Monthly Report: New Drug Approvals in China | February 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.

In February 2022, China NMPA approved 16 new drugs, including 12 chemical drugs and 4 biological products. Among the newly approved drugs, Pfizer's Paxlovid is the first foreign drug against COVID-19 to receive marketing authorization in China. [Read More]

1. Nirmatrelvir/Ritonavir Tablets

1	Generic Name	Nirmatrelvir/Ritonavir Tablets
2	Brand Name	Paxlovid
3	Registration Classification	Class 5.1 chemical drug
4	Application Type	New drug application (NDA)
5	Marketing Authorization Holder (MAH)	Pfizer Inc.
6	Approval Date	Feb. 11, 2022
7	Time from Application Acceptance to Approval	/
8	Priority Review	/
9	Target(s)	/
10	Indication(s)	For treating mild-to-moderate COVID-19 pneumonia in adult patients with a high risk of developing into severe conditions. The high risk may be advanced age, or with a severe disease such as chronic kidney disease, diabetes, cardiovascular disease, or chronic pneumonia.

2. Montmorillonite Suspension

1	Generic Name	Montmorillonite Suspension
2	Brand Name	/
3	Registration Classification	Class 5.1 chemical drug
4	Application Type	NDA
5	MAH	Beaufour-Ipsen (Tianjin) Pharmaceutical Co., Ltd.
6	Approval Date	Feb. 24, 2022
7	Time from Application Acceptance to Approval	232 days
8	Priority Review	No
9	Target(s)	/
10	Indication(s)	For treating chronic or acute diarrhea in adult and pediatric patients. As an adjuvant treatment for pains caused by esophagus, stomach, or duodenum disease. NOT indicated as an antispasmodic drug.

3. Yttrium [Y-90] Resin Microspheres

1	Generic Name	Yttrium [Y-90] Resin Microspheres
2	Brand Name	SIR-Spheres
3	Registration Classification	Class 5.1 chemical drug
4	Application Type	NDA
5	MAH	Grandpharma (China) Co., Ltd.
6	Approval Date	Feb. 9, 2022
7	Time from Application Acceptance to Approval	430 days
8	Priority Review	No
9	Target(s)	/
10	Indication(s)	For treating colon cancer that has spread to the liver and can't be surgically removed after failure of the standard treatment.

4. Ivosidenib Tablets

1	Generic Name	Ivosidenib Tablets
2	Brand Name	Tibsovo (拓舒沃)
3	Registration Classification	Class 5.1 chemical drug
4	Application Type	NDA
5	MAH	Servier Pharmaceuticals LLC
6	Approval Date	Feb. 9, 2022
7	Time from Application Acceptance to Approval	180 days
8	Priority Review	Yes (qualified for conditional approval)
9	Target(s)	Isocitrate dehydrogenase [NADP] cytoplasmic (IDH1)
10	Indication(s)	For treating patient adults with relapsed or refractory acute myeloid leukemia (R/R AML) with an IDH1 mutation.

5. Everolimus Tablets

1	Generic Name	Everolimus Tablets
2	Brand Name	Afinitor (飞尼妥)
3	Registration Classification	Class 5.1 chemical drug
4	Application Type	Supplemental application for adding a new indication
5	MAH	Novartis Pharma Schweiz AG
6	Approval Date	Feb. 9, 2022
7	Time from Application Acceptance to Approval	282 days
8	Priority Review	No
9	Target(s)	mammalian target of rapamycin (mTOR) complex 1; serine/threonine-protein kinase mTOR.
10	Indication(s)	Approved on Feb. 9, 2022: Indicated for treating postmenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer, after failure of treatment with letrozole or anastrozole. Approved previously: Indicated for treating adult patients with pancreas-originated neuroendocrine tumors (NET) which is well-differentiated (which means medium or highly differentiated), progressive, unresectable, and locally advanced/metastatic. For treating adult patients with NET of gastrointestinal or lung origin. The NET should be unresectable, locally advanced/metastatic, well-differentiated, progressive, and non-functional. For treating adult patients with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib. For treating adult and pediatric patients with tuberous sclerosis complex (TSC)-associated subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be resected. For treating adult patients with TSC-associated renal angiomyolipoma (AML) that does not require immediate surgery.

6. Upadacitinib Extended-release Tablets

1	Generic Name	Upadacitinib Extended-release Tablets
2	Brand Name	RINVOQ
3	Registration Classification	Class 2.4 chemical drug
4	Application Type	NDA
5	MAH	Abbvie Pharmaceutical Trading (Shanghai) Co., Ltd.
6	Approval Date	Feb. 24, 2022
7	Time from Application Acceptance to Approval	417 days
8	Priority Review	Yes (pediatric drug)
9	Target(s)	Tyrosine-protein kinase JAK1
10	Indication(s)	For the systemic treatment for patients at the age of 12 or older with moderate-to-severe atopic dermatitis.

7. Ciprofol Injection

1	Generic Name	Ciprofol Injection
2	Brand Name	思舒宁 (Si Shu Ning)
3	Registration Classification	Class 2.4 chemical drug
4	Application Type	NDA
5	MAH	Haisco Pharmaceutical Group
6	Approval Date	Feb. 24, 2022
7	Time from Application Acceptance to Approval	242 days
8	Priority Review	No
9	Target(s)	/
10	Indication(s)	For sedation during digestive endoscopy.

8. Tadalafil Oral Soluble Film

1	Generic Name	Tadalafil Oral Soluble Film
2	Brand Name	/
3	Registration Classification	Class 2.4 chemical drug
4	Application Type	NDA
5	MAH	Qilu Pharmaceutical Co., Ltd.
6	Approval Date	Feb. 9, 2022
7	Time from Application Acceptance to Approval	691 days
8	Priority Review	No
9	Target(s)	cGMP-specific 3',5'-cyclic phosphodiesterase (PDE5A)
10	Indication(s)	For treating erection dysfunction (ED) and benign prostatic hyperplasia (BPH).

9. Levornidazole Dispersible Tablets

1	Generic Name	Levornidazole Dispersible Tablets
2	Brand Name	/
3	Registration Classification	Class 2.2 chemical drug
4	Application Type	NDA
5	MAH	Hunan Mingrui Pharmaceutical Co., Ltd.
6	Approval Date	NDA
7	Time from Application Acceptance to Approval	248 days
8	Priority Review	No
9	Target(s)	deoxyribonucleic acid (DNA)
10	Indication(s)	For treating oral infections (periodontitis, periapical inflammation, and pericoronitis), trichomonas vaginitis, and other infections caused by trichomonas in the genitourinary tract or sensitive anaerobic bacteria (Bacteroides fragilis, Bacteroides disiens, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus, Clostridia, Eubacterium, Peptococcus & Peptostreptococcus, Helicobacter pylori, Bacteroides melaninogenicus, Fusobacterium, Capnocytophaga, Porphyromonas gingivalis, etc.)

10. Ondansetron Oral Soluble Pellicles

1	Generic Name	Ondansetron Oral Soluble Pellicles
2	Brand Name	/
3	Registration Classification	Class 3 chemical drug
4	Application Type	Abbreviated new drug application (ANDA)
5	MAH	Jiangsu Hengrui Pharmaceuticals Co., Ltd.
6	Approval Date	Feb. 9, 2022
7	Time from Application Acceptance to Approval	1,427 days
8	Priority Review	Yes (meeting the consistency evaluation criteria)
9	Target(s)	5-Hydroxytryptamine 3 receptor (5-HT3)
10	Indication(s)	For preventing nausea and vomiting caused by highly and moderately emetogenic chemotherapy, radiotherapy, and surgery.
11	Notes	First generic in China

11. Amlodipine Besilate and Losartan Potassium Tablets (II)

1	Generic Name	Amlodipine Besilate and Losartan Potassium Tablets (II)
2	Brand Name	/
3	Registration Classification	Class 3 chemical drug
4	Application Type	ANDA
5	MAH	Beijing Hanmi Pharmaceutical Co., Ltd.
6	Approval Date	Feb. 9, 2022
7	Time from Application Acceptance to Approval	880 days
8	Priority Review	No
9	Target(s)	/
10	Indication(s)	For treating primary hypertension patients whose blood pressure can't be controlled by a single agent.
11	Notes	First generic in China

12. Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution

1	Generic Name	Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution
2	Brand Name	/
3	Registration Classification	Class 3 chemical drug
4	Application Type	ANDA
5	MAH	Jumpcan Pharmaceutical Co., Ltd.
6	Approval Date	Feb. 9, 2022
7	Time from Application Acceptance to Approval	581 days
8	Priority Review	No
9	Target(s)	/
10	Indication(s)	For cleansing the colon of adults before colonoscopy or other operations entailing colon-cleansing.
11	Notes	First generic in China

13. Rituximab Injection

1	Generic Name	Rituximab Injection
2	Brand Name	汉利康 (Han Li Kang)
3	Registration Classification	Class 2.2 therapeutic biological product
4	Application Type	Biologics License Application (BLA)
5	MAH	Shanghai Henlius Biotech, Inc.
6	Approval Date	Feb. 28, 2022
7	Time from Application Acceptance to Approval	426 days
8	Priority Review	No
9	Target(s)	B-lymphocyte ligand
10	Indication(s)	Approved on Feb. 28, 2022: The drug is indicated in combination with methotrexate for treating adult patients with moderate-to-severe rheumatoid arthritis (RA) for which one or more than one TNF-αinhibitors are ineffective. Approved previously: For treating relapsed/drug-resistant follicular center lymphoma (type B, C, and D of B-cell Non-Hodgkin lymphoma). For patients with CD20-positive follicular Non-Hodgkin lymphoma (NHL) of III-IV phase and without prior treatments, the drug should be used with chemotherapy. For patients with CD20-positive diffuse large B cell lymphoma (DLBCL), the drug should be used for eight courses of combination therapy with the CHOP chemotherapy which includes cyclophosphamide, doxorubicin hydrochloride (hydroxydaunorubicin), vincristine sulfate (Oncovin), and prednisone. Indicated in single-agent maintenance therapy for patients with follicular lymphoma (FL) who have achieved full or partial recovery after the first-line treatment of combination therapy with MabThera (Rituximab). In combination with fludarabine and cyclophosphamide, the drug is indicated for patients with untreated, relapsed or refractory chronic lymphocytic leukemia (CLL).

14. Belimumab Powder for Concentrate for Solution for Infusion

1	Generic Name	Belimumab Powder for Concentrate for Solution for Infusion
2	Brand Name	BENLYSTA (倍力腾)
3	Registration Classification	Class 2.2 therapeutic biological product
4	Application Type	BLA
5	MAH	GlaxoSmithKline (Ireland) Limited
6	Approval Date	Feb. 9, 2022
7	Time from Application Acceptance to Approval	357 days
8	Priority Review	No
9	Target(s)	B-lymphocyte ligand
10	Indication(s)	In combination with routine treatment, the drug is indicated for adult patients with active systemic lupus nephritis (SLE) and positive self-antibodies who have high disease activities (e.g., having positive anti-dsDNA antibodies, being hypocomplementemic, with the SELENA-SLEDAI score≥8) while receiving the routine treatment.

15. Dupilumab Injection

1	Generic Name	Dupilumab Injection
2	Brand Name	Dupixent (达必妥)
3	Registration Classification	Class 3.1 therapeutic biological product
4	Application Type	BLA
5	MAH	Sanofi-Aventis Groupe
6	Approval Date	Feb. 24, 2022
7	Time from Application Acceptance to Approval	284 days
8	Priority Review	Yes (other situations that meet the conditions for priority review)
9	Target(s)	Interleukin-13 receptor; interleukin 4 receptor (IL4R)
10	Indication(s)	The drug is indicated for treating pediatric (≥6 and＜12 years old) and adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The drug can be used with or without topical corticosteroids.

16. Influenza Vaccine (Split Virion), Inactivated, Quadrivalent

1	Generic Name	Influenza Vaccine (Split Virion), Inactivated, Quadrivalent
2	Brand Name	/
3	Registration Classification	Class 3.2 therapeutic biological product
4	Application Type	BLA
5	MAH	Hualan Biological Vaccine Co., Ltd.
6	Approval Date	Feb. 9, 2022
7	Time from Application Acceptance to Approval	258 days
8	Priority Review	Yes (vaccine urgently needed for disease prevention and control)
9	Target(s)	/
10	Indication(s)	Approved on Feb. 9, 2022: For providing immunization against four influenza virus strains to prevent influenza in pediatric patients at the age of six months to three years. Approved previously: For providing immunization against four influenza virus strains to prevent influenza in patients who are three years old or older. The vaccine is especially recommended to people susceptible to complications, such as children, the elderly, the infirm, and those in influenza-active areas.

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