What ArriVent BioPharma, Inc. told the SEC could break it.

A September 2025 announced 100% tariff on brand-name/patented drugs (unless manufacturing is expanded in the U.S.), tariffs still applying to raw materials, and IRA Medicare drug-price negotiation collectively threaten ArriVent's cost structure and future firmonertinib economics given its offshore manufacturing.

“On September 25, 2025, the current U.S. administration announced a 100% tariff on brand-name or patented drugs unless pharmaceutical companies expand their manufacturing operations in the U.S., and may impose more restrictions on goods.”

ArriVent relies on a small number of China-based contract manufacturers (Raybow, WuXi STA, WuXi XDC) for firmonertinib and ARR-217 drug substance and product; both CMs being in China exposes it to supply disruption, a U.S.-China trade war, NDAA FY2026 (BIOSECURE-type) restrictions and regulatory-framework changes.

“Both third-party contract manufacturers are located in China, and we expect to continue to use such third-party manufacturers for such firmonertinib drug substance and drug product supplies.”

ArriVent's near-term prospects depend heavily on its lead candidate firmonertinib, several of whose pivotal trials (and an ARR-217 trial) are conducted outside the U.S. including in China; the FDA may not accept that foreign data, delaying development and harming the business.

“Several of the ongoing clinical trials for our lead product candidate, firmonertinib, and an ongoing trial for ARR-217, are being conducted outside the United States, including in China. However, the FDA and foreign regulatory equivalents may not accept data from such trials, or may expect proportionately more data from subjects in the United States, in which case our development plans will be delayed, which could materially harm our bu”