Recently, Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as "Gan & Lee") received the registration approval for Menthol Insulin Injection (Cassette Vial) (Lot No. II-87550/2023) from the National Agency for Medicines and Technology for Health (Agencia Estatal de Medicamentos y Tecnologías en Salud, AGEMED) of Bolivia. Insulin Injection (Cassette Vial) (Lot No.: II-87550/2023). The relevant information is announced as follows:

I. Basic information of the drug
1、Drug name: ASPARPEN
2、Generic Name of Drug: Mentholatum Insulin Injection
3、Indications: Diabetes mellitus
4、Dosage form: injection
5、Specifications: 3ml: 100U/ml (cassette bottle)
6、Batch No.: Ⅱ-87550/2023
7、Applicant: Gan & Lee Pharmaceutical Co.

II. Other relevant information of the drug
Mentholated insulin injection is a kind of rapid-acting insulin analog, which takes effect within 10~20 minutes after subcutaneous injection, the maximum action time is 1~3 hours after injection, and the duration of action is 3~5 hours, which can effectively control postprandial blood glucose. Mentholated insulin is usually injected immediately before meals, and can be given immediately after meals if necessary. Mentholated insulin has a rapid onset of action, shorter duration of action, lower risk of nocturnal hypoglycemia, and is often used in combination with long-acting insulin to achieve basal and postprandial glycemic control in patients.

Bolivia is located in the center of South America with a total population of 12,224,100 people (2022) and a GDP per capita of $3,600.1 (2022, international exchange rates). According to the latest data released by the International Diabetes Federation (IDF) Global Diabetes Survey 10th Edition (2021), in 2021, there were approximately 395,900 people with diabetes in Bolivia between the ages of 20-79, with a per capita annual expenditure on diabetes of US$898.8, and the prevalence of diabetes in the Bolivian adult population between the ages of 20-79 years was 5.7%. As of the date of the announcement, the main supplier of Mentholated Insulin Injection in Bolivia is Novo Nordisk. Novo Nordisk, as the originator, has global sales of DKK 15.46 billion (approximately US$2,216 million; data from Novo Nordisk's 2022 financial results converted using the DKK to US$ conversion rate published by the State Administration of Foreign Exchange on December 30, 2022) for its menstrual insulin product, Novolog®, in 2022.1 The Company's global sales of Novolog®, as the originator, are estimated to be approximately US$2,216 million. As of September 30, 2023, Gan & Lee has invested RMB176 million in research and development for its Menthol Insulin program.

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