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- 2025-12-23 18:15:22
- Policy
- Hanmi's Suvast 2.5mg has been approved
- by Lee, Tak-Sun Aug 19, 2021 06:03am
- There was no Rosuvastatin 2.5 mg available.Hanmi has started to create a new market by pushing for the approval of combination drug. The MFDS approved Hanmi's Suvast 2.5mg on the 17th. It is Rosuvastatin 2.5mg, which is not released in Korea. It is used in primary hypercholesterol and complex hyperlipidemia. Ministry of Health, Labour and Welfare of Japan recommends Rosuvastatin 2.5mg to Asians with smaller body types. According to indications of Suvast 2.5 mg, the recommended initial dose is 2.5 mg or 5 mg because of increased systemic exposure to Asian patients. Previously, if Rosuvastatin 5mg was used for initial dose, the drug choice that can be used with 2.5mg was increased. Hanmi is known to be planning to market Rosuvastatin 2.5mg strategically. Hanmi is also pushing for the approval of combination drug containing Ezetimibe. It is said that in April, it applied to the MFDS for approval of Rosuzet 10/2.5 mg (Rosuvastatin 2.5mg / Ezetimibe 10mg). Rosuzet posted ₩99.1 billion in outpatient prescription sales last year alone. It is expected to focus on Suvast 2.5mg, and drugs containing Rosuvastatin 2.5mg in Korea. As a result, it is expected that it will emphasize that the amount of Rosuvastatin 2.5mg is more suitable for Koreans with its initial dose. Hanmi conducted phase 3 of Ezetimibe/Rosuvastatin 10-2.5 mg dose group (N=68), this drug (Rosuvastatin 2.5 mg) dose group (N=67), Ezetimibe 10 mg dose group (N=70), and Rosuvastatin 5 mg dose group (N=70) for 8 weeks in 275 patients with primary hypercholesterol. In the primary validation, the LDL-C change rate (%) in this drug (Rosuvastatin 2.5 mg) administration group decreased statistically significantly compared to the Ezetimibe 10 mg administration group, and the average LDL-C change rate (%) in Ezetimibe / Rosuvastatin 10/2.5 mg administration group decreased by 2.5 mg. Through clinical trials, the complex has already been announced
- Policy
- PPIs benefit from ranitidine’s market removal
- by Lee, Jeong-Hwan Aug 19, 2021 06:03am
- MFDS notice regarding ban on ranitidine drugs With proton pump inhibitors (PPI) enjoying reflective interest in sales from the market removal of ranitidine, which was banned due to detection of the potentially carcinogenic substance NDMA(N-Nitrosodimethylamine), criticism is rising that national health insurance finances are being unnecessarily wasted. The point is that PPIs cost on average twice to three times more than tidine-class H2 receptor blockers, and the increased use of the PPIs not only increases NHI expenditures but also increases the financial burden borne by the patients. On the 17th, the pharmaceutical industry was been busy analyzing the changes in the peptic ulcer treatment market brought on by the banned sales of ranitidine drugs after the rise of its NDMA impurity issue in 2019. After ranitidine was removed from the market due to the detection of NDMA impurities, a significant amount of prescriptions have moved from H2 receptor blockers to PPIs. Annual prescription sales from 2018 to 2020 also show that prescription sales of PPIs have increased from ₩454.9 billion in 2018 to ₩523.4 billion in 2019, and ₩633.5 billion last year. On the other hand, prescription of H2 receptor blockers decreased from ₩346.5 billion in 2018 to ₩296 billion in 2019 when NDMA impurities were detected and relevant products were banned from the market, then fell to ₩132.5 billion last year, to be reduced to 1/3 in just 3 years. Numbers show that the size of the peptic ulcer prescription market has rather grown compared to 2018 due to an increase in PPI prescriptions despite the removal of the ranitidine ingredient. The growth of the prescription market was influenced by the increased use of PPIs that cost on average twice to three time more than H2 receptor blockers. More specifically, H2 blockers cost ₩276 to ₩360 a day at an average of ₩314/day, whereas PPIs cost from ₩527 to ₩1,300 at an average of ₩314/day. Due to this, some have criticized that replacing ranitidine prescriptions with the high-priced PPIs that are of a different class when other lower-priced H2 blockers in the same class as ranitidine with no NDMA detected are available increases waste of NHI finances. Their position is that changing prescriptions to higher-priced drugs not only increases NHI expenditures but also increases the financial burden borne by patients in the long term. To resolve the issue, industry experts had suggested that the authorities should provide same-class drug prescription recommendations in the event inevitable recalls and substitution of drugs arise due to safety issues as in the NDMA case, Industry experts believe efforts such as introducing pop-up windows in the DUR system that show same-class drug recommendations when HCPs select and prescribe drugs should be made to prevent an unnecessary increase in NHI expenditures. An official from a domestic pharmaceutical company said, “I am positive about the government’s decision to promptly recall and discontinue sales of the potentially harmful ranitidine substance, but it is unfortunate that there were no specific guidelines on its replacement and that it caused an increase in NHI expenditures. It is a waste of NHI finances as well as an increased financial burden on the patients to substitute ranitidine to high-priced PPIs when there are other, lower-priced drugs available in the same class with the same indications.” He continued, “The replacement process for hazardous drugs should be further improved and advanced using the DUR system, etc. It is the doctor’s responsibility to select or switch drugs due to their lack of effect in the treatment process, however, the use of same-class low-priced drugs should be prioritized for substitutions due to external factors."
- Policy
- It plans to expand its supply of Moderna vaccines in Aug/Sep
- by Kim, Jung-Ju Aug 19, 2021 06:02am
- It plans to expand its supply of Moderna vaccines in August and September. Samsung Biologics' distribution in Korea is still pending. A government delegation to the U.S. announced the results after visiting Moderna The government received an apology from Moderna for the disruption in the domestic supply of COVID vaccines and announced that it will receive more domestic supplies this month and next month and move up the supply schedule early next month. However, the government avoided giving a definite answer as there are many obstacles such as contracts between companies regarding supplying models or products that Samsung Biologics is consigned to Korea first. At the COVID-19 Central Disaster and Safety Counters Headquarters, video conference held today (the 17th), the delegation consisting of Kang Do-tae, the second vice minister, and Ryu Geun-hyuk, the presidential secretary for social policy, reported last week's visit to the U.S. Moderna headquarters, and the company's recent discussion on vaccine supply disruption and supply stabilization. According to the MOHW and Central Disaster and Safety Counters Headquaters, during the visit, Moderna apologized for the government and people's difficulties caused by sudden supply disruptions, and explained that the manufacturing laboratory problems at cooperative manufacturers are now being resolved and gradually released in July. The government asked the company to provide supplies that could not be supplied from August to early September, and to inform the schedule by this week, and Moderna said it would do its best to supply supplies and notify the government of its supply plan. In particular, the government has not received a clear answer on how it can supply production volume of Samsung Biologics, which is consigned to produce Moderna vaccines, to South Korea. In an answer to a regular briefing question, Vice Minister Kang Do-tae said, "It is desirable that domestic consignment production supplies are supplied to Korea in terms of securing safety in the supply of vaccines and streamlining the distribution process. He added, "There is a need for continuous consultation on the contractual relationship between Samsung Biologics and Modena, and the interrelationship between companies and domestic administrative procedures" According to the government, there will be no significant disruption to the age-specific vaccination plan and achievement of the target.
- Policy
- Indication extensions filed by Abilify generics increase
- by Lee, Tak-Sun Aug 18, 2021 05:51am
- Otsuka After Yungjin Pharm finally succeeded in invalidating the use patent of Abilify (aripiprazole·Korea Otsuka Pharmaceutical) after 6 years of patent dispute, other generics products of Abilify are now seeking to extend its indications. The use patent that was in dispute had protected Abilify’s ‘bipolar disorder’ indication, due to which generic companies other than Yungjin Pharm were unable to include the indication in their Abilify generics. According to the Ministry of Food and Drug Safety on the 16th, applications containing the 'treatment of acute manic and mixed episodes related to bipolar disorder' indication are being continuously filed for Abilify generics. Bipolar disorder, commonly known as 'manic-depressive disorder,’ causes extreme mood swings that include a pattern of emotional highs (mania or hypomania) and lows (depression). Abilify is a representative central nervous system (CNS) drug that has many indications, including schizophrenia, bipolar disorder, major depressive disorder, irritability associated with autism, and Tourette syndrome, etc. However, Otsuka had registered use patents for each indication at the time of indication expansion, restricting the use of generics for such indications. As a result, most domestic companies with Abilify generics had released their product in the market with only 1 to 2 indications, such as schizophrenia and Tourette syndrome. On the other hand, Yungjin filed an invalidation suit on the use patent registered for Abilify’s bipolar disorder and received approval for the said indication. The patent suit continued for 5 years from March 2015 when the invalidation claim was first filed. In the first trial, the Intellectual Property Trial and Appeal Board turned down Yungjin’s claim and ruled in favor of Otsuka. However, in the second trial, the Patent Court of Korea overturned the first trial decision and rule in favor of Yungjin Pharm. Last April, the Supreme Court ruled the use patent invalid, ending the fierce dispute in Yungjin Pharm’s victory. For Yungjin, the trial could have ended in immense claims for damages from patent infringement. Moreover, when the Patent Trial and Appeal Board rejected the claim, reducing the possibility of patent invalidation, other generic companies had taken a step back, withdrawing their claims and deleting their indications. After twists and turns, Yungjin, the only company to continued the suit, succeeded in invalidating the use patent. The win came with less than a year left until patent expiry, as the patent was scheduled to expire on January 29 of next year. Yungjin’s win has affected indications filed by other generic companies as well. Daewoong Pharmaceuticals and Pharvis Korea had already received approval for the bipolar disorder indication for their generics. The companies’ products are produced by Yungjin Pharma under a CMO agreement. Other companies have also recently applied for approval of their generics that contain the bipolar disorder indication. As the patent had expired due to patent invalidation, and the number of generics with the bipolar disorder indication is expected to continue to increase in the future. Abilify is a blockbuster drug that posted 45.4 billion won in sales last year. Even after its substance patent expired and generics were introduced to the market, the drug maintained its high market share with its use patents. However, the continued patent challenges filed by generic companies are expected to continue to challenge Abilify's throne in the market.
- Policy
- Moderna apologized to the gov for the disruption in supply
- by Kim, Jung-Ju Aug 18, 2021 05:51am
- Kang Do-tae, the second vice minister of welfare, and other delegations visited the U.S. headquarters for an interview. The government visited the U.S. headquarters of Moderna that supplies the vaccine worldwide to protest against the supply disruption and ask for quick measures. The delegation, composed of Kang Do-tae, the second Vice Minister of health and welfare, and Ryu Geun-hyuk, secretary to the President for Social Policy, received an official protest and apology from the U.S. headquarters of Moderna today. After the meeting, Vice Minister Kang said, "The government asked for a faster supply of COVID vaccines," adding, "Moderna expressed its apology and promised to do its best." However, the company failed to respond to the government's request to move it up as soon as possible, so it plans to hold additional consultations. Therefore, detailed information is expected to be released on the 16th when the team returns back. "Today's meeting was an opportunity for the government and Moderna to enhance mutual understanding," Kang said. "I asked them to move up the schedule as soon as possible. We will make an official announcement after further consultation with the company after returning to Korea. Moderna is experiencing disruptions in supply not only to Korea but also to the world due to production disruptions. Some of its supplies were already delayed once last month in Korea, and this time, the supply was reduced by less than half. As a result, the government has extended the interval between 1st and 2nd vaccinations of mRNA-based vaccines such as Moderna and Pfizer from 4 weeks to 6 weeks. The KDCA signed a contract on the 13th to purchase 30 million doses of Pfizer vaccine and 30 million optional doses to secure the vaccine early. The optional doses is the amount of volume that can be added according to the mutually agreed period and conditions, if necessary. Up to 60 million batches could be supplied. In addition, 300,000 Janssen vaccines, which the U.S. government decided to donate, will arrive at Incheon International Airport on the 15th.
- Policy
- Opdivo's RSA renewed… benefit extended for use with Yervoy
- by Lee, Hye-Kyung Aug 17, 2021 05:52am
- ‘Opidivo inj. (nivolumab),’ the first cancer immunotherapy approved in Korea has successfully extended its contract ahead termination of its risk-sharing agreement (RSA) term. In addition to Opdivo, the breast cancer treatment ‘Kisqali (ribosiclib) was also included in the list of drugs that completed negotiations with the National Health Insurance Service (NHIS) that was recently disclosed by NHIS. The RSA contract term for Opdivo, which was granted reimbursement through the RSA scheme since August 21st, 2017, was set to expire by August 20th this year. Before expiry, Ono Pharma Korea and Bristol-Myers Squibb Korea Pharmaceutical had applied to the NHIS to extend Opdivo's RSA contract and to expand reimbursement for its use in combination with ‘Yervoy(ipilimumab)’ in first-line kidney cancer. The combination of the PD-1 inhibitor Opdivo and CTLA-4 inhibitor Yervoy was approved as a first-line treatment for renal cell carcinoma (RCC) in August 2017. The indication passed NHIS’s Cancer Disease Deliberation Committee review in June last year. In April this year, 9 months after the CDRC review, the combination’s indication for the ‘treatment of patients with moderate- and high-risk, previously untreated advanced renal cell carcinoma (RCC), was recognized appropriate for reimbursement by HIRA’s Cancer Drugs Benefit Appraisal Committee. Since then, the company has been in pricing negotiations with the NHIS. However, in the first 60-day negotiation period, negotiations fell through with the NHIS and pharmaceutical companies being unable to reach an agreement. The two parties finally signed an agreement in the second negotiation that followed. Specifics of the RSA extension for Opdivo and use in combination with Yervoy will be disclosed after amendments to the notice are deliberated and passed by the Ministry of Health and Welfare’s Health Insurance Policy Deliberative Committee. In addition to Opdivo, the NHIS announced that it had also completed negotiations for Kisqali. Kisquali is approved in combination with an aromatase inhibitor in pre-, peri-, post-menopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer; or with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
- Policy
- SK Chemical will sell Zemplar
- by Lee, Tak-Sun Aug 17, 2021 05:52am
- The original Zemplar (Paricalcitol) will be sold by SK Chemical in Korea. It is imported and supplied by AbbVie Korea, and SK Chemical has been in charge of distribution, sales and marketing in Korea since July. SK Chemical is expected to compete fiercely with generic companies. According to industries on the 12th, SK Chemical has been distributing and selling AbbVie's Zemplar in Korea since July. Sales of Zemplar ampules, which had previously been distributed, were discontinued. Zemplar is used to treat and prevent secondary parathyroidism associated with chronic renal failure. It is especially used to treat complications in dialysis patients. Last year, IQVIA was sold at ₩7.9 billion, which is widely used in dialysis complications markets along with Kyowa Kirin Korea's Regpara. Last year, generic for Zemplar was launched for the first time in Korea. Boryung's Pacitol was granted permission on January 30 last year. Pacitol has been on sale since April of that year. As of last year's IQVIA, sales amounted to ₩1.3 billion. Since then, Huons' Hucitol has expanded its consignment production with permission. This change in Zemplar's domestic sales company is interpreted as a response to the generic's offensive. Its strategy is to win the competition with Generic through SK Chemical, which has a well-established distribution network in Korea. The reason why the ampule formulation was discontinued is because of the lower price due to the launch of generic products. Zemplar ampule formulation was twice as expensive as vial formulation, but since April, when generic items were released, both original and generic have become the same price. As a result, competition between original and generic companies is expected to intensify.
- Policy
- GBP510 has been approved for Phase 3, the 1st time in Korea
- by Lee, Tak-Sun Aug 17, 2021 05:52am
- Domestic developed COVID-19 vaccine has entered the final stage of commercialization. A candidate for the COVID-19 vaccine developed by SK Bioscience will conduct phase 3 clinical trial. The MFDS announced on Tuesday that it approved phase 3 clinical trial plan for the first domestic COVID-19 vaccine after thoroughly verifying its safety and scientific feasibility. With the approval, COVID-19 vaccine developed by a Korean company will enter phase 3 clinical trial for the first time. GBP510 is a recombinant vaccine that injects surface antigen protein of the coronavirus created using genetic recombination technology to induce immune response, stimulating immune cells in the body and neutralizing and eliminating the virus when it enters the body. This vaccine has been developed to enhance immune effectiveness by generating a large number of antibodies, especially by utilizing techniques that increase antigen exposure. The three-phase clinical trial approved this time is a clinical trial to evaluate the immune origin and safety of GBP510 for adults aged 18 and older. phase 3 clinical trial is conducted in a comparative clinical manner using Astrazeneca COVID-19 vaccine stocks, which are licensed in Korea and used for vaccination, as a control group. As a control group, AstraZeneca COVID-19 Vacine was selected, considering the absence of a licensed COVID-19 recombinant vaccine. and was designed to confirm the superiority of neutral antibodies and the non-equivalence of serum reactions. Neutralized antibodies are the amount of antibodies that can neutralize a particular virus, and the serum reaction rate is the percentage of test subjects whose antibody price increases more than four times compared to before vaccination. The total number of test subjects is 3,990, 3,000 for the test vaccine, and 990 for the control group will be vaccinated twice every four weeks with 0.5 mg each, and safety and immunogenicity will be evaluated. Phase 3 will be conducted simultaneously not only in Korea but also in Southeast Asia and Eastern Europe. Phase 3 clinical trial is a test to verify the safety and validity of a drug, and its validity is reviewed based on the results of a prior clinical trial, quality of a clinical drug, non-clinical data, etc. In the case of GBP510, phase 2 is currently in progress, but phase 1 showed sufficient safety and immunogenicity, showing the possibility of entering phase 3. After phase 1 and phase 2 was approved on January 26, a phase 1 clinical trial was conducted on 80 healthy adults (ages 19 to 55 years old) and a phase 2 clinical trial is underway on 240 people. As a result of phase 1 intermediate analysis, neutralized antibodies were produced in all vaccinators in terms of efficacy, which was more than five times higher than that of the International Standard Serum (perfection and autoclave). No special side effects have been reported other than cases (injection pain, fatigue, muscle pain, headache, etc.) that are common when vaccinated. In addition, the MFDS explained that it reviewed non-clinical test data such as reproductive toxicity and animal model attack tests, and quality data such as batch analysis results. The MFDS held an advisory meeting with clinical experts on the 9th and consulted on the appropriateness of the evidence data and feasibility of the clinical trial plan to enter phase 3. The MFDS said the approval of the clinical trial is meaningful that it has taken the first step toward self-sufficiency of the domestic vaccine as the first domestic vaccine enters phase 3 amid the coronavirus epidemic. Even though there is no global vaccine leader, it approved phase 3 clinical trials for the development of the COVID vaccines in Korea, and even before the establishment of the Immunological Correlate of Protection (ICP), it introduced a comparative clinical method with active and close screening. Immunological Correlate of Protection(ICP) is most commonly defined as a type and amount of immunological response that correlates with vaccine-induced protection against a clinically apparent infectious disease and that is consider The MFDS stressed that it will continue to communicate with the clinical site after the product's clinical approval so that clinical trials can proceed smoothly, and other products that are undergoing clinical trials in Korea can quickly enter phase 3. It also added that it will thoroughly monitor safety issues such as unexpected adverse reactions of clinical trial participants and medication information that affects clinical trials, and make sure clinical trials are carried out safely.
- Policy
- “Mooncare a success…37 million people saved ₩9 tril.
- by Lee, Jeong-Hwan Aug 13, 2021 05:57am
- President Moon Jae-in said the government will continue and accelerate its efforts to further broaden the NHI coverage in 2022 as in this year. Moon also stated that 37 million people in Korea were able to save a total of 9.2 trillion won in medical costs during the 4 years since Mooncare was implemented. Also, he personally announced that insurance benefits on thyroid and sinus ultrasounds will be applied in Q4 of this year, which is earlier than planned, and NHI coverage will be extended to severe heart diseases, psoriasis, and root canal treatment by next year. The news was announced by President Moon at the ‘Performance review meeting for the 4th anniversary of Mooncare’ that was held on the 12th. He assessed that Mooncar, which was announced in 2017, has played an integral part in realizing the goal of building a nation free from worries about hospital bills while exceeding the target level of health insurance reserves. Moon's understanding was that Mooncare is one of the policies that the people were most satisfied with. As such, the president plans to further broaden and accelerate the NHI coverage enhancement policy. Specifically, he pledged to implement NHI coverage to sinus and thyroid ultrasounds from Q4 this year, and to severe heart diseases, psoriasis, and root canal treatment by the next year. In addition, Moon said the government will expand support for children's public centers and establish a short-term hospitalization service center for severely ill pediatric patients to expand NHI support for children. Also, the government plans to designate a regional hospital as a base hospital for critically ill patients from the second half of this year so that the severely ill may receive treatment in hospitals near their residence. Furthermore, President Moon said that the health insurance will prime and accelerate the development of medical technology in Korea and that the government will make the effort to catch both birds – of securing NHI’s sustainability and expanding coverage. “Mooncare not only tended to disease of individuals, but it also allowed us to promptly and appropriately respond to all areas of healthcare related to infectious diseases, from prevention and diagnosis of COVID-19, its treatment expense, to securing support for medical personnel. In other words, NHI well-played its role as the last defender in controlling the COVID-19 crisis. I would like to express my gratitude to the NHIS and medical personnel for their efforts in strengthening NHI coverage.” The president continued, "The government had focused on enhancing coverage for severe diseases that bring a high medical burden such as cancer. We are also in the progress of abolishing the selective consultation fee system, applying insurance to upper-grade wards, expanding the integrated nursing care service, expanding insurance to MRIs and ultrasounds, and reimbursing non-reimbursed drugs. Also, we will institutionalize disaster medical expenses support for 4 major severe diseases in low-income families, and cover up to 30 million won for all diseases and lower the annual copayment ceiling.” “We enhanced the coverage rate for children who are 5 years or younger, as well as for seniors 65 years and older that more frequently visit hospitals. As a result, 37 million people have saved a total of 9.2 trillion won in medical costs. As a high level of citizenship is central to NHI’s sustainability, the government will make efforts to more transparently manage NHI finances.” MOHW·NHIS "will continue enhancing coverage next year” The Ministry of Health and Welfare and the National Health Insurance Service also added on details to support Moon’s performance report on Mooncare. In 2017, the MOHW had presented measures to lower the patients’ burden by reimbursing the medically necessary non-reimbursed items and drastically reducing the medical cost for the underserved population such as the elderly, children, women, and low-income families. ‘ The coverage enhancement measures that were planned to be implemented by 2022 focused on the following three core areas:▲reimbursing the non-reimbursed ▲relieving out-of-pocket costs for the underserved population ▲reinforcing the medical safety net. To reimbursee the non-reimbursed the authorities had abolished the selective consultation fee, and applied insurance to 2-person and 3-person wards in hospital levels or higher medical institutions. The integrated nursing care service was also expanded by over two times. Also, the non-reimbursed items that are necessary for treatment such as ultrasounds and MRI tests were applied insurance in phases to reduce the medical cost. As a result, NHI coverage in tertiary hospitals increased from 65.1% in 2017 to 69.5% in 2019, and coverage in general hospitals also increased from 63.8% to 66.7% during the same period. By easing the medical cost borne by the underserved population, the burden of hospital expenses for children, the elderly, the disabled, and women were reduced. For children, the copayment rate of the hospital treatment cost was reduced to 5% from 10-20%, and the outpatient cost was also reduced for children under the age of 1. The copayment rate for outpatient cost in premature infants and low birth weight infants was also reduced, and insurance was applied to cavity treatment, cleft lip treatment, and orthodontic braces treatment. For the elderly, the copayment rate for the treatment of severe dementia and other major conditions such as dentures and implants was lowered. For the disabled, eligibility in receiving reimbursement for assistive devices was expanded, and the reimbursed amount for prosthetic legs and hands was raised. In addition, in order to strengthen the medical safety net, the upper ceiling of the out-of-pocket cost paid by the bottom 50% of the income class was reduced to a level near 10% of their annual income, thereby increasing the reimbursed amount for low-income families. As a result, about 37 million people saved 9.2 trillion won in medical cost reduction from 2018 to 2020. Positive responses from the public regarding the coverage enhancing measures also jumped from 39.7 % at the time the policy was announced to 94% in August 2020.
- Policy
- Regkirona's indication expansion has been requested
- by Lee, Tak-Sun Aug 13, 2021 05:57am
- Celltrion's COVID-19 antibody therapy Regkirona is pushing for an expansion of indications based on global phase 3. Regkirona was conditionally approved to submit a clinical trial result report for therapeutic confirmation in February and was used only in patients with mild to secondary COVID groups. Celltrion submitted a report on the results of the clinical trial and applied for a change in efficacy from all mild cases over the age of 12 to secondary patients. The MFDS announced on the 10th that Celltrion has applied for a change in permission of the COVID-19 antibody treatment drug Regkirona (Regdanvimab) based on a global phase 3. Changes include ▲ deletion of permission conditions ▲ expansion of effectiveness ▲ reduction of time spent. Celltrion submitted a clinical trial report on August 10, which should be submitted by December 31. Regkirona's effectiveness was conditionally granted only for "improvement of clinical symptoms in patients with mild to secondary COVID-19" in high-risk groups, but it was changed to "treatment for patients with secondary COVID-19 in adults and 12 years of age and older." Celltrion also requested a change in administration time from IV for 90 minutes to IV for 60 minutes. "We plan to quickly and closely examine the application for the change," said an official at the MFDS. "We will continue to do our best to provide safe and effective treatments to our people quickly," he stressed.
