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    US considers 'severe restrictions' on Big Pharma licensing affordable Chinese meds
    Futurology

    US considers ‘severe restrictions’ on Big Pharma licensing affordable Chinese meds

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    1. upyoars on

      > The current administration is considering putting “severe restrictions” on the increasing flow of investigational drugs from China. A draft executive order is being circulated to Big Pharmas, billionaire stakeholders and biotech VC investors that accuses China “and other hostile actors” of having “exploited gaps in our open scientific and regulatory systems”. The draft order includes a suggested policy that would see **heavier scrutiny on U.S. pharmas’ attempts to license drugs from Chinese biotechs**, including ensuring that these licensing deals are assessed by a U.S. national security committee.

      > These sorts of deals have become an increasingly regular occurrence, with recent months alone seeing **Pfizer pay China’s 3SBio $1.25 billion upfront** for a PD-1xVEGF bispecific, while **AstraZeneca handed over $110 million** to existing Chinese partner CSPC Pharmaceutical to collaborate on chronic disease drugs.

      > Another proposed policy would require a more rigorous review of Chinese clinical trial data by the FDA, along with higher regulatory fees for companies that submit China trial data. But at the same time, there are discussions about looking to **speed up the FDA review process** to allow drugmakers to launch clinical studies sooner. The suggestion **mirrors** a push at China’s medicines regulator to find ways to speed up its own review process.

      > Analysts at Jefferies described how “**China biotechs are reshaping the U.S. biopharma landscape, as in-licensing assets from China could offer multinational corporations a remedy to alleviate pressure affordably and within a manageable time frame.**”

      > In February, the administration issued a memorandum titled the “America First Investment Policy” for several federal leaders. Emphasizing national and economic security, the policy aimed to restrict both inbound and outbound investments related to “foreign adversaries” in certain strategic industries.

    2. GamePois0n on

      this is good, US has been importing so much stuff that they can no longer manufacture anything locally.

      ww2 was won because US was the manufacturer, if china was to initiate ww3, US would only be able to hold out until existing stock are burned through, look at what happened to germany, L bozo