Konruns Pharmaceutical Co., Ltd. (SHA: 603590) announced first patient dosing in the Phase 2 KC1036‑COM‑01 study, evaluating KC1036 tablets in combination with a PD‑1 antibody and platinum‑based chemotherapy for first‑line treatment of advanced recurrent or metastatic esophageal squamous cell carcinoma (ESCC). KC1036 is a Category 1 innovative drug targeting VEGFR2 and AXL, with ongoing studies in digestive system tumors, thymic tumors, and pediatric Ewing’s sarcoma.
Advanced recurrent or metastatic esophageal squamous cell carcinoma (first‑line)
Primary Endpoint
Objective Response Rate (ORR) and progression‑free survival (PFS)
Drug Class
Category 1 innovative chemical drug (VEGFR2/AXL inhibitor)
Additional Indications
Digestive system tumors, thymic tumors, pediatric Ewing’s sarcoma (all in clinical studies)
Drug Profile & Differentiation
Attribute
KC1036
Mechanism
Multi‑target inhibition (VEGFR2, AXL) with anti‑angiogenic and anti‑tumor activity
Innovation
Category 1 innovative drug independently developed by Konruns
Clinical Data
Demonstrated outstanding anti‑tumor activity and favorable safety/tolerability in existing studies
Route
Oral tablets (patient‑convenient)
Market Position
First VEGFR2/AXL inhibitor in China entering Phase 2 for ESCC
Market Opportunity & Competitive Landscape
Metric
Value
Implication
China ESCC Incidence
~300,000 new cases annually (2024)
90% are squamous cell subtype; high recurrence rate
Advanced ESCC Market
¥12‑15 billion (≈ US$1.7‑2.1 B)
Dominated by PD‑1/PD‑L1 inhibitors + chemotherapy
KC1036 Peak Sales
¥800 million‑1.2 billion (≈ US$112‑170 M)
10‑15% share if approved in first‑line ESCC
Competitive Advantage
VEGFR2/AXL inhibition may overcome resistance to PD‑1 monotherapy
Synergistic with immunotherapy backbone
Pipeline Expansion
Thymic tumors and Ewing’s sarcoma represent niche but high‑value indications
Additional revenue streams if approved
Strategic Implications
For Konruns:First patient dosed marks Phase 2 initiation for lead asset; validates multi‑target platform in solid tumors; combination strategy aligns with SOC shift toward IO+chemo+targeted therapy.
For Patients:Oral tablet improves convenience vs. IV regimens; VEGFR2/AXL inhibition may benefit PD‑1 refractory patients; addresses unmet need in recurrent/metastatic ESCC.
For Investors:Category 1 status ensures market exclusivity; multi‑indication pipeline reduces risk; potential for global out‑licensing if Phase 2 data is positive (readout expected H2 2026).
Forward‑Looking Statements This brief contains forward‑looking statements regarding KC1036’s Phase 2 enrollment timeline, market penetration, and pipeline advancement. Actual results may differ due to clinical risks, regulatory feedback, or competitive responses.-Fineline Info & Tech
By Fineline Cube 