On July 28, 2017, the United States Food and Drug Administration (USFDA) officially approved the clinical trial application of Zhuhai Livzon Monoclonal Antibody Biotechnology Pharmaceutical Inc. (hereafter referred to as Livzon MABPHARM Inc.) for the project “recombinant humanized anti-PD-1 monoclonal antibody for injection” (code: LZM009).

Livzon MABPHARM Inc. submitted the clinical trial application to the USFDA on June 29, 2017. No additional materials or data were required, and the application was approved on July 28, 2017. The clinical research is planned to be carried out in the Unites States in August, 2017. The approval of LZM009 by the FDA implies that Livzon made a large step forward in the internationalization process. Livzon MABPHARM Inc. has accumulated abundant innovative pipelines for drug research and development since it was founded. It is estimated that there will be two or three innovative new drugs sold in the international market every year.

PD-1 is the short for Programmed Death 1. The two anti-PD-1 antibodies that have been sold globally — OPDIVO® and KEYTRUDA® — have shown their efficient and broad-spectrum anti-tumor effects, and have become the main drugs used to treat certain types of cancer. According to statistics from MedTrack, the annual global turnover the second year (2016) after OPDIVO® and KEYTRUDA® were sold on the market was over 6 billion US dollars. The future market for the drugs is huge. LZM009 is a new anti-PD-1 monoclonal antibody developed by Livzon MABPHARM Inc. with independent intellectual property rights. Preclinical research has shown its safety and effectiveness.

The drug approval policies and standards of the USFDA have always been regarded as important references for domestic and foreign Pharmaceutical Regulatory Departments and enterprises. FDA approval is an important standard to judge if a drug producer is in line with international conventions. The approval of LZM009 by the FDA marks a first step of Livzon MABPHARM Inc. toward entering the international biological drug market. Reviewing past experiences, application approval within 30 days without being asked for additional materials or data was by no means fortuitous. Livzon MABPHARM Inc. has always adhered to the idea of people-oriented development, and takes platform construction and team-building seriously. The company has successfully built strong technology teams, advanced technological platforms, and stable quality control systems over the recent years. However, the Chinese biopharmaceutical industry has lagged behind that of the US for more than 20 years, and there are great differences in drug administration and regulation between the two countries. Additionally, there is a language barrier. Therefore, getting the USFDA approval for LZM009 was by no means easy for Livzon MABPHARM Inc.

Approval is a process full of challenges. Adequate technology preparation was made, and through efficient project management everybody involved in the project showed his or her talents and all the relevant materials were fully utilized. Overall planning and sufficient preparation were the keys to success. At the beginning of the project, the corporation established the LZM009 Project US Application Work Group by analyzing and assessing the corporate resources. The Work Group included an advisory team, a CMC team, a preclinical and clinical technology team, and a clinical operation CRO team. The corporation made a comprehensive plan for the application, and effectively controlled the quality and progress of the application through all aspect of the process.

The project team has devoted a lot of energy to overcome many difficulties. In order to overcome the difficulty of the English-Chinese language barrier and the 12 hour time difference, members of the project carried out their work 24 hours every day. To submit a high-quality application, the monoclonal antibody team and the adversary team reviewed and modified the materials many times. They checked and improved the scientific nature and logic of the materials, confirmed the technological details, and revised the wording of the documents again and again. Their efforts were rewarded by a fast approval of the application.

The application preparation process established submission templates and built an international clinical application platform, which will be of value for future applications.