[Special Stock] Withus Pharm Achieves World's First Mass Production of Sustained-Release Hair Loss Treatment Injection... Expecting Rapid Product Approval

Withus Pharmaceutical is showing strong performance. The news that it has completed preparations for full-scale production of long-acting hair loss treatment injections and benign prostatic hyperplasia injections, developed in collaboration with Inventage Lab, appears to be influencing its stock price.

At 2:01 PM on the 22nd, Withus Pharmaceutical was trading at 9,300 KRW, up 22.05% from the previous day.

Withus Pharmaceutical recently held a completion ceremony for the injection production plant at its Anseong factory in Miyang-myeon, Anseong-si, Gyeonggi Province, and has completed preparations for production. With an investment of 27 billion KRW, it has secured an annual production capacity of over 2.5 million vials.

The long-acting hair loss treatment injection 'IVL3001' is a finasteride-based hair loss treatment. It is the world’s first long-acting injection developed using microfluidic manufacturing technology, which significantly improves dosing convenience compared to the oral form that must be taken daily. It will be marketed in two types: one administered once every three months and another once every month.

In addition to Withus Pharmaceutical and Inventage Lab, Daewoong Pharmaceutical is also jointly developing the product. Withus Pharmaceutical is responsible for product manufacturing, Inventage Lab handles preclinical, phase 1 clinical trials, and production support, while Daewoong Pharmaceutical manages phase 3 clinical trials, approval, and sales. After completing phase 1 and 2 clinical trials in Australia last year, phase 3 is scheduled to proceed. Once phase 3 is completed, production will begin at the newly established long-acting injection plant. Since IVL3001 is a reformulation of the already marketed finasteride ingredient, it is expected that product approval will proceed quickly.

Withus Pharmaceutical plans to make long-acting injections its new growth engine. Considering that the global hair loss treatment market was valued at 3.6 billion USD (approximately 4.8136 trillion KRW) as of 2020, it is estimated that sales of Withus Pharmaceutical could increase by more than 100 billion KRW by 2025 through the commercialization of long-acting hair loss treatment injections.

In addition to the hair loss treatment injection, Withus Pharmaceutical is also developing a long-acting benign prostatic hyperplasia injection 'IVL3013' together with Inventage Lab. Withus Pharmaceutical holds exclusive production and marketing rights for this drug, which is a reformulation of dutasteride, an already proven prostate treatment ingredient, so it is expected that there will be no difficulties in obtaining product approval.

Sung Daeyoung, CEO of Withus Pharmaceutical, said, "The completion of the world’s first microfluidic long-acting injection production plant is the result of our intensive investment in research and development (R&D)." He added, "We will continue to enhance Withus Pharmaceutical’s manufacturing excellence and strive to become a pharmaceutical company that contributes to public health."