Weekly in Asia 2019｜AUG-1
20190811-0817 Weekly in Asia
U.S. Nonprofit Think Tank ITIF Warns U.S. of China’s Pharmaceutical Industry
In the past twenty years, China has made considerable progress in the growth of pharmaceutical industry relative to the United States. While China formulated some positive biopharma policies, its “innovation mercantilism” strategy, including biased drug approvals, severe price controls, subsidies, import restrictions, and substandard exports, has unfairly benefit Chinse firms and hurt U.S.’s biotechnology industry.
The Information Technology and Innovation Foundation (ITIF), a U.S. nonprofit public policy think tank based in Washington, D.C., recently published a report on the threat China’s “Made in China 2025” is posing on the global biotechnology industry. The report emphasizes the importance of the biopharmaceutical industry to the U.S. economy, reviews China’s strategy and policies in the biopharmaceutical industry, and discusses how the U.S. government should respond. In the end, the report suggests that the U.S. government ensure U.S. policies, such as drug-pricing policies, support industry investment in research and development (R&D) and innovation.
NUS, Agilent, and NUH launch NUS-Agilent Hub to Propel Clinical Diagnostics Singapore
On August 19, the National University of Singapore (NUS), Agilent Technologies, and National University Hospital (NUH), announced the establishment of an integrated translational R&D hub, the NUS-Agilent Hub. Cardiovascular disease and diabetes account for 30 percent of all deaths in Singapore in 2017 and will thus be the research focus. The related lipidomics and synthetic biology research areas will be backed by data analytics, to enhance the accuracy of clinical diagnostics based on data obtained from patients’ blood samples.
The NUS-Agilent Hub aims to become a global standard through the use of cutting-edge technologies to provide greater accuracy in clinical testing. The collaboration between NUS, Agilent, and NUH represents a unique and innovative joint research into major health issues and medical science.
About Agilent Technologies
Agilent Technologies Inc is a global leader in life sciences, diagnostics, and applied chemical markets. The Company offers solutions that improve the efficiency of the entire laboratory, from sample preparation to data interpretation and management.
Xylonix and Biogemex Signs MOU to Co-develop a Cancer Immunotherapy-Response Diagnostic
Xylonix, an immuno-oncology biotech based in Singapore, and BioGemex, a leading Korean medical diagnostic company, announced on August 16th that the two companies have signed a Memorandum of Understanding (MOU) to jointly develop a tumor microenvironment biomarker, XDX-01, to better predict a patient’s response to T-cell mediated cancer immunotherapies in solid tumors.
The preliminary validation of XDX-01 in clinical patient response and survival data showed better prediction power compared to tumor mutation burden (TMB), the current standard. The two companies will work together to scale the manufacturing of XDX-01 and conduct broader clinical validation studies to launch it in 2020.
Xylonix is an immuno-oncology biotechnology company that is developing new ways of combating cancer. Besides the XDX-01 biomarker, Xylonix’s lead development candidates are onco-parthanatos agents C005D and C008D, which are being developed as monotherapies or for use with other immunotherapies.
South Korea-based BioGemex accelerates clinical investigations of cancer immunotherapies. In addition to its R&D and manufacturing operations, BioGemex also offers ODM/OEM pregnancy test kits of the highest accuracy and reliability for Korea and overseas markets.
China NMPA Approves Biktarvy® for Treatment of HIV-1 Infection
In China, more than 150,000 people are diagnosed with HIV each year. The Chinese government has provided free antiretroviral treatment to patients with HIV since 2003.
Gilead Sciences, Inc. announced on August 9th that the China National Medical Products Administration (NMPA) has approved Biktarvy® for the treatment of HIV-1 infection.
Biktarvy is triple therapy with a combination of bictegravir (BIC), emtricitabine (FTC), and tenofovir alafenamide (TAF). Biktarvy is indicated for the treatment of HIV-1 infection in adults without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir. Biktarvy offers high rates of efficacy, high barriers to resistance and a demonstrated tolerability profile, underscoring its role as an important new treatment option for HIV patients in China.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops, and commercializes therapeutics to advance the care of patients. The Company primary areas of focus include HIV, AIDS, liver disease, and serious cardiovascular and respiratory conditions.
Oncologie and Merck Collaborates to Evaluate Bavituximab in Combination with Keytruda® in Advanced Gastric or Gastroesophageal Cancer
Oncologie, Inc., a clinical-stage biopharmaceutical company announced on August 12th that it has entered into a collaboration agreement with Merck Sharp & Dohme Corp. (MSD). The two companies will conduct a Phase 2 single arm open-label study to determine the efficacy and safety of Bavituximab in combination with KEYTRUDA® (pembrolizumab) in patients who have advanced gastric and gastroesophageal cancer but have failed at least one line of treatment. The study is expected to enroll around 80 patients in the U.S., United Kingdom, Korea and Taiwan in the second half of 2019.
Studies find that Bavituximab reverses phosphatidylserine (PS)-mediated immunosuppression by blocking the binding of PS with its receptors, resulting in immune activation and anti-tumor immune responses. This mechanism allows other cancer therapies to attack tumors more effectively.
Oncologie, Inc. is an innovative biopharmaceutical company that manufactures novel pharmaceuticals, drug substances, and other products. Its current pipeline includes clinical programs that improve treatment outcomes by modulating the tumor micro-environment and enhancing the immune response to targeting cancer cells.
Merck Sharp & Dohme Corporation (MSD) operates as a research-intensive biopharmaceutical company. The Company discovers, develops, and provides medicines, vaccines, and animal health products.
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