Weekly in Asia 2019｜JUL
20190721-0727 Weekly in Asia
BIO Asia-Taiwan 2019 – Biotech as the Next Growth Engine for Asia
The Bio Asia-Taiwan 2019 exhibition and conference has kicked off in Taipei, Taiwan, from the 24th to the 28th of July, under the theme “biotech as next growth engine for Asia”. As the greatest biotech industry event in Asia, the BIO Asia-Taiwan 2019 demonstrates biotech as Asia’s next growth engine.
Co-organized by the Biotechnology Innovation Organization (BIO) and the Taiwan Bio Industry Organization (Taiwan BIO), the Bio Asia-Taiwan 2019 featured more than 1,700 booths set up by over 600 exhibitors from about 20 countries and attracted over 1,500 participants from over 25 countries. The BIO Asia-Taiwan has become an important milestone of global recognition for Taiwan’s biotech and healthcare industries.
Dr. Johnsee Lee, Chairman of Taiwan BIO, assured that Taiwan has a great potential for establishing ecosystem for biotechnology and healthcare based on its strong information and communications technology (ICT), and will become the next driving force for Asia as well as for the global biotech.
Mr. James C. Greenwood, President and CEO of BIO, mentioned in the grand opening that Taiwan BIO had organized over 400 people to attend the 2019 BIO International Convention in Philadelphia, US earlier this year. The biotech community realized that Taiwan not only has great potential but also has great possibility to become one of the leading nations in the biotechnology industry. As building a strong biotech sector has become a strategic priority for many global economies, Greenwood concluded by emphasizing that “in biotechnology, we simply must be collaborators before we can be competitors.”
Eisai and Merck & Co. Receive Breakthrough Therapy Designation from FDA for The LENVIMA/KEYTRUDA combination therapy
Lenvima, the oral kinase inhibitor discovered by Eisai, in combination with Keytruda, Merck & Co.’s anti-PD-1 therapy, received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for advanced and/or metastatic renal cell carcinoma and advanced and/or metastatic non-microsatellite instability-high (MSI-H)/proficient mismatch repair (pMMR) endometrial carcinoma, in January 2018 and July 2018, respectively.
On July 23, 2019, the Lenvima (lenvatinib) plus Keytruda (pembrolizumab) Combination Treatment received Breakthrough Therapy designation from the U.S. FDA for the potential first-line treatment of patients with advanced unresectable hepatocellular carcinoma (HCC) that is not responsive to locoregional treatment.
This is the third Breakthrough Therapy designation for the Lenvima plus Keytruda combination.
Keytruda is an anti-PD-1 therapy, which has been approved for multiple indications by the FDA. Lenvima blocks the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1, VEGFR2, and VEGFR3.
The combination of Lenvima plus Keytruda is investigational. The efficacy and safety of this combination has not been established, and has not been approved in any cancer types.
About Merck& Co., Inc.
Merck & Co., Inc., known as MSD outside of the United States and Canada, is a global health care company that delivers health solutions through its prescription medicines, vaccines, biologic therapies, animal health, and consumer care products, which it markets directly and through its joint ventures. The Company has operations in pharmaceutical, animal health, and consumer care.
Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. The company positions oncology as a key therapeutic area and is aiming to discover revolutionary new medicines with the potential to cure cancer.
VolitionRx Limited Partners with Fosun Long March to Commence a Lung Cancer Clinical Study in China
China represents nearly 20% of the world’s population, but accounts for almost 24% of cancer diagnoses and 30% of cancer-related deaths worldwide in 2018.
Belgium based VolitionRx Limited, a multi-national life sciences company developing blood tests, and Shanghai Fosun Long March Medical Science Co Ltd, a manufacturer of diagnostic and laboratory instruments, signed a memorandum of understanding on March 28, 2019, with an expectation of negotiating and entering into a binding agreement to help facilitate the entrance of the Nu.QTM platform into China.
Nu.QTM functions as a routine blood test that detects molecular signatures of cancer by focusing on the nucleosomes in the blood. As cancer cells multiply, several molecular signatures are modified in a way that distinguishes them from healthy cells and the traits of the malignant disease appear on the nucleosomes.
On July 18, VolitionRx Limited and Shanghai Fosun Long March Medical Science Co. Ltd. launched a study that will use Volition’s Nu.QTM assays to screen for lung cancer at Fosun’s hospitals, research institutions and clinics, among other locations.
About VolitionRx Limited
VolitionRx Limited is a multi-national life sciences company developing simple, easy to use blood-based cancer tests to accurately diagnose a range of cancers. The Company’s tests are designed to detect the nucleosome patterns that are specific to cancer in the blood, and identify some of the major nucleosome varieties that differ between cancer types.
About Shanghai Fosun Long March Medical Science Co Ltd
Established in 1989 in Shanghai, Shanghai Fosun Long March Medical Science Co., Ltd is an in-vitro diagnostics enterprise active in manufacturing, marketing and research and development of diagnostic and laboratory instrument and reagent.
Samsung Bioepis’ HADLIMA™ (adalimumab-bwwd) Receives FDA Approval
On July 24, Samsung Bioepis announced that it has gained the US Food and Drug Administration (FDA)’s approval for HADLIMA™ (adalimumab-bwwd), a biosimilar of AbbVie’s blockbuster autoimmune disease treatment Humira, adding the list to the firm’s fourth FDA approved biosimilar, after Renflexis (Infliximab), Ontruzant (Trastuzumab) and Eticovo (Etanercept).
HADLIMA™ (adalimumab-bwwd) is developed by Samsung Bioepis and will be commercialized in the US by Merck, also known as MSD outside of the US and Canada, starting from June 2023, based on a licensing agreement signed with AbbVie Inc. HADLIMA™ is a tumor necrosis factor (TNF) blocker for the following indications: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis.
About Samsung Bioepis Co., Ltd.
Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen established in 2012. Samsung Bioepis is a biopharmaceutical company committed to advance a broad pipeline of biosimilar candidates that cover therapeutic areas, including immunology, oncology and ophthalmology.
Innovent Tests PD-1 and Anti-VEGF Monoclonal Antibody IBI305 in China Lung Cancer Trial
Lung cancer ranks the highest incidence and mortality among all cancers in China. In which, non-squamous non-small cell lung cancer(NSCLC) accounts for about 80% to 85% of all lung cancer cases, and at diagnosis about 70% of NSCLC patients are locally advanced or metastatic. Patients with advanced NSCLC with EGFR mutations are recommended to use EGFR-TKI as first line therapy. However, the treatment options and poor efficacy brings about huge unmet clinical need.
World-class biopharmaceutical company Innovent started a China trial, ORIENT-31, which combines its China-approved PD-1 drug Tyvyt® (sintilimab injection) with its Avastin biosimilar Anti-VEGF Monoclonal Antibody IBI305 to treat lung cancer. The study is a randomized, double-blind, multi-center, Phase III trial that will enroll 480 patients with epidermal growth factor receptor (EGFR)-mutant NSCLC who were previously treated with an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) drug, to evaluate the safety and efficacy of sintilimab and IBI305 in combination with chemotherapy-treated patients with EGFR-mutant NSCLC who have progressed from EGFR-TKI treatment. A total of 480 patients will be enrolled in the study.
Last December, Tyvyt® was approved in China to treat relapsed or refractory classical Hodgkin’s lymphoma. It is currently being tested in the US and China for additional indications. Innovent’s Avastin biosimilar is not yet approved.
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. Innovent has developed a robust pipeline of 20 innovative assets in the fields of oncology, ophthalmology, autoimmune, and cardiovascular diseases based on a fully-integrated platform, which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities.
About Eli Lilly and Company
Eli Lilly and Company discovers, develops, manufactures, and sells pharmaceutical products for humans and animals. Eli Lilly products include neuroscience, endocrine, anti-infectives, cardiovascular agents, oncology, and animal health products.
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