Table 2 Notable innovative drugs approved in China in the past five years
From: Current landscape of innovative drug development and regulatory support in China
Product name | Time of approval | Manufacturer | Indication | Remark |
|---|---|---|---|---|
Chemical and Biotherapeutic Drugs | ||||
Benvitimod Cream | 05/31/2019 | Guangdong Zhonghao | Mild to moderate stable plaque psoriasis in adults | Approved through the priority review and approval process. |
Ormutivimab Injection | 01/25/2022 | North China Pharmaceutical | Passive immunization for adults exposed to rabies virus | Approved through the priority review and approval process; First recombinant human anti-rabies monoclonal antibody in China. |
Tafolecimab Injection | 08/16/2023 | Innovent Biologics (Suzhou) | Primary hypercholesterolemia and mixed dyslipidemia in adults | First domestically developed PCSK9 monoclonal antibody inhibitor in China. |
Surufatinib Capsules (SULANDA) | 12/30/2020 | Hutchison Medipharma (Shanghai) | Neuroendocrine tumors | Approved through the priority review and approval process. |
Narlumosbart Injection | 09/06/2023 | Shanghai JMT | Giant cell tumor of bone in adults | Conditionally approved; First domestically developed RANKL-targeted drug. |
Sunvozertinib Tablets | 08/23/2023 | Dizal (Jiangsu) | Locally advanced or metastatic non-small cell lung cancer in adults | Conditionally approved; First domestic tyrosine kinase inhibitor targeting EGFR exon 20 mutations. |
Simnotrelvir Tablets/Ritonavir Tablets (co-packaged) | 01/29/2023 | Simcere (Hainan) | Mild to moderate COVID-19 in adults | Emergency review and conditional approval; Meets dynamic needs of China’s COVID-19 prevention efforts. |
Deuremidevir Hydrobromide Tablets | 01/29/2023 | Shanghai Wangshi | Mild to moderate COVID-19 in adults | Emergency review and conditional approval; Supports China’s COVID-19 prevention efforts. |
Leritrelvir Tablets | 03/23/2023 | Guangdong Zhongsheng Ruichuang | Mild to moderate COVID-19 in adults | Conditionally approved; First 3CL protease inhibitor approved in China. |
Coblopasvir Hydrochloride Capsules | 02/12/2020 | Beijing Kain-Gelin | Chronic hepatitis C virus (HCV) infection in adults | Approved through the priority review and approval process; First domestically developed broad-spectrum anti-HCV drug. |
Ainuovirine | 06/23/2021 | Jiangsu Hansoh | Chronic hepatitis B in adults | Approved through the priority review and approval process; First domestically developed small-molecule anti-hepatitis B drug. |
Ainomeptide Tablets | 01/04/2023 | Jiangsu Aide | HIV-1 infection in treatment-naïve adults | First domestically developed novel anti-HIV combination therapy. |
Spesolimab-sbzo Injection | 12/14/2022 | Boehringer Ingelheim International GmbH | Generalized pustular psoriasis in adults | Approved through the priority review process; Global simultaneous development and launch. |
Ritlecitinib Tosylate Capsules | 10/19/2023 | Pfizer | Severe alopecia areata in adolescents and adults (12 years and older) | Approved through the priority review process; First drug in China for adolescent alopecia areata; global simultaneous development and launch. |
Risdiplam Oral Solution | 06/17/2021 | Roche | Spinal muscular atrophy (SMA) in patients 2 months and older | Approved through the priority review process; Global simultaneous development and launch; First oral treatment for SMA. |
Siponimod Tablets | 05/11/2020 | Novartis Pharma AG | Relapsing multiple sclerosis in adults | Approved through the priority review process; Global simultaneous development and launch. |
Vericiguat Tablets | 05/19/2022 | Bayer | Chronic heart failure in adults | Approved through the priority review process; Global simultaneous development and launch. |
Pralsetinib Capsules | 03/24/2021 | Blueprint Medicines Corporation | Locally advanced or metastatic non-small cell lung cancer in adults (NSCLC) | Conditionally approved through the priority review process; RET (Rearranged during Transfection) inhibitor. |
Glofitamab Injection | 11/08/2023 | Roche Pharma (Schweiz) AG | Relapsed or refractory diffuse large B-cell lymphoma in adults | Conditionally approved through the priority review process; First bispecific CD3/CD20 antibody approved in China; globally co-developed and launched. |
Vaccines | ||||
Inactivated COVID-19 Vaccine (Vero Cell) | 12/30/2020 | Sinopharm CNBG Beijing | Prevention of COVID-19 | Emergency review and conditional approval; First domestically approved inactivated COVID-19 vaccine. |
Inactivated COVID-19 Vaccine (Vero Cell) | 02/05/2021 | Sinovac Biotech (Beijing) | Prevention of COVID-19 | Emergency review and conditional approval; Second domestically approved COVID-19 vaccine. |
Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) | 02/25/2021 | CanSino Biologics | Prevention of COVID-19 | Emergency review and conditional approval; First domestically approved adenovirus vector COVID-19 vaccine. |
Inactivated COVID-19 Vaccine (Vero Cell) | 02/25/2021 | Sinopharm CNBG Wuhan | Prevention of COVID-19 | Emergency review and conditional approval. |
Recombinant COVID-19 Protein Vaccine (CHO Cell) | 03/01/2022 | Anhui Zhifei Longcom | Prevention of COVID-19 | Emergency review and conditional approval; First globally approved recombinant protein COVID-19 vaccine; First overseas clinical trial inspected by Chinese regulators. |
Oral Trivalent Live Attenuated Rotavirus Vaccine (Vero Cell) | 04/17/2023 | Sinopharm CNBG Lanzhou | Prevention of infant diarrhea caused by rotavirus (types G1, G2, G3, G4, G9) | First domestically developed trivalent rotavirus vaccine. |
Quadrivalent Influenza Virus Subunit Vaccine | 05/12/2023 | Jiangsu Zhonghui Yuantong | Influenza virus infection in individuals aged 3 years and older | First domestically developed quadrivalent influenza virus subunit vaccine. |
Cell and Gene Therapy | ||||
Relmacabtagene Autoleucel Injection | 09/01/2021 | Shanghai, JW Therapeutics | Relapsed or refractory large B-cell lymphoma in adults | First domestically developed and approved Category 1 cell therapy product in China. |
Inaticabtagene Autoleucel Injection | 11/07/2023 | Tianjin Juventas Cell Therapy | Relapsed or refractory B-cell acute lymphoblastic leukemia in adults | Conditionally approved through the priority review process. |
Equecabtagene Autoleucel Injection | 06/30/2023 | Nanjing IASO Bio | Relapsed or refractory multiple myeloma in adults | Conditionally approved through the priority review process. |
TCM Innovative Drugs | ||||
Ramulus Mori (Sangzhi) alkaloids tablets | 03/27/2020 | Beijing Wehand-Bio | Type 2 diabetes | First anti-diabetic TCM drug approved in the last decade. |
Icariin Soft Capsules | 01/10/2022 | Beijing Shenogen | Hepatocellular carcinoma | Conditionally approved through the priority review process; Class 1.2 TCM innovative drug. |
Yiqi Tongqiao Pills | 09/14/2021 | Tianjin Dongfang Huakang | Seasonal allergic rhinitis (lung and spleen qi deficiency syndrome) | TCM compound preparation based on clinical experience. |
