Weekly in Asia 2019｜AUG-2
20190728-0803 Weekly in Asia
CUHK to Launch GMP-certified CAR-T Cell Therapy Laboratory for Haematological Malignancy
Cancer is one of the leading causes of mortality globally. According to estimations, there is an average of 2,000 new cases haematological malignancy each year in Hong Kong. The Chinese University of Hong Kong (CUHK) is planning to conduct clinical trials of Chimeric antigen receptor-T cell (CAR-T cell) therapy targeting patients with this disease in order to increase the survival rate and prolong overall survival. The CUHK is investing HKD 60 million to establish Hong Kong’s first CAR-T cell laboratory licensed with a Good Manufacturing Practice (GMP) certification, which will enable the special manipulation of T cells, genetic modulation of cells, expansion of cells to adequate quantity and to achieve maximal killing of cancer cells. The construction is expected to be completed in 2020. In the future, the facility will undergo clinical trials testing CAR-T cell therapy for other types of cancers.
Korean Seeks Retraction of Japan’s Trade Curbs on the Biotechnology Industry
Japan is the fifth-largest importer of pharmaceuticals and the biggest exporter of Korea. According to South Korea’s Ministry of Food and Drug Safety, South Korea exported US$497.48 million worth of drugs to Japan and imported US$520.66 million from it as of 2017. Biotechnology industry in the two countries has active research collaborations and license deals for commercialization of new drugs.
As the Japan-Korea trade war spat is escalating, on July 1, the Japanese ministry announced that South Korea will be removed from the whitelist, a list of goods designated by the Japanese government whose export procedures are simplified. With the loss of so-called “white country” status, each of the goods that Korean biotech companies import would require a separate permission, and eventually, bilateral cooperation may be disrupted.
On July 24, The Korea Biotechnology Industry Organization (KoreaBio) submitted a petition to Japan’s Ministry of Economy, Trade and Industry requesting it to withdraw its move to exclude South Korea from the whitelist.
Japan to Expand Clinical Research on Detecting Chromosomal Abnormalities
In Japan, the first in vitro fertilization (IVF) baby was born in 1983, and thereafter, the annual number of assisted reproductive technology (ART) cycles increased year by year. Japan is now the largest user of ART worldwide in terms of the annual number of treatments done.
Preimplantation genetic testing for aneuploidy (PGT-A) is a type of testing that seeks to identify preimplantation embryos with abnormalities in the number of chromosomes during in vitro fertilization. The Japan Society of Obstetrics and Gynecology (JSOG) started clinical research on a trial basis at four medical institutions on 85 women who’d had repeated miscarriages since a study found that using PGT-A to select eggs without abnormalities was effective in reducing the likelihood of miscarriage. Recently, the JSOG announced that it will expand the scale of clinical research on the utilization of PGT-A for fertility treatment.
More information about assisted reproductive technology (ART)
ART refers to treatments and procedures that aim to achieve pregnancy, which includes in vitro fertilization-embryo transfer (IVF-ET), gamete intrafallopian transfer (GIFT), zygote intrafallopian transfer (ZIFT), and frozen embryo transfer (FET). These procedures may be an option for people who have already received several infertility treatments but still have not achieved pregnancy.
Samsung BioLogics announces third CMO deal with Belgium’s Union Chimique Belge
On August 1st, South Korea’s leading contract manufacturing organization (CMO) Samsung BioLogics announced the signing of the third CMO contract with Belgium-based pharmaceutical company Union Chimique Belge (UCB), for the agreement to an additional drug substance manufacturing deal.
On top of two other existing deals, Samsung BioLogics will now produce UCB’s anti-tau candidate, a drug being developed for treatment to limit the accumulation of abnormal Tau proteins in progressive supranuclear palsy. The UCB’s anti-tau candidate is currently undergoing clinical trials, pending regulatory approvals. The agreement promises Samsung BioLogics a guaranteed fee of USD 34 million, and could potentially grow to USD 148.2 million upon successful product development.
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. Their facilities are custom designed for monoclonal and recombinant production.
About Union Chimique Belge
Union Chimique Belge is a global biopharma company founded in 1928 and headquartered in Brussels, Belgium. The Company focuses on neurology and immunology.
Xynomic Received China Approval to Start 2 Pivotal Lymphoma Clinical Trials
Non-Hodgkin lymphoma (NHL)is a type of cancer that develops in the lymphatic system. Diffuse large B-cell lymphoma (DLBCL) is the most common aggressive NHL subtype. Follicular lymphoma (FL) is the most common indolent NHL subtype. Approximately 10% to 15% of patients with DLBCL have a concurrent indolent NHL.
Currently, there are no approved treatment options for DLBCL and FL patients once the disease progresses after R-CHOP treatment (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone), the standard front-line therapy for DLBCL.
Xynomic Pharmaceuticals Holdings, Inc., a clinical stage US-China oncology drug development company, announced that it has received approval from China’s National Medical Products Administration (NMPA) to start two pivotal clinical trials in China. Xynomic will test its lead drug candidate abexinostat (as a single agent) as a third-line treatment of DLBCL and as a third-line treatment of FL, respectively.
About Xynomic Pharmaceuticals Holdings, Inc.
Xynomic Pharmaceuticals Holdings, Inc. is a clinical stage biopharmaceutical company. Xynomic owns the global exclusive development, manufacturing and commercialization rights of its 3 drug candidates. Its lead drug candidate abexinostat is in global potentially pivotal clinical trials against renal cell carcinoma and non-Hodgkin’s lymphoma.
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