Korea Stock Market Insights

Tag: AMD

  • Samchundang Pharm. Receives Korean Approval for Eylea Biosimilar ‘Visenfree’: Investment Implications



    Samchundang Pharm. Receives Korean Approval for Eylea Biosimilar 'Visenfree': Investment Implications 대표 차트 이미지






    1. The Significance of Visenfree’s Approval

    On September 22, 2025, Samchundang Pharmaceuticals announced that it had received approval from the Ministry of Food and Drug Safety (MFDS) in South Korea for its Eylea biosimilar, ‘Visenfree’ (SCD411), for the treatment of wet age-related macular degeneration (AMD). Both vial and pre-filled syringe (PFS) presentations were approved, enhancing patient convenience. This marks a significant milestone for the company’s entry into the domestic market and signals its readiness to compete in the rapidly growing AMD treatment landscape.

    2. Analyzing the Impact on Fundamentals: Expecting Revenue Growth and Improved Profitability

    This approval is expected to positively influence Samchundang Pharm.’s fundamentals.

    • Revenue Growth and Market Share Expansion: The launch of Visenfree is projected to drive revenue growth and increase market share. The availability of the PFS presentation is expected to further enhance market competitiveness by improving patient convenience.
    • Profitability Improvement: Sales of the high-value biosimilar are anticipated to contribute to improvements in operating and net profit margins.
    • Validation of R&D Capabilities: The approval validates Samchundang Pharm.’s R&D capabilities and raises expectations for future pipeline development.
    • Improved Cash Flow: Increased sales are expected to improve cash flow from operating activities, which can strengthen investments and financial stability.

    3. Investment Strategies: Considering Growth Potential and Risk Factors

    While this approval is likely to act as a positive catalyst for the stock price, investors should consider the following factors:

    • Market Competition: The intensifying competition within the biosimilar market needs to be addressed strategically.
    • Actual Sales Performance: It is crucial to monitor the actual sales figures and the pace of market penetration post-launch.
    • Global Market Expansion: Closely observe the company’s progress in entering key international markets, such as the US and Europe.


    FAQ

    What is Visenfree?

    Visenfree is a biosimilar of Eylea, developed by Samchundang Pharmaceuticals for the treatment of wet AMD.

    What does this approval mean for Samchundang Pharmaceuticals?

    It’s a crucial step for domestic market entry and is expected to contribute to increased sales and improved profitability.

    What are the key factors to consider for investment?

    Investors should consider the competitive landscape, actual sales performance, and the company’s progress in expanding to international markets.









    Samchundang Pharm. Receives Korean Approval for Eylea Biosimilar 'Visenfree': Investment Implications 관련 이미지
    Samchundang Pharm. Receives Korean Approval for Eylea Biosimilar 'Visenfree': Investment Implications 관련 이미지




  • AptaBio Applies for FDA Phase 1 Trial for AMD Treatment: Investment Opportunity?

    1. What Happened? : ABF-101 IND Application Submitted

    AptaBio officially submitted an Investigational New Drug (IND) application to the U.S. FDA for ABF-101, its AMD treatment candidate, on July 28, 2025. This Phase 1 trial, planned to be conducted in both the US and Korea, will evaluate ABF-101’s safety, tolerability, and pharmacokinetic profile in healthy volunteers and AMD patients.

    2. Why Does It Matter? : A Critical Milestone in Drug Development

    The IND application is a crucial step forward for AptaBio’s drug development pipeline. Given the high growth potential of the AMD treatment market, successful clinical results could significantly enhance AptaBio’s corporate value. Furthermore, a successful Phase 1 trial increases the likelihood of future licensing agreements, potentially improving the company’s financial position.

    3. What’s Next? : Balancing Risks and Opportunities

    • Potential Upsides: Revenue generation through licensing agreements, increased pipeline value, and potential stock price appreciation upon successful clinical trials.
    • Potential Downsides: Risk of clinical trial failure, FDA approval uncertainties, increasing competition, and influence of macroeconomic factors.

    4. What Should Investors Do? : A Cautious Approach Is Recommended

    Investors should carefully weigh the risks and potential rewards. Continuous monitoring of the clinical trial progress, competitor landscape, and macroeconomic conditions is essential for informed investment decisions. Closely watching for licensing agreements and the progression of key pipeline candidates is highly recommended.

    Frequently Asked Questions

    What disease does ABF-101 treat?

    ABF-101 is a drug candidate for the treatment of age-related macular degeneration (AMD).

    When will the Phase 1 trial begin?

    The exact start date of the clinical trial is yet to be announced. Details regarding the timeline will be released following FDA approval of the IND application.

    What are the key investment considerations?

    Investors should carefully consider the uncertainties inherent in clinical trials, the competitive landscape, and macroeconomic factors before making investment decisions.