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AllinkBio’s ALK201 Granted Orphan Drug Designation in Gastric Cancer by the US FDA
Release Time：2026-04-30 10:52:36 Article Source：
Shanghai, China – April 30th, 2026 – Allink Biotherapeutics, Inc. (AllinkBio), a clinical-stage biotechnology company focusing on developing advanced antibody-drug conjugates (ADCs) and multi-specific antibody therapeutics for oncology and immunology, today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to ALK201, an ADC targeting the fibroblast growth factor receptor-2b (FGFR2b), for gastric cancer.
The FDA’s ODD program is designed for investigational therapies addressing rare medical diseases or conditions in patient populations under 200,000. Investigational drugs approved for ODD are eligible for tax credits, marketing exclusivity, fee waivers, and other benefits. This ODD approval for ALK201 is a monumental step in cancer treatment innovation, and ALK201 can potentially offer gastric cancer patients better treatment options.
About Gastric Cancer
Gastric cancer usually begins in the stomach’s inner lining and further develops into the stomach walls. According to GLOBOCAN 2022, gastric cancer is the fifth most common type of cancer in the world, affecting 968,784 patients and leading to 660,175 deaths in 2022 alone. Asia in particular has an extremely high incidence of gastric cancer, reporting 49.2% of all gastric cancer cases and 56.1% of gastric cancer-related deaths in 2022.
In the US, incidence and mortality rates are much lower, with the NIH estimating 31,510 new cases and 10,740 deaths in 2026. However, from 2016 to 2022, the 5-year relative survival rate for patients in the US was 39.8%. Furthermore, 35% of all gastric cancers were metastatic, with a 5-year survival rate of only 8.1%. These numbers reveal a significant unmet need in the gastric cancer treatment landscape worldwide.
About ALK201
AllinkBio’s ALK201 is a FGFR2b targeted ADC, a key mediator of tumor growth and a vital prognostic biomarker in gastric and other epithelial-derived cancers. While FGFR2b supports normal cellular function, its pathological overexpression is frequently associated with aggressive tumor behavior.
In both preclinical and clinical settings, ALK201 has showcased encouraging anti-tumor activity and a favorable safety window, supporting its clinical advancement. Based on its compelling clinical potential, ALK201's therapeutic reach extends beyond gastric cancer to a broad spectrum of malignancies. It is poised to become a foundational backbone therapy for FGFR2b-overexpressing solid tumors, with the potential to redefine the current standard of care.
ALK201 is currently in a first-in-human (FIH), open-label, multicenter dose escalation and expansion phase I/II study (NCT06656390). Using ALK201 as a monotherapy to treat advanced solid tumors, this study further evaluates its safety, tolerability, pharmacokinetics, and antitumor activity.
"The FDA's Orphan Drug Designation for ALK201 is a pivotal regulatory milestone, reflecting the scientific merit and clinical potential of this pipeline," said Dr. Hui Feng, Founder and CEO of AllinkBio. "This designation will accelerate the global development of ALK201 to address the urgent unmet needs in gastric cancer, while enhancing its profile as a high-value global asset for international collaboration."
About AllinkBio
Founded in 2023, AllinkBio is a clinical-stage biotechnology company dedicated to the discovery and development of differentiated ADCs and multi-specific antibodies for oncology and immunology. Leveraging a synergy of innovative platform capabilities and exceptional R&D efficiency, the company has rapidly advanced two ADC candidates, ALK201 and ALK202, into global Phase I/II clinical trials. AllinkBio is committed to advancing ADC and multi-specific antibody innovation to transform lives for patients in need worldwide.
The FDA’s ODD program is designed for investigational therapies addressing rare medical diseases or conditions in patient populations under 200,000. Investigational drugs approved for ODD are eligible for tax credits, marketing exclusivity, fee waivers, and other benefits. This ODD approval for ALK201 is a monumental step in cancer treatment innovation, and ALK201 can potentially offer gastric cancer patients better treatment options.
About Gastric Cancer
Gastric cancer usually begins in the stomach’s inner lining and further develops into the stomach walls. According to GLOBOCAN 2022, gastric cancer is the fifth most common type of cancer in the world, affecting 968,784 patients and leading to 660,175 deaths in 2022 alone. Asia in particular has an extremely high incidence of gastric cancer, reporting 49.2% of all gastric cancer cases and 56.1% of gastric cancer-related deaths in 2022.
In the US, incidence and mortality rates are much lower, with the NIH estimating 31,510 new cases and 10,740 deaths in 2026. However, from 2016 to 2022, the 5-year relative survival rate for patients in the US was 39.8%. Furthermore, 35% of all gastric cancers were metastatic, with a 5-year survival rate of only 8.1%. These numbers reveal a significant unmet need in the gastric cancer treatment landscape worldwide.
About ALK201
AllinkBio’s ALK201 is a FGFR2b targeted ADC, a key mediator of tumor growth and a vital prognostic biomarker in gastric and other epithelial-derived cancers. While FGFR2b supports normal cellular function, its pathological overexpression is frequently associated with aggressive tumor behavior.
In both preclinical and clinical settings, ALK201 has showcased encouraging anti-tumor activity and a favorable safety window, supporting its clinical advancement. Based on its compelling clinical potential, ALK201's therapeutic reach extends beyond gastric cancer to a broad spectrum of malignancies. It is poised to become a foundational backbone therapy for FGFR2b-overexpressing solid tumors, with the potential to redefine the current standard of care.
ALK201 is currently in a first-in-human (FIH), open-label, multicenter dose escalation and expansion phase I/II study (NCT06656390). Using ALK201 as a monotherapy to treat advanced solid tumors, this study further evaluates its safety, tolerability, pharmacokinetics, and antitumor activity.
"The FDA's Orphan Drug Designation for ALK201 is a pivotal regulatory milestone, reflecting the scientific merit and clinical potential of this pipeline," said Dr. Hui Feng, Founder and CEO of AllinkBio. "This designation will accelerate the global development of ALK201 to address the urgent unmet needs in gastric cancer, while enhancing its profile as a high-value global asset for international collaboration."
About AllinkBio
Founded in 2023, AllinkBio is a clinical-stage biotechnology company dedicated to the discovery and development of differentiated ADCs and multi-specific antibodies for oncology and immunology. Leveraging a synergy of innovative platform capabilities and exceptional R&D efficiency, the company has rapidly advanced two ADC candidates, ALK201 and ALK202, into global Phase I/II clinical trials. AllinkBio is committed to advancing ADC and multi-specific antibody innovation to transform lives for patients in need worldwide.
