Shanghai Junshi Biosciences next to test HKEX listing; With one eye on Sage, Marinus reports prelim PPD data

→ The new rule allowing biotechs to list on the Hong Kong exchange before recording revenue or profit has attracted a mixed bag of performers, including Ascletis, BeiGene, and Innovent Biologics. The latest company willing to wager its fortunes is Shanghai Junshi Biosciences (with its 13 biologics in development), which is seeking up to $414 million in a bid to go public on HKEX, according to a Reuters report.

→ Trailing behind Sage Therapeutics $SAGE, Marinus Pharma’s $MRNS postpartum depression drug needed to show a safer profile and at least equivalent efficacy to leapfrog the former’s Zulresso, which is seen as a high-risk affair given the rare, but plausible risk of loss of consciousness in patients given the drug. On Monday, Marinus provided data on its PPD drug, ganaxolone, from twin studies evaluating an IV and an oral formulation. Marinus is pleased with the “early onset, magnitude and durability of efficacy seen with ganaxolone IV over a month after treatment…as well as its safety profile,” it said in a statement, providing scant detail on the actual numbers. Still, the announcement lifted the company’s shares up about 12% in early trading. But analysts at Stifel were unconvinced: “While it’s plausible that Marinus could have a viable product at some point, we don’t think the data today change the set-up or upside case for SAGE,” Paul Matteis wrote.

→ The historic approval of Alnylam’s $ALNY gene-silencing therapy Onpattro in the United States (with a hefty list price of $450,000 per year) and Europe rejuvenated the RNAi field, which has long been littered with failures. But no success goes unnoticed. On Monday, the company said it had settled a global legal battle with fellow RNAi drug developer Silence Therapeutics. Under the deal, in which neither party made any admissions, Silence will receive a royalty on annual net sales of Onpattro in the EU, with tiered royalties of 0.33% – 1.0% through 2023.

→ Immuno-oncology and microbiome-based drugs are all the rage in drug development circles — now Bristol-Myers Squibb $BMY and Vedanta Biosciences are looking at combining the two. Bristol-Myers has tied up with the latter to test its blockbuster Opdivo with Vedanta’s lead microbiome-based immuno-oncology candidate, VE800, based on preclinical testing that has shown that certain gut-dwelling bacterial strains can enhance tumor infiltration.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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Catalytic Data Science Charleston, SC
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Flatiron Health New York City or San Francisco

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