Core Viewpoint - The article highlights the challenges faced by biopharmaceutical companies in Shenzhen regarding the approval of production licenses for standalone factory buildings, emphasizing the need for clearer regulations to support the industry's growth [1][2][3]. Group 1: Industry Challenges - Biopharmaceutical companies are struggling to find suitable standalone factory buildings of approximately 7,000 square meters for the commercialization of new stem cell drugs [1]. - The "industrial building up" policy in Shenzhen has not significantly benefited pharmaceutical companies, as they require standalone buildings to obtain production licenses [1]. - Many companies face a dilemma between choosing standalone buildings, which are more likely to receive production licenses but are often too large for their needs, and opting for "industrial building up," which carries the risk of not obtaining the necessary licenses [1]. Group 2: Regulatory Environment - The Guangdong Provincial Drug Administration has introduced a "one enterprise, one policy" approach to improve service for companies, but many firms find the limited successful cases of "industrial building up" to be of little reference value [2]. - The lack of clear and transparent rules creates uncertainty for biopharmaceutical companies, which are particularly vulnerable during their early stages of development [2]. - There is a call for the establishment of explicit rules for biopharmaceutical companies to alleviate the anxiety surrounding the approval process and to foster a more predictable regulatory environment [3].