Johnson & Johnson and Legend Biotech's Carvykti keeps growing despite a newly launched off-the-shelf option. Novo Holdings joined a $290 million funding round in a Chinese R&D product and service provider. China is stressing biotech as a “major focus” in the government's latest attempt to woo foreign investment.
Johnson & Johnson and Legend Biotech’s Carvykti generated $117 million in second-quarter sales, up from $72 million in the first quarter. Even though J&J recently introduced the off-the-shelf bispecific antibody Tecvayli, doctors are typically using the newer drug as a bridge therapy while patients wait to get their CAR-T treatment, a Legend exec explained.
Novo Holdings participated in a $290 million investment round in Chinese life sciences research enabler Sangon Biotech. Sangon offers products and services related to DNA synthesis, genetic sequencing, and protein- and antibody-related drug research.
The Chinese government released a 24-point list of guidelines to “improve the business environment for foreign investors and boost foreign direct investment.” The new document highlights biotech as “an area of major focus.” It calls for more biotech R&D projects in the country and promised more efficient clinical trials and product registrations for drugs already approved elsewhere.
The Japanese government has awarded two grants totaling $115 million to Arcalis, an mRNA-focused CDMO joint venture between Arcturus Therapeutics and Japanese drug discovery service provider Axcelead. With the money, Arcalis already completed construction of a drug substance plant, and a final drug product plant is expected to go online by 2026.
The FDA has once again found problems at Biocon’s Malaysia manufacturing facility. A new Form 483 laid out some repeat problems that the agency had identified before. Issues the FDA spotted include improper blockage of air filters, insufficient cleaning of sterile machinery, and subpar batch testing and record-keeping.
China’s Gracell has decided to shift more focus on its lead candidate, GC012F, a BCMA/CD19 dual-targeting CAR-T therapy that has shown impressive early results in multiple myeloma. In parallel, the company is deprioritizing three early-stage programs.