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Lijuzhankang Company PD-1 monoclonal antibody has successfully obtained clinical approval from the US FDA.
Release time:
2017-08-01
On July 28, local time in the United States, the FDA officially issued a letter approving the clinical trial application for the injectable recombinant humanized anti-PD-1 monoclonal antibody (code: LZM009) from Zhuhai Lizhu Biotech Co., Ltd. Lizhu Biotech formally submitted the clinical application to the FDA on June 29. During the review, there were no additional requests for information regarding Lizhu's materials, and on July 28 (the 30th day), the clinical trial was successfully approved, with plans to start clinical research in the United States in August. The successful approval of LZM009 for clinical trials in the United States is a significant step for Lizhu towards internationalization. Since its establishment, Lizhu Biotech has accumulated a wealth of innovative drug R&D pipelines.
On July 28, local time in the United States, the FDA officially issued a letter approving the clinical trial application for the recombinant humanized anti-PD-1 monoclonal antibody (code: LZM009) for injection from Zhuhai Lizhu Biotech Co., Ltd. Lizhu Biotech officially submitted the clinical application to the FDA on June 29, and there were no supplementary requests for Lizhu's materials during the review. On July 28 (the 30th day), the clinical trial was successfully approved, with plans to start clinical research in the United States in August. The successful approval of LZM009 for clinical use in the United States is a significant step for Lizhu towards internationalization. Since its establishment, Lizhu Biotech has accumulated a wealth of innovative drug R&D pipelines, and it is expected that 2-3 innovative drugs will enter the U.S. and other international markets each year in the future.
PD-1 stands for Programmed Death 1, an important immune checkpoint on T cells. Cancer cells expressing its specific ligands (PD-L1/PD-L2) can bind to the PD-1 target on T cells, thereby inhibiting the immune killing ability of T cells. It is currently believed to be one of the main mechanisms by which tumor cells evade the immune T cell anti-tumor response. The two anti-PD-1 antibodies that have been marketed globally, OPDIVO® and KEYTRUDA®, have demonstrated high efficacy and broad-spectrum anti-tumor effects in clinical settings, becoming the main force in tumor immunotherapy. According to MedTrack database statistics, the global sales of OPDIVO® and KEYTRUDA® exceeded $6 billion in their second full year on the market (2016), and the future market potential is even greater. LZM009 is a new anti-PD-1 monoclonal antibody molecule owned by Lizhu Biotech with independent intellectual property rights, and preclinical studies have shown good safety and efficacy.
The FDA's drug review policies and standards have always been regarded as an important reference for domestic and foreign drug regulatory departments and pharmaceutical companies. Whether or not to pass the FDA's approval has naturally become one of the important criteria for measuring whether pharmaceutical companies are in line with international standards. The approval of LZM009 by the FDA for clinical trials is the first step for Lizhu Biotech to enter the international biopharmaceutical market. Looking back on this journey, being able to obtain approval smoothly within 30 days without any supplementary requests is certainly not a coincidence! Lizhu Biotech has always adhered to a people-oriented development philosophy, emphasizing platform building and team development. In the past few years, it has successfully built a strong technical team, advanced technical platform, and solid quality system. Of course, due to the fact that China's biopharmaceutical industry lags behind the United States by more than 20 years, coupled with the differences in drug regulations and language barriers between the two countries, the first application in the U.S. is naturally not a smooth path for Lizhu Biotech.
This is a challenging process. While being fully prepared technically, project management must also be organized efficiently, utilizing human resources and materials effectively. Overall planning and thorough preparation are important factors for successful application. In the project initiation phase, through resource analysis and evaluation, the company formed the LZM009 project application working group for the U.S. application, which includes a consultant team, CMC team, preclinical and clinical technical teams, and clinical operation CRO team. A comprehensive application plan was developed, and through planning, implementation, and feedback on key tasks such as data evaluation, supplementary research, PreIND application and issue feedback, IND application document writing, review and submission, and FDA review communication, the quality and progress of the application were effectively controlled.
This is also a challenging process, where the project team invested a lot of energy and overcame many difficulties. Facing an all-English writing and communication environment, and a 12-hour time difference with the consultant team, project team members often worked around the clock to ensure timely and smooth communication. To submit a high-quality application document, the monoclonal antibody team and the consultant team conducted multiple rounds of review and revision of the application materials, clarifying the scientific and logical aspects of the materials, repeatedly confirming technical details, and refining the wording. All these efforts resulted in a good first impression left with the FDA.
At the same time, this is also a process of accumulation. Through this application, Lizhu Biotech not only successfully took the first step towards internationalization and received FDA recognition, but more importantly, it formed a complete template in terms of technology and project management, establishing a foreign clinical application platform, which is very valuable firsthand experience for subsequent project applications.
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