On the 6th, the reporter learned that the subcutaneous injection formulation of the innovative targeted biologic for rare skin diseases, the Spevigo® family (generic name: spesolimab), has been approved for marketing by China's National Medical Products Administration, becoming the first global innovative drug among multinational pharmaceutical companies to be developed simultaneously across global multicenter sites and approved first in China, earlier than in the United States, the European Union, and Japan.

Dr. Zhang Wei, the relevant head of R&D and medical affairs for the multinational pharmaceutical company's Greater China region, told reporters that day: "The approval of the Spevigo® family subcutaneous injection formulation in China ahead of other countries demonstrates the Chinese government's determination to accelerate the review and approval of new and good drugs, focusing on 'clinically urgent needs' and speeding up the delivery of innovative drugs to patients."

Generalized pustular psoriasis (GPP) is a rare, relapsing or persistently active severe skin disease. Unlike ordinary psoriasis, GPP manifests clinically as widespread outbreaks of pustules on the skin, accompanied by pain and possibly systemic symptoms such as high fever. It is reported that the Spevigo® family subcutaneous injection formulation has been approved to reduce GPP flares in adolescents aged 12 and above (weighing ≥40 kg) and adults.

It is understood that GPP flares may lead to hospitalization and may even be accompanied by severe complications that endanger life, such as heart failure, renal failure, and sepsis, while the unpredictability and severity of flares greatly affect patients' quality of life. Therefore, patients urgently need therapies that can reduce GPP flares while also being safe.

The approval of the Spevigo® family subcutaneous injection formulation in China ahead of other countries was based on a global multicenter pivotal clinical study. This was a large-scale multinational randomized clinical study evaluating the reduction of GPP flares. Professor Zheng Min, Director of the Department of Dermatology at the Second Affiliated Hospital of Zhejiang University School of Medicine and the China principal investigator of the relevant clinical trial, said he was pleased to participate in the relevant clinical research together with global experts.

According to the introduction, the study evaluated the efficacy and safety of subcutaneous injection of this product as maintenance therapy in reducing GPP flares and continuously controlling GPP symptoms in adolescents and adults. The study showed that, compared with placebo, the Spevigo® family subcutaneous injection formulation significantly reduced the risk of GPP flares by 84% for up to 48 weeks. In addition, the relevant trial demonstrated that patients in the high-dose group experienced no GPP flares after 4 weeks of treatment.

Professor Zheng Min pointed out that this study has breakthrough milestone significance in the field of GPP treatment. Combined with the previously approved indication for treating GPP flares, the approval of the indication for spesolimab in reducing flares provides GPP patients with a safe and effective full-cycle disease management plan, allowing patients to stay away from the physical and mental distress caused by recurrent GPP flares. The expert said: "We look forward to combining treatment of disease flares with flare-reduction therapy 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 his multinational pharmaceutical company has achieved the global first launch of an innovative drug in the Chinese market, confirming the successful implementation of the company's "China Key" strategy. "In the future, relying on our rich global R&D pipeline, we will continue to work closely with relevant departments to accelerate the introduction of innovative drugs and help more Chinese patients benefit from innovative drugs that combine efficacy and safety."