Monthly Report: New Drug Approvals in China | June 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 June 2022, China NMPA approved 25 new drugs, including 17 chemical drugs and 8 biological products.

1. Jiangsu Hengrui Pharmaceuticals' SHR3680 Tablets;

2. Bayer's Finerenone Film-coated Tablets (Kerendia);

3. Qilu Pharmaceutical's Aripiprazole Oral Soluble Film;

4. Qilu Pharmaceutical's Memantine Hydrochloride Oral Soluble Film;

5. Boehringer Ingelheim's Empagliflozin Tablets;

6. Jiangsu Hengrui Pharmaceuticals' Pyrotinib Maleate Tablets;

7. Shenzhen China Resources Gosun Pharmaceutical's Mitoxantrone Hydrochloride Injection for Tracing;

8. Shanghai Allist Pharmaceuticals' Furmonertinib Mesilate Tablets;

9. Hebei Renhe Yikang Pharmaceutical's Levetiracetam in Sodium Chloride Injection;

10. Sichuan Baili Pharmaceutical's Enalapril Maleate Oral Solution;

11. Chengdu Suncadia Medicine's Tacrolimus Extended-release Capsules;

12. Shijizhuang No. 4 Pharmaceutical's Blonanserin Tablets;

13. EyePoint Pharmaceuticals' Fluocinolone Acetonide Intravitreal Implants (YUTIQ);

14. Basilea Pharmaceutica's Isavuconazonium Sulfate for Injection (CRESEMBA);

15. Italfarmaco's Riluzole Oral Suspension (TIGLUTIK);

16. Laboratorios Farmaceuticos' Bemiparin Sodium Injection;

17. Bayer's Larotrectinib Sulfate Oral Solution;

18. CStone Pharmaceuticals' Sugemalimab Injection;

19. Akeso Biopharma's Cadonilimab Injection;

20. Innovent Biologics' Sintilimab Injection (Tyvyt);

21. BeiGene's Tislelizumab Injection;

22. BMS's Nivolumab Injection;

23. Merck's Cetuximab Solution for Infusion (Erbitux);

24. GenSci's Recombinant Human Growth Hormone Injection (Jintropin).

25. Gilead Sciences' Sacituzumab Govitecan for Injection (Trodelvy).

Details of the approved drugs are listed as follows.

1. SHR3680 Tablets

1	Generic Name	SHR3680 Tablets
2	Brand Name	/
3	Registration Classification	Class 1 chemical drug
4	Application Type	New drug application (NDA)
5	Marketing Authorization Holder (MAH)	Jiangsu Hengrui Pharmaceuticals Co., Ltd.
6	Approval Date	June 30, 2022
7	Time from Application Acceptance to Approval	239 days
8	Priority Review	Yes (breakthrough therapy)
9	Target(s)	Androgen receptor
10	Indication(s)	Indicated for treating metastatic hormone-sensitive prostate cancer (mHSPC) with high tumor burden.

2. Finerenone Film-coated Tablets

1	Generic Name	Finerenone Film-coated Tablets
2	Brand Name	Kerendia
3	Registration Classification	Class 1 chemical drug
4	Application Type	NDA, import
5	MAH	Bayer AG
6	Approval Date	June 30, 2022
7	Time from Application Acceptance to Approval	510 days
8	Priority Review	No
9	Target(s)	Nuclear Receptor Subfamily 3 Group C Member 2 (NR3C2)
10	Indication(s)	Indicated to reduce the risk of sustained eGFR decline and end-stage kidney disease in adult patients (with an estimated glomerular filtration rate (eGFR) of 25-75 ml/min/1.73m2 together with albuminuria) with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).

3. Aripiprazole Oral Soluble Film

1	Generic Name	Aripiprazole Oral Soluble Film
2	Brand Name	/
3	Registration Classification	Class 2.2 chemical drug
4	Application Type	NDA
5	MAH	Qilu Pharmaceutical Co., Ltd.
6	Approval Date	June 24, 2022
7	Time from Application Acceptance to Approval	603 days
8	Priority Review	No
9	Target(s)	5-hydroxytryptamine receptor 1A (HTR1A); 5-hydroxytryptamine receptor 2a (HTR2A); D(2) dopamine receptor (DRD2)
10	Indication(s)	Indicated for treating schizophrenia.

4. Memantine Hydrochloride Oral Soluble Film

1	Generic Name	Memantine Hydrochloride Oral Soluble Film
2	Brand Name	/
3	Registration Classification	Class 2.2 chemical drug
4	Application Type	NDA
5	MAH	Qilu Pharmaceutical Co., Ltd.
6	Approval Date	June 24, 2022
7	Time from Application Acceptance to Approval	582 days
8	Priority Review	No
9	Target(s)	NMDA receptor
10	Indication(s)	Indicated for treating moderate to severe dementia of the Alzheimer's type.

5. Empagliflozin Tablets

1	Generic Name	Empagliflozin Tablets
2	Brand Name	Jardiance
3	Registration Classification	Class 2.4 chemical drug
4	Application Type	NDA, import
5	MAH	Boehringer Ingelheim International GmbH
6	Approval Date	June 10, 2022
7	Time from Application Acceptance to Approval	566 days
8	Priority Review	No
9	Target(s)	Sodium/glucose cotransporter 2 (SLC5A2)
10	Indication(s)	Previously approved: The drug alone is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The drug can be used in combination with Metformin Hydrochloride when Metformin Hydrochloride alone cannot function effectively to control the glycemic level of type 2 diabetes patients on the basis of diet and exercise. The drug can be used with Metformin Hydrochloride and Sulfonylureas when Metformin Hydrochloride and Sulfonylureas cannot function effectively to control the glycemic level of type 2 diabetes patients on the basis of diet and exercise. Limitation of use: the drug is not recommended in patients with type 1 diabetes mellitus or diabetic ketoacidosis. Newly approved on June 10, 2022: Indicated in adults with heart failure and reduced ejection fraction.

6. Pyrotinib Maleate Tablets

1	Generic Name	Pyrotinib Maleate Tablets
2	Brand Name	Ai Rui Ni (艾瑞妮)
3	Registration Classification	Class 2.4 chemical drug
4	Application Type	NDA
5	MAH	Jiangsu Hengrui Pharmaceuticals Co., Ltd.
6	Approval Date	June 2, 2022
7	Time from Application Acceptance to Approval	258 days
8	Priority Review	Yes (conditional approval)
9	Target(s)	Epidermal growth factor receptor (EGFR); Human epidermal growth factor receptor 2 (HER2)
10	Indication(s)	Previously approved: This drug, in combination with capecitabine, is indicated for the treatment of HER2-positive patients with recurrent or metastatic breast cancer no matter the patients have received trastuzumab treatment or not. Patients are required to have received anthracycline or taxane chemotherapy before taking Pyrotinib Maleate Tablets. The indication is conditionally approved based on the results of a phase II clinical trial involving 128 patients with the indication. Full approval will depend on the ongoing confirmatory trial's verification of the drug's clinical benefit in this patient group. Approved on June 2, 2022: This drug, combined with trastuzumab and docetaxel, is indicated as a neoadjuvant therapy for patients with HER2-positive early/locally advanced breast cancer.

7. Mitoxantrone Hydrochloride Injection for Tracing

1	Generic Name	Mitoxantrone Hydrochloride Injection for Tracing
2	Brand Name	/
3	Registration Classification	Class 2.4 chemical drug
4	Application Type	NDA
5	MAH	Shenzhen China Resources Gosun Pharmaceutical Co., Ltd.
6	Approval Date	June 10, 2022
7	Time from Application Acceptance to Approval	272 days
8	Priority Review	No
9	Target(s)	DNA Topoisomerase II Alpha (TOP2A)
10	Indication(s)	Indicated for tracing tumor-draining lymph nodes around thyroid tumor and other tumors.

8. Furmonertinib Mesilate Tablets

1	Generic Name	Furmonertinib Mesilate Tablets
2	Brand Name	Ai Fu Sha (艾弗沙)
3	Registration Classification	Class 2.4 chemical drug
4	Application Type	NDA
5	MAH	Shanghai Allist Pharmaceuticals Co., Ltd.
6	Approval Date	June 30, 2022
7	Time from Application Acceptance to Approval	193 days
8	Priority Review	Yes (breakthrough therapy)
9	Target(s)	EGFR T790M
10	Indication(s)	Previously approved: Indicated for treating adult patients with locally advanced or metastatic NSCLC with disease progression during or after prior EGFR-TKI therapy, and confirmed by testing to be positive for EGFR T790M mutation. Newly approved on June 30, 2022: In combination with trastuzumab and docetaxel, the drug is indicated as neoadjuvant therapy for patients with HER2-positive early/locally advanced breast cancer.

9. Levetiracetam in Sodium Chloride Injection

1	Generic Name	Levetiracetam in Sodium Chloride Injection
2	Brand Name	/
3	Registration Classification	Class 3 chemical drug
4	Application Type	Abbreviated new drug application (ANDA)
5	MAH	Hebei Renhe Yikang Pharmaceutical Co., Ltd.
6	Approval Date	June 20, 2022
7	Time from Application Acceptance to Approval	463 days
8	Priority Review	No
9	Target(s)	Synaptic vesicle glycoprotein 2A (SV2A)
10	Indication(s)	Indicated for the treatment of partial-onset seizures in patients no younger than one month. Indicated as adjunctive therapy for the treatment of myoclonic seizures in patients no younger than 12 old with juvenile myoclonic epilepsy. Indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients no younger than 6 years old with idiopathic generalized epilepsy. Limitations of use: this drug is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible.
11	Notes	First generic drug in China

10. Enalapril Maleate Oral Solution

1	Generic Name	Enalapril Maleate Oral Solution
2	Brand Name	/
3	Registration Classification	Class 3 chemical drug
4	Application Type	ANDA
5	MAH	Sichuan Baili Pharmaceutical Industry Co., Ltd.
6	Approval Date	June 30, 2022
7	Time from Application Acceptance to Approval	515 days
8	Priority Review	No
9	Target(s)	Angiotensin-converting enzyme (ACE)
10	Indication(s)	Indicated for treating hypertension in pediatric patients; Usually used in combination with diuretics and digitalis to improve survival rate, slow the progression of heart failure, and reduce heart failure hospitalizations in the treatment of symptomatic heart failure. Indicated for slowing the progression of heart failure and reducing heart failure hospitalizations in the treatment of asymptomatic left ventricular dysfunction (ejection fraction ≤35%).
11	Notes	First generic drug in China

11. Tacrolimus Extended-release Capsules

1	Generic Name	Tacrolimus Extended-release Capsules
2	Brand Name	/
3	Registration Classification	Class 4 chemical drug
4	Application Type	ANDA
5	MAH	Chengdu Suncadia Medicine Co., Ltd.
6	Approval Date	June 30, 2022
7	Time from Application Acceptance to Approval	561 days
8	Priority Review	No
9	Target(s)	Calcineurin subunit B type 2 (PPP3R2)
10	Indication(s)	Indicated for preventing graft rejection after kidney transplantation or during the maintenance period after liver transplantation; treating graft rejection that cannot be controlled by other immunosuppressive drugs after kidney or liver transplantation.
11	Notes	First generic drug in China

12. Blonanserin Tablets

1	Generic Name	Blonanserin Tablets
2	Brand Name	/
3	Registration Classification	Class 4 chemical drug
4	Application Type	ANDA
5	MAH	Shijizhuang No. 4 Pharmaceutical Co., Ltd.
6	Approval Date	June 20, 2022
7	Time from Application Acceptance to Approval	498 days
8	Priority Review	No
9	Target(s)	5-hydroxytryptamine 2 receptor (5-HT2); D(2) dopamine receptor (DRD2)
10	Indication(s)	Indicated for the treatment of schizophrenia.
11	Notes	First generic drug in China

13. Fluocinolone Acetonide Intravitreal Implants

1	Generic Name	Fluocinolone Acetonide Intravitreal Implants
2	Brand Name	YUTIQ
3	Registration Classification	Class 5.1 chemical drug
4	Application Type	NDA, import
5	MAH	EyePoint Pharmaceuticals, Inc.
6	Approval Date	June 20, 2022
7	Time from Application Acceptance to Approval	435 days
8	Priority Review	No
9	Target(s)	/
10	Indication(s)	Indicated for the treatment of chronic non-infectious uveitis.

14. Isavuconazonium Sulfate for Injection

1	Generic Name	Isavuconazonium Sulfate for Injection
2	Brand Name	CRESEMBA
3	Registration Classification	Class 5.1 chemical drug
4	Application Type	NDA, import
5	MAH	Basilea Pharmaceutica Deutschland GmbH
6	Approval Date	June 20, 2022
7	Time from Application Acceptance to Approval	712 days
8	Priority Review	No
9	Target(s)	Lanosterol 14-alpha demethylase (CYP51A1)
10	Indication(s)	The drug is a new antifungal therapy indicated for treating invasive mucormycosis and/or aspergillosis in adult patients.

15. Riluzole Oral Suspension

1	Generic Name	Riluzole Oral Suspension
2	Brand Name	TIGLUTIK
3	Registration Classification	Class 5.1 chemical drug
4	Application Type	NDA, import
5	MAH	Italfarmaco, S.A.
6	Approval Date	June 2
7	Time from Application Acceptance to Approval	874 days
8	Priority Review	No
9	Target(s)	Metabotropic glutamate receptor 1 (GRM1); Sodium channel
10	Indication(s)	Indicated for treating amyotrophic lateral sclerosis (ALS).

16. Bemiparin Sodium Injection

1	Generic Name	Bemiparin Sodium Injection
2	Brand Name	HIBOR (稀保)
3	Registration Classification	Class 5.1 chemical drug
4	Application Type	NDA, import
5	MAH	Laboratorios Farmaceuticos ROVI, S.A.
6	Approval Date	June 24, 2022
7	Time from Application Acceptance to Approval	295 days
8	Priority Review	No
9	Target(s)	Serpin Family C Member 1 (SERPINC1)
10	Indication(s)	The drug is indicated for preventing venous thrombosis after general and orthopedic surgery; preventing venous thrombosis against the moderate or high risks of causing the disease in non-surgical procedures; secondary prevention of recurrent venous thrombosis in patients with deep venous thromboembolism and transient risk factors. preventing blood from clotting in the extracorporeal circulation during hemodialysis. treating existing deep vein thrombosis, no matter with or without pulmonary embolism.

17. Larotrectinib Sulfate Oral Solution

1	Generic Name	Larotrectinib Sulfate Oral Solution
2	Brand Name	Vitrakvi
3	Registration Classification	Class 5.1 chemical drug
4	Application Type	NDA, import
5	MAH	Bayer AG
6	Approval Date	June 24, 2022
7	Time from Application Acceptance to Approval	399 days
8	Priority Review	Yes (pediatric drug)
9	Target(s)	Neurotrophic Receptor Tyrosine Kinase 1 (NTRK1)
10	Indication(s)	The drug is indicated for treating solid tumors harboring NTRK gene fusions in pediatric and adult patients who have locally advanced or metastatic disease, or may have serious complications due to surgical resection, or don't have satisfactory therapy.

18. 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	June 2, 2022
7	Time from Application Acceptance to Approval	267 days
8	Priority Review	No
9	Target(s)	Programmed death-ligand 1 (PD-L1)
10	Indication(s)	Previously approved: 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. Newly approved on June 2, 2022: The drug is indicated for the treatment of patients with unresectable stage III NSCLC which didn't progress after platinum-based concurrent or sequential chemoradiotherapy.

19. Cadonilimab Injection

1	Generic Name	Cadonilimab Injection
2	Brand Name	Kai Tan Ni (开坦尼)
3	Registration Classification	Class 1 therapeutic biological product
4	Application Type	BLA
5	MAH	Akeso Biopharma Co., Ltd.
6	Approval Date	June 30, 2022
7	Time from Application Acceptance to Approval	275 days
8	Priority Review	Yes (conditional approval)
9	Target(s)	PD-1
10	Indication(s)	Indicated for treating recurrent or metastatic cervical cancer patients with prior failure of platinum-based chemotherapy.

20. Sintilimab Injection

1	Generic Name	Sintilimab Injection
2	Brand Name	Tyvyt (达伯舒)
3	Registration Classification	Class 2.2 therapeutic biological product
4	Application Type	BLA
5	MAH	Innovent Biologics, Inc.
6	Approval Date	June 20, 2022
7	Time from Application Acceptance to Approval	267 days
8	Priority Review	No
9	Target(s)	PD-1
10	Indication(s)	Previously approved indications: For treating relapsed or refractory classical Hodgkin's lymphoma. In combination with pemetrexed and platinum for the first-line treatment of locally advanced or metastatic non-squamous NSCLC. In combination with gemcitabine and platinum-based chemotherapy for the first-line treatment of locally advanced or metastatic squamous NSCLC. In combination with bevacizumab for the first-line treatment of advanced hepatocellular carcinoma. Newly approved on June 20, 2022: In combination of fluorouracil and platinum-based chemotherapy for the first-line treatment of unresectable locally advanced, recurrent or metastatic gastric and gastroesophageal junction adenocarcinoma.

21. 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	June 10, 2022
7	Time from Application Acceptance to Approval	291 days
8	Priority Review	No
9	Target(s)	PD-1
10	Indication(s)	Previously approved: 1. For the second-line treatment of relapsed or refractory classic Hodgkin lymphoma (cHL) patients who have received at least the second-line chemotherapy; 2. For treating 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; 3. In combination with paclitaxel and platinum for the first-line treatment for patients with advanced squamous NSCLC that is unresectable by surgery; 4. For treating hepatocellular carcinoma (HCC) patients who have received at least one type of systemic therapy; 5. In combination with pemetrexed and platinum chemotherapy for the first-line treatment for NSCLC that are EGFR-negative, ALK-negative and unresectable by surgery. 6. For the second-line or third-line treatment for NSCLC patients who have disease progression after platinum chemotherapy. 7. For the treatment of locally advanced, unresectable or metastatic, microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) solid tumors after prior treatment. 8. For the treatment of esophageal squamous cell carcinoma (ESCC) that is unresectable, relapsed, locally advanced or metastatic after prior systemic treatment. Newly approved on June 10, 2022: 9. For the first-line treatment of relapsed or metastatic nasopharyngeal carcinoma.

22. Nivolumab Injection

1	Generic Name	Nivolumab Injection
2	Brand Name	OPDIVO (欧狄沃)
3	Registration Classification	Class 2.1 & 3.3 therapeutic biological product
4	Application Type	BLA, import
5	MAH	Bristol-Myers Squibb Pharma EEIG
6	Approval Date	June 24, 2022
7	Time from Application Acceptance to Approval	280 days
8	Priority Review	No
9	Target(s)	PD-1
10	Indication(s)	Previously approved: 1. For the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with disease progression or intolerance after platinum-containing chemotherapy, and with no EGFR or ALK genomic tumor aberrations. 2. For the treatment of PD-L1 positive (≥1% tumor cells with positive PD-L1 expression) patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy. 3. For the treatment of advanced or recurrent gastroesophageal junction adenocarcinoma in patients who have received two or more systemic treatments; 4. In combination with Ipilimumab in the initial treatment of unresectable non-epithelioid malignant pleural mesothelioma; 5. In combination with fluorouracil and platinum-based chemotherapy for first-line treatment of advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma. Newly approved on June 24, 2022: 6. Indicated as adjuvant therapy for patients with esophageal cancer or gastroesophageal junction cancer and pathological residues after neoadjuvant chemoradiotherapy (CRT) and complete surgical resection; 7. In combination with fluoropyrimidines and platinum-containing chemotherapy for first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma.

23. Cetuximab Solution for Infusion

1	Generic Name	Cetuximab Solution for Infusion
2	Brand Name	Erbitux (爱必妥)
3	Registration Classification	Class 3.1 therapeutic
4	Application Type	BLA, import
5	MAH	Merck Europe B.V.
6	Approval Date	June 20, 2022
7	Time from Application Acceptance to Approval	225 days
8	Priority Review	No
9	Target(s)	EGFR
10	Indication(s)	Previously approved: For the first-line treatment of patients with RAS wild-type metastatic colorectal cancer in combination with FOLFOX or FOLFIRI, or in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy. In combination with platinum-based therapy with fluorouracil for the first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). Newly approved on June 20, 2022: In combination with radiotherapy for the treatment of locally advanced squamous cell carcinoma of the head and neck (LA SCCHN).

24. Recombinant Human Growth Hormone Injection

1	Generic Name	Recombinant Human Growth Hormone Injection
2	Brand Name	Jintropin (赛增)
3	Registration Classification	Class 3.2 therapeutic biological product
4	Application Type	BLA
5	MAH	GeneScience Pharmaceuticals Co., Ltd. (GenSci)
6	Approval Date	June 30, 2022
7	Time from Application Acceptance to Approval	252 days
8	Priority Review	No
9	Target(s)	/
10	Indication(s)	Previously approved: 1. For treating children with slow growth caused by endogenous growth hormone deficiency. 2. For treating children with short stature caused by Noonan syndrome. 3. For treating children with short stature or growth retardation caused by SHOX deficiency. 4. For treating children with short stature due to achondroplasia. 5. For treating growth disorders in girls due to gonadal dysgenesis (Turner syndrome). 6. For treating adults with short bowel syndrome who receives nutritional support. 7. For treating growth hormone deficiency due to confirmed hypothalamic-pituitary disease and severe growth hormone deficiency confirmed by two different growth hormone stimulation tests. 8. For treating severe burn. Newly approved on June 30, 2022: 9. For treating children with growth disorders caused by Prader-Willi syndrome (PWS).

25. Sacituzumab Govitecan for Injection

1	Generic Name	Sacituzumab Govitecan for Injection
2	Brand Name	Trodelvy
3	Registration Classification	Class 3.1 therapeutic biological product
4	Application Type	BLA, import
5	MAH	Gilead Sciences, Inc.
6	Approval Date	June 10, 2022
7	Time from Application Acceptance to Approval	385 days
8	Priority Review	Yes (conditional approval)
9	Target(s)	/
10	Indication(s)	Indicated for treating adult patients with unresectable or metastatic triple-negative breast cancer (mTNBC) who have received two or more systemic therapies (at least one of which was targeted at metastatic diseases).

Contact BaiPharm to know more about drug marketing authorization in China.

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