. Aprepitant Injection

1

Generic Name

Aprepitant Injection

2

Brand Name

/

3

Classification

Class 3 chemical drug

4

Application Type

ANDA

5

MAH

Qilu Pharmaceutical Co., Ltd.

6

Approval Date

Sept. 2, 2022

7

Time from Application Acceptance to Approval

598 days

8

Priority Review

No

9

Target(s)

Substance-P receptor (NK1)

10

Indication(s)

In combination with other antiemetic agents, the drug is indicated for preventing acute and delayed nausea and vomiting associated with initial and/or repeated courses of moderately and highly emetogenic cancer chemotherapy for adult patients with cancer.

11

Notes

First generic drug in China

8. Terlipressin Injection

1

Generic Name

Terlipressin Injection

2

Brand Name

/

3

Classification

Class 3 chemical drug

4

Application Type

ANDA

5

MAH

Hainan Poly Pharm Co., Ltd.

6

Approval Date

Sept. 2, 2022

7

Time from Application Acceptance to Approval

809 days

8

Priority Review

No

9

Target(s)

Vasopressin V1 receptor

10

Indication(s)

   1.  Indicated for treating bleeding in the gastrointestinal tract and genitourinary system, including bleeding caused by esophageal varices, gastric and duodenal ulcers, uterine bleeding caused by functional reasons or other reasons, and bleeding from giving birth or having abortion.

   2.  Indicated for treating post-surgery bleeding, especially in the abdominal and pelvic   areas.

   3.  Local application in gynecological surgery, e.g., in the cervix.

11

Notes

First generic drug in China

9. Compound Vitamins (13) for Injection

1

Generic Name

Compound Vitamins (13) for Injection

2

Brand Name

/

3

Classification

Class 3 chemical drug

4

Application Type

ANDA

5

MAH

Inner Mongolia Baiyi Pharmaceutical Co., Ltd.

6

Approval Date

Sept. 2, 2022

7

Time from Application Acceptance to Approval

1,273 days

8

Priority Review

Yes (ANDA according to the quality and equivalence evaluation standards for generic drugs)

9

Target(s)

/

10

Indication(s)

Indicated for preventing vitamin deficiency in adults or pediatric patients no younger than 11 years old who receive parenteral nutrition.

11

Notes

First generic drug in China

10. Polyethylene Glycol Electrolytes Oral Solution

1

Generic Name

Polyethylene Glycol Electrolytes Oral Solution

2

Brand Name

/

3

Classification

Class 3 chemical drug

4

Application Type

ANDA

5

MAH

Staidson (Beijing) Biopharmaceuticals Co., Ltd.

6

Approval Date

Sept. 23, 2022

7

Time from Application Acceptance to Approval

1,316 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)

Used for cleansing the colon in preparation for colonoscopy or surgery.

11

Notes

First generic drug in China

11. Polyethylene Glycol Electrolytes Powder

1

Generic Name

Polyethylene Glycol Electrolytes Powder

2

Brand Name

/

3

Classification

Class 3 chemical drug

4

Application Type

ANDA

5

MAH

Staidson (Beijing) Biopharmaceuticals Co., Ltd.

6

Approval Date

Sept. 19, 2022

7

Time from Application Acceptance to Approval

1,310 days

8

Priority Review

Yes (pediatric drug)

9

Target(s)

/

10

Indication(s)

   1. Indicated for treating functional constipation;

   2. Used for cleansing the colon in preparation for colon surgery, colonoscopy and other medical tests.

11

Notes

First generic drug in China

12. Ceftriaxone Sodium for Injection and Sodium Chloride Injection

1

Generic Name

Ceftriaxone Sodium for Injection and Sodium Chloride Injection

2

Brand Name

/

3

Classification

Class 3 chemical drug

4

Application Type

ANDA

5

MAH

Hunan Kelun Pharmaceutical Co., Ltd.

6

Approval Date

Sept. 29, 2022

7

Time from Application Acceptance to Approval

1,871 days

8

Priority Review

No

9

Target(s)

Penicillin-binding proteins (PBPs)

10

Indication(s)

Indicated for treating

Ÿ   pneumonia, bronchitis, peritonitis, and pleurisy caused by sensitive bacteria;

Ÿ   infections of skin, soft tissue, urinary tract, biliary tract, bone & joint, eye, nose, mouth, and wound surface;

Ÿ   sepsis and meningitis.

11

Notes

First generic drug in China

13. Sugemalimab Injection

1

Generic Name

Sugemalimab Injection

2

Brand Name

Cejemly (择捷美)

3

Classification

Class 1 therapeutic biological product

4

Application Type

Biologics License Application (BLA)

5

MAH

CStone Pharmaceuticals

6

Approval Date

Sept. 27, 2022

7

Time from Application Acceptance to Approval

16 days

8

Priority Review

No

9

Target(s)

Programmed death-ligand 1 (PD-L1)

10

Indication(s)

Previously approved:

   1. In combination with pemetrexed and carboplatin, the drug is indicated for the first-line treatment of non-small cell lung cancer (NSCLC) that is EGFR mutation-negative, ALK-negative, metastatic, and non-squamous. In combination with paclitaxel and carboplatin, the drug is indicated for the first-line treatment of metastatic squamous NSCLC.

   2. Indicated for the treatment of patients with unresectable stage III NSCLC which didn't progress after platinum-based concurrent or sequential chemoradiotherapy.

Newly approved on Sept. 27, 2022:

   3.  Indicated for treating relapsed/refractory extranodal natural killer (NK) T-cell lymphoma (R/R ENKTL).

14. Pucotenlimab Injection

1

Generic Name

Pucotenlimab Injection

2

Brand Name

Pu You Heng (普佑恒)

3

Classification

Class 1 therapeutic biological product

4

Application Type

BLA

5

MAH

Lepu Biopharma Co., Ltd.

6

Approval Date

Sept. 29, 2022

7

Time from Application Acceptance to Approval

442 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)

   1. Indicated for treating advanced solid tumors that are microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) in patients who have failed at least the first-line systemic treatment.

   2. Indicated for treating unresectable or metastatic melanoma after the failure of systemic treatment.

15. Toripalimab Injection

1

Generic Name

Toripalimab Injection

2

Brand Name

Tuo Yi (拓益)

3

Classification

Class 2.2 therapeutic biological product

4

Application Type

BLA

5

MAH

Shanghai Junshi Biosciences Co., Ltd.

6

Approval Date

Sept. 19, 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)

Previously approved:

   1.  Indicated for treating unresectable or metastatic melanoma after the failure of systemic treatment.

   2. Indicated for the treatment of patients with relapsed or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of systemic therapy.

   3. Indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or the disease progresses within 12 months of neoadjuvant/adjuvant platinum-containing chemotherapy.

   4. Indicated for first-line treatment of patients with locally recurrent or metastatic nasopharyngeal carcinoma in combination with cisplatin and gemcitabine.

   5. In combination with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/relapsed or distant metastatic esophageal squamous cell carcinoma.

Newly approved on Sept. 19, 2022

   6.  In combination with pemetrexed and platinum for the first-line treatment of epidermal growth factor receptor (EGFR) gene mutation-negative, anaplastic lymphoma kinase (ALK)-negative, unresectable locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).

16. Omalizumab Injection

1

Generic Name

Omalizumab Injection

2

Brand Name

Xolair (茁乐)

3

Classification

Class 3.1 therapeutic biological product

4

Application Type

BLA, import

5

MAH

Novartis Europharm Limited

6

Approval Date

Sept. 2, 2022

7

Time from Application Acceptance to Approval

507 days

8

Priority Review

No

9

Target(s)

Immunoglobulin E (IgE)

10

Indication(s)

Indicated for treating moderate to severe persistent asthma in adults and pediatric patients whose symptoms are inadequately controlled by inhaled corticosteroids and inhaled long-acting beta2-adrenergic receptor agonists.

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Grace Wang
ChemLinked Regulatory Analyst
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