Just a few years ago, cancer diagnosis was considered a 'death sentence.'

However, with the advancement of medical technology, the development of innovative cancer treatment methods suggests that conquering cancer is within reach.

Dongsung Pharmaceutical has been dedicated solely to developing PDT cancer treatment for over 15 years, making it the only company in South Korea to do so.

PDT involves:

Injecting photosensitizers into the bloodstream.

Accumulating them in cancer tissues.

Selectively destroying cancer cells by irradiating them with lasers of specific wavelengths.

It has minimal impact on normal tissues and allows for rapid recovery when performed laparoscopically.

Recently, Dongsung Pharmaceutical has completed the application for medical device notification to the Ministry of Food and Drug Safety (MFDS) regarding PDT, signaling a further push in their business endeavors. We met with CEO Lee Yang-gu to learn more.

You recently completed the medical device notification application for a medical device manufacturing permit and medical imaging processing device (medical device name: LubioⓇ PDS) with the MFDS.

The medical device for which the notification application was completed this time is the 'PDD (Photodynamic Diagnosis) Fluorescence Imaging Processing Device.'

It is the result of the 'PDD & PDT Laparoscopic Compound Light Source Device Technology' transferred from the Korea Electrotechnology Research Institute (KER) in 2017.

This medical device irradiates laser light at a wavelength of 405nm through a laparoscope, visualizing the fluorescence emitted to differentiate between tumor sites and normal tissues.

The reason for transitioning from endoscopic to laparoscopic PDT.

During the initial clinical trials of PDT for pancreatic cancer, there were several challenges associated with treating solely with endoscopy.

At some point, it became evident that laparoscopic PDT, which allows direct examination of the lesion while irradiating it with light, was more effective than endoscopic PDT alone.

Subsequently, we contacted the Korea Electrotechnology Research Institute and acquired the technology for developing a 405nm PDT laparoscopic diagnostic device.

This device is expected to be widely used not only for pancreatic cancer but also for solid tumors such as gastric, colorectal, and liver cancers that can be treated with laparoscopic procedures in the future.

Dongsung Pharmaceutical is the only company that has devoted more than 15 years to photodynamic therapy (PDT) for cancer treatment.

In reality, there were numerous obstacles to overcome, particularly concerning the approval of PDT photosensitizers. One memorable challenge involved collaboration with the "Photolon" manufacturer, Bellmedpreparaty (BMP).

Photolon, proven for its efficacy and safety in Belarus, held exclusive distribution rights and supply contracts in 19 countries. However, acquiring regulatory approval from the Korean Food and Drug Administration (KFDA) for its use domestically proved daunting. Despite efforts such as conducting on-site inspections of BMP facilities, improving production processes, and jointly preparing regulatory documents, satisfactory results still needed to be achieved.

As a result, we shifted our focus from seeking approval for Photolon to developing our proprietary photosensitizer.

We have mobilized our specialized research personnel, including those from the Daegu Cancer Center, to enhance the purity of the active pharmaceutical ingredient (API) of the photosensitizer, thereby improving drug safety and stability. We are developing a "Korean-style photosensitizer" and preparing for clinical trials to obtain regulatory approval.

Furthermore, we are planning multicenter clinical trials to elucidate our product's efficacy and safety further.

You are currently tackling various solid tumor treatments, including pancreatic cancer, using PDT. What is the current progress?

The efficacy of PDT photosensitizers has been demonstrated in a wide range of solid tumors, including cervical cancer, bladder cancer, and brain tumors, based on international cases.

Dong Sung Pharm Co., Ltd. aims to be the first in the world to obtain PDT photosensitizer approval for treating pancreatic cancer and gradually expand its indications to include breast, cervical, peritoneal, and others.

Regarding future plans for PDT treatment

Our primary plan is to swiftly advance the development and approval process of PDD&PDT medical devices.

PDT's efficacy and effects have recently been presented at various academic conferences, drawing attention as a future anticancer therapy.

PDT exhibits excellent "abscopal effects" and "immunotherapy effects."

Administering photosensitizers to cancers with severe metastasis can stimulate immune responses, leading to tumor suppression without surgery.

Therefore, we independently develop medical devices and pharmaceuticals for PDT cancer treatment.

We are also planning to complete the medical device notification process, including the DS-PDS100 medical imaging processor and LX-PCS100 medical camera head, acquired through technology transfer from the Korea Electrotechnology Research Institute (KERI), by the end of this year.

The goal for Dong Sung Pharmaceuticals in 2022

The goal for Dong Sung Pharmaceuticals in 2022 is to establish the foundation for its second leap forward.

In preparation for the success of the PDT business, which will be responsible for the next 50 years, we plan to prepare for additional non-clinical and clinical trials diligently, the creation of international standard technical documents (CTDs), and the development and production of medical devices.

We are also prepared to grow Korea's unrivaled No. 1 hair dye brand into a global brand.

Additionally, we will introduce a new concept platform by transitioning our pharmacy business from offline to online.

Reported by Wonguk Lee Translated by Jini Jung 다른기사 보기