Pharmaceutical companies in China will cut the prices for more than five dozen drugs by an average of 61.7% to get them on the latest version of the country’s National Drug Reimbursement List. The National Healthcare Security Administration released the new list on Dec. 3, 2021. The new list includes 74 new drugs, the vast majority of which are branded products without generic versions in China. Only seven of the new drugs on the list have generic versions. Read More
Japan’s Astellas Pharma Inc. is continuing its investment in gene therapies, following up its $3 billion acquisition of Audentes Therapeutics Inc. with a technology licensing deal with Dyno Therapeutics Inc. potentially worth more than $1.6 billion. Central to the deal is Cambridge, Mass.-based Dyno’s adeno-associated virus (AAV) vector technology, which can be used to direct gene therapies to skeletal and cardiac muscle. Read More
Beigene Ltd. has received approval from China’s NMPA to market Sylvant (siltuximab) for the treatment of patients with multicentric Castleman disease, including HIV-negative and human herpes virus-8-negative disease. The green light comes at a good time as the Beijing-headquartered company is preparing for a $3.5 billion listing on Shanghai’s STAR Market, its third listing. The monoclonal antibody siltuximab previously received regulatory approval in the U.S. and Europe. Read More
PERTH, Australia – Neuren Pharmaceuticals Ltd.’s stock nearly doubled on positive top-line phase III results for trofinetide in Rett syndrome, meeting all primary and secondary endpoints in the pivotal phase III trial run by partner Acadia Pharmaceuticals Inc. Read More
Abogen Biosciences Co. Ltd. has raised $300 million in a series C+ round to support the development of its mRNA products, specifically to support the development of its COVID-19 mRNA vaccine and expand to the global market. Read More
Tot Biopharm International Co. Ltd.’s self-developed Pusintin (bevacizumab), a biosimilar to Roche Holding AG’s Avastin, has won marketing approval from China’s NMPA. It was approved for the treatment of patients with advanced, metastatic, or recurrent non-squamous non-small-cell lung cancer and those with metastatic colorectal cancer. Read More
Beyondspring Pharmaceuticals Inc. said it received a complete response letter from the FDA regarding the NDA for plinabulin, the company’s lead asset. The FDA said results of a phase III registrational trial were strong enough to show benefit but a second trial is needed to satisfy the agency. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: AB Science, Adagene, Anji, Arca, Arch Biopartners, Astrazeneca, Betterlife, Bonus Biogroup, Daiichi Sankyo, First Wave, Hepagene, Humanigen, Hummingbird, I-Mab, Immutep, Insilico Medicine Hong Kong, Kyowa Kirin, Lintonpharm, Longeveron, Lynk, Mei, Merck, Nrx, Ose Immunotherapeutics, Pulmotect, RDIF, Revive, Ridgeback, Starpharma, Zai Lab. Read More
