- LOGIN
- MemberShip
- 2026-05-16 03:42:05
- Company
- Four types of PE exemption drugs listed in one month…
- by Eo, Yun-Ho Mar 28, 2022 06:10am
- Coverage expansions of new drugs continue to be reported. In fact, four new drugs were successfully listed last month. According to industry sources, starting with Astellas’ ‘Xospata (gilteritinib)’ in March, Novartis’s ‘Kymirah (tisagenlecleucel),’ Roche’s ‘Rozlytrek (entrectinib),’ Bayer’s ‘Vitrakvi (larotrectinib)’ were listed as new drugs under the pharmacoevaluation exemption track. Despite the difficulties faced during discussions, all the drugs were successfully listed in the end. ◆'Xospata’ resolves the unmet needs in leukemia Xospata is the first treatment approved for FLT3mut+ relapsed/refractory Acute Myeloid Leukemia (AML). The drug, which was approved in March 2020, passed the Health and Insurance Review Service’s Drug Reimbursement Evaluation Committee on the 9th last year, and then started negotiations with the National Health Insurance Service in October of the same year, Although the parties were unable to reach an agreement within the set negotiation period (60 days) and extended the period once more to reach an agreement. Xospata was approved early this month. As a newly introduced treatment option, the public’s interest in on Xostapa’s reimbursement. In fact, the Korea Organization for Patient Group had delivered the opinion on the accelerated reimbursement of new drugs including Xostapa at a roundtable meeting with the MOHW’s Department of Pharmaceutical Benefits. ◆ GOV and company promptly works for the reimbursement of ' Kymriah' The reimbursement of the ultra-high-priced one-shot CAR-T therapy Kymriah has been successfully achieved with the efforts of the government, pharmaceutical company, and the patient. This drug started its reimbursement listing process with the MFDS approval through the approval-reimbursement evaluation linkage system in March last year. Although the agenda was listed for review by the Cancer Disease Deliberation Committee six months later, it was deferred at the time. As soon as the deferral was disclosed by the press, the Korean Alliance of Patient Organization issued a statement criticizing the government and the company. KAPO had previously criticized the delay in deliberations of the agenda by the Cancer Disease Deliberation Committee. As a result, Kymriah passed CDDC in the October of the same year. This was also the first day HIRA had disclosed the CDDC deliberation results. Also, Kymriah passed the review of the first Drug Reimbursement Review and Assessment Service meeting in 2022. And after extending negotiations once, the company succeeded in completing its negotiations and is set to be listed in April. Of course, this is a frustrating period of wait for the patients who long for reimbursement. However, considering the time usually consumed in the registration process for innovative new drugs in Korea, Kymriah’s reimbursement was quick. ◆'Rozlytrek' and 'Vitrakvi’ pave the road for tumor-agnostic drugs Rozlytrek and Vitrakvi had also overcome many obstacles. The two drugs passed the HIRA DREC review but their listing were deferred in the final stages, with the drug pricing negotiations being extended. As these drugs can be applied to many solid cancers that have specific genetic mutations, the authorities had difficulty applying one specific evaluation system and are judged that it will take a while for discussions to be made between the government and the pharmaceutical company. Rozlytrek and Vitrakvi are indicated for the treatment of patients that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic, or where surgical resection is likely to result in severe morbidity and have progressed following treatment or have no satisfactory alternative therapy. In other words, the drugs can be used in most tumors with identified NTRK gene fusions. However still, conservative restrictions remain for the use of the drugs. The use of the two drugs was limited to cancer types mentioned in the NCCN guidelines.
- Policy
- Govn’t to introduce 460,000 courses of oral COVID-19 drugs
- by Kim, Jung-Ju Mar 28, 2022 06:10am
- Ki-il Lee, the first supervisor of the Central Disaster and Safety Countermeasures Headquarters The government will be introducing 460,000 courses of oral COVID-19 treatments by the end of next month. In principle, Paxlovid will be prescribed first, and Lagevrio, which has recently been approved for emergency use, should be used for patients who are restricted from using Paxlovid, such as users of contraindicated drugs. On the 25th, COVID-19 Central Disaster and Safety Countermeasures Headquarters (Head, Prime Minister Boo-kyum Kim) presided over a meeting in the videoconference room at the Sejong Government Complex with the central government departments, 17 metropolitan governments, and 18 cities and provinces on their COVID-19 vaccine/treatment development status and measures for support. According to Ki-il Lee, the first supervisor of the Central Disaster and Safety Countermeasures Headquarters who spoke at a briefing by the disease control and management authorities, the government has procured a total of 1,400,000 courses oral COVID-19 treatments and is in the process of introducing them sequentially. As of the 24th, 163,000 courses of Paxlovid (from Pfizer) have been introduced to Korea, 114,000 courses of which have been used on patients in Korea. On the criticism that Paxlovid is not being actively prescribed by managing medical institutions even if symptoms appear unless older adults in their 60s directly ask for prescriptions themselves, the authorities said they will check on it. Ki-il Lee said, “We will do our best to make sure that institutions that conduct rapid antigen testings can immediately prescribe the drugs to those aged 60 years or older and the immunocompromised. We have requested this from the presidents of 16 doctors’ associations in 16 cities and provinces. W We will do our best to allow prescriptions to be made as soon as possible." Also, the government is continuing negotiations to rapidly introduce oral COVID-19 treatments. Including the 20,000 courses introduced yesterday, the government is pushing for the early introduction of 460,000 courses of oral COVID-19 treatments by the end of April. On the 24th, the first 20,000 courses of Lagevrio were introduced in advance for use from tomorrow (26th). Lagevrio was granted Emergency Use Approval on the 23rd by the Ministry of Food and Drug Safety after conducting safety/efficacy reviews and expert consultations. In consideration of its EUA indication, the drug will be used ▲within 5 days of symptom onset, ▲on patients over the age of 60 or age of 40 with underlying diseases or immunocompromised ▲who have difficulty using existing treatments. The authorities will allow use of Lagevrio in patients who have difficulty using other treatments due to the use of contraindicating medications, etc., although Paxlovid will be first prescribed in principle. Patients with severe hepatic or renal impairment or patients taking drugs of specific ingredients (28 types (23 types that are approved in Korea)) are restricted from the use of Lagevrio. In addition, pregnant women and patients under the age of 18 are excluded from eligible subjects in consideration of the EUA condition set by the MFDS. The government said it is making every effort to ensure that the new oral COVID-19 treatment, Lagevrio, can be safely used in the field. In order to prevent prescriptions from being made to pregnant women, children, and adolescents and its safe use, the drug was registered in the DUR (Drug Utilization Review) system, and relevant systemic improvement measures were completed, such as adding drug information to the patient management information system. Also, the 'Treatment Use Guide (6th edition)' has been distributed to medical institutions to guide Lagevrio prescriptions in institutions, and pharmacies will be distributing detailed medication guides to those patients who have been prescribed Lagevrio. Meanwhile, the government announced that it would monitor the introduction and use of oral COVID-19 drugs, and will continue to compensate for serious adverse events that arise by applying the drug’s side effect damage relief procedures. The current side effects damage relief measures include a lump-sum death compensation (114 million won), funeral expenses (9.8 million won), disability lump-sum compensation (29 million won to 114 million won), and hospitalization & treatment expenses (up to 20 million won). Medical institutions, pharmacies, patients, etc. can report side effects that occur after the use of drugs to the Korea Institute of Drug Safety and Risk Management (report online at www.drugsafe.or.kr) or receive related consultations.
- Policy
- The gov's all-out efforts to promote EUA for overseas drugs
- by Lee, Jeong-Hwan Mar 28, 2022 06:10am
- The government will make all-out efforts to expand the total amount of supply by expanding the production and import of regular medicines such as antipyretic painkillers and cold medicines used to alleviate COVID-19 symptoms. It will even review the emergency introduction of foreign drugs with the same composition as domestic licensed items, quickly review them to prevent disruptions in production due to administrative procedures such as permits, and continue administrative support. The government expressed its willingness to make active efforts with the pharmaceutical industry to stabilize the supply of COVID-19, while also asking the medical and pharmaceutical sectors for cooperation such as prescribing an appropriate amount of solid drugs instead of syrup. Park Hyang, head of the Central Disaster and Safety Countermeasures Headquarters, made the announcement at a regular briefing on the 23rd. As a result of receiving a report from the MFDS on the supply and demand status and action plans for COVID-19, the Central Disaster and Safety Countermeasures Headquarters decided that supply needs to be stabilized. The shortage of some products of antipyretic pain relievers and cold medicines used to alleviate COVID-19 symptoms continues. Accordingly, the government will expand the total supply of COVID-19 medicines. Specifically, it expands production and imports and encourages rapid shipment. It will consider promoting the emergency introduction of overseas drugs with the same composition as domestic licensed products. The government plans to do its best to prevent disruptions in production by providing support for rapid processing such as changing the raw materials and manufacturing plants of standing medicines, quick import approval of drugs and raw materials contained in cold medicines, and convenience of other administrative procedures. It also asked the medical and pharmaceutical sectors to prescribe an appropriate amount of prescription and a solid drug rather than a syrup drug. The government announced its intention to maintain and strengthen support for clinical trials of COVID-19 vaccines and treatments. Currently, eight vaccine companies and 17 treatment companies (18 candidate substances) are conducting clinical trials in Korea. SK Bioscience vaccine has completed recruiting and inoculating phase 3 clinical participants with the aim of completing development in the first half of this year. Subsequently, the procedure for confirming the efficacy of the vaccine through sample analysis is in progress. The treatment is developing an additional antibody treatment (Celltrion) that can respond to mutant viruses, and Ildong Pharmaceutical is jointly conducting clinical trials by securing domestic copyright for Shionogi's developed and edible treatments. The government announced that it is supporting the development of domestic COVID-19 vaccines and treatments with all its might by operating the pan-government support committee for the development of COVID-19 treatments and vaccines. The government said, "For the rapid development of treatments and vaccines, clinical trials are more important than anything else," adding, "We ask the public to actively pay attention to and participate in clinical trials."
- Company
- Sanofi Launches 3rd Generation Antihistamine Alllegra
- by Nho, Byung Chul Mar 28, 2022 06:10am
- Sanofi Korea announced on the 23rd that it released Allegra 120mg, an allergic rhinitis treatment with 3rd generation antihistamine ingredients, in February. Most 3rd generation antihistamines are Rx drugs, which can only be taken after prescription at clinics, but Allegra can be purchased without prescription at pharmacies with permission from OTC for a dose of 120mg. Fexofenadine, the actvie ingredient of Alllegra, is a third-generation antihistamine component. Antihistamines are classified from 1st to 3rd generations according to the development order, and have gradually improved in terms of effects and side effects as generations evolve. The newly launched Alllegra is a next-generation ingredient that improves/complementes the advantages and disadvantages of first- and second-generation antihistamines, and it is a third-generation antihistamine allergy drug that is effective quickly, reduces sleepiness, and lasts 24 hours. Allegra is 10 tablets per pack, and one tablet (120 mg) can be taken once a day with sufficient water before meals. It is expected to improve the quality of life of busy modern people such as drivers, office workers, and students who usually suffer from allergic rhinitis, as the effect is rapidly expressed within 60 minutes on average and the effect lasts for 24 hours. In addition, there is no interaction through hepatic metabolism, so patients taking other drugs can also take them according to the advice of medical experts. Allergic rhinitis, classified as a chronic disease, is mainly caused by allergic antigens such as house dust, mold, cockroaches, and pollen, or by rapid temperature changes, air pollution, and pet hair, and is classified as the most common disease type worldwide. Symptoms of allergic rhinitis are similar to colds, such as stuffy nose, clear runny nose, sneezing, and itchy eyes and nose. Advertising for the new Alllegra will be on-air through TV and digital platforms from March. Under the theme of house dust, pet fur, change of seasons, and air pollution, the advertisement plans to actively promote allergic rhinitis and improve the quality of life through Allegra, a third-generation antihistamine drug, even in various daily situations.
- Policy
- Kymriah's benefit standard has been established
- by Lee, Tak-Sun Mar 25, 2022 05:48am
- The worldChimeric antigen receptor-T cell therapy, which can be effective only once by using cancer patient T cells, is expected to be given to patients after receiving health insurance benefits for the first time in Korea from April. Novartis' Kymriah will enter the benefit range a year after being approved in Korea. The HIRA announced that it will conduct an inquiry on the "Amendment of Public Notice according to Drugs Prescribed and Prescribed to Cancer Patients" from the 24th to the 30th, including the establishment of Kymriah's standards. The amendment will take effect on April 1 unless there is a disagreement. In this amendment, standard was established to allow Kymriah to be administered to an adult (DLBCL) Diffuse Large B-cell Lympoma and B-cell acute lympneumonia (ALL), one of the non-Hodgkin lymphoma. Specifically, after two or more systemic treatments, it is newly established as a tertiary or more monotherapy for DLBCLs in adults who are recurrent or refractory. The recognition period is once in a lifetime per patient, and should be administered by a doctor with sufficient knowledge and experience in chemotherapy at medical institutions capable of responding to emergencies in preparation for unexpected side effects of CAR-T cell therapy. There was a condition that data on the status of medical care benefits should be submitted to the director of the HIRA. Accordingly, a form related to follow-up management should be submitted to the director of the HIRA at the time of administration of Kymriah, 6 months after administration, and 12 months after administration. It is also recognized if Kymriah is administered in post-transplantation recurrence or secondary recurrence and subsequent recurrence or refractory B-cell acute lymphatic leukemia (ALL) treatment in children and young adults under the age of 25. The administration stage should be secondary or tertiary or higher. It can also be administered under the direction of a medical institution suitable for treatment and an educated doctor, and the recognition period is once in a lifetime per patient. Kymriah is the world's first approved CAR-T treatment. CAR-T treatment is an immune cell therapy anticancer drug made by combining genetic information that expresses chimeric antigen receptors specific to cancer cells in patients' T cells. It is in the spotlight as a next-generation anticancer drug that can have a high effect with just one administration. However, insurance authorities have been agonizing over the difficulty of accessing patients due to high costs. Kymriah passed Drug Benefit Evaluation Committee of the HIRA in January and has been negotiating drug prices with the NHIS. Roche's Rozlytrek (Entrectinib), and Bayer's Vitrakvi (Larotrectinib Surfate) also included a new standard. Rozlytrek is newly established as a primary treatment for solid cancer in adults and children over 12 years of age with neurotic tyrosine receptor kinase (NTRK) gene fusion without known acquisition-resistant mutations. Vitrakvi is similar. However, there is no age limit for children. Non-Hodgkin lymphoma combination therapy (secondary or higher) of Rituximab+Revlimid and combination therapy of Bortezomib +Revlimid + Dexamethasone for newly diagnosed for multiple myeloma is newly established for multiple myeloma.
- Company
- Antengene’s first new drug Xpovio lands in hospitals
- by Eo, Yun-Ho Mar 25, 2022 05:48am
- ‘Xpovio, the first drug introduced by the Chinese pharma company Antengene, has landed in general hospitals. According to industry sources, the company’s anticancer drug Xpovio (Selinexor) has passed the review of drug committees (DCs) at 4 of the Big 5 tertiary hospitals - Samsung Medical Center (SMC), Seoul National University Hospital (SNUH), Seoul St.Mary’s hospital, Seoul Asan Medical Center (AMC) – and has been added for prescriptions through an emergency DC at the Severance Hospital. Xpovio, which had been designated as an orphan drug and then approved in August last year, is a drug with a new mechanism of action that selectively inhibits the nuclear export protein XPO1. The drug was approved for two indications: ▲ for use in combination with dexamethasone for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least 4 prior therapies and whose disease is refractory to at least 2 proteasome inhibitors (PI), at least two immunomodulatory medicinal products (IMiD), and an anti-CD38 monoclonal antibody (mAb); and ▲ as a monotherapy for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) who have received at least two prior lines of treatment. XPO1 inhibitors are expected to be used to improve outcomes of various diseases in combination with other regimens (drugs) in the future. The National Comprehensive Cancer Network (NCCN) guidelines currently recommend 5 treatment regimens including Xpovio. Most multiple myeloma recurs and is refractory to treatment, and diffuse large B-cell lymphoma that has failed systemic treatment also has less chance of being cured or achieving long-term progression-free survival every time the disease progresses after treatments. As a result, a dire need has existed for a more safe and effective treatment method in relapsed and/or refractory multiple myeloma and relapsed/refractory diffuse large B-cell lymphoma. However, experts expect that it will take some more time for the drug to be listed for reimbursement. Xpovio had undergone review by HIRA’s Cancer Disease Deliberation Committee in January but had failed to set reimbursement standards. The reason for the failure is known to be that the company wasn’t able to satisfy ‘the number of A7 country released’ requirement. Therefore, the company needs to wait for the drug’s results in other countries to attempt reimbursement in Korea. Meanwhile, the drug’s efficacy was demonstrated through two Phase II trials – the STORM and SANDAL trials. In the STORM study, Xpovio achieved an objective response rate (ORR) of 26% and a clinical benefit rate (CRB) of 39.9% in combination with dexamethasone in patients with relapsed and/or refractory multiple myeloma who have received at least 4 prior therapies In the SADAL study that was conducted on patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) who have received at least two prior lines of treatment, Xpovio as monotherapy had achieved an ORR of 28.3% and a CR of 11.8%.
- Company
- SK Biopharm targets US sales of Xcopri
- by Kim, Jin-Gu Mar 25, 2022 05:48am
- SK Biopharm announced that it will double U.S. sales of Cenobamate (Xcopri) this year. Cho Jung-woo, CEO of SK Biopharm, presented this year's goal at an online press conference on the 24th. SK Biopharm generated 78.2 billion won in sales from Cenobamate in the U.S. last year. Sales have more than increased seven times compared to 10.6 billion won in 2020, the first year of its launch. SK Biopharm plans to double its sales to 160 billion won this year. New marketing plan has been drawn up this year. First of all, the government plans to double the annual number of prescriptions from 90,000 last year to about 90,000 this year. If the company focused on increasing the new prescription rate of doctors who mainly deal with CNS diseases until last year, it plans to expand marketing to target various doctors from this year. It plans to focus on raising awareness of SK Biopharm and Cenobamate in the epilepsy treatment market. It has set a goal to achieve No. 1 recognition of products and companies in the epilepsy treatment market within this year. CEO Cho Jung-woo said, "Cenobamate is growing into a top tier in the U.S. epilepsy treatment market. Considering that patents for major competitors will expire next year, it will be able to establish itself as the only new drug for epilepsy. We will expand face-to-face sales and marketing to double sales in the U.S.," adding, "In the U.S., quarantine guidelines have been eased until the stage of taking off masks." In the second half of this year, face-to-face activities are expected to recover to around 90%." He added, "We will improve awareness of diseases through TV advertisements and SNS marketing, and increase brand awareness of companies and products."
- Policy
- Yoon’s transition team prepares for digital platform govnt
- by Lee, Jeong-Hwan Mar 25, 2022 05:48am
- President-elect Suk-Yeol Yoon’s presidential transition committee announced a policy with the state-led public prescription system in mind. In the process of announcing the creation of a task force (TF) to bring the digital platform government into reality, the committee made a remark that it would be possible that the TF will establish a one-stop hospital treatment and prescription to pharmacy dispensing system. In the transition committee’s press conference that was held at Samcheong-dong, Seoul on the 23rd, the committee announced the creation of a Digital Platform task force (TF). The digital platform government was Yoon’s administration’s pledge to improve administrative efficiency by expanding cooperation between ministries as a state administration system that focuses on digital transformation, artificial intelligence (AI), and big data utilization. The committee’s goal is to ultimately reduce and simplify the steps in the administrative service through data integration by fully disclosing and linking public data owned by government ministries, in principle. The committee said that a site that allows a one-stop, paperless process from hospital treatment and prescription to dispensing in pharmacies needs to be prepared as one case of the digital platform government. This was a statement that can directly affect the establishment of the government-led public prescription system. The Korean Pharmaceutical Association had proposed the establishment of a public prescription issuance system to policy head Hee-Ryoung Won and the healthcare policy promotion director Jeong-Sook Seo during a policy roundtable that was held with Yoon’s policy coordination team last month. Il-Hee Won, senior deputy spokesperson of the transition committee, said, “the TF will consist of 10 members, with the Planning and Coordination Division holding the key and the Science and Technology Education Division and the Political Affairs and Judicial Administration Division working together with private ICT experts. The data is ultimately the public’s asset, therefore it needs to be given back to the people.” Deputy spokesperson Won added, “For example, you now need to receive treatment at a hospital and submit prescriptions to a pharmacy to receive medication. In order for this to become a paperless process, data must be shared, linked, and integrated. We are planning to establish a one-stop, one-site service so that these documents can be issued online." In addition, he said, “If the current government’s system ended at linking the ministries together, the digital platform government pursued by the new government will achieve integration of the ministries We will remove the barriers between ministries and open and release the data to the public, the rightful owners of the data.”
- Policy
- Corona tx Largevrio has been urgently approved
- by Lee, Hye-Kyung Mar 24, 2022 05:54am
- The MFDS (Director Kim Kang-rip) announced on the 23rd that it has decided on the EUA of Largevrio developed by Merck and imported by MSD Korea. Largevrio can be used in patients with severe liver and kidney disorders who are difficult to use injection-type treatments, and patients who cannot take Paxlovid, a conventional PO treatment, for taking certain ingredient drugs. Largevrio, which is inserted instead of RNA in the process of replicating the COVID-19 virus as an RNA-like substance, can be taken twice (every 12 hours) for five days, 800 mg (200 mg x 4 capsules) a day. It should be administered as soon as possible within five days after being diagnosed positive for COVID-19, and mild symptoms with a high risk of developing severe corona due to age and underlying diseases. It targets adult patients with moderate symptoms. Pregnant women or children and adolescents under the age of 18 are prohibited from taking them. On November 17 last year, the KDCA requested Lagevrio's EUA to the MFDS, and the MFDS decided after deliberation by the Public Health Crisis Response Medical Product Safety and Supply Committee. As a result of consultation with external experts (11 people) in various fields such as infectious medicine, toxicology, and virology, it was agreed that the need for emergency use approval of Lagevrio was recognized considering the results of non-clinical and clinical tests and the COVID-19 pandemic in Korea. Considering the results of reviewing animal test data and clinical test data, it was recommended to partially restrict the target patient group, such as not administering it to pregnant women and children and adolescents under the age of 18. The Public Health Crisis Response Medical Product Safety and Supply Committee also acknowledged the validity of emergency use approval by comprehensively considering expert advice, the increase in COVID-19 confirmed patients in Korea, access to treatment for patients who cannot use existing treatments, and medical staff's options. The MFDS will strengthen the collection of side effect information and additional safety use measures in the process of using Largevrio. It has established a system that allows domestic importers to actively collect and report domestic and foreign safety information, and allows medical experts and patients (family members) to report side effects over the phone or online.The government will continue to analyze and evaluate domestic and foreign safety information to promptly take necessary safety measures such as guidance, suspension of use, and recovery of serious side effects, and to evaluate causality and compensate for them. Side effects that occurred after using Lagevrio can be reported to drugsafe.or.kr, and side effects can be reported directly by phone (1644-6223) or related consultations can be made. It is a DUR used by medical experts for prescription and preparation that it cannot be used for pregnant women and children and adolescents under the age of 18, and plans to provide cautionary information on women, men and lactating women planning to get pregnant. In cooperation with the MOHW, the KDCA, and the Korean Pharmaceutical Association, guide patients (guardians) using Largevrio for safe use will be provided, and thoroughly managed not to be prescribed and administered to excluded patients, such as pregnant women and children and adolescents under 18.
- Opinion
- [Reporter’s View] Specific healthcare plans are required
- by Lee, Jeong-Hwan Mar 24, 2022 05:54am
- President-elect Suk-Yeol Yoon’s transition committee has officially started working. Due to the COVID-19 pandemic, Yoon’s transition committee has opted to separately establish a special committee for COVID-19 response and operate the healthcare sector through the subcommittee for social affairs, welfare and culture. Therefore, policies on COVID-19 control, domestic health, and welfare, as well as pharmaceutical and bio-industry will be jointly established by the special COVID-19 committee and the social affairs, welfare, and culture. subcommittee. After the 20th presidential election ended with Yoon’s victory, the domestic healthcare and pharmaceutical-bio industry officials keenly eyed the composition and direction taken by Yoon’s transition committee, as it would become the basis of the next administration. The policy guidelines that the special COVID-19 committee and the social affairs, welfare, and culture subcommittee establish will greatly affect the direction of work of those in the industry. The return of the transition committee is special in that it is the first committee of its form in 10 years and that it works to identify the organization and function of the government and sets a policy base for the new government. Therefore, the committee needs to prepare specific measures and plans for funding to realize the pledges that were made by Yoon. The committees would need to design a more detailed action plan that goes beyond the implementation plan and fiscal measures that Yoon had set as a candidate to promote policies that minimize uncertainty. The direction Yoon takes to implement his pledge acts as an important reference point for pharmaceutical companies in Korea and abroad in developing new drugs and devising business strategies. The healthcare, pharmaceutical, and legal community all began to revisit Yoon's healthcare pledges while working to identify the transition committee’s direction of work in realizing Yoon’s pledges. In addition, government affairs officials in every industry are also starting to work under the table to lead the policy operation direction of the next government to their benefit. Therefore, the responsibility of the transition committee to devise a specific implementation plan for the inauguration of the next government has also grown. Yoon had defined the current government's COVID-19 response measures as a failure and said that he will implement completely different disease control and prevention measures within 100 days of taking office. Along with bold investments to promote the domestic biopharmaceutical industry, Yoon had pledged to prepare various mechanisms to strengthen patient access to relatively expensive innovative new drugs. Based on the expansion of government R&D in the fields of vaccines, treatments, and advanced medical care, Yoon had also pledged to establish a Pharma-Bio Innovation Committee directly under the Prime Minister and promised to strengthen NHI coverage for disease, establish a separate severe disease fund, and industrialize non-face-to-face treatment. Yoon’s transition committee needs to speed up its drawing up a concrete blueprint to bring the promised health care and biopharmaceutical pledges into reality. Yoon’s fulfillment of his pledges will directly translate to the policy management score of the next government. When and how the science-based COVID-19 management and control system, government R&D support for vaccine sovereignty and the establishment of the global vaccine hub, the establishment of a pharma-bio committee, and fostering key talents in the pharmaceutical and bio-industry, and job creation will be implemented or realized in the pharmaceutical and bio sector will be reflected in Yoon’s grades. The committee will receive reports from each ministry until the 29th and then select the final list of tasks for the new administration for a public announcement in early May. With the kick-off of the transition committee, Yoon’s administration has put to the test its ability to fulfill its pledges and manage state affairs. Since his victory to the kick-off of the transition committee, Yoon had repeatedly stated that he “will not hide behind the public and staff, and will communicate sincerely with the public.” Therefore, expectations rise for the transition committee and on how it will present a clear vision to change and develop the paradigm of the healthcare and pharmaceutical, and bio-industry.
