Core Viewpoint - Shenzhen's pharmaceutical companies are facing challenges with the "upstairs" industrial development model due to regulatory approval standards for production facilities, prompting discussions on how to better support these enterprises [1][5]. Regulatory Standards - The Guangdong Provincial Drug Administration clarified that having an independent factory is not a prerequisite for obtaining a drug production license, except for specific high-risk drugs that require dedicated facilities [2][4]. - Approval is based on the compliance of production management, pollution control, ventilation, and transportation conditions with national standards, rather than the independence of the facility [2][4]. Cost Considerations - Pharmaceutical companies weigh the costs of rent and "upstairs" renovations when deciding on their production locations, considering factors like potential interference with neighbors [3]. - The cost of "renovation" in non-independent facilities can be significantly higher due to the need for additional measures to ensure safety and compliance with regulations [3]. Support for "Upstairs" Enterprises - The regulatory body aims to treat "upstairs" enterprises fairly and will not lower standards for their production facilities compared to independent ones, ensuring compliance with national requirements [4][5]. - The administration is exploring ways to better serve companies that choose the "upstairs" model, focusing on professional guidance and support for innovative products [5].

Core Viewpoint - The article discusses the challenges faced by Shenzhen's biopharmaceutical companies in obtaining production licenses when transitioning to multi-story industrial buildings, highlighting the regulatory standards and considerations involved in the approval process [5][6][9]. Approval Standards - The Guangdong Provincial Drug Administration clarified that having an independent factory is not a universal requirement for obtaining a drug production license, except for specific high-risk drugs that necessitate dedicated facilities [6]. - The approval process focuses on whether the production environment meets national standards, including management, pollution control, ventilation, and transportation conditions, rather than the independence of the factory [6][8]. Cost Considerations - Pharmaceutical companies weigh the costs of rent against the expenses associated with adapting to multi-story buildings, considering factors such as potential interference with neighbors and the associated renovation costs [7]. - The article notes that while independent buildings may have higher rent, the renovation costs for non-independent facilities can be significantly higher due to the need for enhanced safety measures [7]. Regulatory Approach - The Provincial Drug Administration aims to treat companies fairly, ensuring that those in multi-story buildings are held to the same standards as those in independent facilities, provided they meet the necessary regulatory requirements [8][9]. - The administration is open to exploring ways to better support companies that choose to transition to multi-story buildings while maintaining strict adherence to national standards [9].

Core Viewpoint - Zhejiang Anglikang Pharmaceutical Co., Ltd. reported a revenue of 1.538 billion yuan and a net profit of 80.3345 million yuan for 2024, reflecting a year-on-year decline of 41.94% in net profit primarily due to increased R&D expenditures [1] Group 1: Financial Performance - The company achieved a revenue of 1.538 billion yuan in 2024 [1] - The net profit attributable to shareholders was 80.3345 million yuan, down 41.94% year-on-year [1] - R&D expenses reached 231 million yuan, an increase of 33.74% year-on-year, accounting for 14.99% of total revenue [1] Group 2: R&D and Innovation - Anglikang secured 19 new invention patents in 2024 and participated in drafting national standards for pharmaceutical excipients [2] - The company received drug registration certificates for six products, including phosphate sitagliptin tablets and sacubitril valsartan sodium tablets [2] - Anglikang is accelerating its transformation towards innovative drugs, collaborating with Shanghai Qinhuli Biotechnology Co., Ltd. on the development of ALK-N001/QHL-1618 [2] Group 3: Industry Upgrades and Pet Medicine - The company is advancing technology upgrades with a focus on "raw materials + formulations" integration, optimizing processes to reduce energy consumption [3] - Significant progress was made in the pet medicine sector, with several products receiving GMP certification and approval numbers [3] - Anglikang is developing innovative vaccines for pets in collaboration with China Agricultural University, and a chronic pain rehabilitation software project has entered the registration application phase [3]