Peptidream Inc., fresh off expanding a multibillion-dollar research and license agreement with Takeda Pharmaceutical Co. Ltd. earlier this week, has inked a brand new deal with Alnylam Pharmaceuticals Inc. Valued at up to $2.2 billion, including milestones, the new deal is aimed at the discovery and development of peptide-siRNA conjugates for the delivery of therapies to a wide range of cell types and tissues beyond the liver, the central target of Alnylam's marketed products to date. Read More
Minovia Therapeutics Ltd. will collaborate with Astellas Pharma Inc. to research, develop and commercialize cell therapy programs for treating diseases brought on by mitochondrial dysfunction. The candidates will come from Astellas’ genetically engineered, induced pluripotent stem cells. Haifa, Israel-based Minovia will receive $20 million in cash up front. Read More
Eli Lilly and Co. has established a multiyear collaboration with Kumquat Biosciences Inc. for the discovery, development and commercialization of new small molecules for stimulating tumor-specific immune responses. Kumquat will receive $70 million up front, including an equity investment, and is eligible for more than $2 billion in potential milestone payments plus royalties on any marketed products. Read More
China’s National Health Commission has just released a new set of regulations to evaluate the clinical value of both approved drugs and those still in trials as part of its efforts to improve the market standards. Read More
Rapid changes, a traditionally conservative approach and a chronic lack of regulatory transparency could undo a lot of the progress that Japan has made in the past few years to speed up approvals and all but eliminate a punishing drug lag that, for decades, held back the development of the country’s biopharma sector. Read More
Zydus Cadila Group could make history after applying for approval for the first ever human DNA vaccine in India. But that could be just the start for a technology that could treat a vast array of diseases, including cancer, infectious diseases and chronic diseases. Read More
Ushering in a new era for the U.S. biosimilar marketplace, the FDA, on July 28, approved its first interchangeable biosimilar, which also will be the first to bring biosimilar competition to the U.S. insulin space. The honor went to Viatris Inc.’s Semglee, which the FDA recognized as both biosimilar to and interchangeable with Sanofi SA’s Lantus (insulin glargine). Read More
Jiangsu Gdk Biotechnology Co. Ltd. will further develop its vaccine pipeline after it started trading on the Shanghai Stock Exchange Star Market on Aug. 2, where it raised ¥1.21 billion ($187 million) through an initial public offering of 22 million shares. The company plans to use the proceeds from the listing to establish a manufacturing plant to produce its quadrivalent influenza vaccine and invest in R&D for other vaccine candidates, as well as replenish working capital and repay bank loans. Read More
Zentera Therapeutics Inc. completed a $75 million series B financing round to help further its candidates in China, as it paves the way for a listing in Hong Kong next year. Read More
Antengene Corp. Ltd. has gained the first greenlight in Asia for the oral exportin 1 (XPO1) inhibitor selinexor, in-licensed from Karyopharm Therapeutics Inc., after South Korea’s Ministry of Food and Drug Safety gave the thumbs up for its NDA. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Beigene, Betterlife, Biocon, Eli Lilly, Everest Medicines, I-Mab, Incyte, Junshi, Kyowa Kirin, Nrx, Scancell, Takeda, Transcenta, Viatris. Read More
