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- 2026-04-16 13:02:51
- Company
- Next-gen Vemlidy prescription grows solely amid COVID-19
- by Kim, Jin-Gu Aug 03, 2020 11:06am
- Product image of Vemlidy The outpatient prescription sales of Gilead Science’s hepatitis B treatment Vemlidy (tenofovir) has gone up by 56 percent compared to the second quarter last year. Although the hepatitis B virus (HBV) infection treatment market size has shrunk amid COVID-19 pandemic, Vemlidy has performed at a satisfying level and salvaged the fall Viread took. ◆Vemlidy prescription volume leaps by 56 percent in a year According to pharmaceutical market research firm UBIST on Aug. 1, Vemlidy has made 6.6 billion won in the second quarter outpatient prescription. Compared to last year’s second quarter making 4.2 billion won, the figure grew by 56 percent. Vemlidy is a next generation HBV infection treatment Gilead Science has launched. It is an updated version of Viread, an existing blockbuster drug treating the infection. The two drugs share the same active pharmaceutical ingredient of tenofovir, but Vemlidy contains one-tenth of the substance. But its efficacy is on par with the existing drug and safety is improved. The novel drug was approved in May 2017. The prescription of the treatment took off from November of that year when it was listed. The prescription reached 7.4 billion won in 2018 and it grew up to 18.3 billion won last year, rightfully taking the title of blockbuster drug. In the first half of this year, the drug was already prescribed for over 10 billion won. Specifically, the prescription marked 12.5 billion won as of last June. Quarterly prescription volume of Viread, Baraclude and Vemlidy in last three years (Unit: KRW 100 million) Source: UBIST The prescription volume would rise even higher when the switch from Viread to Vemlidy, currently under discussion, is fully approved. Currently, the switch procedure is significantly complex according to the healthcare reimbursement standards. The coverage for the switched prescription is limited to patients developing tolerance, showing no reaction or demonstrating serious adverse reaction. The applicable adverse reaction is limited to patient showing estimated glomerular filtration rate (eGFR) less than 60ml/ min/ 1.73m2 and bone density T score lower than -2.5. Regardless, the medical professionals are arguing the standards are excessively tight. Basically, the switch is possible when a patient’s kidney fails completely. The issue was also addressed at last year’s National Assembly audit. The Ministry of Health and Welfare (MOHW) official said, “it would be reviewed when relevant guideline or literature are published overseas.” ◆Prescription dip in Baraclude by 13% and Viread by 28%, affected by COVID-19? Except for Vemlidy, most of the treatments experienced sharp fall in prescription volume. The top market leaders Viread and Baraclude (entecavir) have lost two-digit percent volume. From last year second quarter to this year second quarter, Gilead Science’s Viread prescription has plummeted by 28 percent from 30.6 billion won to 22 billion won. Bristol Myers Squibb’s (BMS) Baraclude prescription has also plunged by 13 percent from 20.2 billion won to 17.7 billion won. The research firm analyzes the COVID-19 pandemic has played a significant role in the rapid change. Due to the novel infectious disease, many patients avoided visiting the healthcare institute and naturally the prescription volume fell. Also the social distancing could have prevented the spreading of the HBV itself. Comparison of outpatient prescription volume of Baraclude generics (left) and Viread generics in second quarters of 2019 and 2020 (Unit: KRW 100 million) Source: UBIST The generics of Viread and Baraclude had mixed outcome. Baraclude generics took a fall in prescription volume, but Viread generics had a surge. The 20 Baraclude generics’ overall prescription volume fell by 10 percent from 8.2 billion won to 7.4 billion won. Dong-A ST’s Baracle was prescribed the most raising 2.2 billion won, followed by Bukwang Pharm’s Bukwang Entecavir (1.1 billion won), Samil Pharm’s Enped (1 billion won), Daewoong Pharmaceutical’s Baracross (500 million won) and Hanmi Pharmaceutical’s Cavir (500 million won). On the other hand, 18 Viread generics’ prescription volume has risen by 9 percent from 3.4 billion won to 3.7 billion won. Dong-A ST’s Virreal had a 45-percent surge from 600 million won to 900 million won. Following after Virreal, Chong Kun Dang’s Tenofobell (800 million won), Daewoong Pharmaceutical’s Virehepa (400 million won), Jeil Pharm’s Tecavir (300 million won) and Samjin Phrm’s Tenolid (300 million won) also had a positive growth in prescription over the year.
- Policy
- Recruitment of 733 COVID-19 cured patients was completed
- by Lee, Hye-Kyung Aug 03, 2020 11:06am
- 1098 patients who were cured revealed their willingness to participate in the development of COVID-19 blood plasma, of which 733 were recruited. At the regular briefing held on the 30th, Kwon Jun-wook, Deputy director of the Central Disease Control Headquarters said, “Recruitment of 733 plasma for cured patients was completed and recovery plasma collected from 6 medical institutions, apart from blood plasma treatment, were from 23 COVID-19 patients." In relation to reports from the foreign media that the duration of the COVID-19 vaccine will be limited to 1 year, he said, “In the case of DNA or mRNA vaccine, the immunity disappears quickly even if the immunity reaches a certain level after 2 doses. There are experts who argue that defense is possible to some extent by being stored in the so-called immunity of the so-called T cells, apart from the loss of immunity.” He said, “Depending on the platform of the four vaccines, the defense, level of defense, and persistence at the time of inoculation of each vaccine, and if it does not persist, whether or not additional vaccination should be given, such as influenza that must be continuously inoculated at regular intervals, it is a situation to do research and analysis." Regarding the point that vaccine development is being delayed while emphasizing stability unlike the United States, he said, “In the case of phase III clinical trials, it usually takes more than a year or two.” Kwon said, "One year, in some cases, in six months, and in some cases, in some countries, the practical use of the vaccine is mentioned even before phase III clinical trials." It is very likely that this is a temporary immunization of the consultation or through such an institutional procedure. In that case, safety is the biggest challenge, not to mention effectiveness.” There were 7 new COVID-9 confirmed patients in Korea, 11 cases of foreign inflows, and the total cumulative confirmed number was 14,269. Currently, 63 new quarantined patients were released and 837 are currently in quarantine.
- Policy
- The promotion for the KCDC are in progress
- by Lee, Jeong-Hwan Aug 03, 2020 11:05am
- On the 28th, the Public Administration and Security Committee held a general meeting without any member of the opposition party, and decided to amend the government organizational law, which included the introduction of multiple vice ministers by the MOHW and the promotion of the KCDC to the Disease Control and Prevention Service. As a result, multiple vice ministers and the promotion of the KCDC leave only the judicial review and review procedures of the Legislation & Judiciary Committee The core of this amendment is the introduction of multiple vice ministers including separate vice minister for health, to strengthen the expertise of the health service and to strengthen the ability to respond to new infectious diseases such as COVID-19 by promoting the KCDC to the Disease Control and Prevention Service. On this day, the Public Administration and Security Committee also decided to amend the Basic Act on Disaster and Safety Management, including expanding the scope and methods of financial support in relation to the COVID-19 economic crisis. The amendment contains provisions to indemnify public officials and employees of public and financial institutions for the consequences of aggressive administration in the financial support process. Members of the United Future Party objected and missed the meeting because the ruling party proposed without limitation the local tax exemption laws and government organization laws related to real estate.
- Product
- Successful August KMA strike all depends on participation
- by Kang, Shin-Kook Aug 03, 2020 11:05am
- The doctors’ organization objecting against the South Korean government intending to expand medical school admission and provide coverage on Korean herbal medicine are drawing up a plan to call a private clinic doctors’ strike. The strike is most likely to be on Aug. 14. According to Korean Medical Association (KMA) on July 29, the issue of calling an organized strike on Aug. 14 would be addressed at the general assembly on July 31 and the organization would publicly announce the result on Aug. 1. A press conference convened in front of the NA Hall on July 23 to reprimand medical school admission expansion. President Choi Dae-zip declared the organization would plan an all-out single-day strike on either Aug. 14 or 18. The board members from 16 cities and provinces across the country gathered for an emergency meeting and shared their opinions on the strike date. Apparently, the meeting convened in Osong city on July 25 had the majority of the opinions leaning towards Aug. 14. But the administration of the organization is concerned of worsening the public opinion with the general strike amid COVID-19. Besides, the regional doctors’ communities are questioning how to convince private clinic doctors when the expected outcome of the strike is unclear, regardless of their justifiable objection against the government policy. However, the KMA administration claims its recent survey on the organization members found that the organization has enough willpower to fight against the government action. Over 95 percent of the doctor members answered they are opposing against the government policy, and over 85 percent said they are willing to participate in a fight against the government policy like an all-out strike to correct the wrongful policy. Moreover, the specialists’ all-out strike to be conducted on Aug. 7 could catalyze the private clinic doctors’ strike. On July 23, the ruling party and the government have decided to gradually expand the medical school admission size from 400 students to 4,000 students through ten years time. Leverage by the super ruling party’s power, the Ministry of Health and Welfare (MOHW) held a meeting with the Health Insurance Policy Deliberation Committee (HIPDC) to swiftly push the plan of conducting a pilot program of granting coverage on Korean herbal medicine that requires budget of 50 billion won. For now, the only option KMA has to reprimand and stop the so-called ‘Four Unjust Policies’ including stipulation of remote medicine, medical school admission expansion, coverage on Korean herbal medicine and establishment of public medical school is an all-out strike. In a letter sent out to specialist doctors on July 29, President Choi Dae-zip stated “The true role of the KMA president is not to hide behind the organization but to lead the fight against wrongful government action in the frontline,” and “I ensure I will serve the role. So please, join the fight against the unjust law. Come together, as we must seize the madness of the government and ruling party constantly pouring out bad healthcare policies.”
- Company
- Generics for NOAC will be released
- by Kim, Jin-Gu Aug 02, 2020 09:47pm
- In the oral anticoagulant (NOAC) market, which forms a market of ₩200 billion annually, the prescription performance of items other than Lixiana has decreased. Generics are gradually increasing sales. The competition in this market is expected to intensify if generics for Xarelto and Pradaxa are released next to generic for Eliquis next year. ◆Lyxiana's sales increased 6% over the same period last year According to UBIST, a pharmaceutical market research agency on the 28th, the total amount of NOAC outpatient prescriptions in the second quarter reached ₩46 billion. This is a 2% increase compared to ₩45.1 billion in the second quarter of 2019. Changes in NOAC The overall prescription size rose slightly, but the prescription amount of most of the original items decreased. Only Daiichi Sankyo's Lixiana increased 6% from ₩15 billion to ₩15.9 billion during the same period. Bayer's Xarelto decreased 4% from ₩13bn to ₩12.5bn, and BMS’ Eliquis fell 3% from ₩12.5bn to ₩11.2bn. Beringer Ingelheim's Pradaxa fell 21% from ₩4.6 billion to ₩3.6 billion. In the case of Eliquis, it was dropped due to the release of generics, but the BMS applied for suspension through administrative action and the court accepted it, and the disposition was postponed. In the future, The amount of prescriptions may decrease depending on the outcome of the lawsuit in the future. Outpatient ◆Generic sales are on the rise while original prescription performance is slow As the growth of original products in the NOAC market has stagnated since the second quarter of last year, generics are gradually increasing their influence. Generic for Eliquis 2nd Quarter of Rx Results (Unit: ₩1 million, Data:UBIST)Currently, only generics for Eliquis has been released on the market. Starting with Chong Kun Dang and Yuhan in the second quarter of last year, 12 pharmaceutical companies are currently selling generics. In the overall NOAC market, generics' prescription increased from 0.1% in the second quarter of 2019 to 0.8% in the third quarter, 1.7% in the fourth quarter, 3.0% in the first quarter of 2020, and 4.0% in the second quarter of 2020. Among the generic items in the second quarter of this year, Liquixia ranked first with ₩500 million of prescription results. It was followed by Samjin's Elxaban (₩400 million), Yuhan's Apixaban (₩300 million), and Aju's Eliban (₩200 million). ◆Generic for Xarelto and Pradaxa waiting to be released… Intensifying competition from next year Next year, generic for Xarelto and Pradaxa are on the way. Competition is expected to intensify from next year, when the trial period ends. The launch of generic for Pradaxa is the first. Huons, Aju, Introbiopharma, and Jinyang will take the right to generic exclusivity after July 2021, when the material patent expires. After April 2022, when the trial period ended, other pharmaceutical companies could also compete. Currently, the remaining items approved by the MFDS are 12 items from 6 companies. Xarelto’s patent expires in October 2021. SK Chemicals and Hanmi won the right. The remaining 28 pharmaceutical companies will be able to launch products after July 2022. In the case of Lixiana, which is currently the No. 1 item on the market, The patent expires in November 2026. Boryung, Samjin, HK inno.N, Chong Kun Dang, Kolmar, Hutex, Kolmar Korea, and Hanmi, which have succeeded in patent avoidance, are expected to compete for the launch of first generic.
- Company
- Choline alfoscerate companies anxious of returning claims
- by Chon, Seung-Hyun Jul 31, 2020 06:34am
- Companies with cognitive enhancer choline alfoscerate products are to face another hurdle. Specifically, the companies are concerned of the clause stipulating the return of the claimed reimbursement when failing the clinical reevaluation during the pricing renegotiation for a product surging in sales. As South Korea’s Ministry of Food and Drug Safety’s (MFDS) clinical reevaluation process has been set, some companies are faced with marketing approval revocation and prescription sales return in the worst case scenario. According to pharmaceutical industry sources on July 30, the price-volume agreement (PVA) negotiation that National Health Insurance Service (NHIS) and pharmaceutical companies are to engage has included a number of choline alfoscerate generics. PVA allows an adjustment of pricing of a drug with a significant surge in use volume through a negotiation between pharmaceutical company and NHIS. Regardless of original or generic, a drug falling under the category of ‘making over 60 percent increase in claim amount compared to the year before, or making over 10 percent increase but increased by over 5 billion won,’ would be designated as a subject for PVA negotiation. Apparently ten choline alfoscerate products have been included for the coming PVA negotiation. As the medication market tends to expand rapidly every year, many generics in the market saw a sharp increase in prescription volume. A pharmaceutical market research firm UBIST found the choline alfoscerate’s outpatient prescription volume in the first half of the year reached 224.1 billion won, growing 19.6 percent from last year. The market volume has tripled in five years from 70.5 billion won in the first half of 2015. Quarterly outpatient prescription volume made in choline alfoscerate (Unit: KRW 1 million) Source: UBIST Regardless, the choline alfoscerate companies notified to participate in the PVA negotiation seems to be pressured about the sales return regulation. In accordance to NHIS drug pricing agreement, a company conducting a clinical trial for item approval renewal and pharmaceutical reevaluation by MFDS is stipulated to notify the details to NHIS. In case the company fails the reevaluation and loses approval, the responsible company has to pay NHIS back all reimbursement claimed from the date the MFDS ordered clinical trial through the date the listing was removed. Ultimately, if a company decides to withdraw its product from the market due to reevaluation outcome after agreeing on the choline alfoscerate’s pricing cut according to PVA negotiation, the company has to return all sales generated in between to NHIS. Choline alfoscerate is actually subjected to undergo clinical reevaluation. MFDS has recently demanded companies with choline alfoscerate products to submit clinical trial data. The relevant protocol has to be submitted by Dec. 23. The companies unable to prove efficacy of their choline alfoscerate during the clinical trial, the products may lose the government approval. And those companies that settled on the PVA would have to refund all prescription sales made from negotiation through approval revocation. And the product partially changing the indication due to clinical reevaluation would also have to return the prescription sales generated from the removed indication. Choline alfoscerate has been indicated to treat patients showing secondary symptoms of cerebrovascular insufficiency and degenerative brain-organic psychiatric syndrome— impairment of sense of direction, motivation, judgment and concentration due to confusion and degenerated memory, judgment and motivation; changes in emotions and behaviors—emotionally insecure, hypersensitive to stimulation, and indifferent to surrounding; and senile pseudo-depression. If any one of the indication gets removed, the pharmaceutical companies would have to pay back a part of their sales to NHIS. And the pharmaceutical industry experts predict the clinical reevaluation would likely to remove at least one of the indications. In fact, another cognitive enhancer acetyl-L-carnitine has lost one of indications after undergoing the clinical reevaluation. The original acetyl-L-carnitine Nicetile by Dong-A ST was indicated to treat patients with primary degenerative disease and secondary degenerative disease induced by cerebrovascular disease. However, the medication failed to demonstrate the efficacy of treating primary degenerative disease in the clinical reevaluation ordered by MFDS in 2015, the indication was removed in July last year. Acetyl-L-carnitine product that had PVA negotiation has to pay back all prescription sales made from the point of negotiation through indication removal. While the health authority has decided to apply selective reimbursement on choline alfoscerate, the companies with the medication subjected to PVA negotiation are heavily burdened. On July 24, MOHW convened the Health Insurance Policy Deliberation Committee (HIPDC) meeting and deliberated reimbursement reevaluation result and applying selective reimbursement on choline alfoscerate. The patient copayment rate on choline alfoscerate would be raised from 30 percent to 80 percent. MOHW preannounced the amendment and plans to enforce it from August. A pharmaceutical company insider complained, “When the market is unstable due to coverage reduction and clinical reevaluation, the company feels even more strained about the risk of returning prescription sales only because of making a significant growth in recent sales and clinical reevaluation result.”
- Company
- LG Chem begins development of Zemiglo + SGLT-2 inhibitor
- by Kim, Jin-Gu Jul 31, 2020 06:33am
- LG Chem will develop a combination of DPP-4 inhibitor and SGLT-2 inhibitor. Currently, three items are permitted as a combination, but no drug has been developed by a domestic pharmaceutical company. According to the pharmaceutical industry on the 29th, the MFDS recently approved LG Chem's Phase I trial plan which comparing the pharmacokinetics, safety and tolerability when Gemigliptin 50mg and Dapagliflozin 10mg are administered respectively and together. ZemigloGemigliptin is a DPP-4 inhibitor developed by LG Chem itself. It is Zemiglo. Dapagliflozin is generic for AstraZeneca's SGLT-2 inhibitor Forxiga. Currently, there are three products approved in Korea for the combination of DPP-4 inhibitor and SGLT-2 inhibitor. No products have been developed by domestic companies yet. Beringer Ingelheim's Glyxambi (Empagliflozin-Linagliptin) and AstraZeneca's Qtern (Dapagliflozin-Saxagliptin) were each approved in March 2017. MSD's'Steagluzan (Citagliptin + Ertugliflozin)' was approved in September 2018. If LG Chem succeeds in developing complex drugs, it will be the fourth drug in the Zemiglo series. Currently, LG Chem possesses ▲DPP-4 inhibitor single ingredient Zemiglo ▲DM complex, Zemimet (Gemigliptin/Metformin) ▲DM and hyperlipidemia complex Zemiro (Gemigliptin/Rosuvastatin). The total prescription amount for the three products last year was ₩97.9 billion. This year, ₩56 billion worth was prescribed until the first half. The products are likely to exceed ₩100 billion annually. ◆The key is whether DPP-4·SGLT-2 combination therapy benefits are recognized. The Korean Diabetes Association submitted an opinion to the government in April that a combination of DPP-4 inhibitors and SGLT-2 inhibitors would require benefits. Prior to this, in 2018, the government tried to find a way to apply benefits. In February of this year, LG Chem and Dong-A ST launched in June, and in June, Handok launched clinical trials. In the case of LG Chem, it is to verify the combination therapy of Zemiglo and Dapagliflozin or Empagliflozin. Dong-A ST also entered a combination clinical trial of its DPP-4 inhibitor, Suganon (Evogliptin) and Dapagliflozin or Empagliflozin. Handok has also been approved for a clinical trial plan to verify the combination therapy of its DPP-4 inhibitor Tenelia (Teneligliptin) and SGLT-2 inhibitor. An official in the pharmaceutical industry said, "If the government recognizes the combination therapy of DPP-4 inhibitors and SGLT-2 inhibitors as reimbursed items, it will be possible to prescribe combination drugs as well as combination therapy."
- Policy
- MFDS to independently investigate data manipulation
- by Lee, Jeong-Hwan Jul 31, 2020 06:33am
- Director Kim Sang-Bong of Biopharmaceuticals and Herbal Medicine Bureau at MFDS (left) and Democratic Party Lawmaker Kang Byungwon “This day in K-Bio is a hurdle we have to overcome to become the new drug developing country that tackles unmet medical needs. But we have already started working on creating fertile grounds to leverage the Korean-made pharmaceuticals in the global market by utilizing this hurdle as an opportunity to tighten administrative investigational power.” On July 29, South Korea’s Ministry of Food and Drug Safety (MFDS) official declared relevant regulations would be tightened for the ministry to independently investigate data manipulation among approved and distributed pharmaceuticals without the help of prosecutors. A discussion panel on strengthening business ethics in pharmaceutical industry was convened by Democratic Party Lawmaker Kang Byungwon, where Director Kim Sang-Bong of Biopharmaceuticals and Herbal Medicine Bureau participated as a panel and presented the ministry’s plan to reinforce quality control in biopharmaceuticals. MFDS means to assertively extend administrative power to prevent previous scandals like revoking marketing licenses of Kolon Life Science’ Invossa and Medytox’ Meditoxin due to their accusation of manipulating data for their biopharmaceutical approval review. Director Kim addressed recent issues like Invossa and Meditoxin and said “ethics and morals in advanced biopharmaceuticals” are the crucial matters to contemplate on at the moment. And he said Korea’s pharmaceutical industry of today stepped on to a phase of developing drugs to treat disease that has never been cured before. The director urged, “The K-Bio is shooting for two key goals of growing the industry and curing diseases. In the process, we have forgotten ethics and morals as if they were like oxygen,” and “unfortunate events like data manipulation and license revocation occurred. We need to mark these events as a turning point.” Director Kim noted it was regrettable that MFDS’ investigation was unable to fully disclose the detailed causes of data manipulation incident, whereas the judicial authority did. Accordingly, the director promised to considerably strengthen the ministry’s current administrative investigational power. His vision is to improve the current macro approach of MFDS evaluation standards and system, to take micro approach to match the speed of advanced biopharmaceutical development, and to systematically enhance the competency of MFDS reviewers in charge. The director elaborated, “The existing segmentalized but short and simple evaluation standards have been expanded to cover 109 items. This would mark the beginning of enhancing administrative investigational power,” and “compared to synthetic pharmaceuticals, advanced biopharmaceutical needs frequent intervention of observer’s objective evaluation. As the future of the industry like cell therapy and gene therapy require close attention, the precedent data manipulation cases cannot be treated as a simple incident.” Director Kim said, “The ministry goal is not to target the judicial authority, but to build a system for the ministry, as an administrative authority, to directly investigate data manipulation,” and “it would require securing general investigational capability, instead of relying on a few reviewers’ specialty.” The director also pin pointed, “The pharmaceutical companies may feel that the ministry is taking a medical evidence-based approach. In the past, a company with archived record was able to dodge the penalty, but they would be penalized without photographed evidence from now on,” because “the ministry would consider it as data manipulation, if a company cannot retrospectively prove the evidence according to the disclosed approval standards agreed upon the industry.” This is the ministry’s effort to step away from the past of concentrating on enhancing the global credibility of the Korean-made drugs. But now the ministry aims to create a ground to develop new drug for the unmet medical needs. The ministry intends to take Invossa and Meditoxin incidents as an opportunity and ask the industry, government, academic societies and the people to play their roles in evolving the Korean pharmaceutical industry. The director concluded, “Expanding the evaluation standards up to 109 items is only a beginning. It would be fine-combed to eradicate any loophole of data manipulation.” He also stressed, “This is relevant to all bio and pharmaceutical industries, not just for specific company or incident.” Lawmaker Kang Byungwon, the organizer of the discussion panel, compared the Invossa and Meditoxin incidents to the Volkswagen’s scandal of cheating the pollution emission test and said he would fully support for the legislation of preventing unethical business practice. Based on his experience of passing the bill to prevent Volkswagen incident and imposing reasonable fine on the responsible company, Lawmaker Kang aims to create an environment for the pharmaceutical industry to never repeat the data manipulation incidents again. The lawmaker urged, “The Korean industries have been blindly advancing forward without looking back. The process did not matter as long as the outcome was satisfying. But such behavior cannot lead Korea to become a developed country, and achieving K-Bio is impossible.” He noted, “The consumers who purchased the imported automobiles did not realize how they were damaging their own body. But the company knew exactly. When the Korean pharmaceutical industry realizes the gravity of their responsibility, it would finally become a global pharmaceutical industry.”
- Company
- GC Pharma, applied for Phase II clinical trial of GC5131A
- by Kim, Jin-Gu Jul 31, 2020 06:31am
- GC Pharma announced on the 29th that it had applied to the MFDS for a clinical trial phase II plan for COVID-19 blood plasma tx, 'GC5131A'. Samsung Medical Center, Asan Medical Center, Chung-Ang University Hospital, Korea University Ansan Hospital, and Chungnam National University Hospital are targeting 60 people. 'GC5131A' is a Hyperimmune globulin made by extracting various effective immune antibodies from the plasma (liquid component of blood) of COVID-19 recovery patient. It has been reported that Hyperimmune globulin has been used in the human body for a long time, so it has been developed rapidly. If the MFDS approves the clinical trial plan, it will enter the Phase II clinical trial in Korea among the candidates for new drugs, excluding products that have initiated the clinical trial through drug re-creation. The GC Pharma explained that production of clinical trial preparations has been completed and that patients will be administered as approved by the MFDS. “We will do our best to put GC5131A into the medical field in a short period of time,” said Kim Jin, head of Medical division, GC PHarma. On the other hand, it is explained that the blood plasma treatment is different from convalescent plasma therapy, which is used to transfuse the plasma of patients in the recovery phase to severely ill patients. Blood plasma therapy is a kind of medical practice, and blood plasma treatment is a medicine made by fractionating only the immunoprotein containing antibodies from the plasma and concentrating it at a high concentration.
- Policy
- “Primary care-based remote medicine as a supplement"
- by Lee, Jeong-Hwan Jul 30, 2020 06:20am
- Professor Hong Yun-chul at Seoul National University Hospital (left) and Secretary General Jeong Ji-yeon at Consumers Union of Korea To respond against novel infectious disease like COVID-19 and super-aged society, experts claim the South Korean society should prepare for an introduction to digital healthcare and remote medicine. In particular, the experts pointed out the remote medicine (non-contact medical care) would not replace the traditional medical care, but it should take root in the society as supplementary care for senior patients and other medically invulnerable community. The experts added the remote medicine should be limited to local clinics practicing primary care to balance out efficiency and equality. At a seminar convened at National Assembly Library on July 29, Professor Hong Yun-chul at Seoul National University Hospital and Secretary General Jeong Ji-yeon at Consumers Union of Korea (CUK) said the above while discussing about plans to strengthen local community primary care competency and digital healthcare. Professor Hong and Secretary General Jeong giving a presentation argued a foundation to utilize digital healthcare and remote medicine in the society should be built. Professor Hong stated COVID-19 and super-aged society have further extended the needs to bring digital healthcare into the social system. While the people and the society are demanding new responsive strategy amid pandemic, the post-coronavirus medical strategy is becoming increasingly more relevant to the society. Professor Hong named it the ‘Post-coronavirus Public-private Collaborative Medical System.’ The system aims to realize Smart medicine based on an integrated platform consisting of state university hospital, regional hospital, public healthcare center and local primary care provider. The professor elaborated the public-private collaborative medical system can be activated by comprehensively utilizing digital healthcare technology in society and medical system and focusing remote medicine on primary care. Professor Hong said, “Since the outbreak of COVID-19, we have actually been in the times of crucial societal changes. The current society is experiencing a historic increase in senior citizens,” and “the society would struggle to support the senior patients in two decades time. Basically, a system should be constructed for the digital healthcare to help senior citizens to maintain their good health.” The professor stated, “In the end, medical care in close enough proximity should be provided. The role of a personal doctor in the center of primary care would be the key.” The professor added, “Remote medicine is a hot potato. The entire competitive system would be faltered when remote medical practice in primary, secondary and tertiary healthcare institute is allowed; primary care providers cannot sustain the competition.” Professor Hong further explained, “Ultimately, the remote medicine should be supported by the government to be applied around local community primary care and utilize personal doctors for it,” and “face-to-face medical care is a principle that should not be shaken. Remote medicine is merely a supplementary tool.” Secretary General Jeong urged the remote medicine should be introduced as a medical system that enhances convenience for the consumers. Her point was healthcare consumer and providers should not blindly oppose against infection- preventive and beneficial remote medicine, but discuss where to put a safety tools in the system. Secretary General Jeong was also against providing non-contact medical service from the beginning of the medical care. She explained using remote medicine as a supplementary tool after a personal doctor sees a patient would be closer to the answer. Secretary Jeong insisted sufficient discussion should be conducted regarding opposing opinion or criticism against remote medicine like commercialization of medical service, and the government should draw up a reasonable means to adopt the system. The secretary general stated, “The remote medical service should be practiced for the consumers. Already experiencing COVID-19, the non-contact industry is rapidly permeating through the society,” and “remote medicine is not optional, but necessary for the society. But it should be a system to support the traditional medical service based on primary care.” Secretary General Jeong added, “Remote medicine should serve a role of completing the patient-centered medical service. The success of primary care-based remote medicine would be only possible, when medical service consumers’ trust is prioritized,” and “also, the introduction of the remote medicine should be discussed from the perspective of improving access to medical service in the age of digitization and aged society.”
