Knee stem-cell treatment “Jointstem” won in court last month.
The court ruled that the Ministry of Food and Drug Safety (MFDS) must cancel its decision to reject the product marketing authorization application.
But this ruling does not mean the drug is now available for purchase. Why not?
3-line summary
1. Jointstem’s first-instance win concerns cancellation of the rejection, not approval.
2. The plaintiff won on July 9, and the MFDS appealed on July 30.
3. The appeal and re-review still remain.
11 months from rejection to victory
In chronological order, this is what happened.
On August 5 last year, the MFDS decided not to grant Jointstem a manufacturing and marketing authorization. The developer filed a lawsuit, arguing that the decision was unlawful.
On July 9 this year, the Seoul Administrative Court ruled in favor of the plaintiff, RNL Institute of Regenerative Medicine. The ruling ordered cancellation of the authorization-rejection decision and required the MFDS to bear the litigation costs.
Then, on July 30, the MFDS appealed. It asked for the first-instance ruling to be overturned and the plaintiff’s claim to be dismissed.
Jointstem is a treatment that cultures stem cells extracted from a patient’s own fat and injects them into the knee. It is intended for patients with severe degenerative knee osteoarthritis whose cartilage has worn down substantially, and it had progressed through domestic clinical trials to the stage of applying for product authorization.
Courts do not grant approval
This is the point most often misunderstood.
In an administrative lawsuit, the court’s role is to determine whether the administrative agency’s disposition complied with the law. The court does not decide in the agency’s place whether approval should be granted.
That is why the judgment says not “grant approval,” but “cancel the rejection disposition.” This means returning the disposition to a state as though it had never existed.
When the disposition is canceled, the application returns to the state of not having been reviewed. The administrative agency then has an obligation to decide again in accordance with the purpose of the ruling. This is called the obligation to issue a new disposition.
A new decision can also mean another rejection. If the agency corrects the error identified by the court and conducts the review again, but the product still falls short of the approval requirements, it may reject the application on different grounds.
A first-instance win goes only as far as “review it again”; it does not mean “the drug may be sold.”
What happens to the ruling after an appeal
Because the MFDS appealed, the first-instance ruling is not yet final.
Korean litigation can proceed through 3 instances. If one side appeals, the case goes to the High Court, and if there is further disagreement there, it goes to the Supreme Court. Until the ruling becomes final, the obligation to issue a new disposition does not arise.
In other words, the current status is: “The developer won at first instance, and the case is still ongoing.”
Why is the court system designed so cautiously? Drug approval involves specialists verifying safety and efficacy using data. If the court were to perform that work directly, review standards would vary from case to case. Courts therefore examine only whether the procedure and decision complied with the law, and return the actual review to the administrative agency.
It may appear slow, but without this structure, a drug that won a lawsuit and a drug that passed regulatory review would have the same standing.
So what is the situation for patients now?
Jointstem is not yet an approved drug in Korea. That remains true after this ruling.
There are many patients with degenerative knee osteoarthritis, and many are looking for options other than surgery. In that situation, it is easy for the phrase “the court recognized it” to leap to “you can now receive it.”
Between those two sentences lie the appeal, a Supreme Court appeal, and the entire re-review process.
Decisions about treatment methods should be discussed with the medical professionals providing care. This article is not intended to recommend or discourage any treatment.
Approval status can be checked directly
The statement “approval has been granted” is not something to confirm through a news article; it is something to look up.
Enter the product name in the MFDS’s Drug Safety Korea database to see immediately whether it is an approved drug in Korea. If it is not listed, it has not yet been approved. Whatever news emerges, this screen is the standard.
There are three things to watch going forward.
What issues are being contested in the appeal. The remaining outcome differs depending on whether the issue identified by the first-instance court was a procedural problem or a problem with the underlying decision itself.
What conclusion the MFDS reaches after a final ruling. Re-review is not the same as approval.
How the two institutions interpret the clinical data. This is a case in which the developer and regulator differed in their interpretation of the same Phase 3 results.
The company’s stock price rose sharply on the day of the ruling. However, this article does not address stocks or investment decisions.
How far does “winning” go?
What the court canceled was the rejection disposition, not the approval requirements.
The MFDS’s appeal means the ruling is not yet final, and even if it becomes final, the next step is re-review, not market release.
When you see the word “victory” in the news, checking what the lawsuit sought to cancel can reveal the procedures that remain.
References
- Yakup Newspaper report on the MFDS appeal
- Korean Pharmaceutical Association News report on the first-instance ruling
- Newsway August 3, 2026 report
- Ministry of Food and Drug Safety Drug Safety Korea — approved drug lookup
The ruling date and litigation history follow the reports above. The explanation of cancellation judgments in administrative litigation and the obligation to issue a new disposition reflects general aspects of the administrative litigation system.