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 May 2021, China NMPA granted nine new drug approvals. The approval details are listed as follows.
1. Pamiparib Capsules
1 | Generic Name | Pamiparib Capsules |
2 | Brand Name | Bai Hui Ze (百汇泽) |
3 | Classification | Chemical drug |
4 | Registration Classification | Class 1: Innovative new drug that has never been marketed in China or any overseas market |
5 | Priority Review & Approval | Yes (conditional approval) |
6 | Time from Application Submission to Approval | 295 days |
7 | Approval Date | May 7, 2021 |
8 | Marketing Authorization Holder (MAH) | BeiGene (Suzhou) Biotech Co., Ltd. |
9 | Target | PARP1, PARP2, Tankyrase-1, Tankyrase-2 |
10 | Indication | Relapsed late-stage ovarian cancer, fallopian tube cancer and primary peritoneal carcinoma with BRCA (gBRCA) mutations after second-line chemotherapy. |
2. Sodium Phenylbutyrate Granules
1 | Generic Name | Sodium Phenylbutyrate Granules |
2 | Brand Name | / |
3 | Classification | Chemical drug |
4 | Category | First generic version of an original drug that has not been marketed in China |
5 | Priority Review & Approval | Yes (Reason: it's a rare disease drug) |
6 | Time from Application Submission to Approval | 1,077 days |
7 | Approval Date | May 13, 2021 |
8 | MAH | Zhaoke Pharmaceutical (Guangzhou) Go., Ltd. |
9 | Target | HDAC |
10 | Indication | It is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC) and argininosuccinate synthetase (AS). It is indicated in all patients with neonatal-onset presentation (complete enzyme deficiencies, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease (partial enzyme deficiencies, presenting after the first month of life) who have a history of hyperammonaemic encephalopathy. |
3. Fampridine Sustained-release Tablets
1 | Generic Name | Fampridine Sustained-release Tablets |
2 | Brand Name | Ampyra |
3 | Classification | Chemical drug |
4 | Category | Imported original drug |
5 | Priority Review & Approval | Yes (Reason: it meets other conditions for priority review and approval) |
6 | Time from Application Submission to Approval | 120 days |
7 | Approval Date | May 18, 2021 |
8 | MAH | Biogen Netherlands B.V. |
9 | Target | Potassium channel |
10 | Indication | To help improve walking ability of adult patients with multiple sclerosis (MS). |
4. Indacaterol Acetate, Glycopyrronium Bromide and Mometasone Furoate Powder for Inhalation (I)
1 | Generic Name | Indacaterol Acetate, Glycopyrronium Bromide and Mometasone Furoate Powder for Inhalation (I) |
2 | Brand Name | / |
3 | Classification | Chemical drug |
4 | Registration Classification | Improved new drug |
5 | Priority Review & Approval | No |
6 | Time from Application Submission to Approval | 370 days |
7 | Approval Date | May 19, 2021 |
8 | MAH | Novartis Pharma Schweiz AG |
9 | Target | ADRB2, NR3C1 |
10 | Indication | For treating uncontrolled asthma. |
5. Indacaterol Acetate, Glycopyrronium Bromide and Mometasone Furoate Powder for Inhalation (Ⅱ)
1 | Generic Name | Indacaterol Acetate, Glycopyrronium Bromide and Mometasone Furoate Powder for Inhalation (Ⅱ) |
2 | Brand Name | / |
3 | Classification | Chemical drug |
4 | Registration Classification | Improved new drug |
5 | Priority Review & Approval | No |
6 | Time from Application Submission to Approval | 370 days |
7 | Approval Date | May 19, 2021 |
8 | MAH | Novartis Pharma Schweiz AG |
9 | Target | ADRB2, NR3C1 |
10 | Indication | For treating uncontrolled asthma. |
6. Axitinib Tablets
1 | Generic Name | Axitinib Tablets |
2 | Brand Name | / |
3 | Classification | Chemical drug |
4 | Catagory | First generic version of an original drug that has not been marketed in China |
5 | Priority Review & Approval | No |
6 | Time from Application Submission to Approval | 498 days |
7 | Approval Date | May 19, 2021 |
8 | MAH | Shandong New Time Pharmaceutical Co., Ltd. |
9 | Target | ABCB1, CYP3A4, UGT1A1, KDR, CYP3A5, CYP1A2, CYP2C19, FLT1, FLT4, SLCO1B1 |
10 | Indication | For treating adult patients with advanced renal cell carcinoma (RCC) after failing a prior cytokine therapy or a therapy with tyrosine kinase inhibitors (TKI). |
7. Fospropofol Disodium Injection
1 | Generic Name | Fospropofol Disodium Injection |
2 | Brand Name | Lusedra |
3 | Classification | Chemical drug |
4 | Registration Classification | Class 1: Innovative new drugs that have never been marketed in China or any overseas market |
5 | Priority Review & Approval | No |
6 | Time from Application Submission to Approval | 960 days |
7 | Approval Date | May 19, 2021 |
8 | MAH | Yichang Humanwell Pharmaceutical Co., Ltd. |
9 | Target | / |
10 | Indication | Acting as a sedative-hypnotic agent through intravenous administration for adults' general anesthesia. |
8. Levornidazole Disodium Phosphate for Injection
1 | Generic Name | Levornidazole Disodium Phosphate for Injection |
2 | Brand Name | Xin Rui (新锐) |
3 | Classification | Chemical drug |
4 | Registration Classification | Class 1: Innovative new drugs that have never been marketed in China or any overseas market |
5 | Priority Review & Approval | Yes ( Reason: it's a qualified innovative new drug) |
6 | Time from Application Submission to Approval | 663 days |
7 | Approval Date | May 26, 2021 |
8 | MAH | Jiangsu Zilong Pharmaceutical Co., Ltd. Under Yangtze River Pharmaceutical Group |
9 | Target | / |
10 | Indication | For treating diseases induced by infections caused by anaerobic bacteria, including Peptostreptococcus anaerobius, Actinomyces israelii, Porphyromonas gingivalis, Bacteroides fragilis, Clostridium perfringens and Prevotella melaninogenica. |
9. Ivabradine Hydrochloride Tablets
1 | Generic Name | Ivabradine Hydrochloride Tablets |
2 | Brand Name | / |
3 | Classification | Chemical drug |
4 | Category | First generic version of an original drug that has not been marketed in China |
5 | Priority Review & Approval | No |
6 | Time from Application Submission to Approval | 560 days |
7 | Approval Date | May 26, 2021 |
8 | MAH | Beijing Bai'ao Pharmaceuticals Co., Ltd. |
9 | Target | CYP3A4HCN2 |
10 | Indication | To treat patients with chronic heart failure of Class Ⅱ-Ⅳ according to New York Heart Association (NYHA), who are in sinus rhythm with resting heart rate ≥ 75 beats per minute. The drug should be used in therapies with betablockers or for patients who have a contraindication or intolerance to beta-blockers. |
