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 Aug. 2021, China NMPA granted 11 new drug approvals:
1. 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 | Marketing Authorization Holder (MAH) | Boehringer Ingelheim Biopharmaceuticals China Ltd. and Guangzhou BeiGene Biopharmaceuticals Co., Ltd. |
5 | Approval Date | Aug. 12, 2021 |
6 | Time from Application Acceptance to Approval | 74 days |
7 | Priority Review | No |
8 | Conditional Approval | Yes (supplemental application for new indication) |
9 | Target | PD-1 |
10 | Indication(s) | Treating patients with relapsed/refractory classical Hodgkin's lymphoma (cHL) who have received at least two prior systemic chemotherapies. |
2. Apremilast Tablet
1 | Generic Name | Apremilast Tablet |
2 | Brand Name | OTEZLA (欧泰乐) |
3 | Registration Classification | Class 5.1 chemical drug |
4 | MAH | Amgen Inc. |
5 | Approval Date | Aug. 16, 2021 |
6 | Time from Application Acceptance to Approval | 196 days |
7 | Priority Review | Yes (other qualified situations) |
8 | Target | PDE4 |
9 | Indication(s) | Psoriasis. |
3. Nivolumab Injection
1 | Generic Name | Nivolumab Injection |
2 | Brand Name | OPDIVO (欧狄沃) |
3 | Registration Classification | Class 2.2 therapeutic biological product |
4 | MAH | Bristol-Myers Squibb Pharma EEIG |
5 | Approval Date | Aug. 30, 2021 |
6 | Time from Application Acceptance to Approval | 239 days |
7 | Priority Review | No |
8 | Target | PD-1 |
9 | Indication(s) | Non-Small Cell Lung Cancer OPDIVO as a monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with progression after platinum-based chemotherapy or with intolerance to another chemotherapy, and with no EGFR or ALK genomic tumor aberrations. Squamous Cell Carcinoma of the Head and Neck OPDIVO as a monotherapy is indicated 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. |
4. Triptorelin Pamoate for Injection
1 | Generic Name | Triptorelin Pamoate for Injection |
2 | Brand Name | / |
3 | Registration Classification | Class 5.1 chemical drug |
4 | MAH | Beaufour-Ipsen (Tianjin) Pharmaceutical Co., Ltd. |
5 | Approval Date | Aug. 5, 2021 |
6 | Time from Application Acceptance to Approval | 366 days |
7 | Priority Review | No |
8 | Target | GNRHR |
9 | Indication(s) | Locally advanced or metastatic prostate cancer. |
5. Penpulimab Injection
1 | Generic Name | Penpulimab Injection |
2 | Brand Name | An Ni Ke (安尼可) |
3 | Registration Classification | Class 1 therapeutic biologic product |
4 | MAH | CTTQ Akeso (Shanghai) Biomedical Technology Co., Ltd. |
5 | Approval Date | Aug. 5, 2021 |
6 | Time from Application Acceptance to Approval | 441 days |
7 | Priority Review | No |
8 | Target | PD-1 |
9 | Indication(s) | / |
6. Teneligliptin Hydrobromide Tablets
1 | Generic Name | Teneligliptin Hydrobromide Tablets |
2 | Brand Name | TENELIA (泰里安) |
3 | Registration Classification | Class 5.1 chemical drug |
4 | MAH | Mitsubishi Tanabe Pharma Corporation |
5 | Approval Date | Aug. 5, 2021 |
6 | Time from Application Acceptance to Approval | 680 days |
7 | Priority Review | No |
8 | Target | DPP4 |
9 | Indication(s) | Type-2 diabetes. |
7. Ozagrel Trometamol Concentrated Solution for Injection
1 | Generic Name | Ozagrel Trometamol Concentrated Solution for Injection |
2 | Brand Name | / |
3 | Registration Classification | Class 2.1 chemical drug |
4 | MAH | Wuhan Hengxinyuan Pharmaceutical Co., Ltd. |
5 | Approval Date | Aug. 16, 2021 |
6 | Time from Application Acceptance to Approval | 1,156 days |
7 | Priority Review | No |
8 | Target | TBXAS1 |
9 | Indication(s) | / |
8. Recombinant Coagulation Factor VIII for Injection
1 | Generic Name | Recombinant Coagulation Factor VIII for Injection |
2 | Brand Name | GreenGene F (绿茵芷) |
3 | Registration Classification | Class 3.1 therapeutic biological product |
4 | MAH | Green Cross Corporation |
5 | Approval Date | Aug. 11, 2021 |
6 | Time from Application Acceptance to Approval | 728 days |
7 | Priority Review & Approval | Yes (rare disease) |
8 | Target | Coagulation Factor X |
9 | Indication(s) | GreenGene F is a recombinant antihemophilic factor for the on-demand treatment and control of bleeding episodes for adults and children (aged 0-16) with Hemophilia A. Perioperative management of bleeding of adults and children (aged 0-16) with Hemophilia A. Routine prophylaxis to reduce the frequency of bleeding episodes and joint injuries in children (this indication is based on results of clinical trials outside of China without collecting data to from Chinese kids). NOT indicated for Von Willebrand disease (VWD). |
9. Dinutuximab beta Injection
1 | Generic Name | Dinutuximab beta Injection |
2 | Brand Name | Qarziba (凯泽百) |
3 | Registration Classification | Class 3.1 therapeutic biological product |
4 | MAH | EUSA Pharma (Netherlands) B.V. |
5 | Approval Date | Aug. 17, 2021 |
6 | Time from Application Acceptance to Approval | 39 days |
7 | Priority Review & Approval | Yes (other qualified situations) |
8 | Target | GD2 |
9 | Indication(s) | Indicated for treating patients (≥12 months) with high-risk neuroblastoma, and the patients' condition should meet the following descriptions: the patients had received prior neoadjuvant chemotherapy and experienced at least partial remission; after that, they received myeloid therapy and stem cell transplantation (SCT) therapy. Indicted for patients (≥12 months) with relapsed or refractory neuroblastoma with or without residual foci. Proper measures should be taken to stabilize the activity or progression of neuroblastoma before the treatment of relapsed neuroblastoma. Dinutuximab beta Injection should be used with Interleukin-2 (IL-2) on patients who have not reached full recovery after the first-line therapy for relapsed/refractory diseases. |
10. Zimberelimab Injection
1 | Generic Name | Zimberelimab Injection |
2 | Brand Name | 誉妥 (Pinyin: Yu Tuo) |
3 | Registration Classification | Class 1 therapeutic biological product |
4 | MAH | Guangzhou Gloria Biosciences Co., Ltd. |
5 | Approval Date | Aug. 30, 2021 |
6 | Time from Application Acceptance to Approval | 542 days |
7 | Priority Review | No |
8 | Target | Programmed cell death protein 1 (PD-1) |
9 | Indication(s) | For the treatment of adult patients with relapsed or refractory classic Hodgkin lymphoma (cHL) after at least two prior systemic chemotherapies |
11. Sildenafil Citrate Tablets
1 | Generic Name | Sildenafil Citrate Tablets |
2 | Brand Name | / |
3 | Registration Classification | Class 5.2 chemical drug |
4 | MAH | Aurobindo Pharma Limited |
5 | Approval Date | Aug. 30, 2021 |
6 | Time from Application Acceptance to Approval | 966 days |
7 | Priority Review | No |
8 | Target | Phosphodiesterase 5A (PDE5A) |
9 | Indication(s) | Sildenafil Citrate Tablets are a phosphodiesterase type 5 inhibitor (PDE5 inhibitor) or the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. |
If you need details of the approved drugs listed above or drug registration procedures in China, welcome to send an email to contact@chemlinked.com.
Know more about drug classifications by reading the articles below: