New Drug Research and Development for Liver Disease and Infectious Diseases

Drug Innovation Collaborative Program to Accelerate Local New Drug Research and Development for Liver Disease and Infectious Diseases

Launching Ceremony

On July 17^th, 2018, China Liver Health under the jurisdiction of Ministry of Civil Affairs launched the Drug Innovation Collaborative Program in Beijing. By establishing a network for domestic and foreign experts, the program aims to accelerate the research and development (R&D) of innovative drugs in China, promote the internationalization of local new drug with independent intellectual property rights, assist the industry to speed up R&D of new drugs, and improve the availability of new drugs, good drugs and life-saving drugs for patients. Shanghai Sinovant Pharmaceutical Technology Co., Ltd. (Sinovant Sciences) was invited to be the first partner. It focuses on intrahepatic cholangiocarcinoma (iCCA) and severe infections caused by drug-resistant bacteria and conducts epidemiological researches, new drug R&D collaboration and public science popularization.

On-the-spot Interview

Academician Zhuang Hui (honorary chairman of China Liver Health, in the middle), Professor Wei Lai (chairman of the China Liver Health, second from left), Professor Wang Lixiang (chairman of the Science Popularization Branch of Chinese Medical Association, third from right), Professor Liu Youning from the PLA General Hospital (third from left), Professor Xu Jianming (head of the department of gastrointestinal oncology of PLA 307 Hospital, second from right), and Dr. Jiang Canwen (CEO of Sinovant Sciences, first from right) conducted on-the-spot interviews on the theme of “Promoting Drug Innovation in the Field of Major Diseases in China”. Professor Cui Fuqiang (first from left) from Peking University Health Science Center presided over the meeting.

Academician Zhuang Hui, Honorary Chairman of China Liver Health

Academician Zhuang Hui pointed out that liver disease had become a global public health problem, which cannot be ignored.

Despite great achievements made in the past 30 years in the field of prevention and control of liver diseases in China, there are still severe challenges caused by viral hepatitis, fatty liver and alcoholic liver disease, drug-induced liver injury, and the resulting liver cirrhosis and liver cancer. The problem of serious infection with drug-resistant bacteria resulting from improper use of antibiotics is also very prominent. It is hoped that the Drug Innovation Collaborative Program for liver disease and infectious diseases can actively carry out work with the aim of promoting R&D of innovative drugs, improving drug accessibility and advocating humanistic care for patients and from multi-dimensions covering public science popularization, new drug innovation, drug approval and medical insurance reimbursement through promoting the joint efforts of government authorities, the pharmaceutical industry and the public.

Prof. Wei Lai said that China Liver Health would jointly establish a domestic and foreign expert network with Sinovant Sciences to accelerate the introduction and research of new molecular entity (NME) drugs for intrahepatic cholangiocarcinoma (iCCA) and severe infections caused by drug-resistant bacteria, facilitate R&D of innovative drugs with independent intellectual property rights in China, and promote the new situation of new drug in China towards novel compounds with new targets.

Dr. Jiang Canwen, CEO of Sinovant Sciences, gave an introduction to Sinovant Sciences.

Sinovant Sciences is a Chinese enterprise in new drug creation founded by returnee scientists and has a core team with rich experience in new drug R&D. It focuses on R&D and commercialization of NME drugs with revolutionary and breakthrough therapeutic effects for major diseases in China and Asia, including cancer, severe infections, rare diseases and refractory gastrointestinal, urinary and dermatologic diseases. The company's existing 11 products have entered the clinical research stage. They cover the fields of malignant tumors, serious bacterial and viral infectious diseases, rare diseases with no effective treatment, refractory digestive and urinary diseases and recurrent intractable dermatologic diseases. Among them, four products have entered or completed key clinical studies internationally and can submit applications for marketing approval or registered clinical trial in China and Asia.

Dr. Jiang Canwen, CEO and Co-founder of Sinovant Sciences

iCCA is the second most common hepatic malignant tumor in China after primary hepatocellular carcinoma. In recent years, the incidence rate of iCCA is on the rise. Due to its concealed symptoms, high malignant degree, high recurrence rate, low sensitivity to chemotherapy and poor prognosis, it is urgent to strengthen the R&D of targeted therapeutic drugs so as to improve the quality of life and improve the survival rate of patients. In addition, the incidence and mortality of severe infections (such as community-acquired pneumonia, CAP) are increasing year by year, causing a serious burden on the social economy. It results from the irregular use of antibiotics, the increase of drug-resistant pathogens, the limitations of pathogenic diagnostic techniques and lack of attention from clinicians to standardized diagnosis and treatment. This situation calls for further standardization of disease diagnosis, rational use of antibiotics to reduce drug-resistant bacteria, and reinforcement of R&D of antibacterial drugs which are safe and efficient in prevention and control of drug-resistant bacteria.

Under the Drug Innovation Collaborative Program, two types of new drugs under study have entered or completed key clinical researches internationally and are expected to bring new hope for patients with iCCA and severe infections in China and the world. Derazantinib for iCCA is a targeted therapeutic drug and proved to be safe and efficient through phase I/II clinical study. A registered clinical study for Derazantinib is currently underway abroad. Lefamulin is an innovative drug with a new antibacterial mechanism and has an antibacterial effect on a variety of currently resistant bacteria. Two phase III clinical studies for Lefamulin have been completed internationally and demonstrated its safety and efficiency in treating community-acquired pneumonia.

China Liver Health under the jurisdiction of Ministry of Civil Affairs is the only national social organization in the field of liver health promotion in China. Under the guidance of the World Health Organization and the China CDC, it has conducted a number of projects in recent years, such as the China Hepatitis C Elimination Alliance Public Welfare Project, an investigation on discrimination against hepatitis B in China and liver disease drug donation project, whichhave achieved good social response.