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- 2026-04-15 21:18:42
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- Patient copayment on Dupixent drops from 60% to 10%
- by Jan 06, 2021 06:18am
- From the break of the new year, the copayment burden on the patients prescribed with an atopic dermatitis treatment Dupixent would be reduced significantly. Sanofi Aventis Korea’s Dupixent would be applied with a special case reimbursement from Jan. 1, 2021 for the patients with severe case of atopic dermatitis. Accordingly, their copayment rate for administering 300 mg of Dupixent would be decreased from 60 percent to 10 percent. The Health Insurance Policy Deliberation Committee (HIPDC) has made the decision at the 22nd meeting convened by the Ministry of Health and Welfare (MOHW) on Nov. 27 last year. A special case reimbursement benefit is provided to patients with rare or severe chronic diseases to cut their copayment rate for the healthcare reimbursement down to 10 percent. To this date, atopic dermatitis was ruled out of the special case benefit as there was no distinction between mild and severe cases. But the relevant legal basis has changed since last July, when a new disease code was designated to a ‘severe case of atopic dermatitis.’ The government also rapidly processed the changes. Now the patients prescribed with Dupixent can only pay 71,000 won, the 10 percent of the listed price 710,000 won per shot. The annual cost of the treatment is estimated to be around 2 million won. Compared to last year, the cost would be maximum 5.82 million won less or about the half. However, the special case reimbursement is only granted to patients who meet the requirements; treating adult patient over the age of 18 with severe atopic dermatitis apparent for over three years, who has uncontrolled condition after four-week topical treatment as first-line treatment, and not showing more than 50 percent improvement in Eczema Area Severity Index (EASI) score after three-month systemic immunosuppressant therapy; has EASI score over 23 before administrating the treatment; and has a record of receiving topical treatment and systemic immunosuppressant therapy within past six months. The Dupixent sales are also expected to surge even more this year as the copayment rate dropped drastically from the New Year’s Day. A pharmaceutical market research firm IQVIA reported Dupixent’s sales income has skyrocketed since last year’s January, when the healthcare reimbursement was granted. The initial quarterly sales making approximately 1 billion won to 2 billion won leaped to 3.3 billion won in last year’s first quarter, and also it soared to 5.2 billion won and 7.1 billion won in the second and third quarters, respectively. As the injection sales accumulated 15.6 billion won as of last year third quarter, Dupixent would likely to break through the 20 billion won record in the first year of reimbursement. Meanwhile, the special case benefit and reimbursement are not applicable on Dupixent 200 mg. The lower dose is currently approved only for adolescents with atopic dermatitis and asthma cases. Sanofi Aventis informed of the detail and explained, “The healthcare reimbursement is not granted for Dupixent 200 mg, so the patients would have to wholly cover the cost of administration.”
- Policy
- AZ has applied for domestic approval of COVID-19 vaccine
- by Lee, Tak-Sun Jan 05, 2021 05:18pm
- The MFDS announced today (4th) that AstraZeneca Korea's application for item approval for COVID-19 vaccine (code name: AZD1222) has been received. This vaccine is a 'viral vector vaccine' manufactured by putting COVID-19 surface antigen gene into a chimpanzee adenovirus vector. Viral vector vaccines are manufactured by inserting viral antigen genes that cause infectious diseases into other viral genes used as carriers and mass-producing them. AstraZeneca vaccine uses adenovirus, which only infects chimpanzees, as a carrier to deliver COVID-19 surface antigen gene into human cells, and the delivered COVID-19 antigen gene synthesizes antigen proteins in the body to induce the production of neutralizing antibodies. US Johnson & Johnson (Janssen) vaccine was developed using a viral vector method. The expected target of AstraZeneca’s vaccine is 18 years of age or older, and the expected dosage is administered twice 4 to 12 weeks after one vaccination. This is the same as indications and dosages approved for emergency use in the UK, and the storage conditions are 2-8℃. AstraZeneca is currently conducting phase III clinical trials in 10 countries including the UK, Brazil and the US. The clinical trial was discontinued (September 6, 2020) due to an unexpected AEFI (one case of transverse myelitis). As a result of safety review, clinical trials were resumed (October 23, 2020, USA, and September 12, 2020, UK) because there was no direct relationship with the vaccine. Transverse myelitis is an inflammatory syndrome that affects the spinal cord and can be caused by a viral infection. However, no direct association with the vaccine was found in this study. The UK confirmed the preventive effect of 11,636 people in the vaccine clinical trial of AstraZeneca and made an Emergency Use Authorization on December 30, and the European Medicines Agency (EMA) has been conducting a preliminary review since October last year. AstraZeneca Korea applied for the approval for products that are consigned to SK Bioscience, a domestic pharmaceutical company, and for products manufactured overseas such as Italy. Item approval/examination data include non-clinical trials, clinical trials, quality, risk management plans, and manufacturing/quality control data. Non-clinical data is a verification of toxicity and effectiveness through animal testing prior to administration of a drug to humans. Clinical trial data confirm the effectiveness and safety when administered to humans. Unlike the clinical evaluation of general medicines that show therapeutic effects, it is important to evaluate the effectiveness of vaccines to prevent infection after vaccination in healthy people. The prophylactic effect (%) in the clinical trial is calculated based on the proportion of infected people who developed each after vaccination in the vaccination group and placebo group. For example, in a phase III clinical trial in which 10,000 people each vaccinated and placebo vaccinated, 10 confirmed cases out of the vaccinated group and 100 confirmed cases out of the placebo vaccinated group occurred, the probability of infection of the vaccinated group Is 1/10 compared to the placebo group, so the effect of preventing COVID-19 infection is calculated as 90%. Looking at the WHO's considerations for COVID-19 vaccine evaluation, it is recommended that the standard of preventive effect of COVID-19 vaccine be at least 50%. The safety is checked and evaluated whether abnormal cases occur after vaccination, and the safety of the vaccine is collected through long-term tracking such as serious abnormal cases. In the 'Guidelines on clinical evaluation of vaccines' by the WHO, it is recommended to follow up for at least 6 months for general vaccines and at least 12 months for vaccines containing immune boosters. It is recommended to perform follow-up observation for at least 1 year in the case of COVID-19. Quality data are data related to the manufacturing process control of the drug and'standards and test methods' for quality control. In addition, the risk management plan (RMP) is data on a comprehensive safety management plan that includes measures to minimize the occurrence of hazards for safety management after marketing. Risk Management Plan (RMP) refers to a comprehensive safety management activity plan that is carried out to collect, investigate, test, and minimize risk occurrence of information on safety and effectiveness over the entire cycle before and after drug approval and marketing. GMP implementation status evaluation data are 10 kinds of data, including facility·environmental management and quality assurance system related to the item for which the license is applied. Good Manufacturing Practice (GMP): Refers to the standards that pharmaceutical manufacturers must comply with throughout facilities, equipment and production processes in order to manufacture excellent pharmaceuticals with guaranteed quality. In addition to general GMP evaluation data, AstraZeneca’s vaccine will be evaluated according to the characteristics of the virus carrier vaccine, such as management of biological raw materials and genetically modified organisms used in manufacturing, and biological safety level (BSL), the MFDS explained. AstraZeneca’s vaccine is planned to be produced in the US, UK, and Italy, as well as SK Bioscience in Korea. As for the quality data, SK Bioscience is currently submitting additional quality data on the original vaccines and finished drugs produced in Korea under consignment from AstraZeneca Company to the AstraZeneca headquarters. AstraZeneca, the original developer, reviews the data to analyze and verify the quality equivalence between the vaccine used in the clinical trial and the vaccine consigned to SK Bioscience in Korea. AstraZeneca prepares data including the results of quality equivalence evaluation between manufacturing sites, and AstraZeneca Korea plans to quickly submit the data to the MFDS. Among the clinical trial data, additional data obtained by collecting and analyzing vaccine adverse events through a planned 12-month follow-up will be submitted, which is the same worldwide. The clinical trial data submitted by AstraZeneca are data from phase I to III being conducted in the UK and Brazil, and the trial is still ongoing for the safety evaluation of the vaccine and is expected to be completed in September 2021. The safety evaluation method of the vaccine is applied to other vaccine methods in the same way, and Pfizer’s vaccine and Moderna’s vaccine will be equipped with additional long-term safety data through follow-up. The MFDS has announced that it will thoroughly verify the safety and effectiveness through the screening of experts in each field and external experts of COVID-19 vaccine and treatment license examination team so that the public can receive a safe and effective COVID-19 vaccine. The MFDS aims to shorten the existing processing period (180 days or more) and process it within 40 days for the rapid approval and review of COVID-19 vaccine and treatment, including the product for this approval. The MFDS is conducting a preliminary review on non-clinical and quality data (non-clinical 10.6~, quality 12.18~) at the request of AstraZeneca Korea and requested data supplementation for nonclinical data. In addition, it is reported that the AstraZeneca vaccine, commissioned and manufactured by SK Bioscience, is preparing for the nation's lot release the fastest. It is explained that the manufacturer's detailed test method was obtained at the end of August last year, and the test method was established at the end of December after receiving reagents such as standard products in November. Vaccines used in the pandemic of infectious diseases are subject to rapid lot release and will be treated preferentially over lot release drugs in other countries, and they plan to quickly complete the national lot release within 20 days, which usually takes 2-3 months or more.
- Policy
- Generics for Arcoxia are coming soon
- by Lee, Tak-Sun Jan 04, 2021 05:58am
- Generic for Arcoxia, COX-2 anti-inflammatory analgesic is expected to be released soon. As the PMS ended on the 22nd of last month, it was confirmed that the generic company received the application on the 23rd, the next day. Since generic companies have already confirmed patent avoidance, they are expected to market their products as soon as they go through approval and reimbursed procedures. According to the MFDS on the 3rd, generic companies for Arcoxia (Etoricoxib) received applications on the 23rd. This drug is used to relieve symptoms or signs of osteoarthritis (degenerative arthritis). MSD Korea's Arcoxia obtained a domestic approval on December 23, 2014. The MFDS ordered a re-examination (PMS) for 6 years, and the end of the re-examination was on the 22nd of last month. Generic companies have been preparing for the market step by step. It succeeded in evading the patent with the remaining term. A trial was filed to confirm the scope of passive rights to evade crystalline patent of Arcoxia, and the claim was finalized in May last year. Participating pharmaceutical companies were Theragen Etex, Hana Pharm, Union Korea, Aju, Arlico, Reyon, Daewoopharm, Boryung Pharmaceutical, Hutecs, and Guju. A bioequivalence test was also conducted for product approval. Three companies of Theragen Etex, Aju, and Arlico conducted a bioequivalence test using Arcoxia as a reference drug. Accordingly, it seems that it succeeded in demonstrating the equivalent of the original drug and applied for permission immediately after the end of PMS. Arcoxia(Etoricoxib) is a nonsteroidal anti-inflammatory analgesic (NSAID) family of selective COX-2 inhibitors. In particular, it attracted attention that it is a follow-up item made by MSD of Vioxx (Rofecoxib), which was removed from the market due to cardiovascular risk as a COX-2 inhibitor. Arcoxia directly conducted clinical trials in Korea to resolve the safety controversy. However, there were fewer recognized indications than the competitive product Celebrex (Celecoxib). Arcoxia is only approved for osteoarthritis, whereas Celebrex has five indications, including ankylosing spondylitis, rheumatoid arthritis, and primary menstrual pain, as well as osteoarthritis. This leads to differences in performance in the market. Looking at the amount of outpatient prescriptions based on UBIST in the first half of last year, sales of Celebrex was ₩20.1 billion, whereas sales of Arcoxia were ₩1.7 billion. Large pharmaceutical companies except for Boryung analyzed that generics for Arcoxia were not very attractive in that they had limited indications for Arcoxia and generics for Celebrex were released after 2015. However, it is expected that the generics applied for approval this time will be able to produce new product effectiveness as they are the first generics that have successfully evaded patents.
- Policy
- Contract for 20 million people with Moderna was completed
- by Lee, Jeong-Hwan Jan 04, 2021 05:55am
- The government officially announced today (31) that it has signed a contract to purchase 20 million COVID-19 vaccines with Moderna, a US pharmaceutical company. As a result, Korea has secured the quantity of Moderna vaccines before the end of this year. This amount exceeds 100% of the population of Korea, and it is evaluated that it is sufficient for the formation of domestic collective immunity. On this afternoon, KDCA Commissioner Jung Eun Kyeong said at a briefing held at the KDCA located in Cheongju, North Chungcheong Province, "We have signed a contract to purchase COVID-19 vaccine for 20 million people with Moderna, and will be supplied to Korea from the second quarter." The government has been negotiating with Moderna for vaccine supply since July. In particular, on the night of the 28th, President Moon Jae-in and Moderna's CEO, Stéphane Bancel agreed on the timing and expansion of the vaccine supply through video calls. At the time, President Moon reached an agreement to supply 20 million people in the second quarter of next year, twice the amount of 10 million people originally secured by the government. Since then, the vaccine purchase contract between the health authority (the KCDA) and Moderna is proceeding smoothly. She said, "This contract was concluded through follow-up negotiations after the agreement to supply a vaccine for COVID-19 in a video call between President Moon and CEO Bancel for 20 million people. The vaccine purchased by the government is for a total of 56 million people, It exceeds 100% of the population. Enough to secure normal population immunity.” She said, "Because there are 30 million people who are eligible for the first vaccination, they must be vaccinated sequentially. In addition, (per person) they need to be vaccinated twice. Therefore, the vaccination starts from the first quarter, but the first vaccination is completed at the end of the third quarter," "We are preparing a plan to finish the second vaccination over a certain period of time." Currently, the MFDS is working on a preliminary review of the Moderna vaccine. The KCDA is planning to announce the current vaccination plan in the next month. The MFDS plans to complete the license/national lot release within 60 days when a pharmaceutical company applies for a license. Vaccination has already begun in the United States and the United Kingdom, and US Armed Forces in Korea has also begun vaccinating Moderna from the 29th. The government secured AstraZeneca’s vaccine for 10 million people, Pfizer for 10 million people, Janssen for 6 million people, COVAX Facility for 10 million people and Modena for 20 million people. With this, Korea will have a total of 56 million COVID-19 vaccines.
- Policy
- GBP510 by SK Bioscience has been clinically approved
- by Lee, Tak-Sun Jan 04, 2021 05:55am
- Another COVID-19 vaccine developed by SK Bioscience has been approved for clinical trials in Korea. The MFDS announced on the 31st that it has approved the clinical trial of the domestically developed COVID-19 vaccine GBP510. GBP510 is a vaccine candidate being developed by SK Bioscience and is different from NBP2001, which was clinically approved in November. This clinical trial is to evaluate the safety and immunogenicity of GBP510 in healthy adults, and phase II will be sequentially conducted after phase I. Immunogenicity refers to the rate of increase in neutralizing antibody that eliminates or lowers viral infectivity. GBP510 is a recombinant vaccine made using gene recombination technology of surface antigen protein of COVID-19. The preventive principle is that the surface antigen protein of the vaccine stimulates immune cells to form neutralizing antibodies to induce an immune response, and when COVID-19 invades, the antibody removes COVID-19. SK Bioscience's recombinant vaccine NBP2001, which was approved clinically on the 23rd of last month (Phase I), induces an immune response with the surface antigen protein of COVID-19, and GBP510 is a surface antigen protein that has a nanostructure (icosahedral particle). There is a difference in inducing an immune response by binding to a specific protein that forms. Novavax in USA is conducting phase III clinical trials of a COVID-19 vaccine using genetically modified technology. The MFDS said, "We plan to do our best to ensure that our people can receive treatment opportunities by supporting necessary matters so that a safe and effective COVID-19 treatment and vaccine can be developed quickly."
- Company
- Industry busy with M&A and investment for new opportunity
- by Chon, Seung-Hyun Dec 31, 2020 06:21am
- In the year 2020, many of South Korean pharmaceutical companies turned their eyes on new potential businesses. They reported major M&A news more than before. Some of them also took a bold step into bio company investment to find new opportunities. ◆GC and Celltrion ink notable M&A deals in hopes of finding new lucrative businesses The industry paid a close attention on GC as it delivered the news of finalizing two big M&A deals. GC Healthcare paid 208.8 billion won in last February to acquire an IT company UB Care. GC Healthcare is a subsidiary of GC that provides customized healthcare service based on IT. UB Care is South Korea’s number one electronic medical record (EMR) solution company, which developed EMR system for the first time in the country. It owns Korea’s biggest medical network and IT-based business platform consisting of 23,900 hospitals and clinics nationwide. Green Cross Holdings anticipates the existing business sectors covering traditional pharmaceutical business, genetic testing, diagnostic testing, medical checkup and many more would maximize the synergy effect in various healthcare sectors after it merges with UB Care. Moreover, bio companies have also joined the colossal M&A market. In last June, Celltrion signed a deal to take over the rights to Takeda’s Primary Care product assets from the Asia-Pacific markets for a total of USD 278 million (approximately 330 billion won). The deal would grant the company all rights over the 18 products available in nine markets including South Korea, Thailand, Taiwan, Hong Kong, Macao, the Philippines, Singapore, Malaysia and Australia. The list of the product assets ranges from prescription drugs like antidiabetic drug ‘Nesina’ and ‘Actos,’ antihypertensive drug ‘Edarbi,’ to OTC drugs like cold drug ‘Whituben’ and stomatitis drug ‘Albothyl.’ In last September, HLB Group acquired Mediforum (previously C-Tri). HLB, HLB Life Science and top shareholders of HLB invested total 16.6 billion won. A biopharmaceutical company Vivozon used its subsidiary to merge with Inist Bio Pharmaceutical. Lumimicro inked a contract to obtain 89.57 percent of Inist Bio Pharmaceutical shares for 60.9 billion won. After merging with the company, Lumimicro re-launched itself as Vivozon Healthcare. Lumimicro manufactures and sells compound semiconductor. Ultimately, Vivozon is merging with Inist Bio Pharmaceutical and taking over the company’s management. Established in 2008, Vivozon is a biopharmaceutical company developing new drugs. Currently, the company is conducting a clinical trial to develop non-narcotic painkiller ‘VVZ-149’ administering to manage post-surgery pain and neuropathic pain. Regardless of the failed attempt to merge, Genexine successfully acquired Toolgen. Genexine secured 16.64 percent of Toolgen’s share and became the biggest shareholder of the company. .Genexine is currently developing immunotherapy and gene vaccine .At the moment, the company is working on global clinical trials in immunotherapy ‘hyleukin-7’ and gene vaccine against cervical cancer .Toolgen owns source technology on third generation CRISPR/Cas9 genome editing, which the company uses it to develop gene therapy .◆Yuhan, Boryung and Huons actively invest externally The pharmaceutical companies were particularly active this year in investing on biopharmaceutical companies .By shaking hands with bio companies for R&D partnership, the pharmaceutical companies aim to seek the next big opportunity .Yuhan Corporation has been fruitful with lazertinib the company took over from Oscotec and licensed out to Janssen .Yuhan spent 38 billion won on four companies as equity investment .In April, the South Korean company invested in Mediogen for 23 billion won .Specializing in probiotics, Mediogen is the biggest shareholder of GI Innovation with 20.79 percent of the share .With Mediogen’s 19.82 percent share gained, Yuhan is now the second biggest shareholder of the company .The company invested quadruple of its last year operating income at 12.5 billion won in an external company for emerging opportunity .Early this year, Yuhan also invested total 15 billion won, or 5 billion won each on Huinno, Amyloid Solution and GI-Biome .Boryung Pharmaceutical reported its nine outward investments took place this year spending total 29.1 billion won .In last July, Boryung Pharmaceutical had decided to invest 24 billion won on a U.S.-based global healthcare investment fund Hayan1 L.P, an investment fund company operated by Boryung’s U.S .branch Hayan Health Network, established for the purpose of healthcare sector investment .Hayan1 fund would seek and invest on promising global bio venture based on 24 billion won Boryung paid out .
- Policy
- Review of new evaluation index for innovative certification
- by Lee, Jeong-Hwan Dec 31, 2020 06:20am
- When the MOHW is certified as an Innovative Pharmaceutical Company, it is expected to initiate a reorganization of the system to create new evaluation indicators that take into account the characteristics of overseas pharmaceutical companies. The goal is to establish a pharmaceutical and bio environment that provides a basis for domestic investment through certification as an innovative pharmaceutical company by a multinational pharmaceutical company. On the 30th, Minister Kwon Deok-chul responded to the written inquiry of Miae Kim, a member of People Power Party of the National Assembly Health and Welfare Committee. The information was answered just before Kwon was appointed, and it shows the direction of policy improvement in the future. Miae Kim inquired to Kwon Deok-chul to "tell your opinoin on the need to provide a basis for domestic investment as an Innovative Pharmaceutical Company certification of a foreign pharmaceutical company." Her inquiry seems to be based on criticism that the Korean government's certification of Innovative Pharmaceutical Company has focused on domestic pharmaceutical companies relatively compared to overseas pharmaceutical companies. The Innovative Pharmaceutical Company certification system has been operated since 2012 as a system to certify and support companies with high R&D proportions and excellent performance. Minister Kwon explained that the system certifies not only domestic pharmaceutical companies, but also multinational pharmaceutical companies that have contributed to the development of the domestic pharmaceutical industry, thereby activating open innovation and technology exchange and cooperation within the industry. It is said that three companies, Janssen Korea, AstraZeneca Korea, and Otsuka, have obtained certification and are applying a fair evaluation method without discrimination between domestic and foreign companies. Minister Kwon said that he would prepare for reorganization, including the establishment of new evaluation indicators that take into account the characteristics of multinational pharmaceutical companies. Minister Kwon said, "The environment of the domestic and foreign pharmaceutical industry is changing and domestic investment by foreign companies is expanding." He replied, "We are reviewing the reorganization of the direction of establishing a new evaluation index considering the characteristics of foreign companies."
- Policy
- Item management of accelerated approval is strengthened
- by Lee, Tak-Sun Dec 31, 2020 06:20am
- The MFDS has established a policy that it will not approve the extension of the deadline if the clinical trial is unsatisfactory for phase III accelerated approval item. Periodic reports should be submitted in the middle of Phase III, and surveys will be conducted if necessary for items with no results. It was to supplement this by creating an internal management guideline for the MFDS in response to the fact that the management of items was insufficient during the last National Assembly audit. According to industry sources on the 29th, the MFDS recently prepared an amendment to the 'Guidelines for approval and management of drugs with conditions related to clinical trials' and began to collect industry opinions. Items subject to phase III accelerated approval are applied to ▲life-threatening or serious serious diseases, ▲no alternative drugs, or products with significant clinical benefit compared to existing drugs. This guideline focuses specifically on the management of accelerated approval items. In particular, detailed information on post-licensing management such as changes in conditions such as clinical trials and submission of periodic reports were included. Although it is possible to change the conditions of approval given earlier, for example, the deadline for submitting the final clinical trial or the number of patients to be tested, it has been decided not to approve the extension of the deadline for submitting items that are unfaithful to the clinical trial. Phase III conditional permit items are notified of the necessity of fulfilling the conditions and actions taken in case of non-compliance 1 month before the approval of the plan and 1 year before the submission of the result report. It monitors the clinical trial progress and distribution status of the item within the deadline of the license conditions, and if there is no performance, the measures taken if the license conditions are not fulfilled. If the Accelerated Approval item does not submit the final clinical trial results or periodic report data, we plan to cancel the item or delete the indication according to the Pharmaceutical Affairs Act. According to this guideline, the management of phase III conditional licensed items after approval is expected to be strict. In particular, it is expected that the Ministry of Food and Drug Safety can actively intervene and take action in the process of clinical trials through regular reports. On the other hand, at the National Assembly audit held in October, it was pointed out that the management of Accelerated Approval items was insufficient. In particular, it was pointed out that the MFDS was passive about the situation in which Accelerated Approved Riavax was revoked due to failure to complete the phase III conditions. Baek Jong-heon, a member of the People Power Party, said that eight out of 32 clinically accelerated applications in Phase III over the past five years have no production performance. This guideline seems to accept these comments and clarify the conditional implementation process. Currently, it is known that Baek Jong-heon plans to initiate a bill to legislate accelerated approval.
- Company
- Celltrion has applied for approval of COVID-19 treatment
- by Chon, Seung-Hyun Dec 31, 2020 06:20am
- Celltrion applied for accelerated approval of an antibody treatment COVID-19, the MFDS initiated a review. Celltrion announced on the 29th that it has applied to the MFDS for accelerated approval of CT-P59 (Regdanvimab), COVID-19 antibody treatment. An application for authorization was filed based on the recently ended global phase II clinical trial. CelltrionBased on the clinical results, Celltrion is also starting a procedure for obtaining EUA in the US and Europe. This global clinical phase II was designed through prior consultation with the MFDS the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA). A total of 327 patients from South Korea, Romania, Spain and the United States participated and completed the final medication on November 25th. Celltrion explained, “We have completed the analysis of the detailed data of this clinical trial through domestic and foreign experts and self-evaluation, and have immediately submitted an application for approval because we have determined that we have secured sufficient grounds for applying for accelerated approval from the Ministry of Food and Drug Safety for CT-P59. The MFDS requested that detailed clinical data related to the safety and efficacy of CT-P59 be not disclosed until there is a separate guideline, in view of the recent focus of the public on COVID-19 treatment. Celltrion plans to present the results of this phase II clinical trial in detail at an international conference soon. In addition, based on the results, it plans to quickly enter phase III clinical trials in 10 countries around the world to further verify the safety and efficacy of CT-P59 through a broader patient group. Celltrion is also promoting the overseas Emergency Use Authorization (EUA) procedure of CT-P59. While sharing the data on the results of this phase II clinical trial in detail with the FDA and EMA, consultations on the submission of applications for approval will be initiated, and They will be submitted to most of these countries in January of next year. When responding to inquiries about orders from overseas government agencies, it plans to induce pre-orders while explaining the results of this phase II clinical trial in detail so that domestic supply is possible as soon as possible as soon as EUA is available. An official from Celltrion said, “We are grateful to domestic and foreign health authorities, medical institutions, and participating patients who have actively supported this clinical trial to be completed smoothly as planned. Special thanks are also to the dozens of our employees who have been dedicated to working in the US and Europe.” The MFDS has initiated the CT-P59 permit review process. The MFDS explained, "As Celltrion submitted the application for permission and related data, the approval review began." The submitted data is preliminary reviewed by the high-tech product licensing officer, and then a pre-configured “COVID-19 Vaccine/Therapeutic License Review Team” examines the data necessary for approval, such as non-clinical, clinical, and quality. After that, the review opinions are synthesized to determine the validity of the permit, and the final approval is obtained after consulting the Central Pharmaceutical Affairs Review Committee composed of external experts. The MFDS aims to shorten the existing processing period (180 days or more) and process it within 40 days for the rapid approval and review of COVID-19 vaccine and treatment, including the product for this approval. An official from the MFDS explained, "We will thoroughly verify the safety and effectiveness by using experts in each field and external experts of COVID-19 Vaccine and Treatment License Examination Team so that safe and effective COVID-19 treatment can be used by the public."
- Company
- Who would manufacture Moderna vaccine in South Korea?
- by Kim, Jin-Gu Dec 31, 2020 06:20am
- President Moon Jae-in and Moderna CEO Stephane Bancel reportedly had a conference call over supplying COVID-19 vaccines for 20 million people in South Korea. Now the question is who would sign the consignment production contract for the vaccine in South Korea. The pharmaceutical industry is mentioning four names of potential candidates, including GC Pharma, Hanmi Pharmaceutical, Samsung Biologics and ST Pharm. ◆Cheong Wa Dae “Strengthening collaboration with Korean CMO for the vaccine” On Dec. 29, Cheong Wa Dae stated the South Korean government plans to reach a purchasing agreement over COVID-19 vaccine for 20 million people with Moderna by the end of the year. Compared to the original plan, the number of doses was increased to vaccinate 10 million more people, and the supply schedule was push up from the third quarter to the second quarter. Also the presidential office disclosed the plan to secure Moderna vaccine through consignment production. Cheong Wa Dae spokesperson Kang Min-seok said, “We have agreed to strengthen the cooperation with Moderna by having South Korean company to manufacture the vaccine under consignment contract.” If the government finalizes the supply contract with Moderna, it would resemble that of the AstraZeneca’s vaccine contract. In last July, the government has inked a three-way contract with AstraZeneca and SK Bioscience for the vaccine supply. The pharmaceutical industry predicts GC Pharma, Hanmi Pharmaceutical, Samsung Biologics and ST Pharm would have a chance at it. ◆Top candidates: GC Pharma, Hanmi Pharmaceutical, Samsung Biologics and ST Pharm GC Pharma has been mentioned as a candidate backed by the company’s Ochang manufacturing facility opened in October. The facility has integrated each vaccine facility previously located in Hwasun and Ochang, Jellanam-do. GC Pharma has also signed a facility utilization contract with Coalition for Epidemic Preparedness Innovations (CEPI) in last October. Basically, the Korean company has agreed to manufacture 500 million doses, if a vaccine developer (including Moderna) successfully develops a vaccine supported by CEPI. According to the agreement, the company plans to manufacture COVID-19 vaccine assigned by CEPI from March 2021 to May 2022. CEPI is part of COVAX Facility along with WHO and GAVI. South Korea has signed to receive vaccines for 10 million people through COVAX Facility, but the said doses are not part of the deal the government and Moderna is lately discussing of. Hanmi Pharmaceutical is also on the list of the Moderna vaccine CMO candidates. The company’s Peongtaek Bio Plant can manufacture maximum 1 billion doses of vaccines per year. Two years ago, Hanmi Pharmaceutical has completed constructing a Bio Plant equipped with 20,000 liter of microbial fermentation and biochemical conjugation reaction processors. Apparently, the plant can manufacture 20 million doses of mRNA vaccine in a week. Along with GC Pharma and Hanmi Pharmaceutical, ST Pharm is mentioned as a manufacturer candidate as the company has been consistently preparing for mass production of mRNA vaccine. Since three years ago, the South Korean company forecasted an anticancer vaccine using mRNA mechanism would be promising and started expanding relevant facilities. On Dec. 2, the company opened mRNA Business Development Department directly under the CEO’s command as an expansion of emerging business, and recruited a gene therapy expert Dr. Yang Joo-sung as the department head. Also the company is reinforcing the related facility as well. However, ST Pharm is backed up with other consignment contracts, and it still lacks the capacity to mass produce mRNA vaccine. Another candidate Samsung Biologics has the world’s biggest biopharmaceutical production capacity. The company has already signed consignment production deals with various global pharmaceutical companies for COVID-19 treatments. Regardless of the colossal facility, the company would have to newly establish facility to mass produce mRNA vaccine. A pharmaceutical CMO industry insider noted, “Moderna would likely to license out the technology for the consignment production as the vaccine is already quite close to commercialization. Due to the government’s settlement with Moderna, a multiple companies may handle the production in South Korea.”
