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Innovent declares Phase 3 success for gastric cancer ADC that attracted huge Takeda deal

on June 05, 2026

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Innovent Biologics has achieved a Phase III success with its gastric cancer antibody–drug conjugate (ADC), arcotatug tavatecan (IBI343/TAK-921), setting the stage for a potential third‑line approval in China.

The international Phase III G‑HOPE‑001 trial met its primary endpoint of progression‑free survival (PFS) in patients with CLDN18.2‑positive advanced gastric or gastroesophageal junction adenocarcinoma who had received at least two prior systemic therapies.

Based on these positive results, Innovent has submitted a New Drug Application to China’s NMPA, which has been accepted with priority review, making arcotatug tavatecan the first CLDN18.2‑targeted ADC to enter regulatory review globally.

Arcotatug tavatecan is the same gastric cancer ADC that underpinned Takeda’s 2025 strategic oncology partnership with Innovent, a deal valued at up to $11.4 billion; Takeda holds global rights (outside China) to the molecule and is developing it as TAK‑921.

Sources:

Innovent eyes third-line nod for gastric cancer ADC on Phase III PFS ...

Innovent Biologics Announces Global Strategic Partnership with ...

Nature Medicine Published Phase 1 Results of Innovent Biologics ...

Oncology Pipeline | Takeda Cancer Drug Development

Nature Medicine Published Phase 1 Results of Innovent Biologics ...

Gastric cancer drug pipeline: HER2 ADC & Claudin 18.2 | PatSnap

Takeda signs deal worth up to $11.4bn with Innovent for cancer drug ...

Innovent Announces Oral Presentation at the ESMO Gastrointestinal Cancers Congress 2024 on Latest Clinical Data of Anti-CLDN18.2 ADC (IBI343) in Patients with Advanced Gastric/Gastroesophageal Junction Adenocarcinoma USA - English APAC - Traditional Chinese APAC

Takeda Announces Oncology Partnership with Innovent

World's First CLDN18.2 ADC for Regulatory Review: Innovent Biologics Announces IBI343 (arcotatug tavatecan) Met Primary Endpoint in International Phase 3 Study in Advanced Refractory Gastric Cancer an

Antibody-drug conjugates: the clinical development in gastric cancer

Takeda R&D Exec Explains How $1.2B Deal Could Become One of ...

Innovent Biologics Announces Global Strategic Partnership with ...

Innovent Biologics Announces IBI343 (arcotatug tavatecan) Met ...

INNOVENT BIO (01801.HK) IBI343 NDA for Advanced Gastric Cancer Accepted by NMPA

arcotatug Claudin-18 Isoform A2 IBI343 Innovent Biologics N-methyl-N-2-(methylsulfinyl)ethylpropionic acid amide NMPA TAK-921 Takeda tavatecan therapeutic autologous dendritic cells

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