Monthly Report: New Drug Approvals in China | July 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 a Chinese company and approved by China National Medical Products Administration (NMPA) with marketing authorization.

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.