Citing recent events that highlighted the risks of investing in companies based in China or that have the majority of their operations there, the U.S. SEC’s Division of Corporation Finance is seeking more specific disclosures from those companies about the legal and operational risks of investing in their securities.

China is making some advances in approving and reimbursing drugs to treat or prevent rare diseases. More than 60 rare disease drugs have been approved for marketing in China, with more than 40 of those included in the national medical insurance system, according to figures released at a national conference on rare diseases held in Beijing Dec. 18.

PERTH, Australia – The FDA has given the green light to Telix Pharmaceuticals Ltd.’s lead radiopharmaceutical imaging agent, Illuccix, for prostate cancer. Illuccix is a kit for the preparation of gallium-68 (68Ga) prostate-specific membrane antigen (PSMA) 11 for imaging prostate cancer with positron emission tomography (PET). It targets PSMA, a protein that is overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells.

There was no slowing of biopharma innovation in 2021, even as industry directed significant resources to, while feeling the impact of, the ongoing COVID-19 pandemic. The year saw big wins for developers of DNA vaccines and biosimilars, while CAR T expanded its reach and a drug target once considered undruggable was finally conquered. And as 2021 gives way to 2022, other potentially game-changing technologies and therapeutics are waiting in the wings.

Shanghai Henlius Biotech Inc.’s self-developed Hanbeitai (bevacizumab biosimilar) has received marketing approval from China’s NMPA.

A cocktail of monoclonal neutralizing antibodies developed by Brii Biosciences Ltd. has become “the first locally-discovered and approved SARS-CoV-2 target-specific treatment in China, through a randomized, double-blind and placebo-controlled trial,” Rogers Luo, president and general manager of greater China at the company, told BioWorld.

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.

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.

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.