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- 2026-04-12 22:51:50
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- SK Bioscience releases second batch of COVID-19 vaccines
- by Kim, Jin-Gu Feb 10, 2022 05:54am
- SK Bioscience announced that it had shipped its second batch of commercial COVID-19 vaccine products. By manufacturing vaccines for AstraZeneca and then Novavax, the industry's evaluation is that the company has well demonstrated its large-scale and stable manufacturing capacity. SK Bioscience announced that it had shipped the first batch of Nuvaxovid from its L House in Andong, North Gyeongsang Province in the morning of the 9th. The released batch is predicted to be 840,000 doses of the vaccine that was approved for lot release by the Ministry of Food and Drug Safety the day before. SK Bioscience plans to ship out 2 million doses by the end of this month. Also, the manufacturing amount is expected to further increase from next month. SK Bioscience had signed an agreement with the government to supply 40 million doses of Nuvaxovid within this year. This is twice the amount of AstraZeneca’s vaccines that were supplied by the company to Korea last year. Last year, AstraZeneca signed a CMO deal with SK Bioscience to supply 20 million doses of its vaccine. SK Bioscience is known to have supplied 9,998,300 doses of AstraZeneca’s vaccine just in August last year, demonstrating its ability to manufacture and supply up to 10 million doses a month. SK Bioscience is considered to have well demonstrated its large-scale vaccine production capacity with its verified commercial batches of AstraZeneca and Novavax vaccines. Biologic agents, including vaccines, require quality verification by the MFDS every time a batch is produced for commercialization. According to SK Bioscience, its L House can manufacture up to 560,000 doses of vaccines per day. Multiplying the capacity by 252 working days, the maximum manufacturing capacity of the plant can be estimated to be around 141.12 million doses. By Q3 of last year, SK Bioscience had manufactured 43.25 million doses of vaccines, including AstraZeneca’s vaccines. In only 3 quarters, the company had manufactured four times the 11.48 million doses it had manufactured during the previous year. By the end of last year, the company had manufactured over 60 million doses. Based on the company’s stable manufacturing capacity, SK Bioscience anticipates it will be able to produce its own COVID-19 vaccine ‘GBP510’ in development without any problem even if it is approved in the first half of this year Currently, 9 lines are in operation in the L House. Excluding the one line used to preserve vaccine solutions (cell bank), a total of 8 lines are being used for the actual manufacturing of vaccines. 3 of the lines produce finished Nuvaxovid vaccine products for domestic supply. 2 of the other 5 lines produce vaccine solutions for separate supply to Novavax. The remaining 3 lines produce chickenpox, shingles, and pneumococcal vaccines. If GBP510 is approved in the first half of the year and starts being supplied in earnest in Korea, the company may switch a few of the chickenpox, shingles, and pneumococcal vaccine manufacturing lines for its manufacture. SK Bioscience plans to further expand its production capacity in the long term. The company plans to expand its manufacturing facility in two phases. First, the company has secured a new site near L House to establish additional manufacturing facilities for finished products such as pre-filled syringes and liquid vials by 2024. Also, the company set a goal of adding 12 animal cell incubators of a 2,000-liter scale and two microbiological incubators of a 1,000-liter scale at the same time. As the second step, the company plans to additionally secure manufacturing facilities for raw and finished products to triple its capacity by 2026.
- Company
- Effect of the release of generics for Tamsulosin
- by Ji Yong Jun Feb 10, 2022 05:54am
- The size of the Tamsulosin market, a treatment for prostatic hypertrophy, has soared. The market is also expanding as the influence of generic products has increased since the patent expired in 2015. According to UBIST, a pharmaceutical market research firm, on the 5th, Tamsulosin's outpatient prescription amount last year was 191.2 billion won, an increase of 5% from the previous year. The Tomsrosine market, which was worth 136.9 billion won in 2017, grew 40% in four years. Tamsulosin is α blocker that selectively act on bladder and prostate receptors to lower side effects. It is an ingredient prescribed for prostate hypertrophy patients. As prostate hypertrophy is an senile disease, the number of patients is also increasing recently. According to The HIRA, the number of patients treated for prostate hypertrophy in 2020 was 1.34,329, an increase of 9.4% from 2017 (1191,1595). Tamsulosin is analyzed to have expanded the market in line with the increase in prostate hypertrophy patients and the generic offensive. After the expiration of the original Harunaldi's patent in 2015, generics began to enter the market one after another. As of last year, 87 companies are competing in the Tomsrosine market, as the number of companies entering the generic market has steadily increased. Generics are increasingly influential in the Tamsulosin market. Last year, the amount of outpatient prescriptions for Tomslosin was 116.7 billion won, up 14% from the previous year. Tomslosin, which was worth 63.7 billion won in 2017, increased 83% in four years to 116.7 billion won in 2021. Generic's market share also jumped 14.5% points from 46.5% to 61% during the same period. Among the generics, Hanmi Tams of Hanmi Pharmaceutical and Hanmi Tams OD stood out. The amount of joint prescriptions for the two items last year was 31.7 billion won, up 16.1% from the previous year. Compared to four years ago, it surged 174%. It increased 27.6% from 11.6 billion won in 2017 to 14.8 billion won in 2018, and continued to grow to 19.8 billion won in 2019 and 27.3 billion won in 2020. Industry people say that the introduction of higher capacity than the original was the main reason why Hanmi Tams and Hanmi Tams OD were able to grow. Among generics, Genuonescience's Taminal amounted to 7 billion won, up 3.9% from the previous year. In addition, Dongkoo's Uropa, Kyung Dong's Uronal, Daewoong Bio's Bearosin, and Celltrion 's Tamsol raised more than 4 billion won in outpatient prescriptions. Sales of the original Harnal-D of Astellas are slowing down a little due to the release of generics. Last year, sales of Harnal-D amounted to 74.5 billion won, down 6% from a year earlier. Compared to the amount of outpatient prescriptions in 2017, it increased by 2%. Harnal-D increased 10.8% over the past two years from 73.2 billion won in 2017 to 81.1 billion won in 2019. However, in 2020, the following year, it fell 1.9% from the previous year to 79.6 billion won, and the decline continued last year.
- Company
- Sales in the PPI market are↑ 60% over the past 3 years
- by Kim, Jin-Gu Feb 10, 2022 05:53am
- The PPI anti- ulcer drug market has changed rapidly since the Ranitidine crisis. The market expanded sharply shortly after Ranitidine crisis, but growth has slowed down in the past year. Esomeprazole, Rabeprazole, and Ilaprazole enjoyed the reflective effect of Ranitidine crisis. On the other hand, in the case of Lansoprazole and Pantoprazole, it was difficult to expand their influence on the Ranitidine situation. ◆PPI market grows 61% compared to just before Ranitidine crisis According to UBIST, a pharmaceutical market research firm on the 4th, the amount of outpatient prescriptions for PPI-based anti- ulcer drugs last year was 732.5 billion won. Compared to 454.9 billion won in 2018, it increased by 61% in three years. PPI-based anti- ulcer drugs are the treatments that treat peptic ulcers and gastroesophageal reflux diseases by blocking proton pumps, the final stage of gastric acid secretion, and maintaining a high hydrogen ion index (pH) in the stomach. The reason for the rapid expansion of the market is the Ranitidine incident that occurred in 2019. In June 2019, impurities were detected in Ranitidine, an H2 receptor antagonist-based anti- ulcer drug. Eventually, the sale of this drug was stopped. When Ranitidine, the most commonly used in the market, was removed from the market, and PPI-based drugs enjoyed reflective effects. The annual prescription performance of PPI drugs by year increased to around 10% every year until 2018. In 2019, when the Ranitidine crisis occurred, the increase increased by 18% year-on-year. Then, in 2020, when Ranitidine was completely removed from the market, it increased 24% year-on-year. However, the growth trend that has continued since Ranitidine crisis last year seems to have slowed somewhat. The prescription amount of PPI-based drugs increased by 10% to 732.5 billion won last year. Some analysts say that the rapid growth of K-cab, a new P-CAB anti- ulcer drug, and the prolonged COVID-19 crisis have played a combined role. HK inno.N's K-Cab has posted 30.9 billion won in prescription performance that year since its release in March 2019. In 2020, it more than doubled to 76.1 billion won. Last year, it recorded 109.6 billion won, exceeding 100 billion won in prescriptions in the third year of its launch. ◆Esomeprazole·Ilaprazole vs Lansoprazole·Pantoprazole Esomeprazole, Ilaprazole, and Rabeprazole greatly expanded their influence after Ranitidine crisis. The drug that enjoyed the greatest reflective effect is Esomeprazole. Esomeprazole posted 319.4 billion won in prescription last year. Compared to 19.8 billion won in 2018, before Ranitidine crisis, it increased 63%. In the case of Rabeprazole, it increased 34% from 125.9 billion won to 169.1 billion won during the same period. Ilaprazole increased 33% from 28.3 billion won to 37.6 billion won. In the case of Lansoprazole and Pantoprazole, it is analyzed that they did not enjoy the reflective effect properly despite the gap of Ranitidine. Lansoprazole's prescription amount increased only 4% from 49.1 billion won in 2018 to 51 billion won last year. Pantoprazole increased 4% from 34.7 billion won to 36.3 billion won during the same period. Last year, both ingredients showed a decrease in prescription performance compared to the previous year.
- Company
- Opdivo to be deliberated by CDDC for stomach cancer indicati
- by Eo, Yun-Ho Feb 09, 2022 06:10am
- Whether a reimbursed treatment option would become available in the field of gastric cancer is receiving attention. According to industry sources, Ono and BMS’s PD-1 inhibitor immuno-oncology drug ‘Opdivo (nivolumab)’ will be deliberated by the National Health Insurance Service’s Cancer Disease Deliberation Committee on the 23rd of this month. In June last year, the Ministry of Food and Drug Safety approved an additional indication for Opdivo as ‘first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy for patients with advanced or metastatic gastric adenocarcinoma, gastroesophageal junction or esophageal adenocarcinoma.’ With the approval, Opdivo became the first and only immunotherapy to be approved in Korea as first-line treatment for gastric cancer. Gastric cancer is considered to be the most important area in need of extended reimbursement for immunotherapy drugs after lung cancer. Gastric cancer is the most prevalent cancer and the fourth most common cause of cancer deaths in Korea. Although gastric cancer has a favorable survival rate when detected in its early stages, its relative survival rate drops to 5.9% with distant metastasis. The current standard of care for HER2-negative gastric cancer has been chemotherapy for the past decade due to the unavailability of new drugs approved for its first-line treatment. Opdivo is expected to become a suitable alternative for these patients. Meanwhile, the efficacy of the combination therapy using Opdivo was demonstrated in the large-scale, Phase III CheckMate-649 trial. The median overall survival (mOS) of patients was 13.8 months for all patients randomly assigned to receive the Opdivo combination compared to the 11.6 months in the control group. Among PD-L1 positive patients (CPS ≥ 5), mOS of the group receiving the Opdivo combination was 14.4 months, a 29% reduction in risk compared to the 11.1 months of the control group. Also, Opdivo improved the overall response rate (ORR) by 12% in the all-randomized population, and by 15% in PD-L1 positive patients (CPS ≥ 5). The complete response (CR) rate was also higher for the Opdivo combination group in both the all-randomized population and PD-L1 positive patients.
- Policy
- Following Kymriah, Zolgensma is also about to be reviewed
- by Lee, Tak-Sun Feb 09, 2022 06:09am
- Jang Yong-myung, executive director of HIRA development, briefing with reporters at Korea Special Press Association on the 8th So-called "one-shot treatments" that treat specific rare diseases with one administration are speeding up the reimbursement. Following Kymriah, which treats blood cancer such as leukemia and lymphoma, Zolgensma (Onasemnogene Abeparvovec), which treats a rare disease called SMA, is also set to be reviewed by HIRA's Drug Reimbursement Evaluation Committee. These drugs were difficult for patients to access because of their high price instead of high therapeutic effects, but if they are reimbursed, the burden of drug prices is expected to be relieved. Jang Yong-myung, executive director of HIRA Development, said at the Korea Special Press Association meeting on the 8th that Zolgensma will deliberate on the Drug Reimbursement Evaluation Committee to evaluate the adequacy of medical care benefits. Zolgensma is a drug that can treat spinal muscular dystrophy with a single dose. Spinal muscular dystrophy is a fatal rare genetic disease in which muscles are gradually contracted due to deficiency or mutation of normal SMN1 genes, and if not treated, 90% of SMA type 1 dies before the age of 2 or requires permanent respiratory aids. More than 30% of SMA type 2 patients can also die before the age of 25, requiring lifelong treatment. Zolgensma replaces genes that can prevent SMA progression, so it is expected to improve the quality of life of patients and their families as it can be fundamentally treated only once in a lifetime with intravenous administration. It is an ultra-high-priced new drug worth about 2 billion won, and it is too expensive for patients to handle, so being paid is the only hope for patients and their families. Accordingly, the solution found by the insurance authorities allows pharmaceutical companies to refund the amount paid to patients who was not effective. Executive Director Jang said, "Kymriah and Zolgensma are one-shot treatments that expect therapeutic effects from single administration, but there is a limit to proving cost effectiveness through existing evaluation methods due to high price and long-term uncertainty." "In the case of Kymriah, all patients who have been administered will be obligated to collect patient conditions for a certain period of time, and according to the results of the patient-level performance evaluation, pharmaceutical companies will refund a certain amount of money after administration," he explained. He also said, "If we claim more than a certain amount, we will pay on the condition of a contract that returns all excess amounts," adding, "We will be subject to risk-sharing revaluation after the fourth year of registration." Kymriah passed the Reimbursement Evaluation Committee on the 13th of last month under these conditions. As the adequacy of benefit has been recognized, it will now be possible if negotiations between the NHIS and pharmaceutical companies proceed smoothly. The HIRA plans to evaluate the adequacy of benefit in the same way as Kymriah or Zolgensma. Novartis applied for a decision on medical care benefits for Zolgensma in May last year and is currently being reviewed by the HIRA. It has been collecting opinions from the society since July last year, and at the end of last year, an expert advisory meeting was held to discuss clinical usefulness. At the end of January, the Drug Benefit Standards Subcommittee also reportedly set the benefit criteria. Executive Director Jang said, "Zolgensma is also considering a therapeutic performance-based refund mechanism to overcome the limitations of proving uncertainty and cost-effectiveness about long-term effects, just like Kymriah, as a drug that is effective with one administration."
- Policy
- Novavax vaccine passed the national lot release procedure
- by Lee, Hye-Kyung Feb 09, 2022 06:09am
- 840,000 doses of Nuvaxovid PFS, a Novavax vaccine, have been released in the national lot. The MFDS (Minister Kim Kang-rip) announced on the 8th that SK Bioscience has approved 840,000 Nuvaxovid PFS manufactured in Korea for the first time. Nuvaxovid PFS, which was approved for shipment to the country this time, is a vaccine manufactured in a way that has already been used for hepatitis B and cervical cancer vaccines. The vaccine can be immediately inoculated with a PFS-typed single injection that contains one dose per vaccine without dilution or subdividing, and the MFDS expects people to be vaccinated conveniently, such as being used for visits by elderly and severely disabled people. National Lot Release refers to a system in which the state comprehensively evaluates the results of the inspection test and the results of the manufacturer's manufacturing and testing for each manufacturing unit (lot) before the vaccine is distributed on the market. The MFDS verified the manufacturer's test method from 2021 for the national lot release of Nuvaxovid PFS, established its own test method, introduced equipment such as enzyme analysts, reviewed the manufacturing and test data for 840,000 times, and decided to release the national lot. As a result, Potency assay and content assay were conducted to confirm that the product was not contaminated by conducting sterility tests and endotoxin tests, and quality test data issued by the manufacturer's quality assurance manager were reviewed to produce consistent quality. The MFDS said, "We will continue to do our best to ensure that quality vaccines are stably supplied by quickly and thoroughly verifying the COVID-19 vaccine introduced in Korea." Information on the national lot release of the COVID-19 vaccine can be found on the COVID-19 vaccine and treatment information (www.mfds.go.kr) on the representative website of the MFDS.
- Company
- Famotidine market triples 2 years after ranitidine issue
- by Chon, Seung-Hyun Feb 09, 2022 06:09am
- The H2 receptor antagonist market had fluctuated with the ban of the ranitidine ingredient in antiulcer drugs. The gap made by the exit of ranitidine initially shrunk the market into nearly half its size. Famotidine enjoyed the most reflective benefits with its market size increasing nearly threefold after the ranitidine impurity issue. Also, nizatidine, which also experienced an impurity issue, recently showed strong growth. According to the market research institution UBIST on the 8th, outpatient prescriptions of H2 receptor antagonists last year recorded ₩151.8 billion, an 11.2% increase from the previous year. This is the first time in 3 years the market showed year-on-year (YoY) growth. H2 receptor antagonists such as ranitidine, famotidine, nizatidine, lafutidine, roxatidine, and cimetidine are used for gastric and duodenal ulcers and reflux esophagitis. The H2 receptor antagonist market had significantly shrunk for two consecutive years since recording ₩346.5 billion in prescriptions in 2018. Its prescription market shrunk 60.6% in two years to record ₩136.5 billion in 2020. The market took a hard blow with the ban of its leading ingredient, ranitidine. In September 2019, the Ministry of Food and Safety decided to ban sales of all products containing ranitidine due to an excessive amount of a carcinogenic substance, ‘n-nitrosodimethylamine (NDMA),' being detected in the products. At the time, prescriptions of ranitidine-containing pharmaceuticals had accounted for 77.7% of the H2 receptor antagonist market, bringing in ₩269.2 billion in prescriptions in 2018. Although the H2 receptor antagonist market took a hard blow with the exit of ranitidine, the market has been making a rebound recently with the increase in prescriptions of other ingredients of the same class. Outpatient prescriptions of H2 receptor antagonists other than ranitidine recorded ₩151.7 billion last year, an 11.2% increase from the previous year. This is more than twice an increase from the ₩77.2 billion made by the same ingredients in 2018, before the ranitidine impurity issue. Among the ingredients, the famotidine market has shown the strongest growth. Prescriptions of famotidine recorded ₩60.5 billion last year, an 8.9% growth from the previous year. Compared to the ₩13.7 billion made in 2018, its market expanded by over threefold in three years. In 2018, famotidine’s sales had been on a downward trend, showing a 44.4% decrease YoY. However, its sales took an upward turn with the exit of ranitidine from the market. Famotidine had only accounted for 4.9% of the market in 2018, but its share surged 39.9% last year. Dong-A ST’s Dong-A Gaster drove the growth. Dong-A Gaster sold ₩12.5 billion last year, a fourfold increase from the ₩3.1 billion 3 years ago. Nizatidine, which had once been embroiled in impurity issues, has also shown strong growth. Nizatidine’s prescriptions recorded ₩46.1 billion last year, which is a 32.9% increase from the previous year. Also, its sales expanded 50.0% in two years from the ₩30.8 billion in 2019. The MFDS had suspended sales of 13 nizatidine products in October 2019 due to excessive level of impurities detected in the products. The industry’s analysis was that the permit to sell the nizatidine products that were not found to have impurity issues had allowed the products to enjoy reflective benefits from the ban of the ranitidine ingredient. Nizatidine had ranked third in the H2 receptor antagonist market after famotidine and lafutidine but then jumped to rank second with the surge in its prescriptions. Prescription of lafutidine products recorded ₩36.1 billion last year, a 2.3% increase from the previous year. This is also an 11.5% increase from the ₩16.8 billion 3 years ago. Although its growth had slowed down somewhat recently, its overall market size had grown significantly since ranitidine’s exit. Sales of roxatidine products had also nearly doubled from ₩2.6 billion in 2018 to ₩5.1 billion last year. The only major H2 receptor antagonist ingredient that did not enjoy reflective benefits from the ranitidine ban was cimetidine. Prescription of cimetidine products fell to ₩3.9 billion, a 75.2% drop from 3 years ago. Such reduction in prescriptions is analyzed to have been due to the prolonged unavailability of key products that arose due to disruptions in the supply of its raw materials.
- Company
- Can the Antigen Rapid Test be widely used?
- by Choi-sun Feb 09, 2022 06:09am
- Although they are concerned about the transition to the COVID-19 test system, which adds the Antigen Rapid Test to the current PCR test, opinions are divided as they argue that this is only a concern. Unlike the initial virus that occurred in Wuhan two years ago, mutant viruses such as Omikron have a lot of detection in the body, so the Antigen Rapid Test can play a sufficient role, but they are still concerned. According to the medical community on the 28th, concerns and expectations were simultaneously confirmed by the medical association over the government's transition to the COVID-19 test system. The COVID-19 test method includes PCR tests that amplify and test genes and Antigen Rapid tests that use the principle of antigen detection by immune responses after virus infection. PCR (rRT-PCR, qRT-PCR), which collects secretions by inserting cotton swabs into the nostrils, has more than 98% accuracy and 100% specificity, and PCR through saliva reaches 92% sensitivity and 100% specificity. Although the accuracy is high, the results can be confirmed one to two days after the test, considering the time required for genetic testing and sample transfer. On the other hand, the Antigen Rapid Test has a sensitivity of 90% or more and a specificity of 99%. The Antigen Rapid Test is used at a time when the amount of virus in the body is high to obtain more accurate results, and when used at a time when the amount of virus is low, false negative results are likely to be derived. GCMS's Antigen Rapid Test "GENEDIA W COVID-19 Ag" The sensitivity of 80% means that 80 out of 100 samples confirmed positive by genetic testing are tested positive, but 20 are incorrectly tested negative. However, the Antigen Rapid Test has the advantage of being able to determine whether or not to be infected immediately when rapid results are needed in the field. The KSLM is concerned about the government's transition to the inspection system Sung Heung-seop, director of infection control at The KSLM, said, "We have built up to 850,000 test capabilities a day with PCR, but it is difficult to understand why it was approved as a test method even though experts pointed out the low sensitivity of rapid antigen testing several times." He pointed out, "The fact that the accuracy of the rapid antigen test is more than 90% is the value when the virus emission is at its maximum level from 3 to 5 days after the onset of symptoms." The argument that the test system needs to be changed is also convincing as antiviral drugs that are directly linked to the prognosis were introduced in the early stages of administration. Unlike the early Wuhan virus, the late mutation that led to Delta and Omicron is characterized by strong propagation power due to the large amount of viruses. 99% of new confirmed patients in the U.S. are infected with Omicron, and more than 50% of them are currently infected with Omicron in Korea, and have already become the dominant species. Kang Yoon-hee, a specialist in diagnostic testing, explained, "Before delta mutations, there were certainly not many detection of viruses in the body, but the situation changed rapidly due to mutations." Specialist Kang Yoon-hee explained, "The lower the Ct value, the higher the amount of virus emitted, the more sensitive the sample was 81%, and most of the ohmicron mutations were less than 23%." Studies on the subject of changes in the sensitivity of antigen testing and relative accuracy with PCR are also accumulating.A comparative test of the Antigen Rapid Test and PCR conducted by researchers at Johns Hopkins Bloomberg School of Public Health (JHSPH) such as Andy Pekosz was released in November last year. The study compared the two test methods by collecting upper respiratory samples from 251 people 7 days after the outbreak of COVID-19. As a result, the positive prediction value of the Antigen Rapid Test was 90%, higher than 70% of rt-PCR. Based on this, the researchers judged that "antigen testing can be a better factor for people with a high risk of having a highly contagious virus."
- Policy
- Focus on the possibility of NovaVax vaccine booster shot
- by Lee, Tak-Sun Feb 08, 2022 05:55am
- Experts expressed great interest in the cross-vaccination use of the vaccine during the Novavax COVID-19 vaccine screening process approved in Korea on the 12th of last month. This is because Novavax is likely to be used for additional vaccinations, so-called booster shots, in a situation where most people have been vaccinated with different types of vaccines. However, the MFDS said that among the clinical data submitted by the company, there is a lack of valid data for cross-vaccination, and that cross-vaccination can be considered only when basic vaccination permission is given priority. Such information is recorded in the minutes of the Central Pharmaceutical Affairs Council released on the website of the MFDS on the 7th. Novavax was approved in Korea under the product name Nuvaxovid PFS on the 12th of last month. SK Bioscience receives technology transfer from Novavax and manufactures the vaccine from the undiluted solution to the finished product. It is the first gene recombination vaccine licensed in Korea, and is the fifth approved COVID-19 vaccine after AstraZeneca, Janssen, Pfizer, and Moderna. After the MFDS' self-examination, it was finally approved through a verification advisory group composed of experts, the Central Pharmaceutical Affairs Council, and the final inspection committee. Among them, the Central Pharmaceutical Affairs Council has the greatest impact on vaccine licensing. Fifteen external experts and eight officials from the MFDS attended the Central Pharmaceutical Affairs Council meeting held at 2 p.m. on the 6th of last month in the headquarters of the MFDS in Osong. Experts who attended that day asked about the evaluation of related efficacy, saying that the Novavax is likely to be used for additional vaccinations (booster shots) with the majority of Koreans receiving the existing vaccine. The MFDS said, "The difference between this applied vaccine and the existing one is a single-use PFS, and if it is not used within the deadline after opening as a multi-use vial, it should be discarded." The MFDS also said, "It is also advantageous in terms of compliance with administration as a vaccine for gene recombination platforms that have already been commercialized." Since the company announced plans to develop adolescents and additional vaccinations, the MFDS expressed expectations for youth use with low vaccination rates. In response, a member of the committee asked, "Is there any study conducted as an additional vaccination for vaccines on other platforms in foreign countries?" and the MFDS replied, "According to data released in the UK, additional vaccinations were made for companies D and B." The MFDS explained, "When additional vaccinations were given to those who completed the basic vaccination of Company D, they showed a higher immune response than those who received the virus vector vaccine." However, the MFDS said, "After deciding whether the safety and effectiveness of the applied vaccine can be recognized in terms of permission, the quarantine authorities will decide whether to use it by reflecting the current situation." The MFDS also stressed, "Additional vaccinations can be reviewed only when permission for basic vaccinations is decided first." Nevertheless, at the meeting, some suggested that an additional phrase "need to check cross-vaccination data later" is needed for Novavax permits. The MFDS replied, "In some cases, normal cross-vaccinations can be confirmed through the published results of other research institutes such as universities, and it is difficult for the company to submit all of them." As a result, the committee agreed to approve the Novavax as "for use twice every three weeks for those aged 18 or older," but did not conclude separately regarding cross-vaccination. Meanwhile, the Novavax is expected to begin vaccination for unvaccinated patients at each hospital and clinic soon after approval from the MFDS.
- Company
- EUSA Pharma establishes subsidary in Korea
- by Eo, Yun-Ho Feb 08, 2022 05:55am
- The UK-based pharmaceutical company EUSA Pharma is entering the Korean market. According to industry sources, EUSA Pharma established the Asia Pacific Regional Headquarters in Korea and launched its Korean subsidiary, EUSA Pharma Korea. EUSA Pharma is a global specialty pharmaceutical company that focuses on rare and incurable diseases that were established with funding support from a leading life science investor EW Healthcare Partners. The company is currently a multinational pharmaceutical company that has branches in Europe, the Middle East, Africa, the United States, South America, the and Asia Pacific region, and recorded sales of 130 million euros as of June 2021. Its leading product is ‘Sylvant (siltuximab),’ a Multicentric Castleman‘s Disease treatment that is being distributed by Janssen Korea in Korea. Sylvant is being listed and prescribed with reimbursement from February 2018. Also, Yeon Jae Lee was appointed General Manager of the Asia Pacific region and Korean subsidiary. Lee is a seasoned professional in the pharmaceutical industry, who served in various posts at Novartis Korea, Daewoong Pharmaceuticals, and as the Country Head of UCB Korea and the Head of Rare Blood Disorders at Sanofi-Aventis Korea. Meanwhile, the Italian pharmaceutical company Recordati confirmed the deal to acquire EUSA Pharma at the end of last year. As the acquisition process is expected to be completed within the first half of this year, Whether EUSA Pharma will be maintained in its current form remains to be seen.
