Innovent's SYCUME® Receives Approval as China's First IGF-1R Antibody for Thyroid Eye Disease

Innovent's Groundbreaking Approval of SYCUME® for Thyroid Eye Disease

In a significant breakthrough for the medical community and patients alike, Innovent Biologics, a leading biopharmaceutical firm based in China, has recently received approval from China's National Medical Products Administration (NMPA) for SYCUME® (teprotumumab N01). This milestone makes SYCUME® the first IGF-1R monoclonal antibody to be authorized for the treatment of thyroid eye disease (TED) in China, and it is only the second approved drug of its kind worldwide.

Thyroid eye disease is an autoimmune condition that primarily affects individuals with thyroid disorders, presenting a unique set of challenges that can severely impact one’s quality of life. TED is notably characterized by symptoms such as proptosis (bulging eyes), diplopia (double vision), and other visual dysfunctions, all of which can lead to profound psychological strains on affected individuals. With the incidence of TED ranging from 16 per 100,000 in women to 2.9 per 100,000 in men, the need for effective treatment options has never been more pressing.

Historically, treatment options for moderate-to-severe active TED have been limited, primarily relying on intravenous glucocorticoid therapy. While this first-line treatment has been standard, it often results in inadequate improvements and presents several systemic side effects. As a consequence, patients have long awaited effective alternatives that address the complexities of this disorder. SYCUME® emerges as a beacon of hope, promising robust efficacy and a favorable safety profile.

The clinical landscape surrounding TED has dramatically shifted following the results from the Phase 3 registrational study (RESTORE-1), highlighting SYCUME®'s potential. The study reported that 85.8% of patients who received treatment with SYCUME® experienced a proptosis reduction of ≥2 mm after just 24 weeks. Participants also noted substantial improvements in inflammation and overall quality of life metrics, bolstered by a favorable safety profile throughout the study duration.

Notably, this approval marks the end of a 70-year drought in new therapeutic options for TED in China, making SYCUME® a pivotal development in the treatment landscape. Prior to its approval, patients seeking IGF-1R therapy faced astronomical costs—upwards of 3 million RMB for each treatment course—further complicating access to care.

Dr. Lei Qian, Senior Vice President of Clinical Development at Innovent, articulated the firm’s commitment to clinical innovation, remarking on SYCUME® as a culmination of expertise in ophthalmology and endocrinology. This therapy is anticipated to fundamentally redefine the standard of care for TED patients in China.

Furthermore, Professor Xianqun Fan, an esteemed academician in the field of ophthalmology, emphasized the critical nature of SYCUME® as a new therapeutic offering. He mentioned that the introduction of IGF-1R-targeted biologics as a treatment option could significantly ameliorate symptoms for patients struggling with TED, addressing both the physical and psychological aspects tied to the disease.

SYCUME® functions by blocking the insulin-like growth factor 1 receptor, which is implicated in the inflammatory pathways associated with the disease. This inhibition results in a decrease in the expression of inflammatory factors and subsequently alleviates clinical manifestations. Its liquid injection formulation also enhances patient compliance and simplifies manufacturing, which is a tremendous advantage over existing treatment modalities.

The approval of SYCUME® is not just a significant achievement for Innovent but represents a broader commitment to improving patient care within the biopharmaceutical industry. The approval of SYCUME® marks a hopeful turning point amidst a landscape that has seen little progress for many years, demonstrating an unwavering dedication to combatting some of the most challenging diseases patients face today. Innovent’s ambition to deliver innovative therapies continues to set them apart as they strive to improve the lives of countless individuals affected by severe illnesses.

In summary, the arrival of SYCUME® on the market is a testament to the rapid advancements in medical science and innovation. By offering a new, effective treatment for thyroid eye disease, Innovent is poised to provide relief and enhance the quality of life for many patients, heralding a new era in the management of this complex autoimmune disorder.