16 hours ago
Here's what I find most puzzling about the FDA's CRL decision: Why would Jiangsu Hengrui Pharmaceuticals, in China, cut a deal with BeyondSpring based on DUBLIN/3's NSCLC results if they weren't good enough? Their scientists surely looked over the trial and could have easily filtered the hype from the from facts. Jiangsu Hengrui is considered the Pfizer of China, so why would they want to compromise their established reputation by cutting a deal with a questionable drug? They don't need the business, so I must assume plinabulin-docetaxel works. Something is very wrong with the FDA's decision:
Fierce Biotech, published Aug 27, 2021: "BeyondSpring has cashed in on the validation of its lung cancer drug. Weeks after shocking analysts with phase 3 trial data that far exceeded expectations, a BeyondSpring subsidiary has secured $30 million upfront for rights to the drug in greater China, sending its share price on another surge.
Jiangsu Hengrui Pharmaceuticals has taken the other side of the deal, handing over $30 million and committing to a further $170 million in regulatory and sales milestones for exclusive regional rights to plinabulin. Wanchunbulin, BeyondSpring’s 58%-owned subsidiary in China, will work with Hengrui to co-develop plinabulin in indications beyond non-small cell lung cancer (NSCLC). Hengrui is also set to invest $15 million in Wanchunbulin.
The deal comes weeks after BeyondSpring reported phase 3 data on plinabulin, a drug that until this month was best known for its potential role in stopping a side effect of chemotherapy. BeyondSpring is closing in on approval in that context in the U.S. and China but is now also positioned to go after a larger therapeutic application of the drug."
https://www.fiercebiotech.com/biotech/beyondspring-flying-high-from-phase-3-success-sells-chinese-rights-to-cancer-drug
Fierce Biotech, published Aug 27, 2021: "BeyondSpring has cashed in on the validation of its lung cancer drug. Weeks after shocking analysts with phase 3 trial data that far exceeded expectations, a BeyondSpring subsidiary has secured $30 million upfront for rights to the drug in greater China, sending its share price on another surge.
Jiangsu Hengrui Pharmaceuticals has taken the other side of the deal, handing over $30 million and committing to a further $170 million in regulatory and sales milestones for exclusive regional rights to plinabulin. Wanchunbulin, BeyondSpring’s 58%-owned subsidiary in China, will work with Hengrui to co-develop plinabulin in indications beyond non-small cell lung cancer (NSCLC). Hengrui is also set to invest $15 million in Wanchunbulin.
The deal comes weeks after BeyondSpring reported phase 3 data on plinabulin, a drug that until this month was best known for its potential role in stopping a side effect of chemotherapy. BeyondSpring is closing in on approval in that context in the U.S. and China but is now also positioned to go after a larger therapeutic application of the drug."
https://www.fiercebiotech.com/biotech/beyondspring-flying-high-from-phase-3-success-sells-chinese-rights-to-cancer-drug
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