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.
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JXSS1800002G
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Enterprise name
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Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
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Handling status
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Approval completed-to be issued certificate
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Status start time
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July 25, 2018, 9:53:10
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Notification time
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Null
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Date of receiving receipt of reference standard
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Not required
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Charge
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Paid
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Charge collection date
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February 8, 2018
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Date of receiving inspection report
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Not submitted
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Pharmaceutical product approval No.
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Content of notice
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Null
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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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Company
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Acceptance No.
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Pharmaceutical product name
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Time of entering CDE
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Indication
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Latest progress
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Time of marketing in China
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BMS
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JXSS1700015
JXSS1700016
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Nivolumab Injection
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November 1, 2017
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Previously treated NSCLC
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Approved for marketing
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June 15, 2018
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MSD
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JXSS1800002
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Pembrolizumab Injection
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February 11, 2018
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Melanoma
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Approval completed-to be issued certificate
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July 25, 2018
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Junshi Biosciences
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CXSS1800006
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Teruipuli mAb Injection
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March 20, 2018
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Melanoma
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Pharmacology and toxicology completed
Clinical trial completed
Pharmaceutical review completed
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N/A
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Innovent Biologics
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CXSS1800008
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Sintilimab Injection
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April 19, 2018
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Relapsed/refractor classical Hodgkin lymphoma
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Pharmacology and toxicology completed
Clinical trial to be reviewed
Pharmaceutical review completed
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N/A
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Hengrui Medicine
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CXSS1800009
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Camrelizumab for Injection
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April 23, 2018
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Hodgkin lymphoma
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Pharmacology and toxicology completed
Clinical trial to be reviewed
Pharmaceutical review completed
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N/A
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2. Keytruda goes ahead steadily and surely on the lung cancer drug market, with 2018 Q2 sales expected to surpass that of Opdivo
BMS’ CheckMate-026 failed the first-line therapy of NSCLC, the star combination of Opdivo/Yervoy was given up the accelerated review, and Opdivo is disadvantaged in the NSCLC indication.
While MSD goes ahead steadily and surely on the lung cancer drug market, and Keytruda or chemotherapy in combination with Keytruda has successively been approved as first-line therapy of NSCLC. The recent excellent data of keynote-189, keynote-042 and keynote-407 will enable Keytruda to have more solid advantages in NSCLC indication. I predict that Keytruda will surpass Opvido in 2018 Q2 sales.
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Approved indications of Keytruda
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Generic name of Keytruda: pembrolizumab
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FDA approval time
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Melanoma, second-line drug
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September 4, 2014
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Melanoma, first-line drug
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December 18, 2015
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Head and neck cancer
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August 5, 2016
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Metastatic non-small cell lung cancer (NSCLC), PD-L1 positive (TPS≥1%), EGFR+/ALK+, patients previously treated with platinum-based chemotherapy, second-line drug
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October 2, 2015
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Metastatic NSCLC, PD-L1 high expression (TPS≥50%), EGFR-/ALK-, single-drug treatment, first-line drug
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October 24, 2016
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Adult and pediatric patients with relapsed/refractory classical Hodgkin lymphoma (cHL)
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March 16, 2017
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In combination with pemetrexed and carboplatin to treat nonsquamous NSCLC, first-line drug
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May 10, 2017
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First-line treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy, and second-line treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
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May 18, 2017
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Patients with unresectable or metastatic solid tumors that have been identified as having a biomarker referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)
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May 23, 2017
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Previously treated patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction cancer
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September 22, 2017
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Previously treated patients with recurrent or metastatic cervical cancer whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1]
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June 12, 2018
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Primary mediastinal large B-cell lymphoma
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June 13, 2018
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Adjuvant therapy in the treatment of patients with high-risk stage III melanoma
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PDUFA, February 16, 2019
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In combination with carboplatin/paclitaxel as a first-line treatment for patients with metastatic squamous NSCLC
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PDUFA, October 30, 2018
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Previously treated patients with advanced hepatocellular carcinoma
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PDUFA, November 09, 2018
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So far, the two best-selling anti-PD-(L)1 antibodies have entered the Chinese market. It is reported that BMS has reached a strategic cooperation agreement for Opdivo with Shanghai Pharma. We will wait and see how the future sales performance of Opdivo/Keytruda will be and how anti-PD-(L)1 antibodies will be priced in China.
Attached table: Development Progress of Indications of Anti-PD-(L)1 Antibodies of Junshi Biosciences, Innovent Biologics, Hengrui Medicine, and BeiGene
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Teruipuli mAb of Junshi Biosciences
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Sintilimab of Innovent Biologics
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Camrelizumab of Hengrui Medicine
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Tislelizumab of BeiGene
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Melanoma
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BLA
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Phase 1
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Hodgkin lymphoma
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BLA
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BLA
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Phase 2
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NSCLC
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Phase 3
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Phase 3
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Phase 3
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SCLC
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Phase 2
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Bladder cancer
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Phase 2
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Phase 2
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NK/T-cell lymphoma
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Phase 2
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Phase 2
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Breast cancer
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Phase 1
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Endocrine neoplasia
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Phase 1
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Renal carcinoma
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Phase 1
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Phase 2
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Gastric cancer
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Phase 1
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Esophagus cancer
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Phase 1
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Phase 2
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Phase 3
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Phase 3
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Nasopharyngeal cancer
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Phase 1
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Phase 1
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Head and neck cancer
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Phase 1
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Hepatocellular carcinoma
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Phase 2
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Phase 3
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