World’s First Bispecific ADC Approved, Ushering in Commercialization Era for Innovative Drugs

Biokin has officially inaugurated its commercialization cycle for self-developed first-in-class innovative drugs, with the world’s first bispecific ADC marking a historic milestone in global targeted therapy. In June 2026, the company’s EGFR/HER3 bispecific ADC, Izabren (BL-B01D1), received NMPA approval for treating recurrent or metastatic nasopharyngeal carcinoma in patients who failed at least two lines of systemic chemotherapy and prior PD-1/PD-L1 inhibitor therapy. The approval establishes Izabren as the world’s first and only commercially authorized bispecific ADC product, breaking global technological and therapeutic barriers.

Backed by robust global clinical evidence, Biokin has launched an extensive multi-center clinical development program for Izabren. The drug has completed 12 Phase III clinical trials across China and 2 Phase II/III studies in the United States, including an independently sponsored global Phase III trial for non-small cell lung cancer (NSCLC). Domestically, NMPA’s Center for Drug Evaluation (CDE) has formally accepted two new drug applications for esophageal squamous cell carcinoma and triple-negative breast cancer indications, paving the way for multi-territory label expansion and rapid revenue monetization.

Frontline Combination Regimen Poised to Reshape Lung Cancer Treatment Landscape

Biokin is actively advancing a novel first-line combination strategy targeting squamous NSCLC, launching the Phase II/III PANKU-Lung05 trial. The study evaluates Izabren combined with AK112, a dual PD-1/VEGF bispecific antibody, in patients with locally advanced or metastatic squamous NSCLC. Enrolling 200 participants, the trial sets ORR and PFS as primary endpoints and adopts AK112 plus carboplatin and paclitaxel as the control arm.

Existing clinical data validates the potent efficacy of AK112-based regimens, demonstrating a 75.9% ORR, 11.14-month mPFS and 27.89-month median OS in frontline squamous NSCLC treatment. The incorporation of Izabren’s dual-target ADC mechanism is expected to further amplify anti-tumor potency, prolong patient survival and redefine the standard-of-care treatment paradigm for high-burden squamous lung cancer.

Robust Pipeline Progresses Across ADC and Bispecific Platforms

Beyond its flagship EGFR/HER3 bispecific ADC, Biokin maintains a high-efficiency iterative pipeline with multiple best-in-class and first-in-class candidates advancing rapidly. T-Bren, a HER2 ADC with broad best-in-class potential, has completed eight Phase III clinical trials, demonstrating superior efficacy and safety profiles for multiple HER2-expressing solid tumors.

The Claudin 18.2 ADC candidate BL-M05D1 has entered Phase III clinical development for first-line gastric cancer, with parallel Phase I trials ongoing in the U.S. to support global registration. The company’s EGFR×HER3 bispecific antibody for NSCLC has fully completed patient enrollment in Phase III trials, accelerating final efficacy and safety validation. Additionally, the PD-1×CTLA-4 dual bispecific antibody is progressing steadily in Phase II clinical stages, enriching the company’s multi-layered innovative immunotherapy portfolio.

With its core flagship drug officially entering commercialization and multiple pipeline candidates advancing toward late-stage clinical readouts, Biokin stands at a critical inflection point of performance release. The company’s differentiated bispecific ADC technology platform and globally leading clinical layout will continuously unlock long-term commercial value and industrial growth potential.