Monthly Report: New Drug Approvals in China | June 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 June 2021, China NMPA granted 21 new drug approvals, of which the details are listed as follows.

1. Levornidazole Disodium Phosphate for Injection

1	Generic Name	Levornidazole Disodium Phosphate for Injection
2	Brand Name	Xinrui (新锐)
3	Registration Classification	Class 1 Chemical drug
4	Marketing Authorization Holder (MAH)	Jiangsu Zilong Pharmaceutical Co., Ltd. of Yangtze River Pharmaceutical Group
5	Approval Date	June 2, 2021
6	Time from Application Acceptance to Approval	663 days
7	Priority Review & Approval	Yes (Reason: innovative drug)
8	Target	/
9	Indication(s) and usage	Levornidazole Disodium Phosphate is indicated for treating multiple infections caused by oxygen-sensitive anaerobic bacteria such as Bacteroides fragilis, Parabacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus, Clostridium Prazmowski, Eubacterium, Peptococcus, Peptostreptococcus, Helicobacter pylori, Prevotella melaninogenica, Fusobacterium, Capnocytophaga, Oribaculum catoniae, etc.

2. Rosuvastatin Calcium Tablets

1	Generic Name	Rosuvastatin Calcium Tablets
2	Brand Name	Crestor (可定)
3	Registration Classification	Class 5.1 Chemical drug
4	MAH	Astrazeneca UK limited
5	Approval Date	June 4, 2021
6	Time from Application Acceptance to Approval	415 days
7	Priority Review & Approval	No
8	Target	Hydroxymethylglutaryl-CoA (HMG-CoA) Reductase
9	Indication(s) and usage	Rosuvastatin Calcium Tablets are indicated for treating primary Hyperlipoproteinemia Type IIa (including familial combined hyperlipidemia) and Type IIb hyperlipoproteinemia that have failed diet and other non-medical treatments. The tablets are also indicated as adjunctive diet therapy or other lipid-lowering treatments for patients with homozygous familial hypercholesterolemia (e.g., LDL apheresis) or indicated alone if these treatments are inapplicable.

3. Sacubitril Valsartan Sodium Tablets

1	Generic Name	Sacubitril Valsartan Sodium Tablets
2	Brand Name	Entresto
3	Registration Classification	Class 2.4 Chemical Drug
4	MAH	Novartis Pharma Schweiz AG
5	Approval Date	June 4, 2021
6	Time from Application Acceptance to Approval	358 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	Sacubitril Valsartan Sodium Tablets are indicated for adult patients with symptomatic chronic heart failure (NYHA CLASS Ⅱ-Ⅳ) and systolic dysfunction (left ventricular ejection fraction [LVEF≤40%] to reduce the risk of cardiovascular death or hospitalization due to heart failure. The tablets can be used instead of an ACE inhibitor or an angiotensin receptor blocker for people with heart failure and a reduced left ventricular ejection fraction (LVEF), alongside other heart failure therapies (e.g. beta-blockers, diuretic, mineralocorticoid-receptor antagonists).

4. Sintilimab Injection

1	Generic Name	Sintilimab Injection
2	Brand Name	Tyvyt (达伯舒)
3	Registration Classification	Class 2.2 Therapeutic Biological Product
4	MAH	Innovent Biologics, Inc.
5	Approval Date	June 4, 2021
6	Time from Application Acceptance to Approval	291 days
7	Priority Review & Approval	No
8	Target	Programmed cell death protein 1 (PD-1)
9	Indication(s) and usage	Sintilimab is indicated for the treatment of relapsed or refractory classical Hodgkin's lymphoma after at least a second-line systemic chemotherapy fails.

5. Contezolid Tablets

1	Generic Name	Contezolid Tablets
2	Brand Name	/
3	Registration Classification	Class 1 Innovative Chemical Drug
4	MAH	Zhejiang Huahai Pharmaceutical Co., Ltd, MicuRx Pharmaceuticals, Inc.
5	Approval Date	June 4, 2021
6	Time from Application Acceptance to Approval	518 days
7	Priority Review & Approval	Yes (Reason: innovative drug)
8	Target	50S ribosomal subunit
9	Indication(s) and usage	Contezolid Tablets are indicated for complex skin and soft-tissue infections caused by Streptococcus bacteria, including Staphylococcus aureus (bacteria strains that are sensitive or resistant to methicillin), Streptococcus, Streptococcus agalactiae, S. dysgalactiae equisimilis, and Streptococcus anginosus.

6. Icotinib Hydrochloride Tablets

1	Generic Name	Icotinib Hydrochloride Tablets
2	Brand Name	Conmana (凯美纳)
3	Registration Classification	Class 2.4 Chemical Drug
4	MAH	Betta Pharmaceuticals Co., Ltd.
5	Approval Date	June 9, 2021
6	Time from Application Acceptance to Approval	8
7	Priority Review & Approval	Yes (Reason: others)
8	Target	EGFR-TKI
9	Indication(s) and usage	Icotinib Hydrochloride Tablets are used as a monotherapy for treatment of locally advanced or metastatic non-small-cell lung carcinoma (NSCLC) after failure of at least one prior chemotherapy (mainly referring to Platinum-based combination chemotherapy).

7. Camrelizumab for Injection (supplemental application)

1	Generic Name	Camrelizumab for Injection
2	Brand Name	AiRuiKa (艾瑞卡)
3	Registration Classification	Class 1 Therapeutic Biological Product
4	MAH	Suzhou Shengdiya Biomedicine Co., Ltd.
5	Approval Date	June 9, 2021
6	Time from Application Acceptance to Approval	84 days
7	Priority Review & Approval	No
8	Target	Programmed cell death protein 1 (PD-1)
9	Indication(s) and usage	Camrelizumab was approved with a new indication: for the treatment of relapsed or refractory classical Hodgkin's lymphoma after at least a second-line systemic chemotherapy fails.

8. Camrelizumab for Injection

1	Generic Name	Camrelizumab for Injection
2	Brand Name	/
3	Registration Classification	Class 2.2 Therapeutic Biological Product
4	MAH	Suzhou Shengdiya Biomedicine Co., Ltd.
5	Approval Date	June 11, 2021
6	Time from Application Acceptance to Approval	213 days
7	Priority Review & Approval	Yes (Reason: others)
8	Target	Programmed cell death protein 1 (PD-1)
9	Indication(s) and usage	Camrelizumab for Injection is used with Cisplatin and Gemcitabine for the first-line treatment of locally relapsed or metastatic nasopharyngeal carcinoma.

9. Donafenib Tosilate Tablets

1	Generic Name	Donafenib Tosilate Tablets
2	Brand Name	ZEPSUN (泽普生)
3	Registration Classification	Class 1 Chemical Drug
4	MAH	Suzhou Zelgen Biopharmaceuticals Co., Ltd.
5	Approval Date	June 11, 2021
6	Time from Application Acceptance to Approval	394 days
7	Priority Review & Approval	Yes (Reason: others)
8	Target	RAF proto-oncogene serine/threonine-protein kinase
9	Indication(s) and usage	Donafenib Tosilate Tablets are used to treat advanced (resistant to surgery or metastatic) hepatocellular carcinoma.

10. Pemetrexed Disodium for Injection

1	Generic Name	Pemetrexed Disodium for Injection
2	Brand Name	Alimta (力比泰)
3	Registration Classification	Class 2.4 Chemical Drug
4	MAH	Eli Lilly Nederland B.V.
5	Approval Date	June 11, 2021
6	Time from Application Acceptance to Approval	344 days
7	Priority Review & Approval	No
8	Target	DHFR; GAR transformylase; Thymidylate synthase; Transferase
9	Indication(s) and usage	Pemetrexed Disodium for Injection is indicated in combination with cisplatin therapy for the initial treatment of patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). The drug alone is indicated for the maintenance treatment of patients with locally advanced or metastatic non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. The drug alone is indicated for the treatment of patients with locally advanced or metastatic non-squamous NSCLC after prior chemotherapy. Pemetrexed Disodium for Injection is NOT indicated for the treatment mainly for squamous cell non-small cell lung cancer.

11. Pemetrexed Disodium for Injection

1	Generic Name	Pemetrexed Disodium for Injection
2	Brand Name	Alimta (力比泰)
3	Registration Classification	Class 5.1 Chemical Drug
4	MAH	Eli Lilly Nederland B.V.
5	Approval Date	June 11, 2021
6	Time from Application Acceptance to Approval	364 days
7	Priority Review & Approval	No
8	Target	DHFR; GAR transformylase; Thymidylate synthase; Transferase
9	Indication(s) and usage	Pemetrexed Disodium for Injection is indicated in combination with cisplatin therapy for the initial treatment of patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). The drug alone is indicated for the maintenance treatment of patients with locally advanced or metastatic non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. The drug alone is indicated for the treatment of patients with locally advanced or metastatic non-squamous NSCLC after prior chemotherapy. Pemetrexed Disodium for Injection is NOT indicated for the treatment mainly for squamous cell non-small cell lung cancer.

12. Disitamab Vedotin for Injection

1	Generic Name	Disitamab Vedotin for Injection
2	Brand Name	/
3	Registration Classification	Class 1 Therapeutic Biological Product
4	MAH	RemeGen Co., Ltd.
5	Approval Date	June 11, 2021
6	Time from Application Acceptance to Approval	302 days
7	Priority Review & Approval	Yes (Reason: conditional approval)
8	Target	Receptor tyrosine-protein kinase erbB-2 (HER-2); Tubulin
9	Indication(s) and usage	Disitamab Vedotin is indicated for the treatment of patients with human epidermal growth factor receptor-2 (HER2) overexpression locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) who have received at least two systemic chemotherapy treatments after relapse or metastasis. HER2 overexpression means the result of ImmunoHistoChemistry (IHC) for HER2 testing is 2+ or 3+.

13. Nemonoxacin Malate and Sodium Chloride Injection

1	Generic Name	Nemonoxacin Malate and Sodium Chloride Injection
2	Brand Name	/
3	Registration Classification	Class 1 Chemical Drug
4	MAH	Zhejiang Medicine Co., Ltd.
5	Approval Date	June 24, 2021
6	Time from Application Acceptance to Approval	1,485 days
7	Priority Review & Approval	Yes
8	Target	Bacterial DNA gyrase; Topoisomerase IV
9	Indication(s) and usage	Nemonoxacin Malate and Sodium Chloride Injection can be used to treat adults aged more than 18 years old with mild, moderate and severe community-acquired pneumonia caused by Streptococcus pneumonia, Staphylococcus aureus, Haemophilus influenza, Haemophilus parainfluenzae, Moraxella catarrhalis, Carbapenem-resistant Enterobacteriaceae (CRE), Escherichia coli, Pseudomonas aeruginosa, Acinetobacter baumannii, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Legionella pneumophila.

14. Ipilimumab Injection

1	Generic Name	Ipilimumab Injection
2	Brand Name	YERVOY (逸沃)
3	Registration Classification	Class 3.1 Therapeutic Biological Product
4	MAH	Bristol-Myers Squibb Company
5	Approval Date	June 11, 2021
6	Time from Application Acceptance to Approval	191 days
7	Priority Review & Approval	Yes (Reason: conditional approval)
8	Target	Cytotoxic T-lymphocyte antigen 4 (CTLA4)
9	Indication(s) and usage	YERVOY, in combination with nivolumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.

15. Risdiplam Powder for Oral Solution

1	Generic Name	Risdiplam Powder for Oral Solution
2	Brand Name	Evrysdi (艾满欣)
3	Registration Classification	Class 1 Chemical Drug
4	MAH	F. Hoffmann-La Roche AG
5	Approval Date	Jun. 16, 2021
6	Time from Application Acceptance to Approval	/
7	Priority Review & Approval	Yes (Reason: A rare disease drug for children)
8	Target	/
9	Indication(s) and usage	EVRYSDI is indicated for the treatment of spinal muscular atrophy (SMA) for patients 2 months of age and older.

16. Herombopag Olamine Tablets

1	Generic Name	Herombopag Olamine Tablets
2	Brand Name	Heng Qu (恒曲)
3	Registration Classification	Class 1 Chemical Drug
4	MAH	Jiangsu Hengrui Pharmaceuticals Co., Ltd.
5	Approval Date	June 16, 2021
6	Time from Application Acceptance to Approval	/
7	Priority Review & Approval	Yes
8	Target	/
9	Indication(s) and usage	PROMACTA is indicated for the treatment of adult patients with chronic primary immune thrombocytopenia (ITP) who (1) have increased risk of bleeding due to platelet reduction and clinical conditions or (2) have had an insufficient response to corticosteroids, immunoglobulins, or other treatments. (Conditional approval for the following indication) It is also indicated for the treatment of adult patients with severe aplastic anemia (SAA) when immunosuppressive therapy to treat SAA has not worked well enough.

17. Axicabtagene Ciloleucel Injection

（Notes: You can also refer to the BaiPharm report on Axicabtagene Ciloleucel [Yescarta] becoming the first CAR-T therapy approved in China）

1	Generic Name	Axicabtagene Ciloleucel Injection
2	Brand Name	Yescarta (奕凯达)
3	Registration Classification	Class 1 Therapeutic Biological Product
4	MAH	Fosun Kite Biotechnology Co., Ltd.
5	Approval Date	June 22, 2021
6	Time from Application Acceptance to Approval	/
7	Priority Review & Approval	Yes
8	Target	B-lymphocyte antigen CD19 (CD19)
9	Indication(s) and usage	Yescarta is indicated for adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy. Specific indications are diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma.

18. Savolitinib Tablets

1	Generic Name	Savolitinib Tablets
2	Brand Name	ORPATHYS (沃瑞沙)
3	Registration Classification	Class 1 Chemical Drug
4	MAH	Hutchison Whampoa Limited (HWL)
5	Approval Date	June 22, 2021
6	Time from Application Acceptance to Approval	/
7	Priority Review & Approval	Yes
8	Target	Hepatocyte growth factor receptor (MET)
9	Indication(s) and usage	Savolitinib Tablets are indicated for treating adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) with MET exon 14 skipping alterations (METex14) who experienced disease progression after previous platinum-based chemotherapy or were intolerant to the chemotherapy.

19. Tenofovir Amibufenamide Tablets

1	Generic Name	Tenofovir Amibufenamide Tablets
2	Brand Name	Heng Mu (恒沐)
3	Registration Classification	Class 1 Chemical Drug
4	MAH	Jiangsu Hansoh Pharmaceutical Group Co., Ltd.
5	Approval Date	June 22, 2021
6	Time from Application Acceptance to Approval	/
7	Priority Review & Approval	Yes
8	Target	/
9	Indication(s) and usage	Tenofovir Amibufenamide Tablets are indicated for treating adult patients with chronic hepatitis B.

20. Hybutimibe Tablets

1	Generic Name	Hybutimibe Tablets
2	Brand Name	Sai Si Mei (赛斯美)
3	Registration Classification	Class 1 Chemical Drug
4	MAH	Zhejiang Hisun Pharmaceutical Co., Ltd.
5	Approval Date	June 25, 2021
6	Time from Application Acceptance to Approval	/
7	Priority Review & Approval	Yes
8	Target	/
9	Indication(s) and usage	Hybutimibe Tablets can be an adjunctive treatment along with diet control. They can also be used alone or in combination with hydroxymethylglutaryl-CoA (HMG-CoA) reductase inhibitors (statins) for the treatment of primary (heterozygous familial or non-familial) hypercholesterolemia.

21. Ainuovirine Tablets

1	Generic Name	Ainuovirine Tablets
2	Brand Name	Ai Bang De (艾邦德)
3	Registration Classification	Class 1 Chemical Drug
4	MAH	Jiangsu Aidea Pharmaceutical Co., Ltd.
5	Approval Date	June 25, 2021
6	Time from Application Acceptance to Approval	/
7	Priority Review & Approval	Yes
8	Target	/
9	Indication(s) and usage	Ainuovirine Tablets are used in combination with nucleoside reverse transcriptase inhibitors (NRTIs) for the first-line treatment of adult patients with HIV-1 infection.