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- 2026-07-25 01:29:41
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- Company
- Invossa still mired in legal battles 7 years after license revocation
- by Kim, Jin-Gu Jul 24, 2026 08:21am
- Kolon TissueGene's knee osteoarthritis candidate TG-C failed to demonstrate improvements in pain and physical function in its U.S. Phase III trial. The clinical setback is expected to have a significant impact on the ongoing litigation involving Invossa Invossa-K Inj (Invossa), which is being pursued against Kolon TissueGene and Kolon Life Science. The two companies are currently involved in a total of 55 Invossa-related lawsuits with claims exceeding KRW 100 billion.Kolon TissueGene and Kolon Life Science in 55 damages lawsuits worth KRW 104.1 billionAccording to Korea's Financial Supervisory Service on July 23, Kolon TissueGene and Kolon Life Science are currently involved in 55 lawsuits related to Invossa—32 involving Kolon Life Science and 23 involving Kolon TissueGene. Most are claims seeking damages related to Invossa, with the total amount in dispute near KRW 104.1 billion.The plaintiffs who filed the lawsuit claim that they suffered physical and financial damages due to the change in Invossa's main cell line, which was revealed in 2019.Invossa drew global attention after receiving approval from Korea's Ministry of Food and Drug Safety (MFDS) in July 2017 as the world's first gene therapy for knee osteoarthritis. TG-C is the product's US development name.However, during the US Phase III trial in March 2019, it was discovered that one of the product's principal components, originally described as cartilage-derived cells, had in fact been replaced with kidney-derived cells that carry tumorigenic potential. The MFDS revoked Invossa's marketing authorization in April 2019, while the US Food and Drug Administration (FDA) placed the clinical trial on hold. The FDA later lifted the clinical hold in April 2020.Kolon TissueGene is currently facing 16 shareholder lawsuits seeking damages for investment losses. A total of 2,048 shareholders are participating in these cases, with claims amounting to KRW 55.5 billion. In addition, 931 patients who received Invossa have filed 6 damages lawsuits against Kolon TissueGene for KRW 12.2 billion.Kolon Life Science is also engaged in large-scale litigation with both shareholders and patients. Shareholders have filed 21 lawsuits seeking KRW 24.1 billion in damages, while 941 patients have filed 10 lawsuits seeking KRW 12.4 billion. The company is also being sued by multiple domestic insurers seeking reimbursement through subrogation claims.Industry and legal experts expect the latest US Phase III results to have little direct impact on the outcome of the damages lawsuits. However, they say the failed trial could increase the companies' financial and legal burdens when courts determine damages or during settlement negotiations.Most cases still await first-instance rulings at 7 years…Kolon loses first patient lawsuitAlthough more than 7 years have passed since the first wave of litigation began, the vast majority of cases have yet to receive even a first-instance ruling.A recent damages lawsuit filed by Invossa patients, however, resulted in the first trial court decision. On July 9, the Seoul Central District Court ruled entirely in favor of 139 patients who sued Kolon TissueGene and Kolon Life Science for damages.The court found that Invossa had been manufactured using kidney-derived cells rather than the cartilage-derived cells identified in the original marketing application, recognizing this as a “manufacturing defect.” It also concluded that marketing and selling the product while labeling it as containing cartilage-derived cells violated both the Pharmaceutical Affairs Act and the Act on Fair Labeling and Advertising. Accordingly, the court held the companies liable for both economic damages and emotional distress suffered by the patients. It rejected Kolon's argument that the defect could not have been identified based on the scientific knowledge available at the time of manufacture.Despite prevailing at trial, it will take more time for patients to receive compensation, as Kolon has appealed the ruling to the Seoul High Court. In addition, Kolon has blocked enforcement actions such as the seizure and collection of claims by patients by filing for a stay of execution.Most shareholder lawsuits likewise remain at the first instance stage. Three lawsuits against Kolon TissueGene have already concluded after plaintiffs withdrew their claims or courts recommended settlement. In 4 of the company's 16 shareholder lawsuits, however, trial courts ruled in favor of Kolon. The plaintiffs have appealed, with those cases now before the appellate court.By contrast, the dispute with Mitsubishi Tanabe Pharma over the return of upfront payments and damages arising from the terminated licensing agreement was resolved early on. In 2016, Kolon Life Science signed a technology licensing agreement with Mitsubishi Tanabe worth up to JPY 50 billion and received an upfront payment of JPY 2.5 billion. Mitsubishi Tanabe terminated the agreement in December 2017 and filed arbitration with the International Chamber of Commerce (ICC) the following April. After the changed cell line issue emerged in May 2019, it was added as an additional ground for termination. Ultimately, Kolon returned the JPY 2.5 billion upfront payment along with JPY 134 million in damages in April 2021.Administrative appeal over ‘Invossa license revocation’ still pending before Supreme CourtKolon Life Science is also pursuing administrative litigation in addition to the civil lawsuits. After the Ministry of Food and Drug Safety (MFDS) revoked Invossa's marketing authorization in 2019, the company filed an administrative lawsuit challenging the decision.Both the Seoul Administrative Court (first instance) in February 2021 and the Seoul High Court (second instance) in February 2024 ruled in favor of the MFDS. The courts found that the discrepancy between the cell component described in the marketing authorization application and the one actually detected constituted a material defect, dismissing Kolon's claims. Kolon subsequently appealed to the Supreme Court, where the case remains pending.In addition to the lawsuit over the revocation of Invossa's marketing authorization, Kolon Life Science also filed lawsuits seeking to ▲overturn the MFDS Commissioner's revocation of its clinical trial authorization, ▲ invalidate the Daejeon Regional Office of Food and Drug Safety's order to recall and dispose of Invossa, and ▲cancel the Ministry of Health and Welfare's and the Ministry of Science and ICT's orders to recover government research funding.Among these, the lawsuits challenging the revocation of the clinical trial authorization and the recall and disposal order were voluntarily withdrawn by Kolon Life Science. Meanwhile, the lawsuit seeking to overturn the government's recovery of research funding ultimately ended in Kolon's favor after reaching the Supreme Court. The company had received KRW 1.25 billion in government funding during the development of Invossa.Executives including former Chairman Woong-yeol Lee and CEO Woosok Lee were acquitted in criminal casesCriminal proceedings against Honorary Chairman Woong-yeol Lee, former CEO Lee Woo-seok, and other Kolon Life Science executives concluded with acquittals.Honorary Chairman Woong-yeol Lee and former CEO Lee Woo-seok were indicted on charges including violations of the Capital Markets Act and the Pharmaceutical Affairs Act. Prosecutors alleged that they concealed the US Food and Drug Administration's clinical hold order, attracted investment through the company's listing, manipulated the share price, and made false disclosures in violation of capital markets regulations.Both the first- and second-instance courts acquitted the defendants. The trial court found that the evidence presented was insufficient to conclude that the defendants knowingly concealed the cell line change or intentionally made false disclosures to attract investment.The appellate court (second instance) ruling was also handed down in February of this year. The Seoul High Court also upheld the acquittals. The appellate court ruled that the misunderstanding regarding the origin of the cells was recognized only after the product had already been manufactured and marketed, characterizing it as an error made during the development process rather than a deliberate cover-up. The acquittals became final after prosecutors decided not to appeal to the Supreme Court.The former head of Kolon Life Science's Bio New Drug Research Center and its former medical team leader were also acquitted by the Supreme Court. They had been charged with obstruction of official duties by fraudulent means, fraud under the Act on the Aggravated Punishment of Specific Economic Crimes, and violations of the Subsidies Management Act.The trial court ruled that there was insufficient evidence to conclude that they had interfered with the MFDS's review process or fraudulently obtained government R&D subsidies by deceiving government evaluators. However, the former medical team leader was found guilty of providing entertainment to an MFDS official and was fined KRW 10 million. The appellate court likewise found no evidence of intentional submission of false data or subsidy fraud, and the Supreme Court upheld those findings by dismissing the prosecution's appeal. The bribery conviction, however, was ultimately upheld, leaving the fine in place.
- Policy
- “Division of industry within the MOHW”…fostering pharma biotech
- by Lee, Jeong-Hwan Jul 24, 2026 08:21am
- Sung-il Oh, the Head of the Division of Pharmaceutical and Biotech Industry"I consider the Division of Pharmaceutical and Biotech Industry as the Division of Industry within the Ministry of Health and Welfare. While the traditional duties of the Office for Healthcare Policy on regulatory laws under the Medical Services Act and the Pharmaceutical Affairs Act, the primary mission of the Division of Pharmaceutical and Biotech Industry is fundamentally to promote and foster technology, markets, and the industry. My priority is to listen extensively and meet as frequently as possible with pharma companies, biotech firms, and healthcare sector stakeholders to build an environment where the industry can perform at its best."Core mission of the Division of Pharmaceutical and Biotech Industry under the Ministry of Health and Welfare (MOHW) include fostering domestic blockbuster novel drugs, providing policy support for the pharmaceutical and biotech sectors to address supply instabilities of essential medicines, modernizing the Innovative Pharmaceutical Company certification system, and nurturing the global pharmaceutical and biotech industry.Sung-il Oh, newly appointed as the Head of the Division of Pharmaceutical and Biotech Industry on July 22, clearly understood the aim of the division and its key responsibilities, despite returning to healthcare administration after a hiatus.Meeting with the press that day, Oh explained that while the current government, including the MOHW, considers strengthening public access to healthcare and enhancing patient convenience a major pillar of healthcare policy, it also recognizes the promotion and development of the pharmaceutical and biotech industry as a vital task to achieve.In outlining his aspirations as the new division head, Oh pledged to "listen as much as possible and meet as many people as possible." As the administration has defined the pharmaceutical and biotech industry as a key growth driver for the nation's future and signaled regulatory rationalization for its fostering and promotion, his commitment signifies an intention to directly observe and hear what regulatory improvements and policies the market actually requires.Oh highlighted, "The current government has a very keen interest in promoting the pharmaceutical and biotech industry, something I observed during my previous role as the Regulatory Reform and Legal Affairs Officer," and added, "Unlike the previous administration where the Regulatory Reform Committee functioned under the Prime Minister, the current administration's Regulatory Rationalization Committee is chaired directly by the President. Biotech has consistently been a major agenda item at presidential meetings."Oh continued, "The advice from senior officials was to listen first. I am personally experiencing that the pharmaceutical and biotech industry has many factors distinct from general healthcare administration, and I am studying various issues extensively." He stated, "I maintain an open-minded approach toward everyone who comes to visit. For now, my focus will be on properly executing well-crafted existing policies, such as the reform plan for the Innovative Pharmaceutical Company criteria."Oh concluded by stating, "Government interest in regulatory rationalization is high, and as the government believes that promoting the pharmaceutical and biotech industry will expand the nation's future growth engines, there seems to be deep deliberation at the top," and added, "While general healthcare administration primarily deals with occupational disputes and conflict mediation, and national health insurance focuses on fee adjustments, the Division of Pharmaceutical and Biotech Industry is a unit built to promote and foster. Perspective needs to shift significantly. I intend to learn thoroughly right from the basics."
- Policy
- Ban on succession of price caps deferred until next year
- by Jung, Heung-Jun Jul 24, 2026 08:21am
- The government will postpone implementation of a new rule blocking the succession of reimbursement price caps during pharmaceutical product transfers and acquisitions until next year, following a grace period through the second half of this year.The change regarding price cap succession in product transfers was not included in the drug pricing reform agenda reviewed by the Health Insurance Policy Deliberation Committee (HIPDC) in March. The government has likely decided to delay implementation in consideration of on-site acceptability.Discussions on improving the implementation of the revised drug transfer and acquisition rules took place during a public-private consultative meeting involving the Ministry of Health and Welfare, the Health Insurance Review and Assessment Service (HIRA), the National Health Insurance Service (NHIS), and industry representatives on July 22.AI-generated imageThe revision to the drug product transfer and acquisition system was included in the Ministry’s May amendment to the 'Standards for Drug Pricing Decisions and Adjustments.' Until now, for products transferred between companies, the same reimbursement price ceiling as before the transfer was applied.Under the revised system, however, products acquired through transfers will instead receive whichever is lower—the newly calculated reimbursement price or the existing price ceiling—to prevent companies from using transfers to circumvent the revised drug pricing system.Because the generic drug pricing rate will change under the new pricing framework, transferred products will effectively be subject to the newly calculated reimbursement price rather than retaining the previous reimbursement ceiling.The rules governing pharmaceutical product transfers have undergone several revisions over the years. Since 2021, however, transferred products have generally been allowed to inherit the existing reimbursement price ceiling.Because the Ministry had initially planned to implement the revised notification on Aug. 1 following its administrative notice in May, the timeline was considered too tight, prompting agreement to introduce a grace period.With implementation now postponed until January next year, products currently under transfer negotiations are expected to proceed without disruption.A wave of last-minute product transfers is expected as companies reorganize their product portfolios in the second half of the year in response to the broader drug pricing reform,Since this will be the final grace period during which acquiring companies can still inherit the existing reimbursement price ceiling, transfer activity is expected to become more active than usual.
- Policy
- Post-listing price cuts to be made every April and October
- by Jung, Heung-Jun Jul 24, 2026 08:20am
- The government is expected to exclude reimbursement expansion-related price cuts from its routine post-listing price cuts, which will take effect next year. The decision reflects concerns that patients could face delays in benefiting from lower drug costs, as well as the administrative complexity of refund procedures.At a public-private consultative meeting on drug pricing reform held on July 22, government and industry representatives discussed measures to improve the standardization of post-listing price cuts.In March, the Health Insurance Policy Deliberation Committee (HIPDC) agreed to align the timing of price cuts under various post-listing management mechanisms to April and October to improve the predictability of reimbursement price reductions.The routine post-listing price cut measure was approved by the HIPDC in March. Price cuts resulting from reimbursement expansions are expected to be excluded.Until now, reimbursement prices have been adjusted whenever a new indication was approved, or reimbursement coverage was expanded. The government sought to reduce these post-listing price cuts to two scheduled adjustments each year—in the first and second half of the year—to improve predictability for the industry.Under the original proposal, reimbursement expansions themselves would still take effect immediately. However, the resulting reimbursement price reduction was set to be deferred until the next scheduled adjustment, with pharmaceutical companies later refunding the difference.For example, if reimbursement coverage were expanded in January and the reimbursement price was therefore subject to a reduction, the amount corresponding to the delayed price cut until the April adjustment would be refunded afterward by the pharmaceutical company.However, this approach raised concerns that patients would not immediately benefit from lower drug costs at the time of reimbursement expansion.In addition, implementing the refund mechanism was expected to create a substantial and unnecessary administrative burden for both pharmaceutical companies and the National Health Insurance Service. As a result, the government has largely decided to exclude reimbursement expansion-related price cuts from the routine post-listing price adjustment schedule.Meanwhile, the government had previously planned to abolish actual transaction price-based price cuts after expanding incentives for lower-price drug purchasing but has decided to maintain the current system due to concerns about potential drawbacks. Reimbursement re-evaluations will also continue to be conducted when warranted rather than on an annual basis. The timing of price adjustments under these mechanisms will likely be brought into line with the new routine schedule.
- Company
- HIV treatment evolving beyond 'once-daily'
- by Son, Hyung Min Jul 23, 2026 09:09am
- Competition in human immunodeficiency virus (HIV) treatment development is shifting from viral suppression efficacy toward enhancing patient dosing convenience.As once-daily oral therapy has become the standard of care, clinical outcomes for once-weekly oral treatments and twice-yearly preventive injections are being disclosed, demonstrating shifts in both therapeutic and preventive strategies.According to industry sources on July 23, major global pharmaceutical companies are scheduled to present research results on long-acting treatment strategies, including once-weekly HIV therapies and twice-yearly pre-exposure prophylaxis (PrEP), at the 26th International AIDS Conference (AIDS 2026) starting on July 26 in Rio de Janeiro, Brazil.First Phase 3 success for a once-weekly oral treatmentThe most highlighted result is the Phase 3 clinical trial results of an oral combination therapy combining Gilead's lenacapavir and MSD's islatravir.Lenacapavir is a long-acting agent that inhibits viral replication by targeting the HIV capsid. Islatravir is a nucleoside reverse transcriptase translocation inhibitor (NRTTI) with a mechanism distinct from conventional reverse transcriptase inhibitors, acting to block viral replication.Gilead is expanding its long-acting strategy in both treatment and prevention based on lenacapavir. Following the launch of 'Sunlenca' as a therapeutic agent, the company applied a separate product name, 'Yeztugo,' for its preventive indication.Until now, long-acting HIV treatment has centered on injectable agents administered up to once every two months or once-daily oral regimens. To achieve injectable-level dosing convenience with an oral formulation, both companies have been developing a once-weekly oral therapy combining the long-acting agent lenacapavir with the novel-mechanism islatravir.The global Phase 3 trials, designated ISLEND-1 and ISLEND-2, evaluated the efficacy and safety of switching from conventional daily oral therapy to once-weekly treatment (lenacapavir + islatravir) in virologically suppressed people living with HIV. Both studies demonstrated non-inferiority in viral suppression efficacy at 48 weeks compared to existing daily oral regimens.ISLEND-1 is a study comparing maintenance therapy with Gilead's 'Biktarvy' (bictegravir + emtricitabine + tenofovir alafenamide) against switching to lenacapavir + islatravir following Biktarvy administration.Among 607 patients evaluated, none in the lenacapavir + islatravir arm failed to maintain viral suppression at week 48, compared with 1 patient (0.3%) in the Biktarvy maintenance arm.Similar results were confirmed in ISLEND-2, which enrolled patients maintaining various daily oral regimens. At week 48, the proportion of patients with HIV RNA at or above 50 copies/mL (the threshold for viral suppression) was 1 patient (0.3%) in the lenacapavir + islatravir group and 4 patients (1.3%) in the baseline regimen group.Safety profiles were also comparable to existing therapies. Concerns regarding decreases in lymphocyte and CD4+ T-cell counts, previously raised during high-dose development, were not observed in these trials.If approved by regulatory authorities, lenacapavir + islatravir will become the world's first once-weekly oral HIV treatment.Twice-yearly era for prevention… Expanding long-acting strategiesGilead 'Yeztugo'In addition to HIV treatment, long-acting strategies are expanding into pre-exposure prophylaxis (PrEP) to prevent infection.Gilead will also present long-term follow-up data for its twice-yearly HIV prevention injection, Yeztugo. This study evaluated post-approval long-term preventive efficacy and real-world persistence, focusing on confirming the clinical value of long-acting PrEP.n the PURPOSE 1 trial, 95% of eligible participants chose to continue with Yeztugo in the open-label extension, with zero incident HIV cases reported during the 52-week follow-up period.In PURPOSE 2 as well, 95% of participants selected Yeztugo administration, maintaining adherence rates above 90%.The twice-yearly administration regimen is recognized as a strategy that reduces pill burden and improves persistence compared to daily oral PrEP.Beyond efficacy into a 'dosing interval' competitionGSK 'Cabenuva'In addition to Gilead, GSK's injectable 'Cabenuva' (cabotegravir + rilpivirine), administered once monthly or once every two months, holds an established position in the long-acting HIV treatment market.Gilead is also pursuing the development of next-generation long-acting therapeutics, including once-weekly oral treatments, twice-yearly preventive injections, and combinations of lenacapavir with broadly neutralizing antibodies (bNAbs).MSD also recently secured FDA approval for its once-daily islatravir-based combination tablet, 'Idvynso,' while concurrently advancing the development of a once-monthly oral PrEP candidate (MK-8527) and a once-weekly oral treatment.Currently, daily oral medication is the standard of care in HIV treatment. As development progresses from long-acting injectables to once-weekly oral therapeutics, options personalized to patients' lifestyles and treatment preferences are expected to become increasingly diverse.
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