Thursday, October 21, 2021

Fierce Pharma Asia—Sanofi’s €400M vaccine site; BeiGene-Novartis’ PD-1 data; India’s remdesivir export ban

Sanofi is building a €400 million vaccine production site in Singapore on the heels of announcing a €600 million flu shot factory in Canada. BeiGene is eyeing global filings for its Novartis-partnered PD-1 inhibitor, tislelizumab, after showing it could pare down the risk of death compared with chemotherapy in previously treated non-small cell lung cancer. India prohibited exports of Gilead Sciences’ antiviral remdesivir as rising COVID-19 cases fuel a demand surge. And more.

1. Sanofi’s latest vaccine plan? A €400M Singapore factory full of ‘boundary-pushing’ tech

Sanofi is pouring €400 million over the next five years into a new vaccine production site in Singapore to boost supply in Asia and support the company’s other manufacturing work in Europe and North America. The French pharma said the site will produce current and future vaccines, without naming specific products. Construction will kick off in the third quarter, and the site is expected to be fully operational by the first quarter of 2026.

2. AACR: BeiGene details Novartis-partnered PD-1’s first global pivotal win in lung cancer. Should Opdivo maker BMS be concerned?

BeiGene’s Novartis-partnered PD-1 inhibitor, tislelizumab, cut the risk of death by 36% over the chemotherapy docetaxel in patients with non-small cell lung cancer who had progressed after one to two lines of therapy. The data, unveiled at the AACR annual meeting, marked the drug’s first global pivotal trial win. The two companies expect its first ex-China filings to be in NSCLC and esophageal squamous cell carcinoma by the end of 2021.

Meanwhile, fellow Chinese biotech Innovent Biologics and partner Eli Lilly showed their PD-1 rival Tyvyt reduced the risk of death by 26% versus docetaxel as a second-line treatment for squamous NSCLC. The data came from a China phase 3 trial, and the pair are eyeing a local approval for now.

3. India axes exports of Gilead Sciences’ remdesivir, plots boost to local production as COVID cases mount: reports

India has banned exports of Gilead Sciences’ remdesivir amid a surge of domestic COVID-19 cases. Seven local companies are partnered with Gilead to make the drug: Cipla, Hetero, Jubilant Life Sciences, Zydus Cadila, Dr. Reddy’s, Mylan and Biocon’s Syngene, according to Bloomberg. Despite their combined capacity of 3.9 million units per month, demand is still not met.

4. China mulls mixing COVID-19 vaccines, adjusting dosing to boost protection (SCMP)

For COVID-19 vaccination, China is exploring new ways to “solve the problem that the efficacy of its existing vaccines is not high,” China’s CDC chief Gao Fu told a conference. It’s considering adjusting the dosage or interval between shots or increasing the number of doses. The other potential option is to mix vaccines developed using different technologies. The idea of combining different COVID-19 shots is being studied in the U.K. in the Com-Cov trial, in which people receive two different vaccines for their first and second doses.

5. Scientists make long-lasting but controversial human-monkey embryos for medical research

Scientists from the Salk Institute for Biological Studies and China’s Kunming University of Science and Technology created the first human-monkey chimeric embryos and cultured them for 20 days. The embryos were grown by injecting human stem cells into monkey embryos. Researchers hope the breakthrough could provide better models to conduct biological research and test drugs. It also holds promise to one day supply transplantable organs. But the work also raised ethical questions.

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