(July 4, 2020, Shanghai) Fosun Pharma (Stock Codes: 600196.SH, 02196.HK) announced today to launch in China its first innovative small molecule medicine Doptelet® (generic name: Avatrombopag Maleate Tablets, or “Avatrombopag” in short) for treating adult patients with chronic liver disease (CLD)-related thrombocytopenia undergoing elective diagnostic procedures or surgery. Avatrombopag is currently the world's first FDA-approved oral thrombopoietin receptor agonist (TPO-RA) for CLD-related thrombocytopenia. Its launch fills a gap in the treatment of CLD-related thrombocytopenia in China and provides a new, globally leading solution with "potent, durable, safe, and convenient" treatment for patients with CLD-related thrombocytopenia in China.

The guests invited to the product launch event included Academician Fan Jia from Zhongshan Hospital of Fudan University, Academician Chen Xiaoping from Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, and Academician Dong Jiahong from Beijing Tsinghua Changgung Hospital, who delivered the opening speeches.

Academician Fan Jia, Zhongshan Hospital, Fudan University:

"The approval for Doptelet® to be marketed in China is another milestone in Fosun Pharma's innovative achievements."

Academician Chen Xiaoping, Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology:

"The launch of Doptelet® provides clinicians with another treatment option and will benefit Chinese thrombocytopenia patients."

Academician Dong Jiahong, Beijing Tsinghua Changgung Hospital:

"As China's first medicine approved for CLD-related thrombocytopenia, Doptelet® will greatly facilitate invasive tests and procedures for clinicians and improve the quality of life for patients."

Professor Wang Guiqiang from Peking University First Hospital, Professor Ma Jun from Harbin Hematology-Oncology Institute, Professor Wu Depei from the First Affiliated Hospital of Soochow University, Professor Teng Gaojun from Zhongda Hospital Southeast University, Professor Zhou Jian from Zhongshan Hospital of Fudan University, and Professor Chen Minshan from Sun Yat-sen University Cancer Centre attended the event and chaired the meeting.

Wu Yifang, President and CEO of Fosun Pharma, said that the launch of Doptelet® ended the longstanding awkward absence of innovative and highly effective medicines for treating CLD-related thrombocytopenia in China and introduced a new world-leading clinical treatment for Chinese patients with CLD-related thrombocytopenia. Fosun Pharma will continue to use innovative research and development as its core driver for faster development of innovative medicines to meet unmet clinical needs and provide high-quality and accessible products and services for patients and customers.

Large patient base requires effective and safe clinical solutions

Although platelets are the smallest blood cells, they play an essential and irreplaceable role. Functioning to promote hemostasis and accelerate blood coagulation, they are an important safeguard for the development of invasive medical operations and surgical procedures. When the peripheral blood platelet count (PLT) is less than 100×109/L, it is clinically diagnosed as thrombocytopenia.

Thrombocytopenia is one of the common complications in patients with chronic liver disease.  Huge volume of patient data is available in China where patients of liver disease are vast in number. The relevant data show that 90 million and 10 million people are infected with hepatitis B virus (HBV) and hepatitis C virus (HCV) respectively. At the same time, there are about 173 to 338 million patients with non-alcoholic fatty liver disease and at least 62 million patients with alcoholic liver disease, of which as many as 7 million have cirrhosis [1]. It is also reported that up to 78% of cirrhosis patients have concomitant thrombocytopenia to various degrees [2]. If a patient with chronic liver disease has CLD-related thrombocytopenia, he/she will have significantly higher risk of hemorrhage making it impossible for him/her to receive a series of clinically invasive examinations and treatments, such as liver biopsy, interventional therapy for liver cancer, etc. That makes the clinical process very difficult. As a result, patients with CLD-related thrombocytopenia have a particularly urgent need for a rapid increase in platelet count within a short time when surgery or other invasive tests are required.

In China, platelet transfusion has always been the only treatment approved for CLD-related thrombocytopenia. However, taking into consideration that patients face risks like insufficient platelet supply and potential infection, more efficient, convenient and safer alternative treatments are urgently needed.

Filling the gap in the treatment of CLD-related thrombocytopenia 

New-generation TPO receptor agonist brings a breakthrough

Avatrombopag is the world's first FDA-approved next-generation TPO-RA for treating CLD-related thrombocytopenia. Its launch in China fills the gap in the treatment of the disease and provides a new treatment option for patients. Currently, Avatrombopag has become the only platelet-increasing medicine recommended by liver disease-related guidelines in China.

Professor Wang Guiqiang, Director of the Infectious Diseases Department and the Liver Disease Center at Peking University First Hospital and Director of the Infectious Diseases Section of the Chinese Medical Association, said, "Patients with CLD-related thrombocytopenia have a significantly higher risk of hemorrhage, making it impossible for them to receive a series of clinically invasive examinations and treatments such as liver biopsy and interventional therapy for liver cancer. It can make the clinical management of the patient quite difficult. Today, the official launch of Doptelet® (Avatrombopag) is good news for patients with CLD-related thrombocytopenia."

In recent years, significant progress was achieved in the research on next-generation TPO receptor agonists and had aroused extensive attention from the academic community. Avatrombopag, a new-generation TPO receptor agonist, is a small-molecule non-peptide which has no sequence homology and immunogenicity with endogenous thrombopoietin (TPO). It has no risk of antibody production and has a superimposed platelet-increasing effect, which allows the platelet count to maintain at a safe level for a more extended period with low potential risk of thrombosis. The oral medication requires no dietary restrictions, so it also improves patients’ quality of life. It is expected the Chinese patients will be provided with a "potent and durable, safe and convenient" treatment.

Commercialization to enhance clinical benefits for Chinese patients

In clinical practice, thrombocytopenia can be secondary to various diseases, increasing the risk of hemorrhage while delaying the treatment process and ultimately affecting the long-term survival of patients. In addition, Avatrombopag also plays an active role in areas such as chemotherapy-induced thrombocytopenia (CIT) and immune thrombocytopenia (ITP). It has a promising prospect of providing innovative treatment options for more patients with thrombocytopenia in China.

Professor Ma Jun, Director of Harbin Institute of Hematology and Oncology, said that in the latest version of CSCO Expert Consensus in 2019, oral TPO-RA was recommended for the first time to treat patients with CIT caused by tumor-chemotherapy which do not respond to traditional therapeutic drugs, and primary clinical efficacy has been observed. The approval of Avatrombopag for patients with CLD-related thrombocytopenia is a good start, and Professor Ma expects that it will bring a safe and convenient treatment to more Chinese patients.

Professor Wu Depei, Director of the Department of Hematology of the First Affiliated Hospital of Soochow University and Chairman of the Hematology Branch of the Chinese Medical Association, said that the approval of Avatrombopag for CLD-related thrombocytopenia was a great encouragement to front-line doctors. He hopes this medicine will achieve fast progresses in its registered clinical trials for ITP in China and provide updated treatment options and more clinical benefits to ITP patients in China as soon as possible.

Li Shengli, Vice President of Fosun Pharma, Senior Vice President of Fosun Pharmaceutical Industrial, and Chairman of Jiangsu Fosun Pharma, said that the launch of Doptelet® would introduce a new clinical treatment model for patients with CLD-related thrombocytopenia in China. Fosun Pharma will also develop the complete ecosystem of "medicine + insurance + health management" as part of its commitment to improving patients' quality of life. It will help more Chinese patients receive beneficial treatments with more affordability and convenience through expansion of indications, drug supply guarantees, innovative payment methods, and digital platforms.

[1] Xiao J, Wang F, Wong NK, at al. Global liver disease burdens and research trends: Analysis from a Chinese perspective. J Hepatol. 2019,71(1): 212–221.

[2] Miller JB, Figueroa EJ, Haug RM, et al. Thrombocytopenia in Chronic Liver Disease and the Role of Thrombopoietin Agonists. Gastroenterol Hepatol (N Y). 2019 Jun;15(6):326-332.