Pfizer is paying $1.25 billion to join the PD-(L1)xVEGF bispecific race. The FDA has granted its first official approval to a blood-based Alzheimer's disease test in a potential boon to anti-amyloid drugs. Samsung Biologics plans to spin off its biosimilars business. And more.
1. Pfizer pays 3SBio $1.25B for PD-1xVEGF bispecific, joining red-hot race with BioNTech, Merck
In another major PD-(L)1xVEGF bispecific deal, Pfizer is shelling out $1.25 billion upfront for ex-China rights to 3SBio’s clinical candidate SSGJ-707. The deal includes up to $4.8 billion in milestones and a $100 million equity investment in the Chinese company. The drug is slated to enter phase 3 in China, with the first late-stage trial to test its mettle in first-line, PD-L1-positive non-small cell lung cancer.
2. FDA clears its first blood test for diagnosing Alzheimer's disease, with Fujirebio's Lumipulse
The FDA has issued the first approval for an Alzheimer’s disease blood test. The approval went to Fujirebio Diagnostics’ Lumipulse G pTau 217/beta-amyloid 1-42 plasma ratio test for the assessment of amyloid plaques. Eisai and Biogen have suggested that blood-based tests have the potential to boost the uptake of anti-amyloid antibodies such as Leqembi by replacing cumbersome PET scans or cerebrospinal fluid tests at least for some patients. But Mizuho analyst Salim Syed argued that payer reimbursement and physician user behavior remain key factors affecting how these tests could help Leqembi grow.
3. CDMO Samsung Biologics telegraphs spinoff of biosim unit
Samsung Biologics plans to spin off its biosimilars outfit Samsung Bioepis as the CDMO tries to allay concerns around potential conflicts of interest. Following the spinoff, Samsung Bio will focus on its contracting business, while Samsung Bioepis will continue to work on biosimilar products. The spinoff is planned for Oct. 1, subject to possible changes.
4. Stars align for CRISPR Tx, Sirius as pair pens siRNA collab with a focus on thrombotic disease
CRISPR Therapeutics is paying $25 million upfront in cash and $70 million in equity to work on multiple siRNA targets with Sino-American company Sirius Therapeutics. The initial focus is Sirius’ lead program, a long-acting, factor XI-inhibiting anticoagulant for thromboembolic disorders. Under the deal, CRISPR can pick up to two more siRNA targets.
5. WuXi Biologics slims down again, handing off German plant to CDMO Terumo for $167M
WuXi Biologics is shedding another facility, this time selling its site in Leverkusen, Germany, site to fellow CDMO Terumo for 150 million euros ($167 million). With the deal, WuXi Bio has finished its strategic review of all its sites, leaving the company to focus on building out its large Singapore site.
6. With Illumina sequencers under an import ban, PacBio expands its footprint in China
As Illumina faces a DNA sequencer ban in China, rival manufacturer PacBio is expanding a distribution agreement with local company Haorui Gene. Under the new deal, the Xi’an-based company will now distribute the recently launched Vego benchtop system, growing the reach of PacBio's hi-fi long-read sequencers.
Other News of Note:
8. Eisai mounts targeted TV ad push to raise awareness of Leqembi
9. CDMO Bora Biologics expands operations in San Diego in wake of acquisition by Tanvex
10. SK defeats Pfizer in Korean patent feud, opening new lines of business for pneumococcal vaccine
11. SK Life Science starts TV ad campaign to drive patients to seizure drug Xcopri