NextCure Expands ADC Portfolio with $745M Deal for Simcere's Phase 1 Drug

NextCure, a biotechnology company focusing on novel cancer immunotherapies, has significantly bolstered its antibody-drug conjugate (ADC) pipeline through a $745 million licensing agreement with Chinese pharmaceutical firm Simcere Zaiming. The deal grants NextCure ex-China rights to SIM0505, a phase 1-stage tumor asset targeting CDH6.

Strategic Pivot to ADC Technology

This latest move underscores NextCure's strategic shift towards ADC development, following the company's decision in November 2024 to prioritize its preclinical B7-H4 ADC program. The acquisition of SIM0505 rights further solidifies NextCure's position in the competitive ADC space, challenging larger pharmaceutical companies in this rapidly evolving field.

Michael Richman, CEO of NextCure, expressed optimism about the deal, stating, "We believe SIM0505 has the potential to be an important new therapy for cancer patients. Partnering with Simcere Zaiming, a leader in antibody-drug conjugates, provides us with an opportunity to advance a class-leading ADC directed to CDH6."

SIM0505: A Promising CDH6-Targeted ADC

SIM0505 combines a CDH6-targeting antibody with a topoisomerase 1 inhibitor (TOPOi) payload, aiming to deliver "broad anti-tumor activity while offering high systemic clearance to enlarge the therapeutic window," according to NextCure. The company plans to initiate its own clinical trial for SIM0505 in the United States during the third quarter of this year, building upon the ongoing early-stage trial in China.

The licensing agreement includes up to $745 million in upfront fees, development, regulatory, and sales milestones, along with tiered royalties on potential future sales outside Greater China. Additionally, NextCure gains access to Simcere's proprietary linker and TOPOi payload technology for developing its own preclinical ADC against an undisclosed target, with Simcere retaining Greater China rights for this asset.

Simcere's Growing Industry Influence

This deal marks another significant partnership for Simcere, following a $1 billion biobucks agreement with AbbVie earlier this year for a phase 1-stage trispecific antibody. Simcere has established itself as a key player in the Chinese pharmaceutical market, with several marketed oncology drugs, including the FDA-approved Cosela for mitigating chemotherapy side effects and Enweida for biliary tract cancer treatment.

The collaboration between NextCure and Simcere highlights the increasing importance of international partnerships in drug development, particularly in the rapidly advancing field of antibody-drug conjugates. As both companies continue to expand their oncology portfolios, the pharmaceutical industry eagerly anticipates the potential impact of these novel therapies on cancer treatment paradigms.