Chinese Pharma Companies Surge into U.S. Clinical Trials, Marking a New Era of Global Innovation

　　【Pharmaceutical Network Industry DynamicsIn recent years, driven by regulatory optimization, global commercialization needs, clinical resource advantages, and capital/BD, Chinese pharmaceutical companies have been intensively conducting clinical trials in the United States. As of January 23, 2026, at least 40 pharmaceutical companies, including BeiGene, RemeGen, Hengrui Medicine, Innovent Biologics, and Akeso Biopharma, have announced news of receiving U.S. clinical approvals and completing the first patient dosing.
 

Recently, Mabwell announced that the first patient has been dosed in the United States in a clinical trial of its innovative CDH17-targeted ADC drug (development code: 7MW4911) for patients with advanced colorectal cancer and other advanced gastrointestinal tumors.
 

It is reported that 7MW4911 is a novel CDH17-targeted ADC developed by Mabwell based on its proprietary IDDC™ antibody-drug conjugate platform. Preclinical studies have shown that 7MW4911 exhibits potent anti-tumor activity in various CDX/PDX models of gastrointestinal tumors. In multidrug-resistant models, its anti-tumor efficacy surpasses that of MMAE/DXd-class ADCs and can reverse tumor progression following treatment with such ADCs, highlighting its advantages in drug-resistant tumor therapy.
 

This clinical trial conducted in the United States represents the first-in-human study of 7MW4911 in American patients, aiming to evaluate its safety, pharmacokinetics, and efficacy in patients with advanced colorectal cancer and other advanced gastrointestinal tumors. Previously, the drug had also been approved for clinical trials in China and completed the first patient dosing.
 

On January 19, D3 BIO announced that the U.S. Food and Drug Administration (FDA) had approved its two new drug clinical trial applications (IND). After receiving FDA IND approval, D3 BIO will advance the Phase I clinical study of D3S-003 in patients with advanced solid tumors carrying the KRAS G12D mutation.
 

D3S-003 is an orally bioavailable, allele-specific KRAS G12D inhibitor that can simultaneously target both GDP-bound (OFF) and GTP-bound (ON) conformations of KRAS. Preclinical data show that D3S-003 demonstrates excellent anti-tumor activity, favorable drug-like properties, and a promising safety window.
 

On January 14, Huadong Medicine Co., Ltd. announced that its controlling subsidiary, Doer Biologics, had received a notification from the U.S. FDA, approving the clinical trial application for DR10624 Injection submitted by the company. The clinical trial can now be conducted in the U.S. for the indication of Metabolism Associated Steatohepatitis (MASLD).
 

DR10624 is a long-acting trispecific agonist independently developed by Doer Biologics, targeting FGF21R, GCGR, and GLP-1R. The drug has successfully completed Phase II clinical research for severe hypertriglyceridemia and obtained positive topline results.
 

On January 13, CSPC PHARMACEUTICAL GROUP LIMITED announced that its developed chemical medicine Type 1 new drug, a potent aldosterone synthase inhibitor (SYH2072 tablets), has been approved by the U.S. FDA to commence clinical trials. The approved clinical indications are uncontrolled hypertension and resistant hypertension.
 

It is reported that SYH2072 is a highly selective and potent aldosterone synthase inhibitor, which can effectively reduce plasma aldosterone levels without affecting cortisol levels. In December 2025, this product has been approved for clinical use in China, with the proposed indications being uncontrolled hypertension and primary aldosteronism.
 

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Overall, in 2026, Chinese pharmaceutical companies are densely deploying clinical trials in the United States, marking that China's innovative drugs have entered a new stage of globalization and are accelerating the leap from "followers" to "system innovators." This phenomenon will accelerate global innovative drug research and development in the future, while also enhancing the globalization capabilities of Chinese pharmaceutical companies and reshaping the global R&D division of labor.
 

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