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- 2026-04-15 22:52:05
- Policy
- What is the future COVID-19 vaccination plan?
- by Lee, Tak-Sun Dec 21, 2020 06:19am
- The government's plan and schedule for introducing COVID-19 vaccine have been established. It was introduced within the first quarter through a pre-purchase with AstraZeneca, and the contract with Pfizer, Modena, and Janssen, which contracts were delayed, will undergo import procedures after the second quarter. Therefore, early approval of the AstraZeneca vaccine is required for vaccination to begin in the first quarter. Prime Minister Jeong Sye-gyun appeared on 'KBS 1TV Sunday Diagnosis Live' on the 20th and announced that the AstraZeneca’s vaccine will be approved by the MFDS by early next year and will be supplied from the first quarter. In addition, he explained that it is difficult to introduce a vaccine from Pfizer, which is expected to contract this month, and Modena, which is pursuing a contract in January next year. This is the same as Im In-taek, head of the Health Industry Bureau of the MOHW, at a briefing on securing a vaccine developed overseas for COVID-19 on the 18th. Director Lim explained, "AstraZeneca’s vaccine will be introduced in Korea first in the first quarter of next year, and the vaccine made by SK Bioscience will be supplied." From the second quarter to the fourth quarter, the rest of the vaccines, such as Pfizer and Modena, will be introduced, and 100% will be supplied for 44 million people who have been confirmed to purchase within the year. Overseas authorities' interest in the UK's MHRA approval, and Korea is likely to judge based on this On the same day, the MFDS initiated a rolling review of the Pfizer vaccine. AstraZeneca’s vaccine has already been reviewed in advance since last October, and the company plans to approve it within 40 days when a formal application for approval is received. Foreign media reports that AstraZeneca's vaccine is likely to be approved by the UK regulatory agency, MHRA, on the 28th or 29th of this month. It is reported that the University of Oxford, UK, which is co-developing the AstraZeneca vaccine, is highly likely to submit final data for phase III clinical trials by the 21st. The UK, which has left the European Union (EU), is not under the jurisdiction of the European Medicines Agency (EMA) and has been approved by its own regulatory body. The previously approved Pfizer vaccine was also independently screened by MHRA. However, MHRA is not an unreliable institution. Moreover, since the development of the Astrazeca vaccine started in the UK, MHRA has been continuously reviewed, so it is highly likely that the EMA and other countries will refer to MHRA's approval in the future. It is reported that the US FDA will urgently approve domestic vaccines Pfizer and Modena, and AstraZeneca vaccine will be approved as early as February, but if MHRA or EMA approval falls, Korea is highly likely to refer to it for review. It is unlikely that the special import system will be utilized as in the case of Remdesivir as it is already in the process of rolling review. Special import is a system introduced through expert review at the request of the KDCA. In the case of Remdesivir, it took only 4 days for the import decision after The KCDC request. However, it is pointed out that it is unreasonable in terms of public opinion and future safety risks to introduce overseas vaccines without going through the safety and efficacy review procedure. Therefore, it is highly likely that the AstraZeneca vaccine will be approved in early February after a 40-day review when the clinical trial ends this month and an official application for approval is received. Japan, which has secured 145 million vaccines through pre-purchase, is also expected to begin its first vaccination in February-March next year, similar to Korea's, after going through its own screening procedure. Pfizer applied for approval of use on the 18th, but it will take some time until the final approval of the license. Japan has decided to introduce Pfizer’s and AstraZeneca’s vaccines for 60 million people each. Therefore, it is expected that the AstraZeneca vaccine will go through a similar approval procedure. Excluding AstraZeneca, it is difficult to introduce it in the first quarter, and there is time until approval by Pfizer or Moderna. However, in the case of Pfizer, unlike AstraZeneca, in the case of a preliminary review application, it is highly likely that domestic approval will be obtained sooner as the clinical trial data have been submitted. Even if 44 million vaccines are imported, demand is key. The vaccine should be given as much as possible When the AstraZeneca vaccine for 10 million people is sequentially introduced from the first quarter, it is expected that medical staff and senior citizens will first be vaccinated. It is explained that the vaccination for the general public will begin according to the timing of the vaccine introduction. The government plans to complete the vaccination at least until the fourth quarter of the flu outbreak. The timing of introduction of vaccines for each type is different, and the supply of vaccines is not constant, so it seems difficult for individuals to choose the type of vaccine. The problem is that there is a high possibility that all 70% of the population must be vaccinated to create collective immunity and fight COVID-19. The 44 million people that the government has confirmed to purchase account for 70% of the population. However, the amount of vaccination seems to be sufficient as the currently developed vaccine has not been verified for vulnerable groups such as children (under 17 years of age) and pregnant women. Therefore, the question is how many people accept vaccination. Since vaccination is not mandatory, some cases are expected to refuse vaccination. However, as experts emphasize that at least 70% of the population must be vaccinated in order to develop collective immunity, the government's promotion of vaccines and persuasion to the public are expected to be important. Experts say that if collective immunity does not develop and the number of confirmed cases does not decrease, there is a high likelihood of getting the vaccine every year like the flu. If the virus is not successfully eradicated at once, it seems that there will be a limit to living a normal life without a mask in the absence of a definitive treatment, such as the flu's Tamiflu. In the case of flu, even if Korea supplied 30 million vaccines every year, 1.77 million cases occurred last year. As of 0 o'clock on the 20th, it cannot be compared with the 49,665 cumulative COVID-19 confirmed cases. Nevertheless, it is managed without inpatient treatment because there is flu treatment, Tamiflu (Oseltamivir). Experts argue that the virus should be virtually eradicated through the formation of collective immunity by getting the vaccine as many as possible as there is no definitive treatment for COVID-19. The focus should be on how much to increase the vaccination rate for the remainder of the period rather than controversy over the timing and quantity of vaccinations.
- Company
- Another effect of Botox, possible to treat hair loss
- by Dec 21, 2020 06:19am
- Following cosmetic surgery, botulinum toxin formulations are expanding their scope to treat hair loss. It is noteworthy as researches confirming the potential as a treatment for hair loss in Korea are ongoing. Byeong-cheol Park, Professor of Dermatology, Dankook UniversityDankook University dermatology professor Park Byeong-cheol confirmed the effect of botulinum toxin on hair loss improvement in the Sponsor- Investigator Trials conducted by Daewoong Pharmaceutical's Nabota. In 22 subjects, Nabota was treated for 6 months and the reaction was confirmed. As a result, the number of hairs increased statistically significantly at week 24. The study results were published in the December issue of the SCI-level journal Journal of the American Academy of Dermatology (JAAD). This study is a kind of exploratory study, and there is a limitation that there is no control group and the number of subjects is small. However, Professor Park Byung-cheol said, "It is meaningful that we have confirmed the mechanism of hair loss treatment of botulinum toxin through a cell experiment, and that the researcher's clinical trial has confirmed its potential. We can proceed to the later phase II clinical trial and the phase III study according to the results. It was an opportunity to lay the groundwork for that,” he revealed the significance of the study. Dailypharm conducted an interview with Professor Park to find out the potential of botulinum toxin preparations to treat hair loss. ▶What are the limits in the treatment of androgenetic hair loss? -The oral drugs Finasteride (Propecia), Dutasteride (Avodart) and minoxidil are the treatments for androgenic hair loss that have been approved by the US Food and Drug Administration (FDA) so far. These are the most important treatments and the basis of hair loss treatment. However, in some patients, the effectiveness of these treatments may be insufficient, and it is true that each drug has side effects. In addition, Finasteride and Dutasteride have limitations that women of childbearing potential cannot take. ▶A study on hair loss treatment was conducted with botulinum toxin. Please explain the research background, design, and results. -Botulinum toxin is used not only to improve wrinkles but also to prevent and treat scars, and one of the main mechanisms at this time is to inhibit TGF-β. TGF-β is also known to inhibit hair growth and progression from hair to telogen hair. I thought there would be something in common, so I started my research. This study was a pilot study, comparing before and after treatment in 22 subjects without a control group. Except that there was no control group, the reaction was confirmed after treatment for at least 6 months following the general guidelines for confirming the improvement in the efficacy of hair loss suggested by the Ministry of Food and Drug Safety. Effectiveness evaluation statistically verified the change in the number of hairs per unit area at 12 and 24 weeks compared to the baseline at week 0 and the degree of improvement by clinical pictures. Side effects were confirmed through vital signs at each visit, medical examination, and blood tests at weeks 0 and 24. The treatment method was to inject botulinum toxin (Nabota) into the hair follicle of the subject every 4 weeks with 30 units of botulinum toxin (Nabota) for a total of 24 weeks for a total of 24 weeks. At week 24 of treatment, the number of hairs increased significantly (p=0.012). No serious drug-related adverse events were reported. Daewoong ▶How was the satisfaction the patient felt after treatment? -In addition to the researcher's objective evaluation, the subject's subjective satisfaction was evaluated through a questionnaire. △ Overall scalp shape improvement, △ improvement of hair density in the area of hair loss, △ improvement of the degree of hair loss, △ improvement of hair growth rate, △ improvement of hair thickness. ▶What mechanism of botulinum toxin preparations has the effect of treating hair loss? -It is assumed that botulinum toxin inhibits the secretion of TGF-β1 from hair follicle cells, which inhibits the progression and growth of hair at rest. The increase in TGF-β1 secretion by'dihydrotestosterone (DHT)' is known to be one of the major causes of androgenic hair loss. In this study, an increase in TGF-β1 was also observed by DHT, and it was confirmed by cell experiments that the expression was decreased when treated with botulinum toxin. ▶Looking at the results of this study, there was a significant improvement at week 24, but not at week 12 (p=0.803). In other words, it means that the change was insignificant until 3 months of the procedure. What do you think is the reason? -I think the cycle of hair or the cumulative concentration of the drug may have had an effect. Normally, the hair growth period is 4-6 years, and the period of regression is 3 weeks, and the period of rest is about 3 months. Considering this, it can be interpreted that it may not be effective at the third month. Or it is thought that a period of cumulative concentration may have been necessary for the drug to exert its effect. Accordingly, a follow-up study currently underway is confirming the treatment response by increasing the concentration slightly. ▶This study was only for men. Could female hair loss patients benefit from hair loss treatment with botulinum toxin? -In fact, there are few treatments for female type hair loss, so many people are also interested in this. Although clinical studies have not been conducted yet, the results cannot be predicted, but since TGF-β1 inhibits general hair growth, it is expected that botulinum toxin that blocks this will be effective in female-type hair loss. Currently, botulinum toxin is also injected into female hair loss patients with consent at the clinic site for therapeutic purposes. ▶Isn't there a tolerance problem even in hair loss treatment of botulinum toxin? -Botulinum toxin has been used for a long time as a treatment for wrinkle improvement, and since it is a topical injection treatment, it has been used without significant side effects. Since hair loss treatment is also a local treatment, it has the advantage that it can be treated while minimizing systemic side effects. In particular, in existing wrinkles, injections are made into muscles with abundant blood supply, but in hair loss, because dermal hair follicle injections are performed, systemic absorption through blood vessels is expected to be less, so there is a high possibility that no noticeable systemic side effects were observed. Since this study was only conducted for 6 months, long-term observation is necessary. Problems have also been raised about the formation of neutralizing antibodies and resistance to botulinum toxin injections, but this is known to occur mainly in patients who frequently receive high-dose intramuscular injections. Hair loss treatment is expected to have less resistance, but this part will be confirmed through follow-up studies. ▶Aren't patients reluctant to get an injection into the scalp? -Because getting an injection into the scalp itself causes pain, there is a factor to be reluctant. However, since there is a motive for the treatment of hair loss, they are injected once a month, and various tips are used to minimize pain during injection, so most patients at the actual clinic say that they have pain, but it is acceptable. ▶Wouldn't the temporary effect of botulinum toxin formulations be a disadvantage? What new treatment benefits do you think can offer more than existing hair loss treatments? -Androgenic hair loss is basically a progressive disease caused by genetic factors, so if you stop taking any medication, hair loss may progress again, and this is the same with botulinum toxin treatment. However, in this study, there are cases in which it was unofficially confirmed that hair loss does not progress for about 3 months after the last treatment. Factors that cause hair loss can vary, and the effects on hair loss treatment are also diverse. Accordingly, botulinum toxin can be used in a variety of ways, including the purpose of increasing the effect in patients with insignificant effect on the existing treatment, the purpose of maximizing the effect in patients with good effect in the past, and alternative purposes in patients with no effect on treatment. .In particular, it is expected that it can be used in patients who are unable to take existing drugs .▶Please tell us about the significance and limitations of this study and the follow-up studies This study is meaningful in that it has confirmed its possibility as an exploratory study as the first step to find out whether botulinum toxin can be used as a hair loss treatment .In particular, the mechanism was also confirmed through cell experiments .Since it is a small-scale study without a control group, it can be recognized as a universal treatment only when the later phase 2 and final phase 3 clinical trials are completed, but it is meaningful in that the basis for these studies has been prepared .As a follow-up study, a study is underway to find the optimal concentration and usage to maximize the therapeutic effect .In the future, we plan to study the therapeutic effect in gynecomastia, the presence or absence of neutralizing antibodies that may occur during treatment, and further analysis of the therapeutic mechanism at the cellular and hair follicle organ levels.
- Company
- US ITC bans Nabota from importing for 21 months
- by An, Kyung-Jin Dec 21, 2020 06:19am
- The US International Trade Commission (ITC) issued an order to ban imports from the US for 21 months on Jubo (Nabota), a botulinum toxin product developed by Daewoong. According to industry sources on the 17th, the US ITC issued a final ruling on the 16th (local time) in a lawsuit between Medy Tox and Daewoong infringement of trade secrets of botulinum strains. However, the period for the US import ban was drastically reduced from 10 years to 21 months. As a result of the preliminary judgment, they accepted the allegations of stealing Medy Tox strain and manufacturing technology, but decided that the strain was not a trade secret and therefore did not fall under the ITC's regulatory matters. Medy Tox and Daewoong have been struggling for a long time over the source of the botulinum strain. In 2019, Medy Tox and Allergan filed a lawsuit against Daewoong and Evolus to the US ITC, and in July this year, the ITC administrative judge ruled that Daewoong's Nabota was banned from US imports for 10 years. Since then, Daewoong has filed for an objection, and ITC accepted it and proceeded with a re-examination. The final judgment was also postponed three times from November 6 to November 19 and again to December 17. The ITC is a federally independent, quasi-judicial body directly under the President of the United States with extensive investigative power on trade issues. After the ITC makes a final decision that a violation of Article 337 exists, it will be passed on to the President and approved by the President. The President of the United States has the right to veto a decision within 60 days of the date of delivery by the ITC. If the President exercises his veto power, the ITC's final decision and action shall take effect on the date the President's veto is notified. In the US, it is believed that Allergan won the ruling. Bloomberg reported on the ITC ruling, "AbbVie has blocked Botox rivals from importing to the United States. As the ITC decided to ban US imports for 21 months on Jubo, which Evolus sells, it will be able to maintain a monopoly." AbbVie owns the license and sales rights of Botox through the acquisition of Allergan. Immediately after the final ITC decision was delivered, Evolus shares, which are listed on the NASDAQ, fell 3.9% from the previous trading day. Evolus, as a partner of Daewoong, is in charge of selling Jubo in the US. However, with this ruling, the dispute between the two companies over the source of the botulinum strain is not expected to end immediately. Daewoong said that the decision made by the ITC Committee regarding the final decision of the ITC was based on Allergan's domestic industrial protectionism to protect the monopoly market, and therefore Daewoong will appeal. An official of Daewoong said, "It is clear that Daewoong developed Nabota without infringement of trade secrets. We will fight to the end by mobilizing all legal procedures in the ongoing dispute to uncover the truth." Nabota's US sales portion of annual sales is currently less than 2%, so the impact on corporate management is expected to be insignificant.”
- Policy
- MOHW to reduce pricing in combination drug changing API
- by Kim, Jung-Ju Dec 21, 2020 06:19am
- The South Korean government is to reevaluate and reduce the reimbursed pricing on drugs that changed the main active pharmaceutical ingredient (API) due to the change of labeling. Immediately, calcium chloride combination injections are subjected to the new change with the updated list of reimbursed drug effective from Dec. 1. As it would be the first case of adjusting reimbursed pricing according to the labeling, the government would swiftly set relevant reimbursement standard or guideline. An industry source reported on Dec. 16 that the Ministry of Health and Welfare (MOHW) unveiled a plan for drug labeling reevaluation based on the order to change the antibiotic injection labeling. The reevaluation was initially planned as the Ministry of Food and Drug Safety (MFDS) amended the labeling of an antibiotic combination drug with calcium chloride. As the substance is categorized as a disintegrating agent, some raised an issue if it should be considered as an API. MFDS has decided to change the key API as an ‘isotonic agent’ after consulting experts about the substance, particularly its related safety and efficacy evidence (reevaluation included) and the international approval status of the drug. Since then the ministry has been in legal suits with the pharmaceutical companies opposing against the decision. However, the litigation was ruled in favor of the government, and MOHW decided to adjust (reduce) the listed combination drug reflecting the change. The pricing adjustment subject drugs would be deduced from the new list of reimbursed drug and their upper limit pricing effective from Dec. 1. And Daily Pharm analyzed the list and found seven combination items containing calcium chloride assumed to be affected. The seven items include UK Chemipharm’s Tagonin Kit Injection (teicoplanin), Meta Kit Injection (cefmetazole sodium), Tetan Kit Injection (cefotetan disodium), Thiam Kit Injection (cefotiam hydrochloride), Trison Kit Injection (ceftriaxone sodium hydrate), Trison Kit 2 g Injection, and Vanco Injection (vancomycin hydrochloride). Labeling adjustment carries onto pricing reevaluation could become a norm after stipulating relevant regulation and guideline However, the problem is that the government has no reimbursement standard or guideline related to the case it was a first case of the labeling change carrying onto reimbursed pricing reevaluation. But the first subject drugs can estimate the adjust pricing by referring to the upper limit pricing of similar combination drugs without calcium chloride. Regardless, the government would have to set down a clarified standard or guideline for the reevaluation, as it normally uses a clear standard to adjust upper limit pricing. In fact, MOHW plans to consult the Drug Reimbursement Evaluation Committee (DREC), associated under the Health Insurance Review and Assessment (HIRA), to compile a related standards and guideline. Without much of trouble, the pricing adjustment could be enforced from the next year first quarter.
- Policy
- Low dose in multiple Vizimpro reduces the insurance benefit
- by Lee, Hye-Kyung Dec 21, 2020 06:18am
- If Pfizer Korea's Vizimpro is prescribed at a low dose in multiple, the benefit will be reduced. The price difference between 1 tablet of Vizimpro 45mg (₩32,105/tab) and 3 tablets of Vizimpro 15mg (₩16,052/tab) is ₩16,051, and the difference between 1 tabelt of Vizimpro 30mg and 2 tablets of Vizimpro 15mg is ₩6,420. Samsung Pregabalin Cap, which costs ₩700 If 2 capsules of Samsung Pregabalin 75mg (₩549/cap) is prescribed instead of 1 capsule of Samsung Pregabalin 150mg, it is automatically checked through DUR. The HIRA recently unveiled a list of cost-effective dose drugs. This list was made in accordance with the amendment of the drug reimbursement list and the upper limit price list on the 27th of last month, and a total of 3,067 items, including 2,642 oral and 425 combinations, will be reduced when low dose in multiple is prescribed. The effective date starts on February 1 of next year. The full list of drugs is subject to automatic electronic inspection during the provision of DUR information and examination of the billing statement for medical care benefits, and medical institutions must be careful when prescribing low dose in multiple. Looking at the combination of oral drugs added this time, Kwang Dong's Nebilet M 1.25-2.5mg, Boryungbio's CL-cox 100-200mg, Donepez 5-10mg, Reprica 75-150mg, Actaz 15-30mg, Day Tams SR 0.2-0.4mg, Glimepiril 2-4mg, Samsung Solifenacin 5-10mg, Samsung Clarithromycin 250-500mg, Kvastin 5-10·5-20mg, Atorsta 10-20mg, Whanin Pharm's Sertraline 50-100mg, and Nexpharm's Tampilon 0.2-0.4mg, etc. Daewoong's Bearlotan is excluded due to the adjustment of the upper limit price. Aricept and Aricept Evess, and Dimenpezil and Dimepezil ODT of Cosmaxbio are excluded from DUR inspection due to deletion of benefit. Unimed's Cerabin C Inj 10-20ml is a production confirmed item and is reduced when prescribed low dose in multiple.
- Company
- Orally taken Rinvoq to be prescribed in general hospitals
- by Eo, Yun-Ho Dec 18, 2020 06:07am
- A third Janus kinase (JAK) inhibitor in South Korea, Rinvoq is swiftly seeking for prescription authorization in general hospitals nationwide immediately after it was listed for the healthcare reimbursement. An industry source reported AbbVie’s Rinvoq (upadacitinib) has been recently passed by the drug committees (DCs) at Seoul Asan Medical Center, Chungnam National University Hospital, Inje University Haeundae Hospital, Hanyang University Hospital, Seoul Medical Center, Kangbuk Samsung Hospital, Wonkwang University Hospital and Sahmyook Medical Center. Listed by the South Korean health authority for reimbursement since Nov. 1, Rinvoq is indicated to treat adult rheumatoid arthritis patients, who qualify the diagnostic criteria set by the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR); patients whose Disease Activity Score (DAS) 28 exceeds 5.1, or over 3.2 and under 5.1 but has developed joint damage confirmed by image exams; patients who did not respond sufficiently to two or more types of anti-rheumatic drugs including methotrexate (MTX) for three months each and six months total, or who halted the treatment due to adverse reaction. Rinvoq was able to earn the reimbursement approval by using the approval-reimbursement linkage system and accepting the weighted average pricing of an alternative drug. Only five months after the official marketing approval was granted in last June, the drug received the healthcare coverage. The industry predicts the general hospitals clearing the prescription code would fully open up the market for the drug. Regarding the treatment for an autoimmune disease, the interest on a JAK inhibitor, such as Xeljaz (tofacitinib), Olumiant (baricitinib) and Rinvoq, has been growing as it is the first to offer an oral option with confirmed effect equal to anti-tumor necrosis factor (anti-TNF) drugs to the patients. .However, the JAK inhibitors’ impact in the market has not been too prominent as other biologics .Compared to the market leader anti-TNF drug and popular anti-interleukin drugs, JAK inhibitors’ indications are limited to rheumatoid arthritis and few other diseases .The first-in-class Xeljanz has expanded its indication to treat ulcerative colitis and psoriatic arthritis, and other follow-on drugs have ongoing studies to expand indication in autoimmune diseases like atopic dermatitis, Crohn’s disease and ankylosing spondylitis .Rinvoq has demonstrated its treatment effect in 4,443 patients with severe level of active rheumatoid arthritis through five Phase III SELECT trials (SELECT-NEXT, SELECT-BEYOND, SELECT-MONOTHERAPY, SELECT-COMPARE and SELECT-EARLY) .The result found using Rinvoq alone or with conventional synthetic DMARD (csCMARD) showed lower disease activity and improved remission rate, compared to using a placebo, methotrexate or Humira (adalimumab) .An internal medicine professor at Hanyang University Rheumatoid Hospital, Dr .Kim Tae-hwan commented, “Rinvoq was able to reach a level of clinical remission improved than the existing standard of care during a clinical trial conducted on various groups of patients .As it also demonstrated an improved effect of reducing pain, patients may anticipate daily life free from pain, joint damage and faltering cognitive function with the help of the reimbursed option of Rinvoq.”
- Company
- When will K-COVID-19 vaccine be released?
- by Kim, Jin-Gu Dec 18, 2020 06:06am
- As Pfizer's COVID-19 vaccination has begun one after another in the UK and the US, interest in domestic companies that have jumped into COVID-19 vaccine development is also increasing. Currently, it is predicted that the commercialization of vaccines developed by domestic companies will be possible only in 2023 even if the commercialization is early. ◆Four domestic companies were clinically approved, results announced in 2023 According to the MFDS on the 15th, five companies and institutions in Korea have been approved for clinical trials for vaccine development. International Vaccine Research Institute (IVI), Genexine, SK Bioscience, Geneone Life Science, Cellid, etc. IVI is conducting global clinical trials of INO-4800 being developed by the US pharmaceutical company Inovio in Korea. However, in the case of IVI, additional information on phase II/III of clinical trials was requested from the US Food and Drug Administration (FDA). There are four domestic companies including Genexine, SK Bioscience, Geneone Life Science, and Cellid. All four companies are in the early stages of development. Genexine, Geneone Life Science, and Cellid are in Phase I/IIa, and SK Bioscience is in Phase 1. According to the MFDS, their target clinical completion is in 2022. ◆Genexine changes candidate substances and starts again from Phase I Genexine was approved by the MFDS on June 11, as a substance called GX-19. On September 4th, it is confirmed that the patient recruitment was successful. However, it is estimated that the clinical results were not satisfactory. Genexine recently announced that it will restart clinical trials by changing the candidate substance to a substance called GX-19N. According to the revised clinical plan, Genexine will re-challenge in Phase I/IIa, targeting 170 people at 8 locations including Severance Hospital and Gangnam Severance Hospital. As Genexine starts again from Phase I, the results are expected to be delayed by 2-3 months. The target date for completion of the clinical trial that Genexine originally submitted to the MFDS as GX-19 was June 2022. According to Genexine's description, the results of Phase I/IIa will be released only in August 2022. However, there is a possibility that the vaccine will be commercialized earlier if the results of phase I/IIa are obtained earlier. The target date for completion of the first results of clinical I/IIa announced by Genexine is March 17, 2021, and the initial clinical results will come out from May to June next year, considering the delay of 2-3 months due to the change of candidate substances. Based on this, it is explained that if phase III clinical trials are initiated promptly, there is a possibility of completing phase III within next year as planned by Genexin and the government. Jun-wook Kwon, head of the 2nd vice president of Central Disease Control Headquarters, explained at a regular briefing on the 15th, "We will discuss with the pharmaceutical company managers at the Therapeutic Vaccine Specialized Committee on the 16th. We will proceed with the goal of completing phase III clinical trials of domestic vaccines by the second half of next year." . ◆SK·Geneone Life Science· Cellid, commercialized after 2023 The development status of domestic companies is in contrast to the fact that 57 global pharmaceutical companies are in the final stage of vaccine development. According to The Korea National Enterprise for Clinical Trials, there are a total of 127 COVID-19 vaccine clinical trials in progress worldwide on the 15th. Of these, 57 cases (45%) entered Phase III. It has entered the final stage of clinical trials less than a year since development began. For example, in the case of Pfizer, vaccination has already begun in the United States and the United Kingdom after receiving urgent approval from the FDA. For Modena, FDA approval is expected as early as this week. AstraZeneca and Johnson & Johnson are looking for approval early next year. Of course, it is not worthless that the timing of vaccine commercialization is delayed compared to global pharmaceutical companies. An official in the pharmaceutical industry said, "We do not know how many years the immune effect of vaccines developed by Pfizer and others will last. If we succeed in developing products with improved effectiveness, safety, and convenience, it will be sufficiently competitive."
- Opinion
- [Reporter's View] Pharmaceutical dept. needs independence
- by Lee, Hye-Kyung Dec 18, 2020 06:06am
- The 'Rules on the Standards for National Health Insurance Medical Care Benefits' revised and implemented by the MOHW on October 8 became the basis for negotiating all reimbursed drugs with the NHIS. At the time, the pharmaceutical industry could not realize the 'power' of the rule amendment, but the NHIS emphasized that all drugs that need to be listed on the drug reimbursement list will go through a negotiation process through meetings with the pharmaceutical industry. The specific basis is that Article 11-2, Paragraph 7 of the Rules, 'All drugs evaluated as having appropriate benefits shall be determined after negotiation within the range of 60 days'. All drugs for which the HIRA has evaluated reimbursement adequacy, so-called all drugs that are about to be listed, must be negotiated with the NHIS. The pharmaceutical industry realized the power of this revised rule through the start of generic drug negotiations. When the HIRA's drug price calculation is complete, the NHIS negotiations have been added to the generic registration process in which the registration was made. Conditions for implementation such as risk-sharing drugs, ▲ confidentiality, ▲ other matters necessary for stable medical care benefits and financial management of health insurance, etc., must be discussed in order to be listed on the list. Small and medium-sized pharmaceutical companies that have not participated in new drug price negotiations or Price-Volume agreements are the first to negotiate with the NHIS. The NHIS says it cannot negotiate a stable supply or quality control for drugs that have not yet been produced. Following the generic negotiations and non-listing of drugs that have not yet been produced, the NHIS also took over the contract for reimbursement of benefits for listed drugs, including 'Choline alfoscerate' formulation, which is about to undergo clinical re-evaluation of the MFDS. The NHIS will sign a payback contract for 230 items of clinical reevaluation drugs by February 9th next year. Drugs subject to additional reevaluation, which will be implemented on January 1 of next year, will also go through the negotiation process of the NHIS. The NHIS drug-related department, which had been the main task of follow-up management such as additional revaluation of clinical reevaluation drug benefits and additional reevaluation drugs will be carried out. The NHIS is in charge of the management of all reimbursed drugs, and pharmaceutical companies feel that the 'power' of the drug department of the NHIS is weaker than the NHIS. Currently, among the NHIS's salary strategy office, the pharmaceutical department consists of four departments: Drug Price System Improvement Department, Drug Price Negotiation Department, Drug Price Post Management Department, and Generic Negotiation Management Department. The HIRA's pharmaceutical department, which started with 3 teams with the introduction of the positive list system in 2006, has grown to 14 teams as of October this year. Of the 107 employees in the Benefit Strategy Office, 62 (54 currently employed, 22 pharmacists) are occupied by the drug-related department. It can be said that the pharmaceutical department has sufficient conditions for the workload and capacity to be independent. The possibility of independence of the pharmaceutical department became an issue every time as the size of the organization increased. The NHIS has been examining the organization this year and reviewing organizational improvement to enhance its status as an insurer. This included expansion of the organization and coordination of work between departments, and it was also discussed that the drug department should be promoted to a management group to form a separate organization. It will be 14 years since the drug price negotiation system between the NHIS and pharmaceutical companies was introduced next year. As the workload related to drugs increases, the number of pharmacists is also increasing. The independence of the department with professional manpower is expected to expand the status of the NHIS pharmacists with the strengthening of the organization's status in the future.
- Company
- Drug export breaks record making near KRW 7 trillion
- by Kim, Jin-Gu Dec 18, 2020 06:05am
- The South Korean-made pharmaceutical export broke the record this year. The accumulated export volume up to November has already exceeded the total export volume in last year. Due to a steep surge in pharmaceutical export, the industry trade performance is expected to hit the highest point in the history. According to the Korea Customs Service on Dec. 15, the cumulative pharmaceutical export in November reached USD 5.89 billion (approximately 6.44 trillion won). Keeping up the inclining trend, the figure could even hit 6.4 billion dollars (7 trillion won) by the end of the year. This year has already recorded the highest pharmaceutical export volume. Even since August, the accumulated export volume has passed the last year’s total export volume 3.70 billion dollars (approximately 4.4 trillion won). Yearly volume of pharmaceutical export reported by the Korea Customs Service (Unit: USD 1 million) As of November this year, the pharmaceutical import volume marked 6.82 billion dollars (approximately 7.42 trillion won). Compared to the same 11 months last year generating 6.01 billion dollars (approximately 6.55 trillion won), this year’s figure was increased by 13 percent. The import volume is expected to increase up to 7 billion dollars by the year end. But as the export volume skyrocketed compared to the import volume, the gap between the pharmaceutical import and export is also expected to narrow down the most in the history. The last year’s import and export had deficit of 2.98 billion dollars, which was lowest since 3.21 billion dollars in 2014. The deficit in this year as of November was 911 million dollars. Since 2010, the pharmaceutical trade deficit was constantly above the 2.5 billion dollar-line. Yearly trade balance in pharmaceutical products reported by the Korea Customs Service (Unit: USD 1 million) By month, the trade balance made surplus four times this year. The trade surplus of 40.38 million dollars, 6.28 million dollars, 82.90 million dollars ad 65.25 million dollars were reported in May, August, September and November, respectively. Ever since the industry statistics were collected, the monthly trade balance has never made surplus. Monthly trade balance in last two years (Unit: USD 1 million) Source: Korea Customs Service The pharmaceutical industry analyzes the big leap in biosimilar export has played a significant role in breaking the record of pharmaceutical export and trade balance performance. In fact, the half-year report each submitted to the Financial Supervisory Service by Celltrion Healthcare ad Samsung Biologics found the two companies have generated export volume of 777.2 billion won and 380.5 billion won, respectively. Compared to last year same time, both companies have made historic records. Celltrion’s exports in Europe and the U.S. have been impressive. From early this year, the company started marketing Remsima SC in Europe, and their Truxima and Herzuma have started making revenue in the U.S. Remsima SC is the world’s first subcutaneous injection with infliximab substance. Samsung Biologics’ performance started to take off from the second half of last year, and its business entered a stable state. The comprehensive performance was boosted by the overall production capacity increased with the third manufacturing plant in full motion, and CMO sales leaned heavy on more highly priced products.
- Policy
- Lee Nak-yon “Nationwide fast COVID-19 testing for all"
- by Lee, Jeong-Hwan Dec 18, 2020 06:05am
- The Democratic Party is to consult with the government and relevant experts to review the necessity of testing everyone in South Korea for COVID-19 via the fast antigen testing kits. At a National Assembly meeting for the political party leaders convened on Dec. 14, the ruling party leader Lee Nak-yon said, “It is time to discuss having the people to primarily self-test COVID-19 with the rapid testing kit and provide further advanced testing for the ones tested positive.” Lee asked the party leaders to “Have the respective policy committees to consider the recommendation with the government and expert to reinforce the current disease control system with the fast self-testing kit.” From Dec. 14, the health authority has decided to apply 50 percent of the National Health Insurance coverage on the fast antigen COVID-19 testing kit used at temporary testing centers to find the infected people with no symptoms. But going beyond the health authority’s measure, Lee is urging all people in South Korea should be tested for COVID-19. The rapid antigen testing kit only require 30 minutes to get the result, which is significantly shorter than the existing PCR type testing kits taking six hours. Instead of inserting a swab deep into the nasal passage for the testing sample, the antigen testing kit only needs to swab the inside of the nose. However, when the nasopharyngeal swab type shows accuracy of 97 percent, the rapid antigen testing kit is about 90 percent accurate. The ruling party leader noted, “Currently, the Medical Service Act does not allow an individual to take their own test sample. However, in the time of a crisis, a breakthrough strategy going beyond the existing system is needed.” He also added, “The number of positive cases is expected to surge, when the nationwide testing is conducted. I kindly ask everyone in every industry and position to cooperate and try to prepare treatment center and hospital beds beforehand.” Moreover, Lee also requested the opposition parties to form a ‘Special Committee for Overcoming COVID-19’ as a whole of the National Assembly. He said, “The COVID-19 seems to be spreading at a concerning rate. This is the time, where the politicians should seek for any contribution they can make to improve the situation. In August, both the ruling and opposition parties have agreed to form five special committees including the Special Committee for Overcoming COVID-19. However, the agreement has not been executed to this date. I request the opposition party to organize and operate the special committee as soon as feasible.”
