Autotelic Bio signs licensing agreement with Chinoin

for the distribution of ATB-101, a combination drug for both hypertension and diabetes

(From the left) Fernando Torres Navarrete, BD Director at Chinoin Productos Farmaceuticos in Mexico , Tae-Hun Kim, CEO of Autotelic Bio

Autotelic Bio announced on the 7th that it has signed an exclusive license and supply agreement with Chinoin Productos Farmaceuticos in Mexico to distribute ATB-101, a novel combination drug for the treatment of hypertension and diabetes.

 

ATB-101 is a fixed-dose combination product comprising of the hypertension drug ‘olmesartan’ and the oral diabetes drug ‘dapagliflozin.’ It is the world's first combination drug that treats both hypertension and Type 2 diabetes, making it easier for patients with both chronic diseases to take their medication.

 

The company has received Phase III IND approval from the Ministry of Food and Drug Safety for ATB-101 and is currently conducting Phase III clinical trials in patients with essential hypertension and type 2 diabetes at more than 35 major hospitals in Korea, including Seoul National University Bundang Hospital.

 

Autotelic Bio is planning to launch the product globally after proving safety and efficacy through the ongoing Phase 3 clinical trial.

 

For this, the company has registered composition patents in the U.S., Japan, Russia, Mexico, and Brazil, in addition to Korea, and is expanding its patent to other countries such as China.

 

The exclusive license and supply agreement it signed in Mexico is to supply more than 30 million ATB-101 tablets over 5 years.

 

The agreement demonstrates the company's potential to expand into neighboring Latin American countries through Chinosa and is expected to serve as a bridgehead for future global expansion.

 

In addition to the upfront payment, Autotelic Bio will receive additional payments based on development, licensing, and commercialization milestones.

 

Mexico's hypertension and diabetes market is the second largest in Latin America after Brazil and has significant potential.

 

Autotelic Bio plans to grow sales in the Mexican market and reinvest the proceeds in the continued development of innovative new medicines.

 

Chinoin Productos Farmaceuticos is a Mexican pharmaceutical company founded in 1924.

 

It owns a pharmaceutical R&D, manufacturing, licensing, sales, and marketing division, and is regarded to have excellent sales and marketing capabilities, ranking among the top 10 pharmaceutical sellers in Mexico.

 

Autotelic Bio recently completed a pre-IND meeting with the U.S.

 

Food and Drug Administration (FDA) to advance ATB-101 into the United States.

 

During the meeting, the company received a positive response from the FDA regarding the ongoing Phase III clinical trial, and that an additional local Phase I clinical trial will be sufficient for approval in the U.S.

 

based on the results of the domestic Phase III trial.

 

Based on the results of the pre-IND meeting, the company will be meeting with more than 10 pharmaceutical companies at Bio USA to discuss global rights agreements for ATB-101, including in the US.

 

This year, Autotelic Bio has joined the Boston C&D Incubation Office, a blockbuster global expansion program organized by the Korea Health Industry Development Institute (KHIDI), to strengthen its network for ATB-101’s clinical development and licensing-out activities and create results in the U.S.

 

market.

 

In addition to the incrementally modified drug, Autotelic Bio is developing two other RNA-based anti-cancer drugs, ATB-320 (a dual-mechanism of action anti-cancer RNA drug that works on the TME and inhibits angiogenesis) and ATB-350 (a next-generation KRAS mutation-targeting anti-cancer RNA drug that targets specific tissue).

 

Also, its ATB-610 (ALK5 inhibitor), an inhaler in the company’s anti-fibrosis drug pipeline, has been selected as a project of the National New Drug Development Project in Korea, adding momentum to the company’s development of new drugs.