China cracks down on some biotechnology ownership transfers—but will the new policy impact licensing deals?; Disc Medicine’s Phase 3 data sweep redeems rejected rare disease therapy, teeing up another FDA run; and the ESMO conference gets underway in Madrid this week, with much-anticipated data from Merck, and Summit Therapeutics.
The Chinese government has rolled out a set of restrictions on biotechnology ownership transfers, an escalation of oversight from the nation’s government that is seeking to spread the region’s influence on the global biopharmaceutical industry. The restrictions apply to five different types of technology including cell and gene therapy. But licensing deals are excepted, meaning its business as usual for global pharmas.
M&A deals are rare for Chinese sellers, with 91% of all deals so far this year coming from U.S.-based companies. BioSpace Senior Editor Annalee Armstrong spoke to CEO of global investment bank Locust Walk, to put the deal activity on both sides into perspective. While China is undeniably capturing the majority of licensing deals at the moment, U.S. biotechs are enjoying a bumper M&A year.
In the clinic, Disc Medicine reported Phase 3 redemption. In February, the FDA surprised Disc—and the whole biopharma industry, really—by rejecting its lead asset bitopertin for erythropoietic protoporphyria (EPP)—a rare disease that causes pain when exposed to the light. This was after previously granting the drug a Commissioner’s National Priority Voucher.
The latest readout showed a reduction in a key biomarker of the disease called PPIX, along with a significant increase in time patients were able to spend in the light. The late-stage trial met all of primary and secondary endpoints, setting the company up for another run at an approval.
Veradermics similarly had a great start to the week, with its oral Rogaine candidate improving hair growth in men during a Phase 3 trial. The data set Veradermics up for an FDA application as well.
And finally, we head to Spain—metaphorically, anyway—to preview the upcoming European Society for Medical Oncology Congress, where antibody-drug conjugates are expected to be the major headline. Merck and partner Kelun-Biotech are expected to present more complete data for sac-TMT; Merck and another partner Moderna will present detailed data on their personalized mRNA vaccine; and Summit Therapeutics and Akeso’s ivonescimab will also get some more time to shine.
