- LOGIN
- MemberShip
- 2025-12-17 01:29:05
Top Head
Headline
- Company
- Takhzyro enters pricing negotiations with NHIS for reimb
- by Eo, Yun-Ho Dec 16, 2025 08:36am
- The hereditary angioedema drug ‘Takhzyro’ has entered the final stage towards reimbursement listing in Korea.Takeda Pharmaceuticals Korea, in accordance with an order from the Ministry of Health and Welfare, has begun price negotiations with the National Health Insurance Service (NHIS) for Takhzyro (lanadelumab), a treatment for hereditary angioedema (HAE). This marks the first tangible step toward reimbursement nearly 5 years after the drug received approval from the Ministry of Food and Drug Safety (MFDS) in February 2021.Therefore, attention is now focused on whether the company will successfully conclude pricing negotiations for Takhzyro so that the drug could emerge as a new treatment option in the HAE, where therapeutic choices remain limited. The drug passed the Drug Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service (HIRA) in November.Hereditary angioedema is a rare disease characterized by recurrent, unpredictable episodes of acute swelling throughout the body caused by abnormalities in the C1 esterase inhibitor (C1-INH) protein.Respiratory swelling can lead to breathing difficulties or even asphyxiation, while gastrointestinal edema causes severe pain and emergency conditions such as bowel obstruction.Approximately 40% of patients experience their first attack before age 5, and 75% before age 15. However, the majority undergo a prolonged “diagnostic odyssey” and receive an accurate diagnosis only in adulthood. Despite an estimated 1,000 HAE patients in Korea, only 200–250 cases had been diagnosed as of last year.On average, it takes about 19 years for patients to receive a diagnosis, and even after diagnosis, they remain constantly exposed to unpredictable attacks and emergency situations.Until now, access to disease-modifying therapies in Korea has been limited, prompting repeated calls from the medical community for the reimbursement of Takhzyro.Whether Takhzyro will successfully complete price negotiations with the NHIS and establish itself as a new therapeutic option in the underserved HAE treatment landscape remains to be seen.Meanwhile, Takhzyro demonstrated its efficacy in the Phase III HELP study. According to the results, patients receiving Takhzyro every two weeks experienced an 87% reduction in the mean monthly number of HAE attacks compared with placebo, while those receiving the drug every four weeks showed a 74% reduction.
- Company
- Ildong's market cap fivefold↑ over eight months
- by Chon, Seung-Hyun Dec 16, 2025 08:36am
- Ildong Pharmaceutical's stock price has surged significantly, setting continuous record highs on expectations for its obesity treatment development. The company's market capitalization has increased nearly fivefold over the past eight months. The oral obesity drug being developed by Ildong Pharmaceutical's subsidiary has demonstrated weight-loss effects in its Phase 1 clinical trial.According to the Korea Exchange on December 13, Ildong Pharmaceutical's stock closed at KRW 44,300 on the 12th, a 9.4% increase from the previous trading day. This continued the sharp rise following a 24.6% surge on the 11th.Ildong Pharmaceutical's stock price showed an increasing trend over five consecutive trading days since a 0.4% increase on the 8th. The stock jumped by 6.6% on the 9th and by 9.4% on the 10th. Compared with the closing price of KRW 27,750 on the 5th, the stock soared 59.6% over the five trading days.Based on the closing price on the 12th, Ildong Pharmaceutical's market capitalization reached KRW 1.4016 trillion, an increase of KRW 523.6 billion from KRW 878.0 billion just a week prior. Ildong Pharmaceutical surpassed the KRW 1 trillion mark again on the 10th, about two months after recording KRW 1.0725 trillion on September 29. The company's market capitalization increased from KRW 1 trillion on December 12 to KRW 1 trillion on December 27, 2022. The largest ever was KRW 1.5412 trillion recorded on July 18, 2022, when the stock surged on expectations for a COVID-19 treatment.The trend of Ildong Pharmaceutical's market capitalization (unit: KRW 100 million, source: Financial Supervisory Service)Ildong Pharmaceutical's stock price continued to soar with the attention to its new oral obesity drug candidate. The value of orally administered obesity treatments has increased significantly overseas.Pfizer recently acquired the rights to the small-molecule GLP-1 class obesity treatment 'YP05002' from China's Fosun Pharma subsidiary, Yao Pharma, for up to $1.93 billion (approximately KRW 3 trillion), including an upfront payment of $150 million (approximately KRW 220 billion).YP05002 is a new drug candidate currently undergoing Phase 1 clinical trials in Australia and is being developed as an oral obesity treatment. Pfizer will conduct the Phase 2 clinical trial after Yao Pharma completes the ongoing Phase 1 trial.This global trend is the background for the high interest in 'ID110521156', the oral obesity drug being developed by Ildong Pharmaceutical's new drug development subsidiary, Yunovia.ID110521156 is a GLP-1 receptor agonist that acts as an analogue of the GLP-1 hormone, which induces insulin secretion to regulate blood sugar levels in the body. The GLP-1 hormone is produced by the beta cells of the pancreas. It plays a role similar to that of GLP-1, which is involved in insulin synthesis and secretion, blood glucose reduction, regulation of gastrointestinal motility, and appetite suppression.While existing GLP-1 receptor agonists are primarily injectable formulations of biological agents such as peptides, ID110521156 is a small-molecule synthetic compound candidate. Ildong Pharmaceutical's strategy is to position the drug as a convenient oral treatment for patients, capitalizing on its structurally stable properties compared to peptide formulations, offering superior manufacturing efficiency and productivity.The weight loss effect of ID110521156 was confirmed in the Phase 1 topline data released in September. The study was conducted on 36 healthy adults admitted to a clinical facility. Participants were divided into three dosage groups ▲50mg ▲100mg ▲200mg, with 12 subjects assigned to each group. ID110521156 was administered once daily for 4 weeks (28 days).Results showed that the 50mg and 100mg groups achieved average weight-loss efficacy of 5.5% and 6.9%, respectively, over 4 weeks. The 200mg group showed excellent weight loss, with an average of 9.9% and a maximum of 13.8%. The company explained that it secured clinically significant data, as the percentage of subjects who achieved 5% or more weight loss after the four-week treatment was 0% in the placebo group, but 55.6% in the 50mg group, 66.7% in the 100mg group, and 87.5% in the 200mg group.Ildong Pharmaceutical's market capitalization was only KRW 294.7 billion on April 9 and remained in the KRW 300 billion range until July 4. The stock surged after hitting the upper limit on July 7 and continued its upward trend, leading to an approximate fivefold increase in market capitalization over eight months.
- Policy
- ‘Expand 1st line reimb for anabolic agents to reduce healthcare costs’
- by Jung, Heung-Jun Dec 16, 2025 08:36am
- Calls have been raised for expanding reimbursement coverage for anabolic agents as first-line therapy in order to prevent osteoporotic fractures and the resulting rise in direct and indirect healthcare costs.As reimbursement for bone-forming agents is limited to second-line treatment only, experts argue that coverage should be expanded to include first-line use. Representative agents in this class include Evenity (romosozumab) and Forteo (teriparatide).Seung-hoon Baek, Director of Insurance and Policy at the Korean Society for Bone and Mineral ResearchOn the 15th, Seung-hoon Baek, Director of Insurance and Policy at the Korean Society for Bone and Mineral Research, emphasized the need for a first-line treatment strategy using anabolic agents at a National Assembly policy forum on osteoporosis fracture prevention held on the 15th.Director Baek stated, “Recent domestic and international guidelines recommend anabolic agents as a first-line treatment strategy for the very high-risk group. Global guidelines, including those from the American Association of Clinical Endocrinology, also position them as first-line treatment options.”The KSBMR also established guidelines in 2024 recommending the use of anabolic agents as first-line therapy in high-risk groups meeting criteria such as: ▲ a fragility fracture within the past year ▲ multiple fractures ▲ a bone mineral density T-score below -3.0.Director Baek explained, “If bone resorption inhibitors are administered first, there is a risk that bone formation may also be suppressed. Therefore, administering anabolic agents first is more effective for improving bone density."A study involving 1,000 women aged 75 showed that 43 fractures occurred when antiresorptive agents were used first, compared with 22 fractures when anabolic agents were used as first-line therapy, confirming a significant fracture-reduction effect.However, in Korea, reimbursement for anabolic agents is granted only if they are used after bone resorption inhibitors prove ineffective, which has been cited as a major limitation.Furthermore, the target population must meet all of the following conditions: ▲ Age 65 or older (or postmenopausal women aged 65 or older for romosozumab) ▲ T-score ≤ -2.5 ▲ History of two or more osteoporotic fractures.Director Baek emphasized, “Korea's reimbursement criteria are excessively restrictive compared to major countries overseas. Following the UK and Japan, Australia also expanded reimbursement for romosozumab as a first-line treatment for high-risk groups in early November last year. While there may be an increase in drug costs in the short term, a reduction in healthcare costs is expected in the long term. Overseas, this is the basis for its use in the first-line.”He further elaborated, “Patients who experience osteoporotic fractures incur approximately 80% higher per-patient medical costs compared to those without fractures. Preventing fractures is key to curbing rising healthcare expenditures.”Specifically, experts proposed recognizing it as a first-line treatment and expanding the target population from postmenopausal women aged 65 and over to include those aged 50 and over. The proposed eligibility criteria include: ▲ Relaxing the bone density test requirement from ≤-2.5 to <-3.0 ▲ Expanding from patients with two or more fractures to those with a fracture within the past year ▲ Patients meeting any one of the following: bone density ≤-2.5 and two or more fractures.
- Opinion
- [Reporter’s View] What about the ‘everyday’ drugs?
- by Kim, Jin-Gu Dec 15, 2025 11:03am
- The government’s newly announced drug pricing reform plan clearly reflects its intention to restructure Korea’s pharmaceutical and biotech industry: reward innovative new drugs, streamline generics, and reduce the public’s drug expenditure burden.However, one critical element is conspicuously absent—supply stability. The ‘supply’ issue, which directly impacts the site and the patients, has not been sufficiently addressed. While an item titled ‘Establishing a Stable Supply System for Essential Medicines’ exists midway through the reform plan, the overall weight given to this area appears insufficient.In recent years, the medical field has suffered from repeated drug supply disruptions. Antibiotic shortages paralyzed pediatric care, while fever and pain reliever shortages made pharmacies reminiscent of rationing. Medical institutions have repeatedly sweated bullets securing substitutes as essential medicines like contrast agents, local anesthetics, and basic IV fluids that are indispensable for treatment, have repeatedly run out. Supply instability has spread beyond specific essential medicines to encompass ‘everyday drugs’ used in routine care, exposing structural weaknesses in Korea’s pharmaceutical supply chain.Of course, supply stabilization measures are included in this reform plan. The threshold for designating exit-prevention drugs was raised by 10%, and the cost recovery standard for low-priced drugs was expanded from an annual claim amount of KRW 100 million to KRW 500 million. A new policy surcharge of up to 7% will be introduced, and the calculation methods for manufacturing and labor costs will be adjusted to reflect reality. For essential medicines, the surcharge pricing period will be stably guaranteed, and the scope of surcharge eligibility will be expanded. A ‘reshoring surcharge’ will also be considered when switching imported items to domestic production. Furthermore, the government will strengthen the public-private joint response system and push to establish a system that automatically guides users to substitute items during the prescription and dispensing stages.However, the pharmaceutical industry's response remains lukewarm. This is because the revised plan still fails to provide pharmaceutical companies with a ‘clear reason’ compelling them to produce low-cost essential medicines. Raw material costs and fixed expenses rise every year, yet numerous items have seen drug prices stagnate for years. Critics argue that limited price incentives confined to specific items cannot resolve structural issues. While plans exist to encourage compliance with supply commitments, encouragement alone cannot sustain manufacturing lines.For these reasons, the reform plan reads like a structure sacrificing fundamentals for innovation. The medicines citizens take daily, the drugs used in emergency rooms, and the medications needed on hospital wards are not mere pharmaceuticals but the very ‘medical infrastructure’ itself. No matter how many innovative new drugs emerge, if the supply of ‘everyday medicines’ – the foundation of the healthcare system – remains unstable, the impact of policy reforms will inevitably fall short.The direction hereon is clear. We must elevate the stability of pharmaceutical supply from a ‘side clause’ in drug pricing system reforms to a ‘core pillar’. Practical and sustained incentives are needed to encourage pharmaceutical companies to compete for the production of essential medicines. Beyond minor adjustments that merely cover costs, we must design realistic and sustainable profit structures that ensure supply continuity. System-level frameworks to support this also require an overhaul.Developing global innovative new drugs is important. However, safeguarding the supply chain to prevent disruptions in medicines that patients urgently need must take precedence over any other policy. What the pharmaceutical industry, the medical community, and patients ultimately desire is a policy that solidly establishes these fundamentals. This is precisely the part the current reform plan has overlooked.
- Opinion
- [Reporter's View] Besides speeding reform of pricing system
- by Jung, Heung-Jun Dec 15, 2025 11:03am
- If the government's goal for reforming the drug pricing system is to improve structure of the pharmaceutical and biotech industry, then an appropriate processing speed is necessary.To encourage pharmaceutical companies to expand R&D investment and align their interests, the government must provide sufficient time for companies to devise new plans.The government will gather industry-wise opinions and finalize the pricing system reform by January. Then, it plans to implement the policy in July, half a year later. The schedule is too fast-paced, as concerns arise about potential exhaustion rather than improvements to the industry structure. The Ministry of Health and Welfare (MOHW) has repeatedly stated that the system reform is not intended to achieve pharmaceutical cost savings. The MOHW asks that the reform, which has been designed to encourage innovations, should be viewed as an attempt to establish South Korea as a strong nation for new drugs.The question is whether companies devising plans in a hurry following the Health Insurance Policy Review Committee's decision in February next year can bring innovation to the industry? Even if the rate of R&D investment can be increased, the policy is highly likely to be a half-baked deal to maximize drug pricing.Furthermore, the greed to reach the goal in a short period may be the underlying reason that pharmaceutical companies with high potential for change give up.The government has suggested direction of the drug pricing system. Now, it should give enough time for the industry to reorganize portfolio and devise 5- to 10-year plans. Six months is too short for the industry to finalize revision measures.If the government were to ignore the industry's reality and focus solely on the roadmap for system implementation, there may be unintended consequences beyond the expected goals.Besides the industry, the government must consider well-designed implementation measures to achieve both goals, including innovation and stable supply.There are concerns about anticipated side effects of changes to the post-marketing management system, including the side effects of simply offering drug pricing priority based on R&D rate or actual transaction price survey.Once the post-marketing monitoring system is reduced to twice a year, remaining tasks to specify include how to permit retroactive application or how to promote listing within 100 days for rare disease pharmaceuticals.It is difficult to build a healthy ecosystem. It carries the danger of collapsing the existing ecosystem while failing to establish the intended ecosystem. Once collapsed, an ecosystem requires substantial financial resources.Setting the right direction and improving the system requires the government's firm stance. However, as this is a critical decision impacting the industry and future business, the government should take the time to carefully review the policy, while the industry works to monitor and develop effective plans.
more articles
-
- "ADC use sufficient in neoadjuvant therapy of breast cancer"
- Enhertu improved pCR over 10% in clinical trials…overcoming limitations of the existing standard of care
-
- ‘Imfinzi demonstrates rationale for perioperative immunotherapy in gastric cancer’
- Consistent benefit confirmed in Asian subgroup analysis of MATTERHORN, with similar improvements in EFS, OS, and pCR
MOST READ
