Hansoh Pharma's ADC HS-20110 Accepted by China's CDE Following $1.5 Billion Roche Deal

The drug had barely cleared the laboratory bench when the phone rang.

In October 2025, executives at Hansoh Pharmaceutical Group Company Limited sat across from counterparts at Roche Holding AG, negotiating terms for what would become one of the largest antibody-drug conjugate deals to emerge from China. The molecule in question—HS-20110—had yet to complete Phase I trials. But the data so far was promising enough that Roche was willing to pay $80 million upfront, with up to $1.45 billion in milestone payments tied to development, regulatory approval, and commercialization progress.

The total potential value: more than $1.5 billion USD.

Eight months later, that bet is looking prescient.

On June 24, 2026, China's Center for Drug Evaluation accepted HS-20110 for clinical trial review under application number CXSL2600666. The filing, submitted jointly by Shanghai Hansoh Biomedical Technology Co., Ltd. and Changzhou Hengbang Pharmaceutical Co., Ltd., marks the latest regulatory milestone for a drug that has moved from Chinese labs to global development at an unusual pace.

The Target

HS-20110 is an antibody-drug conjugate—often called a "biological missile" in oncology circles—that targets CDH17, a protein belonging to the cadherin superfamily. In healthy tissue, CDH17 appears only in the epithelial cells of the small intestine and colon. But in tumors, the expression pattern flips dramatically.

The protein shows up in approximately 99% of colorectal cancers, 86% of gastric adenocarcinomas, 79% of esophageal adenocarcinomas, and 50% of pancreatic ductal adenocarcinomas. That distribution makes CDH17 an attractive target for treating gastrointestinal cancers, a category that remains among the deadliest worldwide.

The drug itself pairs a humanized monoclonal antibody against CDH17 with a topoisomerase inhibitor payload, linked by a covalent bond. The antibody hunts for cancer cells displaying the target antigen; once inside, the payload releases and kills the cell.

The Timeline

Clinical development has moved quickly. A Phase I study evaluating safety and tolerability in patients with advanced solid tumors enrolled its first patient in February 2025. By December 2025, Hansoh had launched a Phase Ib/II trial specifically for advanced colorectal cancer, planning to enroll 502 patients.

The trials are running simultaneously in China and the United States, registered on ClinicalTrials.gov under identifier NCT07283367.

The latest CDE acceptance means regulatory review is now underway in China, potentially accelerating the path toward domestic approval.

The Track Record

HS-20110 is not Hansoh's first ADC to attract global pharmaceutical interest. The company has now licensed three ADC candidates to multinational partners.

A B7-H3-targeting ADC and a B7-H4-targeting ADC were both licensed to GlaxoSmithKline PLC in separate deals. The HS-20110 agreement with Roche is the third—and the largest by potential value.

Under the Roche deal, Hansoh retains development and commercialization rights in mainland China, Hong Kong, Macau, and Taiwan. Roche receives exclusive rights for the rest of the world, along with tiered royalties on future sales.

For patients with gastrointestinal cancers, the timeline matters. These tumors are often diagnosed late and respond poorly to existing therapies. A first-in-class treatment targeting CDH17 could represent a meaningful advance—if the clinical data holds up.

With Roche's resources behind global development and regulatory review now underway in China, HS-20110 is moving from the laboratory toward the clinic faster than most candidates in this space.

The question now is whether the molecule can deliver on the promise that prompted a $1.5 billion bet.