On July 29, 2026 Shanghai Allink Biotherapeutics Co., Ltd. ("AllinkBio") ,a clinical-stage biotechnology company focused on developing differentiated antibody-drug conjugates (ADCs) and multispecific antibody therapies, reported that it has entered into a clinical trial collaboration agreement with Akeso, Inc. (9926.HK) ("Akeso") .
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Under the terms of the agreement, AllinkBio will perform a multi-center, open-label Phase II clinical study evaluating the efficacy and safety of ALK201, a first-in-class/best-in-class FGFR2b-targeted ADC, in combination with Akeso’s PD-1/VEGF bispecific antibody, ivonescimab. The study is designed to assess the potential benefits of this combinatory approach as a first-line treatment for patients with locally advanced or metastatic SqNSCLC.
The IND application for this combination study was recently approved by the NMPA in China. AllinkBio will be fully responsible for the advancement and execution of the clinical study, while Akeso will supply the ivonescimab required for the trial.
Dr. Hui Feng, Founder and Chief Executive Officer at AllinkBio stated
"We are very pleased to partner with Akeso on this clinical collaboration, which received rapid IND clearance from China’s NMPA – a testament to the strong execution of both teams and the clear clinical rationale of this combination.Discovered and developed in-house on our proprietary ADC platform, ALK201 is a first-in-class FGFR2b-targeting ADC that has demonstrated precise and potent tumor cell killing with a favorable therapeutic window in preclinical studies. Ivonescimab, the world’s first PD-1/VEGF bispecific antibody, has redefined first-line NSCLC treatment with positive head-to-head Phase III results. Together, the deep, durable responses of IO 2.0 and the targeted cytotoxicity of ADCs offer the potential to break through the current efficacy ceiling in biomarker-positive squamous NSCLC.
This collaboration marks an important milestone for ALK201 and a strong validation of our platform-driven strategy. We look forward to working closely with Akeso to bring a superior first-line option to patients worldwide.
"We are delighted to see that ivonescimab, in collaboration with Allink Bio’s innovative FGFR2b-targeting ADC, is advancing combination therapy exploration for first-line lung cancer treatment. This represents yet another important validation of ivonescimab’s global value as a cornerstone drug in the Immuno-Oncology 2.0 (IO2.0) era," stated Dr. Xia Yu, Founder, Chairwoman, President, and CEO of Akeso. "Ivonescimab is the world’s first PD-1/VEGF bispecific antibody. Across multiple Phase III studies, it has demonstrated significant clinical breakthrough value over PD-1-based therapies, supported by robust evidence-based data. In the NSCLC field, ivonescimab has achieved multiple positive Phase III results, including head-to-head superiority versus pembrolizumab monotherapy in PD-L1-positive NSCLC and head-to-head superiority versus PD-1 inhibitor plus chemotherapy in first-line squamous NSCLC, redefining the gold standard of first-line treatment for NSCLC. Today, ivonescimab serves as the cornerstone of Akeso’s IO2.0 + ADC2.0 strategy. It is powering a series of high-potential, differentiated combination therapies that continue to drive the upgrade and evolution of global treatment paradigms for major malignancies, including lung cancer and breast cancer. This includes extensive combination explorations with our in-house next-generation ADCs and bispecific ADCs, as well as partnerships with numerous global high-potential ADC assets. We look forward to the ivonescimab plus ALK201 regimen delivering more efficacious and safer next-generation treatment options for patients worldwide."
About ALK201
ALK201 is an innovative, in-house developed ADC targeting FGFR2b. It is designed to exploit multiple synergistic anti-tumor mechanisms, including specific payload delivery, the bystander effect, ligand blockade, and antibody-dependent cellular cytotoxicity (ADCC), effectively countering FGFR2b overexpression associated with poor clinical prognoses. Based on the positive efficacy and favorable safety profile demonstrated in early-stage studies, ALK201’s therapeutic potential is actively being expanded from gastric cancer to a broader range of solid tumors. A clinical study (NCT06656390) evaluating ALK201 in patients with FGFR2b-overexpressing advanced solid tumors is currently underway.
About Ivonescimab
Ivonescimab is Akeso’s first-in-class PD-1/VEGF bispecific antibody. By simultaneously targeting PD-1 and VEGF, ivonescimab exerts synergistic anti-tumor effects and effectively addresses multiple clinical challenges that single-target therapies cannot overcome. In multiple Phase III trials, ivonescimab has demonstrated significant clinical advantages over PD-1 monotherapy, PD-1 plus chemotherapy, and anti-VEGF therapies. Notably, the HARMONi-A study is the first Phase III trial to achieve statistically significant and clinically meaningful improvements in both overall survival (OS) and progression-free survival (PFS) in patients with EGFR-TKI progressed non-squamous NSCLC. Ivonescimab is also the first innovative drug to outperform a blockbuster therapy in a head-to-head Phase III trial. As monotherapy in PD-L1-positive NSCLC, it extended median PFS beyond 11 months and reduced the risk of disease progression or death by 49% compared with PD-1 inhibitors. In the HARMONi-6 study, ivonescimab plus chemotherapy demonstrated statistically significant and clinically meaningful improvements in both PFS and OS compared with PD-1 inhibitor plus chemotherapy, redefining the first-line treatment standard for squamous NSCLC.
Ivonescimab is currently being evaluated in dozens of clinical trials, including 15 ongoing Phase III studies, many of which are international multicenter trials. Two NSCLC indications for ivonescimab have been included in China’s National Reimbursement Drug List (NRDL).
(Press release, Shanghai Allink Biotherapeutics, JUL 29, 2026, View Source [SID1234670858])