Core Viewpoint - The FDA has approved Aduhelm (Aducanumab), the first drug to slow the progression of Alzheimer's disease, marking a significant milestone in the treatment of this condition [1][2][4]. Group 1: Drug Approval and Market Reaction - The FDA's approval of Aducanumab is the first for an Alzheimer's drug since 2003, leading to a nearly 60% surge in the stock price of Biogen [1][2]. - The approval has sparked interest in the domestic market, with companies like Green Valley Pharmaceutical gaining attention for their Alzheimer's drug developments [1][2]. Group 2: Alzheimer's Disease Context - Alzheimer's disease (AD) affects approximately 35 to 50 million people globally, with an estimated 10 million new cases each year, potentially reaching 150 million by 2050 [2]. - The primary pathology of AD is believed to be the accumulation of beta-amyloid (Aβ) plaques in the brain, which Aducanumab targets as a monoclonal antibody [2][3]. Group 3: Development History of Aducanumab - Biogen acquired the rights to Aducanumab in 2007 and faced multiple challenges during its development, including failed trials in 2019 [3][4]. - Despite initial setbacks, Biogen submitted new data in 2019, leading to the eventual approval in June 2021, although the data presented was controversial [3][4]. Group 4: Clinical Efficacy and Safety Concerns - The FDA's approval was conditional, requiring further clinical trials to validate the drug's efficacy, with the possibility of revocation if these trials do not confirm benefits [4][5]. - Concerns about Aducanumab's safety include reports of brain swelling or bleeding in about 40% of high-dose participants, raising questions about its overall effectiveness [6][7]. Group 5: Market Potential and Competitive Landscape - Aducanumab is priced at approximately $50,000 per year for patients, with projected global sales reaching $4.8 billion by 2026 [8][9]. - The Alzheimer's drug market is seen as a lucrative opportunity, despite previous failures by major pharmaceutical companies like Johnson & Johnson and Roche in developing effective treatments [9][10]. Group 6: Domestic Developments in Alzheimer's Treatment - Chinese companies are actively pursuing Alzheimer's drug development, with Green Valley's GV-971 already conditionally approved and other firms like Hengrui Medicine entering the market [10].