麦角硫因到底是不是“假药”？饶毅与科伦对线升级

Core Viewpoint - The ongoing dispute between renowned biologist Rao Yi and Kelun Pharmaceutical regarding the classification of ergothioneine as a "fake drug" has escalated, with Kelun asserting that ergothioneine is recognized internationally as a dietary supplement rather than a drug, thus negating the "fake drug" claim [1][12]. Company Response - On June 6, Kelun Pharmaceutical published a response on its official WeChat account, stating its commitment to clarify misunderstandings with rigorous scientific data and emphasizing that ergothioneine is a health management tool [1]. - Kelun cited various authoritative journals and clinical studies to support its claims about ergothioneine's benefits, including research from the Leibniz Institute and Harvard Medical School, which suggest ergothioneine can mediate healthy aging through dual mechanisms [6][9]. Market Reaction - Following the controversy, Kelun Pharmaceutical's stock price fell by 0.74% to 37.47 yuan per share, resulting in a market capitalization of 598.79 billion yuan [2]. Clinical Evidence - Kelun referenced multiple clinical trials conducted in Japan, Singapore, and Sweden, demonstrating ergothioneine's efficacy in areas such as sleep health, cognitive health, skin anti-aging, and cardiovascular health [7][9]. - The results of these trials were published in reputable journals, with three out of four being top-tier in their respective fields [9]. Regulatory Context - Ergothioneine has been recognized as a novel food supplement in several countries, including the U.S. and Japan, with the U.S. FDA granting it GRAS (Generally Recognized As Safe) status [9]. - However, it is noted that while the National Health Commission of China has accepted an application for ergothioneine as a new food ingredient, it has not yet been approved [9]. Scientific Debate - Rao Yi challenged Kelun's claims, stating that without approval from the National Medical Products Administration, the promotion of ergothioneine could be misleading or deceptive [5][12]. - Kelun responded by arguing that the approval process for drugs differs from that of dietary supplements, emphasizing that ergothioneine serves a different purpose in health management [12].