Big news: The State Drug Administration of China (SDA) updated the marketing application status of MSD’s Keytruda (pembrolizumab) on July 25, 2018 to "Approval completed-to be issued certificate", with the approved indication being melanoma which is also the first indication approved therefor in the U.S. China is speeding up to enter the new era of immunotherapy as pembrolizumab becomes the second anti-PD-(L)1 antibody that enters China. In this article, the registration application progress of the 5 anti-PD-(L)1 antibodies with the fastest progress in China is updated, and the indications of Keytruda approved globally are described.

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Pharmaceutical Product Registration Progress Query Results |
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Acceptance No. |
JXSS1800002G |
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Enterprise name |
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. |
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Handling status |
Approval completed-to be issued certificate |
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Status start time |
July 25, 2018, 9:53:10 |
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Notification time |
Null |
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Date of receiving receipt of reference standard |
Not required |
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Charge |
Paid |
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Charge collection date |
February 8, 2018 |
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Date of receiving inspection report |
Not submitted |
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Pharmaceutical product approval No. |
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Content of notice |
Null |
1. China speeds up to enter the new era of immunotherapy as both Opdivo and Keytruda enter China
BMS’ Opdivo was formally approved for marketing on June 15, 2018, to become the first anti-PD-(L)1 antibody approved for marketing in China, with the review duration of 226 days; while MSD’s Keytruda was approved to enter China on July 25, 2018, to become the second anti-PD-(L)1 antibody approved for marketing in China, with the review duration of 164 days.
Besides Opdivo/Keytruda, Junshi Biosciences’ Teruipuli mAb (monoclonal antibody), Innovent Biologics’ sintilimab, and Hengrui Medicine’s camrelizumab are among the first echelon of anti-PD-(L)1 antibody marketing in China, and Chinese-produced anti-PD-(L)1 antibody is expected to be marketed within this year.
Table I: Registration Application Progress of 5 Anti-PD-(L)1 Antibodies in China









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