A version of this story first appeared in the weekly STAT China newsletter. To receive future editions, sign up here.

Welcome to the first edition of the STAT China newsletter.

My name is Jonathan Chan and I’m writing to you from the bustling city of Hong Kong. Every Tuesday morning — Tuesday night for those of you in my time zone — I will take you through some of the latest health care and biotech developments coming out of China.

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What will the newsletter look like? I’ll round up important stories from the past week, adding some analysis and reporting when I can. With China’s health care system going through reforms, I’ll also tell you about policy changes that could have implications for pharma and biotech companies operating here. Along the way, I hope to highlight interesting biotech startups and executives I come across.

A little background on me: Born and raised in Hong Kong, I went to school in Canada and studied biotechnology. I distinctly remember learning about golden rice and thinking “this will revolutionize health care in developing countries.” (It hasn’t.) Since then I’ve been following health care developments in Asia and started focusing on China in the last few years.

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So why are we starting a STAT China newsletter? It’s no secret that China represents an important growth market for the global biopharma sector – its health care market is widely estimated to exceed $1 trillion this year. Boasting its own stock exchanges and a number of high-tech industrial parks playing host to homegrown pharma and biotech companies, I think there’s still plenty to learn and discover about this emerging market.

With that in mind, I’d like to invite you to explore this new frontier with me, by sharing your tips, thoughts, or feedback on the newsletter. You can find me at jonathan.chan@statnews.com.

Now to the news:

AstraZeneca braces for hit amid coronavirus epidemic

The novel coronavirus outbreak is now entering its eighth week, and it may be too soon to say how it will affect the industry broadly. But at least one drug maker, AstraZeneca, says it’s expecting sales in China to be negatively impacted.

The U.K. drug maker’s heavy investment into the Chinese market means it has greater exposure to the epidemic compared to other global pharma companies; over one-fifth of its product sales come from China, the company disclosed during its latest full-year and Q4 results presentation.

In terms of its guidance for 2020, the company says it is assuming an “unfavorable impact from China lasting up to a few months” as a result of the outbreak.

“Right now, the main impact is that our salespeople cannot visit the hospitals and access the health care professionals because doctors, especially some of the specialties, are focusing on fighting the epidemic,” Leon Wang, the company’s executive vice president, international, said on an earnings call.

He added that disruptions are likely to be temporary, and patients are now going to local pharmacies to refill their prescriptions instead of going to the hospitals.

China
 approves Roche’s Tecentriq

Roche’s lung cancer immunotherapy is making its way into China. The National Medical Products Administration approved atezolizumab, marketed as Tecentriq, for the treatment of extensive-stage small cell lung cancer (ES-SCLC) in combination with chemotherapy.

The immunotherapy will make its way into the world’s second largest pharmaceutical market after gaining approvals for the same indication from the Food and Drug Administration and the European Medicines Agency last year. The Swiss drug maker is working closely with its local partners in China and is expecting to launch Tecentriq “in the following months,” a Roche spokesman told STAT.

Tecentriq, an immune checkpoint inhibitor that targets the PD-L1 protein on tumor cells, is the second anti-PD-L1 drug to enter China after AstraZeneca’s lung cancer immunotherapy Imfinzi beat it to the market in December last year. However, Imfinzi will not compete directly with Tecentriq as it is indicated for patients with unresectable stage 3 non-small cell lung cancer (NSCLC), the more common form of lung cancer.

BrightGene Biomedical manufactures Gilead’s remdesivir — without a license

Gilead’s antiviral drug remdesivir is being tested as a possible treatment for Covid-19, the disease caused by the novel coronavirus. That appears to have motivated one Chinese company, BrightGene Biomedical Technology, to replicate the drug’s active pharmaceutical ingredient.

Despite Gilead’s IP protection on the molecule, BrightGene insists it has not infringed on any patents because the generic treatment is still in a development phase. Gilead will have to out-license the drug in order for the copied version to be marketed, BrightGene’s board secretary told Chinese news publication Jiemian.

Gilead told Bloomberg News it’s aware of BrightGene’s move but that discussion of licensing the investigational drug is “premature.” The company, it said, remains “focused on rapidly determining the potential for remdesivir to treat Covid-19.”

Once a failed Ebola treatment, Chinese scientists from the Wuhan Institute of Virology found remdesivir to be one of the more effective agents that can inhibit the novel coronavirus in the lab. The institute filed a patent for the drug, an unusual move given that Gilead developed remdesivir and applied for a patent in China over three years ago, though it still has not yet been approved.

A Phase 3 trial studying the antiviral’s efficacy and safety in patients with Covid-19 infection is currently underway in China. It is expected to finish by late April.

China clinical trials delayed as outbreak persists

China’s drawn-out fight against the coronavirus outbreak is disrupting hundreds of clinical trials being run by both global and domestic drug makers in the city of Wuhan, Reuters reports.

Heavy travel bans are making it difficult for the studies to stay on schedule, though a number of drug developers said it is too soon to speculate on long-term impacts. Some hospitals have suspended their drug trials, while some contract research organizations report patients having difficulty getting to the trial sites.

So far, the outbreak’s impact on drug R&D has been limited, though. As STAT’s Kate Sheridan reports, for biotech startups that primarily operate in regions other than Hubei province, or CROs operating multiple sites across China such as Wuxi AppTec, the initial disruption has been relatively mild.

Bio-Thera targets $287 million in Shanghai IPO

Bio-Thera Solutions — not to be confused with Minnesota-headquartered Biothera Pharmaceuticals — is looking to raise $287 million from its IPO on Shanghai’s STAR market. The Guangzhou-based company issued 60 million common shares, a company filing said.

According to Bio-Thera’s prospectus, 80% of the capital raised will be used to fund its drug development programs, which mostly consists of cancer and autoimmune disease biologics.

Last November, China’s National Medical Products Administration approved the company’s adalimumab biosimilar, making it China’s first domestic version of AbbVie’s blockbuster rheumatoid arthritis therapy, Humira, the world’s top-selling drug in 2017 and 2018. Bio-Thera’s adalimumab, marketed as Qletli, beat its peers to the market; Innovent Biologics, Henlius Biotech, and Hisun Pharma are all developing their own version of the monoclonal antibody.

And last week, the company reported positive top-line results for its Phase 3 trial of BAT1706, a biosimilar to Genentech’s Avastin.

More reads

  • The World Health Organization draws flak for coronavirus response (WSJ)
  • Why reports about coronavirus death rates can be misleading (STAT)
  • At least 37 groups are developing a COVID-19 vaccine (BioCentury)
  • Beijing reopens obsolete factories to boost mask production (People’s Daily Online)

Thanks for reading! More next week.

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