- LOGIN
- MemberShip
- 2026-03-17 09:48:45
- Policy
- Exemption of some in vivo tests when developing COVID-19
- by Lee, Tak-Sun Apr 14, 2020 06:12am
- The MFDS decided to exempt in vivo tests on some of the formulations for rapid clinical entry of COVID-19 treatments. In order to enter the clinical trial, in vitro and in vivo studies should be completed and reviewed, but in some formulations, such as antiviral drugs, in vivo studies can be replaced with existing test results. According to the industry on the 12th, the MFDS recently released a guideline on Considerations in Developing COVID-19 treatment. The MFDS provided the current position of the MFDS based on discussions conducted over the past two months to minimize trial and error by developers. and it is expected that the entry of clinical trials will provide opportunities for new drugs to work. According to the main contents of the guideline, in vivo testing is conducted in an animal model infected with COVID-19, but considering that the mechanism of action of the drug to be developed is applicable to various viruses, if it is determined that it can be applied to various viruses, In vivo test data using a viral infection animal model is accepted. For example, in the case of a drug that has already been approved and used as an antiviral agent, it is possible to enter the COVID-19 clinical trial based on in vivo test data, clinical trial data, and post-marketing experience submitted at the time of approval. However, in the case of drugs that have not been demonstrated for antiviral activity, in vivo test data using a virus-infected animal model should be secured. The Ministry of Food and Drug Safety presented examples of non-clinical trials of Remdesivir, which is conducting commercial clinical trials of COVID-19 for reference. In the case of anti-inflammatory drugs, data from animal models of virus infections other than COVID-19 are allowed, although it does not limit the type of virus, it is explained that the test results of similar viruses (influenza virus causing respiratory infection, respiratory syncytial virus (RSV), etc.) when the target organ is infected may be considered. The MFDS added that double-blind, randomized, placebo-controlled, and parallel-group trials should be considered as considerations when designing a clinical trial. This is because the current clinical trial of COVID-19 is the first dose of clinical trial drug to the patient, and the nature of the exploratory clinical trial is strong. The Ministry of Food and Drug Safety said that it would reflect relevant information if necessary after hearing opinions from various fields on the guidelines. As the Ministry of Food and Drugs exempts some data, opportunities will increase for companies seeking clinical entry as a COVID-19 treatment.
- Policy
- Saxenda's upgraded injection (once a week) will be imminent
- by Lee, Tak-Sun Apr 14, 2020 06:11am
- Saxenda by NovonordiskSaxenda's upgraded version of the drug, which is causing a sensation in the domestic obesity treatment market, is predicting clinical trials in Korea, attracting attention. It was Ozempic (Semaglutide), which improved the convenience of administration by injection once a week. The MFDS approved IND for Semaglutide applied by Novonordisk on the 8th. The clinical trial is conducted to evaluate the efficacy and safety of Semaglutide 2.4 mg once weekly for weight management in overweight or obese subjects. This is a Phase IIIa, multinational clinical trial. Semaglutide has already been approved for clinical trials in Korea in 2018 as an indication for obesity. At the time, it was conducted on subjects in East Asia who were overweight or obese, and 40 of the 400 subjects were known to be domestic patients. The approved clinical trial seems to be proceeding with an increased dose compared to the previous clinical trial. Ozempic 0.4 mg showed a reduction effect of 13.8% in phase II clinical trials for 52 weeks, suggesting a possibility as a treatment for obesity. Ozempic, which received FDA approval for diabetes treatment in 2017, has not yet been approved for marketing in Korea. Currently, GLP-1 analogue, Saxenda (Liraglutide) are creating a sensation in the domestic obesity treatment market, raising expectations for Ozempic in domestic market. Released in March 2018, Saxenda recorded sales of ₩42.6 billion (IQVIA) last year, creating a sensation of the domestic obesity treatment market. The GLP-1 analogue drug has a mechanism of regulating appetite by reducing hunger and increasing satiety by passing the hormone GLP-1 secreted by the body into the hypothalamus of the brain upon food intake. Saxenda is a once-a-day self-injection, but Ozempic is evaluated as a convenience upgrade once a week.
- Policy
- The government, cuts health insurance premiums by 50%
- by Kim, Jung-Ju Apr 14, 2020 06:11am
- The government has decided to temporarily cut down some health insurance premiums to alleviate the economic damage of low-income and small business owners. The Ministry of Health and Welfare (Minister Park Neung-hoo) announced on the 10th that from March to May, it would reduce (30-50%) the health insurance premiums of the bottom 50% in special disaster areas and the bottom 40% in all other nationwide areas. This was in response to the announcement of the 3rd emergency economic conference announced on the 30th of the same month, with revised supplementary budget of ₩265.6 billion to support the health insurance premiums for vulnerable groups such as low-income and small business owners who suffer severe economic damage due to the recent COVID-19. On the 9th, the government revised and issued the 'Notice of Eligible Persons to Reduce Health Insurance Premiums'. Subject to the revised notice, the subjects will be reduced health insurance premiums from March to May this year, and the reductions in health insurance premiums already paid in March will be retroactively supported in April. The bottom 50% in the special disaster area is reduced by 50% of the health insurance premium, the bottom 20% in all other areas are reduced by 50% of the health insurance premium , and from the excess of the bottom 20% to 40% are reduced 30% of the health insurance premium. Through this support, the government provided a total of ₩91,559 health insurance premiums per person per month over 3 months, including 700,000 people in special disaster areas (400,000 in workplaces, 330,000 in regions), and 10.89 million in other regions (6.6 million in workplaces and 4.24 million in regions). Subjects are selected by the NHIS based on the health insurance premiums of the month without any separate application process. The MOHW and the Health and the NHIS will send a notice to the targeted people from the 13th to the 17th, so that the public can know if they are eligible, and will send out the 22nd and 25th of the April health insurance bill with a retroactive reduction in March.
- Policy
- Chong Kun Dang’s capsuled low-dose Xarelto generic approved
- by Lee, Tak-Sun Apr 14, 2020 06:11am
- Xarelto tablet 2.5mgChong Kun Dang’s generic version of Bayer’s anticoagulant Xarelto (rivaroxaban) tablet was approved as a first capsule form in Korea. The 2.5 mg low-dose capsule would be able to evade Hanmi Pharmaceutical and SK Chemical’s preferential sales rights on their generic products with the change in administration form. On Apr. 9, Ministry of Food and Drug Safety (MFDS) has reported its clearance on ChongKunDang Rivaroxaban Capsule 2.5 mg. The generic the same pharmaceutical substance rivaroxaban as Bayer’s Xarelto tablet, but it is in capsule form. Chong Kun Dang’s generic is the first capsule out of the 22 generics approved with the same substance in Korea. The Korean company has its reason why it changed the form. SK Chemicals and Hanmi Pharmaceutical have already challenged the patent and respectively received the first approvals on their SK Rivaroxaban tablet 2.5 mg and Riroxban tablet 2.5 mg, along with the preferential sales rights. SK Chemicals and Hanmi Pharmaceutical have challenged Xarelto’s pharmaceutical substance patent (expected to expire on Nov. 13, 2024) with low-dose form (2.5 mg) and won the generic market exclusive sales right (preferential sales right) for rivaroxaban. The preferential sales right’s sales ban on other generics would last from Oct. 4, 2021, when Xarelto’s first-to-file (FTF) patent on the product and the use expires, to July 3, 2022. Accordingly, generics sharing a same type of form and active ingredient with Hanmi Pharmaceutical and SK Chemicals’ generic would be ruled out from market release during the sales ban period. But Chong Kun Dang’s capsule can avoid the sales ban with a different form of capsule. Ultimately, the three Korean companies would be able to launch their generics all at the same time. Besides Bayer with the original, Hanmi Pharmaceutical, SK Chemicals, Chong Kun Dang and Hanlim Pharm had their 2.5 mg low-dose rivaroxabans approved. Currently, Hanlim Pharm is in process of patent challenge. But its generic would be banned from the sales during the preferential sales rights period. A study has confirmed 2.5 mg rivaroxaban, combined with Aspirin, reduces the risk of heart attack, ischemic stroke or cardiovascular death in patients either with coronary artery disease (CAD) or peripheral artery disease (PAD) relatively more than the Aspirin monotherapy. Based on the findings, foreign academic societies recommend using Xarelto 2.5 mg plus Aspirin in patients with high-risk chronic CAD. The demand for 2.5 mg dose is exists, but other follow-on drug makers, except for those with preferential sales rights, would be able to launch their products after Nov. 14, 2024, when the original’s patent expires. UBIST reported the mega blockbuster drug Xarelto has made 46.2 billion won last year in outpatient prescription, which is why the industry is keeping their close eye on if Chong Kun Dang would get to successfully launch the capsule-form rivaroxaban dodging the preferential sales ban.
- Policy
- Controversy concludes about COVID-19 & Safety of HTN drugs
- by Lee, in-bok Apr 13, 2020 06:13am
- It is expected that clinical studies will begin in Korea to determine the association between COVID-19 and angiotensin converting enzyme (ACE) -based hypertensive drugs. It is a willingness to uncover whether it can be a threat to domestic hypertensive patients in terms of controversial issues worldwide. #It was confirmed that the public-private council agreed on the plan to promote such clinical research through a recent discussion. A representative participating in the public-private council pointed out that many studies pointed to the need for research on the fact that COVID-19 is spreading controversy over the risk of hypertensive drugs worldwide. and discussions are being made on the specific direction of implementation. Indeed, controversy continues in the academia about angiotensin receptor blockers (ARBs) and angiotensin converting enzyme inhibitors (ACEIs), which have a mechanism to regulate COVID-19 as it spreads ACE2 as a receptor. In response to this, major medical institutions such as the World Congress of Cardiology, the American Heart Association, and the European Society of Cardiology have said that patients should not stop or change hypertensive drugs such as ARB or ACEI, but there is no clear clinical evidence. In the end, in this controversy, the government and the medical community have rolled up their arms to relieve the anxiety of domestic hypertensive patients. Accordingly, this study is expected to be conducted in cooperation with the government and the medical community in line with the purpose of the public-private council. When the medical societies gather and form researchers, a kind of government service that provides the necessary funds and data for the government is influential. The problem is the patient data needed for these studies. This is because the data of patients who are prescribed ARB and ACEI in Korea along with COVID-19 confirmed information is essential. In response, medical associations are requesting that regulations such as personal information be loosened temporarily so that they can use the HIRA’s data, but it has been found that no conclusion has been reached. A representative from the council said that since it is not easy to control COVID-19 confirmed patients, The HIRA’s data is essential for related research. Along with this, it is expected that research on the development of a plasma treatment that has been successfully performed at Severance Hospital will also begin. This is because both the government and the medical community are now sympathetic to the need and have begun discussing it. Plasma recovery and separation technology for patients in recovery phase are still difficult. Although there were many opinions regarding the treatment of plasma, the officials of the council said that the government and the medical community decided to start research and development together because the first priority is therapeutics. Specific tasks will be announced through the Central Clinical Committee after the assignment has been made toward the KCDC.
- Policy
- President Moon “Expediting COVID-19 treatment approval”
- by Lee, Jeong-Hwan Apr 13, 2020 06:13am
- Amid COVID-19 pandemic, President Moon Jae-in of South Korea has expressed his expectation for Korean-made treatment and vaccine to save the humanity. President Moon personally emphasized the government support for the COVID-19 treatment vaccine through R&D investment and expedited approval process. At a meeting convened on Apr. 9 for the COVID-19 treatment and vaccine developing industry-academy-research-hospital collaboration, President Moon urged “Korea and the whole world are desperately waiting for the treatment and vaccine. They are the critical goals we have to achieve to overcome the pandemic completely.” The President Moon’s comment was interpreted as his commitment to bring together the government and corporate capacity on treatment and vaccine R&D as Korean infectious disease test kit and control model have been highlighted by the world amid the pandemic. At the meeting, the Korean president personally mentioned of Institut Pasteur Korea accelerating the treatment development via pharmaceutical substance rediscovery, and other cases of Korean biopharmaceutical companies concentrating on promptly developing treatment based on plasma, antibody and anti-inflammatory. President Moon said, “I have heard the inspiring news that Korea is at an exceptional level in developing COVID-19 treatment. Although the country is comparatively inexperienced in developing pharmaceuticals and lacks in resource aid compared to other developed countries, Korea has endeavored in developing related technology through the struggle we had during the MERS outbreak in 2015.” President Moon stressed, “As we have become an example of infectious disease control, hopefully we could also lead in treatment and vaccine development to give the people courage and confidence and become the hope to our economy,” and “scientists, research institutes, companies, hospitals and the government should work together to promptly develop safe and effective treatment and vaccine.” “More than anything, this could be our opportunity to not only upgrade the infectious disease control capacity, but also to enhance treatment technology,” and “while we put the people’s safety first, fast-track clinical trial review procedure would be implemented,” the President added. President Moon mentioned the government’s plans including opening biosafety laboratory to the public, providing necessary resources like convalescent plasma or patient’s sample, investing 210 billion won on COVID-19 vaccine development, reflecting treatment development cost and R&D investment funding on contingency budget, and establishing novel virus research laboratory. Regarding international collaboration he said, “The G20 have agreed to share related data and cooperate together to develop treatment. Korea would also actively participate in international cooperation led by the World Health Organization (WHO) and the UN.” President Moon emphasized, “The biggest goal of the humanity at the moment is developing treatment and vaccine,” and “The Korean government would do its best to support all of you to solely focus on R&D. And that is our role in saving the lives in all around the world.” And he encouraged the participants of the meeting by noting that “Korea’s mature sense of community is now a global example and standard of containing COVID-19,” and “With each and every one of you here being our driving force, Korea would be able to leap forward in treatment and vaccine development, and also contribute in the global community.”
- Policy
- 161 items, subject to monitoring for Price-Volume agreement
- by Lee, Hye-Kyung Apr 13, 2020 06:12am
- AstraZeneca Korea's Tagrisso 40mg/80 mg (Osimatinib Mesylate) were added to the monitoring target for the price-volume agreement negotiation system in the second quarter of this year. Celgine's Pomalyst (Pomalidomide) 1·2·3·4 mg, Roche Korea's Tecentriq (Atezolizumab), and Jansen Korea's Sylvant (Siltuximab) 100·400 mg are also subject to monitoring. The NHIS recently released on the homepage the Drugs to be used in the second quarter of 2020- the price-volume agreement negotiation system is a method in which the risk of health insurance finance is shared by the NHIS and pharmaceutical companies. From April to June of this year, the monitoring target for the second quarter was 161 items in 92 drug groups. Ibsen Korea's Cabometyx (Cabozantinib) 20·40·60mg, Amgen Korea's Kyprolis (Carfilzomib) 30·60mg, and MSD Korea's Keytruda (Pembrolizumab) are also subject to monitoring. Type A(Ka) of the price-volume agreement negotiation system is when the amount of claims in the same product group with the estimated amount of claims agreed by the NHIS, price negotiations, negotiations on the adjustment of the price increase, negotiations to expand the scope of use, etc. has increased by more than 30%. Type B(Na) In the case of the same product group that has been negotiated by Type A(Ka) or has not been negotiated and has been four years since the date of initial listing, applies when the previous type A(Ka) is increased by more than 60% or more than 10% & 5 billion won more than the previous year's bill every year from the day following the end date of the analysis target period. On the other hand, drugs with an annual billing amount of less than ₩1.5 billion, drugs with lower upper limit than the arithmetic average of the generics, low-cost drugs, and shortage prevention drugs are excluded from the subject of the price-volume agreement negotiation system.
- Policy
- Salt-altering drugs for Pristiq ER got generic exclusivity
- by Lee, Tak-Sun Apr 13, 2020 06:12am
- PfizerPfizer's first generic drug for anti-depressant drug Pristiq ER (Desvenlafaxine) was also approved as generic exclusivity. Accordingly, four generics of Whan In, Myungin, Nexpharm Korea, Hallim, will be able to monopolize in the same ingredient formulation market until January 8, next year. On the 8th, the MFDS approved Whan In’s Defaxine SR 50·100mg, Myungin’s Esven SR 50· 100mg, Hallim’s Prenexa 50·100mg', Nexpharm Korea’s Desvera SR 50·100mg for generic exclusivity. Therefore, drugs with the same ingredients are prohibited from being sold from April 9, 2020 to January 8, 2021. Four items were monopolized for a certain period in the generic market, excluding the original items. Four items applied for the first permission among generic drugs on February 6, and in June of last year, the trial for patent evasion (confirmation of passive scope of rights) was judged and the claims were cited. These items are expected to be released to the market in July after going through the insurance benefit process.
- Policy
- P-CABs, compete for indication expansion
- by Lee, Tak-Sun Apr 10, 2020 06:29am
- The only P-CAB gastric disease treatment drug currently on the market Potassium-Competitive Acid Blocker (P-CAB) drugs, which are called next-generation gastric acid inhibitors, are spurring to expand indications. Currently, the only drug released in Korea is K-Cab by HK inno.N (Tegoprazan). As Vocinti (Vonoprazan by Takeda) is getting permission and is planning to release, Daewoong Pharmaceutical's Fexuprazan has also applied for permission, so the competition between products will soon become fierce. Accordingly, there is competition for development to expand the use of products in the market. Daewoong’s Fexuprazan (Development name: DWP14012) was approved by the Ministry of Food and Drug Safety on the 1st of the Phase III clinical trial protocol to evaluate the efficacy and safety in patients with acute or chronic gastritis. The clinical trial will be conducted at Hanyang University Hospital by October of next year for a total of 327 patients. Fexuprazan is a P-CAB (Potassium-Competitive Acid Blocker) formulation with a mechanism that reversibly blocks the proton pump that secretes gastric acid from the stomach wall and it is a series of drugs such as K-Cab by HK inno.N and Vocinti by Takeda. Daewoong Pharmaceutical has completed phase III clinical trials for 260 patients with erosive GERD and has applied for approval for items to the MFDS earlier this year. However, the clinical trials of Fexuprazan continue. This is because there are limitations only in indications of erosive GERD when faced with competitors in the market. Daewoong is currently conducting Phase III clinical trials to study Fexuprazan for treatment of ▲non-erosive GERD ▲maintenance therapy for patients with cure of erosive GERD ▲ treatment for acute or chronic gastritis. Currently on the market, K-Cab is approved as an antibiotic combination therapy for ▲Antibiotic combination therapy for the elimination of Helicobacter pylori in patients with peptic ulcer and/or chronic atrophic gastritis ▲treatment of erosive gastroesophageal reflux disease ▲ treatment of non-erosive gastroesophageal reflux disease ▲treatment of gastric ulcer In addition, Takeda’s Vocinti was approved for ▲the prevention of recurrence of gastric ulcer or duodenal ulcer when administering nonsteroidal anti-inflammatory drugs (NSAIDs)▲gastric ulcer ▲erosive GERD and maintenance therapy. When comparing the three P-CABs, it has indications for the treatment of erosive gastroesophageal reflux disease and has its own characteristics of use. K-cab has non-erosive GERD indication, and Vocinti has indications that other products do not have the purpose of preventing recurrence of gastric ulcer or duodenal ulcer when administering nonsteroidal anti-inflammatory drugs (NSAIDs). Daewoong Pharm's indications for patients with acute gastritis who are undergoing Phase III clinical trials do not apply to the other two drugs. However, K-Cab and Vocinti are also continuing clinical trials to expand indications. In the case of K-Cab, the treatment of erosive GERD has been confirmed through an endoscope and is currently undergoing phase III clinical trials for maintenance therapy of patients. Although clinical trials in progress have not been confirmed in Korea, Vocinti is said to have been rejected for the treatment of duodenal ulcer in the first application. It is an analysis that if Vocinti completes the reimbursement procedure and launches in earnest, it can be developed in Korea. K-Cab received a positive evaluation that it was able to outweigh the PPI-based treatments, which were established in the existing gastric acid secretion inhibitor market, with an outpatient prescription of ₩26.4 billion last year. Accordingly, attention is also focused on the market strategy of the remaining two P-CABs being prepared for release.
- Policy
- The first generics for Pristiq ER were approved
- by Lee, Tak-Sun Apr 10, 2020 06:28am
- PfizerThe generic drugs that avoided the patent of Pristiq ER obtained the item permission. They are expected to be competitive as first generics in the market. The Ministry of Food and Drug Safety approved the approval of four items of Desvenlafaxine, generic for Pristiq ER on the 7th. The generics are Defaxine SR 50·100mg by Whan In, Desven SR 50·100mg by Myungin, Prenexa SR 100mg by Hanlim, Desvela SR 50·100mg by Nexpharm. They have different salts from the original drug Pristiq ER (Desvenlafaxine succinate), and they changed to succinic acid salts rather than benzoate to avoid product licensing and patents. The four companies received a affirmed decision in June last year at a trial to confirm the passive scope of rights to evade patents. It has overcome the salt patent (expected to expire on October 7, 2022) as a salt change drug. And on the 5th of February, when Pristiq ER's PMS expired, they immediately applied for permission on the 6th. As long as it meets the requirements, Patent evasion is also confirmed without Pfizer appealing. Therefore, it is expected to release the product to the market in July after the reimbursement procedure. Pristiq ER is considered as the next-generation antidepressants because they have a low risk of drug interactions and less adverse reactions such as weight loss and decreased sexual function. According to UBIST last year, the outpatient prescription amount is ₩3.1 billion.
