Ironically, one of the casualties of the COVID-19 pandemic is an overdue review and revision of U.S. dual use research of concern (DURC) policies, as well as the Department of Health and Human Services’ Potential Pandemic Pathogen Care and Oversight guidance. Consequently, several senators are asking the White House to halt all ongoing and new viral gain-of-function and DURC studies in the life sciences that involve enhanced pathogens of pandemic potential.

In a massive deal that is one of the year’s biggest, Akeso Inc. signed a collaboration and license deal with Summit Therapeutics Inc. to out-license its bispecific antibody, ivonescimab (AK-112), for development and commercialization in the U.S., Canada, Europe and Japan.

Tenacia Biotechnology Co. Ltd. has acquired exclusive greater China rights to certain formulations of Marinus Pharmaceuticals Inc.’s seizure therapy, ganaxolone (Ztalmy), in a deal worth up to $266 million. Under the terms, Shanghai-based Tenacia now has the rights to develop and commercialize current oral and intravenous dose formulations of ganaxolone in mainland China, Hong Kong, Macao and Taiwan. It also gained the right to the first negotiation for a new formulation of the drug in the future.

Reistone Biopharma Co. Ltd. said both doses of the JAK1 inhibitor ivarmacitinib, tested against moderate to severe atopic dermatitis (AD) in a multinational phase III trial, met the study’s co-primary endpoints, delivering significant improvements on a common measure of disease severity vs. placebo. It’s the first National Class A new drug for AD that is designed and developed in China, according to the company.

Shanghai Junshi Biosciences Co. Ltd. has submitted a new drug application (NDA) for its anti-PD-1 monoclonal antibody toripalimab to the European Medicines Agency, which marks the first NDA filing of toripalimab in Europe.

Zenas Biopharma LLC has raised $118 million in a series B round to support a global phase III trial of its lead asset as well as other immunotherapies for autoimmune diseases in its pipeline. The study, expected to begin in 2023, will evaluate obexelimab for the treatment of patients with immunoglobulin G4-related disease in late 2022.

Nona Biosciences Co. Ltd., a subsidiary of Harbour Biomed Therapeutics Ltd. launched in November to provide “idea to IND” services, has struck a deal with Moderna Inc. to develop nucleic acid-based immunotherapies. The candidates will be based on Harbour’s heavy chain only antibody discovery platform.

Fresh off announcing a new $1.2 billion joint drug discovery and development project with Sanofi SA, Insilico Medicine Inc. founder and CEO Alex Zhavoronkov joined a chorus of executives at the Asia Summit on Global Health in proclaiming the critical importance of partnership between biopharma, tech companies, and regulators, even amid rising tensions between China and the West.