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- 2025-12-25 15:34:25
- Policy
- COVID-19 vaccine budget KRW 857.1 Bln received
- by Kim, Jung-Ju Jan 14, 2021 06:15am
- The South Korean health authority is fully readying for COVID-19 vaccination starting off from February as they have first secured the budget for the vaccine purchase and expenditure for inoculation. The Korea Disease Control and Prevention Agency (KDCA) announced on Jan. 12 the vaccine purchasing budget and inoculation expense budget of 857.1 billion won and 38 billion won have been allocated, respectively, through first and second budget request. KDCA first received 857.1 billion won to purchase globally developed vaccine, which would sequentially cover the upfront payment for Moderna vaccine and payments for the other vaccine supply deals. The health authority plans to continue seeking for finance from the financial authority for additional payments to procure vaccines for 56 million people. And approximately 35.6 billion won would be requested for preparing vaccine freezer for storing and inoculation, syringe and other equipments and establishing an integrated management system for vaccine distribution and inoculation. KDCA would also set up vaccine distribution, storage and management system before the first inoculation begins. Currently, KDCA is in process of purchasing mRNA vaccine freezer for Pfizer (-75℃±15℃) and Moderna (-20℃) and required syringe via the Public Procurement Service. Bidding for the freezer is ongoing since from Jan. 7, which would procure 100 units within this month and complete installing 250 units within the first quarter. Moreover, KDCA is to ink contracts with distributors within this month to safely ship vaccine to the inoculation centers. The agency official noted it is setting up a tight cold chain management system, as well as an integrated management system to inform the public of the COVID-19 vaccine and book timeslots for inoculation recipient. The budget of approximately 2.4 billion won is allocated for raising public awareness of inoculation, educating about the inoculation, and operating a call center. The training for human resources would be conducted for streamlined inoculation process, while the government would provide accurate information about the process and call center service for better communication and fact checking. Director Jeong Eun-kyeong stated, “The vaccine doses the government has signed the deal for 56 million people would be introduced in phases, and they would be prepared as soon as feasible. When the COVID-19 vaccine inoculation plan is finalized, the government would pay particular attention to the preparation to immediately and promptly conduct the inoculation.”
- Policy
- There is progress in introducing additional COVID-19 vaccine
- by Lee, Jeong-Hwan Jan 14, 2021 06:15am
- Prime Minister Chung Sye-kyun announced that significant progress has been made in introducing additional vaccines from other platforms, including Pfizer, Moderna, AstraZeneca, Janssen, and others regarding the COVID-19 vaccine. Although the spread of COVID-19 has recently slowed, he has been wary of hasty measures to mitigate quarantine. On the 12th, Prime Minister Chung held the Central Disaster and Safety At the Countermeasure Headquarters meeting, he said, "The government has been making efforts to introduce additional vaccines for another platform, and there has been considerable progress recently. Details will be reported to the public after the contract is finalized." Prime Minister Chung Sye-kyun said, "The government has signed a contract for a vaccine for 56 million people, enough to form collective immunity, and is preparing with all its might to start vaccination next month. Even with the vaccine, it is not yet known how long the immunity will last, and there is a possibility of safety issues. If the vaccination is not done within the expiration date, the vaccine may have to be discarded as it is due to the short expiration date." Regarding the recent COVID-19 situation, Prime Minister Chung said, "The spread has slowed since last weekend, and it can be confirmed as an objective indicator." "Danger comes soonest when it is despised," he stressed. He said, "The number of new outbreaks in the last week has decreased to less than a quarter compared to the previous week, and the infection reproductive index has also fallen to less than 1. The metropolitan area's medical response capacity has also recovered a lot." "It will be decided this week whether it will go to a certain level of stability, or if it will re-proliferate after being distracted," he said. "We have experienced what happens when social awareness is weakened, and we have seen the consequences of premature quarantine mitigation measures in the world case." He said, "A number of European countries have entered social blockade again, and Japan has declared an emergency with more than 100,000 confirmed cases in a month. K-quarantine should never commit the same mistake."
- Policy
- All citizens will be vaccinated free of charge
- by Lee, Jeong-Hwan Jan 14, 2021 06:15am
- President Moon Jae-in promised free vaccination for all citizens according to the priority of the COVID-19 vaccine at the New Year's address on the 11th. It also announced a plan to strengthen vaccine sovereignty with the domestic COVID-19 vaccine, and to transparently disclose the entire process of licensing, including the safety and effectiveness of domestic COVID-19 treatment. In the New Year's address in 2021, President Moon said, "In 2020, a new infectious disease threatened human life, and daily life changed completely. In the midst of crisis, medical staff devotedly cared for patients and the people themselves became the subject of quarantine." President Moon said, "We are finally at the end of the dark COVID-19 tunnel. It is an urgent need to quickly return to a normal routine that does not require a mask. We will do our best to end the COVID-19 epidemic early by passing the last hurdle well." President Moon stated that COVID-19 vaccination will begin next month, and announced a policy that all citizens will receive free vaccinations in order according to priority. President Moon said, "We will allow all citizens to receive COVID-19 vaccine for free according to their priorities. We will transparently disclose the entire process of screening treatments developed by domestic companies. We will contribute to strengthening public safety and international health cooperation by securing sovereignty through the development of our own vaccines." President Moon said, "2021 will be the year of recovery, inclusion, and leap forward for our people. Last year, our people showed the world the most common truth that the safety of our neighbors is my safety, with amazing practices. Korean diagnostic kits, drive-through test methods, and quarantine products such as masks have been distributed around the world to protect humanity. K-Quarantine is built on the dedication and sacrifice of the people."
- Policy
- MFDS OK's removing “redundant” narcotics return approval
- by Lee, Jeong-Hwan Jan 13, 2021 06:12am
- The Ministry of Food and Drug Safety (MFDS) and the National Assembly Expert Committee Office approved of a bill to remove the MFDS narcotics pre-return approval procedure. The bill received the nod prior to the National Assembly Health and Welfare Committee’s review. When it is passed, the pharmacists’ convenience in returning the narcotic products would be improved. On Jan. 12, the National Assembly Expert Committee Office disclosed the review report on Democratic Party Lawmaker Kim Woni’s bill to abolish the narcotics pre-return approval procedure. Lawmaker Kim urged that the pre-return approval is unnecessary, as MFDS operates the Narcotics Information Management System (NIMS), where a narcotics handler or narcotics handling authorizer return narcotics or psychotropic drug they used to own or manage. The lawmaker claimed the advance and post-return reporting via NIMS and the pre-return authorization by the Minister of Food and Drug Safety are redundant regulation. The ministry also agreed with the objective of the bill. As NIMS can verify the transfer record, the pre-transfer approval for the product return would not be problematic. MFDS official said, “Returning narcotics has specified receiver, and the transfer record can be confirmed with the narcotic handling report system. It would be reasonable to omit the MFDS authorization procedure.” The National Assembly Expert Committee Office was also in favor of the bill. The current Narcotics Control Act stipulates a narcotic handler and a narcotic handling authorizer to mandatorily report the import and export, manufacturing, sales and purchase, prescription and administration, and transfer records onto the online database. The office elaborated, when returning the narcotics to the original owner, the purchaser would send back the narcotics already reported to the NIMS, and again, both the purchaser and the seller would have to report the NIMS after the transfer. The Expert Committee Office official stated, “The current regulation stipulates the seller and purchaser specified by the NIMS have to each report to the authority after the transfer. And considering the Minister of Food and Drug Safety passes the narcotics return without a thorough review, regulating the narcotic product transfer could be seen as a redundant regulation. Abolishing it would be more reasonable.”
- Policy
- 9 Atozet generic companies to join CKD via consignment
- by Lee, Tak-Sun Jan 12, 2021 06:22am
- A dyslipidemia treating combination drug ‘Atozet’ by MSD Nine pharmaceutical companies, initially preparing to launch a generic version of a dyslipidemia treatment Atozet (atorvastatin plus ezetimibe), joined a group of manufacturers to produce Chong Kun Dang’s evidence-submitting drug as CMO. Instead of generics applying for the health authority approval from this month, the companies seem to have chosen to manufacture the follow-on drug with evidence submission under the consignment contract. Apparently, some of them have already completed the bioequivalence test successfully. On Jan. 8, South Korea’s Ministry of Food and Drug Safety (MFDS) granted approval on 22 companies’ atorvastatin calcium plus ezetimibe combination drugs. Some of the companies are to sign consignment deal with Chong Kun Dang, who earned the approval for a same substance drug undergoing safety and efficacy evaluation in last October. With the deal, Chong Kun Dang has provided the data related to the government-approved same substance drug. The nine companies from the 22 companies are Dongkoo Bio & Pharma, Celltrion Pharm, Yuyu Pharma, Wooridul Pharmaceutical, Jinyang Pharm, Hana Pharm, Korea United Pharm, Korea Prime Pharm, and Hutecs Korea Pharmaceutical. Ultimately, the pricing and launching schedule have convinced the companies to take the consignment contract over the independent generic development. Drugs manufactured with Chong Kun Dang’s consignment would be counted as part of 20 same substance drugs, which means the contracted companies’ drugs would receive better pricing than the drugs launched after the 20th product. Moreover, the drugs sharing the Chong Kun Dang’s evidential material would be able to receive approval even before the original Atozet’s post-marketing surveillance expires. Accordingly, the generics that finished the bioequivalence test may apply for the approval from Jan. 23. For instance, Dongkoo Bio & Pharma was heavily criticized by other CMOs, as the company was originally calling for generic CMO after completing the bioequivalence test, but suddenly settled on an agreement with Chong Kun Dang. Other 13 companies that did not join Chong Kun Dang but received approval on the bioequivalence test would receive the lowest pricing according to the stepped pricing. Regardless, the companies like GC Pharma and Ildong Pharmaceutical would push on with the sales. The Atozet market is to face a drastic dynamic change with a group of follow-on drugs swarming in. The original Atozet is a star drug making 60 billion won a year. Understandably, the follow-on drugs would not miss the chance to absorb the market share. And it is still unknown if Chong Kun Dang would maintain the Atozet co-promotion contract with MSD Korea. The Korean company has been in charge of Atozet sales since it inked the deal in 2016. But the company’s same substance drug has been approved already based on its own clinical trial, and it is named ‘Lipilouzet,’ taking the motif from the main product’s name ‘Lipilou.’ Eventually, the company would highly likely to drop the co-promotion deal and focus on its product. MSD Korea would have to seek for a new partner for the Atozet co-promotion.
- Policy
- Breaking down MOHW 2021 action plan for NHI Master Plan
- by Kim, Jung-Ju Jan 12, 2021 06:19am
- The drug reimbursement benefit would be improved throughout chronic disease treatment this year, centering hepatitis B and C virus treatment and antidiabetic combination drugs. The already listed drug reimbursement reevaluation would be enforced from the latter half of the year, when the subjects are decided in the first half of the year. Moreover, the external reference pricing criteria, generic substitution incentive, also known as Rewards for Saving Drug Expenditure (RSDE), would be amended within this year. South Korea’s Ministry of Health and Welfare (MOHW) is to unfold the ‘2021 Action Plan for the First National Health Insurance (NHI) Master Plan’ as scheduled. These plans would follow the yearly flow of innovative NHI coverage enhancement initiative and the reimbursement quality and finance management programs. Pharmaceutical coverage enhancement initiative—granting reimbursement on non-reimbursed drugs The ‘Reimbursement Provision on Non-reimbursed Drug’ program that enhances coverage while keeping the positive listing system, would expand on chronic disease treatment as it did on musculoskeletal and pain clinic medication and anticancer treatment (adjuvant drug) last year. So far, the government completed newly listing total 60 items (22 anticancer treatments and 38 general drugs) with high social and clinical demand, originally categorized as non-reimbursed drug. An immunotherapy Tecentriq (January 2018), a multiple myeloma treatment Kyprolis (February 2018), a renal cell carcinoma treatment Cabometyx (February 2019) and an immunotherapy Imfinzi (April 2020) are now all covered by NHI. General drugs, such as hepatitis C virus treatment Mavyret (June 2018), a new drug for spinal muscular atrophy (SMA) Spinraza (April 2019), a severe atopic dermatitis treatment Dupixent (January 2020), and a hemophilia treatment Hemlibra (May 2020), were also listed for reimbursement. With the initiative to cover the listed drugs in non-reimbursed criteria, the coverage was applied on total 124 items, consisting of 15 anticancer treatment and 109 general drugs. A chronic lymphocytic leukemia treatment Imbruvica (April 2018), a breast cancer treatment Perjeta (May 2019), a hepatocellular carcinoma treatment Nexavar (January 2020), an acute lymphoblastic leukemia treatment Blincyto (April 2020) and a parenteral iron therapy Venoferrum (May 2020) received the NHI benefit. The drug coverage expansion program is to continue this year as well, concentrating on non-reimbursed treatments for chronic disease, i.e. hepatitis B and C virus treatments and antidiabetic treatment. The government plans to revise the pharmacoeconomic evaluation guideline within the first quarter, and reflect the external reference pricing changes on regulation by the second half of the year. The government expects the patients’ treatment access would be improved and their financial burden would be lessened by the new coverage on drugs with high social and clinical demand. NHI sustainability—reevaluating listed drugs The government has been reassessing the reimbursement adequacy and feasibility on medical service, pharmaceutical, and medical treatment material, in the said sequential order. In November 2019, Drug Post-listing Evaluation Subcommittee under the Drug Reimbursement Evaluation Committee was formed and selected choline alfoscerate to reevaluate the reimbursement from February through July and changed the benefit to selective reimbursement (copayment rate 80 percent) for using the drug in treating conditions other than dementia. Also, the government is to initiate the reevaluation program this year after finalizing the process and revising the weighted drug pricing system since last February. In particular, by integrating the current weighted pricings—‘one year plus infinite (number of companies supplying same substance drug less than three)’ for synthetics, and ‘two years plus one year (number of same substance drug suppliers less than three)’ for biologics—the government is to apply ‘one year plus two years (number of same substance drug suppliers less than three)’ for both synthetics and biologics and to extend two years after deliberation. The weighted pricing reevaluation would be conducted within the first half of the year, and the actual full on reevaluation would start from the latter half of the year after selecting subject drugs with uncertainty. The government anticipates the reevaluation to create a foundation for essential drug-centered coverage expansion. NHI sustainability—improved management of pharmaceutical expense To better manage the pharmaceutical expense, the government has been compiling long and mid-term drug reimbursement strategy so far based on the revised volume-pricing linkage system. First, the RSDE program improvements would be established to control the drug use volume by referring to the previous researches. The government would review the plan in the first quarter, put together the improvements and finalize them by the end of the year. As for pharmaceutical expense control, the detailed drug reimbursement-deciding principles and listing prioritization would be reviewed by the third quarter and finalized within the fourth quarter. The final adjustment would be decided and finalized in the latter half of the year, after thoroughly analyzing the external reference pricing with the current pricing range for each chronic and senile disorder drugs in South Korea.
- Policy
- 22 generics for Atozet by Chong Kun Dang were approved
- by Lee, Tak-Sun Jan 11, 2021 06:10am
- MSD’s Atozet, generics of 22 companies were approved following Chong Kun DangThe products of 22 companies for hyperlipidemia (Ezetimibe/Atorvastatin) consigned by Chong Kun Dang were approved on the 8th. As a result, 20 generisc within the same ingredient were approved, and the next drug price application for the same drug product was reduced to the lowest price. This is because of the stepped drug price system that has been in effect since July of last year. On the 8th, the MFDS approved 22 companies' Ezetimibe/Atorvastatin combination. The companies are Kyongbo, Dongkoo Bio, Celltrion, Yooyoung, YuYu, Kukje, DongKook, Boryung, Samjin, SCD, Ahn-gook, Arlico, Alvogen Korea, SK Chemicals, HK inno.N, Wooridul, Reyon, Jinyang, Hana, Korea United, Korea Prime, and Hutecs. It also includes Dongkoo Bio, which has completed the development of generic and recruited contractors. Chong Kun Dang was approved in October as a drug for data-based re-evaluation through its own development of Ezetimibe/Atorvastatin. MSD Korea's original Atozet was approved before the expiration of PMS. Atozet's PMS will end on the 22nd of this month. Chong Kun Dang also recruited a commissioned generic company. Considering the drug price, more than 20 companies were recruited. This is because if it is less than 20, the next licensed generic drug can also receive the highest price within 20. Chong Kun Dang and consigned pharmaceutical companies promised that Chong Kun Dang would recruit 20 generic companies. In the current drug price system, if more than 20 active ingredients are listed, the upper limit of the newly listed item will drop to 85% of the existing lowest price. Some generic companies said they would file a complaint with the Fair Trade Commission, claiming that Chong Kun Dang and consignment manufacturers are fixing drug prices. They said that if the related companies voluntarily report, they will be excluded from the complaint. However, there was no company that voluntarily reported. The issue of preemption of drug prices through consignment of a drug for data-based re-evaluation led to controversy over revision of the law. Some lawmakers argued that there is a need to limit the number of drugs for data-based re-evaluation as well as generics. Jeong-sook Seo, a member of People Power Party Rep also proposed a related bill. However, small and medium-sized pharmaceutical companies strongly oppose it, and the MFDS, the ministry in charge, is also cautious about this. Therefore, the revision of the law is not expected to be easy. Chong Kun Dang changed the name of the previously approved product. The first licensed product name is used by Kyongbo. Lipilou is a blockbuster hyperlipidemia treatment sold by Chong Kun Dang. The use of the company's product name is a strategy to increase the awareness of the new product to existing customers. Chong Kun Dang's active marketing is expected. Chong Kun Dang is also jointly selling the original Atozet, and it is noteworthy whether there will be any changes due to the release of Chong Kun Dang's new product name.
- Policy
- Plasma treatment was completed in Phase II clinical trial
- by Lee, Tak-Sun Jan 11, 2021 06:10am
- Kwon Jun-wook, the 2nd vice-president of the Central Disease Control HeadquartersThe government confirmed that the patient administration of the clinical II trial of a domestically developed blood system drug has been completed. As in the case of Celltrion's antibody treatment, the application for Conditional Marketing Authorization (CMA) is imminent. Kwon Jun-wook, the 2nd vice-president of the Central Disease Control Headquarters said at a briefing on the current status of COVID-19 in Korea on the 7th, "Phase II clinical trials have been conducted at 13 medical institutions in relation to the clinical trials of blood system drugs currently being developed in Korea. In the situation where the medication was completed to 64 patients.” In this regard, a total of 6,554 people have registered plasma donation, and 4,139 people have actually completed plasma donation. He emphasized that on December 24 of last year, in the update of the COVID-19 treatment guidelines, he recommended the use of Remdesivir among antiviral drugs and Dexamethasone among immunomodulators as a treatment for the elderly, underlying disease and severe patients. He added, "In the case of malaria treatments such as Chloroquine single or combined therapy, it is not recommended because it does not appear to be effective against COVID-19, and HIV protease inhibitors such as Kaletra are also not recommended." Recently, treatments such as Chloroquine seem to have been mentioned to correct this as fake news about the effect of COVID-19 spread through SNS. Meanwhile, Remdesivir has been prescribed to 3,108 confirmed patients in 105 hospitals.
- Policy
- Adenovirus for AZ vaccine, Sinopharm uses inactivated virus
- by Lee, Tak-Sun Jan 11, 2021 06:10am
- Diverse types of COVID-19 vaccines are currently in development. Pfizer and Moderna’s vaccine candidates are based on RNA, when AstraZeneca’s is a virus vector and Korean-based SK Bioscience’ is a recombinant vaccine. These types of vaccine have their respective strengths and weaknesses. Some types have been commercialized already, but mRNA vaccine has never been commercialized, making the COVID-19 vaccine the first product. On Jan. 7, South Korea’s Ministry of Food and Drug Safety (MFDS) explained about the different types of COVID-19 in development and their mechanisms. The international effort to promptly seek COVID-19 vaccine has pushed pharmaceutical companies to explore a variety of vaccine platform technologies, including virus vector vaccine, mRNA vaccine, recombinant DNA vaccine and inactivated vaccine. #AstraZeneca and Janssen take virus vector vaccine, when Pfizer and Moderna take mRNA vaccine A virus vector vaccine injects adenovirus harmless via virus vector to human body to generate the antigen in the body inducing the adequate immune response. AstraZeneca and Janssen, already signed the procurement deal with South Korea, use the mechanism for their vaccines. The AstraZeneca’s vaccine uses adenovirus that only infects chimpanzees. Compared to mRNA vaccine, the virus vector vaccine is considered to be more stable around heat. But the vaccine type requires cold chain maintained at 4 degrees Celsius as it uses a live adenovirus. So far, Janssen’s Ebola vaccine using the mechanism was the only vaccine approved to market. The U.K. health authority has approved AstraZeneca’s vaccine as of Dec. 30, 2020 for an emergency use, whereas European Medicines Agency (EMA) is reportedly conducting an evaluation from October last year. In South Korea, MFDS is currently reviewing the vaccine applied for approval on Jan. 4, 2021. Janssen’s (Johnson and Johnson) investigational vaccine is conducting a Phase III clinical trial since September 2020. The vaccine has already requested for evaluation in South Korea (Dec. 22, 2020) with the non-clinical and quality relevant evidences. A Korean company Cellid’s candidate vaccine is in process of Phase 1/2 clinical study. In development by Pfizer and Moderna, mRNA vaccine injects antigen gene as a messenger RNA form to generate antigen protein that instigates immune response. The type of vaccine is to be introduced to South Korea later this year. Although the particular vaccine type can be mass produced with fast manufacturing speed, maintaining the stability is extremely difficult with the RNA easily broken down by ribonuclease. Accordingly, the vaccine requires cold chain with temperature kept at around minus 20 degrees Celsius or minus 75 degrees Celsius. And it would be the first time for the type of vaccine to be commercialized. RNA, or ribonucleic acid, is one of two nucleic acids in a cell, which carries genetic information and adjusts genetic expression. Currently, the U.K (Dec. 2, 2020), the U.S. (Dec. 11, 2020) and Canada (Dec. 9, 2020) have granted an emergency approval on Pfizer’s vaccine, whereas Switzerland (Dec. 19, 2020) and EU (Dec. 21, 2020) have conditionally approved the vaccine use. MFDS elaborated the ministry is positive about the use of Pfizer’s vaccine as it is widely used all around the world, and even the World Health Organization (WHO) also granted approval on the emergency use (Dec. 31, 2020). The vaccine has applied for evaluation on its non-clinical and clinical data on Dec. 18 last year. Moderna’s vaccine has been approved for emergency use in the U.S. (Dec. 18, 2020) and conditionally cleared by EU (Jan. 6, 2021). The vaccine has not started the review and approval process in South Korea. From South Korea, Genexine and Gene One Life Science are respectively developing DNA vaccine, similar to the mRNA vaccine. DNA, or deoxyribonucleic acid, is one of two nucleic acids in a cell, which archives and conserves genetic information. Novavax and SK working on recombinant vaccine already used for HBV and HPV vaccine Recombinant vaccine directly injects antigen protein made from recombinant DNA technology to induce immune response, which is one of the most commonly used vaccine platforms. Because the recombinant antigen protein could be insufficient for the full immune response, generally an administration route with vaccine adjuvant is needed. But it is known to be the highly safe vaccine for it has been used throughout the time. Hepatitis B virus vaccine and HPV vaccine use the platform, for instance. Novavax is using the platform for a COVID-19 vaccine with an ongoing Phase III clinical trial started from September last year. Regardless, it has not been approved by any foreign health authority. In South Korea, SK Bioscience is running a Phase 1/2 trial for the vaccine candidate. Inactivated vaccine is a traditional platform of vaccine that triggers immune response by injecting antigen made of killed virus. A number of vaccines are made with the technology. It can be rapidly developed when the infectious virus is collected, and the manufacturing process is comparatively simple and it has an advantage of having outstanding neutralizing antibody. However, for the COVID-19, the vaccine would require a manufacturing facility certified over Biosafety Level 3 (BL3). Biosafety level indicates the level of a facility to safely handle potentially lethal infectious pathogen and depending on the level of the lethal disease, the facility is given a level ranging from BL1 to BL4. Hepatitis A vaccine, injected polio vaccine and Japanese encephalitis vaccine use the inactivated virus platform. A Chinese-based Sinopharm has developed COVID-19 vaccine with the technology green lit for use on July 22, 2020 in China. And according to WHO’s COVID-19 vaccine candidate update report, CanSino Bio (virus vector vaccine) and Gamaleya (virus vector vaccine) are also working on other types of COVID-19 vaccines as well. Considering the public’s heightened interest on COVID-19 vaccine, MFDS stated it would constantly update the vaccine’s efficacy and safety information, and focus on creating an environment for the people to get inoculated with no concern. Moreover, the ministry official added they would do their best for the people to use the safe vaccine by strictly reviewing and managing safety and efficacy of the approved vaccine.
- Policy
- Boehringer's new obesity drug is conducting clinical trial
- by Lee, Tak-Sun Jan 08, 2021 06:19am
- Boehringer Ingelheim is conducting a clinical trial of a new obesity treatment in Korea. It is noteworthy whether it will exceed the sales of Saxenda (Liraglutide·NovoNordisk), which is currently leading in the Korean market. The MFDS approved the Phase II clinical trial protocol of BI 456906, a candidate for the new obesity drug of Boehringer Ingelheim on the 4th. This clinical trial is a 46-week trial that is administered subcutaneously once a week compared to placebo in obese or overweight patients. As a multinational clinical trial, 16 patients participate in Korea. The total number of subjects is 350. This drug is known as a candidate for a new drug obtained by Boehringer Ingelheim in partnership with the Danish pharmaceutical company Zealand Pharma A/S. It has a mechanism of dual action on glucagon-like peptide-1 (GLP-1) and glucagon receptors. GLP-1 and glucagon receptors play a role in regulating metabolic function. These substances reduce glucose synthesis in the liver and reduce blood sugar by increasing glucose absorption in the muscles. Saxenda Saxenda is also a GLP-1 analog, which induces weight loss by prolonging the action time of GLP-1. Saxenda ranks first in the domestic obesity treatment market. Cumulative sales in the third quarter of last year (based on IQVIA) were ₩28 billion, far ahead of Qsymia (Phentermine and Topiramate, Alvogen Korea), which recorded ₩16.7 billion. Saxenda is sold as a once-a-day formulation, but NovoNordisk is planning to market it as a once-a-week formulation with improved method. Boehringer's drug, which has been approved for clinical trials this time, is also a subcutaneous injection once a week. If commercialization is successful, it is expected to be a strong candidate against Saxenda.
