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- 2026-05-17 05:43:53
- Policy
- MNCs ask to “Innovate new drug reimbursement environment"
- by Lee, Jeong-Hwan Jan 27, 2022 05:43am
- The key content of the policy proposal that representatives of multinational pharmaceutical companies with branches in Korea presented to the People Power Party’s election campaign committee was that the government should establish or improve the National Health Insurance and drug pricing system to encourage the use of highly effective but expensive innovative new drugs. The policy proposal contained the request to pull forward the timing of insurance coverage for the companies' new drugs with measures such as preparing a separate source of finances other than the NHI finances by setting a new account for pharmaceutical expenses for severe diseases, introducing the ‘pre-(insurance) listing post-evaluation system, diversifying the risk-sharing agreement (RSA) scheme, and introducing a customized reimbursement model, etc. Also, requests on improving the domestic drug pricing system so that the innovative value of new drugs can be fully reflected in new drugs by improving the pharmacoeconomic evaluation system, and building a control tower for new drugs under the direct control of the president to reinforce nurturing/support/development of innovative new drugs. The Korean Research-based Pharmaceutical Industry Association will deliver a healthcare policy pledge proposal for the 20th presidential election that contains the contents above to People Power Party Representative Jun-Seok Lee on the morning of the 27th. The policies KRPIA asked for are laregly: ▲reducing the economic burden of patients by strengthening medical expenditure support ▲ improving the new drug listing system ▲Building a global hub to reinforce capabilities to develop blockbuster new drugs ▲introducing a global level evaluation system to rationalize the drug price decision-making structure ▲establishing a control tower for new drugs under the president. In other words, KRPIA’s policy proposal implies the need for innovation in NHI listing and reform of Korea's drug pricing system to enhance patient access to new drugs that are owned by the MNCs. The association saw that the current health insurance finances and catastrophic medical expense support system were insufficient to enhance patient access to new drugs. As its solution, KRPIA pointed to expanding subjects and the extent of catastrophic medical expense support while preparing a separate source of finances for the reimbursement of severe diseases or high-priced pharmaceuticals. In particular, the association stressed the need to establish a separate account to cover drug expenses for severe diseases by procuring additional finances from the national treasury and the Health Promotion Fund, as well as with refunds that the NHIS receives from the pharmaceutical company under their RSA contract, and cancer management fund, etc. The KRPIA also criticized the problems in Korea’s new drug listing system that reduce the use rate of new innovative new drugs compared to other advanced countries while delaying patient administration of such drugs due to the non-existence of an expedited reimbursement evaluation system. KRPIA suggested that the issue above can be resolved by introducing the ‘pre-listing post-evaluation system that allows for drugs to be listed for reimbursement first then be evaluated by health authorities to decide on a final price, diversifying the risk-sharing agreement (RSA) scheme, and introducing a customized reimbursement model, etc. Table for the pre-listing post-evaluation system KRPIA delivered to PPP KRPIA believed that signing an agreement that allows for the setting of an initial drug price based on foreign drug price while proceeding with the evaluation process so that drugs that are listed at a lower drug price or non-listed can be refunded to the government post-reimbursement, would reduce the government’s concern over wasting NHI finances. Also, as the current RSA system has a narrow scope of application, KRPIA requested that the RSA scheme cover drugs that have fiscal neutrality, recognized for the therapeutic need diseases other than cancer or rare diseases. Also, the association suggested introducing a detailed customized reimbursement model that takes into account the characteristics of individual drugs such as advanced biopharmaceuticals, rare disease drugs, and anticancer drugs and preparing an environment in which new drugs can be effectively listed through an expedited reimbursement evaluation system and advance negotiation system, etc. The KRPIA also raised the need for innovation in Korea’s drug pricing system. With the claim that the current drug pricing method cannot properly reflect the economic value of many new drugs, the association asked that the innovativeness of a drug be reflected in the drug’s price based on a drug price comparison method. Also, KRPIA stressed the need to create an environment in which the true value of a new drug is recognized by improving the evaluation process and increasing the transparency and redundancy of evaluations that are undermined during the process of multiple evaluations conducted for new drugs by several committees. In addition, the association proposed the construction of a control tower for new drugs under the direct control of the president to reinforce the competitiveness of Korea’s pharmaceutical and biopharmaceutical industry and to develop blockbuster new drugs. New drug support in the current administration is less effective as it is tended to by various ministries including the Ministry of Health and Welfare, the Ministry of Science, Technology, and Information and Communication, and the Ministry of Trade, Industry and Energy, with no control tower to oversee the process. KRPIA stressed, “We need to open the era of customized health coverage for the people in which the nation covers the innovative treatment of severe rare diseases. We need to foster Korea to become a blockbuster new drug powerhouse by building an innovative pharmaceutical and biopharmaceutical ecosystem and prepare measures such as introducing an appropriate value appraisal for new drugs.”
- Company
- Celltrion completes transfer of Takeda-acquired products
- by Ji Yong Jun Jan 27, 2022 05:43am
- (Clockwise from the left) Nesina, Actos, Edarbi, Albothyl, Whituben, Nesina Met (Pic=MFDS) The transfer of rights for Takeda Pharmaceutical’s products that Celltrion acquired is now complete. The license of OTCs and diabetes drugs that were sold under Takeda Pharmaceutical’s name has been changed to Celltrion Pharm. According to the industry on the 26th, the ownership of the license for Nesina Act Tab 12.5/30mg has been changed from Takeda Pharmaceutical to Celltrion recently. With the change, the company completed changing the license rights for drugs acquired from Takeda Pharmaceutical. This completion comes in around a year since Celltrion acquired the rights for some Takeda pharmaceutical products in the Asia Pacific region. In December 2020, Celltrion acquired the rights of 18 prescription drugs and OTCs in the Asia Pacific region for a total of $278.3 million (₩307.4 billion). Under the deal, Celltrion Healthcare will own the license and be in charge of distribution and sales overseas, and Celltrion Pharm of distribution and sales in Korea. Under the deal, Celltrion Pharm had been sequentially transferring the rights of Takeda products sold in Korea. The DPP-4 inhibitor class ‘Nesina (alogliptin) series’ and TZD class ‘Actos (pioglitazone) series,’ and ARB class hypertension treatment ‘Edarbi (azilsartan)’ are some of the key products that have been acquired by Celltrion. Also, the company is acquiring permits and rights for Takeda’s OTCs such as the cold remedy ‘Whituben’ and the stomatitis treatment ‘Albothyl.’ Celltrion Pharm secured the license rights of all acquired drugs other than Nesina Act 25/15mg·25/30mg, Actos Met, and Albothyl. The company had sped up the transfer process since then and completed the acquisition of all the rights recently. However, the diabetes treatment Basen and hypertension treatment ‘Madipine‘ were excluded from the transfer of rights. Both products are developed by Takeda and the domestic licensing and manufacture of the products are handled by HK Inno.N in Korea. The sales performance of the key products that were transferred to Celltrion is reflected as Celltrion Pharm’s performance. Last year's performance of such products was estimated to be around ₩700 billion. Data= UBIST Based on UBIST results, the outpatient prescription of products that were transferred to Celltrion from Takeda Pharmaceutical last year amounted to ₩67.9 billion. In detail, its Nesina series sold ₩30.9 billion last year, a 3.7% drop from the ₩32.1 billion of the previous year. In the same period, sales of its Actos series also dropped 8.1% from ₩28.4 billion to ₩26.1 billion. Last year, the Edarbi series maintained sales at a level comparable to the previous year with ₩10.9 billion. Last year’s sales of OTCs like Whituben and Albothyl were not counted yet, but the prolonged COVID-19 crisis and the resulting contraction of the OTC market are expected to have slowed down the performance of the drugs as well. An official from Celltrion Pharm said, “We have completed the transfer of rights for major products that we acquired from Takeda, and is planning to focus on expanding prescription sales in earnest from this year.”
- Policy
- PVA guidelines are about to be revised
- by Lee, Hye-Kyung Jan 27, 2022 05:43am
- The NHIS is internally reviewing a revision to the guidelines that includes a 100 → 90% change in the arithmetic average exclusion standard and a 15 → 2 billion won increase in the claim exclusion standard from this year's "Type Da" negotiations. NHIS' Senior director Lee Sangil said at the Korea Special Press Association briefing held on the 25th, "The guidelines amendment is currently under internal review and will be revised so that it can be applied from this year's Type Da negotiations." On December 2 of last year, the NHIS announced a plan to improve the PVA negotiation system at the 10th public-private consultative body involving the MOHW, the NHIS, the HIRA, KRPIA, and KPBMA. According to the revision to the PVA guidelines, the same product group and upper limit price with the total annual claims of the same product group of less than 2 billion won are items with an arithmetic average of less than 90%. Director Lee said, "The expansion of the arithmetic average price standard is aimed at strengthening the management of large items excluded from the list because of the high insurance financial burden but lower than the arithmetic average," adding, "The upward revision to 2 billion won is to exclude items with small claims from PVA." Regarding the pharmaceutical industry's criticism that the revision of the guidelines was made to "lower prices as the pharmaceutical industry sells more," Director Lee said, "From an economic perspective, it is appropriate to cut prices because fixed costs for drug research and development will decrease costs if actual usage increases." In particular, he stressed that the more companies sell, the lower the price is in line with the purpose of PVA, which cuts the drug price of drugs that are a financial burden on insurance. Director Lee added," Jung Hae-min, head of the drug management office, also said, "As the revision of the guidelines was announced at the end of last year and the implementation date of this year was postponed, I think the pharmaceutical industry is curious about the change in details." It will be roughly released next month, he said. In addition, the NHIS has not yet delivered a review opinion to the MOHW on how to raise the maximum PVA cut rate from the current 10% to 15%. Director Chung said, "We have not yet made a proposal to raise the maximum cut rate by 15%."
- Policy
- The NHIS will begin research on improving the PVA system
- by Lee, Jeong-Hwan Jan 27, 2022 05:43am
- Manager Kim HyundukHealth insurance authorities have announced plans to place an order for research services to evaluate the PVA system and prepare improvement measures. It is said that it will further specify the targets for drug cuts and health insurance financial savings through PVA as large items. However, she replied that it is difficult to accept immediately the standard for PVA exclusion from the current 1.5 billion won to 5 billion won or 10 billion won desired by the pharmaceutical industry. On the 25th, Kim Hyun-deok made the remarks at the National Assembly's policy meeting on "Rational Improvement Plan for PVA." The NHIS said the pharmaceutical industry, pharmaceutical society, the National Assembly, and the Board of Audit and Inspection have agreed on the need to improve the PVA system, one of the ways to reduce drug costs. Kim said she is pursuing the direction of discussions on PVA amendments targeting large items and plans to order research services to prepare overall system improvement measures. Director Kim said that she is aware of the problem of applying the PVA cut formula to all medicines collectively regardless of the absolute amount of increase. Director Kim said, "We are aware of the industrial problem of reviewing only the growth rate without taking into account the absolute increase in claims," adding, "We agree that it is necessary to evaluate PVA in general and prepare improvements." We plan to order research services this year, she explained. Director Kim said, "Many demands for PVA improvement have been raised not only by pharmaceutical and pharmacist societies, but also by the Board of Audit and Inspection and Inspection, no matter how much use increases, it is unreasonable to limit it to 10% with PVA. We will review it through research, she said. "The study also plans to discuss changing the standard amount excluding PVA from 1.5 billion won to 2 billion won, but we have to go step by step," she said adding, "The pharmaceutical community talks about 5 billion won and 10 billion won, but it is difficult to go so quickly." It was originally scheduled to take effect on January 1 this year, but it seems to have been delayed to collect opinions from the pharmaceutical industry, she added.
- Company
- Sales of flu treatments have decreased significantly
- by Chon, Seung-Hyun Jan 27, 2022 05:42am
- The outpatient prescription market also fluctuated two years after the landing of COVID-19. Sales in the pharmaceutical market, which is mainly used for infectious diseases such as influenza (flu) treatments, antibiotics, and expectorants, have decreased significantly. The flu treatment market has virtually disappeared. According to UBIST on the 24th, the amount of outpatient prescriptions for flu treatments last year was only 46 million won. It decreased 99.5% in a year from 8.8 billion won in 2020. Compared to 22.5 billion won in 2019, two years ago, the market size decreased by 99.8%. Flu treatment is the market where the most dramatic change has occurred since the spread of COVID-19. After the spread of COVID-19, the flu treatment market has virtually disappeared as the number of flu patients has plummeted due to strengthening personal hygiene management such as washing hands and wearing masks. According to The KCDA, since March 2020, when COVID-19 began to spread in earnest, the number of suspected patients per 1,000 outpatients has never exceeded the epidemic standard of 5.8 patients. Since recording 6.3 in the first week of March 2020, it has recorded less than five in nearly two years. This year, only 2.1 and 1.8 suspected flu patients per 1,000 outpatients in the first to third weeks of January. The flu treatment market has recorded less than 100 million won for six consecutive quarters since the market size recorded 1.8 billion won in the second quarter of 2020. In the fourth quarter of last year, the market size was less than 10 million won even though it was the flu season. In the case of Tamiflu, a leading flu treatment, the prescription amount reached 37.4 billion won in 2016, but only 40 million won last year. The antibiotic market was also damaged by the COVID-19 incident Last year, the amount of outpatient prescriptions for oral cephalosporin drugs was KRW 1.6.6 billion, down 8.0% from the previous year. It fell 28.2% from 27.1 billion won in 2020. Cephalosporin drugs are widely used antibiotics for pneumonia, sore throat, tonsillitis, and bronchitis. It is analyzed that the prolonged COVID-19 flu or a sharp drop in cold patients also affected the antibiotic market. In the case of other antibiotics, the damage is even greater. Last year, the prescription size of oral PCN drugs was 105.2 billion won, down 15.7% from the previous year. It decreased 40.8% in two years from 182.2 billion won in 2019 before COVID-19 hit. The situation was similar in the prescription market for other antibiotics such as Macrolides and similar drugs. Last year's prescriptions for Macrolides and others amounted to 86 billion won, down 6.6% from the previous year. Compared to two years ago, it fell 35.5%. The market size of expectorants used for phlegm and coughs in patients with colds and flu has also been greatly reduced. In 2019, the size of the prescription for expectorants recorded 182.2 billion won, down 29.8% to 127.8 billion won in 2020. Last year, it fell 15.7% again to 107.8 billion won. Last year, the prescription amount of expectorants shrank 40.8% from two years ago. Last year, the prescription performance of expectorants was 55.1 billion won, down 28.1% from the previous year. It was reduced 53.5% from 118.3 billion won in 2019. Prescriptions for last year fell 57.1% and 50.5%, respectively, from two years ago.
- Company
- KRPIA presidents will meet with Lee Joon-seok
- by Eo, Yun-Ho Jan 26, 2022 05:57am
- Ahead of the presidential election, KRPIA and multinational pharmaceutical presidents will meet with the leader of the main opposition party. According to the Dailypharm's confirmation, the presidents of the KRPIA will hold a meeting with Lee Joon-seok, CEO of People's Power, tomorrow morning (27th). The meeting will be attended by Oh Dong-wook , CEO of Pfizer Korea, Lee Young-shin, full-time vice chairman of KRPIA, Kim Sang-pyo, CEO of AstraZeneca Korea, and Kevin Peters, CEO of MSD Korea. It has been confirmed that Rep. Seo Jung-sook (pharmacist), a member of the National Assembly's Health and Welfare Committee, and Rep. Lee Jong-sung will be present along with Lee Joon-seok . Through the meeting, the presidents of KRPIA are expected to deliver grievances, policies, and pledges from the perspective of pharmaceutical companies with the agenda of "expanding new drug coverage." Lee JunSuk Meanwhile, at the end of last year, KRPIA presidents agreed on the need to expand access to treatments for rare diseases in relation to the current government's plan to expand health insurance coverage called "Moon Care" and submitted a PE expansion opinion to the government. According to the opinion, many rare diseases do not meet the "serious disease conditions of threatening survival (less than two years of life expectancy)," which are conditions that can utilize the current special system (RSA and PE systems), but have a great impact on families, including direct medical expenses of patients. The association argues that evaluating the clinical need of these diseases only as life expectancy does not take into account the characteristics of rare diseases, and that even if the clinical need does not meet the criteria for less than two years of life expectancy, it should be added to the PE targets.
- Company
- Outpatient prescriptions slow for MNCs...Viatris in the lead
- by Jan 26, 2022 05:57am
- Outpatient prescription sales of multinational pharmaceutical companies in Korea had slowed down in general last year. Viatris held the lead among multinational pharmaceutical companies for two consecutive years, but its amount of prescriptions also decreased 0.3% compared to the previous year. The top prescription drug companies such as MSD (Organon), AstraZeneca, Novartis, Astellas, all saw a decline in sales. According to the market research institution UBIST on the 26th, Viatris Korea held the lead in outprescription sales with ₩463.9 billion among multinational manufacturing companies last year. The total prescription amount of the company had fallen 0.3% compared to the ₩465.4 billion in 2020. Lipitor and Celebrex sold ₩205.2 billion and ₩46.3 billion respectively, increasing 0.7% and 3.6%, but Lyrica and Norvasc’s sales fell 3.6% and 1.7% respectively to record ₩69.9 billion and ₩69 billion, respectively. Viatris is a spin-off of Pfizer that was established in 2020 after merging with Mylan in 2020. At the time of the spin-off, the company received Pfizer’s off-patent drugs. With key products such as ‘Lipitor (dyslipidemia treatment),’ ‘Lyrica (neuropathic pain),’ ‘Norvasc (hypertension),’ the company has maintained the lead in outpatient prescriptions ever since its establishment. The outpatient prescription performance of large multinational pharmaceutical companies had decreased in general. MSD (including Organon) recorded ₩437.5 billion in prescriptions last year, which was a 2.4% decrease from the previous year. For MSD, its off-patent drugs and women’s health products are in the process of being transferred to its spin-off Organon. If the product transfers become complete, over half of MSD’s off-patent drugs will be recorded as Organon’s products. These future Organon products account for approximately 58% of the ₩437.5 billion that was sold last year as MSD’s prescriptions. ‘Atozet,’ one of the key products that will be transferred to Organon, had recorded ₩86.8 billion in sales last year, which is a 4.9% increase from the previous year. On the other hand, MSD’s DPP-4 inhibitor ‘Januvia family (Januvia, Janumet, Janumet XR)’ did not perform so well. Sales of Janumet fell 4.1% to ₩78.7 billion, Januvia fell 5.7% to ₩45.9 billion. Only sales of Janumet XR rose 2% to ₩51.8 billion. AstraZeneca, which recorded the 3rd most in sales, recorded 424.7 billion last year, a 6.4% decrease from the previous year. The sales drop was affected by the drop in sales of its lead product, the cholesterol drug ‘Crestor,’ falling 3.4% (₩90.8 billion). Fortunately, the outpatient prescription sales of its SGLT-2 inhibitor ‘Forxiga’ and combo ‘Xigduo’ had driven the outpatient prescription sales of AstraZeneca. The two products sold ₩42.6 billion and ₩37 billion, an 11.9% and 21.1% increase, respectively. Novartis’s sales performance also slowed down, recording a 0.1% decrease from the previous year to ₩422.5 billion in sales. Products that sold over ₩10 billion in outpatient prescriptions last year fell to 8 from the 11 in 2016. All companies other than Boehringer Ingelheim among the Top 5 grossing companies among multinational pharmaceuticals saw a decline in prescription sales last year. However, companies that sold NOAC, antidiabetic, and eye drops such as Daiichi Sankyo, BMS, Janssen, Lilly, and Santen fared better in the previous year. Daiichi Sankyo recorded ₩181.7 billion in sales, a 7% increase from the previous year, benefitting from the 16% sales increase of the NOAC anticoagulant ‘Lixiana.’ Sales of BMs’s prescription drugs also increased 7.6% to record ₩181.7 billion, with sales of the NOAC ‘Eliquis’ rising 18.6%. Lilly’s sales also increased 16.1% to record ₩104.9 billion, with the even expansion in sales of GLP-1 analog ‘Trulicity’ antidepressant ‘Cymbalta,’ JAK inhibitor ‘Olumiant,’ CDK 4/6 inhibitor ‘Verzenio.’ Also, the ‘no Japan’ boycott that started in 2019 in Korea did not affect sales of Japanese pharmaceutical companies. Other than Astellas, other Japanese pharmaceutical companies saw steady growth since 2019. In particular, outpatient prescriptions of Santen Pharmaceutical rose 42.3% from ₩68.4 billion in 2018 to ₩97.3 billion last year. Sales of Santen Pharmaceutical’s eyedrop ‘Cosopt-S’ that it received the license from MSD arose significantly, and prescriptions of the eye drop ‘Cravit’ and the glaucoma treatment ‘Taflotan-S,’ as well as eye drop ‘Ikervis’ had expanded greatly.
- Policy
- PVA price reduction needs to be improved
- by Lee, Jeong-Hwan Jan 26, 2022 05:57am
- Professor Lee Jonghyuk of Chung-Ang University.There is a problem that the reduction rate of small items relatively increases compared to the financial impact by using the same formula for PVA negotiations. It was pointed out that the current PVA is operating too rigidly without reflecting the reality that medicines affect health insurance finances. Critics say that drugs that reduce health insurance finances are not considered or that the criteria for excluding PVA drug prices are unreasonable, adversely affecting sales of some drugs. Professor Lee Jong-hyuk of Chung-Ang University, who was in charge of the presentation at the National Assembly's policy meeting on the 25th, made the remarks. The current PVA cuts and adjusts prices within the range of up to 10% through negotiations if the amount of drug claims listed as benefits increases by more than a certain percentage. With the health insurance authorities announcing their plan to partially revise the current PVA, the pharmaceutical community pointed out some irrationalities in the system and asked to actively reflect their opinions in the revision. Professor Lee believes that it is necessary to examine whether the current PVA is fully considering drugs that contribute to fiscal savings as usage increases. He also said that the validity of the claim amount standard excluding PVA negotiations should be discussed aggressively now as the need for revision is emerging. In particular, Professor Lee believes that it is reasonable to apply the same formula regardless of the financial impact of health insurance or change the exclusion criteria to less than 90% of the arithmetic average during the PVA negotiations. Professor Lee said, "It is pointed out whether it is right to cut drug prices by applying collective standards to drugs that have contributed to financial savings." "We need to think about how to reasonably apply financial savings drugs to PVA negotiations," he explained. Professor Lee said, "It is necessary to fully explain the reasons and grounds for the health insurance authorities to change and revise the standard for claims excluding PVA negotiations from the current 1.5 billion won to 2 billion won." He added, "There is also an evaluation that the annual fiscal savings are about 120 million won when revised." Seo Jung-sook, the People Regardless of the financial impact, there is a problem that the reduction rate of small items is relatively large in fiscal impact by using the same formula in PVA negotiations, he said. "Change of standards excluding negotiations changes rules, so many discussions and agreements between health insurance authorities and pharmaceutical circles are needed." Rep. Seo Jung-sook of the People's Power pointed out that the current PVA is unreasonable due to the application of a uniform system and is causing reverse discrimination against innovative pharmaceutical companies in Korea. She said, "Small and medium-sized pharmaceutical products, whose claims have increased by 600 million won from 1 billion won to 1.6 billion won, have to cut their drug prices, but products with an increase of 4.9 billion won from 10 billion won to 14.9 billion won will be excluded from the cut." Unlike global new drugs that are released after fully equipped with a product line, there is also a side effect of reversely lowering the price of innovative new drugs in Korea, she pointed out.
- Company
- SK Bioscience wins 3rd EU-GMP for its vaccine plant
- by Ji Yong Jun Jan 26, 2022 05:57am
- (Picture of Andong L House=SK Bioscience)SK Bioscience, which has signed a CMO deal to manufacture the Novavax vaccine, has additional received EU-GMP certification from the European Medicines Agency. This is the third EU-GMP certification the company received. On the 25th, SK Bioscience announced that it had received additional EU-GMP certification for the manufacturing facility, process, and quality system of Andong L House that is being operated for the manufacture of the Novavax COVID-19 vaccine. SK Bioscience has been producing the drug substance of Novavax’s COVID-19 vaccine under a CMO (contract manufacturing organization) deal. With the approval, SK Bioscience’s L House received the third EU-GMP approval as a vaccine manufacturing facility. One of SK Bioscience’s vaccine manufacturing facilities for AstraZeneca’s COVID-19 vaccine and one of the three SK Bioscience’s vaccine manufacturing facilities received EU-GMP certification last year. SK Bioscience is also working for EU-GMP certification for its last facility. The company explained that it plans to receive an on-site inspection from the EMA within the first quarter at the earliest. The EU-GMP system evaluates and certifies the entire process of vaccine production, from the purchase of raw materials to manufacturing, quality control, to shipment. It is considered to be the highest level of certification in the world along with the US’s cGMP certification. SK Bioscience passed the on-site investigation and document review of the EMA that took two months since November last year. By receiving EU-GMP certification in 2 of its Novavax COVID-19 vaccine manufacturing facilities, the company will speed up the supply of its Novavax vaccine. Novavax received approval for the use of its COVID-19 vaccine from the EMA, WHO, India, Indonesia, Philippines, France, Australia, among other countries. In Korea, SK Bioscience received marketing approval for Novavax’s COVID-19 vaccine ‘Nuvaxovid’ on the 12th, and is preparing a total of 40 million doses of the vaccine. SK Bioscience plans to further expand its CMO business with global vaccine companies based on the vaccine manufacturing and quality control capabilities proven through its EU-GMP certification in the future. L House is equipped with the base technology including ▲cell culture ▲bacterial culture ▲gene recombination ▲protein conjugation and the R&D personnel necessary including the base technology to mass-produce various vaccines immediately upon development. SK bioscience CEO Jae-Yong Ahn said, “It is a great pleasure that the manufacturing facilities of the L House Plant have been recognized for its global capabilities, receiving a series of the highest-level certifications in the globe. Based on the company’s verified vaccine manufacturing and quality control capabilities, we will continue to expand our CMO business in partnership with global companies.”
- Policy
- The presidential candidate's pledge to expand NIP is fierce
- by Lee, Jeong-Hwan Jan 26, 2022 05:57am
- 3 HPV vaccines that have been approved for sale in Korea The expansion of free HPV vaccine vaccination is spreading to a competition for pledges of presidential candidates between the ruling and opposition parties. As the ruling party candidate adopted the application of the NIP of the bivalent and HPV vaccine as a pledge, the opposition candidate is fiercely fighting, promising to support the cost of vaccination of the expensive 9-ga HPV vaccine. On the 23rd, politicians of the ruling and opposition parties are busy promoting their pledge to strengthen health and welfare, which includes free HPV vaccine vaccination. Currently, HPV vaccine NIP targets 12-year-old female adolescents, and NIP applications are Cervarix, a divalent vaccine, and Gardasil, a quadrivalent Influenza Vaccines. As President Moon Jae In announced last year, the health insurance authorities plan to expand the age of free HPV vaccine vaccination in the first half of this year to 12 to 17 years old. Furthermore, Democratic Party of Korea candidate Lee Jae-myung and the people's power candidate Yoon Seok-yeol are determined to increase the number of HPV vaccine NIP targets and expand free vaccination items. Democratic candidate Lee Jae-myung has repeatedly emphasized the pledge since announcing the policy of expanding the HPV vaccine NIP beyond female youth to male youth as his first pledge on the first day of the new year. As candidate Lee's pledge is to expand the existing HPV vaccine vaccination age and gender, the items to be applied are expected to be divalent Cervarix and tetravalent Gardasil. In a recent video, candidate Yoon Seok-yeol promised to apply the NIP of Gadasil 9 that is more expensive than other vaccines. Candidate Yoon predicts vaccination insurance benefits for women aged 9 to 45 and men aged 9 to 26, which is the recommended age for Gadasil 9, so in some cases, it is expected to require significantly greater financial expenditure compared to the expansion of NIP. Except for the NIP application age group, the cost of inoculation of Cervarix, Gardasil, and Gardasil 9 varies considerably. Candidate Lee Jae-myung of the Democratic Party of Korea and candidate Yoon Seok-yeol of the People Cervarix's total cost is about 300,000 won, Gardasil's cost is about 400,000 won, and Gardasil 9's cost is about 600,000 won, which is about 1.5 times more expensive than other Gardasil products. The presidential candidates of the ruling and opposition parties plan to receive public support for their pledge to expand the relatively expensive HPV vaccine NIP. The National Assembly is also steadily proposing a bill to expand the HPV vaccine NIP to support pledges for presidential candidates. Rep. Han Moo-kyung of the People's Power submitted a revision to the Infectious Disease Prevention and Management Act on the 21st, which provides HPV vaccinations to all children aged 12 regardless of gender. Prior to this, Baek Jong-heon of the same party also proposed a bill in December last year to expand the scope of HPV vaccine NIP to 11-year-old and 12-year-old children regardless of gender. In addition, Rep. Choi Hye-young of the Democratic Party of Korea also proposed a bill in November 2020 to expand the target of HPV vaccine NIP to all children and adolescents under the age of 18. As a result, the policy to expand the HPV vaccine NIP after the upcoming presidential election in March is going smoothly. This is because both ruling and opposition candidates have made pledges, and specific directions for NIP expansion and applicable items are expected to be determined according to the results of the presidential election and details of subsequent pledges.
