Anti-PD-1/PD-L1 monoclonal antibodies, the trailbreaker of tumor immunotherapies, have been chased after by the market since marketing, and become the battleground of international pharmaceutical giants. MSD’s Keytruda and BMS’ Opdivo were successively approved for marketing by FDA in 2014, the first anti-PD-L1 monoclonal antibody—Tecentriq (of Roche) was marketed in 2016, and the Bavencio of Pfizer and MSD, and Imfinzi of AstraZeneca were successively marketed in 2017. Five drugs of the same kind have been successively marketed in just four years, with each having a strong pharmaceutical giant behind, and each company regards their drug as the blockbuster product in the tumor immunotherapy field in the next years.
Anti-PD-1/PD-L1 monoclonal antibodies have lived up to the public’s expectations. Sales of Opdivo (BMS) and Keytruda (MSD) have been soaring since marketed in 2014, separately reaching USD 4.848 billion and USD 3.809 billion in 2017; and even the Tecentriq just marketed in May 2016 achieved the satisfactory CHF 487 million sales.
Companies use most of their firepower in order to gain advantages in this fierce competition, wherein, BMS has successively conducted 40 clinical studies, followed by MSD and Roche separately with 32 and 26 clinical studies.
1. Players rushing on like a swarm of hornets
Targets that have been highly recognized on the European and American markets naturally become preferred target of Chinese biological companies. Therefore, we have such a table (Fig. 1): 31 enterprises join the competition in the anti-PD-1/PD-L1 field in China, 4 have submitted marketing applications (including one that has withdrawn the application), 18 are conducting clinical trials, 9 are waiting for approval of the applications for clinical trial, and there are certainly many companies that have yet filed clinical applications. If the number of clinical trials conducted in the future is estimated according half that of BMS, MSD, or Roche, it may be not a joke that the situation of insufficient patients and clinical experts will happen in clinical trials. Players who have yet filed applications or even are queuing for clinical trials are confronted with the choice to quit competition tenaciously or proceed by facing the "bleak life".
S/N | Pharmaceutical product name | Company name | Target | Clinical application acceptance date/Application No. | Clinical trial approval date | Marketing application acceptance date | Remarks |
1 | Nivolumab | BMS | PD-1 | May 20, 2013* JXSL1300032 | July 27, 2015 | November 1, 2017* JXSS1700015 | Priority review Imported |
2 | Atezolizumab | Roche | PD-L1 | December 17, 2013* JXSL1300075 | November 19, 2015 | | Imported |
3 | Pembrolizumab | MSD | PD-1 | May 6, 2014* JXSL1400030 | February 18, 2016 | February 11, 2018 JXSS1800002 | Imported |
4 | SHE-1210 | Hengrui Medicine | PD-1 | January 19, 2015 CXSL1400153 | February 4, 2016 | | Major special project |
5 | Teruipuli monoclonal antibody | Junshi Biosciences | PD-1 | January 21, 2015 CXSL1400138 | March 9, 2017 | March 20, 2018 CXSS180006 | Major special project |
6 | Durvalumab | AstraZeneca | PD-L1 | February 11, 2015 JXSL1500002 | August 25, 2016 | | Imported |
7 | BGB-A317 (tislelizumab) | BeiGene | PD-1 | November 11, 2015 CXSL1500096 | September 3, 2016 | | Special review |
8 | Xindi monoclonal antibody | Innovent | PD-1 | January 25, 2016 CXSL150016 | September 4, 2016 | December 13, 2017 CXSS1700038 | Special review |
9 | Avelumab | Merck KGaA and Pfizer | PD-L1 | March 23, 2016* JXSL1600011 | November 16, 2016 | | Imported |
10 | PDR001 | Novartis | PD-1 | March 23, 2016* JXSL1600016 | May 26, 2017 | | Imported |
11 | Genolimzumab | Genor Biopharma | PD-1 | April 7, 2016 CXSL1600016 | December 8, 2016 | | |
12 | Recombinant humanized PD-L1 single domain antibody Fc fusion protein | 3DMed | PD-L1 | May 3, 2016 CXSL1600033 | January 11, 2017 | | Special review |
13 | GLS-010 | WuXi AppTec and Gloria Pharmaceuticals | PD-1 | June 6, 2016 CXSL1600045 | March 15, 2017 | | |
14 | Recombinant fully human anti-PD-L1 monoclonal antibody | CStone Pharmaceutical (Shanghai) and CStone Pharmaceutical (Suzhou) | PD-L1 | October 11, 2016* CXSL1600075 | July 17, 2017 | | |
15 | Recombinant humanized anti-PD-1 monoclonal antibody | Bio-Thera Solutions | PD-1 | January 12, 2017 CXSL1600102 | September 14, 2017 | | |
16 | SHR-1316 | Hengrui Medicine | PD-L1 | February 20, 2017 CXSL1700002 | September 14, 2017 | | Special review |
17 | Recombinant humanized anti-PD-1 monoclonal antibody | Hansibio Hanzhongbio Akesobio | PD-1 | February 22, 2017 CXSL1600107 | September 14, 2017 | | |
18 | KL-A167 | Kelun-Biopharmaceutical | PD-L1 | April 13, 2017 CXSL1700026 | September 27, 2017 | | |
19 | Recombinant humanized anti-PD-1 monoclonal antibody | Livzon Mabpharm | PD-1 | April 20, 2017 CXSL1600125 | October 26, 2017 | | |
20 | TQB2450 | Chia Tai Tianqing | PD-L1 | May 11, 2017 CXSL1700018 | November 1, 2017 | | |
21 | Recombinant fully human anti-PD-L1 monoclonal antibody | Zhaoke Oncology | PD-L1 | May 17, 2017 CXSL1700004 | January 17, 2018 | | |
22 | ZKAB001 | Lee’s Pharmaceutical | PD-L1 | ? | January 18, 2018 | | |
23 | Recombinant humanized anti-PD-1 monoclonal antibody | Henlius | PD-1 | August 7, 2017 CXSL1700073 | | | Special review |
24 | AK104 | Akesobio | PD-1 | August 21, 2017 CXSL1700074 | | | |
25 | AK105 | Akesobio | PD-1 | August 21, 2017 CXSL1700075 | | | |
26 | Recombinant humanized anti-PD-L1 monoclonal antibody | BeiGene | PD-L1 | November 13, 2017 CXSL1700104 | | | Special review |
27 | MSB2311 | MabSpace Biosciences | PD-L1 | November 24, 2017 CXSL1700107 | | | |
28 | Recombinant fully human anti-PD-L1 monoclonal antibody | Henlius | PD-L1 | February 13, 2018 CXSL1700206 | | | Special review |
29 | Recombinant humanized anti-PD-1 monoclonal antibody | Sinocelltech | PD-1 | March 6, 2018 CXSL1800025 | | | |
30 | CS1003 | CStone Pharmaceutical (Shanghai) and CStone Pharmaceutical (Suzhou) | PD-1 | March 13, 2018 CXSL1800027 | | | Special review |
31 | Recombinant fully human anti-PD-L1 monoclonal antibody | Hisun Pharmaceutical | PD-L1 | March 26, 2018 CXSL1800028 | | | |
Fig. 1: Anti-PD-1/PD-L1 Monoclonal Antibodies Filed Clinical Trial Applications in China (Sorted by Clinical Application Acceptance Date) Source: CFDA, CDE, news, and Pharmaceutical Cloud Studio
2. Whether products have unique advantages?
3. Influences China’s national macro-policies may bring in the future
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