- LOGIN
- MemberShip
- 2026-04-16 04:58:38
- Company
- Mundipharma Korea appoints Hun Choi as the new CEO
- by An, Kyung-Jin Oct 06, 2020 06:24am
- Hun Choi, new CEO of Mundipharma Korea Mundipharma announced on the 5th that it had appointed Hun Choi (46 yrs old), Managing Director, as the new CEO as of October 1. He graduated from Korea University Department of Chemistry and entered the pharmaceutical industry when he joined Novartis Korea in 2001. He served as a brand manager and sales manager, starting with a salesperson at the anticancer drug division. Since recruiting as head of the anticancer drug division of Mundipharma in 2012, he has served as a managing director of the Ethical division, including the pain division, respiratory division, and medical device division. The company said that the reason for choosing the new CEO Choi is because of its differentiated marketing strategy and leadership. He has been leading the company's sales growth so far, and is evaluated as the right person to lead a successful business even in an environment where uncertainty has increased due to the aftermath of COVID-19. Hun Choi said, "We will lead the company's growth through reorganization of our existing flagship business and new customized strategies. We will play a role as a value accelerator that raises our position as a global big pharma while leading the New Normal of the pharmaceutical industry." Former CEO Lee Myung-se, who led Mundipharma Korea for the past four years, recently moved to Shaperon, a new drug development company.
- Policy
- Mishandled flu vaccines' recognition was announced in 10 hr
- by Lee, Jeong-Hwan Oct 06, 2020 06:24am
- Criticism was raised that the KDCA announced the suspension of vaccination after about 10 hours of being aware of the flu vaccine exposure to room temperature, causing damage to the public. The KDCA announced to domestic medical institutions that Shinsung Pharm’s vaccines would be halted at 11 pm on the 21st of last month, and the recognition of exposure to room temperature was delayed at around 1:30 pm on the same day. On the 5th, Kang Ki-youn, a member of the People Power Party made this claim through the results of an investigation by the KDCA. He pointed out that after the KDCA reported the flu vaccine exposure at room temperature, it was delayed in decision-making, such as finding out the situation and stopping vaccination, resulting in increased damage and confusion between the public and medical institutions. According to him, it was around 1:30 p.m. on the 21st of last month when the KDCA recognized that Shinsung Pharm’s vaccines were exposed to room temperature through a report. Afterwards, the KDCA sent a text message to medical institutions at 11 o'clock on the same night with the details of the suspension of vaccination. As of the last 2 days, the total number of vaccinations supplied by Shinsung Pharm was 704 after the announcement of discontinuation of vaccination. He said that hospitals that were not properly aware of the vaccination stopped at 11 p.m. late on the 21st was vaccinated from the morning of the 22nd. He criticized that it should have been announced much earlier with faster decision-making after receiving the report.
- Company
- Samsung Pharm won second trial with Samsung Electronics
- by Kim, Jin-Gu Oct 06, 2020 06:24am
- Samsung Pharm won the second round of the trademark dispute with Samsung Electronics over the name of 'Samsung'. Like the first trial, the second trial court admitted that Samsung Pharm had used the name Samsung for a longer time. Corporate CI of Samsung Pharm & Samsung Group (Data: the KIPO) The Patent Court of Korea ruled against the plaintiff in a lawsuit for invalidation of trademark registration filed by Samsung Electronics against Samsung Pharm on the 24th. Like the first trial, the Patent Court of Korea sided with Samsung Pharm. The issue was that as Samsung Group's 'Samsung' is a more well-known and well-known trademark to the public, Samsung Electronics argued that the trademark newly registered by Samsung Pharmaceutical in 2015 should be invalidated. Accordingly, the first trial sided with Samsung Pharm. The point of the trial decision is that Samsung Pharm has been using the name ‘Samsung’ for a longer time than Samsung Electronics. ◆1929 vs 1938, "Samsung Pharm precedes Samsung Chamber of Commerce" Samsung Pharm started with 'Samsung Pharmaceutical', established in August 1929. Then, in 1963, it changed its name to 'Samsung Pharmaceutical Industry Co., Ltd.'. In July 2014, the company changed its name again to the current 'Samsung Pharmaceutical Co., Ltd.', and in December of that year, 'Samsung Pharmaceutical Healthcare Co., Ltd.', a health functional food manufacturer, was established. The Patent Tribunal explained that "Samsung Pharmaceutical was established before the Samsung Group, and the abbreviation of Samsung Pharmaceutical has been recognized among domestic general consumers and traders as they have been using the trademark for over 90 years." On the other hand, in the case of Samsung Electronics, it was established in 1938 by 'Samsung Chamber of Commerce'. It means that Samsung Pharm was established nine years before Samsung Electronics. The Intellectual Property Trial and Appeal Board explained that Samsung Pharm was established before the Samsung Group, and the abbreviation of Samsung Pharm has been recognized among domestic general consumers and traders as they have been using the trademark for over 90 years." Regarding the reputation of the trademark, "Samsung Group's pharmaceutical business will be recognized by general consumers as 'Samsung Bio' or 'Samsung Biologics'. He judged that it will be recognized as a different concept. In the case of the second trial, the ruling has not yet been disclosed, but it is said that the ruling was generally made with the same purpose as that of the first trial. ◆Samsung Pharm succeeded in defending all three brands of the first and second trials There are a total of three trademark rights that have problems. There are two 'Samsung Pharm since 1929' and one 'Samsung Pharm Healthcare' with slightly different designs. Samsung Pharm applied for three trademarks in March 2015. It was an application to protect the brand of Samsung Pharm Healthcare, a subsidiary established in December of the previous year. At the same time as the filing, the Samsung Group filed an objection. The KIPO accepted the objection and rejected the registration. In January 2016, Samsung Pharm filed a trial requesting that the decision to reject it be canceled, and the KIPO accepted Samsung Pharm's argument. After twists and turns, three trademarks of Samsung Pharmaceutical were officially registered. Then, this time, Samsung Electronics insisted on the invalidation of the trademark. However, Samsung Pharm succeeded in winning the trademark right as the KIPO and the Intellectual Property Trial and Appeal Board did not accept Samsung Electronics' claims. It has not yet been decided whether Samsung Electronics will appeal to the Supreme Court over the results of the second trial.
- Policy
- Additional evidences asked for 3 patients using Spinraza
- by Lee, Hye-Kyung Oct 06, 2020 06:23am
- The South Korean health authority has asked three preliminary approval applicants seeking to use spinal muscular atropy (SMA) treatment Spinraza with coverage to submit supplementary evidences. After the initial approval on reimbursed use of Spinraza, the applicant has to hand in monitoring report every four months before administering the maintenance dose. As a result, 28 out of 31 cases of the monitoring report have been cleared, and three cases have been ended. On Sept. 29, Health Insurance Review and Assessment Service (HIRA, President Kim Sun-min) disclosed the outcomes of four pre-administration reimbursement review cases deliberated by the Healthcare Review & Assessment Committee in August. One of most expensive new drugs in the world, Sprinraza costs 92.35 million won per 5 ml vial and it requires a healthcare institute to apply for pre-administration approval for reimbursed use. Depending on the reimbursement standard on Spinraza, the health authority approves of the coverage on the drug in patients qualifying all following conditions—positive genetic testing of a deletion or mutation in the survival motor neuron 1 (5q SMN-1) gene, onset of SMA symptoms from age three or less, and not on permanent ventilator. In terms of a 16-year-old male patient with a record of scoliosis surgery and a myelogram, HIRA asked for the related imaging evidence for submission, as the previously submitted evidence could not sufficiently prove if he is able to take continuous intrathecal administration with lumber puncture. A female patient aged 35 was also requested to provide more evidences of her SMA-related symptoms and signs onset before she reached 36 months. Another female patient aged 25 with a record of scoliosis surgery was asked to provide a doctor’s opinion on feasibility of intrathecal administration with lumber puncture by running a myelogram. Also she has to submit a specialist doctor’s opinion, except from her own doctor, regarding her respiratory function as she is currently using a ventilator. Before the Spinraza review, the committee reviewed pre-administration applications on reimbursed use of Soliris (eculizumab). Only two out of four applications from patients with paroxysmal nocturnal hemoglobinuria (PNH) were cleared. One case of reevaluation and 44 monitoring reports were passed for reimbursement. All five applications on using Soliris with reimbursement for treating atypical hemolytic uremic syndrome (aHUS) were denied, but 10 monitoring reports were passed for further reimbursed use. Moreover, HIRA reviewed and green lit all four preliminary applications for reimbursed treatment with ventricular assist device (VAD).
- Company
- Daewoong promotes the development of injectable hair loss tx
- by Nho, Byung Chul Oct 06, 2020 06:23am
- Daewoong is developing long-lasting hair loss treatments for male in earnest through open innovation that introduces promising external technologies. Daewoong (CEO Seng-Ho Jeon) signed a joint development contract with Inventage lab (CEO Ju Hee Kim), a drug delivery system platform venture company, on the 25th, and is conducting joint research, development and commercialization of long-lasting hair loss treatment drugs (IVL3001, IVL3002) owned by Inventage Lab. IVL3001 & IVL3002 jointly developed by Daewoong as a pipeline are injection formulations administered once every 1 or 3 months. Inventage Lab's drug delivery system (DDS) platform technology, IVL-PPF Microsphere® (IVL-Precision Particle Fabrication Microsphere), is equipped with hair loss treatment for male. Finasteride is one of the most proven hair loss treatment ingredients approved by the US Food and Drug Administration (FDA), and has proven its efficacy and safety in preventing hair loss and is widely used. The existing oral formulation of hair loss treatment for male should be taken once a day. However, long-lasting injections are expected to improve patient compliance, improve hair loss treatment, and reduce the likelihood of side effects by minimizing the dose of drugs for the same efficacy. IVL3001 (1 month long-lasting male pattern hair loss treatment) is scheduled to be released in 2024 with a non-clinical study scheduled to be conducted in early 2021, and IVL3002 (3-month-lasting male pattern hair loss treatment) is currently in non-clinical studies. CEO Seng-Ho Jeon said, “Daewoong has a variety of R&D pipelines such as anticancer drugs, CNS, diabetes, and obesity based on long-term continuous injection production and research experience over the past 20 years.” and he added that it plans to accelerate the development of long-lasting hair loss treatments for male to advance into overseas markets based on Daewoong's excellent R&D capabilities and commercialization know-how. Ju Hee Kim, CEO of Inventage Lab said, “It is a very valuable achievement to jointly develop Inventage Lab's long-lasting drug, which is developing innovative new platform technology in this field, with Daewoong, which has development expertise and sales network as a leader in domestic long-lasting injections, and we will do our best to provide better treatment options to 10 million hair loss patients in Korea through close cooperation with Daewoong and to make it a commercially successful drug in the global market.”
- Policy
- Daewoong's DWP16001, approved for Phase III clinical trial
- by Lee, Tak-Sun Oct 05, 2020 06:22am
- The SGLT-2 diabetes treatment drug being developed by Daewoong is entering phase III of clinical trial. This drug is expected to become the first domestic SGLT-2 diabetes drug if it obtains product approval. On the 29th of last month, the MFDS approved phase III clinical trial plan for Daewoong's new drug candidate 'DWP16001'. DWP16001 is a SGLT-2 inhibitor drug such as Forxiga (AZ), Jardiance (Boehringer Ingelheim), and Suglat (Astellas) that are commercially available in Korea. Daewoong is developing and introducing substances from GC Pharma in May 2016. Inhibition of SGLT-2 Diabetes treatment has a mechanism of selectively inhibiting SGLT-2, a transporter that reabsorbs glucose from the kidneys, preventing glucose from being reabsorbed, and controlling blood sugar by excreting it in the urine. It is also famous as a 'fat-losing diabetes medicine' because it has weight control effects. SGLT-2 inhibitor drugs and DPP-4 inhibitory drugs are rivals in the domestic diabetes treatment market. According to UBIST, Forxiga's outpatient prescriptions amounted to ₩17.6 billion in the first half of this year, up 10.1% year-on-year. Sales of Jardiance was ₩16.8 billion, up 66.7% year-on-year, and Suglet’s sales amount was ₩1.6 billion, up 16.7% year-on-year. Daewoong has been jointly selling Forxiga in cooperation with AstraZeneca since 2018. It can be said that distribution network has already been established before the development of new drugs. In addition, Daewoong is selling DPP-4 diabetes treatment Zemiglo (LG Chem), showing its strong influence in the diabetes drug market. This phase IIII clinical trial of DWP16001 is conducted to evaluate the safety and efficacy of a combination therapy with Metformin in patients with type 2 diabetes who have insufficient glycemic control with Metformin and monotherapy in type 2 diabetes patients. Phase III clinical trial of monotherapy is conducted at Seoul National University Hospital for 140 domestic patients. The phase III clinical trial of Metformin combination therapy will be conducted in 190 patients at Seoul St. Mary's Hospital. It is interpreted as a strategy to simultaneously acquire major indications by conducting two-tracks. Daewoong revealed the results of phase I clinical trial of DWP16001 through a poster presentation at the '2019 European Association for the Study of Diabetes (EASD)' held in Barcelona, Spain in September last year. According to the results, in phase I, DWP16001 showed excellent urinary glucose secretion (glucose excreted in the urine) at a dose of 1/100 compared to drugs of the same category. In addition, when repeated administration for 15 days, the daily urinary glucose secretion of the active control group was 40g, while the daily urinary glucose secretion of the DWP16001 group was 50g or more. Daewoong received approval for phase II clinical trial from the MFDS in May last year, and approved phase III clinical trial within 1 year and 5 months, and is proceeding with commercialization plans smoothly. Daewoong plans to release this drug in Korea in 2023.
- Policy
- Health vice-minister answers questions on MOHW drug pricing
- by Kim, Jung-Ju Oct 05, 2020 06:21am
- Kang Do-tae (Master’s degree in Public Administration at Seoul National University) has been appointed as a first second vice-minister of Ministry of Health and Welfare (MOHW) to lead the health sector of the ministry amid COVID-19. And during an interview on him, the vice-minister expressed his commitment to not only focus on the infectious disease control but also to pay attention to healthcare development planning the administration is firmly pressing on. A month into his new appointment, the second vice-minister is in charge of the entire health sector including the healthcare and pharmaceutical industry. During an interview with the industry news media, Vice-minister Kang affirmed his approach on the health policies and determination to communicate with the industry as much as possible. He also said more comprehensive and systematic healthcare developing roadmap would be taken by sufficiently surveying opinions from various stakeholders. However, he was particularly careful on speaking about sensitive issues like choline alfoscerate substitution prescription and non-proprietary name prescription, coverage on Korean herbal medicine, and alternative exam date for medical school students who were on strike. Following is the detailed interview with the vice-minister. ▶The Korean pharmaceutical industry is complaining about the skewed regulatory policy, namely the generic pricing system revision. While the administration is pressing on the coverage enhancement, the public is criticizing on the insufficient fostering initiative for the Korean pharmaceutical industry and unilateral policy execution. Regarding the criticisms, what is your opinion on them and how do you plan to approach the said policies? “Since the valsartan contamination incident in 2018, the notion of generally amending the generic management system has been suggested. MOHW then discussed with the Ministry of Food and Drug Safety (MFDS) and collected the pharmaceutical industry’s opinions to revise the drug pricing system to ultimately improve the generic quality management and competitiveness. We would push on with the pricing policies announced already, but also sufficiently communicate with the industry when setting up detailed action plans. While streamlining the pricing system, we would constantly seek for policies to foster and support the pharmaceutical industry—the key emerging industry of the country. The ministry has drawn up and started executing the biohealth industry innovation strategy plan and the Second Five-year Comprehensive Plan (2018-2022) for Pharmaceutical Industry Fostering and Supporting, which includes R&D investment expansion, major specialist training, and biohealth technology innovation ecosystem establishment. The ministry would continue to provide supports for the industry for its further innovation and better global competitiveness.” ▶Pharmaceutical companies are urging the government to differentiate pricing as a new drug, when an anticancer therapy adds a new indication. The industry apparently wants to communicate with the government on its stance, but they say the government has not been responding. What is your opinion on the matter? “A new drug pricing system that gives different pricings on a drug based on indication could help improving the access to needed treatments. But we need to first evaluate if such system can be realized within the current National Health Insurance (NHI) and its billing and payment system. Also, the indication-based differentiated pricing should be decided after surveying a wide array of stakeholders including the relevant government bodies, industries and civic groups. Regarding the communication with the pharmaceutical industry, the ministry would regularly convene a meeting with the related industry organizations for their in-depth opinions.” ▶Recently, the court has ruled to halt the reimbursement reduction order on choline alfoscerates. With the decision, would you say the reevaluation on other drugs are also on hold or halted as well, or that the ministry is planning to continue on with the reevaluation program according to the newly written reevaluation clause within the revised reimbursement regulation? “So far, the National Assembly, the media and civic groups have pointed out how reevaluation is needed for those drugs with questionable clinical efficacy. As a first case, we have selected and reevaluated drugs with choline alfoscerate, and newly added a legal basis within the National Health Insurance reimbursement standard to adjust reimbursement on already-listed drugs through reevaluation. Other drugs would be reevaluated next year, and we would fully communicate with the pharmaceutical industry, experts and civic groups during the process.” ▶While the trend of pharmaceutical companies signing deals with CSOs is becoming more apparent, is there any CSO management plan including the expenditure report management the MOHW is preparing? “There have been concerns of the industry finding new means to provide rebate as more companies are working with CSO. Accordingly, the ministry is to also seek measures, based on the Pharmaceutical Affairs Act, to prevent CSOs providing rebate by penalizing them with business suspension. Also the CSO would be responsible to document financial benefit provided to healthcare providers and to file expenditure report under the supervision of the consigner. By raising awareness of the expenditure report system that requires healthcare providers and pharmaceutical industry to verify the report, the ministry would encourage the CSOs to be better self-managed.” ▶Until now, the government has acknowledged the necessity of generic substitution and non-proprietary prescription, but turned them down due to conflict between the healthcare providers and pharmacists. What is your opinion on the issue? “There are so many different opinions suggested by the medical and pharmaceutical experts from health industries to academic societies regarding the government promoting non-proprietary prescription and generic substitution. So we would need to first create a social consensus to reflect not only the medical and pharmaceutical industries, but also the public.”
- Policy
- Off-label coverage on Cellcept and Mabthera expanded
- by Kim, Jung-Ju Oct 05, 2020 06:21am
- From next month, the off-label reimbursement would be expanded on Roche Korea’ immunosuppressant Cellcept Capsule (mycophenolate mofetil) and chronic lymphocytic leukemia and rheumatoid arthritis treatment Mabthera injection (rituximab). Lilly Korea’s psoriatic arthritis and ankylsoing spondylitis treatment Taltz Prefilled Syringe Injection (ixekizumab) would receive reimbursement as a second-line treatment on severe case of ankylsoing spondylitis. South Korea’s Ministry of Health and Welfare (MOHW) has partially revised the ‘Healthcare Reimbursement Standard and Application Details (Pharmaceuticals)’ to reflect the said changes as of Oct. 1. First, an oral mycophenolate mofetil Cellcept would expand the coverage based on indications approved in South Korea and overseas, textbooks, clinical guideline, clinical literature, and related academic recommendations. The new coverage on Cellcept would apply on patients with advanced diffuse cutaneous systemic sclerosis and systemic sclerosis associated interstital lung disease. The reimbursement would be granted for patients with diffuse cutaneous systemic sclerosis, who have not sufficiently responded to one or more types of other immunosuppressant, such as azathioprine, and scored over 12 points in modified Rodnan Skin Score (mRSS). Also, patients with systemic sclerosis associated interstital lung disease, who have not sufficiently responded to one or more types of other immunosuppressant, such as azathioprine, and their Forced Vital Capacity (FVC) ranging from 45 percent to under 80 percent. For both diseases, 250 mg to 3,000 mg of the drug would be administered daily. The off-label use of the rituximab injection would obtain reimbursement, when treating children with chronic nephritic syndrome. The new off-label coverage would be available to patients with steroid-dependent nephritic syndrome frequently relapsing regardless of receiving steroid and immunosuppressant (cyclosporine, cyclophosphamide, tacrolimus or mycophenolate mofetil), patients with steroid-dependent nephritic syndrome who do not demonstrate remission or frequently relapsing regardless of receiving steroid and immunosuppressant (cyclosporine, cyclophosphamide, tacrolimus or mycophenolate mofetil), and patient who cannot use steroid or immunosuppressant (cyclosporine, cyclophosphamide, tacrolimus or mycophenolate mofetil). The reimbursement would be provided for an initial administration of 375 mg/ m2 (maximum 500 mg), and another follow-up administration after three to six months (maximum twice a year). The treatment can be re-administered, if the patient relapses. However, patients with chronic or acute infection, who received live attenuated vaccine within a month, or who test absolute neutrophil count (ANC) under 500/ mm³ would not be eligible for the administration. The reimbursement on an ixekizumab treatment, Taltz Prefilled Syringe Injection would be additionally granted as a second-line treatment on patients with severe case of ankylsoing spondylitis by referring to the reimbursement standard on interleukin-17 inhibitors (IL-17i). Patients with severe and active ankylsoing spondylitis, who do not respond well to one or more types of tumor necrosis factor-α (TNF-α) inhibitor or halted treatment due to adverse reaction, would be eligible for the coverage. The sustained administration of six months with reimbursement would be approved to patients scoring 50% on Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) or reduced more than two (scale 0 to 10) after using the treatment for 16 weeks. The evaluation would be conducted every six months from then on, and the sustained administration would be allowed if the patient maintains the evaluation result from the first 16 weeks. Also the coverage would be granted for patients, who do not respond to the treatment or have to halt the administration due to adverse reaction, but switching to a TNF-α inhibitor (etanercept, adalimumab, infliximab or golimumab injection) that has not been used before or to a secukinumab injection. However, in such case, the patient has to submit a doctor’s recommendation on the switch. As the reimbursement on Taltz Prefilled Syringe Injection has been expanded to patients with ankylsoing spondylitis, the treatment’s substance name would be added to golimumab’s reimbursement standard as an option for switch. Janssen Korea’s Simponi Prefilled Syringe Injection 50 mg is the most famous brand name for golimumab.
- Policy
- A government-ruling party, pay attention to Syntekabio
- by Lee, Jeong-Hwan Oct 05, 2020 06:21am
- As it is known that the drug efficacy of the new drug substance for COVID-19 being developed by Syntekabio is more than twice that of Remdesivir, a government-ruling party is paying attention to this. On the 28th, Lee Nak-yeon, leader of the Democratic Party and Representative Han Jeoung-ae (General Manager of the National Disaster Recovery Committee), Seo Youngseok (Health and Medical Special Committe), Jo Seounglae, Kim Youngbae, and Han Junho visited the KRIBB in Daedeok Innopolis in Daejeon. Yong Hong-taek, head of the R&D policy department of the Ministry of Science and ICT, attended. On this day, the government-ruling party met with an official who took the lead in the development of COVID-19 treatment and vaccine to discuss the current status of treatment and vaccine, and to discuss a message to the public. Jang Seong Kim, the KRIBB’s chairman, explained that the efficacy of Syntekabio's COVID-19 treatment candidate was twice as high as that of the standard treatment Remdesivir. Syntekabio's new drug substance is known to have a therapeutic effect of 94.3% compared to 44.3% of Remdesivir as a result of animal experiments conducted through the KRIBB. Lee Nak-yeon expressed interest by encouraging the researchers of the KRIBB, and at the same time confirming whether the COVID-19 candidate is twice as effective as Remdesivir in animal experiments. He said, “Amid the COVID-19 crisis, we must protect the quarantine and economy and prepare for the future. The KRIBB, which developed the world's fourth primate infection model, is making a feat of stabilizing the COVID-19 clinical trial. We want to hear how our party can help.”, also he added, “the expansion of research facilities and data centers seemed urgent and we will help.”
- Company
- Choline alfoscerate coverage reduction order suspended again
- by Chon, Seung-Hyun Oct 05, 2020 06:20am
- The court has once again approved to halt the administrative order on the cognitive enhancer ‘choline alfoscerate.’ Previously, the court has decided to suspend the order until the final ruling of the litigation, but another litigation case added 30 days to the already-approved order suspension. According to the industry sources on Oct. 28, the Seoul Administrative Court has decided to withhold the effect of partially revised health insurance reimbursement standard the pharmaceutical companies filed litigation against on Oct. 25, regarding the choline alfoscerate coverage reduction, for 30 days from the day the litigation is concluded. Represented by the law firm Lee & Ko, 39 pharmaceutical companies and one individual, including Daewoong Bio, has requested the order suspension. On Sept. 26, the Ministry of Health and Welfare (MOHW) issued a revised notice on the reimbursement standard, which stipulated adjustment of choline alfoscerate coverage. From this month and on, the government’s new reimbursement standard was supposed to raise the patient copayment rate from 30 percent to 80 percent, if a patient who has not been diagnosed with dementia were to use a choline alfoscerate drug. The court ruled, “Halting the administrative order on choline alfoscerate does not seem to significantly affect the public welfare.” The court also pointed out the patients could continue to use choline alfoscerate, regardless of the burdening copayment rate, or give up on the drug use due to reduced healthcare benefit on the drug. Moreover, the court judged the coverage adjustment on choline alfoscerate with insufficient clinical evidence could bring a grave impact on the related market as it would defame the credibility and reputation of the drug and the companies. Currently, two litigation cases against the administrative order on choline alfoscerate are in process. The law firm Shin & Kim is representing 39 companies and eight individuals including Chong Kun Dang, and the law firm Lee & Ko is representing 39 companies and one individual. Shin & Kim and Lee & Ko have filed the litigations on Sept. 27, immediately after the ministry issued the notice. The order suspension request made by Shin & Kim has been approved until the day of the final ruling. And now, the request by Lee & Ko has been accepted as well. The two cases do not conflict issues on respective order suspension. Meanwhile, MOHW has reportedly filed an appeal on the Shin & Kim case.
