Weekly in Asia 20190526-0601

Public Insurance to Cover Cancer Therapy Genetic Test in Japan

On May 29th, Japan’s Ministry of Health, Labour and Welfare announced that genetic tests to help identify the best drugs and therapies for cancer patients will be covered between 70% to 90% by the public health insurance system starting on June 1st. The insurance coverage will be applicable to patients with solid tumors who have not responded to surgery or drug treatments, pediatric cancer patients, and patients with rare cancers.

Last December, the Japanese government approved the marketing of two cancer genome profiling systems, the OncoGuide™ NCC Oncopanel, developed by the National Cancer Center and Sysmex Corporation, and FoundationOne CDx, developed by Foundation Medicine and marketed by Chugai Pharmaceutical Company. Both systems are capable of profiling over 100 types of cancer-related genes in a single test by analyzing tumor tissue. Without insurance coverage, the cost for either product would be ¥560,000 (USD$5,100).

According to estimations, it is expected that up to 26,000 people will be benefited, with sales of the products totaling around ¥15 billion annually.

Viela Bio and Hansoh Pharma Collaborates to Develop and Commercialize Inebilizumab in China

Viela Bio, a AstraZeneca spinout and Chinese drugmaker Hansoh Pharmaceutical Group announced a collaboration on the development and commercialization of Viela’s humanized anti-CD19 monoclonal antibody inebilizumab in China for neuromyelitis optica spectrum disorder (NMOSD), as well as autoimmune and hematologic cancer indications.

Under terms of the collaboration, Viela will receive an up-front payment and additional payments for certain development, regulatory, and commercial milestones, all of which could exceed $220 million. Hansoh Pharma will be in charge of the development and commercialization of inebilizumab in China.

Inebilizumab is a humanized monoclonal antibody that binds to CD19, a protein expressed on B cells, including antibody-secreting plasmablasts and plasma cells. After binding to CD19, these cells are rapidly depleted from circulation. The U.S. FDA granted a breakthrough therapy designation to inebilizumab last month.

About Viela Bio
Viela Bio, headquartered in Maryland, U.S.A., is a clinical-stage biotechnology company pioneering and advancing treatments for severe inflammation and autoimmune diseases by selectively targeting shared critical pathways of diseases.

About Jiangsu Hansoh Pharmaceutical Group

Jiangsu Hansoh Pharmaceutical Co., Ltd. engages in the research and development, manufacture, and sale of pharmaceuticals and active pharmaceutical ingredients (APIs). The company was founded in 1995 and is based in Lianyungang, China.

Harbour BioMed Signs Licensing Agreement with a Top-Ten Global Pharma for Next Generation Human Antibody Discovery

Harbour BioMed, a global biopharmaceutical company developing innovative therapies for cancer and immune-driven diseases and an unnamed top-ten pharma in immunology enters into license agreement to develop, discover, and commercialize biologic therapeutics using the Harbour BioMed’s transgenic mouse platform.

Fully human heavy chain antibodies generated by Harbour BioMed’s platform accelerates the discovery and development of biologic therapeutics. Harbour has applied this platform to create alternatives for single domain antibodies, bi-specific and multi-specific antibodies, and chimeric antigen receptor (CAR) T-cell therapies.

Through this agreement, Harbour will receive an undisclosed upfront payment and will receive further development and sales related milestone payments and royalties.

About Harbour BioMed

Harbour BioMed is a global biopharmaceutical company developing innovative therapies for cancer and immune-driven diseases. The company has a growing clinical portfolio and an emerging pipeline of next generation biologics based on its two, patented transgenic mouse platforms (Harbour Mice™) for producing fully human antibodies.

CytoDyn and Samsung BioLogics Signs Manufacturing Agreement

Samsung BioLogics, a global leader in contract manufacturing organization (CMO) services and CytoDyn Inc., a biotechnology company focused on the clinical development and commercialization of humanized monoclonal antibodies for the treatment and prevention of human immunodeficiency virus (HIV) infection, signed a manufacturing agreement that was previously announced on April 2, 2019.

Leronlimab is a humanized IgG4 monoclonal antibody that masks CCR5, a receptor related to HIV infection, tumor metastases and immune signaling. In combination with highly active antiretroviral therapy (HAART), the combination therapy for HIV-infected patients and for metastatic triple-negative breast cancer was conducted by CytoDyn in a Phase 2 human clinical trial in triple-negative breast cancer and was granted Fast Track designation by the U.S. FDA in May 2019.

About CytoDyn

CytoDyn Inc., a clinical-stage biotechnology company, focuses on the clinical development and commercialization of humanized monoclonal antibodies for the treatment and prevention of human immunodeficiency virus (HIV) infection.

About Samsung BioLogics

The Samsung subsidiary started out in April 2011 as a contract manufacturing organization. It bridged out to contract development business in 2018 and is quickly expanding.

Mycenax Biotech Inc. and Vectron Enters Non-exclusive Collaboration to Offer Microbial Production of Therapeutic Proteins

Mycenax Biotech Inc., a Taiwan-based contract development and manufacturing organization (CDMO) for biopharmaceuticals, and Vectron Biosolutions AS, a Norway-based service provider for industrial production of recombinant proteins, announced on May 28th that they have signed a memorandum of understanding (MOU). Under the terms of the MOU, Vectron’s proprietary VB Expression technology platform will be integrated to Mycenax’s biopharmaceutical manufacturing facility, to develop robust and cost-efficient microbial strains for production of pre-clinical and clinical therapeutic proteins. The combined services will provide CDMO customers with protein production of large scale, low cost and high quality.

Vectron’s VB Solutions, a new technology developed on the basis of a controlled gene expression system in E. coli, may turn an insoluble protein into a predominantly soluble protein. The technology can achieve stable microbial strains with yields of up to 50 g/L, nearly 50 times higher than other existing technologies on the market. The significant increase in solubility of protein improves the productivity and hence enhances competitiveness of the product.

About Mycenax Biotech Inc.

Mycenax Biotech Inc. offers state-of-the-art biopharmaceutical development and manufacturing services for mammalian and microbial systems.

About Vectron Biosolutions AS

Vectron Biosolutions AS supplies the life science industries with superior technologies and solutions for robust and cost-efficient production of recombinant proteins in E. coli and other bacteria.

References:
1. http://www.asahi.com/ajw/articles/AJ201905300059.html
2. https://vielabio.com/hansohpharma/
3. http://www.harbourbiomed.com/en/newsContent.html#112
4. https://www.samsungbiologics.com/front/eng/media/press-releases-view.do?boardSeq=351&boardDtm=2019-05-31%2001:00:00.0&schBoardCtgryCcd=&schString=&page=1
5. http://www.mycenax.com.tw/en/news.php?act=view&no=43

Author

GeneOnline