By Fineline Cube 
China‑based Zhuhai Beihai Biotech Co., Ltd. announced today that its Category 1 innovative drug BH1621 has received U.S. Food and Drug Administration (FDA) approval for its Investigational New Drug (IND) application. The approval marks a critical milestone for the first‑in‑class anti‑tumor peptide‑drug conjugate (PDC) developed exclusively by Beihai Biotech.
Product Overview
- BH1621 – a first‑in‑class (FIC) anti‑tumor peptide‑drug conjugate that couples a novel tumor‑specific peptide to a potent cytotoxic payload.
- Targeted Delivery – engineered to home in on tumor cells, releasing the toxic payload only within malignant tissue, thereby expanding the therapeutic window and minimizing off‑target toxicity.
- Indication – intended for the treatment of advanced solid tumors across multiple cancer types.
Preclinical Highlights
| Study | Key Finding |
|---|---|
| In‑vitro | BH1621 dramatically inhibited growth of a panel of human tumor cell lines, outperforming standard cytotoxics by 3–5× in IC₅₀ values. |
| In‑vivo | In mouse xenograft models, BH1621 reduced tumor volume by >70 % with no observable weight loss or organ toxicity. |
| Pharmacodynamics | The conjugate maintained a high plasma half‑life (≈ 12 h) while delivering the payload preferentially to the tumor microenvironment. |
Strategic Implications
- Accelerated Development Path – FDA IND clearance enables Beihai Biotech to begin Phase 1 clinical trials in the U.S., opening access to a large oncology market and potential partnership opportunities.
- Competitive Advantage – The unique peptide‑targeting platform differentiates BH1621 from other PDCs and antibody‑drug conjugates (ADCs) currently in the pipeline.
- Future Pipeline – Successful IND studies will position Beihai Biotech to pursue additional indications and expand the BH1621 platform across other solid tumors.
About Zhuhai Beihai Biotech
Zhuhai Beihai Biotech Co., Ltd. is a China‑listed (Category 1) biotechnology company focused on discovering and developing innovative therapeutics for oncology and other high‑need disease areas. The company leverages proprietary peptide chemistry and conjugation technology to create next‑generation targeted therapies.-Fineline Info & Tech