Korea Stock Market Insights

Tag: Nesuparib

  • Onconik Therapeutics Enters Phase 2 Clinical Trial for Pancreatic Cancer Drug: Investment Outlook

    1. What Happened?

    On August 18, 2025, Onconik Therapeutics submitted an application for an Investigational New Drug (IND) amendment to the Ministry of Food and Drug Safety (MFDS) in South Korea. This amendment allows the company to proceed with a Phase 2 clinical trial evaluating the safety, tolerability, and efficacy of Nesuparib (JPI-547) in combination with existing chemotherapy regimens (mFOLFIRINOX or GemAbraxane) for the treatment of pancreatic cancer.

    2. Why is this Important?

    Pancreatic cancer is a devastating disease with a poor prognosis and limited treatment options. Nesuparib, a dual PARP/Tankyrase inhibitor, offers a new approach that may overcome the limitations of current therapies. Its designation as an orphan drug by the U.S. FDA for pancreatic cancer and gastric/gastroesophageal junction cancer further elevates expectations for clinical development and approval. Entering Phase 2 is a significant milestone for Nesuparib’s development and positive results could signal the arrival of a groundbreaking treatment for pancreatic cancer.

    3. So What?

    Positive Phase 2 clinical trial results are expected to increase the likelihood of technology transfer and contribute significantly to the company’s enterprise value. Stable sales of ‘Jacubo’ support the funding required for Nesuparib’s development, and the company’s robust financial structure enables continued investment in new drug development.

    4. What Should Investors Do?

    Onconik Therapeutics exhibits high growth potential based on the success of ‘Jacubo’ and the potential of Nesuparib. Investors should closely monitor upcoming key events, such as the announcement of Phase 2 clinical trial results, technology transfer agreements, and ‘Jacubo’s’ expansion into overseas markets. It’s also important to consider risk factors, including the inherent uncertainties of clinical trials and market competition.

    What is Nesuparib (JPI-547)?

    Nesuparib is a dual PARP/Tankyrase inhibitor, a novel anti-cancer drug that can effectively target cancer cells resistant to existing treatments.

    Which patients are eligible for this Phase 2 clinical trial?

    Patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) are eligible.

    What are Onconik Therapeutics’ other businesses?

    The company markets ‘Jacubo,’ a treatment for acid-related gastrointestinal diseases, in domestic and international markets.

  • Onconic Therapeutics Q2 2025 Earnings: A Mixed Bag of Profits and Losses

    1. Onconic Therapeutics Q2 2025 Performance: What Happened?

    Onconic Therapeutics reported revenue of ₩9.4 billion and operating profit of ₩1.1 billion in Q2 2025, marking a return to profitability. However, the company recorded a net loss of ₩0.1 billion. While Zastaprazan sales fueled the positive turnaround, the net loss raises questions for investors.

    2. Drivers of Performance: Why These Results?

    • Zastaprazan Sales Growth: Following approval for the treatment of gastric ulcers, Zastaprazan has become a key growth driver, accounting for ₩16.4 billion of the ₩18.6 billion in H1 2025 revenue.
    • Nesuparib Clinical Development: Ongoing Phase 1b/2 and investigator-initiated Phase 2 trials for Nesuparib provide long-term growth potential.
    • Technology Licensing Agreements: Deals for Zastaprazan in China, India, and South America contributed ₩2.18 billion to H1 2025 revenue, diversifying income streams.

    3. Outlook and Investment Strategy: What’s Next?

    In the short term, investors should monitor market reaction to the Q2 net loss. Volatility may increase depending on Zastaprazan’s market penetration and Nesuparib clinical trial results. Longer term, market share expansion for Zastaprazan and successful clinical outcomes for Nesuparib will be key drivers of value creation.

    4. Key Investor Takeaways: What to Watch

    • Zastaprazan market penetration and sales growth
    • Nesuparib Phase 2 clinical trial results
    • Further technology licensing agreements
    • Improvement in operating margin and sustained net income profitability

    Frequently Asked Questions

    What is Onconic Therapeutics’ main business?

    Onconic Therapeutics is a biopharmaceutical company developing Zastaprazan, a gastric acid secretion inhibitor, and Nesuparib, an anticancer drug.

    What is Zastaprazan’s competitive advantage?

    Zastaprazan is a next-generation P-CAB inhibitor offering advantages over traditional PPI drugs.

    What is the outlook for Onconic Therapeutics’ future growth?

    Future growth will depend on Zastaprazan’s market share expansion and the success of Nesuparib clinical trials.

  • Onconik Therapeutics’ Stomach Cancer Trial Expansion: A Potential Catalyst for Growth?

    Onconik Therapeutics Expands Nesuparib Trials to Stomach Cancer: What Happened?

    On July 30, 2025, Onconik Therapeutics announced the filing of an amendment to its Nesuparib clinical trial plan for stomach cancer, marking a progression from the existing Phase 1b pancreatic cancer trial to Phase 1b/2 for stomach cancer. The company awaits approval from the Ministry of Food and Drug Safety (MFDS).

    Why is This Trial Expansion Significant?

    Nesuparib has already received Orphan Drug Designation (ODD) for pancreatic, stomach, and gastroesophageal junction cancers. This expansion holds significant implications for Onconik Therapeutics:

    • Pipeline Diversification: Reduces reliance on Zastaprazan and diversifies its business portfolio, mitigating risks.
    • Market Expansion Potential: Stomach cancer has a larger market than pancreatic cancer, and the ODD provides a favorable position for market entry. Successful clinical results could lead to more favorable terms in licensing agreements with global pharmaceutical companies.
    • Potential Catalyst for Stock Price Increase: Positive news regarding clinical progress can act as a positive signal for investors, potentially driving stock price appreciation.

    Investment Strategy: Opportunities, Risks, and Action Plan

    While this expansion presents numerous positive aspects, investors should also consider the following risks:

    • Uncertainty of Clinical Success
    • Launch of Competing Drugs
    • Potential Failure of Licensing Agreements

    Therefore, investors should consider the following action plan:

    • Monitor upcoming clinical trial results and licensing agreement announcements.
    • Analyze the development status and market competitiveness of competing stomach cancer treatments.
    • Continuously monitor details of Zastaprazan’s licensing agreement and Onconik Therapeutics’ funding plans.

    ※ This content is not intended as investment advice. Investment decisions are the sole responsibility of the investor.

    What stage is Nesuparib’s stomach cancer clinical trial in?

    Nesuparib has applied for an amendment to its clinical trial plan for stomach cancer, transitioning to Phase 1b/2. The company is currently awaiting approval from the Ministry of Food and Drug Safety (MFDS).

    What types of cancer is Nesuparib effective against?

    Nesuparib has received Orphan Drug Designation (ODD) for pancreatic, stomach, and gastroesophageal junction cancers. Clinical trials are currently underway for pancreatic and stomach cancers.

    What is Onconik Therapeutics’ main business?

    Onconik Therapeutics is a biopharmaceutical company focused on developing anticancer drugs. Its main pipelines include Zastaprazan, a gastric ulcer treatment, and Nesuparib, an anticancer drug.

  • Onconik Therapeutics Stock: Soaring on Gastric Cancer Trial Expansion? Analysis of Nesuparib and Investment Strategy

    1. Onconik Therapeutics Expands Clinical Trials to Gastric Cancer

    Onconik Therapeutics applied to the Ministry of Food and Drug Safety (MFDS) on July 30, 2025, for approval to amend its Phase 1b/2 clinical trial plan for the anticancer drug candidate Nesuparib to include gastric cancer. This expansion, following the existing pancreatic cancer clinical trial, represents a significant step in demonstrating Nesuparib’s market scalability.

    2. Analyzing Key Growth Drivers: Zaqub & Nesuparib

    2.1 Zaqub: Steady Growth, but Concerns about Intensifying Competition

    Zaqub showed a successful market entry, achieving close to 7 billion won in sales in the first quarter of 2025. Technology transfer agreements with 19 countries are expected to act as a long-term growth momentum. However, the possibility of intensifying competition and uncertainties surrounding the technology transfer agreements require continuous monitoring.

    2.2 Nesuparib: A High-Risk, High-Return Investment

    Nesuparib has increased its chances of successful drug development by receiving FDA Orphan Drug Designation. Its differentiated mechanism as a PARP/Tankyrase dual inhibitor is advantageous for securing global competitiveness. However, being in the Phase 1b/2 clinical trial stage, considerable time and funds are required until market launch, and the uncertainty of clinical trial results remains high.

    3. Macroeconomic Impact on Onconik Therapeutics

    • Positive Factors: Low South Korean base rate is positive for Zaqub’s sales growth, low US 10-year Treasury yield is positive for the overall investment environment.
    • Negative Factors: High US base rate could increase Nesuparib’s development funding costs and investment risks.

    4. Investment Strategy: Thorough Analysis and Risk Management are Essential

    Onconik Therapeutics has growth potential, but the results of Nesuparib’s clinical trials will significantly impact its corporate value. Investment decisions should be made after thorough analysis of clinical results, progress of technology transfer agreements, changes in macroeconomic indicators, and the competitive landscape, along with a well-defined risk management strategy.

    Frequently Asked Questions

    What stage are the Nesuparib clinical trials in?

    Nesuparib is currently in the phase of applying for approval to amend the Phase 1b/2 clinical trial plan for gastric cancer. The decision to proceed to Phase 2 will be based on the DLT (Dose Limiting Toxicity) assessment results of Phase 1b.

    What is the sales status of Zaqub?

    Zaqub achieved close to 7 billion won in sales in Q1 2025. It is expected to secure long-term growth momentum through overseas technology transfer agreements.

    What are the key considerations when investing in Onconik Therapeutics?

    Carefully analyze the uncertainties surrounding the Nesuparib clinical trial results, the progress of technology transfer agreements, changes in macroeconomic indicators, and establish a risk management strategy.