BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177), a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as "BIO-THERA" or the "Company", today announced that its Phase II clinical trial application (IND) for BAT8006 (ADC- FRα) for injection has been approved by the U.S. Federal Drug Administration (FDA). The Company today announced that it has recently received approval from the U.S. Food and Drug Administration (FDA) for a Phase II clinical trial (IND) of its investigational drug, BAT8006 for injection, to evaluate its efficacy and safety in patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. Previously, BAT8006 has initiated a Phase I dose-escalation and dose-expansion study in China with phase I data.

BAT8006 is an antibody drug coupling (ADC) developed by BIO-THERA targeting folate receptor alpha (FRα), which is intended to be developed for the treatment of solid tumors.FRα is a folate-binding protein located on cell membranes and is overexpressed in a variety of solid tumors, such as ovarian, lung, endometrial, and breast cancers, but is expressed at a lower level in normal human tissues. The difference in expression levels in tumor and normal tissues makes FRα an attractive target for the development of antitumor drugs.

BAT8006 consists of a recombinant humanized anti-FRα antibody and a toxic small molecule topoisomerase I inhibitor, linked by a shearable linker developed by BIO-THERA. Preclinical studies have shown that BAT8006 has highly efficient anti-tumor activity. The toxin small molecule has strong cell membrane permeability, and can further release and kill nearby cancer cells after ADC kills cancer cells, generating a bystander effect, which is expected to effectively overcome the heterogeneity of tumor cells. Meanwhile, BAT8006 exhibits excellent stability with extremely low release of toxin small molecules in plasma, reducing the risk of off-target toxicity. Currently, the Phase I clinical trial of BAT8006 is in the dose expansion phase, with dose optimization as well as efficacy exploration in multiple tumor cohorts. Preliminary clinical data show that BAT8006 has best-in-class potential, and updated clinical data will be reported at relevant future medical congresses.

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