SK Biopharm Aiming for DTx Entry: "We Will Leap to Global Healthcare Top 10" (Comprehensive)

Real-Time Measurement for Epilepsy
'Seizure Zero' Vision Presented

To Be Showcased at Next Year's CES
Wearable Device Clinical Trials to Start Soon

Ultimately Aiming for DTx
Will Differentiate with 'Convergence' Keyword

On the 14th, Hwang Seon-gwan, Vice President of SK Biopharm, is speaking at SK Biopharm's CES 2023 pre-briefing held at the Koreana Hotel in Jung-gu, Seoul. (Photo by Lee Chun-hee)

[Asia Economy Reporter Lee Chun-hee] SK Biopharm has declared its entry into the digital healthcare business, including digital therapeutics (DTx), under the vision of becoming a 'Global Top 10 Healthcare' company.

Ahead of its participation in the Consumer Electronics Show (CES) 2023 held in Las Vegas, USA, next January, SK Biopharm held a pre-briefing session on the 14th at the Koreana Hotel in Jung-gu, Seoul, to introduce the roadmap and vision for its digital healthcare business.

Hwang Seon-gwan, Vice President of SK Biopharm and Head of the R&D Innovation Headquarters, stated at the event, "Our goal is to leap into the global healthcare top 10," adding, "We will not stop at expanding into the digital healthcare field through the fusion of innovative new drug development and digital technology, but will leap forward as a global comprehensive healthcare solution company."

Building on SK Biopharm's strengths accumulated so far, such as being the first in Korea to discover candidate substances, obtain approval from the U.S. Food and Drug Administration (FDA), and directly sell the epilepsy drug Cenobamate (U.S. launch name Xcopri), the company plans to advance into digital healthcare, presenting a digital innovation model that can contribute to the entire patient management process. Vice President Hwang emphasized, "All global top 20 pharmaceutical companies, although in different fields, are attempting digital transformation," highlighting this movement as a global trend.

SK Biopharm's wearable device 'Zero Wired' (Photo by SK Biopharm)

First, centered on Xcopri, the plan is to develop a comprehensive healthcare solution targeting epilepsy that covers not only medication but also prevention, diagnosis, and management. SK Biopharm named this project 'Project ZERO' to signify its goal of complete seizure elimination in epilepsy patients.

The first step involves wearable devices that collect patients' EEG, ECG, and movement data in real time. The plan is to introduce a total of five epilepsy-specific devices: 'Zero Glass,' 'Zero Wired,' 'Zero Headband,' 'Zero Earbud,' and 'Zero Headset.' Previously, Zero Glass and Zero Wired received the CES 2023 Innovation Award.

Starting with Zero Wired next year, the company plans to enter full-scale clinical trials. Since the EEG measuring device, shaped like a stethoscope, is attached to the head and connected to a smartphone via cable to accumulate data in real time, it was selected as the first clinical trial subject due to its higher accuracy compared to wireless measuring devices.

In the long term, the goal is DTx. The plan includes developing an AI (artificial intelligence) model that analyzes collected data to detect seizure occurrences, and a mobile app that provides seizure detection alerts to patients and records and analyzes their history to assist in disease management. Vice President Hwang said, "Epilepsy is a disease where sudden unexpected death in epilepsy (SUDEP) can occur," adding, "By predicting seizures in advance and taking acute seizure medication beforehand, we aim to realize 'Zero Seizure,' which will be a game changer."

On the 14th, at the Koreana Hotel in Jung-gu, Seoul, Hwang Seon-gwan, Vice President of SK Biopharm, explained SK Biopharm's digital healthcare vision called "Zero Seizures" at the CES 2023 pre-briefing session. (Photo by Lee Chun-hee)

Furthermore, in terms of indications, SK Biopharm plans to accelerate the development of DTx not only for central nervous system (CNS) diseases such as epilepsy but also for new fields including attention deficit hyperactivity disorder (ADHD), depression, schizophrenia, Alzheimer's disease, and oncology. Since continuous measurement is possible through wearable sensors, accumulating big data related to EEG will provide sufficient momentum for subsequent development.

Regarding the difficulties faced by companies like Pear Therapeutics and Akili Interactive, which have developed DTx ahead overseas, in entering the market, SK Biopharm proposed differentiation through 'fusion.' Vice President Hwang emphasized, "From previous cases, the important factor is fusion," adding, "When measurement through sensors and management aspects are fused along with new drugs, differentiation in commercialization can occur." On the aspect that combining sensors might conflict with the existing definition of DTx as Software as a Medical Device (SaMD), he explained, "We are also reviewing the development direction related to this."

This content was produced with the assistance of AI translation services.