Fruquintinib

Eli Lilly's Alzheimer's drug Kisunla (donanemab) gains approval in Japan, following US FDA approval in July. Kisunla targets early symptomatic Alzheimer's, showing significant cognitive decline reduction in the TRAILBLAZER-ALZ 2 study. Japan's aging population makes it a key market, with dementia cases expected to reach 5 million by 2030, mostly Alzheimer's. Lilly emphasizes Kisunla's cost-effectiveness due to fixed treatment duration.

Takeda secures Japanese MHLW approval for FRUZAQLA capsules to treat advanced or recurrent colorectal cancer, based on FRESCO-2 trial results showing significant improvement in overall survival and progression-free survival.

Takeda receives approval for FRUZAQLA (fruquintinib) in Japan for advanced or recurrent colorectal cancer, based on FRESCO-2 trial results showing consistent benefits and manageable safety profile.

Takeda UK announces MHRA approval of fruquintinib (Fruzaqla) for metastatic colorectal cancer, based on studies FRESCO-2 and FRESCO. Fruzaqla, which inhibits tumour blood vessel formation, showed median survival of 7.4 months versus 4.8 months for placebo, with common side effects including reduced platelets and joint pain.

Cyramza plus Lonsurf did not significantly improve overall survival in heavily pretreated metastatic colorectal cancer patients compared to Lonsurf alone, according to the phase 3 IKF-AIO-RAMTAS trial. However, female patients and those with left-sided tumors showed potential benefit.

The phase 3 IKF-AIO-RAMTAS trial found no significant OS improvement with ramucirumab + TAS-102 vs TAS-102 alone in heavily pretreated mCRC patients, though benefits were seen in female patients and those with left-sided tumors. The combination showed improved PFS and DCR but increased hematotoxicity and dose reductions.

New therapies like trifluridine/tipiracil plus bevacizumab and fruquintinib expand options for refractory metastatic colorectal cancer (mCRC). Efforts focus on moving targeted therapies to earlier lines and developing novel therapies for previously undruggable mutations. Immunotherapy lags in mCRC, but combinations and new approaches show promise. Enrolling in clinical trials is crucial for further progress.

The article highlights the evolution and current state of the biotechnology industry, emphasizing the U.S.'s leadership in biotech innovation and the emerging competition from China. It discusses China's strategic shift towards biotech innovation, supported by government policies, financial incentives, and the establishment of biotech clusters. The article also explores the challenges China faces in commercializing scientific discoveries and the importance of building a comprehensive biotech ecosystem to enhance commercialization capabilities.