Introduction:New Alzheimer's Drug Reported to Cause Fatal Brain Hemorrhage in Clinical Trials; Scientists Create "Living" Blood Vessels; Head of U.S. CDC Recurrence After 5 Days of COVID-19 Antiviral Treatment... BioExploration brings you the latest "pharma" news and explores the value of biotechnology!
01 New Alzheimer's Drug Reported to Cause Fatal Brain Hemorrhage in Clinical Trials
Recently, according to foreign media reports, one patient death occurred during the phase III clinical trial of Biogen and Eisai's Alzheimer's drug Lecanemab. In September, Biogen and Eisai stated that the study, named Clarity AD, involved approximately 1,800 patients and achieved its primary goal. However, it was reported that one investigator in the study reported a death case, stating that the patient died after experiencing intracerebral hemorrhage and concluded that this was related to the experimental treatment. Eisai Co., Ltd. disagreed with this statement and pointed out other possible factors, including multiple falls, heart attack, and minor strokes as causes of death.
According to the experimental data published by Biogen, Lecanemab achieved the primary endpoint in the Phase 3 clinical trial. Based on the latest topline readout from the Clarity AD trial, in approximately 1,800 patients with early Alzheimer's disease over 18 months, treatment with Lecanemab reduced "clinical decline" as defined by the Global Cognitive and Functional Scale (CDR-SB) by 27% compared to the placebo group, reaching the primary endpoint. For researchers, this trial result is an important milestone. However, although Lecanemab appears to significantly slow the progression of the disease, the drug does not restore cognitive abilities or completely prevent cognitive loss.
02 Scientists Create "Living" Blood Vessels That Closely Resemble Natural Ones in Appearance and Function
Recently, an international research team led by the University of Sydney has developed a new technology capable of creating materials that mimic the structure of living blood vessels, a breakthrough that holds significant importance for future surgical procedures. Preclinical test results showed that after researchers transplanted these specially designed blood vessels into mice, the mice’s bodies accepted the material, and new cells and tissues grew in the correct locations, indicating that these materials transformed into genuine living blood vessels.
Researchers say that although there have been previous attempts to create blood vessels with varying degrees of success, this is the first time scientists have seen artificial blood vessels develop to a level so similar to the complex structure of natural blood vessels. This technology’s ability to reconstruct the complex architecture of biological tissues suggests it has not only the potential to engineer blood vessels for surgical assistance but also lays the foundation for creating other synthetic tissues in the future, such as heart valves.
03 CDC Director Recurrence After 5 Days of COVID-19 Treatment
On October 22, the CDC announced that Walensky tested positive for COVID-19 on the evening of the 21st and was experiencing mild symptoms. She has received the latest vaccine, and after her diagnosis, she has been isolating at home while being treated with Pfizer's oral antiviral medication.
After completing a course of Pfizer's special drug Paxlovid, Walensky again showed "mild symptoms" and tested positive for COVID-19 on the 30th. The CDC stated, "According to the guidelines of the Centers for Disease Control and Prevention, she is currently isolating at home and will participate online in previously scheduled meetings."
Report: Relapse after using Paxlovid "not surprising." In fact, Walensky is the third key government official to experience a relapse after being treated with Paxlovid, following U.S. President Biden and White House Chief Medical Advisor Fauci.
04 China's First Lung Cancer PCR Multi-Gene Companion Diagnostic Kit Approved
On October 26, Guangzhou Maijing Gene Medical Technology Co., Ltd.'s developed and produced lung cancer PCR multi-gene companion diagnostic kit (trade name: Maifeijie) was approved for marketing by the National Medical Products Administration. The kit can detect core driver genes such as EGFR, ALK, and ROS1 in non-small cell lung cancer, and has been approved for companion diagnostic functions of multiple important targeted drugs, becoming the first non-small cell lung cancer PCR multi-gene detection kit with a companion diagnostic function to be approved by the NMPA in China.
05 Zhuhai Kairui Bio Completes Nearly RMB100 Million Series A Financing
Recently, Zhuhai Carefree announced that it has completed nearly 100 million yuan in financing, with investors including Juke Investment, Yanghe Investment, Gree Industrial Investment, Jet Biochemical and Dingcheng Cloud Creation. After this round of financing, Zhuhai Carefree will rely on its newly built 6,000-square-meter R&D laboratory and GMP production workshop to develop the industry's most comprehensive serum-free cell culture reagent system and provide CRO services for antibody new drug and cell therapy product R&D on two parallel tracks. Zhuhai Carefree Biotechnology Co., Ltd. was established in 2014 and focuses on developing internationally leading serum-free cell culture technology products to continuously provide a full set of technical solutions for the R&D and production needs of biopharmaceutical product development institutions in China.
