Servier Accelerates Early Access to Vorasidenib, the First-in-Class IDH1/2 Inhibitor, to Address Urgent Clinical Needs of Glioma Patients in China

Servier's Vorasidenib, the world's first IDH dual-target inhibitor, has been approved for urgent clinical use as an imported drug in Beijing. It has officially landed at the Beijing Tianzhu Comprehensive Bonded Area and can be used in designated medical institutions to treat patients with IDH-mutant diffuse glioma. As the first group of patients received treatment with this innovative drug at Beijing Tiantan Hospital, Capital Medical University, and Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Vorasidenib has now entered clinical application in Beijing. This enriches the medication options for IDH-mutant diffuse glioma, providing more patients with precious treatment time and hope.

As the world's first IDH dual-target inhibitor, Vorasidenib is the first innovative targeted drug in the field of IDH-mutant diffuse glioma treatment in nearly 20 years. Following its approval and market launch in the United States on August 6, 2024, Vorasidenib was subsequently approved for marketing in Canada, Australia, Israel, Switzerland, and the UAE. On November 24, 2024, Vorasidenib was introduced to Boao Lecheng Pilot Zone in Hainan, achieving the "first use in Asia." This time, Vorasidenib's introduction to Beijing benefited from the innovative policy known as the "Clinical Urgent Import Drug and Device Approval Green Channel," which accelerates the introduction of treatments and technologies that are already marketed overseas but not yet approved in China, significantly reducing patients' waiting time for medication and allowing them to simultaneously benefit from the latest achievements in global medical technology.

Manuel RUIZ, General Manager of Servier China, stated: "Following the Boao Lecheng initiative, we are extremely proud that Vorasidenib has been successfully introduced in Beijing and begun serving patients through the innovative Early Access Program. Servier always prioritizes patients, not only accelerating the introduction of globally leading innovative drugs that fill clinical gaps to meet urgent patient needs, but also continuously exploring early access pathways and scenarios to improve patient access to these innovations. The process of providing innovative drugs to patients through the Early Access Program has now taken its first step. Moving forward, we will continue to apply for access in regions offering progressive policies, expanding the availability of early access to innovative drugs and benefiting an even broader population of patients."

Since the onset, progression, and treatment side effects of gliomas may involve functional areas of the brain, patients often face the dilemma of high mortality, high disability rates, and high recurrence rates. Among the currently limited treatment options for gliomas, surgical resection cannot completely remove the tumor, while radiotherapy and chemotherapy may cause long-term severe side effects on the patient’s body or neurocognitive functions across multiple domains. Even with comprehensive treatments involving surgical resection, concurrent chemoradiotherapy, and adjuvant chemotherapy, more than 90% of glioma patients still experience recurrence and progression.

Notably, patients with IDH-mutant diffuse glioma have a median age of onset around 40 years. These individuals are in their prime, serving as the "backbone" of their families and the "core force" in the workplace. However, most patients experience varying degrees of physiological and socio-psychological impairments post-surgery, such as memory deficits, motor dysfunction, aphasia, anxiety, and depression. These conditions not only restrict daily activities and social participation but also significantly impact the quality of life for both patients and their families.

As the first comprehensive bonded area in China established at an air port, Beijing Tianzhu Comprehensive Bonded Area has formed a full industrial chain layout for health care services, featuring cross-border pharmaceutical trade. With mature integrated customs clearance services, a global airline network, and green channel policies, Beijing Tianzhu Comprehensive Bonded Area has established a "white list" system covering the entire process of temporary import, distribution, and use of urgently needed medicines for rare disease clinical treatment, providing one-stop services for rare disease drugs and other urgently needed medical devices.

Vorasidenib belongs to the first batch of clinically urgently needed anti-tumor drugs approved for import. It has now entered clinical application at the "Frontier Innovative Treatment (CURE) Combined Clinic for Glioma" of Beijing Tiantan Hospital, Capital Medical University, and the neurosurgery outpatient department of Peking Union Medical College Hospital.

At the same time, the new list of special drugs for the 2025 Beijing Inclusive Health Insurance will officially take effect on June 10. Among them, five overseas special drugs, including Vorasidenib introduced by the Beijing Tianzhu Comprehensive Bonded Area, have been included in the reimbursement scope. Insured individuals can enjoy the one-stop special drug reimbursement service of the Beijing Inclusive Health Insurance at designated medical institutions within Beijing, further enhancing the treatment experience and sense of gain for patients, and helping to improve survival benefits.