膳食补充剂

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科伦药业“麦角硫因胶囊”被指资质缺失 跨境电商模式销售存疑
Xin Hua Wang· 2025-08-12 05:38
Core Viewpoint - The controversy surrounding Kelun Pharmaceutical's product "Ergothioneine Capsules" continues, primarily due to its advertising methods and product claims, raising questions about regulatory compliance and potential legal violations [1][4]. Group 1: Product and Sales Information - Kelun Pharmaceutical's "Ergothioneine Capsules" are marketed as a cross-border product, developed in collaboration with a century-old Japanese company, with a current retail price of 1499 yuan per 60-capsule bottle, leading to estimated sales exceeding 38 million yuan [2]. - The product contains 30mg of ergothioneine per capsule and is sold through a mini-program linked to the company's WeChat account, which is operated by its wholly-owned subsidiary [2]. Group 2: Regulatory Compliance Issues - The "Ergothioneine Capsules" have not been registered with the National Market Supervision Administration or obtained drug approval, and while a new food raw material application was accepted in 2024, it is still under review [2]. - The sales model employed by Kelun, which involves exporting raw materials to Japan for production and then importing them as personal use items, raises concerns about circumventing domestic safety assessments required by the Food Safety Law [3]. Group 3: Advertising and Legal Concerns - The product's marketing claims, including references to anti-aging benefits, may violate advertising laws, as the term "dietary supplement" lacks a legal definition in China, and the product's claims suggest health benefits that are not substantiated [4][5]. - Legal experts indicate that the promotional content constitutes a clear violation of the Advertising Law and Food Safety Law, particularly due to claims of health benefits and the use of a celebrity endorsement that may mislead consumers [5].
科伦药业麦角硫因产品陷假药争议 刘革新三年薪酬加分红入账8.2亿
Chang Jiang Shang Bao· 2025-06-08 23:09
Core Viewpoint - The controversy surrounding Kelong Pharmaceutical's product, Ergothioneine capsules, has raised questions about its legitimacy as a dietary supplement, with accusations of it being a "fake drug" by a prominent academic [1][6][8]. Financial Performance - In Q1 2025, Kelong Pharmaceutical reported a revenue of 4.39 billion yuan, a year-on-year decline of 29.42%, and a net profit of 584 million yuan, down 43.07% [2][10]. - The company's revenue for 2024 was 21.81 billion yuan, a slight increase of 1.67% year-on-year, while net profit reached 2.94 billion yuan, up 19.53% [9]. - Over the past three years, Kelong's sales expenses totaled 12.67 billion yuan, accounting for approximately 20% of its revenue during the same period [3][11]. Product and Market Position - Ergothioneine is marketed as a dietary supplement rather than a drug, with Kelong asserting its safety and efficacy based on scientific validation and international recognition [6][7]. - The product is priced at 1,499 yuan per bottle (60 capsules), claiming to have effects significantly greater than Vitamin C and Coenzyme Q10 [5]. Management and Compensation - Kelong's chairman, Liu Gexin, received a total compensation of approximately 820 million yuan over the past three years, including salary and dividends [4][12][13]. - Liu holds 379 million shares in the company, with a significant portion pledged as collateral, but the company asserts that there is no risk of forced liquidation [11].
饶毅再发文批麦角硫因 科伦永年大健康:麦角硫因非药品
Bei Ke Cai Jing· 2025-06-06 11:13
Core Viewpoint - The debate surrounding the efficacy of ergothioneine as a dietary supplement has intensified, with prominent figures from both sides presenting conflicting arguments regarding its legitimacy and effectiveness [1][2][3]. Group 1: Company Actions and Responses - On June 5, the "Kelong Yongnian Health" public account published an advertisement for ergothioneine capsules, featuring Kelong Pharmaceutical's chairman Liu Gexin, promoting the product's anti-aging benefits [1][4]. - Following the advertisement, Liu Gexin issued two open letters to the public, endorsing the efficacy of ergothioneine and outlining the company's strategic focus on the anti-aging sector as part of its fourth entrepreneurial venture [1][4]. - Kelong Yongnian Health emphasized that ergothioneine is recognized internationally as a dietary supplement rather than a pharmaceutical drug, positioning it as a health management tool [5]. Group 2: Market Reaction - The stock price of Kelong Pharmaceutical experienced a decline of 4.96% on June 5, closing at 37.47 yuan per share on June 6, with a further drop of 0.74% [6].
麦角硫因到底是不是“假药”?饶毅与科伦对线升级
Xin Lang Cai Jing· 2025-06-06 09:24
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].
关于《假药靠肌肉男真人“赤膊上阵”,真药伟哥仅以小小 “老鼠作证”》一文,科伦药业回应→
第一财经· 2025-06-06 06:14
Core Viewpoint - The controversy surrounding Kelun Pharmaceutical's product, Ergothioneine capsules, has intensified following public criticism from renowned biologist Rao Yi, who labeled the product as a "fake drug" due to its lack of regulatory approval [1][2]. Group 1: Product Controversy - Rao Yi's article questioned the legitimacy of Ergothioneine capsules, suggesting that if the product had genuine health benefits, it would have received regulatory approval [1]. - Kelun Pharmaceutical responded by asserting that Ergothioneine is classified as a dietary supplement and not a drug, thus challenging the notion of it being a "fake drug" [1][2]. Group 2: Regulatory Status - Ergothioneine has been recognized as a novel food supplement in developed countries, with the FDA granting it GRAS (Generally Recognized as Safe) status and the European Food Safety Authority approving it as a new food supplement [2]. - Kelun Pharmaceutical's application for Ergothioneine as a new food ingredient was accepted by the National Health Commission in 2024, although it is still under review [2]. Group 3: Company Stance - In response to accusations of misleading marketing, Kelun Pharmaceutical welcomed scrutiny from academia, regulatory bodies, and consumers, urging an objective evaluation of emerging technologies [2].
麦角硫因究竟是不是“假药”?科伦药业公开回应饶毅多条质疑
Di Yi Cai Jing· 2025-06-06 05:07
Core Viewpoint - The controversy surrounding the product Ergothioneine from Kolun Pharmaceutical is primarily focused on its classification as a dietary supplement rather than a drug, which has led to accusations of it being a "fake drug" by a prominent biologist [1][2]. Group 1: Product Classification and Controversy - Kolun Pharmaceutical asserts that Ergothioneine is recognized internationally as a dietary supplement and not a drug, countering claims of it being a "fake drug" [1]. - The core of the dispute revolves around the product's qualifications, with Kolun responding to criticisms regarding the lack of drug approval by citing studies published in the high-impact journal "Cell Metabolism" that support its health benefits [1]. Group 2: Safety and Regulatory Status - Ergothioneine has been classified as a new type of food supplement or functional health food ingredient in developed countries, receiving GRAS certification from the FDA and approval from the European Food Safety Authority [2]. - Kolun Pharmaceutical has submitted an application for Ergothioneine as a new food ingredient to the National Health Commission, which is currently under review [2]. - The company welcomes scrutiny from the academic community, regulatory bodies, and consumers regarding its research and products, advocating for an objective perspective on emerging technologies [2].
科伦药业回应饶毅“假药”质疑:麦角硫因价值通过科学验证 定位为膳食补充剂而非药品
Mei Ri Jing Ji Xin Wen· 2025-06-06 02:56
Core Viewpoint - The core controversy revolves around whether the product Ergotioneine capsules from Kelun Pharmaceutical is a dietary supplement or a "fake drug" as claimed by Peking University’s Rao Yi [1][4]. Group 1: Company Position - Kelun Pharmaceutical asserts that Ergotioneine is recognized internationally as a dietary supplement and not a drug, thus challenging the notion of it being labeled as a "fake drug" [1][4]. - The company emphasizes that the value and safety of Ergotioneine have been scientifically validated through various studies, including those published in top journals [2][3]. - Kelun Pharmaceutical calls for an objective industry perspective on emerging technologies to shift the nutrition and health industry from a marketing-driven approach to a science-driven one [1][6]. Group 2: Scientific Evidence - The company cites two studies published in "Cell Metabolism" demonstrating that Ergotioneine can significantly extend the lifespan of model organisms and improve their physical performance [2]. - Additional clinical research indicates that Ergotioneine may help reduce sleep difficulties, improve cognitive functions in patients with mild cognitive impairment, decrease skin wrinkles, and lower the risk of coronary artery disease [3]. - The safety of Ergotioneine has been established in toxicity tests and randomized controlled trials, with its acceptance as a new food supplement in developed countries [3]. Group 3: Market Performance - Despite the controversy, Kelun Pharmaceutical's Ergotioneine products continue to be sold, with prices ranging from 1,199 yuan to 4,476 yuan, and sales exceeding 18.83 million yuan as of June 5 [5].