Legubicin for Injection (Legubicin), a globally first-in-class (FIC) anti-tumor drug independently developed by Affinity (Shanghai) Biopharmaceutical Co., Ltd., has officially been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of Soft Tissue Sarcoma (STS) recently. This landmark designation not only represents a high recognition of Legubicin’s potential in rare tumors but also brings new hope to STS patients worldwide.

Legubicin is the world’s first legumain-activated albumin-drug conjugate, developed based on Affinity’s proprietary Tumor Microenvironment-Activated (TMEA) technology platform. Leveraging high legumain expression in solid tumors as a "biological switch," the drug achieves targeted delivery and tumor microenvironment-specific activation, featuring two core advantages: low systemic toxicity and highly efficacious targeted activation. This enables potent tumor cell killing while substantially expanding the therapeutic window.

Clinical data demonstrates that Legubicin exhibits superior anti-tumor activity and safety compared to Doxorubicin, the widely used first-line therapy in current clinical practice. Legubicin doubled median progression-free survival (mPFS) while drastically reducing adverse events, fully overcoming the cardiotoxicity limitations of Topo II inhibitor anthracyclines. The clear survival benefit trend positions Legubicin as a promising long-term, safe maintenance therapy for patients receiving first-line STS treatment, as well as those with metastatic or recurrent unresectable STS, supporting it as a potential first-line alternative to Doxorubicin.

Following the ODD, Legubicin will receive additional guidance and support from the FDA in subsequent U.S. clinical trials, which is expected to significantly shorten the development cycle and accelerate patient access worldwide. Furthermore, upon approval, the product will be eligible for a 7-year market exclusivity period in the United States. This lays a solid foundation for Affinity’s global commercialization strategy and ensures stable returns for its innovations. Most importantly, this marks another milestone recognition for Affinity’s TMEA platform following clinical data validation, proving the transformative impact of legumain-targeted strategies in addressing unmet needs in solid tumor treatment and establishing a robust foundation for the development of the platform’s subsequent pipeline assets.

As Affinity’s core asset, Legubicin has advanced steadily in clinical development, demonstrating exceptional potential in advanced STS and promising efficacy across multiple high-incidence malignancies. To date, beyond soft tissue sarcoma, its broad clinical application spans indications including non-small cell lung cancer, ovarian cancer and choriocarcinoma, and breast cancer, with multiple ongoing trials underway.

Looking ahead, Affinity will continue to focus on tumor microenvironment-targeted therapies, developing more globally innovative anti-tumor drugs to contribute China’s expertise and capabilities to addressing more difficult-to-treat cancers worldwide.

About FDA Orphan Drug Designation

FDA Orphan Drug Designation is a pivotal policy designed to incentivize the development of drugs for rare diseases. Under the U.S. Orphan Drug Act, this designation is eligible for  drugs intended to treat rare diseases or conditions affecting fewer than 200,000 patients in the United States.

About Legubicin

Legubicin is the world’s first legumain-activated albumin-drug conjugate, developed based on Affinity’s proprietary Tumor Microenvironment-Activated (TMEA) technology platform. It is currently in registrational clinical development and is poised to become the world’s first NDA-approved drug conjugate utilizing a Topo II inhibitor (doxorubicin) as the payload. Leveraging its unique mechanism of action, Legubicin is expected to serve as a safer and more effective alternative therapy for all patient populations currently treated with doxorubicin, and potentially broader populations. Its primary indications currently include soft tissue sarcoma, non-small cell lung cancer, ovarian cancer, and breast cancer, among others. 

About Affinity (Shanghai) Biopharmaceutical Co., Ltd. ("Affinity")

Leveraging its globally first-in-class and proprietary Tumor Microenvironment-Activated (TMEA) technology platform, Affinity develops and advances highly selective, low-toxicity innovative anti-cancer drugs. The company is dedicated to solving the toxicity challenges of traditional chemotherapy and targeted therapies, focusing on unmet medical needs in oncology, with the potential to transform traditional treatment approaches and reshape the cancer care paradigm.

Looking ahead, Affinity aims to become a fully integrated biopharmaceutical company with robust manufacturing and commercialization capabilities.