Weekly in Asia｜Dec-3

20191223-1229

USFDA Nods on Daiichi Sankyo and AstraZeneca’s Breast Cancer Drug

Human epidermal growth factor receptor 2 (HER2)-positive breast cancer is a difficult-to-treat breast cancer population, in which HER2 promotes the growth of cancer cells. According to statistics, in about 1 of every 5 breast cancer patients, a mutated gene produces an excess of HER2 protein. HER2-positive breast cancers are found to be more aggressive than any other types of breast cancer, be sensitive to hormone therapy. Although many people with HER2-positive breast cancer can still benefit from hormone therapy, treatments that specifically target HER2 are very effective. These treatments are so effective that the prognosis for HER2-positive breast cancer is actually quite good. Common treatments of HER2-positive breast cancer include: Ado-trastuzumab emtansine (Kadcyla), Lapatinib (Tykerb), Neratinib (Nerlynx), Pertuzumab (Perjeta) and Trastuzumab (Herceptin).

Daiichi Sankyo and AstraZeneca announced on December 26th 2019 that the U.S. Food and Drug Administration (FDA) has approved antibody-drug conjugate ENHERTU® (trastuzumab deruxtecan), a human epidermal gㄋrowth factor receptor 2 (HER2)-targeted antibody drug conjugate (ADC), for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer patients who failed on multiple available treatments.

About AstraZeneca

AstraZeneca is a global biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in Oncology, Cardiovascular, Renal and Metabolism (CVRM) and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

About Daiichi Sankyo

Daiichi Sankyo Company, Limited is a global pharmaceutical company and the second-largest pharmaceutical company in Japan. The Company provides medicines for high and low blood pressure, heart related events, and other related diseases.

Gilead and Eisai Enter Into Agreement in Japan for the Co-Promotion of the Investigational Rheumatoid Arthritis Therapy

On December 24, 2019, Gilead Sciences, Inc., a research-based biopharmaceutical company headquartered in California, United States, and Japanese pharmaceutical company Eisai Co., Ltd., have announced that the two companies have entered into an agreement for the distribution and co-promotion of filgotinib, an investigational, oral, selective Janus kinase 1(JAK1) inhibitor in Japan, pending regulatory approval for the treatment of rheumatoid arthritis (RA).

Through this collaboration, Gilead Japan will retain responsibility for manufacturing and marketing approval of filgotinib, while Eisai will be responsible for product distribution in Japan in RA and other potential future indications. Once being approved, the companies will jointly commercialize the medicine.

About Eisai

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.

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.

Astellas Strengthens Immuno-oncology Portfolio by Acquiring Xyphos

On December 26, 2019, Tokyo, Japan-based Astellas Pharma Inc. and Xyphos Biosciences, Inc., a San Francisco, California privately held development-stage biotechnology company, announced that Astellas has acquired Xyphos. Xyphos is now a wholly owned subsidiary of Astellas. The transaction is valued at $665 million, including fee for closing of the acquisition and potential future development milestone payments. Xyphos’ first convertible CAR-T cell product candidate, developed by the companys’ novel and proprietary ACCEL (Advanced Cellular Control through Engineered Ligands) technology platform, is in preclinical development and is scheduled to be tested in a first-in-human clinical study in 2021. The merger of the two companies is expected to accelerate next-generation cancer immunotherapy in the near future.

About Astellas Pharma Inc

Astellas Pharma Inc. is a Japan-based company mainly engaged in the research, development, manufacture and sales of pharmaceutical products. The Company is involved in the manufacture and sale of pharmaceutical products in Japan, the United States, Europe, China, Korea, Taiwan and other markets through its subsidiaries.

About Xyphos Biosciences, Inc.

Xyphos Biosciences is a biotechnology company focused on the development of cancer immunotherapy products. The Company is headquartered in South San Francisco, California and was founded in 2017.

GenScript, Selecxine Collaborate to Develop Novel Antibody Drugs

On December 23rd, 2019, the world’s leading contract development and manufacturing organization (CDMO) biotech company GenScript announced that it has signed a strategic collaboration agreement with Selecxine Inc., a Korean immuno-oncology biotechnology company, to generate innovative cytokine-antibody drug complexes.

According to the agreement, GenScript will be responsible for preclinical research and IND filing. Compared with classic monoclonal antibody and protein drug, this project provides a new insight into new drug development.

About Genscript Corporation

Genscript Corporation provides biological research and drug discovery services. The Company offers bio-reagent, custom molecular biology, custom peptide, protein production, and custom antibody production services, as well as assay development and screening, antibody drug development, and cell line production services. Genscript serves customers worldwide.

About Selecxine

Selecxine was a newly established bio start-up founded in Pohang, Korea in the year 2018. The Company develop antibodies that bind to specific epitope on target protein for modification and amplification of the desired signal from bifunctional biomolecules such as cytokines and cytokine receptors.

Surgical System Xvision Developed by Israeli Receives FDA Approval

Augmented reality is considered as the future of the gaming industry. In combination with medical instruments, the advent of augmented reality-assisted surgery (ARAS) is now changing several aspects of healthcare sector.

On December 23, Israeli’s Augmedics gained FDA approval for its wireless headset. The xvision headset allows a surgeon to visualize the 3D anatomy of the patient’s spine, through their skin, by looking directly at the patient as if they had “X-ray” vision. This helps surgeons to accurately place screws and other instrumentation within the spine, and the whole system is contained in a lightweight headset. Augmedics said the xvision system consists of a transparent near-eye-display headset and all elements of a traditional navigation system.

About Augmedics Ltd

Augmedics Ltd develops surgical visualization systems. The Company offers a software that can be applied in the research and development of pre-clinical and clinical trials.

Reference:

1. https://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/007088.html
2. https://www.gilead.com/news-and-press/press-room/press-releases/2019/12/gilead-and-eisai-enter-into-agreement-in-japan-for-the-copromotion-of-the-investigational-rheumatoid-arthritis-therapy-filgotinib-pending-regulatory
3. https://www.astellas.com/en/news/15516
4. http://www.biospectator.com/view/news_view.php?varAtcId=9208
5. https://www.jpost.com/Israel-News/Israeli-developed-surgical-xvision-system-receives-FDA-approval-612571

Author

GeneOnline