'NewG Lab Pharma' Transforming into a Bio Innovation Company

[Asia Economy Reporter Yoo Hyun-seok] Newgelab Pharma is making a quantum jump as a bio company this year together with its subsidiaries.

According to the financial investment industry on the 14th, Newgelab Pharma's U.S. branch received approval for clinical phase 2A+1 of KAT (Ko Anti-cancer Technology), a metabolic anti-cancer drug for liver cancer treatment, and on the same day, Newgen Therapeutics also received approval for clinical phase 2 of Taletrectinib, a lung cancer treatment.

The main pipelines, cancer treatments, have consecutively succeeded in clinical approvals. Newgelab Pharma has begun a full-fledged leap as a new drug development company. In the synthetic new drug field, it is also creating a foundation to generate sales and profits in a short period by announcing plans to develop improved new drugs for diabetes combination therapies.

Recently, the global landscape of cancer drug development is changing. Due to the limitations of existing anticancer drugs, combination therapy strategies are pouring out. However, combination therapies are criticized for having too many strategies and failing to properly solve fundamental issues such as resistance, toxicity, and low response rates. This is why metabolic anti-cancer drugs with new mechanisms are attracting attention from global scholars as the 'next-generation anticancer drugs.' A Newgelab Pharma official explained, "The global anticancer drug market has reached a plateau, and a paradigm shift is urgently needed," adding, "Metabolic anti-cancer drugs are being recognized as the 4th generation cancer treatments that meet the needs of the medical community."

The plateau of 1st generation chemical anticancer drugs is estimated to be 20 years. The 2nd generation targeted anticancer drugs lasted about 10 years, and the 3rd generation immuno-oncology drugs are estimated to have a shorter span of 5 years. Immuno-oncology drugs have shown their limitations just five years after entering the market. When immuno-oncology drugs first appeared, it was thought they could solve all cancers, but the actual response rate was only 20%.

Metabolic anti-cancer drugs work by selectively blocking nutrients to cancer cells, causing cell death, so they can be effective against almost all cancer types. As a relatively new anticancer technology, there are no successful commercialization cases targeting solid tumors yet. In this situation, if the metabolic anti-cancer drug 'KAT' targeting liver cancer is commercialized, the company expects it to achieve blockbuster new drug status.

The original founder of the metabolic anti-cancer drug theory is Dr. Otto Warburg from Germany (Nobel Prize in Physiology or Medicine recipient). Dr. Ko Young-hee has inherited the theory and is regarded as the world's top authority in this field, especially leading its direct development.

To secure various global innovative new drug pipelines in the anticancer field, Newgelab Pharma introduced Taletrectinib, a global phase 2 non-small cell lung cancer treatment, last year through its subsidiary Newgen Therapeutics. Taletrectinib is undergoing global clinical trials in the U.S., Japan, and Korea, conducted by U.S. company AnHeart and Newgen Therapeutics. The Hong Kong-listed biotech company Innovent Bio is responsible for clinical trials in China.

A company official said, "Treatment for non-small cell lung cancer patients involves battling brain metastasis and drug resistance. In global phase 1 clinical trials, Taletrectinib showed a case of complete remission where cancer completely disappeared in patients resistant to Pfizer's Xalkori, and it demonstrated the ability to cross the blood-brain barrier (BBB) to suppress metastatic brain cancer," adding, "We aim to quickly commercialize after completing phase 2 clinical trials through orphan drug designation."

Newgelab Pharma recently announced plans to develop improved new drugs, generics, and over-the-counter drugs, starting with diabetes combination therapies, to generate profits in the pharmaceutical and bio business in the short term.

Based on the GMP production facilities of Arije Pharmaceutical, acquired earlier this year, and Newgen Therapeutics' new drug development capabilities, the company is establishing itself as a 'comprehensive pharmaceutical group' with finished drug production capacity. Newgelab Pharma plans to participate in the distribution business of pharmaceuticals such as diabetes combination drugs developed and produced by its subsidiaries to create a stable sales and profit base.

A Newgelab Pharma official explained, "Not only new anticancer drug development but also improved new drugs for combination therapies and generic drug development are important indicators showing a pharmaceutical company's R&D potential," adding, "Improved new drugs and generic product lines that enhance medication convenience and drug accessibility will be a pillar of growth and an important foundation for future new drug development."

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