Abstract: As the global biologics market burgeons, the adequacy of international intellectual property protection frameworks under evolving pharmaceutical landscapes warrants scrutiny. This article examines whether Article 39.3 of the TRIPS Agreement mandates biologics regulatory data protection and analyzes this question under PRC laws. A meticulous analysis of pharmaceutical classification and Article 39.3 drafting history under the treaty interpretation principles demonstrates that Article 39.3 exclusively applies to new chemical entity drugs. China’s Article 39.3 equivalent has mirrored the same position since China’s accession to the WTO in 2001, despite its recent failed attempts to extend the protection scope to biologics. The article advocates establishing a biologics-specific regulatory data protection regime under the PRC laws from three perspectives: (1) the inadequacy of patent protection, (2) the encouragement of biologics innovation and the promotion of public health, and (3) the fulfillment of international law obligations in good faith. In conclusion, while the TRIPS Agreement does not mandate biologics data protection, China’s technological ambitions and public health objectives necessitate a sui generis biologics regulatory data protection regime balancing innovation incentive with equitable access, positioning China as a leader in the biotechnology era.