Withus Pharm Completes Production Plant for 'Long-Acting Hair Loss Injection'... "Expecting Over 100 Billion KRW Sales in 2025"

Joint Development of Long-Acting Injectable Drugs with Inventage Lab
Hair Loss Injection 'IVL3001' Also in Collaboration with Daewoong Pharmaceutical
Benign Prostatic Hyperplasia 'IVL3013' Also Under Development

Withus Pharmaceutical has completed preparations for the full-scale production of long-acting hair loss treatment injections and benign prostatic hyperplasia (BPH) injections, developed in collaboration with Inventage Lab.

Injectable drug freeze dryer newly built at Withus Pharm Anseong Plant in Anseong-si, Gyeonggi-do
[Photo by Withus Pharm]

Withus Pharmaceutical announced on the 21st that it held a completion ceremony for the injection production plant on the 20th at its Anseong Plant in Miyan-myeon, Anseong-si, Gyeonggi Province, and has completed preparations for production operation. Through this production facility, built with an investment of 27 billion KRW, Withus Pharmaceutical 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 that eliminates the inconvenience of daily oral intake by being developed as the world's first long-acting injection using microfluidic manufacturing technology, significantly improving dosing convenience. It is planned to be marketed in two types: one administered once every three months and another once a month.

Not only Withus Pharmaceutical and Inventage Lab but also Daewoong Pharmaceutical are jointly developing the product. Withus Pharmaceutical is responsible for product manufacturing, Inventage Lab supports preclinical, phase 1 clinical trials, and production support, while Daewoong Pharmaceutical handles phase 3 clinical trials, approval, and sales. After completing phase 1 and 2 clinical trials in Australia last year, phase 3 trials are scheduled, and once completed, production will begin at the newly established long-acting injection plant. Since IVL3001 is a formulation change of the already marketed finasteride ingredient, it is expected that product approval will proceed quickly.

Withus Pharmaceutical plans to make long-acting injections a new growth engine. Considering that the global hair loss treatment market was valued at 3.6 billion USD (approximately 4.8136 trillion KRW) in 2020, it is estimated that Withus Pharmaceutical’s sales could increase by more than 10 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 the long-acting BPH injection 'IVL3013' together with Inventage Lab. Withus Pharmaceutical holds exclusive production and marketing rights for this drug, which is also a formulation change of dutasteride, an already proven prostate treatment ingredient, so it is expected that there will be no difficulties in product approval.

A Withus Pharmaceutical official said, “Many patients who have endured the inconvenience of daily medication are likely to switch to long-acting injections,” adding, “Withus Pharmaceutical, through technical cooperation with Inventage Lab, is the only contract manufacturing organization (CMO) with a track record in the production and development of hair loss and prostate treatment drugs, positioning itself at the center of the related market growth.”

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