FAQs アーカイブ - Page 3 of 7

Q: What is the purpose of developing the new drug?

The purpose is to completely cure diabetes and its complications in pets. This new drug aims to improve not only the insulin deficiency or resistance in pets, normalizing their blood sugar levels, but also achieving complete remission (cure). Currently, pets rely on daily insulin injections, which is a significant burden for pet owners. The development of this new drug could improve the quality of life for pets and significantly reduce the mental and financial burden on owners. Additionally, it aims to improve animal health and welfare and achieve longer lifespans.

Q: Is the new drug effective for Type 1 diabetes?

The drug is intended for all patients with diabetes, regardless of the severity or type (Type 1 or Type 2), and is also expected to be effective for almost all complications of diabetes. Please refer to the drug's mechanism of action for more details.

Q: What are the development costs and funding plans for the new drug?

The development cost for the new drug typically requires several ten of million to hundreds of USD. Our company is considering raising funds through investors, government and private grants, and joint research partnerships to secure the necessary funds for research and development, clinical trials, and regulatory applications. Efficient fundraising and resource optimization are essential for the success of new drug development.

Q: Is there a plan to launch the new drug in the international market?

The expansion into international markets will be considered based on the regulations and market demands of each country. Diabetes is a global health issue, so there is an anticipated international demand.

Q: How is the target patient group for the new drug determined?

The target patient group is determined based on the results of clinical trials. Particularly, patients with severe diabetes or those who have not improved with other treatments may be prioritized.

Q: What are the main challenges in the development of the new drug?

The primary challenge in developing the new drug is finding an effective treatment that addresses the fundamental cause of diabetes. Current treatments mainly focus on managing blood sugar levels and do not lead to a complete cure of the disease itself. Additionally, it is necessary to confirm the safety and efficacy of the new drug and obtain regulatory approval. This requires extensive clinical trials and rigorous data analysis.

Q: What competitive advantage does the diabetes cure have in the market?

This drug focuses on the root cause of diabetes, offering a different approach from current symptomatic treatments. It aims for complete healing of the patient, giving it a competitive edge. Specifically, the drug acts directly on the root cause of diabetes, especially targeting the abnormal stem cells believed to trigger the disease, with the goal of normalizing them. This aims to resolve diabetes and its complications fundamentally, significantly improving patients' quality of life. It represents a new approach different from existing treatments, potentially enabling a complete cure for diabetes.

Q: Is there a development of a new diagnostic drug for diabetes?

A new diagnostic drug is being developed to identify abnormal stem cells that cause diabetes. This could provide greater accuracy than traditional diagnostic methods, such as fasting blood sugar levels and Hemoglobin A1C (HbA1C) values.

Q: What about the safety of the new drug?

HDAC inhibitors are already commercially available for other uses, and their safety is established. This allows for shorter development time and costs compared to completely new drugs.

Q: When is the new drug expected to be introduced to the market?

The market launch of the new drug requires successful clinical trials and regulatory approval such as FDA. The goal is to start Phase 1 trials in 2024, and enter Phase III trials in late 2025 to early 2026. If successful, this new drug could be a significant hope for diabetes patients, potentially reducing medical expenses and socio-economic burdens. It is also expected to be effective against diabetes complications.

FAQs

KIYAN Group and Collaborating Research Institutions

KIYAN PHARMA Co., Ltd.

KIYAN MEDICAL Co., Ltd.

Biozipcode, Inc.

Shiga University of Medical Science, Dep. of Regenerative Medicine

Biozipcode, Inc.

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