By Fineline Cube 
Sino Biopharmaceutical Limited (HKG: 1177) announced that its self‑developed LM‑350, a CDH17‑targeting Antibody‑Drug Conjugate (ADC), received clinical trial approval from China’s National Medical Products Administration (NMPA), advancing the first‑in‑class asset toward human studies.
Regulatory Milestone
| Item | Detail |
|---|---|
| Product | LM‑350 (CDH17‑targeting ADC) |
| Company | Sino Biopharmaceutical Limited (1177.HK) |
| Agency | NMPA (China) |
| Approval Type | Phase 1 clinical trial approval |
| Target | CDH17 (Cadherin‑17) |
| Indication | Advanced solid tumors (initial focus: colorectal cancer) |
| Platform | LaNova Medicines’ next‑generation LM‑ADC platform |
| Next Step | Initiate Phase 1 dose‑escalation trial H1 2026 |
Drug Profile
- Mechanism: High‑selectivity binding to CDH17 with strong internalization; delivers cytotoxic payload while retaining wild‑type IgG1 configuration and Antibody‑Dependent Cell‑Mediated Cytotoxicity (ADCC) activity for dual‑mode tumor killing
- Innovation: First‑in‑class CDH17‑targeting ADC globally; CDH17 is overexpressed in >90% of colorectal cancers and 70% of gastric cancers, with minimal normal tissue expression
- Differentiation: ADCC‑enhanced ADC may overcome resistance to conventional ADCs; preclinical data show strong efficacy in MMAE‑ and irinotecan‑resistant CRC xenograft models
- Pipeline: Sino Biopharm’s third ADC to enter clinic, strengthening its oncology‑focused biologics portfolio
Clinical Development Plan
| Parameter | Detail |
|---|---|
| Study Phase | Phase 1 (dose escalation & expansion) |
| Population | CDH17‑positive advanced solid tumors (CRC, gastric cancer) post‑standard therapy |
| Primary Endpoints | Safety, tolerability, MTD, RP2D |
| Secondary Endpoints | ORR, DCR, PFS, biomarker analysis (CDH17 expression levels) |
| Competitive Edge | First CDH17 ADC; unique ADCC capability may enable lower doses vs. traditional ADCs |
Market Impact & Outlook
- China CRC Market: ~550,000 new cases annually; CDH17 positivity in >90% creates addressable population of >500,000 patients .
- Gastric Cancer Add‑On: Additional 450,000 patients annually with 70% CDH17 expression expands total addressable market to >800,000 patients.
- No Approved CDH17 Therapies: Globally empty competitive landscape; closest rivals are CLDN18.2 ADCs (e.g., LaNova’s LM‑302) but CDH17 offers broader tumor coverage.
- Revenue Forecast: Analysts project ¥3.5‑4.5 billion (~US$480‑610 million) China peak sales potential by 2033 if Phase 1 data support advancement to pivotal trials.
- Partner Leverage: LaNova’s LM‑ADC platform provides validated linker‑payload technology, de‑risking manufacturing and accelerating timeline vs. de‑novo ADC development.
- Next Catalysts: Phase 1 first‑in‑human data expected Q4 2026; fast‑track designation likely given unmet need in refractory CRC.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding LM‑350’s clinical development, regulatory pathway, and market potential. Actual results may differ materially due to risks including clinical trial outcomes, safety profiles, and competitive dynamics in the ADC space.-Fineline Info & Tech