In June 2026, iza-bren (Izalontamab Brengitecan Yizekang^®) received approval from the National Medical Products Administration (NMPA) of China, becoming the world's first bispecific antibody-drug conjugate (ADC) to reach the market. The approval represents a major milestone in the field and is expected to reshape the oncology treatment landscape, ushering in a new era of bispecific ADC therapeutics!

Yizekang^® is a first-in-class EGFR×HER3 bispecific ADC with a novel mechanism of action.  It is also currently the first and only bispecific ADC drug approved for marketing worldwide. This approval marks an important milestone in Biokin Pharmaceutical's development strategy of “taking root in China, going global, focusing on oncology, and becoming a multinational corporation (MNC).”

As of June 2026, Yizekang^® has launched more than 40 cross-tumor clinical trials in the two core markets of China and the United States. To date, it has received a total of eight Breakthrough Therapy Designations—seven from the Center for Drug Evaluation (CDE) and one from the U.S. Food and Drug Administration (FDA)—and two indications have been granted Priority Review designation by the CDE, including the approved indication for nasopharyngeal carcinoma. In China, Yizekang^® has initiated 15 pivotal Phase II/III registrational clinical studies under the PANKU series program, spanning multiple cancer types, including lung cancer, esophageal squamous cell carcinoma, breast cancer, ovarian cancer, urothelial carcinoma, and cholangiocarcinoma, among which the marketing applications for the two indications of esophageal squamous cell carcinoma and triple-negative breast cancer have been officially accepted by the CDE. Globally, Yizekang® has simultaneously launched 3 pivotal Phase II/III registrational clinical studies under the IZABRIGHT series program, covering lung cancer, triple-negative breast cancer, and urothelial carcinoma. From China to the global stage, from “the first bispecific ADC to enter Phase III trials” to “the first bispecific ADC to receive regulatory approval”, Yizekang ® is poised to continue reshaping the oncology treatment landscape across multiple cancer types.

When a colleague showed me the official confirmation that the NMPA had approved iza-bren in China and asked, “Are you happy?”, my genuine feeling was not excitement, but rather the sense of relief that comes from having survived a catastrophe.

I asked ChatGPT, “What does it feel like to survive a catastrophe?” ChatGPT replied, “It is rarely a simple feeling of happiness, but rather a profoundly complex mixture. Perhaps it is the shock of being pulled back from the brink of death—not just relief, but relief, lingering fear, disbelief, clarity, gratitude, and a renewed perspective on life, all flooding in at once.”

Yes, that was roughly how I felt at that time.

Twelve years ago, in 2014, when we decided to develop this EGFR×HER3 bispecific ADC, it was known internally as C3-ADC. Nine years later in 2023, when its clinical data were first unveiled at the ASCO Annual Meeting, it became known as BL-B01D1. Today, twelve years after that journey began, it has received its first regulatory approval in China, where it was born, and has become known as iza-bren and been assigned the Chinese nonproprietary name “Lunkang Yilongtumab”. In the future, physicians and patients will also affectionately call it “Yizekang”, a name whose meaning speaks for itself.

       From today onward, Yizekang will embark on its own legendary journey, standing shoulder to shoulder with physicians and patients in the fight against tumors. Its achievements, its legend, and its story will continue to live on for many, many years to come…

Yet what will always remain in the depths of my heart is the time when it was called C3-ADC.

Finally, I would like to express my sincere gratitude to every one of you who has trusted and supported us. Your unwavering trust has been the driving force behind our commitment to advancing innovative drug development and overcoming medical challenges. We will remain patient-centered, honor the trust you have placed in us, and continue moving forward without hesitation!