Weekly in Asia｜Oct-2
20191013-1019 Weekly in Asia
Daiichi Sankyo Launches New Drug for Relapsed/Refractory AML Patients
Acute myeloid leukemia (AML) is the most common adult leukemia in Japan, around 5,500 new cases are diagnosed yearly. The five-year survival rate of AML reported was the lowest of all leukemias.
FLT3-ITD is the most common genetic abnormality in AML, approximately one in four patients with AML harbor this mutation. FLT3-ITD is a driver mutation that presents with high leukemic burden and has poor prognosis and a significant impact on disease management for patients with AML. Patients with FLT3-ITD AML have a worse overall prognosis, including an increased incidence of relapse, an increased risk of death following relapse, and a higher likelihood of relapse following hematopoietic stem cell transplantation, as compared to those without this mutation.
Daiichi Sankyo Company, Limited, announced on October 10th the launch of VANFLYTA® (quizartinib), an oral FLT3 inhibitor, for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML) in Japan.
The marketing approval of VANFLYTA® by Japan’s Ministry of Health, Labor and Welfare (MHLW) in June 2019 was based on the results of the global pivotal phase 3 QuANTUM-R study.
About Daiichi Sankyo
Daiichi Sankyo Company, Limited is a global pharmaceutical company and the second-largest pharmaceutical company in Japan. The Company provides medicines for high and low blood pressure, heart related events, and other related diseases.
Viela Bio Collaborates with Mitsubishi Tanabe Pharma to Develop and Commercialize Autoimmune Disease Drug in Japan and Other Asia Regions
The U.S. Food and Drug Administration (FDA) recently approved Viela’s Biologics License Application (BLA) for inebilizumab for the treatment of neuromyelitis optica spectrum disorder (NMOSD).
Viela Bio, Inc. and Mitsubishi Tanabe Pharma Corporation (MTPC) announced on October 9th a collaboration focused on the development and commercialization of Viela’s humanized anti-CD19 monoclonal antibody – inebilizumab.
Under the collaboration agreement, MTPC will be responsible for leading development and commercialization of inebilizumab in nine Asia regions, Japan, Thailand, South Korea, Indonesia, Vietnam, Malaysia, The Philippines, Singapore, and Taiwan. Viela is eligible of receiving an up-front licensing fee of USD $30 million as well as additional payments of certain development and commercial milestones, depending on sales revenue.
About Viela Bio
Viela Bio, Inc., headquartered in Gaithersburg, Maryland, is a clinical-stage biotechnology company pioneering treatments for autoimmune and severe inflammatory diseases.
About Mitsubishi Tanabe Pharma
Mitsubishi Tanabe Pharma, founded in 1678, is headquartered in Doshomachi, Osaka. The Company produces pharmaceutical products for cardiac arrest, hypertension, circulatory disease, and ulcer.
Bayer Inks a Deal with Wellthy Therapeutics Under G4A Digital Health Partnerships Program
The current population of India is 1.3 billion. One of the biggest challenges to healthcare in India is chronic diseases. According to statistics, most chronic diseases are equally prevalent in poor and rural populations and often occur together. Much of the care for chronic diseases and injuries is provided in the private sector and can be very expensive.
Bayer announced on October 10th that the companys’ G4A Digital Health has signed collaboration agreements with eleven digital health startups from all over the world, including one from India- Chronic disease management firm Wellthy Therapeutics, to help improve its product, regulatory and commercialisation capabilities and explore areas of collaboration.
About Wellthy Therapeutics Pvt Ltd
India-based Wellthy Therapeutics Pvt Ltd operates as a digital therapeutics company. The Company offers patient centric solutions and programs for controlling diabetes through digital intervention and management.
Bayer is a global enterprise that produces and markets products such as aspirin, antibiotics, anti-infectives, cardiovascular, oncology, central nervous system drugs, diagnostics, and animal health products.
Innovent and Chi-Med Expand Global Collaboration to Evaluate the Combination Treatment for Solid Tumors
On October 10th, Innovent Biologics of Suzhou and Hutchison China MediTech (Chi-Med) expanded their global collaboration to include a combination of Innovent’s approved PD-1 drug, Tyvyt® (sintilimab), and Chi-Med’s surufatinib. The expansion builds on the existing global collaboration agreement between the two companies on sintilimab in combination with Chi-Med’s highly selective VEGFR inhibitor, fruquintinib.
Under the agreement, the two companies will evaluate the safety and efficacy of the combination treatment in patients with advanced solid tumors.
Innovent’s Tyvyt® is a fully human anti-programmed cell death protein 1 (anti-PD-1) monoclonal antibody jointly developed in China by Innovent and Eli Lilly and Company. Chi-Med’s surufatinib is a novel inhibitor of vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor 1 (FGFR1) and colony stimulating factor-1 receptor (CSF-1R).
About Innovent Biologics, Inc.
Established in 2011, Innovent is a Chinese biopharmaceutical company committed to developing, manufacturing and commercializing high quality innovative medicines for the treatment of major diseases.
Hong Kong-based Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and markets pharmaceutical products. The Company has a portfolio of eight cancer drug candidates currently in clinical studies.
Taiwan’s Ministry of Health and Welfare is Set to Regulate Genetic Testing
In Taiwan, genetic testing is commonly used to enable personalized medication. It can be processed not only in hospitals but also at sites other than that.
Ms. Liu Yueh-ping, Senior Specialist of the Department of Medical Affairs, the Ministry of Health and Welfare, said that last year there was the idea of the primary authority to regulate genetic testing, but due to the fact that genetic tests have been developed for complex interaction conditions of genes and environmental factors, it did not take place.
The Ministry of Health and Welfare recently announced that at the end of this year, special measures will be included in gene testing, and it is planned to limit the genetic testing to be performed in medical institutions.
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