Why joined Laekna?

A: I have been working on regulatory affairs in this industry for more than 20 years, experienced the registration of more than 20 new drugs. However, most of the "new drugs" introduced by MNCs have already been marketed overseas or China is only involved when entered Phase III international multicenter clinical trials. This is not a real "new drug" for China. Therefore, I especially hope to help a locally developed innovative drug to achieve NDA from 0 to 1.

How important is Regulatory Affairs for pharmaceutical companies? What professional qualities are needed to do this job well?

A: Registration Affairs almost covers the entire life cycle of a new drug, including the registration applications during the R&D stage and management after NDA approved. It requires a very broad knowledge base and a comprehensive understanding of various regulatory laws and application requirements. To do this job well, you need to constantly learn and master relevant regulations, and integrate them. Furthermore, you need to have the spirit of embracing challenges and conquering difficulties because each project may encounter new problems. In addition, cross-departmental communication and coordination are also key to ensuring a smooth registration progress, which requires us to not only listen but also cooperate.

 What is the most impressive thing you have experienced since joined Laekna?

A: The third new drug clinical trial application I worked on at Laekna was probably a project that had "no precedent" in China at the time – a compounding application of two innovative drugs (normally, an IND compounding application would include one innovative drug candidate plus one marketed drug or two marketed drugs). At that time, the IND review and development had just begun as n new function of the CDE, and the lack of nonclinical data support for combination administration meant that the possibility of rejection was extremely high. However, to achieve the company's goals is my responsibility. I made sufficient preparations in advance and sorted out several key logical points, presented plenty scientific evidence on nonclinical research data and overseas clinical progress on compounding administrations., which helped the pre-IND communication meeting passed smoothly. Subsequently, the IND review was also a success: we submitted the application in June and received approval in August.

How do you see the future of China's biopharmaceutical industry and bio-techs?

A: Looking back at the achievements China has made in the administrations of innovative drugs in the past five years, it is unimaginable for veterans like me who have been in the industry for nearly 30 years. Policies and regulations are rapidly approaching international standards. Joined ICH, implementing the MAH system, and the construction of various aspects of the evaluation and approval system including various guidelines and technical evaluation guides have greatly improved the efficiency of innovative drug reviews and approvals, creating a very favorable overall environment for the development of innovative drugs. I am full of expectations for the next five years.