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Double report and double approval, congratulations!
Release time:
2017-11-06
Recently, Zhuhai Lizhu Monoclonal Antibody Biotechnology Co., Ltd., a subsidiary of Lizhu Pharmaceutical Group Co., Ltd., received the "Drug Clinical Trial Approval" issued by the National Medical Products Administration (Approval No.: 2017L04883). 1. Main content of the drug approval Drug name: Recombinant Humanized Anti-PD-1 Monoclonal Antibody for Injection English name/Latin name: Recombinant Humanized anti-PD-1 Monoclonal Antibody for Injection Dosage form: Injection Specification: 50mg/
Recently, Zhuhai Lizhu Monoclonal Antibody Biotechnology Co., Ltd., a subsidiary of Lizhu Pharmaceutical Group Co., Ltd., received the approval issued by the National Medical Products Administration."Drug Clinical Trial Approval Document" (Approval No.: 2017L04883).
1. Main Content of the Drug Approval Document
Drug Name: Recombinant Humanized Anti-PD-1 Monoclonal Antibody for Injection
English Name/Latin Name: Recombinant Humanized anti-PD-1 Monoclonal Antibody for Injection
Dosage Form: Injection
Specification: 50mg/bottle
Application: Domestic Drug Registration
Registration Category: Therapeutic Biological Products
Applicant: Zhuhai Lizhu Monoclonal Antibody Biotechnology Co., Ltd.
Approval Conclusion: According to the "Drug Administration Law of the People's Republic of China" and relevant regulations, after review, this product meets the relevant requirements for drug registration and is approved for clinical trials.
2. Drug Research and Development and Related Situations
The "Recombinant Humanized Anti-PD-1 Monoclonal Antibody for Injection" has undergone 2 years of research and development, with the first submission of the clinical trial application accepted on December 26, 2016.(Acceptance No.: CXSL1600125 Guangdong), the molecular sequence and applications patent for this drug have been applied for in China and PCT.
The clinical trial application for the "Recombinant Humanized Anti-PD-1 Monoclonal Antibody for Injection" was officially submitted and accepted by the U.S. FDA on June 29, 2017.(Acceptance No. IND133742), and it received formal approval from the U.S. FDA on July 28, 2017.
The "Recombinant Humanized Anti-PD-1 Monoclonal Antibody for Injection" is suitable for immunotherapy of various advanced solid tumors, capable of blocking the PD-1/PD-L1 immune checkpoint signaling pathway,promoting T-cell immune anti-tumor responses; the preclinical in vivo metabolism of this drug shows basic linear pharmacokinetic characteristics;Preclinical pharmacological and toxicological studies also indicate that this drug has good safety and efficacy.
As of today, the total investment in research and development for the "Recombinant Humanized Anti-PD-1 Monoclonal Antibody for Injection" has reached approximately 56.5755 million RMB.
3. Market Status of Similar Drugs
Currently, there are 2 anti-PD-1 monoclonal antibody products that have been launched abroad, with the trade names OPDIVO? and KEYTRUDA?.
According to MedTrack database statistics, the global sales of OPDIVO? in 2016 were 4.686 billion USD, and the global sales of KEYTRUDA? in 2016 were 1.402 billion USD.
There are currently no similar products on the domestic market. As of now, there are a total of 9 manufacturers (including Lizhu Monoclonal Antibody) that have been approved for clinical use of monoclonal antibody drugs targeting "PD-1".
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