Monthly Report: New Drug Approvals in China | March 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 March 2022, China NMPA approved 23 new drugs, including 15 chemical drugs and 8 biological products.

1. Ensartinib Hydrochloride Capsules

1	Generic Name	Ensartinib Hydrochloride Capsules
2	Brand Name	Bei Mei Na (贝美纳)
3	Registration Classification	Class 2.4 chemical drug
4	Application Type	New drug application (NDA)
5	Marketing Authorization Holder (MAH)	Betta Pharmaceuticals Co., Ltd.
6	Approval Date	March 18, 2022
7	Time from Application Acceptance to Approval	246 days
8	Priority Review	Yes (reason: meeting other conditions for priority review)
9	Target(s)	ALK; Ros1 tyrosine kinase receptor.
10	Indication(s)	Approved on March 18, 2022: Indicated for the first-line treatment of patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) that is locally advanced or metastatic. Approved on November 19, 2020: Indicated for the treatment of patients with ALK-positive NSCLC that is locally advanced or metastatic with progression after prior crizotinib therapy or resistance to the crizotinib.

2. Remimazolam Besylate for Injection

1	Generic Name	Remimazolam Besylate for Injection
2	Brand Name	Rui Ma (锐马)
3	Registration Classification	Class 2.4 chemical drug
4	Application Type	NDA
5	MAH	Yichang Humanwell Pharmaceutical Co., Ltd.
6	Approval Date	March 11, 2022
7	Time from Application Acceptance to Approval	250 days
8	Priority Review	No
9	Target(s)	/
10	Indication(s)	Approved on March 11, 2022: Indicated for the induction and maintenance of general anesthesia. Approved on July 20, 2020: Indicated for sedation during colonoscopy.

3. Rivaroxaban Tablets

1	Generic Name	Rivaroxaban Tablets
2	Brand Name	Xarelto
3	Registration Classification	Class 2.4 chemical drug
4	Application Type	NDA
5	MAH	Bayer AG
6	Approval Date	March 11, 2022
7	Time from Application Acceptance to Approval	558 days
8	Priority Review	No
9	Target(s)	Coagulation Factor X (F10)
10	Indication(s)	Approved on March 11, 2022: Indicated for treating and preventing the relapse of venous thromboembolism (VTE) at least five days after the first-line treatment for non-oral anticoagulant(s) in children and adolescents no more than 18 years old and weighing more than 30kg. Approved previously: Indicated for preventing VTE in adult patients after elective hip/knee arthroplasty. Indicated for treating DVT and pulmonary embolism (PE) in adult patients. Indicated for reducing the relapse risk of DVT and/or PE in adult patients who face the risk continuously at least six months after the first-line treatment. Indicated for reducing the risks of apoplexy and systemic embolism in adult patients with non-valvular atrial fibrillation who have one or multiple risk factors (e.g., congestive heart failure, hypertension, age ≥75, diabetes, and the history of apoplexy or transient ischemic attack). *Rivaroxaban has limited data to prove the efficacy of lowering the risk of apoplexy and systemic embolism in comparison with warfarin when the patient's condition is well controlled under the warfarin therapy.

4. Duvelisib Capsules

1	Generic Name	Duvelisib Capsules
2	Brand Name	Copiktra
3	Registration Classification	Class 5.1 chemical drug
4	Application Type	NDA, import
5	MAH	CSPC Pharmaceutical Group Co., Ltd.
6	Approval Date	March 18, 2022
7	Time from Application Acceptance to Approval	329 days
8	Priority Review	Yes (reason: qualified for conditional approval)
9	Target(s)	/
10	Indication(s)	Indicated for treating patients with relapsed or refractory follicular lymphoma (FL) after at least two systemic treatments.

5. Pralsetinib Capsules

1	Generic Name	Pralsetinib Capsules
2	Brand Name	GAVRETO (普吉华)
3	Registration Classification	Class 5.1 chemical drug
4	Application Type	NDA, import
5	MAH	Blueprint Medicines Corporation
6	Approval Date	March 11, 2022
7	Time from Application Acceptance to Approval	329 days
8	Priority Review	Yes (reason: breakthrough therapy)
9	Target(s)	Proto-oncogene tyrosine-protein kinase receptor Ret (RET)
10	Indication(s)	Indicated for the treatment of adult and pediatric patients ≥12 years old with advanced or metastatic medullary thyroid cancer who require systemic therapy and are difficult to be cured by radioactive iodine (if the radioactive iodine therapy is applicable). Indicated for the treatment for adult patients with metastatic RET fusion-positive NSCLC after prior platinum-based chemotherapy.

6. Brigatinib Tablets

1	Generic Name	Brigatinib Tablets
2	Brand Name	Alunbrig (安伯瑞)
3	Registration Classification	Class 5.1 chemical drug
4	Application Type	NDA, import
5	MAH	Takeda Pharmaceutical Co., Ltd.
6	Approval Date	March 24, 2022
7	Time from Application Acceptance to Approval	425 days
8	Priority Review	No
9	Target(s)	ALK tyrosine kinase receptor (ALK); Epidermal growth factor receptor (EGFR); Proto-oncogene tyrosine-protein kinase ROS (ROS1); Ros1 tyrosine kinase receptor.
10	Indication(s)	Indicated as a single agent for the treatment of patients with ALK-positive NSCLC that is locally advanced or metastatic.

7. Trametinib Tablets

1	Generic Name	Trametinib Tablets
2	Brand Name	Mekinist (迈吉宁)
3	Registration Classification	Class 5.1 chemical drug
4	Application Type	NDA, import
5	MAH	Novartis Europharm Limited
6	Approval Date	March 24, 2022
7	Time from Application Acceptance to Approval	197 days
8	Priority Review	Yes (reason: qualified for conditional approval)
9	Target(s)	Dual specificity mitogen-activated protein kinase kinase 1 (MAP2K1); Dual specificity mitogen-activated protein kinase kinase 2 (MAP2K2).
10	Indication(s)	Approved on March 24, 2022: Indicated in combination with dabrafenib mesylate for the treatment for patients with metastatic BRAF V600 mutation-positive NSCLC. Approved previously: Indicated in combination with dabrafenib mesylate for the treatment of BRAF V600 mutation-positive melanoma that is unresectable or metastatic. Indicated in combination with dabrafenib mesylate for the adjuvant treatment of patients with BRAF V600 mutation-positive melanoma following complete resection.

8. Dabrafenib Mesylate Capsules

1	Generic Name	Dabrafenib Mesylate Capsules
2	Brand Name	Tafinlar (泰菲乐)
3	Registration Classification	Class 5.1 chemical drug
4	Application Type	NDA, import
5	MAH	Novartis Europharm Limited
6	Approval Date	March 24, 2022
7	Time from Application Acceptance to Approval	197 days
8	Priority Review	No
9	Target(s)	Serine/threonine-protein kinase B-raf (BRAF)
10	Indication(s)	Approved on March 24, 2022: Indicated in combination with trametinib for the treatment of patients with metastatic NSCLC with BRAF V600 mutation. Approved previously: Indicated in combination with trametinib for the treatment of BRAF V600 mutation-positive melanoma that is unresectable or metastatic. Indicated in combination with trametinib for the adjuvant treatment of patients with BRAF V600 mutation-positive melanoma following complete resection.

9. Upadacitinib Sustained-release Tablets

1	Generic Name	Upadacitinib Sustained-release Tablets
2	Brand Name	RINVOQ (瑞福)
3	Registration Classification	Class 5.1 chemical drug
4	Application Type	NDA, import
5	MAH	AbbVie Deutschland GmbH & Co. KG
6	Approval Date	March 24, 2022
7	Time from Application Acceptance to Approval	445 days
8	Priority Review	No
9	Target(s)	Tyrosine-protein kinase JAK1
10	Indication(s)	Indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers.

10. Nitric Oxide for Inhalation

1	Generic Name	Nitric Oxide for Inhalation
2	Brand Name	INOmax
3	Registration Classification	Class 5.1 chemical drug
4	Application Type	NDA, import
5	MAH	INO Therapeutics LLC
6	Approval Date	March 11, 2022
7	Time from Application Acceptance to Approval	787 days
8	Priority Review	Yes (reason: for rare disease)
9	Target(s)	/
10	Indication(s)	As a vasodilator, the drug is indicated for improving the oxygenation and reducing the need for extracorporeal membrane oxygenation of neonates (>34 weeks' gestation) with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilation and other appropriate agents.

11. Articaine Hydrochloride and Epinephrine Tartrate Injection

1	Generic Name	Articaine Hydrochloride and Epinephrine Tartrate Injection
2	Brand Name	Primacaine Adrenaline (必兰)
3	Registration Classification	Class 5.1 chemical drug
4	Application Type	NDA, import
5	MAH	Produits Dentaires Pierre Rolland
6	Approval Date	March 24, 2022
7	Time from Application Acceptance to Approval	544 days
8	Priority Review	No
9	Target(s)	/
10	Indication(s)	Indicated for local dental anesthesia, especially in surgery involving osteotomy and mucosal incision.

12. Hemofiltration Replacement Fluid of Sodium Bicarbonate and Phosphate

1	Generic Name	Hemofiltration Replacement Fluid of Sodium Bicarbonate and Phosphate
2	Brand Name	/
3	Registration Classification	Class 5.1 chemical drug
4	Application Type	NDA, import
5	MAH	Gambro Lundia AB
6	Approval Date	March 11, 2022
7	Time from Application Acceptance to Approval	858 days
8	Priority Review	No
9	Target(s)	/
10	Indication(s)	Indicated as a replacement fluid for the treatment of acute kidney failure during continuous renal replacement therapy (CRRT).

13. Cyproheptadine Hydrochloride Oral Solution

1	Generic Name	Cyproheptadine Hydrochloride Oral Solution
2	Brand Name	/
3	Registration Classification	Class 3 chemical drug
4	Application Type	Abbreviated new drug application (ANDA)
5	MAH	Chengji Pharma Co., Ltd.
6	Approval Date	March 24, 2022
7	Time from Application Acceptance to Approval	623 days
8	Priority Review	No
9	Target(s)	Histamine receptor
10	Indication(s)	Indicated for the treatment of Perennial and seasonal allergic rhinitis; Vasomotor rhinitis; Allergic conjunctivitis due to inhalant allergens and foods; Mild, uncomplicated allergic skin manifestations of urticaria and angioedema; Amelioration of allergic reactions to blood or plasma Cold urticarial; Dermatographism; As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.
11	Notes	First generic drug in China

14. Miglitol Orally-disintegrating Tablets

1	Generic Name	Miglitol Orally-disintegrating Tablets
2	Brand Name	/
3	Registration Classification	Class 3 chemical drug
4	Application Type	ANDA
5	MAH	Zhejiang Medicine Co., Ltd.
6	Approval Date	March 11, 2022
7	Time from Application Acceptance to Approval	626 days
8	Priority Review	No
9	Target(s)	Lysosomal alpha-glucosidase; Neutral alpha-glucosidase C; Maltase-glucoamylase, intestinal.
10	Indication(s)	Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
11	Notes	First generic drug in China

15. Methacholine Chloride for Inhalation

1	Generic Name	Methacholine Chloride for Inhalation
2	Brand Name	/
3	Registration Classification	Class 3 chemical drug
4	Application Type	ANDA
5	MAH	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
6	Approval Date	March 24, 2022
7	Time from Application Acceptance to Approval	732 days
8	Priority Review	No
9	Target(s)	muscarinic acetylcholine receptors (mAChRs)
10	Indication(s)	Indicated for the diagnosis of bronchial airway hyperreactivity in adults and pediatric patients five years of age and older who do not have clinically apparent asthma.
11	Notes	First generic drug in China

16. Serplulimab Injection

1	Generic Name	Serplulimab Injection
2	Brand Name	Han Si Zhuang (汉斯状)
3	Registration Classification	Class 1 therapeutic biological product
4	Application Type	Biologics License Application (BLA)
5	MAH	Shanghai Henlius Biotech, Inc. (Parent company: Fosun Pharma)
6	Approval Date	March 24, 2022
7	Time from Application Acceptance to Approval	333 days
8	Priority Review	Yes (reason: qualified for conditional approval)
9	Target(s)	Programmed cell death protein 1 (PD-1)
10	Indication(s)	Indicated for the treatment of unresectable or metastatic microsatellite instability-high (MSI-H) solid tumors that fail to respond to the standard therapy.

17. Adalimumab Injection

1	Generic Name	Adalimumab Injection
2	Brand Name	Jun Mai Kang (君迈康)
3	Registration Classification	Class 2 therapeutic biological product
4	Application Type	BLA
5	MAH	Shanghai Junshi Biosciences Co., Ltd.
6	Approval Date	March 3, 2022
7	Time from Application Acceptance to Approval	839 days
8	Priority Review	No
9	Target(s)	tumor necrosis factor (TNF)
10	Indication(s)	Used in combination with methotrexate for inhibiting the progression of structural damage and improving physical function of adult patients with moderately to severely active rheumatoid arthritis who don't respond to methotrexate and other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). Indicated for the treatment of adult patients with active ankylosing spondylitis who don't respond to standard treatments. Indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who require systemic therapy or phototherapy, and don't respond to systemic therapies (including cyclosporine, methotrexate, and photochemotherapy). The drug should only be administered to patients who will be closely monitored and have regular follow-up visits with physicians.

18. Porcine Fibrin Sealant Kit

1	Generic Name	Porcine Fibrin Sealant Kit
2	Brand Name	Bei Xiu Jiao (倍绣胶)
3	Registration Classification	Class 2.2 biological product
4	Application Type	BLA
5	MAH	Guangzhou Bioseal Biotech Co., Ltd.
6	Approval Date	March 24, 2022
7	Time from Application Acceptance to Approval	545 days
8	Priority Review	No
9	Target(s)	/
10	Indication(s)	Indicated for preventing wounds fromexuding liquids, small vein bleeding, and tissue adhesion during surgery.

19. Atezolizumab Injection

1	Generic Name	Atezolizumab Injection
2	Brand Name	Tecentriq (泰圣奇)
3	Registration Classification	Class 2.2 therapeutic biological product
4	Application Type	BLA, import
5	MAH	F. Hoffmann-La Roche Ltd.
6	Approval Date	March 18, 2022
7	Time from Application Acceptance to Approval	259 days
8	Priority Review	No
9	Target(s)	Programmed death-ligand 1 (PD-L1)
10	Indication(s)	The drug, in combination with carboplatin and etoposide, is indicated for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).

20. Tislelizumab Injection

1	Generic Name	Tislelizumab Injection
2	Brand Name	Bai Ze An (百泽安)
3	Registration Classification	Class 2.2 therapeutic biological product
4	Application Type	BLA
5	MAH	BeiGene (Shanghai) Biotechnology Co., Ltd.
6	Approval Date	March 11, 2022
7	Time from Application Acceptance to Approval	277 days
8	Priority Review	Yes (reason: qualified for conditional approval)
9	Target(s)	Programmed cell death protein 1 (PD-1)
10	Indication(s)	Approved on March 11, 2022: The drug received the conditional approval for the treatment of locally advanced, unresectable or metastatic, microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) solid tumors after prior treatment. Approved on January 5, 2022: The drug received the full approval for being used in the second-line or third-line treatment for NSCLC patients who have disease progression after platinum chemotherapy. Approved on June 22, 2021: The drug received the full approval for being used with pemetrexed and platinum chemotherapy in the first-line treatment for NSCLC that are EGFR-negative, ALK-negative and unresectable by surgery. Approved on June 22, 2021: The drug received a conditional approval for treating hepatocellular carcinoma (HCC) patients who have received at least one type of systemic therapy. Approved on January 18, 2021: The drug received the full approval to be used in combination with paclitaxel and platinum in the first-line treatment for patients with advanced squamous non-small cell lung cancer (NSCLC) that is unresectable by surgery. Approved on April 13, 2020: The drug received a conditional approval for urothelial cancer (UC) and small lymphocytic lymphoma (SLL) patients with high PD-L1 expression, prior failure of platinum chemotherapy, and disease progression within 12 months after the neoadjuvant or adjuvant chemotherapy. Approved on Dec. 31, 2019: The drug received a conditional approval for the second-line treatment for relapsed or refractory classic Hodgkin lymphoma (cHL) patients who have received at least the second-line chemotherapy.

21. Ramucirumab Injection

1	Generic Name	Ramucirumab Injection
2	Brand Name	Cyramza (希冉择)
3	Registration Classification	Class 3.1 therapeutic biological product
4	Application Type	BLA, import
5	MAH	Eli Lilly and Company
6	Approval Date	March 18, 2022
7	Time from Application Acceptance to Approval	419 days
8	Priority Review	No
9	Target(s)	Vascular endothelial growth factor receptor 2 (KDR); Vascular endothelial growth factor A (VEGFA); Vascular endothelial growth factor C (VEGFC) Vascular endothelial growth factor D (VEGFD).
10	Indication(s)	The drug, in combination with paclitaxel, is indicated for the treatment of patients with advanced, gastric or gastro-esophageal junction adenocarcinoma with disease progression during or after prior fluropyrimidin- or platinum-containing chemotherapy.

22. Emapalumab Injection

1	Generic Name	Emapalumab Injection
2	Brand Name	GAMIFANT
3	Registration Classification	Class 3.1 therapeutic biological product
4	Application Type	BLA, import
5	MAH	Swedish Orphan Biovitrum
6	Approval Date	March 11, 2022
7	Time from Application Acceptance to Approval	453 days
8	Priority Review	Yes (reason: qualified for conditional approval)
9	Target(s)	Interferon gamma (IFNG)
10	Indication(s)	Indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy.

23. Inebilizumab Injection

1	Generic Name	Inebilizumab Injection
2	Brand Name	UPLIZNA (昕越)
3	Registration Classification	Class 3.1 therapeutic biological product
4	Application Type	BLA, import
5	MAH	Viela Bio, Inc.
6	Approval Date	March 11, 2022
7	Time from Application Acceptance to Approval	510 days
8	Priority Review	No
9	Target(s)	B-lymphocyte antigen CD19
10	Indication(s)	Indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

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