Monthly Report: New Drug Approvals in China | July 2021

In July 2021, China NMPA granted 14 new drug approvals for ten imported products and four domestic ones.
by Grace Wang Aug 16, 2021

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 July 2021, China NMPA granted 14 new drug approvals. The details are listed as follows. 

1.  Sonidegib Capsule

1

Generic Name

Sonidegib Capsule

2

Brand Name

Odomzo (奥昔朵)

3

Registration Classification

Class 5.1 imported chemical drug

4

Marketing Authorization Holder (MAH)

Sun Pharma Global FZE

5

Approval Date

July 28, 2021

6

Time from Application Acceptance to Approval

160 days

7

Priority Review & Approval

Yes

8

Target

/

9

Indication(s) and usage

ODOMZO (sonidegib) is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred after surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.


2. Gemcitabine Hydrochloride for Injection

1

Generic Name

Gemcitabine Hydrochloride for Injection

2

Brand Name

Gemzar (健择)

3

Registration Classification

Class 2.4 imported chemical drug

4

MAH

LILLY FRANCE

5

Approval Date

July 26, 2021

6

Time from Application Acceptance to Approval

263 days

7

Priority Review & Approval

No

8

Target

Deoxyribonucleic acid (DNA)

9

Indication(s) and usage

  • Indicated for locally advanced or metastasized non-small cell lung cancer (NSCLC);

  • Indicated for locally advanced or metastasized adenocarcinoma of the pancreas;

  • GEMZAR in combination with paclitaxel is indicated for unresectable/locally relapsed/metastatic breast cancer after failure of prior adjuvant/neoadjuvant anthracycline-containing chemotherapy. Anthracyclines would have been used in the chemotherapy unless they were clinically contraindicated.

 

3. Perampanel Tablets

1

Generic Name

Perampanel Tablets

2

Brand Name

FYCOMPA (卫克泰)

3

Registration Classification

Class 5.1 imported chemical drug

4

MAH

Eisai GmbH

5

Approval Date

July 30, 2021

6

Time from Application Acceptance to Approval

291 days

7

Priority Review & Approval

No

8

Target

AMPA receptor

9

Indication(s) and usage

  • FYCOMPA is indicated as an adjunctive therapy for the treatment of partial seizures (with or without secondarily generalized seizures) in pediatric epilepsy patients aged 12 or older and adult epilepsy patients.

  • FYCOMPA alone is indicated for partial seizures in pediatric epilepsy patients aged 6 or older.

 

4. Sevelamer Carbonate Tablets

1

Generic Name

Sevelamer Carbonate Tablets

2

Brand Name

RENVELA (诺维乐)

3

Registration Classification

Class 5.1 imported chemical drug

4

MAH

Genzyme Europe B.V. (part of Sanofi)

5

Approval Date

July 26, 2021

6

Time from Application Acceptance to Approval

321 days

7

Priority Review & Approval

No

8

Target

Phosphate binder

9

Indication(s) and usage

Renvela is indicated for the control of serum phosphorus in adults who are on dialysis for chronic kidney disease (CKD).

 

5. Azvudine Tablets

1

Generic Name

Azvudine Tablets

2

Brand Name

/

3

Registration Classification

Class 1 innovative chemical drug

4

MAH

Henan Zhenshi Biotechnology Co., Ltd.

5

Approval Date

July 28, 2021

6

Time from Application Acceptance to Approval

386 days

7

Priority Review & Approval

Yes (reason: drug in urgent clinical need; new drug for preventing and treating serious infectious diseases/rare diseases, etc.)

8

Target

Nucleoside reverse transcriptase

9

Indication(s) and usage

Indicated for treating patients infected with Human Immunodeficiency Virus (HIV).

 

6. Sacubitril Valsartan Sodium Tablets

1

Generic Name

Sacubitril Valsartan Sodium Tablets

2

Brand Name

Entresto (诺欣妥)

3

Registration Classification

Class 2.4 imported chemical drug

4

MAH

Novartis Pharma Schweiz AG

5

Approval Date

July 8, 2021

6

Time from Application Acceptance to Approval

392 days

7

Priority Review & Approval

No

8

Target

Type-1 angiotensin II receptor (AGTR1);

Epithelial discoidin domain-containing receptor 1 (DDR1)

9

Indication(s) and usage

  • ENTRESTO is indicated to reduce the risk of cardiovascular death and hospitalization of adult patients with chronic heart failure  (New York Heart Association (NYHA) class Ⅱ-Ⅳ) or with left ventricular ejection fraction (LVEF) below normal (≤40%).

  • ENTRESTO can replace Angiotensin Converting Enzyme Inhibitors (ACEI) or Angiotensin II Receptor Blockers (ARBs), to be used in combination with other chronic heart failure medications such as β-receptor blocker, diuretics, and mineralocorticoid antagonists.

 

7. Infliximab for Injection

1

Generic Name

Infliximab for Injection

2

Brand Name

类停

3

Registration Classification

Class 2 therapeutic biologic product

4

MAH

Taizhou Mabtech Pharmaceutical Limited

5

Approval Date

July 16, 2021

6

Time from Application Acceptance to Approval

529 days

7

Priority Review & Approval

No

8

Target

Tumor necrosis factor (TNF)

9

Indication(s) and usage

(1) Rheumatoid arthritis (RA)

  • The drug, in combination with methotrexate, is indicated for reducing signs and symptoms of RA, improving patient's physical function, inhibiting the progression of structural damage in patients with moderately to severely active RA.

(2) Crohn's disease (CD) in adults and pediatric patients aged 6 or older with moderately to severely active CD who have had an inadequate response to conventional therapy

  • Indicated for reducing signs and symptoms of CD, inducing and maintaining clinical remission, inducing mucosal healing in adult patients, and helping adult patients to reduce or stop the use of adrenocortical hormones.

(3) Fistula Crohn's disease

  • Indicated for reducing the number of enterocutaneous or rectovaginal fistulas, inducing and maintaining fistula healing, and reducing signs and symptoms.

(4) Ankylosing spondylitis (AS)

  • Indicated for reducing signs and symptoms of AS, increasing the range of motion, and improving body functions.

(5) Psoriasis

  • Indicated for the treatment for adult patients with chronic severe plaque psoriasis who need systemic therapy and have had an inadequate response to cyclosporin A/methotrexate therapy or photochemotherapy.

  • Should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

(6) Ulcerative colitis (UC) in adults

  • Indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and reduce or stop the corticosteroid use in adult patients with moderately to severely active UC who have had an inadequate response to conventional therapy.

 

8. Carfilzomib for Injection

1

Generic Name

Carfilzomib for Injection

2

Brand Name

Kyprolis (凯洛斯)

3

Registration Classification

Class 5.1 imported chemical drug

4

MAH

Onyx Pharmaceuticals, Inc.

5

Approval Date

July 9, 2021

6

Time from Application Acceptance to Approval

591 days

7

Priority Review & Approval

No

8

Target

Proteasome subunit beta type-5 (PSMB5);

Proteasome subunit beta type-8 (PSMB8);

Proteasome subunit beta type-2 (PSMB2);

Proteasome subunit beta type-10 (PSMB10);

Proteasome subunit beta type-1 (PSMB1);

Multidrug resistance protein 1 (ABCB1);

Proteasome subunit beta type-9 (PSMB9).

9

Indication(s) and usage

Kyprolis is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma.

 

9. Multi-trace Elements Injection (III)

1

Generic Name

Multi-trace Elements Injection (III)

2

Brand Name

/

3

Registration Classification

Class 5.1 imported chemical drug

4

MAH

Fresenius Kabi AB

5

Approval Date

July 23, 2021

6

Time from Application Acceptance to Approval

666 days

7

Priority Review & Approval

No

8

Target

/

9

Indication(s) and usage

/

 

10. Olaparib Tablets

1

Generic Name

Olaparib Tablets

2

Brand Name

LYNPARZA (利普卓)

3

Registration Classification

Class 5.1 imported chemical drug

4

MAH

AstraZeneca AB

5

Approval Date

July 28, 2021

6

Time from Application Acceptance to Approval

859 days

7

Priority Review & Approval

No

8

Target

Poly [ADP-ribose] polymerase 1 (PARP1);

Cytochrome P450 2B6 (CYP2B6);

Poly [ADP-ribose] polymerase 3 (PARP3);

Cytochrome P450 3A4 (CYP3A4);

Poly [ADP-ribose] polymerase 2 (PARP2).

9

Indication(s) and usage

LYNPARZA is indicated for

  • the maintenance treatment for adult patients with (i) germline or somatic BRCA-mutated (gBRCAm/sBRCAm) advanced epithelial ovarian cancer, (ii) fallopian tube cancer or (iii) primary peritoneal cancer who have complete or partial response to first-line platinum-based chemotherapy.  

  • the maintenance treatment for adult patients with recurrent platinum-sensitive epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer, who have complete or partial response to platinum-based chemotherapy.

 

11. Oxycodone Hydrochloride Sustained-release Tablets

1

Generic Name

Oxycodone Hydrochloride Sustained-release Tablets

2

Brand Name

/

3

Registration Classification

Class 5.1 imported chemical drug

4

MAH

Purdue Pharma L.P.

5

Approval Date

July 8, 2021

6

Time from Application Acceptance to Approval

904 days

7

Priority Review & Approval

No

8

Target

Opioid receptor mu

9

Indication(s) and usage

Indicated for relieving the sustaining moderate to severe pain.

 

12. Raltegravir Potassium Tablets

1

Generic Name

Raltegravir Potassium Tablets

2

Brand Name

ISENTRESS (艾生特)

3

Registration Classification

Class 5.1 imported chemical drug

4

MAH

Merck Sharp & Dohme B.V.

5

Approval Date

July 8, 2021

6

Time from Application Acceptance to Approval

955 days

7

Priority Review & Approval

No

8

Target

Integrase

9

Indication(s) and usage

Indicated in combination with other antiretroviral agents for the treatment of adult human immunodeficiency virus (HIV-1)  patients who show evidence of virus replication and are intolerant to multiple antiretroviral agents.

 

13. Sodium Levofolinate Acid for Injection

1

Generic Name

Sodium Levofolinate Acid for Injection

2

Brand Name

/

3

Registration Classification

Class 2.2 chemical drug

4

MAH

Shanghai Huilun Jiangsu Pharmaceutical Co., Ltd., Shanghai Huilun Life Science &Technology Co., Ltd.

5

Approval Date

July 8, 2021

6

Time from Application Acceptance to Approval

1,259 days

7

Priority Review & Approval

Yes

8

Target

/

9

Indication(s) and usage

  • Indicated for diminishing the toxicity and counteracting the action of folic acid antagonists such as methotrexate in cytotoxic therapy and overdose in adults and children,

  • In combination with 5-fluorouracil in cytotoxic therapy for stomach/colorectal cancer.

 

14. Safflower Yellow Capsules

1

Generic Name

Safflower Yellow Capsules

2

Brand Name

/

3

Registration Classification

Class 5 traditional Chinese medicine

4

MAH

Reyoung Pharmaceutical Co., Ltd.

5

Approval Date

July 22, 2021

6

Time from Application Acceptance to Approval

3,447 days

7

Priority Review & Approval

No

8

Target

/

9

Indication(s) and usage

Indicated for cerebral infarction.

 

If you have any questions about drug registration and marketing approval procedures in China, please send them to contact@chemlinked.com. Our ChemLinked BaiPharm Team will be glad to offer answers and solutions. We also recommend you to sign up at the ChemLinked webinar "China Drug Registration Classification System" which is scheduled to take place on Sept. 15. Webinar link: https://baipharm.chemlinked.com/new-webinar/china-drug-registration-classification-system.

Grace Wang
ChemLinked Regulatory Analyst
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