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On October 7, with comprehensive support from CIRS Group, Inner Mongolia Kingdomway Pharmaceutical Limited (hereinafter referred to as “Kingdomway”) officially received a “FDA Has No Questions Letter” from the U.S. Food and Drug Administration (FDA) for its fermentation-derived brazzein (GRAS Notice No. 001305). This milestone marks the successful completion of the FDA’s review of the company’s GRAS notice for the product.
This successful FDA evaluation marks a major breakthrough in the product’s international compliance capabilities, providing a solid foundation for the company’s overseas business expansion and the implementation of its global strategy.
On July 6, Henan Zhongda Hengyuan Biotechnology Stock Co., Ltd. (Hengyuan) received a "no questions" letter from the FDA regarding the GRAS (Generally Recognized as Safe) notice for its D-psicose. Produced via an enzymatic bioconversion process, the ingredient's safety has now been officially recognized by the FDA.
Recently, S-adenosyl-L-methionine disulfate tosylate (SAMe-DT), independently developed by Shandong Freda Biotechnology Co., Ltd. (hereinafter refered to as Shandong Freda), has successfully completed FDA New Dietary Ingredient (NDI) notification, with the NDIN number being 1473, marking the ingredient’s compliance for entry into the U.S. dietary supplement market. CIRS Group provided full support throughout the notification process.
Recently, Enhe Aiju (Hangzhou) Science and Technology Co., Ltd. (Enhe Aiju) has completed the FDA GRAS notice for its self-developed zeaxanthin, produced via fermentation using production strain Yarrowia lipolytica CGMCC 39021 (GRN No. 1300). This is the world’s first high-concentration crystalline zeaxanthin product manufactured at commercial scale using cell factory technology to receive GRAS, fully under the support of CIRS Group.
Recently, Shandong Weiyan Biotechnology Co., Ltd. (“Shandong Weiyan”) achieved a milestone in its international compliance journey for its product, astaxanthin. With comprehensive professional support from CIRS Group, the company’s astaxanthin has been concluded by GRAS Panel as Generally Recognized as Safe (GRAS).
On February 5, 2026, China’s NHC issued the No.1 Announcement of 2026. 3’-SL was approved as a new food nutrition enhancer, becoming the third officially authorized human milk oligosaccharide (HMOs) following 2’-FL and LNnT.
Earlier in September 2025, Shandong Runhan Biotechnology Co., Ltd. (“Runhan”) achieved a milestone in its international compliance journey for its core product, GlcNac. With comprehensive professional support from CIRS Group and its U.S. subsidiary, the company’s GlcNac has been concluded by GRAS Panel as Generally Recognized as Safe (GRAS).
Recently, VDK’s synthetically produced β-carotene, manufactured using synthetic biology technology, obtained self-GRAS notification. This milestone signifies the product’s approval as a safe food ingredient for sale and use in the American market, providing crucial support for VDK’s global expansion strategy. This notification was fully supported by CIRS Group.
On December 8, 2025, Tianjin Hesheng Biotechnology Co., Ltd. (HS SynBio) (Tianjin) received “FDA has no questions” letter. This marks the official recognition of its HMO 2'-Fucosyllactose (2'-FL) as GRAS.