BLTE Belite Bio Inc

Lin BioScience (6696. Taiwan OTC), a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting acute leukemia that have significant unmet medical needs, today announced that its lead pipeline, LBS-007, has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia. Lin BioScience is currently conducting a phase 1/2 trial in patients with relapsed or resistant acute leukemias in the US, Australia, and Taiwan, and has been granted for orphan drug designation (ODD) for acute myeloid leukemia and acute lymphocytic leukemia by the U.S. FDA.

“We are thrilled to see LBS-007 showing signs of early treatment response and potential efficacy in addressing this critical unmet medical need,” said Dr. Tom Lin, Chairman of Lin BioScience. “Receiving FDA Fast Track Designation is a significant milestone, offering an expedited pathway to advance the development of this promising therapy. We remain deeply committed to delivering transformative solutions for patients in need.”

“During the phase 1 dose escalation, we have not observed any Definitely or Probably Related Adverse Effects in all patients who have received low to high doses, demonstrating the safety profile is very tolerable and promising,” said Dr. Irene Wang, President & CSO of Lin BioScience.

About Fast Track DesignationFast Track is a process designed to facilitate the development, and expedite the review, of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapies. Once a drug receives Fast Track designation, it is eligible for more frequent meetings with the FDA, more frequent written communication from the FDA, Accelerated Approval and Priority Review if relevant criteria are met, and Rolling Review. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

About LBS-007LBS-007 is a natural, non-ATP cell cycle inhibitor targeting a broad array of cancers. LBS-007 functions by blocking the kinase activity of CDC7, a key regulator of the cancer cell cycle. Inhibiting CDC7 stops the proliferation of tumor cells and results in cancer cell death. LBS-007 has demonstrated very potent activity against leukemia and multiple solid tumors in preclinical studies.

Media Contact:Serena Chen CFOOffice: (02) 8780-5008Email: serenachen@linbioscience.com

About Lin BioScience:Lin BioScience (6696. Taiwan OTC), founded in 2016, is a drug development company focused on unmet medical needs through developing first-in-class therapies for cancer, ophthalmology, and metabolic diseases. The Company currently has four primary drug candidates under development, including LBS-008 (for Geographic Atrophy [GA] in advanced dry age-related macular degeneration [AMD] and Stargardt Disease type 1 [STGD1]) and LBS-009 (for non-alcoholic steatohepatitis [NASH]), both developed by its subsidiary Belite Bio (NASDAQ: BLTE), as well as LBS-007 (for acute leukemia and solid tumors) and LBS-002 (for primary and metastatic brain cancers) developed by Lin BioScience.

Significantly, LBS-008 has been granted Orphan Drug Designation (ODD) for the treatment of STGD1 from the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. It has also received Fast Track Designation and Rare Pediatric Disease (RPD) designation from the U.S. FDA, along with Sakigake Designation from the Ministry of Health, Labour and Welfare (MHLW) in Japan. Additionally, LBS-007 has been granted ODD for the treatment of acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML), as well as Fast Track Designation for the treatment of AML, from the U.S. FDA.

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Disclaimer:This press release and the concurrently released related information contain forward-looking statements, based on existing risks and potential uncertainties, including market factors and other causes beyond the control of Lin BioScience (referred to hereafter as the Company). These forward-looking statements rely on current forecasts and assessments, and the Company undertakes no obligation to update the information, except as required by law.