Toei Shinyaku Receives U.S. Notice of Allowance and Chinese Registration Notice for β-Glucan Measurement Technology Born from Agaricus KA21 Research

Toei Shinyaku Co., Ltd. (Mitaka, Tokyo; Representative Director: Akitomo Motoi), maker of open-field-cultivated Agaricus KA21, has received a Notice of Allowance from the United States Patent and Trademark Office dated June 4, 2026, for "Method for detecting and quantifying β-1,6-branched β-1,3-glucan or β-1,3-glucan, and kit for detecting and quantifying the same," which arose from joint research with the Department of Immunology, School of Pharmacy, Tokyo University of Pharmacy and Life Sciences. In addition, the company has received a notice dated September 1, 2026 from the China National Intellectual Property Administration regarding the grant of the patent right and registration procedures.

Open-field-cultivated Agaricus KA21

Important: This announcement does not mean that patents have already been registered or have taken effect in the United States or China. In the United States, a patent is issued after the prescribed procedures, such as payment of the issue fee. In China, the patent right takes effect after the registration procedures, such as payment of the annuity within the deadline, and publication of the grant.

■ Relationship Between Open-Field-Cultivated Agaricus KA21 Research and This Technology

This technology was conceived in joint research between Toei Shinyaku and Tokyo University of Pharmacy and Life Sciences on the measurement and mechanisms of action of β-glucans contained in open-field-cultivated Agaricus KA21.

The properties of β-glucans contained in mushrooms such as Agaricus differ depending on their bonding patterns and branching structures. This invention relates to a method and kit for detecting and quantifying β-1,6-branched β-1,3-glucan or β-1,3-glucan. Expected applications include measuring the β-glucan content of supplements made with Agaricus KA21, research on the mechanisms of action of β-glucans, and the diagnosis of fungal infections.

■ Notification Dates and Current Status of Procedures by Country

[United States]

Notification date: June 4, 2026

Notice received: Notice of Allowance

Content of the notice: This notice indicates that, following examination, the application was found eligible for a patent. A patent right has not yet been established at this stage; the patent is expected to be issued after the prescribed procedures, such as payment of the issue fee.

[China]

Notification date: September 1, 2026

Notice received: Notice regarding the grant of the patent right and registration procedures

Content of the notice: This notice states that, following examination, a patent right will be granted for the application. After the prescribed annuity is paid within the deadline, the patent certificate will be issued following registration and publication by the China National Intellectual Property Administration, and the patent right takes effect on the publication date. At present, the application is at the stage before registration and publication.

■ The Invention

Title of the invention: Method for detecting and quantifying β-1,6-branched β-1,3-glucan or β-1,3-glucan, and kit for detecting and quantifying the same

U.S. Application No.: 17/910,526

Chinese Application No.: 202180032661.0

Applicant: Toei Shinyaku Co., Ltd.

Inventors: Daisuke Yamanaka, Yoshiyuki Adachi

■ β-Glucan Measurement Patents Held by Toei Shinyaku

Three β-glucan measurement patents, including this invention, are registered in Japan. Two of them have also been granted in the United States.

[Patent No. 1]

Japanese registration date: October 26, 2021

Japanese title and patent number: β-glucan-binding protein, β-glucan detection kit, artificial DNA and bacterium (Japanese Patent No. 6966756)

U.S. patent granted: US 11,542,307 B2 (issued January 3, 2023)

[Patent No. 2]

Japanese registration date: April 4, 2022

Japanese title and patent number: β-1,6-glucanase variant and method for measuring β-1,6-glucan (Japanese Patent No. 7052967)

U.S. patent granted: US 11,479,803 B2 (issued October 25, 2022)

[Patent No. 3]

Japanese registration date: February 10, 2025

Japanese title and patent number: Method for detecting and quantifying β-1,6-branched β-1,3-glucan or β-1,3-glucan, and kit for detecting and quantifying the same (Japanese Patent No. 7632898)

Status in the U.S. and China: United States — Notice of Allowance dated June 4, 2026; China — notice regarding the grant of the patent right and registration procedures received on September 1, 2026 (before registration and publication)

Neither patent has been registered or taken effect yet.

■ About β-Glucans

β-glucans are polysaccharides found in the cell walls of fungi, including mushrooms such as Agaricus, molds and yeasts. Known types include β-1,3-glucan and β-1,6-glucan. Measurement of β-glucan is also used in clinical practice to help diagnose invasive fungal infections.

■ Future Outlook

Toei Shinyaku is currently carrying out the procedures required for the issuance of the patent in the United States and the registration of the patent in China. We will make another announcement when the prescribed procedures are completed in each country and the patent rights take effect.

■ About Toei Shinyaku Co., Ltd.

Toei Shinyaku Co., Ltd. is a research-focused Agaricus manufacturer founded in 1973. Since 1996, it has been engaged in the research, development and commercialization of "Agaricus KA21 (King Agaricus KA21)," grown in open fields in Brazil using its proprietary KA21 strain. Through joint research with Tokyo University of Pharmacy and Life Sciences, Azabu University, Keio University, the National Center for Geriatrics and Gerontology, Juntendo University, the University of Tokyo, Shigakkan University and others, it has accumulated scientific data and published 34 international papers to date.