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the competition in the anti-PD-1/PD-L1 field in China, 4 have submitted marketing applications (including one that has withdrawn the application), 18 are conducting clinical trials, 9 are waiting for approval of the applications for clinical trial, and there are certainly many companies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 | <...
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