Press Release

February 19, 2024

FDA opinion received, indicatinghigh probability of “De Novo” classification
FDA 513(g) pre-submission consultation completed
for breast cancer navigation drug (GCP-006)

On July 13, 2023, Goryo Chemical Co., Ltd. (head office: Sapporo, Japan; CEOand Representative Director: Ken-ichi Maruyama; hereinafter "Goryo") andSolasia Pharma Co., Ltd. (head office: Tokyo, Japan; President and CEO:Yoshihiro Arai, hereinafter "Solasia") entered into a feasibility study agreement
to explore the possibility of jointly commercializing pharmaceuticals based on
Goryo’s technologies and assets, including the development of candidate drugs
for therapeutic as well as in-vitro and in-vivo diagnostic use.
As part of this study, Goryo submitted a “513 (g) application (note 1)” to theUS Food and Drug Administration (FDA) for GCP-006, the navigation drug forthe breast cancer (note2), which has been returned with an indication that
GCP-006 could have a high probability of receiving “De Novo (note3)”
classification if submitted to the FDA.
Based on the FDA’s indication, we will further advance the jointcommercialization study to allow GCP-006 to be marketed and delivered topatients and medical institutions in the US, including the identification of anout-license partner for the US market as well as other regions and countries.
(Note 1) A regulatory scheme that allows you to make a request to the FDA to classify a medical
devices targeted for sale in the US, where continuous efforts are being made to incorporate
innovative technologies. A 513(g) application scheme can be used to enhance the predictability

of the development process and its efforts, since a device classification can have significant impact
on the development cost and speed.
(Note 2) Technology for a diagnostic drug for rapid detection of breast cancer and its remnants
during the surgery. An NDA (New Drug Application) was submitted to the regulatory authority inJapan, the PMDA (Pharmaceutical and Medical Devices Agency) on March 28, 2023, and iscurrently under review.
(Note 3) When a medical device intended for the US market is determined, through the 513(g)scheme, that it does not fit into an existing classification, that no prior device exists, and yet that
it is highly unlikely to receive a high-risk classification (Class III), the FDA determines whether
the relevant device should be classified as Class I or II, and whether a new product code orregulatory number should be issued for the device. As for classification of new and innovative
medical devices, FDA tends to classify them as class III (high-risk classification) device. However,
not all of them are necessarily high-risk devices, in which case the FDA could grant “De “Novostatus” whereby such device could be marketed without undergoing extensive clinicaldevelopment.

1. Overview of the companies
Name
Head officeaddress
Representative
Established
Business and its
scopeCompany Name
Head office

Goryo Chemical Co., Ltd.
35-100 Kita 8-jo Nishi 18-chome, Chuo-ku, Sapporo,
Hokkaido, Japan
Representative Director and CEO: Ken-ichi Maruyama
July 2010
Manufacture and sale of functional fluorescent probes,
contract synthesis, development of navigational drugs
using functional fluorescent probes for cancer surgery
Solasia Pharma K.K.
Sumitomo Fudosan Shibakoen Tower 4F, 2-11-1

address

Shibakoen, Minato- ku, Tokyo, Japan

Representative

Representative Director Yoshihiro Arai

Established
Business and its
scope

January 2006
Development, sales, import/export, etc. ofpharmaceuticals and medical devices2. (Reference) Goryo Chemical Co., Ltd.
Goryo has developed and manufactured the world's first product that selectively
illuminates the cancer tissue only a few minutes after a fluorescent probe issprayed on a human tissue fragment.

Based upon this technology, Goryo has

developed reagent businesses for research use and has been expanding its
business scope to include developing navigation drugs for both in-vitro and invivo diagnostic use to be utilized during surgical procedures, mainly for cancer.
The navigation drug, also known as "Fluorescent Image-Guided Surgery"(surgical support using fluorescent imaging (Note 4)), is a new and emerging
mode of technology that is increasingly attracting attention for research andclinical use.
Goryo’s focus thus far has mainly been on the development of navigation drugs
that can be applied in surgery and/or medical checkups for various types ofcancers, in order to allow early detection and treatment, prevent recurrence
and promote early recovery post-surgery.

In addition to developing navigation

drugs for cancer, Goryo’s unique fluorescent technology can also be applied tothe early detection and treatment of non-cancerous diseases.

The fluorescentprobe to detect calpain enzyme, currently being developed by Goryo, is a good
example of the new endeavor by the company to expand its scope of R&D
activities into new target fields other than cancer. To this end, Goryo hasformalized a global license agreement for the ophthalmology area with Senju
Pharmaceutical, Inc. on April 5, 2023 (refer to the press-release of the samedate).

In addition to the development of candidates for diagnostic use, Goryois also engaged in developing new drug candidates for therapeutic use, bymaking the best use of its knowledge and know-how accumulated throughdeveloping fluorescent probe technology.
(Note 4) Fluorescence imaging: A technique that enables observation of the localization andmovement of cells, specific proteins, etc. by shining a laser or other light on various fluorescentdyes and fluorescent proteins.

Contact：
Takuma Nakatsuka Goryo Chemical Co., Ltd.
Email: nakatsuka@goryochemical.com