Pharmaceutical Industry Roundup: Major Deals, Diagnostic Breakthroughs, and Strategic Shifts

Pfizer's Billion-Dollar Bispecific Bet and FDA's Alzheimer's Test Approval Headline Industry Developments

In a week marked by significant pharmaceutical industry developments, Pfizer's substantial investment in bispecific antibodies and the FDA's groundbreaking approval of an Alzheimer's blood test stand out as transformative events. Meanwhile, strategic shifts in the biosimilars market and advancements in genetic sequencing technology underscore the industry's ongoing evolution.

Pfizer Joins PD-1xVEGF Race with $1.25 Billion Deal

Pfizer has made a bold move into the competitive PD-(L1)xVEGF bispecific antibody field, securing ex-China rights to 3SBio's clinical candidate SSGJ-707 for $1.25 billion upfront. The agreement, which includes up to $4.8 billion in milestones and a $100 million equity investment in 3SBio, positions Pfizer alongside industry leaders like BioNTech and Merck in this promising therapeutic area.

SSGJ-707 is poised to enter phase 3 trials in China, with the initial study focusing on first-line, PD-L1-positive non-small cell lung cancer. This substantial investment underscores the pharmaceutical giant's commitment to expanding its oncology portfolio and capitalizing on the potential of bispecific antibodies in cancer treatment.

FDA Approves First Blood-Based Alzheimer's Diagnostic Test

In a landmark decision, the U.S. Food and Drug Administration (FDA) has granted approval to Fujirebio Diagnostics' Lumipulse G pTau 217/beta-amyloid 1-42 plasma ratio test for Alzheimer's disease assessment. This approval marks a significant advancement in Alzheimer's diagnostics, potentially streamlining the process for identifying patients who may benefit from anti-amyloid therapies like Eisai and Biogen's Leqembi.

The blood test, which measures the ratio of phosphorylated tau and beta-amyloid proteins, could replace more invasive and costly PET scans or cerebrospinal fluid tests for some patients. However, Mizuho analyst Salim Syed cautions that payer reimbursement and physician adoption will be critical factors in determining how quickly this new diagnostic tool impacts the uptake of drugs like Leqembi.

Strategic Shifts in Biosimilars and CDMO Landscapes

Samsung Biologics has announced plans to spin off its biosimilars unit, Samsung Bioepis, in a move aimed at addressing potential conflicts of interest and refining its business focus. The spinoff, scheduled for October 1st, will allow Samsung Biologics to concentrate on its contract development and manufacturing organization (CDMO) operations, while Samsung Bioepis continues its work on biosimilar products.

In related news, WuXi Biologics is divesting its Leverkusen, Germany facility to fellow CDMO Terumo for €150 million ($167 million). This sale concludes WuXi Bio's strategic review of its global sites, enabling the company to focus on expanding its large-scale operations in Singapore.

Advancements in Genetic Sequencing and siRNA Therapeutics

As Illumina faces import restrictions on its DNA sequencers in China, competitor PacBio is seizing the opportunity to expand its presence in the market. PacBio has extended its distribution agreement with Xi'an-based Haorui Gene to include its new Vego benchtop system, broadening the reach of its high-fidelity long-read sequencers in the region.

In the realm of RNA therapeutics, CRISPR Therapeutics and Sirius Therapeutics have formed a collaboration focused on siRNA targets, with an initial emphasis on thrombotic diseases. The partnership, secured with a $25 million upfront cash payment and $70 million in equity from CRISPR Therapeutics, will first explore Sirius' lead program: a long-acting, factor XI-inhibiting anticoagulant for thromboembolic disorders.