Chinese authorities this year for the first time allowed access for complete U.S. Public Company Accounting Oversight Board (PCAOB) audit inspections and investigations of PCAOB-registered public accounting firms headquartered in China and Hong Kong, in accordance with U.S. securities law.

3D Medicines Inc. has raised HK$408 million (US$52.5 million) in a listing on the Hong Kong Stock Exchange. Its shares opened at HK$29 apiece, jumped by more than 20% by the middle of the day, and closed at HK$31.45 on the first trading day of Dec. 15.

Innovent Biologics Inc. has in-licensed LG Chem Ltd.’s tigulixostat (LC-350189), a late-stage non-purine xanthine oxidase inhibitor for managing chronic hyperuricemia in patients with gout, in a deal worth up to $95 million.

Pfizer Inc. has acquired rights to respiratory syncytial virus (RSV) drug candidate sisunatovir from Lianbio Co. Ltd. in a deal worth up to $155 million covering development and commercialization rights in mainland China, Hong Kong, Macau and Singapore. With this agreement, Pfizer now holds global development and commercialization rights to the candidate, an orally administered fusion inhibitor is designed to block RSV replication by inhibiting F-mediated fusion with the host cell.

China recently approved four COVID-19 vaccines for emergency use in a span of two days. The nods were granted to Clover Biopharmaceuticals Ltd., Sinocelltech Group Ltd., Beijing Wantai Biological Pharmacy Enterprise Co. Ltd. and Westvac Biopharma Co. Ltd. There is still no mRNA vaccine approved in the country.

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.