As Yizhong Pharma’s CRO partner, Medicilon executed full-scope preclinical studies (PD, PK, Tox) for YXC -001 under GLP requirements supporting China-US dual filings. For YXC-002, Medicilon completed full CMC deliverables (API, DP) alongside its complete preclinical package(PD, PK, Tox). High-quality datasets and on-time project delivery underpinned the successful IND approvals.
Scientific Progress: Two Novel Candidates Address Unmet Oncology Needs
Discovery landscape is advancing toward refined, differentiated and original innovation. Multi modal fusion antibodies and next-generation targeted small molecules represent key strategies to overcome clinical drug resistance and improve patient outcomes.
YXC-001 targets advanced solid tumors while YXC-002 is developed for non-small-cell lung cancer (NSCLC). Powered by novel mechanisms and compelling preclinical activity, both candidates may expand therapeutic options for difficult-to-treat patient populations.
YXC-001: First-in-Class Tri-functional Antibody Fusion Protein for Advanced Solid Tumors
YXC-001 is a first-in-class tri-functional antibody fusion protein designed to resolve the long standing efficacy toxicity trade off in advanced solid tumor therapy via structural engineering and tumor targeted delivery, representing a shift from single target blockade toward multi mechanism, spatially controlled immunomodulation.YXC- 002: 4th-Generation High Brain-Penetrant EGFR-TKI for NSCLC with Drug Resistance and CNS Metastases
YXC-002 in tablet formulation is Yizhong Pharma’s proprietary Class 1 small-molecule EGFR-TKI. It covers canonical and non-canonical EGFR driver and resistance mutations in NSCLC and is intended for patients with central nervous system (CNS) metastases.Its unique structural design yields three core advantages
It confers activity against the C797S resistance mutation with high selectivity for mutant over wild type EGFR to minimize off target effects; it shows stronger anti tumor activity than BDTX 1535 (a Phase II stage 4th generation EGFR TKI), particularly against 19del sensitizing mutation and L858R T790M C797S triple mutation; and its molecular architecture enables robust blood brain barrier penetration.Medicilon’s One Stop Preclinical CRO Accelerates IND Progress
Medicilon deployed dedicated cross functional project teams for both programs, delivering end to end services covering CMC, PD, PK, Tox and regulatory support. Customized development strategies were implemented through close inter department collaboration.The Medicilon’s pharmacodynamics team built bespoke in-vivo models for trispecific antibodies and EGFR- resistant tumors to match the projects’ cutting-edge requirements. Medicilon maintains a portfolio of more than 800 oncology pharmacology models, enabling comprehensive evaluation of small-molecule agents, monoclonal/bispecific antibodies, ADC/AOC modalities and CAR-T/CAR- NK cell therapeutics.
The Medicilon’s toxicology group tailored preclinical strategies according to each molecule’s structure and mechanism‑of‑action to generate robust safety data. The regulatory team provided full‑cycle support including dossier preparation, regulatory submission and CDE query responses, removing roadblocks throughout the IND review process.
Medicilon congratulates Yizhong Pharma on the clinical approval of YXC‑001 and YXC‑002. We look forward to positive clinical outcomes that will benefit patients. Moving forward, Medicilon will continue to enhance its integrated platform. With robust technical capabilities, reliable delivery and rigorous compliance frameworks, we will support more original‑innovation programs and accelerate the translation of novel drug concepts into clinical candidates.
