四中全会精神解读·市场最前沿丨当“中国原研”印上药盒：中国药品产业开启加速跑

Core Viewpoint - The Chinese pharmaceutical industry is undergoing a significant transformation, shifting from a focus on generic drugs to the rise of original research and development (R&D) drugs, driven by policy innovation, technological breakthroughs, and capital support [1][2]. Group 1: Policy and Regulatory Changes - The reform of the drug review and approval system in China is a long-term initiative aimed at addressing structural issues such as backlog in drug reviews and a high proportion of low-level generics [2]. - Since the 14th Five-Year Plan, a series of policy benefits have been released, establishing green channels for breakthrough therapies, conditional approvals, and priority reviews, which have greatly stimulated innovation [2]. - The average review time for drug clinical trials has decreased from 108 days in 2018 to 50 days in 2024, with pilot regions like Beijing and Shanghai reducing it to under 30 days for eligible innovative drugs [2]. Group 2: Innovation and Development - The R&D of innovative drugs in China has achieved significant advancements in both quantity and quality, with companies like Zhejiang Maitong Biopharmaceutical launching innovative drugs that fill international treatment gaps [3]. - The shift from follower innovation to original innovation is evident, with Chinese companies now capable of achieving optimal or even pioneering solutions in certain therapeutic areas [3]. Group 3: Market Access and Affordability - The optimization of the medical insurance access mechanism has significantly reduced the time from drug launch to inclusion in the insurance catalog, making innovative drugs more accessible to patients [4]. - Since the establishment of the National Medical Insurance Bureau in 2018, the number of approved innovative drugs has reached 265, with 68 approved in 2025 alone, over six times the total for 2018 [4]. - The introduction of early resolution mechanisms for patent disputes has encouraged innovation and investment in R&D [4]. Group 4: International Recognition and Expansion - Chinese original research drugs are gaining international recognition, with companies like BeiGene and CanSino Biologics developing competitive products that outperform international counterparts [5]. - The internationalization of Chinese pharmaceutical companies is deepening, with efforts to expand overseas markets and establish R&D centers abroad [5]. - The 15th Five-Year Plan emphasizes support for the development of innovative drugs and medical devices, aiming to integrate more Chinese innovations into the global pharmaceutical landscape [5].