2018 was the first year of the tumor immunotherapy in China. The new era of tumor immunotherapy has begun in China with the marketing of anti-PD-(L)1 antibodies represented by Opdivo, Keytruda, and Tuoyi, etc. in China. The development progress of the anti-PD-(L)1 products are analyzed here in this article.
I. China accelerating entry into the era of tumor immunotherapy: 4 anti-PD-(L)1 antibodies approved
BMS’ anti-PD-1 monoclonal antibody: Opdivo was the first of the 4 approved for marketing on June 15, 2018, which is approved to treat EGFR/ALK- patients who have locally advanced or metastatic non-small cell lung cancer (NSCLC) with progression on or intolerance to prior platinum-based chemotherapy. China has since entered the era of tumor immunotherapy.
4 anti-PD-1 monoclonal antibodies have so far been approved in China, and 3 anti-PD-(L)1 antibodies are in the marketing review stage.
Wherein:
Among the marketed anti-PD-1 monoclonal antibodies:
1. There are 2 imported drugs and 2 Chinese-produced drugs;
2. 3 indications are covered, separately being NSCLC, melanoma, and Hodgkin’s lymphoma (HL);
3. The review time was about 165-272 days;
4. In terms of price, the annual cost of imported drugs is RMB150,000-200,000, while that of Chinese-produced drugs is lower than RMB100,000 (price after drug donation/assistance).
Region | Opdivo | Keytruda | Tuoyi | Tyvyt |
China, RMB | 100mg/10mL: 9,260; 40mg/4mL: 4,591 | 100mg/4mL: 17,918 | 240mg/6ml: 7,200 | 100mg/10mL |
Hong Kong, S.A.R., China, HKD | 100mg/10mL: 20,000; 40mg/4mL: 9,500 | 100mg/4mL: 30,000 | N/A | N/A |
U.S., USD | 100mg/10mL: 2,500 | 100mg/4mL: 4,800 | N/A | N/A |
Usage and dosage | 3mg/kg, once every two weeks, intravenous drip | 2mg/kg, once every three weeks, intravenous drip | 3mg/kg, once every two weeks, intravenous drip | 200mg, once every three weeks, intravenous drip |
50-60kg patient | RMB360,000-479,000 / year | RMB305,000 / year | RMB187,000 / year | Not published |
Drug donation/assistance | "6+7" drug donation | "3+3" drug donation for low-income patients; 24 months of free use for patients entitled to the subsistence allowances | "4+4" drug donation | Not available |
Opdivo assistance program:
See the Assistance Program of Opdivo Patient Assistance Project of Cancer Foundation of China
http://www.cfchina.org.cn/show.php?contentid=1717
Keytruda assistance program:
MSD has conducted the charitable aid activity for malignant melanoma patients in association with China Primary Health Care Foundation (CPHCF). See the f...
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