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- 2025-12-24 02:11:43
- Policy
- Exempt PVA for drugs with claims less than ₩10 billion
- by Lee, Hye-Kyung Dec 16, 2021 05:51am
- The pharmaceutical industry officially delivered its position that it cannot accept any of the measures set for the improvement of the detailed guidelines for the Price-Volume Agreement negotiations that were disclosed by the National Health Insurance Service. The NHIS had collected industry opinion until the 14th after disclosing the proposed revisions to the KPBMA, KRPIA, and KOBIA at the 10th public-private consultative meeting that was held on the 2nd. In particular, the KPBMA opposed both the revision of Article 6.1.1 of the guideline that calls for expanding the total claims amount set for a product group from 'less than ₩1.5 billion' to 'less than ₩2 billion,' and Article 6.1.2 that reduces 'items with an upper limit of less than the arithmetic average of drugs with the same ingredient' to 'less than 90% of the arithmetic average.' In addition, the industry added that the items that were initially listed at a low price should be added to subjects eligible for exclusion from price cuts or price cut rate reductions. The main reason why the industry opposed the improvement in the PVA guidelines was that the financial savings gained on the NHIS's part were insignificant. If the revision that expands the amount of the annual claims from less than ₩1.5 billion to less than ₩2 billion is applied, drugs that have an annual claims amount of ₩1.2 billion will also be subject to PVA negotiations if their use volume increases by over ₩800 million. If the amount is calculated at the discount rate of 6.0% in line with the reference formula, the savings amount will be around ₩120 million. The industry pointed out that “₩120 million is an insignificant amount of savings on the NHIS’s part. However, from the small-and-mid-sized pharmaceutical company’s viewpoint, a 6% drop in a drug’s price will be discouraging as the company will not invest in such a product as its main item, which will then become an obstacle to corporate growth that can be achieved from sales expansions. Therefore, from the industry’s viewpoint, the government's negotiations should be focused on mid-to-large sized items whose use exceeds ₩10 billion in line with the PVA system's purpose, and the amount subject to exclusion from PVA to be increased to be set at ₩10 billion or less. Also, on changing the ‘same ingredient’ term to ‘main component code’ for all items other than the disposable eye drops and reducing the limit from the arithmetic average to 90% of the arithmetic average, the industry requested the government retain the current guideline. The industry said, “The arithmetic average is a social convention and an absolute standard for judging whether the insurance finances can be saved, and therefore, it is in line with the system's purpose to exclude drugs that cost under the arithmetic average from negotiations. Abuse of the system, such as evading negotiations by voluntarily reducing the price to less than the arithmetic average may be well prevented by changing the time of application of the arithmetic average to the time when the monitoring starts.” With the opinion that the arithmetic average will be adjusted with the graded system for pricing generic drugs and the reevaluations planned to be implemented in July 2023 for already-listed drugs, the industry expressed concerns that enforcing the revisions will rather diminish the companies’ efforts to save NHI finances through voluntary low price listing or voluntary price cuts. In addition, the industry requested the ‘low-priced drugs’ to be added to drugs eligible for price cut rate reductions as proposed by the public-private consultative body. The currently announced guideline allows companies that voluntarily cut the price of drugs (if the 1-year period from the voluntary price cut is included in the period of analysis) may be exempted from a single negotiation under the PV guidelines or be calculated for a negotiation reference price that takes into account the voluntary price cut rate. The industry said, “Although drugs that were initially announced at a lower price (scheduled sales price) than what can be calculated have a positive effect on health insurance finances from the time of its listing, the reduced rate is not reflected during PVA negotiations. We ask that new drugs that are initially listed at a low price also be applied the exemption for one single negotiation or be reflected for its low price when assessing eligibility for PVA negotiations and in calculating the negotiation reference price.”
- Policy
- Janssen keeps the Tylenol name for its imported product
- by Lee, Tak-Sun Dec 16, 2021 05:51am
- As expected, Janssen is keeping its brand name, ‘Tylenol,' for its antipyretic analgesic. The company had dropped the license of its domestically manufactured Tylenol Tab. 500mg in line with the shutdown of its Hyangnam plant and changed the name of its imported item that was approved in August to ‘Tylenol Tab. 500mg.’ The expectations held by frontline pharmacies that the company may give up the use of its brand name and use the ingredient name, INN (International Nonproprietary Name), had been let down. According to the Ministry of Food and Drug Safety on the 14th, the product name of ‘Janssen Acetaminophen Tab.’ was changed to ‘Tylenol Tab. 500mg’ on the 13th. The product was approved for import on August 23rd. Janssen had obtained the approval for the imported item that can substitute its manufactured item in advance before the shutdown of its Hyangnam manufacturing plant that was planned for the end of this year. At the time of approval, the company had obtained approval for the drug as ‘Janssen Acetaminophen,' according to its INN mark. However, industry prospects were that this was just a temporary measure made because another approved product had existed under the ‘Tylenol Tab. 500mg’ name, As expected, the company had dropped the license for its manufactured ‘Tylenol Tab. 500mg’ since then and changed the name of its Janssen Acetaminophen to the existing brand name. Frontline pharmacies had once hoped that the drug would be released as Janssen Acetaminophen. When the COVID-19 vaccinations began in Korea, the Korea Disease Control and Prevention Agency had referred to the ‘Tylenol’ name as the medicine to use to alleviate the side effects of vaccinations, leading to the heavy purchase of only Tylenol among the various acetaminophen drugs. As a result, frontline pharmacies had faced difficulties because they could not keep up with the demand and had experienced Tylenol shortages. At the time, pharmacists had criticized KDCA for mentioning a specific brand rather than a generic name. The pharmacies had expected that the release of Janssen Acetaminophen, not Tylenol, would resolve the Tylenol-concentrated market demand. However, as companies follow profits, it would have been difficult for the company to give up its brand name as the booster COVID-19 vaccinations starting in earnest is expected to further increase Tylenol sales. According to IQVIA, Tylenol recorded ₩50.1 billion in cumulative sales by Q3 this year and recorded No.1 in the OTC market.
- Policy
- Moderna Korea has obtained permission for sales
- by Lee, Tak-Sun Dec 15, 2021 05:52am
- On the 13th, Moderna Korea, which was approved for Spikevax, an mRNA-based COVID-19 vaccine commissioned by Samsung Biologics, was approved for the ninth time in Korea as a "medical consignment manufacturing and sales business." According to the MFDS on the 14th, Moderna Korea acquired a drug consignment manufacturing and sales business at the same time as the Spikevax product license. The CEO is Son Ji-young, who worked for a global pharmaceutical company for more than 20 years and served as president of CSL Behring Korea until just before. CEO Son is known to have graduated from Ewha Womans University College of Pharmacy and completed an MBA at Korea University Graduate School of Business. Since then, he has worked at Pfizer Korea, Roche Korea, and Roche Switzerland headquarters. Moderna Korea's sales office is located in Saemunan-ro, Jongno-gu, Seoul. The pharmaceutical consignment manufacturing and sales business was newly established in 2007. At that time, the MFDS established a new industry so that companies without factories in Korea can obtain permission for pharmaceutical items. In 2008, GL Pharm Tech was licensed as the No. 1 industry, and since then, MSD Korea, Corepharmbio, Crystalgenomics, Abbott, Gunkang Pharmaceuticals, AstraZeneca Korea, Woosung Pharma, and Moderna Korea have acquired consignment manufacturing and sales. In particular, AstraZeneca Korea Covid-19 Vaccin, a COVID-19 vaccine that entrusts production to SK Bioscience, has also obtained additional approval for new industries following the import industry. Only two companies have acquired consignment manufacturing and sales businesses only with the COVID-19 vaccine. As domestic companies' production capacity is receiving favorable reviews with the COVID-19 vaccine, more and more companies are expected to acquire the drug consignment manufacturing and sales business. Spikevax of Moderna Korea is the first domestic consignment production in the mRNA method among the approved COVID-19 vaccines in Korea. Samsung Biologics is receiving raw material drugs and producing them as finished drugs through various processes. In response, CEO Stéphane Bancel Moderna said, "The Moderna COVID-19 vaccine production partnership with Samsung Biologics is helping Moderna improve its production capacity outside the United States. Moderna will take the lead in ending the COVID-19 pandemic." John Lim, CEO of Samsung Biologics, also said, "Through rapid response and close cooperation between the national government and Moderna, the first product produced by Samsung Biologics to obtain permission for mRNA vaccine items in Korea has set another meaningful milestone."
- Policy
- The project to expand the age of NIP will be implemented
- by Lee, Jeong-Hwan Dec 14, 2021 05:58am
- The project to expand the age of free vaccination (NIP) against human papillomavirus (HPV) promised by President Moon Jae In will be implemented within the first quarter of next year. The KDCA plans to implement it immediately as soon as the notification revision process necessary for expanding the subject of HPV vaccine NIP is completed between January and March next year. In this case, free HPV vaccinations, which are currently applied only to girls aged 12, will be expanded to those aged 12 to 17, and low-income women aged 18 to 26 will also be able to benefit from free vaccinations. An official from the vaccination management department explained in a phone interview with Dailypharm on the 13th, "We are currently collecting expert opinions on the HPV vaccine NIP age expansion project and will proceed with the administrative notice process for the new year." President Moon Jae In promised to expand the free HPV vaccine, called cervical cancer prevention vaccine, to under the age of 17, in the process of directly responding to the public to mark the fourth anniversary of the national petition on August 19. President Moon said that women aged 18 to 26 would be vaccinated free of charge from low-income families and gradually expand the scope. The KDCA, the ministry in charge of vaccination, has taken follow-up measures after President Moon's promise to expand the HPV vaccine NIP. The KDCA succeeded in winning 21.5 billion won as a regular budget for next year by starting to secure the budget needed immediately to expand NIP. The KDCA is in the midst of establishing related guidelines and promotional materials and establishing a vaccination system with the aim of implementing the project in the first quarter of next year. All procedures were carried out after collecting opinions from experts, and the revision of the notice to expand the NIP was intended to be completed within January to March of the new year. From the time the revision of the notification is completed, the age of free HPV vaccination will be expanded, and free vaccination will not be retroactively applied if vaccinated before the revision of the notification. Vaccines included in the NIP are expected to be GSK Cervarix and tetravalent MSD Gardasil. MSD Gardasil 9, a 9-valent vaccine, has also obtained domestic approval, but has not yet been applied to the NIP program. The cervical cancer prevention vaccine has excellent preventive effects in adolescence without sexual contact and is known to maintain antibodies for about 30 years. Cervical cancer is evaluated as a 100% preventable carcinoma among currently known cancers. When the KDCA completes the revised notification of the expansion of HPV vaccine NIP targets early next year, the free vaccination age range will be significantly expanded from 12-year-old girls, but the number of additional vaccinations will not increase significantly immediately. The HPV vaccine has been applied with NIP since 2016, and girls born between 2003 and 2004 were the first subjects, as children in the age group to be expanded this time are eligible. In other words, among female teenagers aged 13 to 17, those who missed the past NIP vaccination period will be able to benefit. According to KDCA, the first vaccination rate for those born in 2003 in the first year of HPV vaccine NIP application was 61.5%, which allows female adolescents who have not been vaccinated so far to benefit. 72.6% of those born in 2004 and 87.2% of those born in 2018 have already received vaccines. A KDCA official said, "The expansion of the NIP age can be implemented only by revising the notice without revising the law." He said, "We will soon promote the expansion of the target age and implement it as a revision of the notification early next year."
- Policy
- Promotion of legislation to expand HPV vaccine NIP to boys
- by Lee, Jeong-Hwan Dec 14, 2021 05:57am
- Following the ruling party, the opposition party will also push for a bill to expand the NIP range of HPV (human papilloma virus) vaccines from girls to boys. Currently, the target of HPV vaccine NIP is 12-year-old girls, and the legislative goal is to prevent diseases caused by HPV such as cervical cancer by expanding them to "11-year-old and 12-year-old children" regardless of gender. On the 13th, Rep. Baek Jong-heon of the People Power Party announced that he had proposed a "partial amendment to the Infectious Disease Prevention and Management Act." Rep. Baek submitted the bill on the 8th. HPV is the main cause of cervical cancer, and the most effective way to prevent cervical cancer is HPV vaccination. Currently, the target of HPV vaccine NIP is limited to 12-year-old girls. However, it is pointed out that HPV infection can be infected by both men and women through sexual contact, so not only girls but also boys should be included in the vaccination list. Twenty out of 37 OECD countries, including the United States, Canada, and the United Kingdom, already include boys in the HPV vaccination list. Men's HPV vaccination is effective in preventing cervical cancer in women, and HPV causes male anal cancer, penis cancer, and mouth pharyngeal cancer in addition to cervical cancer in women, so men also need to be vaccinated. Rep. Baek Jong-heon proposed a bill to expand the HPV vaccine NIP to children aged 11 and 12 regardless of gender. It also included a clause that complements the limitations in responding to infectious diseases that are prevalent at certain times as mandatory vaccination infectious diseases are set every five years. Rep. Baek said, "Cervical cancer is the only preventable cancer because it spreads to the virus, and if it is completely prevented, it can be eradicated. I hope that Korea will become a country that has eradicated cervical cancer with the passage of the bill." The ruling party also proposed a bill similar to Baek's bill. Rep. Choi Hye-young of Democratic Party of Korea proposed a bill in November last year to expand the target of HPV vaccine NIP to "all children and adolescents under the age of 18." President Moon Jae In also promised to expand the age range of HPV vaccine NIP to female adolescents under the age of 17 to mark the fourth anniversary of the national petition.
- Policy
- A clinical study on CAR-T tx at SNUH has been approved
- by Kim, Jung-Ju Dec 14, 2021 05:56am
- A clinical study at Seoul National University Hospital for CART-T (Chimeric Antigen Recepter-T cell) treatment for pediatric leukemia patients was first approved. This is the first approval since the enforcement of the "The Act on the “Safety and Support of Advanced Regenerative Medical and Advanced Biopharmaceuticals” (hereinafter Advanced Bio Act)" in September last year. The MOHW (Minister Kwon Deok-cheol) and the MFDS (Minister Kim Kang-rip) announced on the 8th that the clinical research plan applied by Seoul National University Hospital (Professor Kang Hyung-jin) was approved as the first high-risk high-tech regenerative medical clinical study since the implementation of the "Advanced Bio Act." CAR-T is the introduction of a gene that combines the receptor site of immune cells (T cells) and the characteristic antigen recognition site of the cancer cell surface into the patient's T cells, which has the function of specifically recognizing and attacking the surface antigen of cancer cells. The clinical study applied by Professor Kang Hyung-jin's team this time is a phase 1b clinical study of CD19 chimeric antigen receptor T cells (SNUH-CD19-CAR-T) produced by children and adolescents, which are recurrent or non-adaptive CD19-positive B cells acute lymphoid leukemia. This case is a "clinical study with uncertain or high risk of impact on human life and health (Article 2, Item 3 (a) of the Advanced Regenerative Bio Act), and high-risk clinical studies require detailed examination of safety and effectiveness as they can be treated in innovative ways different from previous treatments. In the case of high-risk clinical studies, clinical research plans can be conducted after being approved by the Minister of Food and Drug Safety after deliberation by the Advanced Regenerative Medicine and Advanced Biopharmaceutical Review Committee under the Advanced Regeneration Bio Act. Considering that this is the first high-risk clinical study, the deliberation committee and the MFDS thoroughly verified research capabilities, protection of research subjects, safety and effectiveness, and completed approval of the committee's results under the Advanced Regeneration Bio Act. The approved clinical study aims to treat patients with acute lymphocytic leukemia in children and adolescents using CAR-T. Patients with acute lymphocyte leukemia in children and adolescents have been treated with chemotherapy, but in the case of recurrent and non-adaptive patients, leukemia cells did not decrease with existing treatments, so there was a limit to leukemia treatment. It is the principle of attacking cells that proliferate at an excessively high rate, and it simultaneously attacks existing proliferating cells (bone marrow, mucous membrane, hair, etc.) as well as cancer cells that proliferate rapidly. Treatment using CAR-T is expected to minimize damage to normal cells in the body while accurately targeting only cancer cells, increasing the therapeutic effect, and minimizing the side effects of existing treatments. We will do our best to promote the regenerative medical field through related projects such as clinical research funding projects and pan-ministerial regenerative medical technology development projects, said Kim Young-hak, head of the regenerative medical policy department.
- Policy
- 241 items of the impurity detected Losartan were recovered
- by Lee, Tak-Sun Dec 14, 2021 05:56am
- Azido impurities are detected in Losartan, HTN treatment , and all 241 items are recovered, and only some manufacturing numbers of 54 items are recovered. However, 11 items are sold as they are because impurities are not detected excessively. The MFDS explained that the risk of harm to the human body is very low, but in the case of patients, it is possible to exchange products, be re-prescribed, and be re-dispensed. It has been decided that Hanmi Pharmaceutical products can be sold. The MFDS announced on the 7th that as a result of a safety survey on impurities in the middle of the drug containing Lozartan, which is a treatment for hypertension, the daily intake allowance (1.7~88.7㎍) was exceeded (1.5㎍/day), but concerns about human harm were very low. This impurity is an Azido impurity that occurs specifically in Losartan, and its mutagenicity (genetic mutation-causing property) has been confirmed and carcinogenicity has not been confirmed. It is explained that the impurities of the Losartan product are different from the impurities AZBT identified among Sartan products in September, and the safety survey was conducted according to the safety information of medicines such as overseas recovery. As a result of the safety survey, all or some lot number products of 295 items (98 companies) that are feared to exceed or exceed the daily intake allowance of Losartan impurities out of 306 items (99 companies) in circulation are voluntarily recovered by pharmaceutical companies. It is voluntarily being recovered from the pharmaceutical company. However, the MFDS confirmed that all or some of the 65 items (23 products) are within the daily intake allowance, and from December 1, only products with less than the allowable amount of Losartan impurities have been shipped. Patients taking Losartan should not stop taking it arbitrarily, but should decide whether to continue taking it after consulting with a doctor or pharmacist. It is explained that if necessary, it can be ▲exchanged for a different manufacturing number ▲ or re-prescribed and re-dispensed with another product. The MFDS consulted the Central Pharmaceutical Review Committee to set the daily intake of Azido impurities, and applied the International Guidelines (ICHM7) in the pharmaceutical sector to set it at 1.5//day. ICHM7 sets a "negligible level" as a daily intake allowance for mutagenic impurities that have not been confirmed to be carcinogenic when consumed daily for life (70 years). As a result of evaluating the health effects of most patients who took Losartan, which daily intake allowance of Losartan impurities was excessively detected, it was found that 0.54 out of 100,000 people had a very low possibility of developing additional cancer, which was negligible. It is explained that the human impact assessment of patients taking excess impurities detection products of Losartan was conducted according to ICHM7 by comprehensively considering ▲ the HIRA's prescription data for the past six years ▲ the maximum dose per day ▲ impurity test results. The MFDS stressed that patients prescribed the product should not arbitrarily stop taking drugs because taking Losartan, which exceeds the daily intake of impurities, has little impact on health. However, patients with health concerns visited the hospital where the drug was prescribed and asked the medical staff to consult whether they were taking the drug and the need to re-prescribe it. They can be exchanged for another lot number by visiting a pharmacy they previously prepared without visiting a medical institution, and patients wishing to re-prescribe can be re-prescribed and re-dispensed with other hypertension treatments. In the case of re-prescribing, re-dispensing, or exchanging medicines at hospitals, clinics, or pharmacies that have previously been prescribed or dispensed, patient compensation is exempted only once for the first time. It will support the use of the health insurance claim system for smooth cost settlement between nursing institutions and pharmaceutical companies. An official from the MFDS emphasized, "We will continue to strictly manage only Losartan, which is less than the daily intake allowance, to supply safe and effective high-quality medicines based on scientific knowledge and regulatory expertise."
- Policy
- Phase III for Amivantamab-Lazertinib was approved
- by Lee, Tak-Sun Dec 13, 2021 05:57am
- Leclaza (Lazertinib), a non-small cell lung cancer tx by YuhanLazertinib was exported to Janssen in 2018 worth 1.4 trillion won. Janssen is attempting to overcome existing treatments through the combination of its developed non-small cell lung cancer treatment "Amivantamab (Rybrevant)" and Lazertinib. The MFDS approved a phase 3 clinical trial plan for "JNJ-61186372" applied by Janssen Korea on the 10th. This clinical trial is the second phase 3 combination therapy of Amivantamab-Lazertinib in Korea. This test is a phase 3, label disclosure, and randomized clinical trial comparing platinum-based chemotherapy and combination therapy of Amivantamab and Lazertinib in clinical trial subjects with EGFR-mutagenic or metastatic non-small cell lung cancer that failed Tagrisso treatment. Tagrisso is a third-generation EGFR (Oral Epithelial Cell Growth Factor Acceptance)-TKI (Tyrrosine Inhibitor) such as Leclaza, and is the latest drug and widely used in the non-small cell lung cancer treatment market. Based on IQVIA, Tagrisso's 2020 sales alone amounted to 106.4 billion won. Janssen is developing combination therapy between Amivantamab and Lazertinib as a competitive drug for Tagrisso. In September last year, phase 3 comparative clinical trials with Osimertinib or Lazertinib were approved by the MFDS as the primary treatment for clinical trial subjects with EGFR mutant local progressive or metastatic non-small cell lung cancer. Leclaza, which was approved in Korea in January, was released by Yuhan in July. It recorded 1.5 billion won in sales in the third quarter of last year based on IQVIA. Janssen's Amivantamab is also known to be under review by the MFDS, and is expected to obtain domestic approval soon. This drug is attracting attention as a treatment for MET mutations in non-small cell carcinoma patients. In May, it was approved by the U.S. FDA as an indication to block EGFR and MET mutations at the same time. If the combination therapy of Amivantamab and Lazertinib is recognized for its efficacy and successfully commercialized, it is expected to lead to a rise in the global value of Lazertinib. Developer Yuhan Corporation can also expect royalties revenue.
- Policy
- MFDS is considering changing the permission of Remdesivir
- by Lee, Tak-Sun Dec 13, 2021 05:56am
- Attention is focusing on whether COVID-19 treatment Veklury (Remdesivir) will be officially approved. In July last year, Veklury of Gilead Science Korea was conditionally licensed based on non-clinical test literature and interim clinical trial analysis results. At that time, the MFDS quickly approved the final results of clinical trials, some GMP data, and additional risk mitigation measures on the market. According to the industry on the 9th, Veklury submitted data that satisfies the conditions granted at the time of approval to the MFDS and applied for permission to change. On the 7th, an advisory meeting of the Central Pharmaceutical Affairs Council was also held. For now, there is a high possibility of Veklury's permission to change. The U.S. FDA officially approved Remdesivir in October last year. In a clinical trial conducted on 1,062 COVID-19 patients in the United States, the Remdesivir-treated group showed 10 days to recover, and the placebo-treated group showed 15 days, indicating that it was effective in shortening treatment time. However, the WHO announced that Remdesivir was not effective, sparking controversy. In October last year, the WHO reported that in a large-scale clinical trial, Remdesivir was found to have little or no effect in overall mortality, hospitalization period, and need for ventilation. In a small clinical trial released in July this year, Remdesivir drew attention by saying that it had no antiviral effect. In Korea, researchers at 20 university hospitals led by Professor Baek Kyung-ran of Infectious Diseases at Samsung Medical Center earlier this year announced the results of clinical effects. As a result of the analysis of 110 patients, 22.9% of the Remdesivir dosing group deteriorated enough to apply mechanical respiration as of the 28th day of hospitalization, lower than that of other treatment groups (44.7%). Based on this, some argued that Remdesivir should be administered early to severely ill COVID-19 patients. In Korea, Remdesivir and Dexamethasone, which controls immune response inflammation, are used in combination for severely ill patients who are hospitalized and treated. According to Central Disease Control Headquaters, Veklury was administered to 172 hospitals and 22,571 patients by the 3rd. Currently, only Remdesivir and Celltrion's Regkirona are approved treatments for COVID-19. Regkirona is being used to treat mildly high-risk COVID-19 and all secondary adult patients with permission to change. Currently, the MFDS is reviewing the EUA, Merck's oral treatment, and Pfizer's products are also being reviewed in advance before the approval review. Remdesivir is needed until a treatment that shows a definite effect is released. Attention is focusing on whether the controversy over the efficacy will disappear through this review of the change permit.
- Policy
- Janssen Korea voluntarily withdrew Tylenol 500mg
- by Lee, Tak-Sun Dec 10, 2021 05:51am
- It is known that the item license for Janssen Korea's antipyretic analgesic "Tylenol 500mg" will be withdrawn soon. This was expected to some extent because the Hyangnam plant will be shut down at the end of this year. Janssen has already been approved for imported items with the same ingredients and the same dosage. According to the MFDS on the 9th, Janssen Korea expressed its intention to withdraw "Tylenol 500mg," which was approved in Korea in 2001. This product has been manufactured at Janssen Korea's domestic factory (Hyangnam). However, as Janssen announced that the Hyangnam plant will be shut down this year, related manufacturing items are also undergoing withdrawal procedures. Janssen's Hyangnam plant was acquired by Whanin Pharmaceutical for about 46 billion won in November last year, and it was decided to withdraw from Korea for the first time in 38 years. In preparation for the withdrawal of the item, Janssen has already been approved for imported items with the same ingredient (Acetaminophen) in August. The product name is Janssen Acetaminophen. This product is expected to replace 500 mg of Tylenol, which is suspended from manufacturing in Korea. Janssen is known to have put in a large number of inventory items this year as demand for "Tylenol 500mg" surged to ease the break from COVID-19 vaccination. Tylenol recorded cumulative sales of 50.1 billion won in the third quarter of this year based on IQVIA, showing a whopping 177% year-on-year growth. In particular, the demand for Tylenol is likely to increase as the number of COVID-19 confirmed cases has soared recently and new and additional vaccinations are expected to increase as vaccine passes are implemented. Janssen is expected to make the most of the inventory items manufactured at the Hyangnam plant, but to hurry to introduce imported items. Until now, it has been found that there is no shortage of Tylenol inventory on the market.
