Cailian Press, January 26 (Reporter Lu Afeng) Recently, Fushine Pharmaceuticals (300497.SZ) announced that the Self-GRAS (Self-affirmed Generally recognized as safe) scientific evaluation of its subsidiary Weiran Protein in accordance with the U.S. FDA GRAS guidelines was approved by an expert group, officially becoming one of the few Chinese companies in the field of synthetic biology to obtain U.S. market access.

It is reported that Fushine Pharmaceuticals' Weiran protein is a filamentous fungal protein produced by fermentation of Fusarium oxysporum, which has the characteristics of being rich in protein, high in dietary fiber and low in fat.

Fushine Pharmaceuticals said that in the United States, furan protein can be used as a food ingredient and can be safely used in meat substitutes and protein sources in various food categories under the expected conditions of use, such as meal replacement foods, various beverages, dairy products and other food categories.

This time, Fushine Pharmaceuticals' Wei Ran protein successfully passed the Self-GRAS certification, which means that the product has passed the scientific evaluation process and obtained market access permission from the US FDA. It can be sold and used in the US market as a safe food ingredient.

A person close to Fushine Pharmaceuticals told a reporter from Cailianshe that the certification of Weiran protein in the United States will accelerate its development in the US market, and relevant partners are currently promoting commercialization.

It also stated, "The certification of Weiran Protein in the U.S. provides a strong endorsement for Fushine Pharmaceuticals' related synthetic biology products in other regions, such as Southeast Asia and China, in terms of review and approval, and market access, which will accelerate the company's international development."

Simultaneously with the above announcement was the company's 2024 performance forecast. During the reporting period, Fushine Pharmaceuticals achieved revenue of 1.05 billion to 1.3 billion yuan, a net loss attributable to the parent company of 220 million to 280 million yuan, and a net loss excluding non-recurring items of 260 million to 320 million yuan. Compared to the same period last year, Fushine Pharmaceuticals' revenue has narrowed somewhat, while its net loss has widened somewhat.

Fushine Pharmaceuticals explained in its announcement that its pharmaceutical business revenue declined, and some product prices remained low. Furthermore, the prices of key raw materials for some pharmaceutical products remained high, squeezing the company's profit margins. In the new energy sector, although the company's lithium battery electrolyte additives achieved record shipments, the continued operation of the new energy lithium battery materials industry chain at the bottom of the industry, coupled with declining prices, resulted in overall performance below expectations. Furthermore, the company's recent expansion into new businesses such as new energy and microbial protein has increased depreciation costs on related fixed assets, impacting profits. However, the company's operating cash flow continued to grow during the reporting period.

Fushine Pharmaceuticals also stated that in 2025, the company will continue to increase its investment in microbial proteins in the synthetic biology sector and strive to create new growth points.

A reporter from Cailianshe learned that Fushine Pharmaceuticals' overseas investment activities were relatively active in the second half of last year: On November 7, 2024, Fushine Pharmaceuticals issued an announcement stating that in order to meet strategic development needs and accelerate the expansion of the microbial protein business market, the company plans to use its own funds to establish subsidiaries in Shanghai and Singapore; On December 1, 2024, Fushine Pharmaceuticals announced a proposal to cooperate with Wilmar Golden Dragon Fish Food Group Co., Ltd. and the People's Government of Fuyu County, Heilongjiang Province to establish two joint ventures. Fushine Pharmaceuticals invested a total of 165 million yuan in the two joint ventures.

Previously, Fushine Pharmaceuticals disclosed that it is constructing the "Annual Production of 200,000 Tons of Microbial Protein and Its Resource Comprehensive Utilization Project (Phase I)". After the project is completed and put into production, it will be able to form an annual production capacity of 20,000 tons of microbial protein and 50,000 tons of amino acid water-soluble fertilizer.

(Source: Cailianshe)

(Original Title: Fushine Pharmaceuticals' Weiran Protein Receives Self-GRAS Certification and Officially Enters the US Synthetic Biology Market)