Monthly Report: New Drug Approvals in China | July 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.

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In July 2022, China NMPA approved 10 new drugs, including 8 chemical drugs and 2 biological products. Among the drugs, Genuine Biotech's Azvudine Tablets is the first homegrown oral drug to get NMPA's approval for COVID-19 treatment.

Genuine Biotech's Azvudine Tablets
Haisco Pharmaceutical's Ciprofol Injection
Yichang Humanwell Pharmaceutical's Remimazolam Besylate for Injection
Xiamen LP Pharmaceutical's Clonidine Hydrochloride Sustained-release Tablets
Anbison Lab's Carbamazepine Sustained-release Tablets (II)
G1 Therapeutics' Trilaciclib for Injection
Roche's Entrectinib Capsules
Toray Industries' Beraprost Sodium Sustained-Release Tablets
Lepu Biopharma's Pucotenlimab Injection
Eli Lilly's Ixekizumab Injection

1. Azvudine Tablets

1	Generic Name	Azvudine Tablets
2	Brand Name	/
3	Registration Classification	Class 2.4 chemical drug
4	Application Type	New drug application (NDA)
5	Marketing Authorization Holder (MAH)	Genuine Biotech Co., Ltd.
6	Approval Date	July 25, 2022
7	Time from Application Acceptance to Approval	/
8	Special Approval	Yes
9	Target(s)	Nucleoside reverse transcriptase; Viral infectivity factor (Vif)
10	Indication(s)	Previously approved: 1. Indicated to be used with nucleoside reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs) for the treatment of HIV-1-infected adult patients with high viral loads. Newly approved on July 25, 2022: 2. Indicated for treating adult patients with COVID-19 pneumonia.

2. Ciprofol Injection

1	Generic Name	Ciprofol Injection
2	Brand Name	Si Shu Ning (思舒宁)
3	Registration Classification	Class 2.4 chemical drug
4	Application Type	NDA
5	MAH	Haisco Pharmaceutical Group
6	Approval Date	July 13, 2022
7	Time from Application Acceptance to Approval	230 days
8	Priority Review	No
9	Target(s)	GABAA receptor
10	Indication(s)	Previously approved: 1. Indicated for sedation and anesthesia in non-tracheal-incubation surgeries/operations. 2. Indicated for the induction and maintenance of general anesthesia. Newly approved on July 13, 2022: 3. Indicated for sedation for patients in intensive care units (ICUs).

3. 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	July 22, 2022
7	Time from Application Acceptance to Approval	244 days
8	Priority Review	No
9	Target(s)	GABAA receptor
10	Indication(s)	Indicated for sedation in colonoscopy and bronchoscopy for invasive procedures.

4. Clonidine Hydrochloride Sustained-release Tablets

1	Generic Name	Clonidine Hydrochloride Sustained-release Tablets
2	Brand Name	/
3	Registration Classification	Class 3 chemical drug
4	Application Type	Abbreviated new drug application (ANDA)
5	MAH	Xiamen LP Pharmaceutical Co., Ltd.
6	Approval Date	July 4, 2022
7	Time from Application Acceptance to Approval	433 days
8	Priority Review	Yes (pediatric drug)
9	Target(s)	Alpha 2 adrenoceptor
10	Indication(s)	The drug is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as a monotherapy or an adjunctive therapy to stimulant medications.
11	Notes	First generic in China

5. Carbamazepine Sustained-release Tablets (II)

1	Generic Name	Carbamazepine Sustained-release Tablets (II)
2	Brand Name	/
3	Registration Classification	Class 3 chemical drug
4	Application Type	ANDA
5	MAH	Anbison Lab
6	Approval Date	July 22, 2022
7	Time from Application Acceptance to Approval	908 days
8	Priority Review	No
9	Target(s)	Sodium channel
10	Indication(s)	1. The drug is indicated for treating epilepsy. It is highly effective for complex partial seizures and secondary seizures, and also effective for primary generalized seizures, simple partial seizures, and mixed seizures. 2. The drug is indicated for relieving trigeminal neuralgia and glossopharyngeal neuralgia, and preventing/treating bipolar manic depression and central partial diabetes insipidus.
11	Notes	First generic in China

6. Trilaciclib for Injection

1	Generic Name	Trilaciclib for Injection
2	Brand Name	Cosela
3	Registration Classification	Class 5.1 chemical drug
4	Application Type	NDA, import
5	MAH	G1 Therapeutics, Inc.
6	Approval Date	July 13, 2022
7	Time from Application Acceptance to Approval	223 days
8	Priority Review	Yes (conditional approval)
9	Target(s)	Cyclin-dependent kinase 4 (CDK4) Cyclin-dependent kinase 6 (CDK6)
10	Indication(s)	The drug is indicated to decrease the incidence of chemotherapy-induced myelosuppression in patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC).

7. Entrectinib Capsules

1	Generic Name	Entrectinib Capsules
2	Brand Name	ROZLYTREK
3	Registration Classification	Class 5.1 chemical drug
4	Application Type	NDA, import
5	MAH	Roche (China) Investment Co., Ltd.
6	Approval Date	July 29, 2022
7	Time from Application Acceptance to Approval	270 days
8	Priority Review	Yes (conditional approval)
9	Target(s)	ALK tyrosine kinase receptor Ros1 tyrosine kinase receptor Neurotrophic receptor tyrosine kinase 1 (NTRK1) BDNF/NT-3 growth factors receptor (TrkB) NT-3 growth factor receptor (NTRK3)
10	Indication(s)	The drug is indicated for treating NTRK gene fusion-positive solid tumors that is locally advanced or metastatic.

8. Beraprost Sodium Sustained-Release Tablets

1	Generic Name	Beraprost Sodium Sustained-Release Tablets
2	Brand Name	Dorner
3	Registration Classification	Class 5.1 chemical drug
4	Application Type	NDA, import
5	MAH	Toray Industries, Inc.
6	Approval Date	July 29, 2022
7	Time from Application Acceptance to Approval	816 days
8	Priority Review	No
9	Target(s)	Prostacyclin receptor (PTGIR)
10	Indication(s)	Indicated for improving symptoms including ulcers, intermittent claudication, pain, and feeling of coldness.

9. Pucotenlimab Injection

1	Generic Name	Pucotenlimab Injection
2	Brand Name	Pu You Heng (普佑恒)
3	Registration Classification	Class 1 therapeutic biological product
4	Application Type	Biologics License Application (BLA)
5	MAH	Lepu Biopharma Co., Ltd.
6	Approval Date	July 22, 2022
7	Time from Application Acceptance to Approval	266 days
8	Priority Review	Yes (conditional approval)
9	Target(s)	Programmed cell death protein 1 (PD-1)
10	Indication(s)	Indicated for treating advanced solid tumors that are microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) in patients who have failed at least the first-line systemic treatment.

10. Ixekizumab Injection

1	Generic Name	Ixekizumab Injection
2	Brand Name	TALTZ (拓咨)
3	Registration Classification	Class 3.1 therapeutic biological product
4	Application Type	BLA, import
5	MAH	Eli Lilly and Company
6	Approval Date	July 29, 2022
7	Time from Application Acceptance to Approval	306 days
8	Priority Review	No
9	Target(s)	Interleukin-17A (IL17A)
10	Indication(s)	Indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.