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- 2025-12-24 23:30:08
- Policy
- Chong Kun Dang's CKD-306 is approved for phase I
- by Lee, Tak-Sun Feb 03, 2020 06:20am
- Duvie, a new diabetes drug made by Chong Kun DangChong Kun Dang is continuing to develop a combination of diabetes drug 'Duvie' and DPP-4 inhibitor 'Sitagliptin'. In 2016, Chong Kun Dang, a candidate for the development of a combination drug known through clinical approval of drug interactions, was recently approved for phase I clinical trials and is now in full swing. The Ministry of Food and Drug Safety approved the Phase I clinical trial plan for CKD-396 by Chong Kun Dang on the 21st. CKD-396 is known to be a combination of Lobeglitazone, a diabetes drug called 'Duvie' and Sitagliptin, one of the DPP-4 inhibitor. In March 2016, a phase I trial protocol for drug interactions has already been approved. The trial will be conducted at Severance Hospital. The control drug is Januvia(100mg Sitagliptin phosphate hydrate) and Duvie 0.5 mg (Lobeglitazone sulfate). 26 healthy adults were compared with the pharmacokinetics and safety of CKD-396 and the control group. Clinical trials are scheduled from February to December. Duvie by Chong Kun Dang is a domestic new drug (No. 20) approved in July 2013. It is a Thiazolidinediones-based diabetes treatment drug that increases insulin reactivity, reduces blood sugar levels, and maintains pancreatic function. Chong Kun Dang has continued to develop complexes since Duvie was approved. In June 2016, Duvimet (Lobeglitazone sulfate-Metformin Hydrochloride), which was combined with Metformin hydrochloride, the first treatment for type 2 diabetes, was approved. The development of a combination of DPP-4-based therapeutic agents, Sitagliptin, is also part of the lineup. Pioglitazone (brand name: Actos by Takeda), already a competitor of Duvie, is commercially available as 'Nesina act', a combination of DPP-4 inhibitor, Alogliptin (brand name: Nesina by Takeda). Nesina act was approved in October 2014, and recorded last year's outpatient prescription amount of ₩11 billion based on UBIST, showing off as a blockbuster. In the medical field, the combination of Thiazolidinediones and DPP-4 series doubles the effect of diabetic treatment and is used as a treatment option. There are also several clinical data that show actual results. As a result, the Lobeglitazone-Sitagliptin combination may be useful in patients. It is noteworthy whether Chong Kun Dang's clinical research conducted in 2016 will bear the final commercialization.
- Policy
- Industry welcomes pricing benefit unchanged for IMD
- by Lee, Jeong-Hwan Jan 31, 2020 06:35am
- The Korean pharmaceutical industry is positively reacting to Ministry of Health and Welfare’s (MOHW) revised drug pricing system including the weighted pricing benefit for incrementally modified drug (IMD) as it would allow IMDs to remain as a cash cow generating finance for new drug R&D. Although they are regretful the weighted pricing is limited only to government-designated IMD and excluded other ‘drugs for data submission,’ the majority of the industry says the government started recognizing the value of IMDs. On Jan. 28, a pharmaceutical industry insider commented “MOHW reissued a notice of revised ‘Criteria for Decision or Adjustment on Drugs’ that saved IMD from leveling itself down with other generics. But it also highlighted the importance and need for Korean pharmaceutical companies to switch their core business model.” MOHW re-notified the revised generic drug pricing criteria including the weighted pricing for IMD on Jan. 28. The key change made was maintaining the pricing benefit for IMD until other generic is released, as the drugs work as a stepping stone to new drug development. Quoting the notice issued by the ministry, the weighted pricing benefit would be applied to “IMD (including incrementally modified combination drug) until other single or combination drug with same administration method, content, and formulation is listed.” The industry perceives the change as the government’s ultimatum for Korean pharmaceutical companies to shift away from generic development to better-priced IMD development. Among all drugs for data submission, the pricing benefit was limited to IMD designated by Ministry of Food and Drug Safety (MFDS), which also means IMD’s individual patent registration and four to six years of post-marketing surveillance (PMS) period would come in effect as well. For pharmaceutical companies, the revision would encourage them to explore patent difficult for competitors to replicate and to develop IMD to ultimately block off other generic competitors while making profit during the PMS period. The PMS period is valid for four years on extended release drug with prolonged effect, and six years on combination drug or drug improving benefit with alternative administration method. Until the PMS period expires, other generic launch is restricted for the IMD to dominate the market to some extent. As a result, IMDs that MFDS sees inventiveness in safety, efficacy and utility (drug compliance, convenience and etc.) based on pharmaceutical approval and registration review regulation would be provided with benefits of market exclusivity and pricing. A pharmaceutical company official commented, “Many opinions of IMD-focused companies have been reflected. As the purpose of the revision was to improve the weighted pricing system, MOHW seems to have widely accepted of the industry’s opinions,” but “limiting the pricing benefit only to MFDS-designated IMD, instead for all drugs for data submission, is regretful.” The official elaborated, “The restriction means drugs for data submission with change in saline base, isomer and formulation would be neglected from the pricing benefit. Accordingly, Korean pharmaceutical companies would have to act fast analyzing the changes and to plan for new business model,” as “the government has technically sketched out the prospective of the industry with pricing benefit, so lingering in the generic game would eventually risk the business.”
- Policy
- Besivo's reimbursement standards expanded
- by Kim, Jung-Ju Jan 31, 2020 06:35am
- If the patient progresses to liver cancer during treatment with Besifovir oral medications, the benefit is still acceptable. In the case of Ramosetron HCl oral medications, there will be no restriction on the duration of administration, up to 12 weeks. The Ministry of Health and Welfare was confirmed on 28th after hearing opinions by the 22nd on the partial amendment of 'Details on the Standards and Methods of Application of Medical Benefits (Pharmaceuticals)'. The effective date is the 1st of next month. Looking at the reimubrsement criteria to be applied next month, patients with chronic hepatitis B begin treatment with Besifovir (generic for Besivo), and if the disease progresses to liver cancer, the patient can continue to receive the benefits. This means that even if hepatitis B patients are diagnosed with cancer from now on, they will receive the benefit for continuous administration. There is no restriction on the duration of the administration of Ramosetron HCl oral medications such as Irribow by Korea Astellas. Currently, the duration of administration is limited to a maximum of 12 weeks, and further administration is being reduced. As Boryeong’s combination drug of Fimasartan, Amlodipine & Rosuvastatin is newly listed on the 1st day, it is added to the 'high blood pressure + hyperlipidemia' complex oral reimbursement standard. When using Infliximab products such as Crohn's disease treatment, Remicade by Janssen, immunoglobulin-resistant refractory Kawasaki disease (including typical and atypical) that exceeds the licensed range is also approved. Basiliximab injections, such as Simulect by Novartis , used in adult kidney transplantation, specify the dosage and frequency of heart, liver, lung, small intestine transplantation, and pancreatic and pancreatic transplants in excess of the approved range. This makes the standard clearer than before. In detail, according to the permission (use and dose), it is specified as 20 mg per dose and 2 doses. In case of Abatarcept injections, such as 250mg of Orencia inj and Orencia subQ pfs(125mg) by BMS Korea, benefits are expanded by adding 'expandable minority arthritis' among pediatric idiopathic arthritis. Agalsidase β 35mg injections, such as Fabrazyme from Sanofi-aventis Korea, an enzyme replacement therapy for Fabry disease's confirmed patients, are changed based on the amounts listed on the current insurance benefit list. The ingredient is actualized. In addition, Jext inj (children/adults, Epinephrine single use autoinjector) and Dibenyline capsules (Phenoxybenzamine oral drugs), which were reimbursed as urgent drug and decided to be deleted due to supply failure, as of the 31st of the six-month grace period, the benefit will be also deleted.
- Policy
- Cresemba, Pfizer Korea's antifungal drug, approved
- by Lee, Tak-Sun Jan 30, 2020 06:34am
- Pfizer Korea obtained the product license of the antifungal drug Cresemba (Isavuconazole Sulfate) in Korea. The drug is expected to have a lower mortality rate than Pfizer's Vfend. The Ministry of Food and Drug Safety approved on the 29th the sale of 'Cresemba capsule 100mg' and 'Cresemba injection 200mg' of Pfizer Korea. Cresemba is licensed for the treatment of invasive aspergillosis in adults 18 years of age and older and for invasive hair fungus in which Amphotericin B is not suitable for adults 18 years of age or older. The FDA approved this drug in March 2015. Cresemba is a drug jointly developed by Switzerland's Basilea and Japan's Astellas. Pfizer holds the EU release rights and the Asia-Pacific rights, including Korea. Astellas was approved in the United States and Japan. The drug has been shown to have a lower mortality rate than Voriconazole (generic for Vfend) in clinical trials in 516 patients with invasive aspergillosis. The mortality from all causes at 42 days was 18.6% (48/258) in the Isabuconazole group and 20.2% (52/258) in the Voriconazole group. Aspergillosis is a disease caused by a respiratory infection caused by a fungus called Aspergillus, and occurs when immunity is compromised due to leukemia or chemotherapy. Symptoms include chills, bleeding, chest pain and shortness of breath. Particularly invasive, the infection spread systemically can cause tissue damage, thrombosis, etc. due to impaired blood supply, severe sepsis can cause death. Voriconazole is the generic for Vfend sold by Pfizer. Vfend recorded annual sales of about ₩10 billion (Reference: IQVIA) in Korea. However, in the case of Vfend, Chong Kun Dang turned into a competitive system with the introduction of Vorico, the first generic in 2017. Cresemba is emerging as a new alternative to Vfend. Meanwhile, the MFDS approved MSD Korea's new AIDS treatment drug, Delstrigo (Doravirine-Lamivudine -Tenofovir disoproxil fumarate).
- Policy
- President Moon wearing a mask visited the NMC
- by Kim, Min-Gun Jan 30, 2020 06:33am
- President Moon Jae-in visits the National Medical Center in the morning on the 28th for a briefing on Wuhan pneumonia. Cheong Wa Dae announced at 10:31 am on the 28th that President Moon Jae-in visited the National Medical Center, which is treating a new type of coronavirus infection, and directly inspected the field response system and ordered a total response posture. Mr. Moon made this report at the spot where he received on-site response system reports such as patient selection criteria, response measures, and operation procedures for screening clinics from the Director of National Medical Center Ki-hyun Chung and the Director of operation support team, Yeon-jae Kim. Mr. Moon said, "The government needs to be powerful and speedy enough to evaluate the preemptive measures a little too much, and investigate all persons who have passed through the airport asymptomatically and quarantine those who have confirmed symptoms and take measures to prevent secondary infections as much as possible". President Moon emphasized that such measures should be made transparent to the public to relieve anxiety. In particular, Cheong Wa Dae said that President Moon called for greater awareness of where medical institutions did not use the contact function (to the KCDC or the public health centers) or are not complying with their obligations to do so. President Moon Jae-in visits the National Medical Center on the 28th and checks the field response system. On the other hand, President Moon visited medical staff, screening clinic, negative pressure ambulance, and on-site emergency clinic where mobile X-rays could be taken. He boarded the mobile CT vehicle and listened carefully to the explanations from the director and the officials. In addition, President Moon called for efforts to resolve local anxiety by asking whether the NMC has enough know-how as a nationally-designed quarantine bed when the MERS outbreak occurred.In addition, and the status of securing a nationally designated quarantine bed. President Moon also visited a negative pressure containment ward where a second Korean confirmed patient was admitted to the hospital to check the patient's condition, as well as concerns about the possibility of secondary infections caused by asymptomatic community activities and related measures. President Moon also received reports from the vice director, Im seok Ko, on the status of the wards and the system for responding to infectious diseases at each stage. President Moon asked if there were any concerns about the spread of infections in screening systems, quarantine beds, and negative pressure rooms. This is because inpatients during the MERS outbreak were infected with other patients, clients and medical staff. The vice director said, “The hospital was shut down in a severe stage during the MERS outbreak, treated 60 patients with MERS, and there was no hospital infection at all, and as it is more systematically developed, I don't think there is any possibility of infection in the hospital or transmission of local infections”. President Moon praised the medical staff at the National Medical Center, which had suffered during the New Year's holidays, and said he hopes to deal with it without slowing down until the end.
- Policy
- Amendment to cascading drug price revision revealed
- by Kim, Jung-Ju Jan 30, 2020 06:33am
- Finally came the result. The reinstatement of the cascading drug price system was revised and revised to change the generic insurance price according to whether or not it had its own bioequivalence test. As is known, there is a difference in the price of IMDs and generics. Revisions were included to keep the addition in recognition of the effort and innovation. However, in the case of listed drugs, the application sentence linking permit and drug prices after three years of preparation period is missing from the readministrative notice. This was confirmed that there would be no change as a result of the planned re-evaluation process (3 years) to be carried out through a re-evaluation procedure separately announced according to the 'Criteria for Decision or Adjustment on Drugs'. The Ministry of Health and Welfare announced ‘a partial revision of the Criteria for Decision or Adjustment on Drugs’ today (Jan 28) morning and looked up opinion in the industry. When the first notice amendment was issued on July 2 last year, the government decided to revise the notice in early September and enter into full-scale implementation this year. However, due to the high impact of drug price reform, some additions were inevitable due to continued protests and protests. ◆Standard to estimate the drug price (including eye drops)= Looking at the contents, the first relevant revision notice and the basic framework of July 2 last year are the same. The revised bill for the price standard system, which cuts the generic price by 15% according to its own and co-prosperity into 'stairs' and limits the same number of generics as the so-called 'cut line', was also included in the revised proposal. In detail, a new set of criteria for applying differential prices (submission of biometric data or evidence of clinical trials and the use of registered ingredients) has been established. The cascading reorganization will change the price of the drug depending on the criteria, provided that the same formulations are listed under 19 products. 53.55% if all are met, 45.52% if only one is met, and 38.69% if there is no requirement. In the case of 'A cut off point system', when more than 20 products of the same formulations are listed, it is calculated automatically 85% of the lower amount between the lower price of the upper limit of the same system and the amount calculated as 38.69%. Eye drops are also multi-use or single-use eye drops. However, if the applied product is a single-use or multi-use product, the calculation criteria will be pushed forward. Eye drops are also multi-use or single-use eye drops. However, if the applied product is a single-use or multi-use product, the calculation criteria will be pushed forward. If revised, it will take effect on July 1st. ◆Reorganization of Addition System= The industry's current focus is on this reform. The reorganization plan includes all the contents of the first draft made last year, including the comprehensive maintenance of synthetic and biologic drugs, and the extension of the period of addition. Looking specifically at the addition of IMDs, the IMD maintains the addition until the IMD or the individual single or complex constituting the product and the same route of administration, ingredient, and formulation are listed. This includes IMD complexes. Just this has a condition. Excludes two or more listed companies that have the same dosage, route, ingredient, and formulation as the individual single compound and compound listed in the combination. Also, products added after the addition period has passed cannot be added. In addition, the addition requirements for both synthetic (chemical) and biologics are the same as those published last year. The addition period and the number of companies that have been set for each standard have been unified and maintained. Specifically, the period for adding synthetic and biopharmaceuticals is one year, and if the number of companies is three or less, the period for adding and maintaining all of them is up to two years. However, if the pharmaceutical company wants to extend the addition period, the government prepared a system to adjust the addition rate and extend the addition period within the two-year limit through the review of the Pharmaceutical Benefits Advisory Committee. The government plans to implement this addition system by January 17, next year after receiving opinions.
- Policy
- Rafinlar-Meqsel combination done with pricing negotiation
- by Lee, Hye-Kyung Jan 30, 2020 06:33am
- A combination therapy of Rafinlar and Meqsel treating patients with ultra-rare late stage BRAF-mutant lung cancer would be available for reimbursed prescription from next month at earliest. Korea’s National Health Insurance Service (NHIS) has recently announced pricing negotiations on four items—Novartis’ Rafinlar (dabrafenib) 50 mg and 75 mg, and Meqsel (trametinib) 0.5 mg and 2 mg—have been wrapped. First released for the Korean market in December 2017 as a melanoma treatment, Rafinlar and Meqsel have been additionally indicated to treat patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation in March 2018. And to win reimbursement on the combination therapy of the two, they have been deliberated by Health Insurance Review and Assessment Service’ (HIRA) Cancer Disease Deliberation Committee and Drug Reimbursement Evaluation Committee (DREC) and started a drug pricing negotiation with NHIS from last year. Rafinlar and Meqsel combination therapy has been raised as an issue at the National Assembly audit session last year. During the audit, Liberty Korea Party Lawmaker Kim Se-yeon strongly appealed the need to provide reimbursement on the combination therapy of Meqsel and Rafinlar to treat patients with stage IV lung cancer. However, Ministry of Health and Welfare (MOHW) answered negatively by stating, “Reimbursement for a drug is decided by comprehensively reviewing clinical efficacy, cost-effectiveness and other various factors based on ‘Detailed Evaluation Standard of New Drug for Negotiation,” and “the combination therapy has uncertainty in cost-effectiveness.” While an alternative option of chemotherapy costs 20 million won a year with progression-free survival (PFS) of 8.9 months, MOHW claims the combination therapy of Meqsel and Rafinlar costing 120 million won a year to achieve PFS of 10.9 months is not cost-effective. However, the health authority and Novartis have negotiated financial means to cover the uncertainty in cost-effectiveness, and reached an agreement to complete the pricing negotiation in early January. Health Insurance Policy Deliberation Committee (HIPDC), under MOHW, is scheduled to discuss about the reimbursement decision on Rafinlar and Meqsel combination therapy and to finalize the data providing the reimbursement. Meanwhile, NHIS has also announced Yooyoung Pharmaceutical’s chronic constipation treatment Rucalo tablet (prucalopride succinate) 1 mg and 2 mg, and Astellas Pharma Korea’s overactive bladder treatment Betmiga PR (mirabegron) 25 mg and 50 mg have also finished the pricing negotiation as of Jan. 21.
- Policy
- Janssen prepares to close Hyangnam plant, renewing licenses
- by Lee, Tak-Sun Jan 29, 2020 06:27am
- Janssen Korea is to close Hyangnam plant in 2021 and the company is speeding up the process of transferring items manufactured in Hyangnam to other facilities. Apparently some of them would be transferred to other Korean manufacturing companies, whereas some would be manufactured abroad and imported to Korea. As of Jan. 28, Korea’s Ministry of Food and Drugs Safety (MFDS) cleared Janssen Korea’s antipsychotic medicine, Invega (paliperidone) ER tablet in 3 mg, 6 mg, and 9 mg doses. These items are the same items approved back in April 2010. But the newly approved items would be imported to Korea, unlike the previously approved ones manufactured in Hyangnam plant. Janssen Korea has preemptively notified the change to drug distribution channels in Korea and forewarned the drug supply would be suspended until coming May. With the new license in Korea as an imported drug, Invega is expected to be listed for reimbursement from April. UBIST reported Invega has generated 2.3 billion won in Korea for outpatient prescription last year. The drug manufacturing plant is reportedly moving to Italy from Hyangnam, Korea. And the global company would obtain more new drug import licenses, as Janssen has notified Jurnista SR tablet and Topamax springkle capsule would also be manufactured abroad and imported back to Korea. The existing license on Invega has been returned as of passed Jan. 17. Janssen Korea canceling the license and leaving void period in between licenses are inevitable at the moment. Regardless, Invega Sustenna injection would be supplied without a break. Invega Sustenna, unlike the tablet form, was approved as an imported drug in July 2010. Janssen has already registered the injection’s DMF with Irish and Belgian plants as manufacturer of active ingredient paliperidone. Some items are transferring to other Korean manufacturers. Pain reliever Ultracet is transferred to Handok, and gastro-oesophageal reflux disease treatment Pariet is running bioequivalence test for approval to be transferred to Kolmar Korea. And Tyrenol 8-hour ER tablet is highly likely to be transferred to Handok. Janssen’s Hyangnam plant, built in 1983, would stop its production life of 38 years after a year. As it was the center of global drug manufacturing plant in Korea, the Korean pharmaceutical industry is left with bittersweet sentiment of the plant.
- Policy
- Korea-Switzerland promulgated an AMR on GMP
- by Lee, Jeong-Hwan Jan 29, 2020 06:26am
- The AMR (Agreement on Mutual Reliance) on GMP (Good Manufacturing Practice) between Korea and Switzerland was promulgated on the 23rd. It is a follow-up after the MFDS (Ministry of Food and Drug Safety) signed a GMP agreement with the SWISSMEDIC (Swiss Drug Agency) on December 18 last year. The agreement promulgated the mutual recognition that strengthening cooperation between Korea and Switzerland would mitigate trade barriers and create mutual benefits. Above all, it reaffirmed its importance in promoting international trade between the Republic of Korea and Switzerland and ensuring the global supply chain integrity of pharmaceuticals and the production of high quality pharmaceuticals. In conclusion, the results of the GMP survey between the MFDS and the SWISSMEDIC can be replaced by a GMP certificate issued in the country. Trust article in the GMP agreement between Korea &Switzerland This shortens the registration period for domestic pharmaceutical and bio companies by exempting GMP evaluation from the SWISSMEDIC. The GMP requirements apply to all human medicines, including investigational medicinal products (IMPs), active pharmaceutical ingredients (APIs), chemicals, biologics (including biologicals) or herbal preparations. Switzerland is one of the strongest pharmaceutical groups in A7 countries, and Korea's GMP system and management level is equivalent to that of Switzerland, which means that Korea's regulatory capacity and pharmaceutical industry are internationally recognized. The A7 countries are the United States, the United Kingdom, France, Germany, Italy, Switzerland, and Japan, which are advanced pharmaceutical countries that are used when deciding or reassessing domestic drug prices. As the ratification takes effect, Korean pharmaceutical companies are exempt from GMP due diligence when exported to Switzerland, and it is expected that market entry will be easier due to cost reduction and shortening of the permit period. In particular, as pharmaceutical quality management and regulatory levels are recognized by Switzerland, the possibility of equal treatment in the European market increases. so it will be a good opportunity for Korean pharmaceuticals to enter the European market.
- Policy
- Hanmi’s salt-modifying drug for Galvus was approved
- by Lee, Tak-Sun Jan 29, 2020 06:25am
- A salt alteration drug of Galvus(Vildagliptin) by Hanmi, a DPP-4 inhibitor for diabetes was approved. But one indication in the original drug is excluded. It is understood as a strategy to avoid patent The Ministry of Food and Drug Safety approved the generic product (50mg) for Galvus by Hanmi. Unlike the original galvus, this generic has the HCl of the main ingredient, Vildagliptin. There are four efficacy and effectivess (indications) of Vildagle tablet 50mg including ▲monotherapy as an adjunct to diet and exercise therapy to improve glycemic control in patients with type II diabetes, ▲combination with Metformin if no prior diabetes medication has been received and monotherapy is not enough to control blood sugar, ▲concomitant use with Vildagle if Sulfonylureas and Metformin combinations do not provide sufficient glycemic control, ▲and combination with Vildagle when Insulin (Insulin alone or with Metformin) therapy does not provide sufficient glycemic control. One indication, which is concomitant use in case of Sulfonylurea, Metformin or Thiazolidinediones monotherapy does not provide sufficient blood sugar control, is missing compared to the original Galvus 50 mg. This is due to the fact that the Galvus’ Material Patent received an extension of its duration (2 years 2 months 23 days). One of the indications is excluded that Concomitant use is possible for insulin-independent diabetic patients (type II), if diet and exercise therapy are not sufficient to control glycemic control with Metformin, Sulfonylurea, or Thiazolidinedione alone. In other words, with the exception of the indication, it seems to be a strategy to circumvent the scope of rights of the extended patent for material and to release the product at the time of expiration of the material patent (December 9 2019). Hanmi requested a passive judgment on the scope of the rights of Galvus in December last year. If the claim is quoted, the reimbursement process can be used to bring the product to market immediately. This is a different strategy from Ahn-gook Pharm, which was previously approved for the same ingredient. Ahn-gook obtained the same indication as the original Galvus 50mg with Ahn-gook’s generic drug. Instead, due to the problem of extending the life of the material patent, it succeeded to invalidate 187 days of the extended 2 years 2 months 23 days. Thus, it became the sales base from August 30 2021. In addition, the company obtained a successful patent challenge and a generic monopoly 'generic exclusivity' granted to the first applicant. In order for Hanmi to release its products earlier than Ahn-gook, it must be cited by the passive jurisdiction checker who claimed at the end of last year. Hanmi also co-sold Galvus with Novartis in 2014. It is important to note whether the company will compete as a competitor in the former peer market through patent evasion.
