STAT Newsmaker: STAT Newsmaker: I-MAB Biopharma's Joan Shen

As part of an occasional series of Q&As with pharma newsmakers in China, this week I talked with Joan Shen, CEO of I-Mab Biopharma. This transcript has been edited for length and clarity.

Before joining I-Mab, you worked in the U.S. and China, holding positions at Pfizer, Johnson & Johnson, and Hengrui Medicine. Now you're leading a U.S.-listed biotech based in Shanghai. What important lessons have you learned to help you run a fast-growing company like I-Mab?

My experiences in two vastly different worlds, an American big pharma and a Chinese domestic pharma, have broadened my viewpoints. They have shaped how I see I-Mab as a truly global company, not just a China-based biopharma listed on the Nasdaq.

The shift from Pfizer to Hengrui was an especially significant change. I realized the unique needs of the U.S. and Chinese medical industries prospectively, including their strengths as well as their shortcomings. As I navigated these differences, I gained a deep understanding of the world's largest pharma markets, their business structures, and cultural dynamics. This knowledge has guided the way I lead I-Mab to bring about global innovation through the most effective means.

In the past few years, more Chinese biotechs have completed IPOs on the Hong Kong Stock Exchange or Shanghai's STAR market. Bucking the trend, I-Mab listed on the Nasdaq instead. What was the thought process behind that decision, and should investors expect to see a secondary listing closer to home in the future?

We selected Nasdaq for several reasons: It has been the home for a large majority of biotech listings given its maturity, the volume of liquidity, and the sophistication of specialist international investors who understand highly complex and innovative technology.

For a clinical-stage biotech company with a significant pipeline of innovative assets, listing on Nasdaq allows us to tap into an investor base and capital that would propel us to become a global biopharmaceutical company as we look to expand and deepen our portfolio as well as our footprint in the U.S. In terms of a secondary listing, we remain open-minded but will have to evaluate the opportunities as well as global economic conditions before making any decisions.

What are some developments we should expect to see from I-Mab's pipeline this year?

Our portfolio candidate TJC4, a CD47 antibody, is a great example of our in-house innovation. CD47 has emerged as one of the most promising immuno-oncology targets, and TJC4 has the potential to stand out from other clinical-stage CD47 antibodies. Unlike other molecules, it is designed to uniquely minimize binding to red blood cells while retaining anti-tumor activities in line with other antibodies of the same class. We are at the final stage of the dose-escalation study. As the clinical data accumulate, we are now confident about the key advantages or differentiation of TJC4 on clinical safety and pharmacokinetics as it interacts minimally with red blood cells. We have also started a clinical trial in patients with acute myeloid leukemia in China. Our aim is to quickly reach a pivotal trial after an accelerated dose/safety study.

Another innovative compound in development is our proprietary compound TJD5, a CD73 antibody, which alters the tumor growth environment. It is also in clinical development in both China and the U.S. We are expecting Phase 1 safety data to be available by the fourth quarter of 2020.

We are gearing up for product registration in China for our lead late-stage asset, TJ202, a CD38 monoclonal antibody, in multiple myeloma. This will be our first commercial product and we are priming for commercialization.

One of the most significant developments for I-MAB is our contribution to the fight against the Covid-19 pandemic. We are in the process of studying our GM-CSF neutralizing antibody, TJM2, in cytokine-release syndrome in severely ill Covid-19 patients. The first part of the study was completed successfully. We are now in the second part; top-line data are expected in the third quarter of this year.

As one of only a handful of women leading Chinese biotechs, what's it like being a female leader in China? Drawing experiences from your career so far, how important do you think diversity has been in shaping the biotech industry?

I believe that inclusion and diversity are essential to the health of our environment and our society; it is even more important for this industry. Differences in individual experiences, backgrounds, and gender prompt diversity in thought and ideas, which further fosters greater thinking and solutions to problems — that is the rudimentary foundation from which innovation stems.

I feel extremely enthused and fortunate to be part of this cultural and dynamic shift in the biotech and life science industry that have so far been dominated by men. Female leaders are increasingly supported by this industry and opportunities are no longer scarce compared to the early days of my career.

Although significant progress has been made, we should not grow complacent in this space. In my position, I feel a responsibility to shape the future for other women: to mentor and coach young women around me to equip them with the tools and the confidence to become female leaders themselves. I hope many more talented and ambitious women will rise forward in the near future and demonstrate their capacity to impact this industry. I fully trust and believe in them.