Health & Beauty

From 2015 to 2022, the National Drug Evaluation Center approved 205 new dermatological drugs for clinical trials, including 84 biological products and 121 chemical drugs; A total of 22 new dermatological drugs and 3 new drug indications have been approved for marketing. On March 19th, at the "China Dermatology New Drug Research and Development and Innovation Summit Forum under the Global Vision" hosted by the China New Drug Journal, Xie Songmei, Director of the Chemical Medicine Clinical Department II of the Drug Evaluation Center of the National Drug Administration, shared a group of data on new dermatology drugs in China, and pointed out that the innovation of dermatology drugs in China is showing an increasing trend year by year, and Huacheng Import and Export Data Observation Report.

Most skin diseases are already treatable with drugs

Kong Fanpu, Chief Researcher of Tsinghua University and former Director of the Drug Evaluation Center of the State Drug Administration, pointed out that since the reform of the drug review and approval system in 2015, the State Drug Administration has provided a series of policy guarantees and technical support to encourage and promote drug innovation and meet the clinical drug use needs of patients, and a large number of new drugs have accelerated the market to benefit patients. In the past, there was a lack of effective treatment methods for refractory skin diseases that seriously affected the quality of life of patients. With new safe and effective drugs, the treatment of skin diseases in China is undergoing tremendous changes.

"In recent years, the intensive marketing of new dermatological drugs in China has brought new treatment options for patients with dermatosis. Biological agent therapy for psoriasis, topical aromatic hydrocarbon receptor (AhR) modulators for psoriasis, biological agent therapy for atopic dermatitis, JAK inhibitor therapy for atopic dermatitis, urticaria biological agent therapy, and JAK inhibitor therapy for alopecia areata have been pointed out by Zhang Jianzhong, director of the dermatological department of Peking University People's Hospital.", In the past decade, the research and development of new drugs for skin diseases has entered a fast lane, and the treatment of skin diseases has entered a new stage. The vast majority of infectious diseases have been effectively treated, and the vast majority of physical skin diseases are easy to treat. Huacheng Import and Export Data Observation Report.

Multidimensional construction of new drug creation ecology

New drugs in dermatology have achieved fruitful results, and the treatment of skin diseases has developed by leaps and bounds. These remarkable achievements have benefited from the general trend of the reform of the national drug review and approval system to promote the rapid development of new drug research and development, and have gathered the dedicated efforts of scientists to tackle key issues. Moreover, they cannot be separated from the scientific guidance and strong support of drug review experts. At the forum, drug review experts and scientists from the frontline combined their own experiences to produce a theme report on the creation of new drugs in dermatology.

Xie Songmei introduced that the current review and approval speed and efficiency of innovative drugs in China are synchronized with the international level, and some even lead the international level. In 2022, China participated in global international multicenter clinical trials and was approved for the launch of three new dermatological drugs, achieving global synchronous research and development and synchronous launch. The time difference between domestic and foreign approvals was only one month. It is worth mentioning that the independently developed and innovative Benvimod cream in China was first approved for listing in 2019, a full three years earlier than the listing in the United States. In addition, Xie Songmei shared the key points she and her review team had made before the research and development of Phase I, II, and III clinical trials in Benvimod. She communicated with the enterprise for many times and gave detailed and specific scientific suggestions on key technical issues in the design of clinical trials in each phase, greatly improving the quality and efficiency of the enterprise's research and development. Huacheng Import and Export Data Observation Report.

Wang Yamin, Director of the First Department of Chemical Pharmacy of the Drug Evaluation Center of the State Drug Administration, said that under the new drug supervision, review and approval mechanism, it is particularly important to strengthen communication and exchange in new drug pharmacy. He reminded that it is necessary to combine the characteristics of the drug itself and the cognitive and production experience accumulated during the phase I/II clinical trial research phase, address the remaining issues related to traditional Chinese medicine in the clinical trial notice as soon as possible, and improve the relevant research in accordance with the technical requirements such as the "Guidelines for Pharmaceutical Research Information in Phase III Clinical Trial of Innovative Drugs (Chemical Drugs)". At the same time, pharmaceutical communication and exchange meetings before phase III clinical trials are particularly important for raw materials, complex preparations, and complex pharmaceutical and mechanical combinations with complex processes and difficult quality control.

Aromatic hydrocarbon receptor modulators change the treatment pattern of skin diseases

Psoriasis is a systemic inflammatory disease that seriously endangers human health. In recent years, the incidence rate of psoriasis has been rising. In terms of treatment, Lu Qianjin, Executive Director of the Dermatology Hospital of the Chinese Academy of Medical Sciences and Chairman of the Dermatology and Venereology Branch of the Chinese Medical Association, introduced that psoriasis is not a simple skin problem, but a systemic disease. In the leap from broad-spectrum therapy to the era of precision, biological agents have brought revolutionary changes to the treatment of psoriasis. It is gratifying that the enthusiasm for research and development in the industry has been rising all the way. Currently, the research and development of psoriasis treatment drugs is showing a situation where a hundred flowers bloom and a hundred schools of thought contend. Many new research achievements have emerged in external medication, small molecule oral drugs, stem cell therapy, and other aspects, and the future can be expected.

According to Huacheng Import and Export Data Observation, in 2022, the internationally authoritative journal Nature Review - Drug Discovery reviewed the progress of new drug research and development in China over the past decade, with 1404 new drugs listed in China from 2010 to 2020. Among them, Benvimod is one of the three First-in-class new drugs. Dr. Chen Genghui, inventor of the innovative AhR target drug Benvimod and CEO of Shanghai Zederman Pharmaceutical Technology Co., Ltd., introduced that AhR is a transcription regulatory factor that can bind ligands within cells, helping cells perceive the external environment. Recent studies have shown that AhR participates in physiological processes such as cell physiology, host defense, immune cell proliferation and differentiation, and detoxification, and regulates the immune system by integrating genes and environmental factors.

"AhR is widely expressed in the human body and is a potential target for the treatment of various diseases." Regarding drug development ideas targeting AhR, Chen Genghui stated that AhR is a potential target for the treatment of various diseases such as age-related macular degeneration, glaucoma, chronic obstructive pulmonary disease, asthma, psoriasis, and atopic dermatitis. In particular, in the field of skin immune regulation, AhR modulators have a unique mechanism of action in the treatment of inflammatory skin diseases, and are becoming a change in the treatment pattern of skin diseases.

How does the review and approval of new dermatological drugs align with international standards to promote China's global leadership in the research and development of new dermatological drugs? After the theme report, the forum also held a salon discussion on "scientific regulation enabling innovative drugs to go to sea". Leaders from the national drug review department, experts from different fields such as clinical frontline, innovative drug research and development, warmly discussed the relationship between the development process of innovative drugs in China and drug scientific supervision in recent years.

In addition, according to the Huacheng Import and Export Data Observation Report, in order to promote the collaboration of innovative drug research and development in China's dermatology department in an all-round and full chain, we have integrated resources from academic organizations, medical institutions, pharmaceutical enterprises, and relevant industry experts to build an innovative drug research and development and academic exchange platform for production, learning, research, and use. At the forum, experts and entrepreneurs proposed the establishment of the "China Dermatology Innovative Drug Alliance", and the preparatory work for the alliance was led by Shanghai Zederman Pharmaceutical Technology Co., Ltd.