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- 2026-04-17 06:15:02
- Policy
- Asan Medical Center to test Kaletra's effect on COVID-19
- by Lee, Tak-Sun Mar 24, 2020 05:19am
- An investigator-sponsored trial (IST) in Korea is in preparation to confirm efficacy of Kaletra and hydroxychloroquine in patients with mild case of COVID-19. On Mar. 20, Korea’s Ministry of Food and Drug Safety (MFDS) has granted an approval on an IST protocol submitted by Seoul Asan Medical Center. The protocol is on open-label, randomized controlled clinical trial among AbbVie’s HIV treatment Kaletra tablet (lopinavir and ritonavir), Elyson Pharm’s malaria treatment Oxiklorin tablet (hydroxychloroquine sulfate) and placebo in patients with mild case of COVID-19 infection. The two drugs are already used in the medical field to treat patients with COVID-19, but the trial is to properly confirm safety and efficacy of those drugs. Central Institutional Review Board (Central IRB) presented COVID-19 treatment guidance on Feb. 13 and recommended using two tablets of Kaletra twice-daily, or 400 mg of hydroxychloroquine as a first-line treatment. However, the medical experts started claiming Kaletra’s efficacy on COVID-19 should be tested as some overseas studies could not confirm the treatment effect. Researchers from Chinese clinical trial centers and University of Oxford, the U.K., have co-conducted a randomized, controlled, open-label trial in 199 confirmed cases of COVID-19 in China, and found 99 patients who received Kaletra and standard of care simultaneously and 100 patients who only received standard of care showed no meaningful difference. Mortality rate for the Kaletra group was at 19.2 percent, whereas the standard-care group was at 25.0 percent. Although there was a gap, statistically speaking the gap was insignificant. Hydroxychloroquine has been controversial recently as the U.S. President Donald Trump has said on Mar. 19 that it received Food and Drug Administration’s (FDA) approval as a COVID-19 treatment, but FDA official soon clarified it was an incorrect information.
- Company
- Multinational Pharmaceuticals, COVID-19 Relief Goods
- by Eo, Yun-Ho Mar 24, 2020 05:19am
- Multinational pharmaceutical companies make donations to overcome COVID-19 crisis. According to the related industry, Korean corporations from multinational pharmaceutical companies such as Novartis, Mundipharma, Bayer, and Ferring, including the Korean Research-based Pharma Industry Association (KRPIA), have supported donations and relief supplies this month (March). Novartis recently donated 30,000 masks to the vulnerable. For the vulnerable people who are having difficulties in supply and demand, the company has delivered masks supported by the global headquarters to the KOREA PHS. The KOREA PHS is sponsoring educational and social welfare organizations approved by the MOEL, and are carrying out various sponsorship projects for the health and safety of the vulnerable to overcome this situation. On the 18th, Mundipharma donated a sanitary product kit to overcome COVID-19 crisis to the Seoul branch of the KACCC. Hygiene kits have been prepared to help personal hygiene management, such as washing hands of children and adolescents, in a situation where it is difficult to secure a quantity due to the recent increase in demand for hygiene products. the KACCC is a non-profit organization that provides integrated education and social welfare services to help children and adolescents in need of social care throughout the country enjoy a safe and happy life. Hygiene products will be delivered to each child center in the Seoul area and will be provided to children in need. Pharmaceutical companiesIn the case of Bayer, opinions were collected for each division. The company's contrast agent’s business division supported 280 contrast agents worth ￦13 million for chest coronary augmentation in severe COVID-19 infected patients through the Korean Open Doctors Society composed of medical workers. In addition, Bayer Healthcare recently provided 500 Redoxon vitamins to the Wolseong Social Welfare Center to support overcoming COVID-19 crisis in the Daegu region, which is struggling with the massive spread of COVID-19. Ferring Pharmaceuticals purchased 2,000 hand sanitizers and 200 protective clothing as donations from employees who voluntarily raised them, and donated them to the Daegu Metropolitan City Office's Disaster Safety Response Headquarters on the 5th. This donation started with the suggestion of one employee, and the purpose was to help the Daegu and Gyeongbuk areas, which suffered the most from the COVID-19 crisis. The KRPIA, a representative organization of multinational pharmaceutical companies, decided to donate ￦100 million to the Korean Red Cross so that they could be used at the COVID-19 quarantine site. Individual donations of pharmaceutical's employees are also conducted. If employees participate in a small fundraising, the KRPIA will add donations to the matching fund. The donations are sent to the Senior Citizens Support Center for Living Alone, which is affiliated with the Ministry of Health and Welfare, and are used to purchase emergency kits for food and beverages and supplies for health aids to the elderly living alone in vulnerable groups, including Daegu and Gyeongbuk. Avi BenShoshan, President of the KRPIA said, "Global pharmaceutical companies, as part of the Korean society, will strive to contribute to the efforts of various local communities to overcome COVID-19. We will accelerate our R&D activities to develop vaccines and therapeutics that are our duties".
- Policy
- DNA vaccine for COVID-19, what are the complications?
- by Lee, Tak-Sun Mar 24, 2020 05:19am
- As the U.S. and China have initiated their clinical trials on COVID-19 vaccines, the public is keen on when Korea would start its vaccine commercialization process. The vaccine currently in the clinical trial phase is a DNA vaccine. The type of vaccine is developed by artificially replicating a part of infectious agent, which makes the development process relatively easier with ensured safety. But because no DNA vaccine has been commercialized for human so far, demonstrating its efficacy would be the crucial key. According to the industry on Mar. 20, the Korean government is in process of discussing with pharmaceutical companies about initiating a COVID-19 vaccine clinical trial. And DNA vaccine is showing the fastest progress at the moment. Among all candidates, a DNA vaccine named ‘GX-19’ seems to be the most likely candidate. Genexine has recently partnered with BINEX, a clinical pharmaceutical CMO, to develop a vaccine. GenNBio, a transplantation specialist company, would be in charge of non-clinical trial in primates to confirm efficacy and safety. The consortium of these companies is aiming to submit the Investigational New Drug (IND) in coming June. The Ministry of Food and Drug Safety (MFDS) plans to expedite the review on the submitted IND. The key is the vaccine’s proven efficacy. MFDS stated sufficient data set is required for an expedited IND review. “Prophylaxis against COVID-19 has to be proven in animal trial or at least in a laboratory setting. Because a vaccine has to be used on human, its efficacy and safety has to be confirmed even before running a full-on clinical trial,” MFDS official said. Apparently, DNA vaccine’s prophylaxis has been confirmed against MERS, another type of coronavirus. However, MFDS explains there has not been data confirming the prophylaxis of the vaccine against COVID-19. Due to the ministry’s requirement, some are skeptical that the clinical trial would start around June or July as planned. The U.S. and China are also accelerating the DNA vaccine development. In the U.S., Moderna Therapeutics’ DNA vaccine, ‘mRNA-1273,’ started its clinical trial from Mar. 16. The U.S.-based company is shooting for commercialization in June 2021. The Chinese state broadcaster CCTV reported Major General Chen Wei’s research team, associated under the Academy of Military Medical Sciences (AMMS), has been approved to conduct a clinical trial on their investigational vaccine. Sources report Major General Chen Wei’s research team has an experience in developing an Ebola vaccine, and both of their Ebola and COVID-19 vaccines are based on DNA. Although the two investigational vaccines’ had their clinical protocols approved through fast-track review with minimized animal testing, the public is raising issues with safety. Sources reported the Korean health authority has not received any inquiry about a clinical trial on Moderna’s or Major General Chen Wei team’s vaccines. The generic style of vaccine development takes longer time than artificially made DNA vaccine, as it has to cultivate a natural form of either virus of cell. However, pharmaceutical companies and health authorities around the world are conservative about conducting clinical trial on DNA vaccine against COVID-19 as not many cases of the vaccine type have been commercialized. Korea’s top vaccine makers like GC Pharma and SK Bioscience have started a research on vaccine commercialization. SK Bioscience is working on developing protein-based subunit vaccine and viral vector vaccine. The Korean company is also in development of ‘vaccine platform’ that could prevent infection from MERS, SARS and COVID-19. GC Pharma has discovered candidate substance from protein found on the surface coronavirus, which the company would be able to mass-produce by using the generic recombinant technology. MFDS official said, “The ministry is having ongoing discussions not only with pharmaceutical companies, but also with ventures developing vaccines. Based on positive data of prophylaxis against COVID-19, the ministry would expedite the review process.”
- Policy
- Price of Roche's Herceptin 150mg (Trastuzumab) falls 8.1%
- by Kim, Jung-Ju Mar 24, 2020 05:18am
- Korea Roche's blockbuster anticancer drug Herceptin 150mg (Trastuzumab) is being added, and the insurance premium will be reduced by more than 8% starting next month. Nelson Pharm's Bedesta cream and Ahn-gook Pharm's Saerogenta cream fell 25.4% each due to governmental adjustment. There are a total of 23 drugs falling due to authority adjustment. AbbVie’s Synagis (Palivizumab) will be voluntarily cut of 1% for each content and item. According to a related industry on the 19th, the MOHW is promoting the revision of the 'pharmaceutical reimbursed list & the upper limit on reimbursements'. Once the revision is confirmed, it will take effect on April 1st. ◆Additional point maintenance and termination = Two items were determined to be maintained on the 1st of next month, and 1 item for items that have been closed. The government maintains additional points until the number of companies are more than 4, if one year has elapsed since the first generic was registered, but the number of companies with the same product is 3 or less. Generics that are listed after one year has elapsed from the first generic registration date are not added. First of all, Myungin Acamprosate 333mg Tablet is increased by 11.1% from ￦135 to ￦150. Whanin Acamprosate Tablet also rises 30.4% from ￦135 to ￦176. On the other hand, Roche's Herceptin 150mg (Trastuzumab) falls 8.1% from ￦394,298 to ￦362,340 after the addition period ends. ◆Authority adjustment and addition termination of authority adjustment items= 23 items of cuts in authority adjustment as of the 1st of next month, and 9 items that had been added were cut by the adjustment and then dropped again at the end of the addition. When the generic is registered, the government directly regulates the upper limit of the first listed product and the product with the same administration route, ingredients, and formulation as the first listed product. In addition, for the first year from the date the first generic was registered, the first listed product is added (or maintained) at 70%, and then the additional point is ended. However, even if one year has elapsed, if the number of companies with the same product is 3 or less, the addition is maintained until 4 or more. First, among the 23 items falling by the authority adjustment, Tronain cream 450g dropped by 12% from ￦22,500 to ￦19,800, and JW shinyak's Panaderm cream fell by 18.5% from ￦24,300 to ￦19,800. Nelson's Bedestar cream 450g fell 25.4% from ￦26,550 to ￦19,800, Bedestar cream 30g from ￦1,770 to ￦1,320, and Ahn-gook's Saerogenta cream from ￦26,550 to ￦19,800. Some products that have been added have dropped due to the adjustment, and some products have been dropped after the addition period has expired. CJ Healthcare’s Almarl 10mg tablet (Arotinolol HCl) from ￦320 to ￦280 from April 1st, Almarl 5mg from ￦207 to ￦182, 12.5% and 12.1%, respectively, will be reduced. As of March 1, next year, the addition will be over and Almarl 10mg will be dropped by ￦214 and Almarl 5mg will be dropped by 23.6% to ￦139 again. As of April 1, Hanmi Urea cream 50g fell from ￦2,495 to ￦2,157, and Hanmi Urea cream 450g from ￦22,472 to ￦19,412, by 13.5% and 13.6% respectively. It is lowered by adjustment, as of March 1, next year, Hanmi Urea cream 50g will be dropped from ￦2,157 to ￦1,650 again, and Hanmi Urea cream 450g will be dropped from ￦19,412 to ￦14,850, by 23.5%. ◆Voluntary price cut = 9 items in which the drug price goes down by the company itself. The government lowers the price by calculating the amount of the application if a manufacturer, consignment manufacturer, seller or importer applies for a lower price at an amount lower than the upper limit of the drug registered in the company's circumstances such as marketing or market share By each item, AbbVie Korea’s Synagis inj fall by 1% by content. For the item, Synagis 50mg will be cut from ￦541,531 to ￦536,116. Synagis 100mg drops from ￦932,996 to ￦923,666 respectively. Hyundai's Uremin 0.1mg (Desmopressin acetate) falls 0.8% from ￦735 to ￦729, and Uremin 0.2mg falls 0.5% from ￦1,136 to ￦1,130. ◆Make up for cost of shortage prevention drugs= 2 items are designated as shortage prevention drugs for cost preservation and 3 items that increase the price. The government has designated drugs that are essential for patient care, but do not have payability, so manufacturers, consignment manufacturers, and importers avoid production or imports and require production or import cost preservation as shortage prevention drugs to conserve costs. Shortage prevention drugs are determined in accordance with the criteria such as: ▲Designation of cost preservation ▲ Adjustment of the upper limit of production cost preservation items ▲ Designation of cost preservation and adjustment of upper limit. First, the production cost preservation items are SK Plasma’s Hepabulin SN (for intravenous hepatitis B human immunoglobulin) and Hepabig inj by Green Cross (for intravenous hepatitis B human immunoglobulin). There are two drugs that raise the upper limit as a production cost preservation item. Celltrion Oxymetholone’s price is raised 20.7% from ￦588 to ￦710 next month. Yuyu ‘s Lincocin 500mg capsule (Lincomycin HCl) will be increased by 13.6% from ￦184 to ￦209. Some drugs are designated as cost-preserving products and have an upper limit. Bukwang's Holoxan 1000mg (Ifosfamide) is raised by 28.5% from ￦12,275 to ￦ 15,779.
- Company
- Listed ovarian anticancer Zejula applies for new indications
- by Eo, Yun-Ho Mar 23, 2020 06:28am
- PARP inhibitor Zejula Anticancer treatment Zejula, listed for pharmaceutical reimbursement last year, is now preparing for expanded label. According to related industry on Mar. 23, Takeda Pharmaceuticals Korea has recently submitted an application to expand reimbursement on DNA repairing Poly ADP-ribose Polymerase (PARP) inhibitor Zejula (niraparib). The anticancer treatment is targeting two additional indications; monotherapy for the maintenance treatment of BRCA-negative patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy; and monotherapy to treat relapsed ovarian cancer after receiving third or later-line chemotherapy. Zejula is the first PARP inhibitor, used regardless of BRCA, indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian (fallopian tube or primary peritoneal cancer), who are in response (complete or partial) to platinum-based chemotherapy in Korea last March. Although it was listed for reimbursement last December, the first reimbursement standard is limited to patients with BRCA mutation. However, in major clinical studies, Zejula has demonstrated outstanding improvement on median Progression-Free Survival (mPFS) against placebo. For the fourth-line treatment indication was based on mutlicenter, open-label QUADRA study in adult patients with ovarian cancer, who have received third or later-line treatment. During the clinical study, Zejula demonstrated clinical efficacy with an object response rate (ORR), a primary efficacy endpoint. The patient group with platinum-sensitive homologous repair deficiency (HRD) demonstrated ORR of 24 percent, where as BRCA-positive platinum-sensitive group, BRCA-positive platinum-resistant group and BRCA-positive platinum-refractory group recorded ORR of 39 percent, 29 percent and 19 percent, respectively. And median duration of response (mDOR), a secondary efficacy endpoint, of Zejula was 8.3 months for platinum-sensitive HRD patient group. The study concluded the treatment’s safety profile can be adequately managed with adjusted dosage. Zejula was listed for reimbursement at a price of 76,400 won. The Korean health authority evaluated the treatment is more cost-efficient than AstraZeneca’s Lynparza (olaparib). But because Lynparza was listed with risk sharing agreement (RSA) and pharmacoeconomic evaluation-exemption track, the identical expenditure cap RSA was applied on Zejula as well.
- Policy
- Neutropenia is common in children when taking Entecavir
- by Lee, Tak-Sun Mar 23, 2020 06:27am
- Baraclude (Generic: Entecavir)The MFDS has begun to change the license because there have been reports of Neutropenia in pediatric clinical trials of Entecavir, one of hepatitis B treatment. Neutrophils are a type of white blood cells that are granulocytes responsible for the body's immunity. The MFDS announced on the 20th that it is reported that Neutropenia is very common (1 out of 10) in pediatric subjects' clinical trials in Entecavir formulations, and that they are listening to opinions from companies according to the permission change. The safety information came from the European Agency for Medicine (EMA). Based on the information, the Ministry of Food and Drug Safety plans to add to the item of 'extreme adverse reactions-Neutropenia reported very frequently (≥1 / 10)' in pediatric subjects. The pediatric clinical trial indicated in the permit was 195 HBeAg-positive subjects who were treated with this drug for a median duration of 99 weeks. Existing permits included "The adverse drug reactions reported in more than 1% of pediatric subjects included abdominal pain, rash, poor taste, nausea, diarrhea, and vomiting". It is added that "very common (≥1/10) neutrophil reductions have been reported". Entecavir is the most commonly prescribed drug with Tenofovir among hepatitis B treatments. Baraclude by BMS, the original drug for Entecavir, recorded an outpatient prescription amount of ￦71.4 billion last year (Source:UBIST). There are also a number of generic drugs on the market, and 128 items (of 63 companies) are currently licensed. The MFDS instructed related companies to submit the reason and supporting data if there was a review opinion by the related companies by April 6th.
- Company
- Chong Kun Dang co-market Xofluza with Roche
- by Chon, Seung-Hyun Mar 23, 2020 06:27am
- Chong Kun Dang announced on the 19th that it recently signed a joint sales contract with Roche Korea for domestic distribution of the influenza treatment drug 'Xofluza'. Xofluza by RocheRoche Korea and Chong Kun Dang jointly handle marketing and sales of Xofluza, and Chong Kun Dang is responsible for distribution. Xofluza is a drug used to treat influenza virus A/B infection in adolescents and adults over 12 years of age. This product has attracted attention as a new antiviral drug with a new mechanism of action developed after about 20 years since Tamiflu. Unlike conventional oral influenza treatments, which had to be administered for 5 days, Xofluza improved medication convenience so that it could be treated with only one dose. After taking it, it is evaluated that the symptom relief rate is fast and the time to stop the influenza virus detection is shortened. Nic Horridge, President of Roche Korea, said, "Xofluza is an influenza treatment with a new mechanism of action that suppresses the replication of influenza viruses. It has the convenience of a single dose. In cooperation with Chong Kun Dang, who has expertise in sales and marketing, we will present solutions to treatment areas that the existing antiviral drugs have not met and contribute to the promotion of public health”. President Young-ju Kim of Chong Kun Dang said, “We have continued to cooperate with Roche Korea in 2012 by jointly selling Tamiflu for the treatment of influenza. It is expected that this agreement will further strengthen cooperation between the two companies and show synergy”.
- Policy
- IMD Vildagle to receive reimbursed price of KRW 403
- by Kim, Jung-Ju Mar 23, 2020 06:27am
- Hanmi Pharmaceutical’s dipeptidyl peptidase-4 (DPP-4) inhibiting diabetic treatment Vildagle 50 mg tablet (vildagliptin hydrochloride) would receive health insurance reimbursement from next month. The treatment is an incrementally modified drug (IMD) of Galvus tablet (vildagliptin) that evaded the original’s patent, and it would be listed at a price range of 400 won per tablet. The reimbursed price of Boryung Pharmaceutical’s Pacitol injection (paricalcitol) would be dropped by over 21 percent when its premium pricing period ends in March last year. According to the pharmaceutical industry on Mar. 18, Korea’s Ministry of Health and Welfare (MOHW) is in process of amending the ‘List of Reimbursed Drugs and Maximum Price’ with the said changes. The revision would come in effect from Apr. 1. ◆ Drug listed with maximum price of target product profile (TPP): Hanmi Pharmaceutical’s Vildagle 50 mg tablet would receive reimbursement from next month. Unlike the original Galvus, the IMD has hydrochloride base other than the active ingredient vildagliptin, which was the key to evade the patent. And apparently the IMD has one less indication than the original of ‘using combination therapy when blood sugar level is uncontrollable with sulfonylureas, metformin or thiazolidinediones monotherapy.’ As the drug is on condition to submit evidential data, the ministry is predicted to price the drug at 403 won, or at 90 percent of the TPP. In case the TPP or same-substance drug is not on the list of reimbursed drug, the drugs to submit evidential data but approved as an IMD or as a new formulation would be priced at 90 percent of the TPP. ◆ License-withdrawn items: From next month, total 29 items would be unlisted for reimbursement with their companies voluntarily withdrawing the item license. According to the Pharmaceutical Affairs Act, MOHW is to immediately remove reimbursement on a listed drug which the license is voluntarily returning by its company to Ministry of Food and Drug Safety due to an internal issue. Pharmaceutical companies choose to terminate license on an items as a survival strategy, or for sales or marketability issues. Some of them include Leucokain injection by CJ HealthCare, Montelu V tablet by LG Chem, Solifenocil tablet by Mothers Pharm and Daviroad tablet by GC Pharma. ◆ Pricing reduction after pricing benefit period: The pricing reduction rate for first generics, currently priced with weighted pricing benefit for a year, has been calculated. One of the big names is Boryung Pharmaceutical’s Pacitol injection (paricalcitol). Its price would be adjusted to 53.55 percent of the first-in-class, and it would maintain the price of 15,309 won for one year, until Mar. 31 next year, with the pricing benefit for the Innovative Pharmaceutical Company added. However, the government sustains the pricing benefit until the number of same-substance generic makers is three or less. From Apr. 1 next year, the drug would be priced at 12,056 won with 21.2 percent drop. The pricing benefit on DHP Korea’s Bromonac eye drops (bromfenac sodium hydrate) would also be stripped off from Dec. 31, and its price would be reduced from the beginning of next year. The drug receives weighted pricing of 59.5 percent of the original’s price for a year from the point when the first generic is listed. The pricing benefit would be maintained until the number of same-substance generic makers is three or less. After the pricing benefit period, the eye drop’s price would fall from 1,829 won to 1,646 won by 10 percent. Eight other drugs’ pricing would be lowered by 10 percent when the benefit period expires. These drugs receive pricing benefit of 59.5 percent of the maximum price for a year from the point when the first generic is listed. The benefit would last until the number of same-substance generic makers becomes four or more. The pricing benefit on KMS Pharm’s Elqueenxaban would be dropped from May 31, and the benefits on Union Korea’s Union Rasagiline, Korea Prime Pharm’s Rasat, Korea Pharma’s Pharma Rasagiline, Celltrion’s Cellpaline would be expired from Jan. 31 next year. From then on, their pricing would be reduced by 10 percent.
- Policy
- Revised generic reimbursement regulation to get delayed
- by Lee, Hye-Kyung Mar 23, 2020 06:27am
- Apparently, the postponed action plan on the revised reimbursed generic pricing management, covering all procedures of the listing, would also likely to affect drug pricing negotiation schedule. As the Korea’s Ministry of Health and Welfare (MOHW) is preoccupied with response against COVID-19 outbreak and the main division director’s position still open, the preannouncement of revising ‘Regulation on National Health Insurance Reimbursement Standard’ is getting delayed. The National Health Insurance Service (NHIS), in charge of drug pricing negotiation, has been processing the legislative preannouncement with the government to apply the pricing negotiation terms, previously used on new drug and price-volume linkage system, on generic products as well. A draft of the preannouncement briefly posted on the Ministry of Government Legislation website in February stipulated generic exempted from pricing negotiation for reimbursement listing would be subjected to pricing negotiation track. A pharmaceutical company with generic product has to undertake pre-agreement terms with NHIS on negotiation and agreement compliance when applying for reimbursement to Health Insurance Review and Assessment Service (HIRA). When HIRA completes drug pricing calculation, the applicant company has to negotiate pricing with NHIS for 60 days before the Health Insurance Policy Deliberation Committee (HIPDC) deliberation. The initial plan was to pre-announce the revised regulation and to accept public opinion from February to April, and to start the pricing negation from June. As the negotiation takes at least about 60 days, NHIS had to create a legal foundation before the revised generic pricing system was enforced. However, NHIS’ plan to initiate the generic pricing negotiation by the end of June would be postponed as the legislative preannouncement has not been issued, yet. The NHIS’ key roadmap of the year originally aimed to finish off designing generic negotiation agreement and compliance management task process until coming May with the Generic Negotiation Management Task Force formed under NHIS Health Benefit Strategy Office in January, and also to start drug pricing negotiation and negotiation agreement compliance monitoring in June and July, respectively.
- Why rapid diagnostic kit for COVID-19 is not used in korea?
- by 박상준 Mar 23, 2020 06:27am
- “The current diagnosis method of COVID-19 is as if there are two diagnostic methods, MRI and X-ray, and it is said to use only MRI. Even when it takes a lot of time and money”. This is a metaphor for the reality that the Korea Small and Medium Hospital Association's Chairman Sang-il Kim (President H Plus Yangji Hospital), which is currently applying limited diagnostic methods in the COVID-19 crisis. #The KSMHA invited five in-vitro diagnostics companies from the meeting room of the Korean Hospital Association on the afternoon of the 17th to discuss the exploration of the rapid test method in addition to the rt-PCR, a diagnosis method for suspected COVID-19. The key point of the meeting was focused on how long the time-consuming and expensive rt-PCR diagnosis maintain when COVID-19 crisis dragged out for too long. Particularly, Sang-il Kim, the chairman of insurance committee, the KHA and Cheol-jun Kim (Daejeon Wellness Hospital), the chairman of the Policy Board, the Korean Medical Corporation Association emphasized the need for a faster and more efficient method of diagnosing COVID-19 at the medical site. The meeting was attended by Jeong-eun Lee, the vice president of Sugentech, Dong-jin Shin, the CEO of TCM bioScience, Min-jeon Lee, Access Bio’s Director, Yoon-suk Lee, Boditech , and Park Hee-kyung, the CEO of Seasun Biomaterial. What they are trying to say is to allow more suspicious patients to be tested by granting approval for rapid tests other than the diagnosis of COVID-19 through rt-PCR. According to the industry, at the beginning of COVID-19, the KCDC approved the use of rt-PCR methods of four bio-companies at the time of emergency use. Other types of methods were excluded. The introduction of the rt-PCR test in the early stages of COVID-19 was an appropriate measure, but these companies explained that as it has already spread to the community, it has become the stage to introduce an immune antibody test. Immuno-antibody tests was difficult to introduce in the early stages of infection spread, because the patient's sample (blood) is needed to evaluate the test results. However, as domestic sample data accumulates, it has been fully verified now. In addition, IgM (immunoglobulin M, antibody proteins, the first antibody produced during infection), IgG (immunoglobulin G, the last antibody remaining until the last infection) in 10 minutes with a single drop of blood While all possible, the cost is inexpensive than the existing rt-PCR test. In fact, China has already introduced an immune antibody test to confirm COVID-19, and the United States CDC also announced that it would seek a company capable of testing for immune antibodies. Overseas authorities are worried because there are no companies with the technology, but it is time to review the introduction at this time because there are domestic companies that have products with technology. Some companies have obtained European CE approval. #There are opinions that first-line medical institutions also need to allow additional examination methods that are suitable. Chairman kim said, "If dozens and hundreds of patients with underlying diseases in nursing homes have fever, they will not be accepted even if they are sent to an advanced hospital for an examination. The situation in which the number of cases spread without knowing the infection was inevitably increased because the COVID-19 test was not carried out on time". He said, "The problem is that we will not be able to stop school and religious activities for long time, and one day we will release the quarantine, I wonder if I can afford it with rt-PCR tests that require a lot of time and money. I think we need another screening method". His explanation is that it is not enough to mobilize all of the weapons to end the COVID-19, but the situation is limited to one weapon. Chairman Chul-jun Kim also said, "Some scholars are more anxious because they are predicting that the current spread of infection may be abated for a while and then soar again this fall. It is necessary to have a simple and efficient diagnostic kit product in preparation for prolongation". Among them, the companies are preparing for export permission as the domestic COVID-19 diagnostic method is receiving worldwide attention and orders are rushing. An official from a company attending the conference said, “With the global spread of COVID-19, orders are rushing to the point where overseas buyers want to receive products even for research purposes. While preparing to export abroad, I hope many people in Korea will benefit from it". In addition, Chairman Cheol-Joon Kim, who organized the meeting, said that he would go forward and continue to discuss the fundamental methods for resolving problems in the future and continue to discuss with government agencies in order to move to concrete implementation. "The rt-PCR test and the rapid immunodiagnosis have different complementary functions, and this is used for optimal diagnosis according to the patient's situation in the clinical field, so the two diagnostic methods will be complementary to each other in COVID-19 crisis for a long time", he said. He said, "In the current national emergency, we must take all possible measures to swiftly resolve the situation, to ensure patient safety, and to reduce the burden of medical expenses. I would like the government to make a quick review so that the rapid biomedical testing kits of domestic bio companies, which are rushing to be introduced worldwide, can be used in medical fields as soon as possible".
