Revolutionizing Cancer Treatment with Photodynamic Therapy

• To Solid cancers such as liver cancer from pancreatic cancer

• Direct observation of the affected area by irradiating it with light

• Plan to prepare for new drug approval, including medical device development

Even a few years ago, a cancer diagnosis was considered a "death sentence." However, as a new cancer treatment concept is developed with the expansion of medical technology, conquering cancer will not be too long. Dongsung Pharmaceutical is the only company in Korea that has been dedicated to the "photodynamic (PDT) cancer treatment new drug development project" for over 15 years.

PDT injects a photosensitizer into the blood vessel to accumulate it in the cancerous tissue and selectively destroys only cancer cells by irradiating a specific wavelength laser. It has almost no side effect on normal tissues, and the recovery speed is fast as it is operated laparoscopically.

Dongsung Pharmaceutical recently reported accelerating its business by completing an application for a medical device item notification for PDT to the Ministry of Food and Drug Safety (hereafter referred to as the Ministry of Food and Drug Safety). I met with CEO Yang-gu Lee to hear more details.

- Recently, Dongsung Pharmaceutical completed an application for a medical device manufacturing license and medical device item notification for a medical image processing device (medical device name: Lubio® PDS) to the Ministry of Food and Drug Safety.

This time, the medical device we have completed the notification application is a 'PDD (photodynamic diagnosis) fluorescence image processing device.' This device results from 'PDD&PDT Laparoscopic Complex Light Source Device Technology' transferred from Korea Electrotechnical Research Institute (KER) in 2017. This medical device indeed distinguishes the tumor site from the normal tissue by irradiating a laser with a wavelength of 405 nm for a photosensitive agent through a laparoscope and imaging the fluorescence.

- Any reason for switching from endoscopic to laparoscopic PDT?

In the first PDT clinical trial for pancreatic cancer, I experienced several difficulties using an endoscope. At some point, I was convinced that laparoscopic PDT, which can irradiate light while viewing the affected area, is more productive than endoscopic PDT. After that, I contacted the Korea Electrotechnical Research Institute to introduce the 405nm PDT laparoscopic diagnostic device development technology. This device will be widely used not only for pancreatic cancer but also for solid laparoscopic cancers such as stomach, small intestine, and liver cancers.

- Dongsung Pharmaceutical is the only company that has devoted itself to photodynamic cancer treatment for more than 15 years.

We had many difficulties. In particular, the collaboration with Belmedpreparati (BMP), the manufacturer of 'Photoron,' which was carried out to obtain approval for a new drug for PDT photosensitizer, is particularly memorable. Photoron was a raw material that had proven its effectiveness and safety in Belarus, and exclusive sales rights and supply contracts with 19 countries had been closed. However, to use it in Korea, approval from the Ministry of Food and Drug Safety was required. To this end, we made efforts in various fields, such as on-site inspection of the BMP plant, improvement of the production process, and proposal for joint preparation of permit data, but we didn't get good results.

Then, we changed the strategy from obtaining new drug approval for 'Photoron' to self-developed photosensitizer approval. Currently, with all of our specialized research personnel, including the Daegu Cancer Center, we are developing a 'Korean-style photosensitizer' that would improve drug safety and stability by increasing the purity of the API. We are preparing for approval for clinical trials and planning a multicenter clinical trial to clarify effectiveness and safety further.

- PDT is recognized for pancreatic cancer and various solid cancer treatments. What is the current progress?

PDT is effective in treating all solid cancers, including pancreatic cancer. In fact, in many foreign cases, PDT photosensitizers are used in various types of cancer, such as cervical cancer, bladder cancer, and brain cancer. Dongsung Pharmaceutical aims to be the first in the world to acquire approval for a new drug for PDT photosensitizers for pancreatic cancer indications, gradually expanding its indications and effectiveness to breast cancer, cervical cancer, and peritoneal cancer.

- Regarding PDT treatment, what are your plans?

First, we prepare to expedite the development and approval process for PDD&PDT medical devices. Recently, as the efficacy and effect of PDT were announced at various conferences, it is attracting attention as a future anti-cancer treatment. PDT has exceptional 'Abscopal effect' and 'immunotherapy effect.' In other words, when used in a cancer area that has metastasized and is challenging to operate on, photosensitizer produces an immune substance. It has a tumor-suppressive effect without surgery.
 We are developing our own medical devices and medicines to treat PDT cancer. By the end of this year, we are preparing to complete the notification of medical devices necessary for PDD&PDT, such as medical image processing device (DS-PDS100) and medical camera head (LX-PCS100), which has been transferred technology from Korea Electrotechnical Research Institute.

- What is Dongsung Pharmaceutical's goal for 2022?

2022 will be a year that will pave the way for Dongsung Pharmaceutical's second leap forward. We intend to diligently prepare for new drug approval, including additional non-clinical/clinical, international standard technical documentation (CTD) preparation, and medical device development and production, for the success of the PDT project that will lead the next 50 years. We are prepared to grow the hair dye into a global brand, which has maintained the undisputed No. 1 position in Korea. Also, we schedule to present a new concept platform that converts the pharmacy business previously conducted only offline to online.