News
Focus on the early discovery and clinical development of bispecific antibody and ADC.
EGFR/cMET Bispecific ADC Program - ALK202 Received NMPA IND Approval and Completed First Patient Dosing
Release Time：2025-03-14 18:00:35 Article Source：AllinkBio
Highlights:
• Received IND clearance from NMPA for ALK202, a novel EGFR/cMET bispecific antibody-drug conjugate (ADC)
• Successfully dosed first patient in Phase 1 clinical trial in Australia
• Represents AllinkBio’s first bispecific ADC program to enter clinical development
China, Shanghai – Mar 14, 2025 - Allink Biotherapeutics (AllinkBio), a clinical-stage biotechnology company focus on developing innovative cancer and immunology therapies, has received Investigational New Drug (IND) clearance from China's National Medical Products Administration (NMPA) for ALK202, its proprietary EGFR/cMet bispecific antibody-drug conjugate. The U.S. Food and Drug Administration (FDA) have already cleared ALK202 IND application in December 2024, and the first patient has been successfully dosed in Australia. Concurrently, AllinkBio is advancing the Phase 1 trial across the United States, China and Australia, reinforcing the company's broader global development strategy for its clinical-stage programs.
EGFR and c-MET are expressed across various solid tumors and closely associated with tumor pathogenesis, progression, metastasis and drug resistance, with MET amplification recognized as a key mechanism of tumor cell resistance to EGFR inhibitors. ALK202, an innovatively designed EGFR/c-MET bispecific ADC, addresses resistance challenges associated with single-target therapies while enhancing antitumor efficacy. The molecule's optimized binding affinities effectively reduce target-related toxicities, offering an improved therapeutic index for patients.
"We are pleased to have achieved these important milestones for ALK202," said Dr. Hui Feng, Founder and CEO of AllinkBio."The IND approval and the initiation of our global clinical trial reflect the dedication of our team and the strength of our bispecific ADC platform. We are confident that ALK202 has the potential to become a valuable new treatment option for patients battling advanced malignancies."
The ongoing Phase 1, multi-center, open-label clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary anti-tumor activity of ALK202 in patients with advanced solid tumors that have progressed on standard therapies. The trial consists of a dose-escalation part followed by a dose-expansion part in selected patient populations.
AllinkBio will continue to uphold its innovation-driven development strategy, fully leveraging its proprietary technology in bispecific antibody and ADC platforms to accelerate the development of ALK202 and other pipeline products. The company remains committed to addressing global unmet medical needs and bringing patients with better and more accessible therapeutic solutions.
About ALK202
ALK202 is a proprietary EGFR/c-MET bispecific ADC, featuring common light chain technology to prevent light-heavy chain mispairing and incorporating a topoisomerase inhibitor payload, with this dual-targeting approach demonstrating broad-spectrum antitumor potential that may overcome resistance mechanisms while enabling precise patient stratification. Currently ALK202 is being evaluated in a global multicenter Phase I clinical trial to assess its efficacy and safety profile in advanced solid tumors.
About AllinkBio
Founded in 2023, AllinkBio is a clinical-stage biotechnology company leveraging its innovative proprietary platforms in bispecific antibodies and ADCs to develop a diverse pipeline of First-in-Class (FIC) and Best-in-Class (BIC) therapeutics. AllinkBio aims to develop treatment paradigm shifting new drugs for patients in the oncology and immunology disease areas and address critical unmet medical needs globally.
• Received IND clearance from NMPA for ALK202, a novel EGFR/cMET bispecific antibody-drug conjugate (ADC)
• Successfully dosed first patient in Phase 1 clinical trial in Australia
• Represents AllinkBio’s first bispecific ADC program to enter clinical development
China, Shanghai – Mar 14, 2025 - Allink Biotherapeutics (AllinkBio), a clinical-stage biotechnology company focus on developing innovative cancer and immunology therapies, has received Investigational New Drug (IND) clearance from China's National Medical Products Administration (NMPA) for ALK202, its proprietary EGFR/cMet bispecific antibody-drug conjugate. The U.S. Food and Drug Administration (FDA) have already cleared ALK202 IND application in December 2024, and the first patient has been successfully dosed in Australia. Concurrently, AllinkBio is advancing the Phase 1 trial across the United States, China and Australia, reinforcing the company's broader global development strategy for its clinical-stage programs.
EGFR and c-MET are expressed across various solid tumors and closely associated with tumor pathogenesis, progression, metastasis and drug resistance, with MET amplification recognized as a key mechanism of tumor cell resistance to EGFR inhibitors. ALK202, an innovatively designed EGFR/c-MET bispecific ADC, addresses resistance challenges associated with single-target therapies while enhancing antitumor efficacy. The molecule's optimized binding affinities effectively reduce target-related toxicities, offering an improved therapeutic index for patients.
"We are pleased to have achieved these important milestones for ALK202," said Dr. Hui Feng, Founder and CEO of AllinkBio."The IND approval and the initiation of our global clinical trial reflect the dedication of our team and the strength of our bispecific ADC platform. We are confident that ALK202 has the potential to become a valuable new treatment option for patients battling advanced malignancies."
The ongoing Phase 1, multi-center, open-label clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary anti-tumor activity of ALK202 in patients with advanced solid tumors that have progressed on standard therapies. The trial consists of a dose-escalation part followed by a dose-expansion part in selected patient populations.
AllinkBio will continue to uphold its innovation-driven development strategy, fully leveraging its proprietary technology in bispecific antibody and ADC platforms to accelerate the development of ALK202 and other pipeline products. The company remains committed to addressing global unmet medical needs and bringing patients with better and more accessible therapeutic solutions.
About ALK202
ALK202 is a proprietary EGFR/c-MET bispecific ADC, featuring common light chain technology to prevent light-heavy chain mispairing and incorporating a topoisomerase inhibitor payload, with this dual-targeting approach demonstrating broad-spectrum antitumor potential that may overcome resistance mechanisms while enabling precise patient stratification. Currently ALK202 is being evaluated in a global multicenter Phase I clinical trial to assess its efficacy and safety profile in advanced solid tumors.
About AllinkBio
Founded in 2023, AllinkBio is a clinical-stage biotechnology company leveraging its innovative proprietary platforms in bispecific antibodies and ADCs to develop a diverse pipeline of First-in-Class (FIC) and Best-in-Class (BIC) therapeutics. AllinkBio aims to develop treatment paradigm shifting new drugs for patients in the oncology and immunology disease areas and address critical unmet medical needs globally.
