A Global Spotlight on a “Hidden Gem Stock”
On August 29, international news outlet IBTimes featured Japanese biotech company AnGes, Inc. (TSE:4563) as a “Hidden Gem Stock”, drawing strong attention from overseas investors.
The company’s lead gene therapy drug, Collategene®, has successfully completed its U.S. clinical trial and is now preparing for a Biologics License Application (BLA) submission to the FDA.
Once the BLA is formally accepted by the FDA, approval is widely regarded as only a matter of time.
The FDA has already granted Collategene Breakthrough Therapy Designation, which signifies “substantial clinical improvement for a serious condition with no effective existing therapies.”
Historically, nearly all drugs with this designation have ultimately been approved.
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Why the Boehringer Ingelheim Partnership Matters
The greatest challenge in gene therapy development lies in ensuring manufacturing stability (CMC issues).
AnGes has already secured a production agreement with global pharmaceutical leader Boehringer Ingelheim, a rare move at this stage of the regulatory process.
Such a partnership strongly suggests that large-scale production is being prepared with FDA approval effectively assumed—a sign of the confidence within the pharmaceutical industry.
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Accelerated Approval Pathway
While standard FDA reviews typically take around 10 months, Collategene is likely eligible for priority review (within 6 months) under its Breakthrough Therapy status.
• Filing acceptance: by end of 2025
• Priority review initiation: early 2026
• Final approval decision: within 2026
Comparable gene therapies with the same designation, such as Zolgensma (AveXis) and Luxturna (Spark Therapeutics), were approved within roughly two years of application. Collategene appears set to follow the same path.
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“No Red Flags in Sight”
From a regulatory and clinical perspective, Collategene stands out as one of the smoothest gene therapy approval cases to date:
• Clinical trials completed successfully
• FDA Breakthrough Therapy Designation granted
• Manufacturing supported by a global leader
• High medical need (CLTI) with limited alternatives
The only remaining factor is time. There appear to be no fundamental obstacles to approval.
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Implications for Investors — Time to Price in “Post-Approval”
AnGes’ current market capitalization of around ¥34 billion is strikingly undervalued considering clinical success and FDA designation.
By precedent, valuation could surge into the hundreds of billions to ¥1 trillion range the moment approval is announced.
One European analyst commented:
“Collategene already has both proven clinical efficacy and solid manufacturing backing. FDA approval is essentially a procedural step.”
With IBTimes highlighting the company globally and overseas investors increasingly attentive, the valuation gap between Japanese and international markets is becoming impossible to ignore.
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Conclusion — “Approval Is Only a Matter of Time”
• BLA preparation itself signals the final stage toward approval
• Breakthrough Therapy Designation provides the strongest regulatory support
• Manufacturing is secured through Boehringer Ingelheim
• Investor focus should shift from “what if approval happens” to “what comes after approval”
Collategene is no longer just a candidate drug.
It is positioned to become the world’s first gene therapy for CLTI, with approval now widely viewed as inevitable.