NextCure, Inc.

AstraZeneca and CSPC's chronic disease collaboration, an FDA ban on shipping cells to China, and China's proposed new clinical trial review timeline made our news this week. 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 diseasesAstraZeneca 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 ChinaThe 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 developmentChina 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.4. Trump rekindles pharmaceutical tariff threat, suggesting import duties could come 'very soon': ReutersSenators bring back bill to bolster US pharma supply chain by awarding contracts to domestic producersThe 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: PwCAs 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.  Other News of Note:6. South Korean biotech's GLP-1 drug scores MASH win while reducing weight7. NextCure advances ADC pivot with $745M deal for Simcere's phase 1 drug8. Astellas offers lab space to startups to help Japanese biotechs 'go global'

Bengaluru: Drug developer NextCure said on Monday it had signed a deal worth up to $745 million with China-based drugmaker Simcere Zaiming to develop a cancer therapy for solid tumors . NextCure said it will gain global rights to the experimental therapy, SIM0505, in all regions except Greater China, where Simcere Zaiming will retain control. Zaiming is eligible to receive payments throughout the potential development phases, including upfront payment and other milestones up to $745 million, as well as tiered royalties up to double digits on net sales outside China, NextCure added. WHY IT'S IMPORTANT Simcere's SIM0505 belongs to a class of drugs known as antibody-drug conjugates (ADCs), which are more targeted than conventional chemotherapy. These therapies, also known as 'guided missiles', use antibodies to deliver toxic drugs directly to cancer cells, helping to destroy the tumor while leaving healthy cells unharmed. CONTEXT U.S. drugmakers have been licensing drugs from China for potential new medicines at an accelerating pace, as they look to rebuild pipelines of future products while facing a patent cliff for the older drugs. WHAT'S NEXT The experimental cancer drug is currently being tested in an early-stage trial in China. Initial data from the trial is expected in the first half of next year. The company expects to begin studying the drug in the U.S. in the third quarter of 2025. (Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Shreya Biswas)

Bengaluru: Drug developer NextCure said on Monday it had signed a deal worth up to $745 million with China-based drugmaker Simcere Zaiming to develop a cancer therapy for solid tumors . NextCure said it will gain global rights to the experimental therapy, SIM0505, in all regions except Greater China, where Simcere Zaiming will retain control. Zaiming is eligible to receive payments throughout the potential development phases, including upfront payment and other milestones up to $745 million, as well as tiered royalties up to double digits on net sales outside China, NextCure added. WHY IT'S IMPORTANT Simcere's SIM0505 belongs to a class of drugs known as antibody-drug conjugates (ADCs), which are more targeted than conventional chemotherapy. These therapies, also known as 'guided missiles', use antibodies to deliver toxic drugs directly to cancer cells, helping to destroy the tumor while leaving healthy cells unharmed. CONTEXT U.S. drugmakers have been licensing drugs from China for potential new medicines at an accelerating pace, as they look to rebuild pipelines of future products while facing a patent cliff for the older drugs. WHAT'S NEXT The experimental cancer drug is currently being tested in an early-stage trial in China. Initial data from the trial is expected in the first half of next year. The company expects to begin studying the drug in the U.S. in the third quarter of 2025. (Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Shreya Biswas)