STAT Newsmaker: Li Ning

This is part of an occasional series of brief Q&As with pharma newsmakers in China. This week we talked to Li Ning, CEO of Junshi Biosciences. This transcript has been edited for length and clarity.

What is Junshi Biosciences’ origin story and is there a meaning behind its name?

At the end of 2012, Junshi Biosciences was established in a laboratory of less than 300 square meters in “Zhangjiang Pharma Valley” in Shanghai. At the very beginning, it was just a simple idea “to make our own domestic antibody drugs” that brought the founders together. They were eager to take a real road of innovation and become a China-based multinational biopharmaceutical enterprise driven by innovation.

The word “Junshi” (君实) refers to “大人不华，君子务实,” a sentence from a classic work in the Han dynasty, which means “Excellent people prefer to make pragmatic endeavors instead of pursuing fame.” So over the past seven years, we have maintained such a low-key and pragmatic attitude, dedicated to delivering innovative products we have promised.

You joined Junshi in 2018 and led the company to its IPO by the end of the year. But before that, you had a long career with the FDA and Sanofi. What were those experiences like, how did the Junshi opportunity come up, and what ultimately led you to make the move?

Previous work has allowed me to accumulate experience in the management of international multiculture staff and running large regulatory and clinical programs.

Before I joined Junshi, some scientists and board members of Junshi were already friends of mine for years, as we were all Chinese working in the pharmaceutical industry. I used to be a reviewer of oncology drugs, so I had the inclination toward anti-oncology drug projects. When Junshi approached me, they told me their PD-1 inhibitor was doing clinical trials in China and invited me to join them. I really hoped to make contributions to this project, which would benefit not only the company and the industry, but also hundreds and thousands of patients. I think my expertise could help accelerate its progress. Junshi and I share the same goal and value, so I decided to become a member of the team.

What should people know about Junshi’s pipeline and areas of focus?

Junshi Biosciences focuses on “patient access” and being “innovation-driven.” We have established a diversified R&D pipeline compromising 19 innovative candidate drugs and two biosimilars at all stages from early discovery to commercial with therapeutic areas covering cancer, metabolic diseases, autoimmune diseases, neurologic diseases, and infectious diseases. Product types include monoclonal antibodies, fusion proteins, antibody-drug conjugates, and small molecule drugs.

With an enriched pipeline and further exploration in combination treatment, our innovation will continue to expand to more types of drugs including small molecule drugs, antibody drug conjugates (ADCs), and dual antibodies. We will explore the next generation of innovative therapies for cancer and autoimmune diseases.

We were the first Chinese pharmaceutical company that obtained marketing approval for a PD-1 monoclonal antibody and clinical trial approval for an anti-PCSK9 monoclonal antibody from NMPA. The world’s first-in-human anti-BTLA antibody for solid tumors was officially approved for drug clinical trials by the FDA and NMPA. From this year onwards, Junshi Biosciences collaborated with Chinese science institutions to co-develop JS016, China’s first neutralizing human monoclonal antibodies against SARS-CoV-2, which has entered clinical trial, as our continuous innovation efforts for disease control and prevention in China and beyond.

Toripalimab was part of a first-to-market race for PD-1 cancer drugs and ultimately became China’s first homegrown PD-1 cancer drug to launch in 2019. Was being one of the first PD-1s in China important to you? And as an innovative company in China, how important is it to stay at the forefront of drug R&D?

Toripalimab was the first domestically developed anti-PD-1 mAb to get marketing approval in China. Being one of the first means a lot to a startup biopharma company. First, we have greater opportunities to earn market share. Second, it makes us become a blockbuster, which help promote the company’s branding and reputation among doctors, patients, talent, investors, and also the public. Third, it endorses our R&D capabilities that we could make innovative drugs as quick and as well as the multinational companies. It is time for the world to recognize Chinese biotech and biopharma companies.

Innovation is the core competence of an innovative company, meaning [inventing] things no one has achieved before. So always staying at the forefront, making first-in-class and best-in-class drugs is a goal every innovative company is fighting for, I believe. That’s why we set up two innovation centers in the U.S., where our scientists could keep up with the latest trends in biotechnological innovation.

For toripalimab, regarding its broad-spectrum anticancer character, we’ve initiated over 30 clinical studies around the world, and some of the indications have never been challenged. For example, we just filed the supplementary NDA to the China NPMA for the treatment of advanced NPC.

It is the world’s first new drug application of anti-PD-1 mAb for the treatment of recurrent/metastatic nasopharyngeal carcinoma. Toripalimab’s combination therapy for the treatment of mucosal melanoma was granted ODD from FDA. We’re the first PD-1 product to get granted FDA’s ODD in mucosal melanoma area.

Also, we have several candidates with the potential to be first-in-class. JS004, our first-in-human anti-BTLA mAb for tumor treatment is undertaking Phase 1 clinical trials in both China and the U.S. JS016, the anti-SARS-CoV-2 mAb co-developed by IMCAS and Junshi, has entered clinical trials as China’s first neutralizing antibody in this area. We have also collaborated with outstanding domestic and overseas innovative companies to develop novel combo therapies and next generation immunotherapies, aiming for better efficacy and precision.

How have you adapted your work and family life during the current pandemic, and how have you kept yourself and your team at Junshi motivated and productive in this new working environment?

The pandemic does affect every family’s life. Work-from-home and online communication becomes the new norm.

Our colleagues have strived so hard to keep our manufacturing, clinical studies, and commercial activities going in the midst of quarantine, transport blockages, and hospital shutdowns. But most of the patients we served are cancer patients, so we must try our best to be of help.

We initiated the JS016, anti-SARS-CoV-2 neutralizing antibody program in February, so our R&D and manufacturing teams have been working day and night to advance the program into clinical trials in the past four months. We are tired but excited. We take it as our duty to provide potential treatment against the virus, since we have the biotechnology and capability to realize it.

What is one thing you’d recommend someone do if they’re visiting Shanghai for the very first time?
I recommend them to climb to the Oriental Pearl TV Tower to have a dinner and enjoy a bird-view of the night of Shanghai.

Photo credit: Junshi BioSciences