China & United States — Food and Drug Administration
41 shared events · Importance 4 · Last updated Aug 24, 2026
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Regulatory
China: China is the market where the NDA was submitted, representing a significant commercial opportunity for NCX 470.
United States — Food and Drug Administration: The FDA is reviewing the U.S. NDA for NCX 470, with approval expected in summer 2027. Its decision is critical for the drug's launch in the U.S.
Aug 10, 2026 · 6 articles
Regulatory
China: China is the location of Aurisco's manufacturing site, and this approval highlights the country's growing capabilities in advanced pharmaceutical manufacturing.
United States — Food and Drug Administration: The USFDA conducted and approved the inspection, playing a regulatory role that validates Aurisco's compliance and sets a precedent for future generic oligonucleotide approvals.
Aug 12, 2026 · 7 articles
Tech
China: China has demonstrated leadership in neurotechnology by approving and deploying the first commercial BCI, aligning with its strategic goal to dominate future industries and potentially boosting its tech sector.
United States — Food and Drug Administration: The FDA has not yet approved Neuralink's device for commercial use, contrasting with China's NMPA and highlighting regulatory differences.
Jul 06, 2026 · 10 articles
Business
China: China is the world's second-largest pharmaceutical market and a fast-growing source of drug innovation. VivoSim's entry into China reflects the country's growing demand for advanced preclinical testing services.
United States — Food and Drug Administration: The FDA's April 2025 plan to phase out animal testing requirements for certain drugs is a regulatory tailwind that supports adoption of VivoSim's non-animal NAM methods globally.
Jul 21, 2026 · 6 articles
Tech
China: Regulators in China are considering bepirovirsen, which could expand the drug's market reach and provide a new treatment option for patients in the country.
United States — Food and Drug Administration: The United States — Food and Drug Administration is currently reviewing bepirovirsen for fast-track approval, and its decision in October will be crucial for the drug's market entry in the United States.
May 28, 2026 · 8 articles
Business
China: Regulatory progress; BLA accepted and designated for priority review.
United States — Food and Drug Administration: Approved Leqembi Iqlik on July 13, enabling the US launch.
Aug 24, 2026 · 6 articles
International
China: Pax Silica aims to reduce reliance on Chinese tech, potentially affecting China's tech influence.
United States — Food and Drug Administration: Agreed to resume product testing in Bangladesh, supporting regulatory cooperation.
Aug 01, 2026 · 6 articles
Regulatory
China: China is the target market for Lerociclib, with an estimated 400 million individuals suffering from dyslipidemia and a significant unmet medical need for lipid-lowering treatments.
United States — Food and Drug Administration: The United States — Food and Drug Administration (FDA) has already approved Lerociclib, indicating its efficacy and safety profile, which supports its regulatory review in other regions.
Jun 26, 2026 · 8 articles
International
China: China reported stronger-than-expected export and import growth, driven by demand for autos and technology goods, despite the Iran war.
United States — Food and Drug Administration: The United States — Food and Drug Administration is the regulatory body that Revolution Medicines will seek approval from for its experimental pancreatic cancer drug, daraxonrasib.
May 18, 2026 · 316 articles
Business
China: Granted Breakthrough Therapy Designation for bexicaserin, indicating regulatory support in a key market.
United States — Food and Drug Administration: Granted Breakthrough Therapy Designation for bexicaserin in DEEs, facilitating development.
Jul 20, 2026 · 6 articles
Business
China: China, through its China — National Medical Products Administration (NMPA), is the regulatory authority that accepted the IND application for HBM7004, facilitating its potential clinical development within the country.
United States — Food and Drug Administration: The United States — Food and Drug Administration (FDA) previously cleared the IND for HBM7004, setting a precedent for the NMPA's acceptance and indicating broader international regulatory progress for the drug.
Jun 10, 2026 · 7 articles
Business
China: China is mentioned as a location of operations for Median Technologies, but not directly involved in this agreement.
United States — Food and Drug Administration: The FDA cleared eyonis LCS, enabling its U.S. commercialization; this regulatory approval is foundational to the agreement.
Jul 30, 2026 · 8 articles
Accidents
China: China>>> is developing an mRNA vaccine that has shown promise against Uganda — Bundibugyo in mice and has pledged to send medical specialists to the Democratic Republic of the Congo>>> to assist with the outbreak.
United States — Food and Drug Administration: The United States — Food and Drug Administration has approved Inmazeb, a combination of antibodies, to treat Zaire Ebolavirus infection, which Regeneron Pharmaceuticals has donated for potential use in the current outbreak.
May 18, 2026 · 505 articles
Tech
China: China is the home country of Puncture Robotic and the regulatory origin of HAIRO's NMPA certification.
United States — Food and Drug Administration: FDA clearance is a target for international expansion; not yet obtained.
Jul 10, 2026 · 6 articles
Business
China: Zegfrovy is approved in China; CDE granted Breakthrough Therapy Designation for first-line use.
United States — Food and Drug Administration: FDA received sNDA for first-line Zegfrovy and granted Breakthrough Therapy Designation.
Jul 14, 2026 · 8 articles
Business
China: Fosun's operations and CSR programs are primarily based in China, contributing to its reputation there.
United States — Food and Drug Administration: Granted Orphan Drug Designation to HLX22 for gastric cancer.
Aug 06, 2026 · 6 articles
Tech
China: China is referenced for its high prevalence of cervical cancer cases, underscoring the significant market need for United Therapeutics' therapy in the Asia-Pacific region.
United States — Food and Drug Administration: The United States — Food and Drug Administration is mentioned as the body that has not yet approved the investigational therapy, indicating future regulatory hurdles for United Therapeutics.
May 19, 2026 · 7 articles
Tech
China: China is the location where the initial PoC clinical study for IBI363 was conducted and where Innovent Biologics is based. The China NMPA has also granted Breakthrough Therapy Designations for IBI363.
United States — Food and Drug Administration: The United States — Food and Drug Administration (FDA) has granted two Fast Track Designations to IBI363, indicating its potential to address unmet medical needs and expedite its development and review process.
May 21, 2026 · 9 articles
Regulatory
China: China is mentioned as the location of a Carl Zeiss Meditec innovation center, but it is not directly affected by this event.
United States — Food and Drug Administration: The FDA granted 510(k) clearance for ZEISS CLINIC 360, a regulatory action that enables the product's commercial launch in the U.S. This clearance is a routine but essential step for medical device software.
Aug 19, 2026 · 6 articles
Tech
China: China is relevant as the country where golidocitinib received approval from the China — National Medical Products Administration (NMPA).
United States — Food and Drug Administration: The United States — Food and Drug Administration (FDA) granted Fast Track Designation to golidocitinib in February 2022, accelerating its development pathway in the US.
May 31, 2026 · 6 articles
Regulatory
China: China is a major producer of active pharmaceutical ingredients (APIs) but is not directly targeted by this tariff plan.
United States — Food and Drug Administration: The FDA noted that generics constitute over 90% of US prescriptions, highlighting the policy's broad impact.
Jul 21, 2026 · 73 articles
Business
China: Cosela is already marketed in China; the partnership does not directly affect the Chinese market.
United States — Food and Drug Administration: The FDA approved Cosela, which is the basis for its use; the partnership does not directly affect the FDA.
Jul 21, 2026 · 8 articles
Business
China: Profound Medical's Sonalleve is cleared in China.
United States — Food and Drug Administration: FDA has cleared TULSA-PRO and approved Sonalleve in the US.
Jul 16, 2026 · 7 articles
Business
China: Ascentage Pharma operates in China and has approvals from Chinese regulators, but this event does not directly impact the country.
United States — Food and Drug Administration: The FDA has cleared several of Ascentage Pharma's Phase III trials, but this event does not directly involve the FDA.
Jul 26, 2026 · 6 articles
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