CHINA Trends and Developments Contributed by: Min Zhu, Ya-ling (Michelle) Gon, Yang (Aaron) Gu, Chai Lu, Ying Li and Shiye Yuan, Han Kun Law Offices
restrictions and even criminal liability. 12 enterprises in the biopharmaceutical industry were listed as “seri- ously illegal and untrustworthy entities” for fabricat- ing technical solutions. Fabricating technical schemes and falsifying experimental data have become key enforcement targets, and applicants are required to submit complete experimental records and raw data. These measures have comprehensively lifted the qual- ity of biopharmaceutical and broader health-sector patent applications. Changes in policies, regulations and examination practice CNIPA’s newly revised Guidelines for Patent Examina- tion came into force on 1 January 2026. Key revisions relevant to the life sciences and healthcare sector include: • clarifying the definitions of biological materials and plant varieties, expanding the scope of patent-eli- gible subject matter, forming a rational and effec- tive connection with the new plant variety protec- tion system and strengthening IP protection for the seed industry; and • strengthening AI ethics review. Invention patent applications involving AI, big data and other technologies with algorithmic features or commercial rule/method features will not be grant- ed patent rights if they contain content that violates laws, public morality or public interests – for example, where data collection, label management, rule-setting, a recommendation or decision-making involves illegal conduct, contravenes principles of fairness and jus- tice, or embodies discriminatory bias. Cutting-edge technologies, and surge in AI drug discovery patents In 2025, patent filings in biopharmaceuticals were highly concentrated in frontier technologies, with a notable increase in AI-driven drug discovery patents – for example: • ADC-related patent applications accounted for 18%; • next-generation ADC patents (bispecific ADCs, dual-payload ADCs, etc) made up 45% of all antibody-related filings;
• gene-editing-related patents accounted for 15%; and • patents for precision editing technologies (base editing, guide RNA optimisation, etc) surged by 67%, with China accounting for 28% of global fil- ings. Cell therapy-related patents represented 12%, with CAR-T and TCR-T technologies expanding from hae- matological tumours to solid tumours. AI-assisted R&D has raised drug development success rates while cutting costs by 60%. AI drug discovery patents accounted for 10%, and patents for target prediction, molecular design and other applications jumped by 120%. Higher proportion of core patent applications The share of core invention patents (covering com- pound structures, preparation methods) rose from 27% to 32%, while the proportion of derivative improvement patents declined. In core patent families for cutting-edge fields such as oncology and autoim- mune diseases, the share held by Chinese institutions soared from 5% in 2020 to 22% in 2025. Booming overseas licensing of Chinese patents In 2025, the total value of out-licensing transactions for innovative drugs from China reached a record high. This surge reflects a structural upgrade in China’s pharmaceutical exports, from “product exports” and “overseas manufacturing” to “patent exports”, driv- ing a significant appreciation in pharmaceutical patent value. Tax Concerns VAT law and implementation rules The Value-Added Tax Law enacted at the end of 2024 and its implementation rules issued at the end of 2025 have brought clarity to the VAT system, and have also generated significant impacts across sectors, includ- ing the biopharmaceutical industry. Business taxpay- ers need to pay close attention to the practical appli- cation of exemptions for R&D and technology transfer services, the withholding and remittance obligations for VAT on outbound payments under non-trade trans- actions, as well as the boundaries for claiming input VAT credits on R&D equipment, reagents and con- sumables, and outsourced R&D services. To achieve
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