Weekly in Asia 20190602-0608
Thermo Fisher Scientific’s NGS-based Companion Diagnostic Test Receives Reimbursement Coverage in Japan
Tumor samples collected from non-small lung cancer (NSCLC) patients are often limited in quantity. Thermo Fisher Scientific’s Oncomine Dx Target Test utilizes the company’s Ion AmpliSeq technology, only very small amounts of biopsied tumor samples are needed. The potential for risky second biopsies and unnecessary physical burden to patients are therefore reduced.
On June 3rd, Thermo Fisher Scientific announced that its next-generation sequencing (NGS)-based companion diagnostic (CDx) Oncomine Dx Target Test has received reimbursement coverage from Japan’s Ministry of Health, Labour and Welfare.
Japanese non-small lung cancer (NSCLC) cancer patients now have access to this reimbursed NGS test to detect multiple key driver genes at the same time within four days, which will help identify if they are candidates for one of eight targeted therapies.
Oncomine Dx Target Test is FDA approved to simultaneously report 23 genes clinically associated with NSCLC. Of those 23, three contain markers that are approved for use as a companion diagnostic for specific targeted therapies.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of more than $24 billion and approximately 70,000 employees globally. The company helps customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity.
Genecare Partners with Jupiter Chain to Release a Secure Online Genetic Profiling Platform
A leading ASEAN genetics testing company, Genecare, and Jupiter Chain, a smart consentable data exchange platform, announced their collaboration to develop a secure online genetic profiling platform. Genecare’s app, NexTx, will gather medical professionals and lifestyle service providers who offer precise and targeted advice based on the client’s genetic profiling for preventive healthcare consultation with shortened time to exchange information across different systems. Medical data will be protected by blockchain technologies developed by Jupiter Chain.
Genecare is a precision, preventive healthcare company founded in 2017 to design a unique integrated end-to-end healthcare solution for clients through genetic testing, IOT and smart dispenser.
About Jupiter Chain
Jupiter Chain is a blockchain project by JEDTrade. It is a smart consentable data exchange platform that aims to create a privacy preserving federated blockchain which enables the use of analytics. Data owners can control their data and provide access to other parties to receive tailored services.
Great Bay Bio to Build a Platform for CMC Technology and Pre-Clinical R&D of Big Data Services in Hong Kong
Great Bay Bio, a leading biotechnology company dedicated to innovative drug CMC (Chemistry Manufacturing and Controls) and pre-clinical development of big data service platform, established its headquarter in Hong Kong, aiming to expand business domestically and internationally.
The company currently focuses on two major business lines-CMC platform technology services and product development, including 2 subsidiaries, Dongguan Taili Biotech Co., Ltd. and Guangdong Taili Biomedical Technology Co., Ltd.
The development target of Great Bay Bio is to focus on the fusion and development of Greater Bay Area to help pharmaceutical innovation, explore the new service package of CMC/CDMO, deepen the service system and construct one-stop new drug service.
About Great Bay Bio
Headquartered in Hong Kong, the CMC/CDMO platform of Great Bay Bio was originally established in 2002. The company has a strong existing track record of developing CMC packages for products entering NDA stage, some of which are national class I projects of innovative biological New drugs.
HitGen Enters into DNA-Encoded Library Based Drug Discovery Research Collaboration with Gilead Sciences
HitGen Inc. and Gilead Sciences announced that the two companies have entered into a drug discovery research collaboration to identify potential small molecule leads against targets of interest to Gilead. In this collaboration, HitGen will apply its DNA-encoded library (DEL) technology platform to discover novel leads. HitGen will work closely with Gilead to generate new small-molecule lead compounds for their research programs to help bring transformative medicines to patients. Under the terms of the agreement, HitGen will receive an undisclosed upfront payment and will be eligible for milestone payments from Gilead.
About HitGen Inc.
HitGen is a rapidly growing biotech company with headquarters and custom-built research facilities based in Chengdu, China, with a subsidiary in the USA. HitGen has established an industry-leading platform for early-stage drug discovery research centred on DNA encoded chemical libraries (DELs).
About Gilead Sciences
Gilead Sciences, Inc., a research-based biopharmaceutical company, discovers, develops, and commercializes medicines in the areas of unmet medical needs in the United States, Europe, and internationally.
Cstone Submits First New Drug Application, Seeking Approval for Tibsovo in Taiwan
Acute myeloid leukemia (AML), an aggressive cancer of the myeloid cells, is the most common acute form of leukemia in adults. The incidence rate is approximately 800 annual cases in Taiwan, with five-year survival rate of 26%. The prognosis for relapsed or refractory (R/R) AML patients after currently available treatment is poor. Around 6%-10% of all AML cases inherit the isocitrate dehydrogenase-1 (IDH1) mutation.
Discovered by CStone’s partner, Agios Pharmaceuticals, TIBSOVO® (ivosidenib), is a first-in-class, oral, potent and selective inhibitor of the mutant IDH1 enzyme. It was approved by the U.S. FDA for adults with R/R AML with an IDH1 mutation in 2018.
CStone Pharmaceuticals recently announced the submission of a new drug application (NDA) for TIBSOVO® to the Taiwan Food and Drug Administration (TFDA) as the first to-be-approved treatment of adult patients with R/R AML with a susceptible IDH1 mutation. The TFDA awarded TIBSOVO the NDA filing priority review status on April 24, 2019.
About Cstone Pharmaceuticals
Cstone Pharmaceuticals is a biopharmaceutical company devoted to the development of a new generation of innovative drugs. The company develops cancer therapeutics with a focus on immuno-oncology based combination therapies and engages in developing model for drug development with a focus on clinical development.
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