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- 2026-05-06 03:12:13
- Policy
- President Moon "will make all efforts to return to normalcy"
- by Lee, Jeong-Hwan Jan 04, 2022 05:56am
- During his 2022 New Year’s address, President Moon Jae-in expressed his gratitude and respect to the medical professionals and personnel working to contain and prevent COVID-19 and restressed the excellence of Korea’s disease control and prevention system. The president also expressed his ambition to achieve complete recovery of the peoples’ lives by strengthening epidemic prevention and control in the new year. While delivering his New Year’s address at Cheong Wa Dae on the 3rd, President Moon Jae-In said,” Korea’s response to the virus has risen to prominence on its merit amid the global fight against COVID-19." “During the past two years of the COVID-19 pandemic, the Government and the people have come together as one to surmount crises. We have turned those crises into opportunities while demonstrating once again the potential of the crisis-resilient Republic of Korea. This achievement has been made possible by combining the efforts of the Government, the dedication of medical professionals, and our people’s strong sense of solidarity.” President Moon said, "We stand again on the starting line of a New Year. I wish everyone a happy New Year and a year to make yet another leap forward, inspired by the tiger’s vigorous energy. Even at this moment, our anti-epidemic workers and medical professionals are struggling in freezing temperatures. Once more, I extend my profound respect and gratitude to them.” President Moon emphasized that moving toward normal daily routines while strengthening epidemic prevention and control is the starting point for a full recovery and that the country's anti-epidemic measures have begun to take effect. He expected that as the number of confirmed cases will continue to decrease, the number of severely or critically ill patients will also decline soon. However still, the president expressed concerns over the rise of COVID-19 cases due to the spread of the Omicron variant. The president is determined to make all-out efforts to overcome the COVID-19 crisis that arose from the variant and achieve complete recovery in the people's lives. President Moon said, “The administering of booster shots and the inoculation of adolescents are also picking up speed, and a great number of hospital beds and medical professionals are being secured. Starting this month, pills for oral COVID-19 treatment will be dispensed. However, it is too early to let our guard down as the number of newly confirmed cases is breaking records around the world due to the Omicron variant." “We will work intensively to overcome this crisis. With a long-term perspective, the government will nourish hope for a return to normal life by riding out the difficulties along with the people in a steady manner. It is truly regrettable that our people are facing growing hardships in their livelihoods with tightened anti-epidemic measures being extended and a return to normalcy being delayed. I’d like to give special words of comfort to the microbusiness owners.” While mentioning the upcoming presidential election in March, the president expressed wishes for the election to become an election of unity that embodies the hope of the people, instead of hostility, hatred, and division. President Moon said, “With the presidential election up ahead, I hope that the election will become a celebration of democracy in which a candidate is chosen by the people through fierce competition, for the sake of people’s lives and the country’s future. Our people are the master of politics, and their participation is what advances democracy and raises the level of politics.” He added, “As an administration devoted to overcoming the crises and pioneering the future, my administration will work at full capacity for the remaining four months.”
- Policy
- Minister Kwon said he would develop vaccines and txs
- by Kim, Jung-Ju Jan 04, 2022 05:55am
- Minister of Health and Welfare said he will foster the biohealth industry by investing in building a global bio-human resource training hub, developing vaccines and treatments, creating a "K-Global" vaccine fund and revitalizing the use of domestic medical devices in 2022. Minister Kwon issued a New Year's address today (31st) and explained tasks and directions such as responding to the current COVID-19 crisis, developing and fostering the health industry, establishing a medical system, and strengthening health insurance coverage. First of all, the government's budget for next year has been confirmed to be 607.7 trillion won, of which the budget is set at 97.4767 trillion won. It accounts for the largest portion of the government's budget at 16%. Minister Kwon said, "Next year, we will do our best to overcome the COVID-19 crisis by actively investing our budget in preemptive securing of COVID-19 vaccines and treatments, securing treatment beds for severely ill patients, and supporting COVID-19 depression." Regarding the pharmaceutical bio-industry, he also explained that he plans to foster the bio-health industry by investing in building a global bio-human resource training hub, developing vaccines and treatments, creating a K-global vaccine fund, and activating the use of domestic medical devices. Minister Kwon said, "The MOHW will always think about whether even a single policy can change the lives of the people and contribute to the happiness of the people, and work while finding answers and communicating on the spot." He said, "As it is Year of the Black Tiger, I look forward to starting the year vigorously with the spirit of Black Tiger and overcoming the COVID-19 crisis."
- Policy
- Additional contracts for COVID-19 PO tx are under discussion
- by Kim, Jung-Ju Jan 04, 2022 05:55am
- The government is pushing for additional purchases of oral COVID-19 treatments separately from existing contracts.The KDCA announced its 2022 work plan today (30th) under the theme of "COVID-19 Disease Control and Prevention Response and National Health Support." Authorities plan to strengthen severe prevention by introducing oral treatments next year. It plans to expand the target institutions for domestic antibody treatment and operate a rapid supply system to reduce the transition of mild patients to severe diseases. It will also actively introduce oral treatments to supply them to home treatment patients and hospitalized patients dedicated to infectious diseases, reduce hospitalization or death of patients, and maintain a medical and quarantine system. Currently, authorities are pushing for a pre-purchase contract for 1 million and have signed a contract for 604,000 people so far. Authorities said they are discussing additional purchase contracts separately from the existing contract volume for the spread of Omicron and a soft landing of daily recovery, and will sign the contract in early January next year and disclose it to the public. ◆ By strengthening daily disease prevention and management= the KDCA operates a visiting tuberculosis screening and regular screening center, and strengthens support for tuberculosis patients in vulnerable groups through integrated health and welfare services. In addition, genital infections caused by HPV, the main cause of cervical cancer, can be prevented by vaccinating more than 90%, but it will be actively supported by expanding the free support for HPV vaccinations due to expensive vaccination costs. The target, which was limited to 12-year-old girls this year, will be expanded from next year to girls aged 13 to 17, basic livelihood recipients aged 18 to 26 from 2018 to 2026, and women in the second-highest class.The government will continue to promote the prevention and management of non-infectious diseases by expanding the scope of registration management of hypertension and diabetes and medical expenses to rare diseases. The results of the first climate health impact assessment will be announced in the first half of next year after evaluating the impact of climate change on people's health, and based on this, a disease management policy will be established to prepare for climate change. In preparation for future public health threats, the government will provide all-out support to advance the national quarantine system = commercialization of COVID-19 vaccine in Korea, and strengthen its full-cycle investment in R&D to secure various technologies such as new technology platform vaccines (mRNA). The KDCA expands core technology development, non-clinical research, and establishes a regular cooperative system for clinical research to strengthen its capability to develop new strain virus treatments such as COVID-19. International cooperation will be strengthened through cooperation in sharing information and substances on infectious diseases through participation in WHO new hubs and expansion of ASEAN infectious diseases and technological cooperation. In order to respond quickly and effectively to new infectious diseases such as COVID-19, related systems such as infectious disease systems and quarantine systems will be efficiently integrated to establish an integrated quarantine information system. It plans to systematically collect and manage information related to COVID-19 (confirmed patients, vaccinations, adverse reactions, etc.) and promote policies to respond to infectious diseases based on scientific evidence.
- Policy
- Changes in Benefit standards such as diabetes drugs
- by Kim, Jung-Ju Dec 31, 2021 05:50am
- The general principles of diabetes solvents and psychotropic drugs and some of Soliris (Eculizumab)'s detailed recognition criteria and methods for benefits change. Testosterone undecanoate, such as Andriol Testocaps Soft Cap, a male hormone drug, is classified by item, and detailed recognition criteria and methods are deleted. The MOHW announced on the 28th a partial amendment to the details (drugs) on the application standards and methods of medical care benefits. As Vildagliptin PO is newly registered next month, it will be added to the general principles of diabetes solvents, single and complex sectors. This standard will take effect and apply on the 9th of next month. Some specified doses are deleted to reflect the MFDS permits (treatment period) of Zolpidem CR 6.25 mg and Zolpidem CR 12.5 mg. Specifically, from the 1st of next month, the doses previously defined as Zolpidem 5mg and Zolpidem 10mg will be deleted. After discontinuation of Soliris administration to Atypical Hemolytic Uremic Syndrome, benefits related to recurrence are expanded. Specifically, it is the case where the improvement of symptoms is stopped according to the recommendations and decisions of the committee and the judgment of the medical staff. The part requiring medical judgment was subject to the committee's decision. Meanwhile, Testosterone undecanoate is deleted from the drug benefit list and the standard notice is also deleted, and the date of other central neuropharmaceuticals, such as Wakix Film Coated Tab 5mg, is changed from January 1 to February 1 next year.
- Policy
- Will Boryung succeed in tackling Sprycel’s patent
- by Lee, Tak-Sun Dec 30, 2021 05:51am
- Whether a generic for the second-generation chronic myeloid leukemia treatment ‘Sprycel (dasatinib, BMS)’ will be introduced following generics for the first-generation ‘Gleevec (imatinib mesylate, Novartis)' is gaining attention. If introduced, Sprycel’s generic is expected to greatly improve patient accessibility. According to the industry on the 28th, Boryung Pharmaceutical is starting to develop a generic for Sprycel. Since 2013 when the first generic Gleevec was introduced to the market, domestic pharmaceutical companies have attempted the development of a generic version of Sprycel. However, the companies were not able to progress due to patents, etc. No approvals nor bioequivalence tests were made for generic Sprycel since its PMS expiry on August 19th, 2016. Some domestic pharmaceutical companies had attempted patent challenges in 2015 but dropped their suits the same year. Sprycel’s substance patent expired last year on April 12th. Attempts at generic Sprycel started again in December last year with Boryung Pharmaceutical filing an invalidation trial and a Passive trial to confirm the scope of the patent on Sprycel’s use patent (expires on March 23rd, 2024) and crystalline form patent (expires on February 4th, 2025). Daewoong also joined in the invalidation trial on Sprycel’s use patent. Boryung Pharmaceutical then applied and received approval for a bioequivalence test protocol on 'BR2009' from the Ministry of Food and Drug Safety. The BR2009 targets chronic myeloid leukemia like Sprycel. Given this, analysts are assuming that the bioequivalence test is for the development of a generic for Sprycel. Boryung Pharmaceutical currently owns a generic version of Gleevec, ‘Glima Tab.’ The company had opened the doors for generic entry by winning the patent invalidation suit for Gleevec’s composition patent. If Boryung Pharmaceutical succeeds in releasing a generic version of the second-generation Sprycel following its success in releasing a generic for the first-generation Gleevec, the company’s status and competitivity in the relevant market is expected to further increase. However, it is difficult to predict the success as the company is in the early stages of the patent challenge. Therefore, attention is focused on whether Boryung Pharmaceutical will be able to open the tightly closed latch for generic versions in Sprycel as in Gleevec.
- Policy
- The MFDS plans to approve Daewoong's Fexuprazan
- by Lee, Tak-Sun Dec 30, 2021 05:51am
- Fexuprazan, a new drug for GERD that Daewoong Pharmaceutical has researched and developed for 14 years, is expected to obtain domestic approval soon. When Fexuprazan is released, Daewoong is expected to fill the gap in the PPI-based treatment Nexium. According to the industry on the 28th, the MFDS completed the safety and effectiveness examination of Fexuprazan and left only the final approval procedure. Fexuprazan applied for an item license to the MFDS in November 2019. Fexuprazan is P-CAB drug such as K-Cab (Tegoprazan, HK inno.N) licensed in July 2018. The advantage of P-CAB-based drugs is that they have a longer gastric acid secretion inhibition effect than conventional PPI-based drugs. Therefore, it is possible to administer regardless of meals. With the launch of K-Cab, the existing PPI-oriented GERD market structure is also changing. K-Cab is expected to achieve 100 billion won in sales this year and has risen to the No. 1 item in the market. Prior to the launch of K-Cab, the No. 1 item in the market was Nexium. Nexium is an imported drug developed by AstraZeneca and has long been sold by Daewoong Pharmaceutical in Korea. AstraZeneca recently terminated its Nexium co-promotion contract with Daewoong Pharmaceutical and chose Ildong Pharmaceutical as a new sales partner. Analysts say that Daewoo's termination of the contract for Nexium, which generates annual sales of 50 billion won, is due to the imminent approval of Fexuprazan. With K-Cab has become the next-generation leader in GERD, so it is predicted that Fexuprazan's launch will quickly resolve the gap in Nexium. If Fexuprazan is approved, it is likely to become the 34th new domestic drug. The MFDS approved two new domestic drugs this year, with No. 32 Leclaza and No. 33 Rolontis (Hanmi Pharmaceutical). If Fexuprazan is approved by the end of this year, three new domestic drugs will be released a year.
- Policy
- Paxlovid is a new weapon added to our fight against COVID-19
- by Lee, Jeong-Hwan Dec 29, 2021 05:58am
- Minister Gang-lip Kim “An oral-type treatment will be prescribed to patients with severe or critical COVID-19 that are unsuitable to be treated with an injection-type (antiviral). In other words, we have secured another option in our armory to use against COVID-19.” Ministry of Food and Drug Safety Minister Gang-lip Kim This is what Minister Gang-lip Kim of the Ministry of Food and Drug Safety said, explaining that a new viable strategy for the control and management of COVID-19 will be added with the early use authorization of the oral COVID-19 treatment ‘Paxlovid.’ Although it is too early to jump to a conclusion on whether the oral pill has a better effect than the injectable drug, Minister Kim sees that the added option for severe or critical COVID-19 patients can bring a synergetic effect with the national vaccination scheme and social measures and diversify the methods against COVID-19. Kim said the decisive difference between the oral and injectable drugs is in their convenience in storage, distribution, and intake, and that the oral option may be a more appropriate option for patients treated from home. Minister Kim explained so on CBS radio’s ‘Kim Hyun-Jung’s News Show’ on the 28th after the MFDS had granted emergency use authorization for Pfizer’s oral COVID-19 treatment Paxlovid on the 27th. Kim said although Paxlovid cannot be directly compared with the injection-type form of treatment, it is a reassuring ‘weapon’ added to the fight against COVID-19. Therefore, he said it is too soon to call it a game-changer. The oral COVID-19 pill Paxlovid is taken as three tablets at once. More specifically, a set of drugs (two pink pills, one white pill) is taken together orally every 12 hours for five days. Kim said even if Paxlovid is distributed, it would be difficult to purchase Paxlovid other general prescription drugs. The government handles all of the purchased Paxlovid and will coordinate its provision to the patients. “The government plans to first purchase all of the pills then provide them to those in need. The authorities with the Korea Disease Control and Prevention Agency (KDCA) are discussing the best way to distribute and administer the drug in the field.” In addition, Kim said that the oral pill is significantly different in terms of storage, distribution, and administration compared to the injected-type drug that is being used in severe patients. “Subjects eligible for the oral pill are virtually the same as those for injections. The biggest difference is that the injection needs to be administered by another person for an hour. The oral pill may be self-administered with prescription every 12 hours for 5 days, and therefore is appropriate for patients treated at home.” “Also, in terms of storage, the drug can be stored at room temperature. Therefore, the decisive difference between the oral and injectable drug is in its convenience in storage, distribution, and intake.” On the question of whether the injection and oral pill has the same effect, Kim said that the two options cannot be compared horizontally. Rather, the use of oral drugs should be considered as an additional option to the injection already in use, and one more option in the fight against COVID-19. Kim said, “The most difficult question to answer is whether the treatments have the same effect. The treatments had different subjects in clinical trials and we cannot tell whether the drugs have the same effect or which is superior. Paxlovid and the existing injection-type treatment both showed a significant effect on severe and critical COVID-19 patients at analysis. We will be able to provide treatments appropriate for every patient -injection for hospitalized patients and oral pills for those that cannot receive the injections - with the added option. In other words, we have secured another weapon against COVID-19.”
- Policy
- Gov-National Assembly introduce oral treatment for COVID-19
- by Lee, Jeong-Hwan Dec 29, 2021 05:57am
- First Deputy Director Kwon Deok Cheol of CDSCHQ. As COVID-19 spreads to the Omicron mutation following the delta mutation, and the number of deaths and new confirmed patients increases, the attention of the National Assembly and the government is focusing on treatments.The National Assembly's Health and Welfare Committee is urging the U.S. FDA to preemptively secure domestic antibody treatments that are actively considering introducing COVID-19 oral drugs Poxlovid와 Lagevrio. The quarantine authorities are also expressing their willingness to respond quickly to securing oral drugs because they had difficulty in early vaccinations due to failure to secure vaccine supplies in the early stages of the spread of COVID-19. The Central Disaster and Safety Counters Headquaters announced on the 27th that it has signed a pre-purchase contract for COVID-19 oral medicine for a total of 604,000 people. CDSCHQ's Deputy General Manager Kwon Deok-cheol (Minister of Welfare) explained, "Following the United States, the government is also rapidly proceeding with the oral EUA process," adding, "We will be able to administer COVID-19 treatment as early as the end of January next year." The CDSCHQ is taking procedures for the oral drug EUA of COVID-19. The MFDS has announced that it will hold a "Safety Management and Supply Committee for Medical Products Responding to Public Health Crisis" to decide whether to approve the emergency use of COVID-19 oral drugs. In the case of the United States, approval for use has already been completed. The FDA approved the use of Lagevrio on the 23rd following the EUA approval of the Pfizer's Poxlovid on the 22nd (local time). The National Assembly Welfare Committee is also calling for securing COVID-19 treatments, citing cases in advanced countries. Rep. Kang Ki-yoon pointed out the reality that Korean quarantine authorities focused only on securing oral treatments. Kang's view is that next year's government budget bill could also be insufficient to respond to securing various COVID treatments by arranging only the cost of purchasing oral drugs. In particular, he also questioned the treatment effect of Lagevrio, which the quarantine authorities have started purchasing. He pointed out that unlike Merck's 50% reduction in hospitalization and death rates, FDA submission reports fell sharply due to a 30% reduction. The intention is that various treatments need to be secured as the effectiveness of the COVID-19 oral drug has not yet been clearly proven. Furthermore, through expert opinions, he said that measures should be prepared to diversify the use of antibody treatments such as Regkirona and Xvudy so that patients can be treated customized. Advanced countries such as the United States and Europe are actively purchasing various treatments in preparation for the increasing number of COVID-19 patients due to mutations, Kang said. "The United States, Europe, and Australia have started to secure Xvudy supplies, and Regkirona is also approving conditional permits." "Overseas countries are making efforts to select and secure drugs that are effective for severe coronavirus due to the increase in the number of people infected with Omicron," he said. "Korea should also prioritize securing various treatments considering continuous mutations." Customized treatment is required for each patient, he added.
- Policy
- Entry of FDA-approved new Chinese blood cancer drug imminent
- by Lee, Tak-Sun Dec 28, 2021 05:51am
- A new blood cancer treatment that was developed by a Chinese pharmaceutical company and approved by the US FDA will be soon introduced to Korea. The drug awaiting entry is BeiGene Korea’s ‘Brukinsa.’ If approved, Brukinsa will be the second new drug approved by a Chinese pharmaceutical company following Antengene’s ‘Xpovio tab 20mg.’ According to the industry on the 27th, the Ministry of Food and Drug Safety completed the safety and efficacy review of BeiGene Korea’s ‘Brukinsa,’ and the countdown for its marketing authorization has started. Brukinsa is a Bruton's Tyrosine Kinase inhibitor used in patients with B-cell primary central nervous system lymphoma. A BTK inhibitor is a targeted anticancer therapy that suppresses the survival and proliferation of malignant B-cells by blocking Bruton's tyrosine kinase protein, a signal that affects the survival and growth of B-cells. Other BTK inhibitors approved in Korea include Janssen’s ‘Imbruvica,’ AstraZeneca’s ‘Calquence,’ and ONO’s ‘Velexbru.’ Brukinsa is also famous as the first drug that was approved by the FDA based on a clinical trial conducted in China by a Chinese pharmaceutical company. It received FDA approval in November 2019. In the same year, the global pharmaceutical company Amgen acquired 20.5% of BeiGene’s shares. In particular, Beigine’s new innovative drug is being received with anticipation in Korea with the news that the company sells its drug at a reasonable price. Beigine had established its Korean subsidiary and prepared entry into the domestic market since October 2019. In addition to Brukinsa, the company has also been working to commercialize its immuno-oncology drug ‘tislelizumab.’ Antengene’s ‘Xpovio Tab. 20mg (Selinexor),' the first new drug developed by a Chinese pharmaceutical company to be approved in Korea, was introduced in July this year. It was approved in Korea for the treatment of refractory multiple myeloma and refractory diffuse large B-cell lymphoma and marked the start of the Chinese pharmaceutical companies’ entry into the Korean market. In addition to Beigine Korea that is working to receive marketing authorization for its new drug, Dizal Pharmaceutical is also conducting a clinical trial for a non-small cell lung cancer treatment, driving the entry of Chinese pharmaceutical companies into the Korean market in earnest.
- Policy
- MFDS approves emergency use of Pfizer’s oral COVID-19 drug
- by Lee, Tak-Sun Dec 28, 2021 05:50am
- Pfizer’s oral COVID-19 treatment ‘Paxlovid’ received emergency use authorization in Korea as well. Authorities plan to use the drug to treat adults and pediatric patients over the age of 12 with mild-to-moderate COVID-19 at high risk of progressing to severe disease. Pharmacies will be supplying the pills for patients treated from their homes. On the 27th, the Ministry of Food and Drug Safety announced that it had authorized the emergency use of ‘Paxlovid,’ an oral COVID-19 treatment developed by the US company Pfizer. The decision was made after a comprehensive deliberation into the need to introduce oral treatment options that patients can self—administer amid the growing number of confirmed severe/critical COVID-19 cases and the MFDS’s safety/efficacy review results, as well as expert advisory meeting results at the ‘Public Health Crisis Response Medical Product Safety Management and Supply Committee.’ ‘Paxlovid’ is the first oral treatment to be introduced to Korea. The government said that it plans to diversify treatment options that may be used by patients in addition to the shot-type treatment used in the field and expect the addition of Paxlovid to support the prevention of patients treated at residential treatment centers and home from progressing to severe diseases. Paxlovid Paxlovid inhibits a proteolytic enzyme (3CL protease) to prevent the production of proteins needed for virus replication and virus proliferation. In a clinical trial that enrolled 2,246 non-hospitalized, mild-to-moderate COVID-19 patients at high risk of progressing to severe disease, the drug reduced COVID-19 hospitalization or death by 88% in patients who took the pill within 5 days of symptom onset. In particular, the drug also showed the same effect in a clinical trial that enrolled around 300 Asians, including 19 Koreans. The drug may be administered on adult patients and pediatric patients (12 and older weighing at least 40 kg) with mild-to-moderate COVID-19 that are at high risk of progressing to severe COVID-19 due to age, underlying disease, etc. Paxlovid is administered as ‘three tablets (two tablets of nirmatrelvir and one tablet of ritonavir) taken together orally, twice daily for five days, and should be initiated as soon as possible after the diagnosis of COVID-19 and within five days of symptom onset. The Korea Disease Control and Prevention Agency (KDCA) has requested a priority review of ‘Paxlovid’ on the 22nd to the MFDS due to the rising need to introduce oral COVID-19 treatments that patients can take on their own in the process of returning to normal. The MFDS has been conducting a preliminary review on the quality, clinical, and nonclinical data of ‘Paxlovid’ from November 10th before the KDCA requested a review for the emergency use approval. Also, the ministry had received advice from external experts (9 people) in various fields including infectious diseases, respiratory medicine, toxicology, and virology. As a result, experts agreed on the need to grant emergency use approval for ‘Paxlovid’ in consideration of the COVID-19 pandemic situation and the nonclinical and clinical trial results, and the feasibility of the subject patient population as proposed by the MFDS. The MFDS said it will continue its efforts after granting the emergency use approval to collect information on adverse events that may arise in the process of using ‘Paxlovid’ while preparing further safety measures. In addition, the authorities will request the company that imports Paxlovid to actively collect and report safety information on the drug and has improved related systems so that medical experts, as well as patients receiving treatment at residential treatment centers and homes, may report their side effects. Also, through continuous analysis·assessment of safety information on Paxlovid in Korea and abroad, the authorities will make the safety measures necessary including precautions, discontinuations, and recalls. With patient safety as a top priority, the authorities plan to take measures such as compensating for damages after evaluating the causality of the side effects that may occur. An MFDS official said, “The drug may be used with doctors’ prescriptions. However, as it is an oral pill rather than a shot, it will be distributed through pharmacies and supplied to patients that receive treatments at home.” Meanwhile, Paxlovid received emergency use authorization from the US FDA on the 22nd.
