[Special Stock] Daehwa Pharmaceutical, World's First 'Oral' Anticancer Drug... Continuing HLB's 11 Trillion Won Legend

Dawha Pharmaceutical is showing strong performance. On the 26th, it announced that it had obtained marketing approval from the China National Medical Products Administration (NMPA) for Liporaxel solution (Liporaxel), an oral paclitaxel formulation, for the treatment of gastric cancer.

At 10:01 AM on the 8th, Dawha Pharmaceutical was trading at 15,920 KRW, up 19.77% from the previous day. Its market capitalization exceeded 290 billion KRW.

Previously, RMX Biopharma, the Chinese partner company to which Dawha Pharmaceutical exported the technology, and its parent company High Bio Pharma, applied for marketing approval from the China National Medical Products Administration in September 2022.

Liporaxel is an oral formulation and improved new drug of paclitaxel, a blockbuster anticancer drug with a global market size of 5 trillion KRW. Dawha Pharmaceutical applied its proprietary lipid-based self-emulsifying drug delivery system (DHLASED) platform technology to develop Liporaxel, the world's first oral formulation of the poorly soluble drug paclitaxel.

Liporaxel eliminates the need for pre-treatment and over 3 hours of administration time required in the conventional intravenous (IV) paclitaxel therapy. Clinical trials for gastric cancer showed improved results compared to IV therapy, especially in side effects such as hair loss and peripheral neuropathy.

Dawha Pharmaceutical has been focusing on the Chinese market since 2011. It is expected to begin full-scale sales of Liporaxel, which has received marketing approval from Chinese authorities, starting next year. Dawha Pharmaceutical is also known to plan its first delivery within this year. According to Zhiyanzixun, a Chinese market research firm, the market size for paclitaxel formulations in China grew from 8.76 billion yuan (approximately 1.7 trillion KRW) in 2022 to 10 billion yuan (approximately 1.9 trillion KRW) last year. Dawha Pharmaceutical aims to capture 40% of the entire Chinese paclitaxel formulation market (approximately 800 billion KRW for all indications including gastric cancer).

Dawha Pharmaceutical plans to target neighboring Asian countries, the Middle East, Europe, and the Americas sequentially, including China. In February, it obtained orphan drug designation (ODD) from the European Medicines Agency (EMA) for Liporaxel’s treatment of gastric cancer. Dawha Pharmaceutical is also expanding Liporaxel’s indications to breast cancer. Currently, phase 3 clinical trials for breast cancer are underway in ▲South Korea ▲China ▲Bulgaria ▲Hungary ▲Serbia.

According to Precision Report data, the global paclitaxel formulation market size is expected to grow from 3.79 billion USD (approximately 5 trillion KRW) last year to 7.13 billion USD (approximately 9.4 trillion KRW) by 2032.

A Dawha Pharmaceutical official said, "There was a time when a Chinese company (Lvye) dominated more than half of the Chinese paclitaxel formulation market with a similar lipid-based intravenous paclitaxel injection called Lipusu. We expect Liporaxel, which improves dosing convenience, to also dominate the Chinese market."

Dawha Pharmaceutical is showing a stock price trend similar to HLB, whose market capitalization is approaching 11 trillion KRW. In 2014, Hansoh Pharmaceutical received approval from the National Medical Products Administration (NMPA) for rivoceranib (Chinese name Apatinib) as a third-line treatment for gastric cancer. Hansoh Pharmaceutical expanded clinical trials of rivoceranib to various cancers including liver cancer, nasopharyngeal carcinoma, and colorectal cancer. HLB’s stock price rose 2600% over 10 years starting from 2015.