The anti-PD-1 monoclonal antibody JS001 of Junshi has been completed the first patient administration of Phase I clinical trial in the U.S. several days ago, which has aroused wide attention from the insiders. What are currently the hottest star drugs in the pharmaceutical industry? Anti-PD-1/PD-L1 drugs are definitely one among them, with any news able to shake the industry. Today, I’d like to make the most comprehensive summary ever and talk about anti-PD-1/PD-L1 drugs.

Anti-PD-1/PD-L1 drugs will occupy two positions among the Top 5 in global drug sales in the future

According to EvaluatePharma’s forecast of rankings of global drug sales in 2022 not long ago, the monoclonal antibody drug Opdivo and Keytruda that target PD-1 enter the Top 5 upon good therapeutic effect and multiple indications, with annual sales to separately approach USD 10 billion.

EvaluatePharma’s Forecast of Top 5 in Global Drug Sales in 2022

 (Source: Website of EvaluatePharma)

There are 5 anti-PD-1/L1 drugs approved for marketing in the world

There are 5 anti-PD-1/L1 drugs approved for marketing in the world, wherein, BMS’ Opdivo and MSD’s Keytruda were marketed early both in 2014, while the other 3 drugs were marketed after 2016. All those 5 drugs have not been marketed in China, however, Opdivo and Keytruda have been filed the marketing application in China.

From the perspective of the indications approved, anti-PD-1/PD-L1 drugs have shown good clinical response, wherein, MSD’s Keytruda and BMS’ Opdivo both showed broad-spectrum oncology, and have separately been approved 8 and 7 indications; from the perspective of therapeutic regimen, they are mainly second-line and third-line regimens, with clinical trials on first-line treatment of non-small cell lung cancer (NSCLC) and melanoma still underway.

Marketed Anti-PD-1/PD-L1 Drugs in the World

 (Source: FDA, by March 26, 2018)

4 pharmaceutical enterprises have filed the marketing applications for anti-PD-1/PD-L1 drugs in China

4 pharmaceutical enterprises have filed the marketing applications for anti-PD-1/PD-L1 drugs in China, with imported and Chinese-produced drugs separately accounting for half, separately being BMS’ Opdivo, Innovent Biologics’ Xindi monoclonal antibody (code: IBI308), MSD’s Keytruda, and Junshi Biosciences’ Teruipuli monoclonal antibody (code: JS001).

 (Source: CFDA, by March 26, 2018)

R&D layout of anti-PD-1/PD-L1 monoclonal antibody drugs in China

There are many Chinese pharmaceutical enterprises researching anti-PD-1/PD-L1 drugs in full swing. From the perspective of indication selection, indications of clinical trials of Chinese enterprises are mainly NSCLC and esophageal cancer, etc., and cancers with low incidence among the Chinese people like melanoma have low proportions.

R&D layout of anti-PD-1/PD-L1 monoclonal antibody drugs in China

(Source: CFDA, China Drug Trials, and company websites, by March 26, 2018)

Besides, the anti-PD-1 drugs of Taizhou Hanzhong, Bio-Thera, Livzon Pharmaceutical Group, Henlius, and Hisun Pharmaceutical have received clinical approvals, and so have the anti-PD-L1 drugs of Hengrui Medicine, Zhaoke Oncology, CStone Pharmaceuticals, and Kelun Industry Group.

Besides the single drugs, the drug combinations are also a new trend in the world, and Hengrui Medicine, Innovent Biologics and Junshi Biosciences have conducted relevant research in drug combination, wherein, Hengrui Medicine is researching the drug combination of anti-PD-1 drug and apatinib tumor-targeted small molecule drug.

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