Inno Medicine Granted FDA Fast Track Designation for YN003 Injection to Treat Glioma, Including Glioblastoma

BEIJING & SHANGHAI, China, July 22, 2026 — Inno Medicine today announced that its proprietary actively targeted nanomedicine, YN003 Injection, has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with glioma, including glioblastoma. This designation marks significant regulatory recognition from a leading international authority regarding YN003's innovative delivery system, mechanism of action, and clinical potential, which is expected to substantially accelerate its clinical development and regulatory review timeline globally.

This designation follows the recent FDA approval of the Investigational New Drug (IND) application for YN003 on July 13, 2026. As a breakthrough actively targeted delivery therapeutic, YN003 is capable of crossing the blood-brain barrier (BBB) to targetedly deliver its encapsulated payload to glioma, achieving high-concentration drug accumulation within the tumor microenvironment. This targeted delivery significantly enhances antitumor efficacy while minimizing systemic toxicity and damage to healthy brain tissue. Furthermore, YN003 activates the host adaptive immune system, delivering a powerful dual-action therapeutic response combining direct cytotoxic cell killing with long-lasting antitumor immunity.

The FDA Fast Track Designation is intended to facilitate the development and expedite the review of therapies being developed for serious conditions with unmet medical needs. Under this designation, Inno Medicine will benefit from more frequent communication with the FDA, early regulatory guidance, and potential eligibility for Rolling Review and Priority Review mechanisms, accelerating YN003’s path toward potential market approval for patients in urgent need.

Dr. Qian Ma, Founder, Chairwoman, and CEO of Inno Medicine, stated: "Securing both FDA IND approval and Fast Track Designation for YN003 in such rapid succession is a strong validation of Inno Medicine's R&D capabilities, global regulatory strategy, and proprietary nano-delivery technology platform. Glioma, particularly glioblastoma, remains an exceptionally aggressive malignancy with highly limited treatment options and profound unmet medical needs. Encouraged by this regulatory milestone, our team is fully committed to advancing YN003 through global clinical evaluation with scientific rigor and efficiency, striving to bring this innovative therapeutic to patients as soon as possible."

About YN003

YN003 is an investigational, actively targeted nanomedicine developed by Inno Medicine for the treatment of glioma, including glioblastoma. The drug candidate is capable of effectively crossing the blood-brain barrier to enhance brain delivery efficiency, targetedly delivering and accumulating the therapeutic payload within tumor tissues to achieve high-efficiency, precision dosing while reducing systemic toxicity. Beyond direct cytotoxic killing, YN003 induces immunogenic cell death (ICD), activating dendritic cells and T-cell-mediated adaptive immune responses to clear tumor antigens and elicit durable, synergistic immunotherapeutic efficacy, thereby achieving long-term antitumor effects. YN003 was granted Orphan Drug Designation (ODD) by the FDA in November 2023.

About Inno Medicine

Founded in 2016, Beijing Inno Medicine Technology Co., Ltd. is a national high-tech biopharmaceutical enterprise dedicated to the discovery, development, and commercialization of innovative, precision-targeted therapeutics. Driven by high-value unmet clinical needs worldwide, Inno Medicine leverages its proprietary Nano-Delivery Technology Platform to build a robust product pipeline spanning major disease areas, including cardiovascular diseases and neuro-oncology.

As a dedicated innovator in targeted nanomedicine delivery, Inno Medicine developed YN001—the world's first actively targeted candidate capable of reversing atherosclerotic plaque—which has successfully obtained dual IND approvals from both the U.S. FDA and National Medical Products Administration (NMPA) in China and is currently undergoing clinical trials. Moving forward, Inno Medicine continues to expand its globally proprietary pipeline to deliver precise, effective, and transformative treatment options to patients worldwide.