Shares of BOAN BIOTECH (06955.HK) surged 11.42% in pre-market trading on Thursday, following the announcement that its drug candidate BA1302 has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for two types of cancer.

According to a statement from Shandong Boan Biotechnology Co Ltd, the FDA has granted ODD to BA1302 for the treatment of Small Cell Neuroendocrine Carcinoma (SCNC) and pancreatic cancer. This significant regulatory milestone has sparked investor optimism, driving the stock's substantial pre-market rally.

The Orphan Drug Designation is a special status granted by the FDA to drugs intended to treat rare diseases or conditions. This designation provides various benefits to the developing company, including tax credits for clinical trials, exemption from user fees, and potentially seven years of market exclusivity upon approval. For BOAN BIOTECH, this development could accelerate the path to market for BA1302 and potentially boost the company's position in the competitive oncology drug market.