San Francisco, USA and Suzhou, ChinaJune 4, 2026 /PRNewswire/ — Innovent Biologics, Inc. (HKEX: 01801), a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative drugs for major diseases such as oncology, autoimmune, metabolic, and ophthalmology, announced that the international Phase III clinical study (G-HOPE-001, NCT06238843) of IBI343 (a CLDN18.2 ADC with a topoisomerase I inhibitor payload, Takeda development code: TAK-921) for advanced gastric cancer has completed the first interim analysis per the pre-specified protocol, meeting the primary endpoint. IBI343 has demonstrated excellent efficacy, a favorable safety profile, and good tolerability in the treatment of advanced gastric cancer. Based on these positive Phase III results, Innovent has taken the lead in submitting a New Drug Application (NDA) for IBI343 to China’s National Medical Products Administration (NMPA). The application has been accepted and granted priority review for the treatment of locally advanced unresectable or metastatic CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma in patients who have received at least two prior systemic therapies. IBI343 is the first CLDN18.2-targeted ADC to receive regulatory review acceptance globally.
IBI343 is a biomarker-driven, CLDN18.2-targeting antibody-drug conjugate (ADC) developed as a precision therapy for the treatment of various CLDN18.2-positive tumors. The drug utilizes a cleavable linker to selectively deliver a highly active exatecan payload (a topoisomerase I inhibitor) to tumor cells. It also incorporates an Fc-silent design to minimize off-target toxicity.
The G-HOPE-001 study is an international, multi-center, randomized, open-label Phase III clinical trial conducted in China and Japan. It is designed to evaluate the efficacy and safety of IBI343 monotherapy compared to the investigator’s choice of treatment in subjects with locally advanced unresectable or metastatic CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma who have received at least two prior systemic therapies. The primary endpoints of the study are progression-free survival (PFS) and overall survival (OS). Data from this clinical study are planned to be presented at future academic conferences or published in journals.
Professor Lin Shen, Director of the Department of Gastrointestinal Oncology at Peking University Cancer Hospital, stated: “We are delighted to see that the pivotal Phase III clinical study of IBI343 has been successfully conducted in the Asia-Pacific region and has met its primary endpoint. This represents a significant breakthrough in targeted precision therapy for gastrointestinal tumors. With its excellent efficacy and manageable safety profile, this product is expected to offer a new standard treatment option for patients with advanced gastrointestinal cancers, further enriching the current treatment landscape and addressing unmet clinical needs. Concurrently, the formal acceptance of the IBI343 NDA by the NMPA, along with the accelerated pace of its development and launch, will also drive the upgrade of precision diagnosis and treatment systems for gastrointestinal tumors in China, optimize the comprehensive management plan for advanced patients, bring benefits of longer survival and higher quality of life to patients, and help elevate the overall level of standardized diagnosis and treatment for gastrointestinal tumors in China.”
Professor Kohei Shitara from the National Cancer Center Hospital East in Japan stated: “IBI343 is a next-generation ADC targeting CLDN18.2. Based on clinical study data, the drug demonstrates a good overall safety profile and tolerability, with a low incidence of gastrointestinal-related toxicities. Furthermore, it has shown promising and encouraging anti-tumor efficacy in patients with CLDN18.2 medium-to-high expressing gastric cancer/gastroesophageal junction adenocarcinoma. The G-HOPE-001 study successfully completed its first interim analysis according to the pre-specified protocol and achieved its pre-defined primary endpoint, laying a solid foundation for subsequent clinical application.”
Dr. Hui Zhou, Chief Medical Officer (Oncology) at Innovent Biologics, stated: “Patients with gastric cancer who have undergone prior lines of therapy often have a poor prognosis, are prone to disease progression, and lack effective later-line treatment options, with an expected survival of approximately six months, representing a significant unmet clinical need. We are very pleased that the international multi-center Phase III study of IBI343 has successfully met its primary endpoint and has been accepted for regulatory review by the NMPA. We look forward to this innovative therapy providing a more ideal treatment choice for advanced gastric cancer patients in China.”
About Gastric/Gastroesophageal Junction Adenocarcinoma
Gastric cancer is one of the most common malignant tumors worldwide and a leading cause of cancer-related death globally. The 5-year survival rate for patients with metastatic gastric cancer is less than 5%[1]. China and Japan are regions with a high incidence of gastric cancer[2]. Currently, chemotherapy combining fluoropyrimidine and platinum, along with immune checkpoint inhibitor therapy, constitutes the standard treatment for patients with advanced metastatic gastric cancer. The efficacy of systemic therapy for advanced gastric cancer is limited, especially for patients in the third-line setting or beyond, who typically have a poor prognosis, limited treatment options, and a short expected survival, with a median overall survival of about six months[3].
CLDN18.2 is a tight junction protein specifically expressed in normal gastric mucosa and aberrantly highly expressed (positive rate of approximately 80%) in gastric cancer and gastroesophageal junction adenocarcinoma. It is considered a highly promising star target in the field of precision therapy for gastric cancer.
About IBI343
IBI343 is a biomarker-driven, CLDN18.2-targeting antibody-drug conjugate (ADC) developed as a precision therapy for the treatment of various CLDN18.2-positive tumors. The drug utilizes a cleavable linker to selectively deliver a highly active exatecan payload (a topoisomerase I inhibitor) to tumor cells. It also incorporates an Fc-silent design to minimize off-target toxicity. This drug is the first CLDN18.2-targeted ADC to submit a regulatory review application globally.
IBI343 is currently under review by China’s National Medical Products Administration (NMPA) and is undergoing clinical studies for various indications in gastric cancer and pancreatic cancer, as follows:
- Based on the positive results from the first interim analysis of the international multi-center Phase III study G-HOPE-001, an NDA has been submitted to China’s NMPA for the treatment of locally advanced unresectable or metastatic CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma in patients who have received prior systemic therapy. This application is currently under priority review;
- IBI343 is undergoing a Phase III clinical study in China for patients with CLDN18.2-positive advanced pancreatic cancer;
- IBI343 is also being explored in Phase I clinical studies for the first-line treatment of patients with gastric cancer and pancreatic cancer.
About Innovent Biologics
“Start with Integrity, Succeed through Action” – Innovent’s mission and goal is to develop high-quality biologics that are affordable for the people. Founded in 2011, Innovent is dedicated to researching, developing, manufacturing, and commercializing innovative drugs for major diseases such as oncology, autoimmune, metabolic, and ophthalmology, allowing our work to benefit more lives. The company has 18 approved products on the market: sintilimab injection (Tyvyt®), bevacizumab injection (Byvasda®), adalimumab injection (Sulinno®), rituximab injection (Dabohua®), pemigatinib tablets (Pemazyre®), olverembatinib tablets (Nerlynx®), ramucirumab injection (Cyramza®), selpercatinib capsules (Retevmo®), equecabtagene autoleucel injection (Fucaso®), tafolecimab injection (Sintbilo®), fulzerasib tablets (Dabote®), pirtobrutinib tablets (Jaypirca®), taletrectinib adipate capsules (Dabole®), limertinib tablets (Aoyixin®), tebotelimab N01 injection (Sintbimin®), mazdutide injection (Xinerme®), picankibart injection (Xinmeiyue®), and ipilimumab N01 injection (Daboxin®). Currently, one product is under NMPA review, four new drug molecules have entered Phase III or pivotal clinical studies, and 14 new drug candidates have entered clinical research.
The company has entered into over 30 strategic collaborations with international partners such as Eli Lilly, Roche, Takeda, Pfizer, Sanofi, Incyte, and MD Anderson Cancer Center. While continuously innovating and developing its own drugs and pursuing growth, Innovent adheres to a people-centered development philosophy in economic construction. Over the years, it has always been guided by scientific goodwill, adhered to a “patient-centered” approach, cared for patients and their families, and actively fulfilled its social responsibilities. The company has initiated and participated in multiple drug assistance programs, enabling more and more patients to benefit from advances in life sciences and to afford and access high-quality biologics. To date, Innovent’s patient assistance programs have benefited over 200,000 ordinary patients, with the total value of donated drugs reaching RMB 4 billion. Innovent hopes to work together with everyone to improve the development level of China’s biopharmaceutical industry, in order to meet the people’s need for accessible medicines and their aspirations for a healthy life.
For more information, please visit the company’s website: www.innoventbio.com or the company’s LinkedIn account: www.linkedin.com/
Disclaimer:
1. Innovent does not recommend the use of unapproved drugs/indications.
2. Ramucirumab injection (Cyramza®), selpercatinib capsules (Retevmo®), and pirtobrutinib tablets (Jaypirca®) were developed by Eli Lilly.
Forward-Looking Statements
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References
- Xu B, Wang JM. Epidemiological study of gastric cancer[J]. Chin J Cancer Prev Treat, 2006,13(1): 81-87.