On the morning of July 24th, the world's first and only targeted biologic agent Dabitol (dupliu monoclonal antibody injection) approved for the treatment of moderate to severe atopic dermatitis in adults was developed by the director of the Department of Dermatology, Huashan Hospital, Fudan University Professor Jinhua Xu issued the first prescription in Shanghai.
On the same day, in the outpatient clinic of Professor Zhang Jianzhong, the director of the Dermatology Department of Peking University People's Hospital, and Professor Yang Bin, the chief physician of the Southern Medical University Dermatology Hospital, patients from Beijing and Guangzhou also ushered in this new drug in anticipation.
In order to meet the urgent needs of patients with moderate to severe atopic dermatitis for innovative drugs, Dabituo has been running fast to China at a "lightning" speed-thanks to the promotion of the national drug regulatory reform, Dabituo is ahead of the original plan It has been approved for two years; thanks to the speed-up of the import inspection process of innovative drugs, Dabituo has obtained the Imported Drug Registration Certificate (IDL) from June 28 to July 22. A new record for the speed of preparations on the market in China.
"Itching" of insomnia at night, patients are eager for a new treatment
Moderate to severe atopic dermatitis (AD) is a refractory, recurrent, inflammatory skin disease, with recurrent severe itching and rash as the main clinical manifestations , Patients often have other atopic diseases such as allergic rhinitis and asthma. Many surveys in Asian countries and regions have shown that the prevalence of atopic dermatitis in adults is 0.9%-2.1%.
"When I was in the third year of high school, I got sick and itching made people unable to sleep at night. I woke up every night and scratched, sometimes scratching my skin, and my body was covered with bloody dander. I was not concentrated in class during the day, which greatly affected my college entrance examination preparation. My family has taken me to many hospitals and used many methods, but I have never received effective treatment.” Hu said that after the illness, it has a great impact on study and life. At one time, my mentality was both low self-esteem and laxity. Gained confidence.
Dabitol's first prescription in Shanghai area received injection of
. This is not a case. Most patients with moderate to severe atopic dermatitis have pain and discomfort symptoms caused by skin cracking, crusting, and exudation. If they are not effectively controlled, they will affect their mood and psychological state, leading to anxiety, depression, and loneliness.
"Lightning" speed benefits patients, and innovative biologics accelerate the market.
Professor Xu Jinhua said: "Currently, the treatment of atopic dermatitis is based on the patient's condition, with external medications such as topical glucocorticoids and oral glucocorticoids. Mainly with immunosuppressants, but hormone therapy is a double-edged sword. Long-term medication may cause side effects, and there is still a lack of effective and safe methods. As a targeted therapy, Dabituo’s approval for marketing is epoch-making The significance of this is that it can not only effectively, quickly and continuously relieve symptoms such as itching and skin lesions after use, but also as a fully human monoclonal antibody, it rarely induces acquired immune responses in the body, and the incidence of anti-drug antibodies is low. The overall safety of placebo is similar, which can effectively improve the quality of life of patients and bring new hope to patients." As an innovative biological agent,
is different from many traditional chemical drugs which are mainly metabolized by the liver and kidneys. eliminate. In addition, Dabituo does not need to perform pre-medication inspections required for general biological preparations, and its effectiveness and safety have been confirmed by a number of clinical studies and real-world studies. Thanks to the "National Nine Articles" policy, in February 2019, Dabituo was introduced to Boao Super Hospital Dermatology Clinical Medical Center, which also showed good safety and tolerability in patients receiving injection therapy. After learning about the news through patient organizations such as the China AD Home, many patients expressed their expectations for the early listing of Dabituo.
"Inspired by the national priority review and approval policy, the introduction of innovative original research drugs has been creating a'China speed'. The speed of the introduction of Dabituo has exceeded industry expectations. It is the country's acceleration of innovative drugs to benefit Chinese patients. Vigorous practice." Professor Xu Jinhua said.
's continuously accelerating drug supervision mechanism has accelerated the launch of clinically urgently needed innovative drugs. Shi Xiaoye, Director of the Business Section of the Shanghai Food and Drug Inspection Institute, said: “This new record comes from our continuous exploration of innovative mechanisms for biological agents, opening up a green channel for innovative drugs such as Dabitol and serving as a therapeutic category for the National Food and Drug Administration. The key laboratory for monoclonal antibody quality control, in the face of the ever-increasing launch of innovative drugs, responds and reserves technically and talents, and completes import statutory inspections in the shortest time with superb technology and high-quality services. , I hope to make every effortChinese patients use innovative drugs one day earlier. "
Sanofit Pharmaceuticals Global Business Unit China General Manager Wang Bokang said: "We are proud to have achieved Dabituo's approval for listing in China in just 25 days. This new industry benchmark is inseparable from government regulatory agencies at all levels. Shanghai Customs and Shanghai Food and Drug Inspection Institute provide strong support for the launch of innovative drugs, as well as the active cooperation of partners. Sanofi adheres to the patient-first and scientific-leading concept, and joins hands with Magnesium Health to jointly launch the "Care and Care" patient care project to reduce the financial burden of patients and enable Dabito to benefit more patients. "
Attached: Dabituo Shanghai diagnosis and treatment map
(Dabituo is a prescription drug, please follow the doctor's advice, if you need to consult a professional doctor about related questions, you can go to each hospital for inquiries)
