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- 2026-04-14 23:24:30
- Policy
- Rucalo & Xeljanz are subject to usage monitoring in 2Q
- by Lee, Hye-Kyung Apr 26, 2021 01:32am
- Yooyoung Pharmaceutical's chronic constipation treatment Rucalo(Prucalopride Succinate) 1mg and 2mg were included in the price volume agreement monitoring. Pfizer Korea's Xeljanz (Tofacitinib Citrate) 5-10mg, Novartis Korea's Revolade (Eltrombopag) 25-50mg also decreases in price due to drug price negotiations as the usage increases. The NHIS recently unveiled the drugs subject to monitoring in the second quarter of 2021 price volume agreement negotiations (Type Ka and Na) on the website. The targets for monitoring in the second quarter of this year are 187 items in 89 drug groups. The price volume agreement negotiation system is a method in which the NHIS and pharmaceutical companies share the risk to health insurance finances. In the case of drugs with a sharp increase in usage, drug prices are reduced through negotiations with the NHIS. Type Ka under price volume agreement negotiations is a case in which the amount of the same product group claim that has been agreed upon by the NHIS for drug price negotiations, estimated billing amount negotiations, drug price increase adjustment negotiations, and scope expansion negotiations has increased by more than 30% from the expected billing amount. For Type Na, in the case of the same product group that has been negotiated with Type Ka or that has not been negotiated with Type Ka and has passed 4 years from the date of initial listing, the previous type will increase by 60% or more or 10% or more from the previous year's bill every year from the day after the end of the analysis target period. This applies to cases of more than ₩5 billion. Meanwhile, drugs with an annual billing amount of less than ₩1.5 billion, drugs with an upper limit price lower than the arithmetic average price of the same ingredient, low-cost drugs, and shortage prevention drugs are excluded from the price volume agreement. The drug groups included this time include Sanofia Ventis Korea's Dupixent Prefilled Inj.(Dupilumab) 300mg, Jeil's' Apydamole ER Cap, and Hyundai's Dipyanox ER.
- Company
- The market share of Hanmi & Chong Kun Dang's is 16%
- by Kim, Jin-Gu Apr 26, 2021 01:29am
- BetmigaCompetition for the generic drug Betmiga (Mirabegron), an overactive bladder treatment, is intensifying in the outpatient prescription market. According to the drug market research agency UBIST on the 20th, the Mirabegron market scale in the first quarter reached ₩18.3 billion. It increased by 9% compared to ₩16.7 billion in the same period last year (1st quarter of 2020). It is an analysis that the addition of generics has contributed to the expansion of the market size. Hanmi Pharm and Chong Kun Dang released Mirabek and Selebeta consecutively in June and July of last year through the avoidance of Betmiga patents. The sales of both items totaled ₩1.4 billion in the third quarter of 2020. The prescription amount for the two items increased to ₩2.3 billion in the fourth quarter, then to ₩2.9 billion in the first quarter of this year. In half a year, prescription performance more than doubled. Generic market share also doubled from 8% to 16% during this period. It is possible to exceed ₩10 billion in annual prescriptions. The prescription amount of the original Betmiga in the first quarter was ₩15.4 billion, down 8% from ₩16.7 billion a year earlier. As the drug price of Betmiga remains almost the same as before, it is interpreted that generic drugs have a direct effect on the decline in original performance. Astellas has postponed the government's disposition of drug price cuts following the release of generics to filing an administrative lawsuit. However, from March this year, the upper limit price was cut by 5.5% according to the price-volume agreement. From 2Q, competition in the Mirabegron market is expected to intensify. This is because Mirabek and Selebeta's generic for exclusivity period ended in February of this year. According to the MFDS, 26 companies in addition to Hanmi and Chong Kun Dang have received the generic for Betmiga license. Betmiga is an overactive bladder treatment launched by Astellas in October 2015. It became a representative item at the same time as it was released. The annual prescription amount is ₩28.8 billion in 2016, ₩41.9 billion in 2017, ₩54.8 billion in 2018, ₩64.7 billion in 2019, and ₩65.1 billion in 2020. About 40 domestic companies challenged the patent. Since 2015, it has filed a request for an invalidation trial and a negative trial for confirming the scope of rights for material patents, formulation patents, crystalline patents, and use patents. Hanmi and Chong Kun Dang won generic for exclusivity. The generic for exclusivity period was from May 4 last year to February 3 this year.
- Company
- Domestic drug Rosuzet/K-CAB sales performance is very good
- by An, Kyung-Jin Apr 26, 2021 01:28am
- Lipitor Lipitor, a treatment for hyperlipidemia, kept the lead in outpatient prescription sales. Drugs developed with domestic technology such as Rosuzet and Zemiglo, led by HK inno.N's K-CAB, increased sales despite prolonged COVID-19. Original drugs are on a decreasing trend after patent expiration. According to UBIST, a drug research institute on the 20th, Pfizer's Lipitor took the lead in overall outpatient prescriptions with ₩43 billion in the first quarter. Lipitor is an Atorvastatin-based treatment for hyperlipidemia, which Pfizer Korea introduced to the domestic market in 1999. After the expiration of the patent, the insurance drug price has dropped to half, and more than 130 generics have been poured out, but except for 2017 alone, it has maintained the lead in prescription sales for the past 10 years. However, the uptrend has slowed. Lipitor reduced the size of quarterly prescriptions by 8.5% compared to ₩47 billion a year earlier. In January and February, prescriptions decreased by 9.9% and 11.2%, respectively. The prescription amount in March was ₩15.3 billion, recovering to the previous year's level. Hanmi's Rosuzet ranked second in prescriptions with an outpatient prescription amount of ₩26.6 billion, up 16.3% year-on-year. Rosuzet is a hyperlipidemia complex consisting of two ingredients: Rosuvastatin Calcium and Ezetimibe. Since its launch at the end of 2015, it has been ranked No. 1 in the same ingredient market. It is analyzed that the strategy of entering the market before competitors while securing the right to use Ezetimibe from the patent holder MSD was effective. Rosuzet recorded an increase of more than 10% each month compared to the previous year, even when there were many restrictions on face-to-face sales marketing activities due toCOVID-19 incident last year. Rosuzet surpassed Gliatamin in the second half of last year, exceeding ₩8 billion in monthly prescriptions. In March, it set its own highest prescription record at ₩9.4 billion and the monthly prescription amount exceeded ₩10 billion. Daewoong's Gliatamin amounted to ₩23.2 billion in outpatient prescriptions in the first quarter of last year, down 1.7% from the same period last year. Gliatamin is generic containing Choline alfoscerate, a brain function improvement agent. As the government imposed two sanctions, including reduction in reimbursement and negotiations for redemption, and pharmaceutical companies protested, an unprecedented legal battle is expected, but the market impact of prescription drugs is still strong. During the same period, the competitive item CKD Gliatilin Soft Cap is ranked 9th overall with outpatient prescription performance of ₩19.8 billion, up 1.2% from the same period last year. HK inno.N's K-CAB showed an unrivaled growth rate, rising 54.7% year-on-year to ₩22.5 billion in prescriptions in the first quarter of last year. K-CAB (Tegoprazan 50mg) is a P-CAB-based anti-ulcer drug released by HK inno.N in March 2019. In gastric parietal cells, it represents a new mechanism of action that inhibits gastric acid secretion by competitively binding the proton pump and potassium ions located in the final stage of acid secretion. The monthly prescription for K-CAB in the first year of its release rose from ₩1.7 billion to ₩5 billion. After securing the indication for GERD as the first indication, the amount of prescriptions increased further with the addition of the indication for gastric ulcer treatment in July of the same year. In January and February this year, when most pharmaceuticals were sluggish, the prescription ranking rose by two steps in the first quarter. It is evaluated that the joint sales strategy with Chong Kun Dang, which has differentiated mechanisms compared to the existing PPI and strong sales power in the digestive system field, created synergy. LG Chem's diabetes combination drug Zemimet's outpatient prescription for the first quarter was ₩20.8 billion. It changed its own prescription record, rising 12.2% from the same period last year. Zemimet is a combination drug that combines Metformin with Zemiglo, a new diabetes drug based on DPP-4 inhibitors developed by LG Chem. Since 2016, it has signed a co-promotion contract with Daewoong and has been selling it jointly. Eutropin, a growth-promoting hormone developed by LG Chem, doubled from the same period last year as it was prescribed ₩17.9 billion worth in the first quarter. Since it was listed on the list of selective benefits at the end of 2018, it has grown rapidly in the prescription drug market. Patent expiration drugs, which are copyrighted by global pharmaceutical companies, still rank at the top of the outpatient prescription market, but the uptrend did not show the same trend as in previous years. The quarterly prescription size of the top 10 outpatient prescription drugs with expired patents such as Boehringer Ingelheim's high blood pressure combination drug Twynsta, Sanofiaventis' antithrombotic drug Plavix, Gilead Science's hepatitis B treatment Viread, and AstraZeneca's hyperlipidemia treatment Crestor declined. Twynsta's outpatient prescription amount fell 7.7% YoY to W21.8bn in 1Q. Twynsta is a hypertensive combination drug that combines ARB-based Telmisartan and CCB-based Amlodipine Besylate. Yuhan Corporation has been selling jointly since 2010, but sales have declined compared to K-CAB since the third quarter of last year. The two hepatitis B treatments that once dominated the prescription drug market had poor prescription performance. Viread barely maintained ₩20 billion, with prescriptions falling 5% in the first quarter. Baraclude by BMS Pharmaceutical, a rival drug, was ₩16.3 billion, down 5.1% from the previous year, ranking 20th in the prescription ranking. For Plavix and Crestor, the amount of prescriptions decreased by 7.5% each. For dementia treatment Handok Aricept, the quarterly prescription amount decreased by 7.3%. Aricept developed by Eisai was changed from Daewoong to Handok in Korea for some items such as Aricept and Aricept Evess in May of last year. The quarterly prescriptions for MSD's diabetes combination drug JANUMET and Astellas Pharmaceutical's prostatic hypertrophy treatment Harnal fell 3.5% and 6.2% respectively.
- Tamiflu hit hard by COVID-19, prescription drops 99.9%
- by Chon, Seung-Hyun Apr 23, 2021 05:53am
- The market for the influenza (flu) treatment ‘Tamiflu’ has virtually become moribund this year. Its market size fell 99.9% due to the rapid drop of flu cases in the prolonged coronavirus disease-2019 (COVID-19) pandemic. According to the pharmaceutical market data research firm UBIST on the 22nd, outpatient prescription of ‘oseltamivir’ recorded 10.27 million won in the first quarter of this year. This is a 99.9% drop from the 8.3 billion won recorded in the first quarter of the previous year. This is the second consecutive quarter in which virtually no prescriptions were written for oseltamivir, the main ingredient of Tamiflu. The prescription sales amount of oseltamivir in the fourth quarter of last year was 25.42 million won. Quarterly outpatient prescription sales of oseltamivir (Unit: 1 million won, Source: U-BIST) The Tamiflu market had a repetitious pattern where most of its prescriptions were made during the flu season - the first and fourth quarter of each year. In the fourth quarter of 2018 and first quarter of 2019, the prescription record of Tamiflu was 18.9 billion won and 7.2 billion won, respectively. The market stayed strong until the fourth quarter of 2019, maintaining a market size of 7.5 billion won. However, in the latest flu season that started in the fourth quarter of last year, the Tamiflu market has virtually become non-existent. Experts owe this change to the prolonged COVID-19 crisis. The improved personal hygiene management has significantly reduced the incidence of infectious diseases, which consequently would have reduced the number of hospital visits. According to the Korea Disease Control and Prevention Agency (KDCA), the number of suspected flu patients per 1,000 outpatients during the first 8 weeks of this year were 2.4, 2.4, 2.6, 2.3, 1.9, 1,9, 1.9, 2.0, remaining well below the national epidemic threshold of 5.8. Weekly no. of suspected flu patients per 1,000 outpatient population during week1-13 in 2020·2021 (Unit: no. of ppl, Source: KDCA) The number of suspected flu patients per 1,000 outpatients from week 1 to week 8 of the previous year were 49.1, 47.8, 42.4, 40.9, 28.0, 16.4, 11.6, and 8.5. Comparing the two periods, it is evident that the number of flu cases has decreased substantially. The number of suspected flu patients per 1,000 outpatients during weeks 9-13 of this year was similar to those in the previous weeks in January to February, around 1-2 patients. The prescription amount of oseltamivir by product shows that only Tamiflu had produced results, making 10.27 million won in the first quarter of this year. Chong Kun Dang is in charge of the local sales and distribution of Tamiflu. Other oseltamivir products that had raised over 1 billion won in the Tamiflu market in the past, including products produced by Hanmi Pharmaceutical, Kolon Pharmaceuticals, Yuhan Corp., and Jeil Pharmaceutical, showed no results during the first quarter of this year.
- Company
- Big 5 Hospitals actively prepare CAR-T ‘Kymria' centers
- by Eo, Yun-Ho Apr 22, 2021 05:53am
- The ‘Big-5’ tertiary hospitals in Korea are working fast to introduce the first CAR-T therapy ‘Kymriah’ to their institutions. According to industry officials, among the Big-5s, Seoul National University Hospital (SNUH), Asan Medical Center (AMC), Seoul St. Mary’s Hospital, and Severance Hospital are in the process of acquiring the ‘human cell management business approval’ from the Ministry of Food and Drug Safety, and Samsung Medical Center (SMC) already obtained the approval. In Seoul National University Hospital, Kymriah (tisagenlecleucel) passed the drug committee (DC) review in April, and the drug is also expected to land in Samsung Medical Center in May. Kymriah developer Novartis has allowed general hospitals to be paid for the ancillary costs by establishing Kymriah centers in their institutions. SMC and SNUH will open their Kymriah centers in May, and other tertiary hospitals are expected to follow. To establish the center, hospitals are first required to receive a permit for the human cell management business under the newly implemented ‘Advance Regernative Bio Act.’ Kymriah is the first CAR-T therapy and the most expensive drug in Korea up to date. The drug is indicated for adult patients with diffuse large B cell lymphoma (DLBCL) and young adult and pediatric patients with acute lymphoblastic leukemia (ALL). Both indications are for late-stage patients that are in relapse post-transplant or in second or later relapse after two or more lines of therapy. CAR-T therapy takes a different approach in its method of treatment. Unlike conventional drugs that are produced as finished products, for CAR-T, the hospital first collects T cells from the patient's white blood cells, then freezes and sends them to a manufacturing facility. At the facility, the T cells are genetically engineered to express the chimeric antigen receptors (CARs) that allow the T cells to recognize tumor cells, cultivated, then sent back to the hospital. In other words, after the hospital sends the raw material (patient’s T cells) to the company, the company makes the finished ‘Kymriah’ product with the raw material and sends it back to the hospital. The hospital maximizes the effect of Kymriah by using lymphodepleting chemotherapy to reduce the white blood cell count in advance. After 4-5 weeks, the processes are all complete, and Kymriah is finally infused into the patient. “Kymriah is an innovative, personalized treatment for each patient with a new mechanism of action that allows the patient to complete treatment with just ‘one shot.' It is a treatment that has never been seen in the history of anticancer treatment.,” said Sung-soo Yoon, professor of Hemato-Oncology at the Seoul National University Hospital. “Patients with relapsed∙refractory DLBCL who failed two or more lines of treatment or transplant that are left with a life expectancy of only three to six months can reach complete remission after a single treatment and increase their rate of survival.” “Relapsed∙refractory ALL patients are very rare in Korea, however, these few young patients that are diagnosed every year are in the fight for their lives,” Said Chuhl Joo Lyu, professor of pediatric Hematology-Oncology at Severance Hospital said. “The government, pharmaceutical company, and the medical community should work together to create an environment for these young patients to enable timely treatment with Kymriah.”
- Company
- Tremfya reimbursement approved for palmoplantar pustulosis
- by Apr 22, 2021 05:53am
- Janssen’s interlukin-23 (IL-23) inhibitor ‘Tremfya (guselkumab)’ will be reimbursed from May 1st for the treatment of palmoplantar pustulosis. The reimbursement will apply to patients over the age of 18 years who were diagnosed with moderate to severe palmoplantar pustulosis that has lasted for more than 6 months that ▲ have a Palmoplantar Pustulosis Area and Severity Index (PPPASI) score of 12 or higher and have no response to Acitretin for at least 3 months or had to discontinue treatment due to side effects(medical report required); or ▲have a PPPASI score of 12 or higher and show no response to phototherapy for at least three months or had to discontinue treatment due to side effects; Tremfya is the first and only biological treatment in Korea available for patients with palmoplantar pustulosis. In a Phase III clinical trial, the patient group treated with Tremfya significantly lowered their PPPASI score compared to the placebo group. At 52 weeks, patients in the Tremfya treatment group still showed continuous improvement, and achieved a PPPASI-50(≥50% improvement) and PPPASI-75(≥75% improvement) response of 83.3% and 55.6%, respectively. “With the reimbursement approval, we are pleased to be able to provide a new treatment option to palmoplantar pustulosis patients in Korea," said TaeYun Jung, Director of the Immunology Business Unit at Janssen. "Starting with the TNF-a blocker Remicade to Stelara, Janssen has been in the forefront of providing new treatment options for patients suffering from psoriasis. We will continue to spare no effort for our patients that suffer from immune disorders, including psoriatic diseases.” Palmoplantar pustulosis is a chronic inflammatory skin disorder that presents as sterile pustules or red patches on one's palms and soles.
- Company
- Sanofi to sell Hanmi's AmosartanQ' in Russia
- by An, Kyung-Jin Apr 22, 2021 05:53am
- AmosartanQHanmi's IMD AmosartanQ will be launched in the Russian market through Sanofi. Hanmi announced on the 20th that Sanofi has obtained marketing approval from the MOH for AmosartanQ under the product name Tristanium. AmosartanQ is a combination drug that combines Amlodipine Camsylate, a component for treating hypertension of CCB, and Losartan potassium, a component for treating hypertension of ARB, and Rosuvastatin Calcium, a component for treating hyperlipidemia. Sanofi is in charge of local licensing, sales marketing, and sales in Russia by receiving the right to use exclusive Russian license materials for AmosartanQ from Hanmi. This time, with the marketing approval, it is planning to establish a sales marketing strategy for AmosartanQ and launch it officially. Hanmi produces finished products at the Paltan Smart Plant in Gyeonggi Province and exports them to Russia. According to Hanmi, Russia is the second largest pharmaceutical market in Europe. In particular, the hypertension treatment market is evaluated for its high potential growth rate. According to the European Society of Cardiology, the incidence of hypertension in Russia is as high as 4 out of every 10 people, but only about 20% are actively treated. AmosartanQ (Amlodipine, Losartan, and Rosuvastatin) is ganerating market sales of about ₩400 billion ($3.9 billion) in Russia. Amosartan (Amlodipine and Losartan) has been on sale in Russia with Sanofi since 2017. It has grown at an annual average rate of 21% over the past four years. Hanmi expects that AmosartanQ will receive a positive response in the Russian market as well. AmosartanQ is an important product of the Amosartan Family, which records annual prescription sales of ₩100 billion in Korea," said Jongsoo Woo, CEO of Hanmi. He said, "Starting with Russia, we will do our best to accelerate entry into the global market."
- Product
- Why are pharmacists in the AZ vaccination relay?
- by Apr 22, 2021 05:53am
- On social media, pharmacists' vaccination application reservation verification shots appeared in a row. "I made an appointment for vaccination", "I applied for it too" Since yesterday (19th), a vaccine application for pharmacies through the KCDA website has been in progress, and pharmacists who have completed reservations are sharing information related to the vaccine as well as photos notifying the completion of authentication on SNS. SNS를 통해 약사들이 백신 예약 신청 릴레이 인증을 하고 있다. Pharmacist Kim Soo-gil was the first to start the relay. On the 19th, pharmacist Kim, who is in charge of Hubase Affiliate & CSR, proposed a relay to Hubase member pharmacies. Pharmacist Kim Soo-gil posted on Instagram with hashtags such as'Hubase','Pharmacist's Social Responsibility','Vaccines', and'Corona 19 Go Back' as an expert. The way to take off the mask as soon as possible is to reach mass immunity, and vaccines are the answer.' He left a message saying,'As a pharmacist, I applied with a sense of responsibility as a health care professional.' Other Hubase-affiliated pharmacists also said,'The vaccine is inoculated after determining the optimal dose through clinical trials. Depending on the person, the immune response may be different and there may be discomfort, but this immune response was posted with an article titled'controlled immune response' and a notice on adverse reactions provided by the KCDA. Another pharmacist said,'It's scary that we all get coronavirus, and I hope the corona ends soon. However, I am also worried that the side effects of the vaccine will occur to me as well.” “Wouldn't the corona disappear if all the vaccines except me were taken? I'll get another company vaccine later. Seeing that others are right, you should be right. It is the same that I avoid it with this mind and I also like that,” he said. “Even so, I meet most sick and fever patients in our neighborhood. Most of the people I meet have weak immunity and are the most likely to meet other corona confirmed patients or contacts, so I am afraid, but I applied for vaccination. Other pharmacists also uploaded their reservation details as verification shots. After vaccination, they guided them to apply cold compresses with a clean dry towel in case of swelling or pain at the vaccination site, drink plenty of fluids and take a rest if they have a mild fever, and take antipyretic analgesics if they are uncomfortable with fever or muscle pain. Pharmacist Kim Soo-gil said, "There are many parts that many people misunderstand about vaccination, but it would be good if pharmacists who are experts came out to guide and deliver a message to meet together, so we started relaying." He said, "I want people to know that the vaccine is the right part by adjusting the dose, and although it may be uncomfortable, it is a natural immune response." He explained, "With the desire to return to a world without masks as soon as the whole people get a vaccine this year, collective immunity is formed, and pharmacists are joining the vaccination together."
- Company
- Schingles is expected to be released in the end of the year
- by Apr 21, 2021 05:50am
- GSK's Schingles, which boasts the highest efficacy among the existing shingles vaccines, is expected to receive product approval at the end of the year as soon as possible. When Schingles is released in Korea, fierce competition is expected with Zostavax and Sky Zoster. According to the pharmaceutical industry on the 21st, GSK applied for Schingles item approval from the MFDS in January and is currently undergoing review. Approval is expected within the year, considering the period of time it normally takes for a permit review. It is expected that it will be able to obtain a permit at the latest early next year. Schingles was first approved in the United States in October 2017 and in Europe and Japan. In the US, the market share reached 98% a year after the launch of Schingles. Worldwide sales amounted to ￦1.1 trillion in 2018, ￦2.5 trillion in 2019, and ￦3 trillion in 2020. The defense rate is stronger than other products. In a clinical trial involving adults 50 years and older (ZOE-50), Schingles demonstrated a 97.2% ERA at 3.2 years of follow-up. Those over 70 years old (ZOE-70) showed 89.8% efficacy after 3.7 years of follow-up. The conventional vaccine, MSD's Zostavax, showed 51% protection in patients over 50 years of age. It was 41% of those over 70 years old. SK Bioscience's Sky Zoster has no known ERA figures. With a non-inferiority test against Zostavax, it can be assumed that the ERA is similar. Schingles is an inactivated vaccine, unlike the live attenuated vaccine Zostavax, and is particularly recommended for patients with weakened immunity. Accordingly, the CDC recommended Schingles first over existing products as a shingles vaccine for adults over 50 years of age. People who had previously been vaccinated with Zostavax also recommended Schingles re-vaccination. Schingles has two doses and is a bit more expensive. Zostavax and Sky Zoster are given a single dose, whereas Schingles requires two doses at intervals of 2 to 6 months. The price is also expected to be higher than the two products. Concerns over Schingles' supply shortages are reported to be largely resolved. At the time of launch, there was a shortage of supply due to failure to keep up with demand. Accordingly, GSK is continuously expanding its production capacity and increasing its supply. Currently, the domestic shingles vaccine market includes Zostavax and Sky Zoster. Originally, Zostavax was the only one, but with the launch of Sky Zoster in October 2017, it quickly eroded the market. Market sales of Zostavax and Sky Zoster based on IQVIA last year were ￦43.2 billion and ￦29.1 billion, respectively. Competition between the three products will be fierce from next year when Schingles sales are in full swing.
- Policy
- AZ vaccine’s import authorization still under review
- by Lee, Tak-Sun Apr 21, 2021 05:50am
- Attention has been rising on the reason for the delayed approval of the imported AstraZeneca’s COVID-19 vaccine, which was the first vaccine to submit its application in Korea. Although the Ministry of Food and Drug Safety (MFDS) had shortened the review period to 40 days, 3 months have passed and no news on the approval of the imported product has been heard to date. This means that Korea’s procurement of AstraZeneca vaccines depends solely on the local supply produced by SK Bioscience. On January 4th, AstraZeneca had submitted two applications for its vaccine; one for the manufacture and marketing authorization of its products manufactured by its CMO SK Bioscience, and the other for the import authorization of products manufactured outside of Korea, including those from Italy. The ‘Korea AstraZeneca’s COVID-19 Vaccine Inj.’ which is manufactured under a CMO deal by SK Bioscience was been approved on February 10th and became the first COVID-19 vaccine to receive marketing authorization in Korea. The approval process took only 40 days through a rolling review by MFDS. However, the application for the imported product that was submitted the same day is still under review. Regarding the matter, an MFDS official explained, “The GMP site data is known to be insufficient. It seems that the submission of supplementary data by the company is being delayed due to the global use of the vaccine.” However, he added that the review process will not take long. Among the AstraZeneca vaccines in use, 1.57 million doses (for 780,000 people) that were secured via independent contracts were approved for national lot release on February 17th. However, due to the limited supply, authorities are having trouble speeding up the vaccination process. Fortunately, an additional 7 million doses are expected to be introduced from May to June to be used for vaccination of those aged 65 or older However, regrets remain as the approval of the imported vaccine would have made procurement much easier. 3 types of vaccines – Pfizer and Janssen’s vaccines in addition to the AstraZeneca vaccine produced by SK bioscience – are currently approved in Korea. On the 12th, GC Pharma, which is responsible for the domestic distribution of the Moderna vaccine, applied for approval. All vaccines other than the AstraZeneca vaccine are imported products. The prevailing opinion is that we need more locally manufactured vaccines for better procurement. In the same line, the possibility of Moderna establishing a subsidiary in Korea for local production of vaccines has been raised. In the ‘Moderna plans to establish a subsidiary in Korea’ report, Byung-Gook Park, a researcher at NH Investment & Securities stated that “Moderna had mentioned the possibility of establishing a subsidiary in Korea in its second Moderna Vaccines Day held on the 15th. It plans to strengthen its vaccine capability by establishing subsidiaries in Korea, Japan, and Australia this year.” For a locally manufactured Moderna vaccine to be introduced to the market, the company would need to submit an additional marketing authorization application for the drug to MFDS.
