2019-11-27| Asia-Pacific

Weekly in Asia|Nov-2

by GeneOnline
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Japan Grants Orphan Drug Designation to Merck’s investigational therapy Tepotinib

According to estimations, the incidence of cancer has increased at a rapid pace and hence, it has ascended to the second leading cause of death, closely after cardiovascular disease. Among which, lung cancer is the most common type, with two million cases diagnosed annually. Non-Small Cell Lung Cancer (NSCLC) accounts for about 85% of all lung cancers. 3-5% of NSCLC patients harbor MET gene alterations, a factor associated with aggressive tumor behavior and poor clinical prognosis.

On November 20, Merck KGaA, a leading science and technology company, announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted orphan drug designation (ODD) for its investigational MET inhibitor tepotinib as a treatment for patients with metastatic NSCLC with MET exon14 (METex14) alterations.

Tepotinib is an investigational drug designed to inhibit the oncogenic MET receptor signaling caused by MET alterations. It has the potential to improve outcomes in aggressive tumors that suffer from poor prognosis. In March 2018, tepotinib received SAKIGAKE ’fast-track’ regulatory designation in Japan and in September 2019 received Breakthrough Therapy Designation in the U.S.

About Merck KGaA

Founded in 1668 and headquartered in Darmstadt, Germany,

Merck KGaA is the world’s oldest operating chemical and pharmaceutical company, as well as one of the largest pharmaceutical companies in the world.



Anti-Epileptic Drug XCOPRI® Approved by the U.S. FDA

Epilepsy is a common neurological disorder characterized by seizures. According to the Centers for Disease Control and Prevention (CDC), the leading national public health institute of the United States, approximately 3 million adults live with epilepsy in the U.S. Nearly 60% reported have seizures, even if they took anti-epileptic drugs (AED). There is an urgent need to advance research and introduce new treatment options.

SK Biopharmaceuticals, Co., Ltd., an innovative global pharmaceutical company, and its U.S. subsidiary SK Life Science, Inc., announced on November 21 that the U.S. Food and Drug Administration (FDA) approved XCOPRI® (cenobamate tablets) as a treatment for partial-onset seizures in adults.

The approval of XCOPRI® will provide clinicians with an effective medication for patients having focal (partial-onset) seizures. The approval also marks the first time a Korean company has independently brought a compound from discovery to U.S. FDA approval.

About SK Biopharmaceuticals, Co., Ltd. and SK Life Science, Inc.

SK Biopharmaceuticals and its U.S. subsidiary SK life science focus on the research, development and commercialization of treatments for disorders of the central nervous system (CNS). Additionally, SK Biopharmaceuticals is focuses on early research and development in oncology. Both are part of SK Group, one of the largest conglomerates in Korea.


Astellas and Welldoc Enter into Strategic Alliance to Develop and Commercialize Digital Therapeutics BlueStar® Globally

Japanese drugmaker Astellas Pharma Inc. and American disease management company Welldoc, Inc. announced on November 20 that the two companies have entered into a collaboration and license agreement toward the development and commercialization of digital health solutions.

BlueStar®, a digital health solution for type 1 and type 2 diabetes developed by Welldoc, provides tailored guidance driven by artificial intelligence. The U.S. FDA initially cleared BlueStar® in 2010 and since then Welldoc has received six additional 510(k) clearances from the FDA.

Under the agreement, the two parties will jointly develop and commercialize BlueStar® in Japan and other Asian markets, as well as collaborate to broaden the adoption of BlueStar® in the U.S. market, and jointly develop and commercialize digital therapeutics in other therapeutic areas globally. Astellas will make an upfront payment of $15 million to Welldoc.

About Astellas

Astellas Pharma Inc. is a Japan-based pharmaceutical company committed to a wide range of therapeutic fields. The Company researches, develops, manufactures, and promotes its prescription drugs through subsidiaries in the US, Europe, and Asia.


About WellDoc Inc.

Welldoc is a leading digital health company revolutionizing chronic disease management to help transform lives.

The Company develops solutions to support diabetes management. WellDoc serves patients and health care providers worldwide.


CStone Announces First Patient Dosed in the Phase I Bridging Registrational Study of TIBSOVO® (ivosidenib)

With the advent of DNA sequencing technology, the detection of genetic mutations has presented new opportunities and challenges for many treatments. Acute myeloid leukemia (AML), the most common acute leukemia affecting over 30,000 adults in China every year, is now catching up with this trend. A transformation in the detection of AML is being witnessed, where the disease-related IDH1 mutations are found in 6% to 10% of all AML cases.

CStone Pharmaceuticals announced on November 20 that the first patient has been dosed in the Phase I bridging registrational study of TIBSOVO® (ivosidenib) in China. This stand-alone trial is designed to validate the efficacy, safety, and pharmacokinetics of ivosidenib in patients with IDH1 mutant relapsed or refractory acute myeloid leukemia (R/R AML).

Developed by Agios Pharmaceuticals, CStone’s partner, ivosidenib was approved by the U.S. FDA in July 2018 for the treatment of adult patients with R/R AML with a susceptible IDH1 mutation as detected by an FDA-approved test. In May 2019, CStone submitted a new drug application (NDA) for the drug in Taiwan for the treatment of adult patients with IDH1 mutant R/R AML.

About CStone

Cstone Pharmaceuticals is a biopharmaceutical company devoted to the development of a new generation of innovative drugs with a focus on immuno-oncology based combination therapies.


WuXi STA Forms Strategic Partnership with Impact Therapeutics

WuXi STA Pharmaceutical Co., Ltd., a subsidiary of WuXi AppTec, and Impact Therapeutics, a China-based biotech focused on innovative drug discovery and development in anti-cancer therapeutics, announced on November 22 the signing of a strategic partnership agreement.

Impact Therapeutics holds independent intellectual property rights for a broad pipeline of anti-cancer candidates that cover a spectrum of therapeutic areas, including PARP Inhibitors (IMP4297), Wee1 Inhibitors (IMP7068), DDR target Inhibitors and Hedgehog Pathway Inhibitors (IMP5471). Currently, IMP4297 is in Phase III clinical trials in China, with early clinical data targeting better safety and a wider treatment window.

Under the terms of this accord, WuXi STA will become the preferred Contract Development and Manufacturing Organization (CDMO) partner of Impact Therapeutics, and will accelerate the its new pipeline drug development towards commercialization both in China and in the U.S.

About WuXi STA

WuXi STA Pharmaceutical Co., Ltd., a subsidiary of WuXi AppTec, is a leading Contract Development and Manufacturing Organization (CDMO) company, with operations in China and the United States. WuXi STA offers efficient, flexible and high-quality solutions for integrated CMC (Chemical, Manufacturing, and Control) solutions from preclinical to commercial uses.


About Impact Therapeutics

Impact Therapeutics is a privately held clinical-stage biopharmaceutical company incorporated in Nanjing, China, dedicated to the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality.





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