Hansoh Pharma's CDH17-Targeted ADC HS-20110 Receives CDE Acceptance with Potential Deal Value Exceeding $1.5 Billion

HS-20110 is a novel, potential first-in-class antibody-drug conjugate (ADC) independently developed by Hansoh Pharma. It comprises a humanized monoclonal antibody targeting cadherin-17 (CDH17) covalently linked to a topoisomerase inhibitor (TOPOi) payload. ADCs are often referred to as “biological missiles” in cancer therapy—the antibody component is responsible for precisely recognizing specific antigens on the surface of tumor cells, while the payload is released inside the tumor cells to exert its cytotoxic effect.

CDH17 belongs to the cadherin superfamily and is expressed exclusively in the epithelial cells of the small intestine and colon in normal human tissues; however, in tumor tissues, CDH17 is highly expressed in approximately 99% of colorectal cancers, 86% of gastric adenocarcinomas, 79% of esophageal adenocarcinomas, and 50% of pancreatic ductal adenocarcinomas. This unique expression profile makes CDH17 an ideal target for precision therapy in gastrointestinal tumors.

The clinical development of HS-20110 is proceeding at a notably rapid pace. According to the Drug Clinical Trial Registration and Information Publicity Platform, a Phase I clinical study evaluating the safety and tolerability of HS-20110 in patients with advanced solid tumors enrolled its first patient in February 2025. In December 2025, a Phase Ib/II clinical study targeting advanced colorectal cancer was officially launched, with a planned enrollment of 502 patients.

The product is currently undergoing simultaneous global clinical trials in China and the United States for colorectal cancer and other solid tumors.

What truly sparked industry-wide excitement for HS-20110 was the landmark licensing agreement reached with Roche, the global leader in oncology drugs, in October 2025. Under the terms of the agreement, Hansoh Pharma granted Roche exclusive rights to develop and commercialize HS-20110 worldwide (excluding Mainland China, Hong Kong, Macao, and Taiwan). Hansoh Pharma will receive an upfront payment of $80 million and is eligible to receive up to $1.45 billion in milestone payments based on progress in development, regulatory approval, and commercialization, as well as tiered royalties on future potential sales.

This potential deal, with a total value exceeding $1.5 billion, marks another landmark case of Chinese ADC companies expanding globally. Notably, this represents Hansoh Pharma’s third successful overseas licensing deal in the ADC field, following its previous out-licensing of B7-H3 ADC and B7-H4 ADC to GlaxoSmithKline (GSK).

The renewed acceptance of the HS-20110 clinical trial application by the CDE signifies that the domestic development pace of this highly promising CDH17-targeted ADC is accelerating.

With Roche’s support, HS-20110 is poised to accelerate toward global approval and patient access. For patients with gastrointestinal tumors, a potential first-in-class innovative therapy is steadily progressing from the laboratory to the clinic.