Innovative drugs from multinational pharmaceutical companies are the first to be approved for marketing in China, benefiting GPP patients aged 12 and above

2024-03-08

On the 6th, the reporter learned that the innovative targeted biological agent for rare skin diseases, Sanlizhuo? The family subcutaneous injection formulation (commonly known as Pesorizumab) has been approved for market by the National Medical Products Administration of China, becoming the first global innovative drug among multinational pharmaceutical companies to be developed and approved in China through multi center synchronous research and development, ahead of the United States, the European Union, and Japan. Dr. Zhang Wei, R&D and medical director of a multinational pharmaceutical company in Greater China, told reporters on the same day that "the Shenglizhuo? Family subcutaneous injection preparation was first approved in China, demonstrating the Chinese government's accelerated promotion of drug review and approval for new drugs, and its determination to bring innovative drugs to patients around" clinical urgent needs ". Generalized Pustular Psoriasis (GPP) is a rare, recurrent or persistent serious skin disease.". Unlike common psoriasis, GPP presents with widespread skin eruptions of pustules accompanied by pain, and may be accompanied by systemic symptoms such as high fever. It is reported that this time Saint Lizzo? Family subcutaneous injection preparations have been approved for reducing GPP attacks in adolescents aged 12 and above (weight ≥ 40 kg) and adults. It is understood that GPP attacks may lead to hospitalization and even be accompanied by serious complications that endanger life, such as heart failure, renal failure, and sepsis. The unpredictability and severity of disease attacks greatly affect the quality of life of patients. Therefore, patients urgently need therapies that can reduce GPP attacks while also being safe. Saint Lizzo? The family subcutaneous injection formulation was first approved in China based on a global multicenter, critical clinical study. This is a large-scale multinational randomized clinical study evaluating the reduction of GPP episodes. Professor Zheng Min, Director of the Department of Dermatology at the Second Affiliated Hospital of Zhejiang University School of Medicine and Chief Researcher of Clinical Trials in China, expressed his pleasure to participate in relevant clinical research with global experts. According to the introduction, this study evaluated the effectiveness and safety of subcutaneous injection of this product as maintenance therapy in reducing GPP episodes and continuously controlling GPP symptoms in adolescents and adults. Research shows that compared to placebo treatment, Sanlizhuo? Family subcutaneous injection preparations can significantly reduce the risk of GPP attacks by 84% for up to 48 weeks. In addition, relevant trials have shown that patients in the high-dose group did not experience GPP episodes after 4 weeks of treatment. Professor Zheng Min pointed out that this study has a groundbreaking milestone in the field of GPP treatment. Combined with the previously approved indications for treating GPP attacks and the approval of indications for reducing attacks with Pesorizumab, it provides a safe and effective full cycle disease management plan for GPP patients, allowing them to stay away from the physical and mental distress caused by repeated GPP attacks. The expert said, "We look forward to the combination of treating disease seizures and reducing seizures to provide patients with 'dual protection' and better safeguard the physical and mental health of GPP patients." Dr. Zhang Wei said that this is the first time that his multinational pharmaceutical company has achieved a global debut of an innovative drug in the Chinese market, confirming the successful implementation of the company's' China Key 'strategy. In the future, we will rely on the rich global R&D pipeline and continue to work closely with relevant departments to accelerate the introduction of innovative drugs, helping more Chinese patients innovate from both efficacy and safety

Edit:GuoGuo    Responsible editor:FangZhiYou

Source:chinanews.com

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