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Another Major Milestone! Iza-Bren Receives Marketing Approval for the Treatment of Esophageal Squamous Cell Carcinoma

2026-07-20

On July 16, 2026, Iza-Bren (Yizekang®), the world's first approved bispecific antibody-drug conjugate (ADC) and an EGFR × HER3 bispecific ADC, achieved another major milestone: it received approval from the National Medical Products Administration (NMPA) for the treatment of recurrent or metastatic esophageal squamous cell carcinoma in patients whose disease had progressed following prior treatment with a PD-1/PD-L1 inhibitor in combined with platinum-based chemotherapy.

Following the approval of its nasopharyngeal carcinoma indication, Iza-Bren has achieved another major breakthrough in an important cancer indication. With this approval, Iza-Bren becomes the world's first bispecific ADC approved for the treatment of esophageal squamous cell carcinoma. This milestone ushers in a new era of bispecific ADC therapy for the disease and is expected to reshape its clinical diagnosis and treatment landscape, while potentially informing further updates to authoritative clinical practice guidelines. The approval also further validates the ability of this first-in-class bispecific ADC, independently discovered and developed in China, to continually provide new treatment options for patients with high-burden cancers in China and to steadily advance the reshaping of treatment paradigms across multiple tumor types.

 

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One month later, Yizekang® was officially approved for the second-line treatment of advanced esophageal squamous cell carcinoma.

 

If the approval of Yizekang® for nasopharyngeal carcinoma represented a hard-won breakthrough, then the approval of its esophageal cancer indication marks an even deeper fulfillment of our founding R&D mission. Esophageal cancer is not only one of the most prevalent cancers in China, but also a malignancy associated with substantial unmet medical needs worldwide. Countless patients with advanced disease have had no viable second-line treatment options and have been left to endure prolonged suffering caused by the disease.

 

From its early days the laboratory code C3-ADC to where it stands today, more than a decade of dedicated research has finally enabled us to bring a new treatment option to these patients. This achievement belongs to every member of the Baili Pharma team who has stayed the course.

 

There is no finish line on the road ahead. We will continue to expand the range of indications and usher in a new era of bispecific ADC therapy across more tumor types.


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