SIM0613 / Ipsen, Simcere - LARVOL DELTA

SIM0613-101: SIM0613 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=294 | Recruiting | Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

First-in-human • New P1 trial • Oncology • Solid Tumor

SIMCERE PHARMA…announced that its self-developed LRRC15-targeting antibody-drug conjugate, SIM0613 for injection, has received a Clinical Trial Approval Notice issued by the National Medical Products Administration of China (iis.aastocks.com) - "The drug is planned to commence clinical trials for advanced solid tumors."

New trial • Solid Tumor

Ipsen…announced today an exclusive licensing agreement for global rights outside of Greater China, for SIM0613, an antibody-drug conjugate (ADC) with best-in-class potential. (GlobeNewswire) - "Program expected to enter Phase I clinical development in H2 2026....Under the terms of the agreement, Simcere Zaiming is eligible to receive up to $1.06B comprising upfront, development, regulatory and commercial milestone payments, and tiered royalties on sales, contingent upon successful development and regulatory approvals. Ipsen will have manufacturing rights, following the tech transfer process and will assume responsibility for all activities outside Greater China including Phase I preparation activities and submission of the Investigational New Drug and Clinical Trial applications."

Licensing / partnership • New P1 trial • Solid Tumor