Q1 We learnt that you have overlapped with Henlius for years. Could you share with us the story?

It was April 2015 when I first met Scott, the co-founder of Henlius. I felt deeply inspired by his philosophy of "to improve patients' lives by timely providing them with quality and affordable protein therapeutics", so I joined Henlius as Quality Head, and then took charge of regulatory affairs. During my first stay at Henlius, I played an important role in developing strategies for the CMC for HLX01 NDA in China and the globalization of HLX02. The company's pilot plant and commercial-scale manufacturing facility also successfully passed the QP audit and received QP Declaration. It is not easy to make these achievements in one and a half years, but the trust and support of Scott encouraged me a lot. It was a hard time then, but as I look back, I know it is rewarding.

After leaving Henlius in September 2016, I held COO positions in other companies, and further sharpened my strategic vision. In May 2019, I returned to Henlius, and got impressed by its rapid development and globalization strategy. I hope I could make my contribution to R&D of new drugs in China together with the company.

Q2 What are the challenges in the development of clinical trials and MAA for HLX02 in the EU?

In 2015, Henlius defined the globalization strategy, and planned to start with HLX02 for clinical trials and marketing in EU. At that time, there were few people in China familiar with the EU legislations and regulations, or having the experience of biosimilar filing in EU.

The first challenge we encountered was to ensure our manufacturing in compliance with EU GMP standards. Therefore, we immediately set up a GMP task force team, and hired experienced domestic and global consultants. Under the joint efforts of colleagues from Quality, Manufacture and Engineering, we finally received the QP Declaration. This is our first step to meet international GMP standards.

The other challenge lies in the design of CMC strategy and clinical trials for HLX02. After studying a large number of literatures and China and EU regulations, we finally designed a three-arm comparability study for CMC similarity study and Phase 1 clinical trial, which is HLX02 vs. China-sourced Herceptin vs. EU-sourced Herceptin. For phase 3 clinical trial, we consulted with CDE experts several times, and also initiated the procedure for EU Scientific Advice meeting request. The study was designed as a randomized, double-blind, parallel controlled head-to-head phase 3 clinical trial conducted in China, Poland, Ukraine and the Philippines, making HLX02 the first biosimilar in China to conduct a global multi-center phase 3 clinical trial. Up to now, HLX02 has been accepted for NDA review by the NMPA and for MAA review by EMA.

Q3 As the head of RA (Regulatory Affairs) & CMC (Chemistry, Manufacturing and Controls) Operations, what's the linkage between these two departments? What's your future plan for these two departments?

Pharmaceutical development mainly consists of CMC, non-clinical studies and clinical trials. As an important part of pharmaceutical development, CMC is also referred to as the pharmacology study. CMC involves cross-functional collaboration, including process development, analytical methods development, product manufacturing, QC testing and QA release. The CMC Operations department is responsible for coordinating and managing the whole process to ensure the projects stay on track. The main responsibility of Regulatory Affairs department is to integrate the works and data of CMC, non-clinical studies and clinical trials, and submit IND or NDA applications to regulatory agencies. Therefore, Regulatory Affairs and CMC Operations are closely related.    

With the advance of globalization of the company, RA and CMC Operations will also be in line with the globalization strategy. CMC project managers shall coordinate and manage the CMC projects, and apply the QbD concept to develop and produce quality and affordable drugs meeting international standards and requirements of ICH guidelines. In addition to recruitment of experienced domestic and global talents, we're also planning to set up RA offices in the US and Europe, enabling RA department not only to file more INDs/NDAs in China, but also to file more CTAs/MAAs in EU and INDs/BLAs in US, and establish good communication pathways with EMA and the FDA. The mission of RA department is to make our products globally available and affordable to meet the clinical and market needs of patients.

Q4 Could you please talk more about the globalization of product development?

As one of the first batch products under the company's globalization strategy, HLX02 is developed in compliance with both China and the EU GMP standards in terms of pharmaceutical development, product manufacturing and clinical trials. With the fast growth and accelerating globalization of the company, the whole process of product development, including selection of raw materials, process development, analytical methods development, animal studies and clinical trials, should be following the ICH guideline to meet the GMP, GLP and GCP requirements in China, the EU and the US. Leveraging the global resources of company's three R&D centers in Shanghai, Taipei and California, we will also improve our RA capability to expand global presence. 

Q5 We are very impressed by your personal experiences and spare time in the Q2 all-staff meeting. Could you share more with us?

I grew up in Shanghai. After my undergraduate study，I went to the US for further study and lived there for 30 years before returning to China. I like travelling and have been to many places over the years, enriching my personal experiences and helping me understand different cultures. I also have great interest in culture and art, especially in visiting European museums to enjoy the masterpieces of the Renaissance masters. I will travel to more places to explore different civilizations. Hope I could keep a good work and life balance, as the saying goes in America, "work hard, play hard".