AstraZeneca has penned a drug discovery pact focused on chronic diseases with China's CSPC Pharma. The FDA has halted new trials that export U.S. individuals' living cells to China. Chinese regulators are proposing to shorten clinical trial review times for novel medicines. And more.
1. AstraZeneca pens $5.3B pact to use CSPC's AI platform to develop oral drugs for chronic diseases
AstraZeneca is paying China’s CSPC Pharmaceutical $110 million upfront to discover new oral drugs for chronic diseases, including one potential project for immunological diseases. The deal includes up to $5.2 billion in potential milestones and will see CSPC use its AI-driven discovery platform to analyze the binding patterns of target proteins with existing compounds.
2. FDA blocks new clinical trials that ship cells from US to China
The FDA has halted new clinical trials that export American citizens’ living cells to “China and other hostile countries for genetic engineering and subsequent infusion” back into American patients, according to an agency announcement. The FDA said such studies “may have exposed Americans’ sensitive genetic data to misuse by foreign government” and blamed the issue on a “sweeping exemption” in a Biden-era executive order about preventing access to sensitive American data.
3. China proposes shorter clinical trial reviews in efforts to accelerate drug development
China is proposing to cut the clinical trial reviewing waiting period for novel medicines to 30 working days from the current 60 working days. Similar to the U.S., a clinical trial may automatically proceed in China if the sponsor doesn’t receive any objections from regulators within a certain time frame. If implemented, the new review timeline would match that of the U.S. FDA.
The U.S. continues its push to onshore drug manufacturing. President Donald Trump told reporters Tuesday that U.S. tariffs on pharmaceuticals will come “very soon,” Reuters reports. Meanwhile, four U.S. senators have reintroduced a bipartisan bill that would require the U.S. government to contract U.S.-based drugmakers or those that operate in a member of the Organisation for Economic Cooperation and Development.
5. China's rapid rise creates 'heightened risks' for pharma: PwC
As more pharma licensing deals feature Chinese assets, PwC noted that these activities have “brought additional scrutiny from a geopolitical and national security perspective.” The emergence of a “multifaceted regulatory and geopolitical set of challenges” means companies need “comprehensive due diligence and strategic foresight” in dealmaking, PwC analysts wrote in a midyear report.
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