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[August 6, 2018 / R&D NEWS]Pfizer’s Breakthrough Innovative Drug Ibrance for Breast Cancer Treatment Approved in China; Poly Pharma’s Pantoprazole Sodium for Injection Receives Marketing Authorization in Australia; Hengrui Medicine’s Tolvaptan Receives Tentative Approval from the U.S. FDA; Major Breakthrough: New Anti-Cancer Drug May Induce Permanent Dormancy in Cancer Cells...
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Pfizer’s Breakthrough Innovative Drug Ibrance for Breast Cancer Treatment Approved in China
On August 6, the world’s first cyclin-dependent kinase (CDK) 4/6 inhibitor, Ibrance®IBRANCE®Approved by the China National Medical Products Administration on July 31. Compared with letrozole monotherapy, Ibrance® in combination with letrozole significantly extended the median progression-free survival by 10 months in patients with advanced breast cancer.
Puli Pharmaceutical announced that its customer recently received marketing authorization for Pantoprazole Sodium for Injection from the Therapeutic Goods Administration (TGA) of Australia. The announcement indicated that Puli Pharmaceutical initiated the product’s research and development in 2012 and, following successful development, sequentially submitted registration applications to multiple domestic and international markets.
Hengrui Medicine’s Tolvaptan Receives Tentative Approval from the U.S. FDA
Hengrui Medicine’s Abbreviated New Drug Application (ANDA) for Tolvaptan Tablets (15 mg and 30 mg strengths) submitted to the U.S. FDA has received tentative approval. The receipt of this tentative approval from the U.S. FDA indicates that the product meets all review requirements for generic drugs; however, marketing authorization in the United States will only be granted after the relevant patents expire and final approval is obtained from the U.S. FDA.
Impression Biopharmaceuticals Secures $30 Million in Funding to Advance “Best-in-Class” Drugs
Nanjing Impact Therapeutics Co., Ltd. recently announced the completion of a $30 million Series C financing round, led by Decent Capital and participated in by Lilly Asia Ventures. The proceeds from this round will primarily be used to accelerate the clinical development of IMP4297, a Class 1.1 novel PARP inhibitor with best-in-class potential, as well as to support other projects.
Thrombopoietin (TPO) Receptor Agonists: A Hotspot in R&D
Recently, the U.S. FDA announced the approval of Shionogi’s new drug Mulpleta (lusutrombopag) for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo medical or dental procedures. This marks another thrombopoietin (TPO) receptor agonist approved following the authorization of Dova Pharmaceuticals’ subsidiary AkaRx’s Doptelet (avatrombopag) in May this year.
Recently, Wuhan BinHui Bio announced the completion of its RMB 110 million Series A financing round, exclusively led by Lepu Biopharma, a subsidiary of Lepu Medical. Liu Binlei, core founder of BinHui Bio, is dedicated to research in tumor immunology and oncolytic viruses, with his R&D work in the field of oncolytic viruses reaching an internationally leading level. The “oncolytic type I herpes simplex virus tumor therapeutic injection, T-Vec,” which he was responsible for developing in the UK, is the first oncolytic virus proven effective in Phase III clinical trials.
Major Breakthrough! New Anti-Cancer Drug May Induce Permanent Dormancy in Cancer Cells
Recently, a research report published in the international journal Nature revealed that scientists from the Walter and Eliza Hall Institute of Medical Research in Melbourne, Australia, have discovered for the first time a novel anticancer drug that may induce permanent dormancy in cancer cells while avoiding the harmful side effects associated with conventional cancer therapies.
Research Finds: “Latent” Viruses Affect Patients’ Response to Vaccination
Recently, researchers from the University of California, Davis, discovered that cytomegalovirus (CMV) has a significant impact on microbial and immune cell populations. Furthermore, it affects the immune system's response to influenza virus vaccines. The relevant findings were published in the latest issue of the Journal of Virology.
Cell Res: New Study Explores Applications of Stem Cells in Transplantation Therapy
Recently, researchers from the Stowers Institute for Medical Research have discovered a method to differentiate hematopoietic stem cells from adult umbilical cord blood. This approach facilitates cell transplantation therapies for specific diseases—such as leukemia, blood disorders, immune system diseases, and cancer—beyond the limited number of successful matched bone marrow transplants.
Cannabinoid Combination Therapy May Triple Pancreatic Cancer Survival Time
Pancreatic cancer is not only one of the most lethal types of cancer worldwide, but decades of cancer research have yet to yield effective treatments. Over the past 40 years, the 5-year survival rate for patients has remained stagnant at approximately 5%, ranking lowest among all cancer types. The existing standard chemotherapy drug, gemcitabine, can only extend patients’ survival by a few weeks.
*Disclaimer: This article was written by an author contributing to Sina Pharmaceutical News. The views expressed are solely those of the author and do not represent the position of Sina Pharmaceutical News.