Recently, Baileyn announced that it has received a milestone payment of $250 million from BMS.

Previously, in December 2023, Baili Tianheng entered into an exclusive licensing and collaboration agreement with BMS for its world-first-in-class EGFR×HER3 bispecific antibody ADC project iza-bren (BL-B01D1) to jointly develop and commercialize it globally.

Under the agreement, BMS will pay the company an upfront payment of $800 million and two contingent payments of $250 million in the near future; upon achieving development, registration, and sales milestones, the company will receive additional payments of up to $7.1 billion; the potential total transaction value could reach up to $8.4 billion.

In September of this year, Baili Tianheng's global Phase II/III pivotal registration clinical trial, IZABRIGHT-Breast01, reached a milestone, triggering this payment. This is the largest milestone payment for a single ADC asset in any disclosed overseas transaction of a domestic innovative drug to date.

Baili Tianheng is collaborating with BMS to jointly conduct three global pivotal registration studies, including Phase II/III registration clinical trials for first-line advanced triple-negative breast cancer, advanced non-small cell lung cancer after EGFR-TKI resistance, and previously treated advanced metastatic urothelial carcinoma, as well as multiple Phase I/II clinical studies for non-small cell lung cancer, advanced solid tumors, and other conditions.

At the European Society for Medical Oncology (ESMO) Annual Meeting held in October this year, Perceptron presented clinical research data on iza-bren for the treatment of Western solid tumor patients for the first time. The results showed that the efficacy of iza-bren was highly consistent in patients from both the East and the West, verifying its great therapeutic potential across populations and tumor types, and also reflecting Perceptron's global clinical research standards.

In China, Iza-bren has had two confirmatory registration Phase III clinical trials that have met their primary endpoints, including the interim analysis of the Phase III clinical trial BL-B01D1-303 for nasopharyngeal carcinoma, which met its primary endpoint; and the interim analysis of the Phase III clinical trial BL-B01D1-305 for esophageal cancer, which met both the primary endpoints of progression-free survival (PFS) and overall survival (OS).

In November of this year, the marketing authorization application for iza-bren was successfully accepted by the National Medical Products Administration (NMPA) and included in the priority review list by the Center for Drug Evaluation (CDE). It is indicated for patients with recurrent or metastatic nasopharyngeal carcinoma who have failed prior PD-1/PD-L1 monoclonal antibody therapy and at least two lines of chemotherapy (at least one line platinum-based). This means the drug is expected to be launched in China as early as 2026.

As a leading innovative drug company in China, Baili Tianheng has more than 10 ADC drugs that have entered the clinical research stage in addition to iza-bren, including BL-M07D1 (T-Bren) which has entered the Phase III clinical stage, the next-generation toxin ADC drugs BL-B16D1, BL-M17D1, and BL-M24D1, and the ARC (antibody-radioactive nuclide conjugate) drug BL-ARC001, among other high-potential projects.

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