Core Viewpoint - The article discusses the challenges faced by Green Valley Pharmaceutical (referred to as "the company") regarding its core product GV-971, an Alzheimer's drug, highlighting the company's financial struggles, workforce reductions, and regulatory hurdles in the drug approval process [2][9][34]. Group 1: Company Overview and Financial Status - Green Valley has invested nearly 4 billion yuan in the development of GV-971 since its inception, yet the company has not achieved profitability [2][9]. - The company has over 1,000 employees, with a significant portion in sales, and is set to lose nearly 80% of its workforce due to recent layoffs [3][4]. - The sales of GV-971 had been growing at nearly 50% annually post-pandemic, with projected sales for 2024 reaching 600 million yuan, but the company now faces a critical situation with inventory depletion and production halts [7][31]. Group 2: Regulatory Challenges - GV-971's drug registration certificate is set to expire on November 2, 2024, and the company has been in the process of applying for a new license since May 2024 [12][14]. - The National Medical Products Administration (NMPA) has imposed stricter requirements for GV-971's approval, necessitating additional data and studies due to its unique mechanism of action [20][21]. - The drug's approval process has been complicated by its status as the first Alzheimer's drug to be conditionally approved in China, leading to a more cautious approach from regulatory bodies [19][25]. Group 3: Market Dynamics and Future Prospects - The company has faced significant market disruptions, including stock shortages and increased prices on e-commerce platforms, leading to a halt in sales and production [16][18]. - Despite the controversies surrounding GV-971, there remains a strong demand from patients who have used the drug, indicating its perceived value in the market [32][34]. - The future of GV-971 and Green Valley's operations hinges on the successful navigation of regulatory challenges and the ability to secure funding for ongoing clinical trials [40].