Baili Tianheng: The phase III clinical trial of innovative biological drugs completed the enrollment of the first subject
DATE:  Mar 02 2025

Baili Tianheng(688506. SH) announced on March 2 that the phase III clinical trial of BL-B01D1 (EGFR×HER3 bispecific antibody ADC) for injection combined with osimertinib for first-line EGFR-mutant locally advanced or metastatic non-small cell lung cancer has recently completed the enrollment of the first subject.

It is reported that BL-B01D1 is the world's exclusive bispecific antibody ADC drug that can target both EGFR and HER3 in the phase III registration clinical trial stage independently developed by Baili Tianheng. In addition to the newly enrolled clinical trials, BL-B01D1 is also in the stage of subject enrollment in 7 domestic phase III registration clinical trials such as lung cancer, breast cancer, nasopharyngeal cancer, and esophageal squamous cell carcinoma, said Baili Tianheng.

According to public information, Baili Tianheng was established on August 17, 2006 and landed on the Science and Technology Innovation Board on January 6, 2023.

It is worth mentioning that the performance express report recently released by Baili Tianheng shows that in 2024, the company will achieve a total operating income of 5.823 billion yuan, a year-on-year increase of 936.31%; The net profit attributable to the owners of the parent company was 3.658 billion yuan, an increase of 4.438 billion yuan over the same period of last year, and the net profit after deduction was 3.604 billion yuan, an increase of 4.416 billion yuan over the same period of last year. In response to the sharp increase in performance, Baili Tianheng said that it was mainly due to the company's receipt of an irrevocable and non-deductible down payment of US$800 million from Bristol-Myers Squibb (BMS), an overseas partner of its core product BL-B01D1 (EGFR×HER3 bispecific antibody ADC), based on the cooperation agreement.

Previously, Baili Tianheng submitted the first application to the Hong Kong Stock Exchange in July 2024, but due to the expiration of the document, it resubmitted the prospectus on January 21, 2025. According to Baili Tianheng's previous announcement, the company's Hong Kong stock listing has entered the hearing stage. If the hearing is successfully passed, there will be a roadshow, IPO, public offering results and other steps.

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