ASKA Pharmaceutical : April 7 2023 ASKA licensee Hyundai files New Drug Application in Korea for OC Drospirenone

Press Release

ASKA Pharmaceutical licensee Hyundai files New Drug Application in

Republic of Korea for Oral Contraceptive Drospirenone

TOKYO, April 7, 2023 - ASKA Pharmaceutical Co., Ltd. (Head Office: Minato-ku, Tokyo/ President,

Representative Director: Sohta Yamaguchi, hereinafter referred to as "ASKA"), a subsidiary of ASKA Pharmaceutical Holdings Co., Ltd., announced that its licensee, Hyundai Pharm. Co., Ltd. (Head Office: Seoul, Republic of Korea, hereinafter referred to as "Hyundai Pharm"), filed an application with a Korean regulatory authority, the Ministry of Food and Drug Safety "MFDS", on March 31, 2023, for the oral contraceptive drug, drospirenone (hereinafter referred to as "Product") as a sole Active Pharmaceutical Ingredient.

ASKA acquired exclusive rights to develop and market the Product for the territories of Japan and Republic of Korea from Insud Pharma (Head Office: Madrid, Spain) in January 2020. In June 2022, ASKA and Hyundai Pharm concluded an Agreement to grant exclusive rights to develop and market the Product in Republic of Korea. In the United States and Europe, Marketing Approvals of the Product were granted in 2019 under the brand name "SLYND®" and "SLINDA®" respectively and Insud Pharma has commercialized the product in these countries through Exeltis, its branded pharmaceutical unit focused on Women's Health. ASKA is conducting Phase III Clinical Development of the Product in Japan.

ASKA looks forward to providing a new option for Korean women, who wish to access innovative contraceptive drugs, through the licensing of this Product to Hyundai Pharm. As a specialty pharmaceutical company in the field of obstetrics and gynecology, ASKA will continue with its mission to make further contributions to women's health, at every stage of their lives.

About Hyundai Pharm

Hyundai Pharm (http://www.hyundaipharm.co.kr/english/index.jsp) is a pharmaceutical company with its Head Office in Seoul, Republic of Korea. Hyundai Pharm is currently expanding its women's health portfolio to be a leading company in the area. Hyundai believes the Product will contribute to unmet medical needs for women.

About Insud Pharma

Insud Pharma (https://www.insudpharma.com/en/) is a leading Spanish company with a track record in the pharmaceutical and healthcare industry spanning over 45 years. With 7,300 employees worldwide, Insud Pharma's contribution to global public health is enormous, thanks to the medicines and APIs developed and manufactured at its three highly synergic business units: industrial (Chemo), brand (Exeltis) and biotechnology (mAbxience).

About Exeltis

Exeltis (https://www.exeltis.com/) is a fast-growing division of the integrated health sciences group Insud Pharma. It boasts a leadership position in the Women's Health segment, and is constantly innovating and seeking new treatments and devices to improve women's health and wellbeing around the world.

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