On the evening of July 2nd, Baili Tianheng announced that its independently developed EGFR × HER3 dual antibody ADC (iza bene), which is a first in class, new concept, and the only one to enter the Phase III clinical stage, has reached the primary endpoint in the Phase III clinical trial of nasopharyngeal carcinoma (study protocol number: BL-B01D1-303). The indication is for recurrent or metastatic nasopharyngeal carcinoma that has been previously treated with PD-1/PD-L1 monoclonal antibodies and has failed at least two lines of chemotherapy (at least one line containing platinum).
The announcement shows that Iza bren is conducting over 40 clinical trials targeting multiple types of tumors in China and the United States. As of now, Iza bren has 5 indications included in the breakthrough treatment list by the Drug Evaluation Center of the National Medical Products Administration.
Baili Tianheng presented Phase I research data on Iza bren treatment for nasopharyngeal carcinoma at the 2023 American Society of Clinical Oncology Annual Meeting. The results showed that after treatment, the ORR of 24 nasopharyngeal carcinoma patients was 45.8%, and the disease control rate (DCR) was 100%. The updated Phase I clinical data in the Lancet journal showed that for nasopharyngeal carcinoma indications, the ORR increased to 59.5% among 37 patients with assessable efficacy.
It is worth mentioning that in December 2023, Baileys Tianheng signed an exclusive license and cooperation agreement for the BL-B01D1 project with the global leading pharmaceutical company BMS, with a potential total transaction value of $8.4 billion. This marks the entry of a new concept developed locally in China and the first of its kind bispecific antibody drug conjugates into the international market.
According to a research report by Dongwu Securities, under the cooperation agreement with BMS, Baili Tianheng will receive a milestone payment of $250 million after launching its first overseas first-line Phase III clinical trial. At the same time, the early basket studies of BL-B01D1 as a single drug overseas and in combination with Axitinib/PD-1 are progressing smoothly with BMS. It is expected that more solid tumor overseas registration clinical trials will be launched by 2025, and the first market application will be submitted to the FDA (US Food and Drug Administration) as early as 2028.
Baili Tianheng reminds investors that according to the relevant laws and regulations on drug registration in China, drugs need to complete relevant clinical trials and pass the review and approval of the National Medical Products Administration before they can be listed for sale. Due to the high-tech, high-risk, and high added value characteristics of pharmaceutical products, the drug production cycle from clinical trial approval to production is long and involves multiple stages, making it susceptible to uncertainties. The company will actively promote the above-mentioned research and development projects in accordance with relevant regulations, and strictly fulfill its information disclosure obligations for the subsequent progress of the projects in a timely manner.
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