Global Launch Event for iza-bren Phase III Nasopharyngeal Carcinoma Research Results Successfully Held, Streamed on ESMO Official Website

SHANGHAI, Oct. 24, 2025 /PRNewswire/ -- At 15:00 Beijing Time (09:00 am Berlin Time) on October 20, the "Global Launch Event for Iza-bren (EGFR×HER3 Bispecific ADC) Nasopharyngeal Carcinoma BL-B01D1-303 Research Results" was held at the venue of the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin. eChinaHealth held a forum on progress of nasopharyngeal carcinoma, and Biokin Pharma participated in sharing the research results and reported the Iza bren BL-B01D1-303 research report.

The Launch Event focused on the BL-B01D1-303 study (hereinafter: 303 Study) led by Chinese scholars. The study evaluated the efficacy and safety of iza-bren for later-line treatment of recurrent/metastatic nasopharyngeal carcinoma (R/M NPC). Recognized for its "doubled efficacy" outstanding efficacy data and significant clinical importance, the study was selected as a Late-breaking Abstract (LBA) for the Developmental Therapeutics Session at this ESMO Congress and was simultaneously published in The Lancet, fully demonstrating the international academic community's full affirmation of this research^[1],[2].

The Launch Event received widespread attention from the global medical community and media. The venue gathered eight authoritative domestic and international media outlets. ESMO official also provided strong support, conducting a live broadcast via its official website and providing replay videos for continuous learning by global doctors, fully showcasing the academic influence and R&D strength of China's innovative drugs on the international stage.

The study's Leading Principal Investigator: Professor Li Zhang from Sun Yat-sen University Cancer Center; the 303 Study presenter at the ESMO Congress: Professor Huaqiang Zhou from Sun Yat-sen University Cancer Center; and Dr. Jonathan Cheng, Chief Medical Officer of SystImmune, Inc, attended the Launch Event. They systematically elaborated the key path of iza-bren from biological validation to clinical practice translation and answered questions from Chinese and international media reporters on hot topics related to the research.

Scientific Breakthrough and Clinical Value: Iza-bren Achieves Technological Revolution in Delaying and Overcoming Resistance

At the beginning of the conference, Professor Li Zhang stated in his speech that the great success of the global first Phase III study of a bispecific ADC for later-line treatment of recurrent/metastatic nasopharyngeal carcinoma is an important milestone of iza-bren and will lead global nasopharyngeal carcinoma treatment into the ADC era.

Dr. Jonathan Cheng reviewed the journey of the EGFR×HER3 bispecific ADC from target biological validation to clinical development, and provided a forward-looking perspective on the future clinical application prospects and development path of iza-bren.

The innovative design concept of iza-bren is remarkable:

• The EGFR×HER3 bispecific antibody design adopted by iza-bren is not a simple "1+1" superposition. Compared to single-target ADCs, such bispecific ADCs have more and more significant advantages in design, including higher target specificity, stronger binding capacity to tumor tissues, and lower off-target toxicity to normal tissues, thereby significantly improving therapeutic efficacy. Particularly outstanding is the ability of bispecific ADCs to simultaneously block the initial treatment target and resistance-related targets, effectively delaying or overcoming the emergence of resistance mechanisms, a characteristic difficult to achieve with single-target ADCs.
• Iza-bren's dual mechanism of action blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. In addition, upon antibody mediated internalization, iza-bren's therapeutic novel topo-I inhibitor payload (Ed-04) payload is released causing cytotoxic stress that leads to cancer cell death.
• The drug-to-antibody ratio (DAR) of iza-bren is 8, which helps enhance its bystander effect and improve its killing capacity against tumor tissue cells.

Based on the widespread expression of EGFR in various solid tumors, iza-bren is demonstrating significant cross-tumor potential. To date, more than ten registrational Phase III clinical studies have been initiated globally, covering multiple solid tumor areas including lung cancer, breast cancer, esophageal cancer, urothelial carcinoma, and ovarian cancer, including three global multi-center clinical trials, laying a solid foundation for China's innovative drugs to enter the international market.

Outstanding Data and Global Debut: iza-bren Doubles Efficacy! Nasopharyngeal Carcinoma Leads Solid Tumor Treatment into the Bispecific ADC Era

Professor Huaqiang Zhou provided a systematic and in-depth interpretation of the 303 Study, pointing out that this study is expected to completely reshape the diagnosis and treatment landscape of nasopharyngeal carcinoma in China and even globally.

The 303 Study is the world's first Phase III clinical study for later-line treatment of recurrent/metastatic nasopharyngeal carcinoma, providing high-quality evidence-based medicine for later-line treatment in this field. While confirming the significant clinical efficacy of iza-bren, this study also clarified that the objective response rate (ORR) of later-line monotherapy chemotherapy regimens is approximately 30%. Furthermore, this study is also the world's first Phase III clinical trial on a bispecific ADC, marking the official transition of bispecific ADC drugs, represented by iza-bren, from the proof-of-concept stage to the comprehensive clinical validation stage.

The study enrolled a total of 386 patients, all of whom had previously received at least two lines of systemic therapy, overall belonging to a heavily pre-treated, high tumor burden population. Over 40% of patients had received ≥3 prior lines of therapy, and nearly 50% of patients had distant organ metastases such as liver, bone, or lung metastases at baseline.

In this patient population with significant clinical challenges, iza-bren delivered excellent results, achieving "doubled efficacy" in multiple dimensions compared to the gemcitabine-containing monotherapy chemotherapy regimen!

• The confirmed Objective Response Rate (cORR) reached 54.6%, significantly higher than 27.0% in the control group, achieving a doubling; subgroup analysis showed that regardless of patient baseline characteristics, iza-bren could bring consistent and stable high response rates. Notably, complete response (CR) cases were observed in the iza-bren group, demonstrating its excellent ability to clear tumor lesions^[1],[2].
• The median Progression-Free Survival (mPFS) broke through 8 months for the first time, reaching 8.38 months, also doubling compared to 4.34 months in the control group; the results of various pre-specified subgroup analyses were consistent, with hazard ratios (HR) all less than 0.5, indicating that patients with different baseline characteristics can benefit from iza-bren treatment, and the treatment benefit is universal^[1],[2].
• The risk of disease progression or death was significantly reduced by 56%, the highest reduction reported so far in the field of later-line treatment for recurrent/metastatic nasopharyngeal carcinoma, fully demonstrating the significant advantage of iza-bren in disease control, far exceeding the existing standard treatment level, and significantly enhancing the treatment confidence of clinicians and patients^[1],[2].

In terms of safety, iza-bren demonstrated a predictable and manageable safety profile in the 303 Study, with no new safety signals identified. The most common ≥Grade 3 treatment-related adverse events (TRAEs) were primarily hematological toxicities, most of which were transient and relatively simple to manage clinically; the median correction times for neutropenia and thrombocytopenia were 4 days and 5 days, respectively, indicating that its toxic reactions are usually short-lived and easy to recover from, conducive to long-term treatment maintenance and sustained clinical benefit for patients^[1],[2].

Professor Huaqiang Zhou quoted a comment from The Lancet: "In the 303 study, iza-bren achieved doubled efficacy compared to chemotherapy, the results are encouraging, ADC will become an important pillar of nasopharyngeal carcinoma treatment."^[3]

Broad Layout and Global Leadership: From Reshaping Nasopharyngeal Carcinoma Treatment Standards to Pan-Tumor Internationalization Layout

Representatives from global media engaged in in-depth exchanges with Professor Li Zhang, Professor Huaqiang Zhou, and Dr. Jonathan Cheng on various aspects, including the global leadership of this research, the advantages of iza-bren's mechanism of action (MOA), and the company's international strategic layout.

The success of the 303 Study has significant clinical importance and historical value, providing key reference for clinical research and diagnosis and treatment practice in the global nasopharyngeal carcinoma field.

As the first-in-class EGFR × HER3 bispecific antibody-drug conjugate, iza-bren, with its innovative molecular structure design and dual-target inhibition mechanism, has achieved overwhelming efficacy data. Multiple clinical studies, including the 303 Study, have shown excellent efficacy data, fully validating the advantages of its mechanism of action.

At this ESMO Congress, iza-bren also announced for the first time its treatment results in Western solid tumor patients. This validates its cross-racial, cross-tumor treatment potential, injecting strong momentum into the exploration of iza-bren in pan-tumors. "In the entire field of oncology treatment research, iza-bren has clearly become a star, attracting the attention of scholars, patients, and media whenever it appears," Professor Li Zhang said.

Research on iza-bren within the pan-cancer scope is continuing to deepen. Recently, the triggering of the first phase of the collaboration agreement between Bristol Myers Squibb and Biokin Pharma was triggered due to the IZABRIGHT-Breast 01 study reaching an important milestone. Driven by the synergy of domestic and international innovative companies, the clinical research of iza-bren is being efficiently advanced, and its application will be further expanded in multiple tumor types including breast cancer and bladder cancer in the future.

Charting the Blueprint and Future Outlook: Chinese Innovative Drugs Contribute to the Global Anti-Cancer Cause

For patients, the success of the 303 Study provides them with an efficient new treatment option, offering new hope to patients who originally had "no drugs available." Particularly valuable is that iza-bren enabled some patients to achieve complete response, which is extremely rare in later-line treatment, meaning the possibility of touching cancer cure.

For clinical practice, the 303 Study is the first to establish a new standard for later-line treatment of nasopharyngeal carcinoma through a high-standard randomized controlled trial, with significant therapeutic effects and good safety, solving a long-standing clinical pain point.

For industry development, the bispecific ADC iza-bren reflects the successful strategic transformation of China's innovative drug development from "fast-follow" to "first-in-class," proving that China's independent innovation platforms, innovative drugs, and innovative research will contribute wisdom to global medical development.

On September 5, 2025, the CDE official website announced that the iza-bren nasopharyngeal carcinoma indication was officially included in the priority review, meaning that this innovative therapy will be accelerated to benefit Chinese patients first. With the advancement of the priority review, the expansion of global development, and the exploration of pan-cancers, iza-bren is expected to become another milestone drug in the history of tumor treatment, bringing new treatment options to global tumor patients.

About iza-bren

iza-bren (BL-B01D1), a bispecific antibody-drug conjugate (ADC) that targets both EGFR and HER3, which are highly expressed in various epithelial cancers and are known to be associated with cancer cell proliferation and survival. Iza-bren's dual mechanism of action blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. In addition, upon antibody mediated internalization, iza-bren's therapeutic novel topo-I inhibitor payload (Ed-04) payload is released causing cytotoxic stress that leads to cancer cell death.

About Biokin Pharma

Founded in 1996, Biokin, after 26 years of steady growth, has become a biopharmaceutical company integrating the full life cycle of new drug and pharmaceutical product development from new drug research and development to production and marketing. Biokin has built a proprietary and fully integrated biological drug development platform in China and the United States, a world-leading tumor antibody drug development platform and research pipeline and owns a comprehensive and well-preserved intellectual property portfolio. Biokin operates a nationally certified technological center and is an inaugural member of the Chinese Pediatric Medicine R&D and Industrialization Alliance. Biokin has won numerous awards, including recognition as "China's Best Industrial Company in Pharmaceutical R&D Product Line."

Biokin is a biopharmaceutical company, integrating drug research and development, production, and marketing. Biokin owns R&D centers in China and the United States (US: Systimmune, Inc.; China: Baili Pharmaceutical and Baili-Bio Pharmaceutical, etc.), a biological drug and antibody conjugated drug production facility (Baili-Bio Pharmaceutical), two pharmaceutical formulation facilities (Baili Pharmaceutical and Guorui Pharmaceutical), one active pharmaceutical ingredient production facility (Jingxi Pharmaceutical), one chemical intermediate manufacturer (Hayate Technology) and two pharmaceutical marketing companies (Biokin and Lhasa Xinbo). 

About SystImmune, Inc.

SystImmune is a clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has several assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development.

Forward-Looking Statements

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SOURCE eChinaHealth