Home Innovation Beihai Biotech's Class 1 novel drug BH1621 has IND application cleared by U.S. FDA

Beihai Biotech's Class 1 novel drug BH1621 has IND application cleared by U.S. FDA

Oct 13, 2025 08:43 CST Updated 15:42

Zhuhai Beihai Biotech Co., Ltd. ("Beihai Biotech") announced that the Investigational New Drug (IND) application for its self-developed Class 1 innovative drug, BH1621, has been cleared by the U.S. Food and Drug Administration (FDA).


About BH1621


BH1621 is a first-in-class anti-tumor drug independently developed by Beihai Biotech, demonstrating excellent anti-tumor activity and intended for the treatment of advanced solid tumors. Utilizing an innovative molecule-targeted delivery technology, BH1621 precisely targets tumor cells and tissues, directionally releasing its payload toxin to achieve tumor cell killing. This design is expected to widen the drug's therapeutic window while effectively reducing toxicity and side effects on healthy tissues.


In multiple preclinical studies, BH1621 has exhibited outstanding anti-tumor efficacy and a favorable safety profile. Results from both in vitro and in vivo efficacy experiments indicate that BH1621 significantly inhibits the growth of human-derived tumor cells in culture and markedly expands the therapeutic window of the payload toxin, thereby enhancing clinical safety. BH1621 is expected to provide a superior treatment option for patients with advanced tumors, potentially extending survival and improving quality of life.


About Beihai Biotech


Beihai Biotech is an innovative biopharmaceutical company guided by the principle of "Putting Patients First, Innovation for All." We focus on various disease areas, including oncology and pain management, with a special emphasis on developing groundbreaking oncology drugs to address significant unmet clinical needs. With a global perspective, the company possesses two pioneering global drug technology platforms, demonstrating sustained innovative research and development capabilities.We have strategically planned over 10 differentiated innovative drug development pipelines and obtained more than 30 authorized invention patents in China, the United States, the European Union, and other regions, committed to pioneering innovation in drug development.

Currently, Beihai Biotech has obtained nine clinical trial permits (IND) in China and the United States, with several new drug projects entering critical phases of clinical trials and NDA submissions.