GlycoNex's pipeline currently comprises five programs across two therapeutic modalities. The lead asset, GNX1021, is a glycan-targeted antibody-drug conjugate (ADC) cleared by Japan's PMDA in April 2026 for Phase 1 trials in gastrointestinal cancers. Two preclinical ADC programs extend this approach into pro-antibody (GNX201-ADC, co-developed with Nippon Kayaku) and bispecific (GNX203) formats. Two biosimilar programs — SPD8 (anti-RANKL, Phase 3 complete) and SSR (a biosimilar for an autoimmune disease, preclinical) — extend GlycoNex's biosimilar capabilities across two therapeutic areas.
PIPELINE OVERVIEW · TWO:4168 · UPDATED MAY 2026
Five programs across ADCs and biosimilars
From a clinical-stage glycan-targeted ADC to preclinical bispecific design, GlycoNex's pipeline spans glycan-directed ADCs and biosimilars, grounded in twenty years of glycobiology.
Programs
5
across two modalities
Clinical Stage
2
GNX1021 Phase 1 · SPD8 Phase 3
Preclinical / Optimization
3
GNX201-ADC · GNX203 · SSR
Lead Asset
GNX1021
Japan PMDA cleared
01 — Overview
How the pipeline is organized
02 — Programs
Five programs in development
GNX1021
Anti-Glycan ADC
Gastrointestinal cancers — gastric, colorectal, pancreatic
Japan first patient · Jun 2026
GNX201-ADC
Pro-Antibody ADC
Solid tumors — target withheld under partnership
IND target · 2028 · with Nippon Kayaku
Coming soon
GNX203
Bispecific ADC
Pancreatic, colorectal, and gynecologic cancers
Patent prosecution & preclinical advancement
Coming soon
Biosimilar Franchise
SPD8
Single drug substance · SPD8-R via PMDA data extrapolation
Biosimilar — anti-RANKL
Osteoporosis (SPD8-P) · cancer-related skeletal events (SPD8-R)
Topline data · Q2 2026
03 — Strategy
Glycan-directed ADCs and biosimilars
Glycan-Directed ADCs · Three Programs
Three glycan-targeted ADC programs across distinct designs
GlycoNex's three glycan-directed ADC programs share the GlycoSH antibody library: clinical-stage GNX1021 (Phase 1, Japan PMDA cleared April 2026), and preclinical GNX201-ADC and GNX203. GNX1021 targets branched Lewis B/Y (bLeB/Y), a tumor-associated glycan overexpressed in gastrointestinal cancers. GNX201-ADC, co-developed with Nippon Kayaku since March 2026, applies pro-antibody activation chemistry to a separate glycan target. GNX203 extends the approach further into bispecific ADC design, combining glycan and protein tumor antigen targeting.
Biosimilars · Two Programs
Biosimilar capability now extending beyond Japan
SPD8 is GlycoNex's denosumab biosimilar candidate, co-developed with Mitsubishi Gas Chemical since 2018 and now Phase 3 complete in Japan, with topline data expected Q2 2026. Japan commercial rights have been out-licensed; ex-Japan rights remain available for partnership. SSR — initiated February 2026 and developed in-house — is a biosimilar for an autoimmune disease, extending GlycoNex's biosimilar capability into a second therapeutic area.
Discuss any program in our pipeline
GlycoNex welcomes inquiries on out-licensing, regional licensing, co-development, and CDMO collaborations across the pipeline. For asset-specific deal structures, see the relevant program detail page or contact our business development team directly.