Onconic Therapeutics' new drug for gastroesophageal reflux disease (GERD), "Jakyubo," is set to enter the Chinese market, the largest market in the world.
On August 18, Onconic Therapeutics announced that Livzon Pharmaceutical, the leading company in the field of GERD in China, has successfully completed Phase 3 clinical trials of its P-CAB new drug "Zastaprazan" (marketed in Korea as "Jakyubo Tab.") and has submitted a New Drug Application (NDA) to the National Medical Products Administration (NMPA) of China.
In April 2023, Onconic Therapeutics and Livzon signed a technology transfer agreement granting exclusive rights for the Greater China region (China, Hong Kong, Macau, and Taiwan), and received an upfront payment of $15 million (approximately KRW 20 billion). In Korea, there have been only about ten major technology export deals with upfront payments exceeding KRW 20 billion. Considering that this deal is limited to the Greater China region, the size of Livzon's upfront payment is seen as highly significant in terms of the potential marketability of P-CAB new drugs.
Livzon, Onconic's Chinese partner, received IND approval for Phase 3 clinical trials in November 2023 and began dosing the first patient in December of the same year. Although Phase 3 trials typically take more than a year, or even several years, Livzon successfully completed the trial in about seven months. With this NDA submission, Livzon is now poised to enter the Chinese P-CAB market in earnest.
Livzon is the leading company in China's gastrointestinal therapeutics market, generating annual sales of around KRW 600 billion. Its total annual revenue reaches KRW 2.4 trillion, and it is a major pharmaceutical company in Greater China, dual-listed on the Hong Kong and Shenzhen stock exchanges with a market capitalization of KRW 12 trillion.
According to global market research firm IQVIA, the global GERD market is expected to grow from approximately KRW 30 trillion in 2023 to KRW 40 trillion by 2025. Of this, the Chinese market is estimated to be the largest in the world, ranging from about KRW 4 trillion to KRW 6 trillion. The P-CAB market in China is currently an emerging market of about KRW 241.4 billion, with an annual growth rate of 81.22% in 2024. This rapid growth is expected to accelerate the market shift from PPIs to P-CABs. As a result, industry experts predict that the success of P-CABs in China will significantly accelerate the timeline for global commercialization of P-CABs, including in the United States.
According to a recent report by Morgan Stanley, the current global market for obesity treatments is estimated at around KRW 20 trillion. In comparison, the GERD market is much larger, suggesting that the active overseas expansion of domestically developed P-CAB new drugs could be a key factor in raising the profile of K-BIO on the global stage.
Zastaprazan (Jakyubo Tab.) is a P-CAB class GERD treatment developed directly by Onconic Therapeutics, which received approval as Korea’s 37th locally developed new drug from the Ministry of Food and Drug Safety in April last year. Within six months of its launch in October of the same year, it recorded cumulative outpatient prescription sales of KRW 10 billion. By the third quarter after its launch, quarterly outpatient prescriptions reached KRW 10.5 billion, marking its rapid rise as a blockbuster new drug.
If Jakyubo maintains its current growth trajectory, its annual prescription sales are expected to reach KRW 100 billion next year. To date, Jakyubo has signed four technology export and distribution agreements overseas and is emerging as one of the representative new drugs of K-BIO, having entered 26 countries worldwide.
Unlike most domestic biotech companies that focus on early-stage technology transfers and raise expectations for future profitability, Onconic Therapeutics has directly developed and successfully obtained approval for its new drug and is now expanding its approved drug into global markets. This approach is being recognized as a new model in the domestic biotech industry.
A representative from Onconic Therapeutics stated, "Livzon, with its strong sales capabilities and track record in the Chinese gastrointestinal therapeutics sector, will rapidly shift the existing PPI market to the P-CAB market," adding, "With the early completion of clinical trials and the resulting acceleration of the approval process, the timeline for realizing profits in the Chinese market will also be expedited."
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