Monthly Report: New Drug Approvals in China | Dec 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 Dec 2021, China's NMPA approved 11 new drugs, including 7 chemical drugs and 4 biological products.

1. Omadacycline Tablets

1	Generic Name	Omadacycline Tablets
2	Brand Name	NUZYRA®
3	Registration Classification	Class 1 chemical drug
4	Application Type	New drug application (NDA)
5	MAH	Zai Lab Limited
6	Approval Date	Dec. 16, 2021
7	Time from Application Acceptance to Approval	661 days
8	Priority Review	Yes (innovative drug)
9	Target(s)	/
10	Indication(s)	1. Community-acquired bacterial pneumonia (CABP); 2. Acute bacterial skin/skin structure infections (ABSSSIs).

2. Omadacycline for Injection

1	Generic Name	Omadacycline for Injection
2	Brand Name	NUZYRA®
3	Registration Classification	Class 1 chemical drug
4	Application Type	NDA
5	MAH	Zai Lab Limited
6	Approval Date	Dec. 16, 2021
7	Time from Application Acceptance to Approval	661 days
8	Priority Review	Yes (innovative drug)
9	Target(s)	/
10	Indication(s)	1. Community-acquired bacterial pneumonia (CABP); 2. Acute bacterial skin/skin structure infections (ABSSSIs).

3. Almonertinib Mesilate Tablets

1	Generic Name	Almonertinib Mesilate Tablets
2	Brand Name	Ameile® (阿美乐)
3	Registration Classification	Class 2.4 chemical drug
4	Application Type	NDA
5	MAH	Jiangsu Hansoh Pharmaceutical Group Co., Ltd.
6	Approval Date	Dec. 16, 2021
7	Time from Application Acceptance to Approval	208 days
8	Priority Review	Yes (Breakthrough Therapy Designation)
9	Target(s)	Receptor tyrosine kinases (RTKs)
10	Indication(s)	1. Indicated for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are EGFR 790 mutation-positive and have disease progression during or after a prior epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) therapy. This indication was approved on March 18, 2020. 2. Indicated for the first-line treatment for locally advanced or metastatic NSCLC adult patients with EGFR exon 19 deficiency or exon 21 L858R mutation. This indication was approved this time.

4. Ciprofol Injection

1	Generic Name	Ciprofol Injection
2	Brand Name	/
3	Registration Classification	Class 2.4 chemical drug
4	Application Type	NDA
5	MAH	Liaoning Haisco Pharmaceutical Co., Ltd.
6	Approval Date	Dec. 10, 2021
7	Time from Application Acceptance to Approval	305 days
8	Priority Review	No
9	Target(s)	/
10	Indication(s)	1. Sedation in gastrointestinal endoscopy. This indication was approved on Aug. 12, 2021. 2. Sedation in bronchoscopy. This indication was approved this time.

5. Selinexor Tablets

1	Generic Name	Selinexor Tablets
2	Brand Name	XPOVIO®
3	Registration Classification	Class 5.1 chemical drug
4	Application Type	NDA
5	MAH	Antengene Corporation Limited
6	Approval Date	Dec. 16, 2021
7	Time from Application Acceptance to Approval	316 days
8	Priority Review	Yes (conditional approval)
9	Target(s)	Exportin-1 (XPO1)
10	Indication(s)	In combination with dexamethasone for the treatment of relapsing or refractory multiple myeloma patients who have received prior therapy and whose disease is refractory to at least one proteasome inhibitors, at least one immunomodulatory agents, and at least one anti‐CD38 monoclonal antibody.

6. Dronedarone Hydrochloride Tablets

1	Generic Name	Dronedarone Hydrochloride Tablets
2	Brand Name	MULTAQ®
3	Registration Classification	Class 5.1 chemical drug
4	Application Type	Import
5	MAH	Sanofi (China) Investment Co., Ltd.
6	Approval Date	Dec. 22, 2021
7	Time from Application Acceptance to Approval	316 days
8	Priority Review	No
9	Target(s)	Sodium channel; adrenergic receptor; calcium channel; potassium channel.
10	Indication(s)	Dronedaroneis an anti-arrhythmia drug indicated to reduce the risk of hospitalization for patients with atrial fibrillation (AF) or atrial flutter (AFL). It is also indicated for patients with recent paroxysmal AF/AFL and cardiovascular risk factors, and patients can restore a normal sinus rhythm or heart rhythm.

7. Isavuconazonium Sulfate Capsules

1	Generic Name	Isavuconazonium Sulfate Capsules
2	Brand Name	Cresemba® (康新博)
3	Registration Classification	Class 5.1 chemical drug
4	Application Type	Import
5	MAH	Basilea Pharmaceutica Deutschland GmbH
6	Approval Date	Dec. 16, 2021
7	Time from Application Acceptance to Approval	517 days
8	Priority Review	No
9	Target(s)	Lanosterol 14-alpha demethylase (CYP51A1)
10	Indication(s)	Cresemba is a new antifungal drug indicated for adult patients for the treatment of invasive mucormycosis.

8. Sugemalimab Injection

1	Generic Name	Sugemalimab Injection
2	Brand Name	Cejemly (择捷美)
3	Registration Classification	Class 1 therapeutic biological product
4	Application Type	Biologics License Application (BLA)
5	MAH	CStone Pharmaceuticals
6	Approval Date	Dec. 22, 2021
7	Time from Application Acceptance to Approval	392 days
8	Priority Review	No
9	Target(s)	/
10	Indication(s)	In combination with Pemetrexed and Carboplatin, the drug is indicated for the first-line treatment of non-small cell lung cancer (NSCLC) that is EGFR mutation-negative, ALK-negative, metastatic, and non-squamous. In combination with Paclitaxel and Carboplatin, the drug is indicated for the first-line treatment of metastatic squamous NSCLC.

9. Camrelizumab for Injection

1	Generic Name	Camrelizumab for Injection
2	Brand Name	AiRuiKa™ (艾瑞卡)
3	Registration Classification	Class 2.2 therapeutic biological product
4	Application Type	BLA
5	MAH	Suzhou Shengdiya Bipharmaceutical Co., Ltd.
6	Approval Date	Dec. 10, 2021
7	Time from Application Acceptance to Approval	392
8	Priority Review	No
9	Target(s)	Programmed cell death protein 1 (PD-1)
10	Indication(s)	Camrelizumab is indicated for the treatment of relapsing or refractory classic Hodgkin lymphoma (HL) in patients who have received at least second-line chemotherapy. This indication is granted conditional approval based on the objective response rate (ORR) and response duration in a single-arm clinical trial. The full approval will depend on the ongoing randomized controlled trial to prove that the Camrelizumab has more clinical benefit than the standard therapy. In combination with Paclitaxel and Carboplatin, Camrelizumab is indicated for the first-line treatment of unresectable esophageal squamous cell carcinoma that is locally advanced, relapsing or metastatic.

10. Ofatumumab Injection

1	Generic Name	Ofatumumab Injection
2	Brand Name	Kesimpta®
3	Registration Classification	Class 3.1 therapeutic biological product
4	Application Type	Import
5	MAH	Novartis
6	Approval Date	Dec. 22, 2021
7	Time from Application Acceptance to Approval	405
8	Priority Review	Yes (other qualified conditions)
9	Target(s)	/
10	Indication(s)	Indicated for treating adult patients with relapsing multiple sclerosis (RMS), including clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and secondary progressive multiple sclerosis (SPMS).

11. Siltuximab for Injection

1	Generic Name	Siltuximab for Injection
2	Brand Name	Sylvant (萨温珂)
3	Registration Classification	Class 3.1 therapeutic biological product
4	Application Type	Import
5	MAH	EUSA Pharma (Netherlands) B.V.
6	Approval Date	Dec. 2, 2021
7	Time from Application Acceptance to Approval	303 days
8	Priority Review	Yes (other qualified conditions)
9	Target(s)	Interleukin-6 receptor subunit alpha (IL6R); heat shock protein.
10	Indication(s)	Indicated for the treatment of multicentric Castleman's disease (MCD) in adult patients who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.

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