A version of this digest first appeared in the weekly STAT China newsletter. To receive future editions, sign up here.
Happy Tuesday and welcome back to STAT China. The CEO of Junshi Biosciences joins us for our latest “newsmaker” interview, and we’ve got lots of news from the IPO and vaccine front.
Lineup for Hong Kong IPO grows
With investors bullish on the Chinese biotech sector, two more clinical-stage companies filed paperwork last week to list on the Hong Kong Stock Exchange.
Shanghai-based Antengene has been planning a listing in Hong Kong for some time. Led by ex-Celgene executive Jay Mei, the cancer drug developer is looking to raise about $200 million, according to an IFR report. Founded in 2016, the company’s first pipeline asset is onataserib, an mTORC1/2-targeting cancer drug candidate that was in-licensed from Celgene — now part of Bristol Myers Squibb — and currently in Phase 2 trials.
Antengene’s other core asset is in-licensed selinexor, Karyopharm Therapeutics’s XPO1 inhibitor marketed in the U.S. as Xpovio. The company has rights to develop and commercialize selinexor and three other novel compounds from Karyopharm in China and other Asia-Pacific markets.
Bio-Thera Solutions, which raised $241 million in its IPO on Shanghai’s STAR market in February, hopes to repeat its success with another listing this time in Hong Kong. The Guangzhou-based biotech has a pipeline of 24 drug assets, anchored by Qleti, the company’s Humira biosimilar and first commercialized product approved last year. The company said the money raised will go toward developing its core assets, including BAT4306F, an anti-CD20 therapy for treating B-cell non-Hodgkin lymphoma and other similar malignancies; BAT8001, an anti-HER2 antibody-drug conjugate for breast cancer; and BAT1706, an Avastin biosimilar expected to be approved next year and recently licensed to BeiGene for commercialization in China.
Will Brii join the IPO frenzy?
Brii Biosciences is also mulling a listing in Hong Kong, Bloomberg reported, citing sources familiar with the situation.
The China-focused biotech is said to be working with investment banks on an IPO that could raise between $200 million and $400 million. The company is also seeking about $100 million from private investors in a pre-IPO round, sources told Bloomberg.
Founded just two years ago, Brii focuses on developing therapies for infectious diseases such as hepatitis B and HIV. In March, the company partnered with Tsinghua University and Shenzhen’s Third People’s Hospital to develop two potential monoclonal antibody treatments for Covid-19.
With winter coming, China broadens emergency use of vaccines
China has approved several locally developed Covid-19 vaccines under emergency use authorizations, Reuters reported last week.
According to sources familiar with the matter, Sinovac Biotech’s inactivated vaccine candidate, CoronaVac, was approved in July for emergency use for people at high risk of contracting the novel coronavirus, a group that includes medical staff. State-owned drug maker Sinopharm also announced through its social media platform on WeChat that its vaccine candidate – still in Phase 3 testing in several foreign countries – is cleared for emergency use for high-risk personnel.
Fearing that a new wave of Covid-19 will arrive in the fall and winter, Chinese health officials told state media last week that the government began expanding its emergency use program to stay ahead of the virus.
Canadian vaccine trial falls through as CanSino shifts focus to other markets
CanSino Biologics’ Covid-19 vaccine testing plans have been denied a homecoming in Canada, The Globe and Mail reported.
Health Canada and the Tianjin-based vaccine maker first agreed to jointly develop CanSino’s vaccine back in May, but shipments of the vaccine candidate had been held up by Chinese customs for weeks. The decisions in China on whether to send the vaccine to Canada were “caught in the bureaucracy,” said CanSino’s chairman and CEO Xuefeng Yu, a Canadian national.
Some divisions of the Chinese government were not clear on whether the vaccine should “go to global trials or how to handle it,” and the time to do those trials has “already passed,” Yu told the Canadian news outlet.
The delay to the vaccine shipments comes at a time when bilateral relations between the two countries are strained over Canada’s arrest of Huawei executive Meng Wanzhou, Beijing’s jailing of two Canadian nationals charged for spying, and the import ban on Canadian meat and canola.
The company subsequently denied having spoken to the media regarding its vaccine plans in Canada.
Meanwhile, the Wall Street Journal reported that CanSino has been in talks with several countries to get its Covid-19 vaccine approved under an emergency use authorization. The vaccine, which is jointly being developed with China’s Academy of Military Science, has been approved for use by the country’s military since June.
Getting the vaccine out to millions of people now, before clinical trials are complete, would broaden the base of knowledge about the drug’s safety and effectiveness, said Pierre Morgon, senior vice president for international business at CanSino.
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.