Takeda Pharmaceutical Co. Ltd.’s dengue fever vaccine, Qdenga, was approved in Indonesia Aug. 23, making it the first global approval for the tetravalent vaccine. The approval marks Takeda’s first marketed vaccine outside of Japan. Indonesia’s National Agency for Drug and Food Control approved the vaccine for prevention of dengue disease caused by any serotype in individuals 6 years to 45 years of age. Read More
Lee’s Pharmaceutical (HK) Ltd. and its affiliate, Zhaoke Pharmaceutical (Hefei) Co. Ltd., expanded their rights to lucinactant Surfaxin, lyophilized lucinactant Surfaxin LS and Aerosurf from Windtree Therapeutics Inc. in a $78.9 million global license deal to develop and commercialize the candidates for the treatment of preterm infants with respiratory distress syndrome and other potential indications. Read More
Hansoh Healthtech Co. Ltd., part of Jiangsu Hansoh Pharmaceutical Group Co. Ltd., has acquired exclusive worldwide rights to develop and commercialize an oral SARS-CoV-2 3C-like protease inhibitor from Beijing Huayi Health Drug Discovery Institute, also known as the Global Health Drug Discovery Institute (GHDDI). The deal includes ¥12 million (US$1.8 million) up front and up to ¥1.68 billion in potential milestone payments, plus tiered royalties on net sales. Read More
Australian radiopharmaceutical company Advancell Co. Ltd. closed an AU$18 million (US$12.4 million) series B round that will take its lead targeted alpha-emitting radiotherapy, ADVC-001, for metastatic prostate cancer to the clinic by the end of 2022. Read More
Japan’s Healios K.K. is in discussions with Japan’s Pharmaceutical and Medical Devices Agenc about the regulatory path forward for its Multistem somatic stem cell products, for which it conducted phase II/III trials in ischemic stroke and a phase II trial in acute respiratory distress syndrome. Read More
For the first time since they’ve had access to U.S. capital, biopharma and med-tech companies based in China and Hong Kong are having to comply with the same accountability standards companies in the U.S. and other countries must follow as a condition of trading on U.S. markets. Read More
It’s that time of year when the U.S. Trade Representative asks for help as it prepares its list of notorious markets for counterfeiting and piracy. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Alpha, Amniotics, Biontech, Clarity, Clover, Innovent, Pfizer, Ranok, Recce, Telix, Tonix. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Biocytogen, Finch, Lee’s, Merck, Oragenics, Takeda, Windtree, Zhaoke. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Accutar, Adjutor Healthcare, Ainos, Ascletis, Astrazeneca, Beigene, Biontech, Innocare, Keymed, Merck, Novavax, Pfizer, Takeda, Valneva, Veru. Read More
