Each week we highlight five things affecting the life sciences industry. Here’s the latest.
Major pharma company enters oncology collaboration with Chinese biopharma
- The deal covers 12 early-stage cancer programs, with total deal value up to $10.5 billion ($650 million upfront + milestones). The Chinese company will lead through Phase 1, after which the major pharma company will take a larger development role.
- The deal reflects a broader trend of Big Pharma sourcing innovation from China, with shared/global licensing structures and co-development economics, while also raising increasing U.S. policy scrutiny around outbound biotech investment and data security, according to Endpoints News.
U.S. lawmakers push to curb China biotech ties amid industry debate
- A bipartisan group of U.S. lawmakers introduced the Biotech Investment National Security Act of 2026, which would expand federal scrutiny of U.S. investments and dealmaking with Chinese biotech firms, including licensing, joint ventures and equity stakes.
- Endpoints News reports that the proposal highlights growing tension between policymakers who want tighter restrictions on China ties and those in the biotech industry who argue that imposing limits could hurt U.S. competitiveness and patient access, especially given the critical role cross-border deals play in accessing lower-cost innovation and accelerating drug development.
New targeted therapy data signals ‘paradigm shift’ in rare gut cancer treatment
- Early clinical data presented at the American Society of Clinical Oncology Meeting 2026 suggests a new tyrosine kinase inhibitor could improve outcomes for patients with gastrointestinal stromal tumors—a rare cancer where treatment options have remained largely unchanged for two decades—reports Fierce Biotech.
- The results are being positioned as a potential ‘paradigm shift’ according to a medical oncologist at Dana-Farber Cancer Institute and highlight continued momentum in precision oncology approaches targeting resistance mechanisms in rare cancers.
Guidance released on use of prior knowledge for cell and gene therapies
- The U.S. Food and Drug Administration drafted guidance encouraging sponsors developing genome editing gene therapies to leverage prior knowledge (public scientific data and platform experience) across chemistry, manufacturing and controls, nonclinical, and clinical areas to streamline development, reduce redundant testing and accelerate timelines, particularly for serious or rare diseases.
- Leveraging is not automatic. Companies must demonstrate scientific justification based on similarity of products, processes and data, and still generate product-specific evidence where needed—especially for safety, potency and clinical outcomes—with early FDA engagement recommended.
Streamlining safety in oncology drug development
- Recent FDA drafted guidance promotes streamlined nonclinical safety testing for oncology biologics and conjugated products, allowing reduced reliance on animal studies (e.g., fewer or shorter toxicology studies) and encouraging alternative approaches (such as single-species studies or eliminating certain studies) when scientifically justified to improve efficiency without compromising patient safety.
- Sponsors are encouraged to use a weight-of-evidence risk assessment, which combines existing nonclinical/clinical data, literature, known class toxicities and other methodologies, as a potential substitute for some animal studies, provided they can adequately demonstrate and justify product safety to the FDA.
For more insights in life sciences, check out RSM’s industry outlook.
