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- 2025-12-24 13:21:13
- Policy
- CSL, Australian company, licensed for business in Korea
- by Lee, Tak-Sun Apr 28, 2020 06:24am
- CSL, an Australian global pharmaceutical company, conducts full-scale marketing in Korea. It was the first time in the domestic pharmaceutical industry to acquire a business license and an item license. CSL Behring Korea, a subsidiary of CSL, received a drug import license from the MFDS on the 16th. General manager, Ji-Young Sohn, who has served as the marketing and strategy planner of Korea Pfizer Pharmaceuticals and the head of the department of anti-cancer drugs at Roche Korea. Sohn is a pharmaceutical management expert who graduated from the College of Pharmacy at Ewha Womans University and Korea University (MBA) Along with the business license, CSL Behring Korea also brought permission to approve ‘Afstyla’, a type A hemophilia treatment. This product, which was licensed in January, was the first subsidiary of Zuellig Pharma Korea Ltd. to be registered as a license holder. This is because CSL Behring Korea did not obtain a business license, so Zanovex Korea acted as an item license. However, recently, Afstyla's license for item approval has been changed to CSL Behring Korea. Afstyla is now owned by CSL because it is generally assumed that the licensed company holds the copyright. However, Afstyla will be sold by SK Plasma. Unfortunately, Afstyla is a product developed by SK Chemicals, a subsidiary of SK Plasma, to preclinical and technically exported to CSL. In March, it was approved for the marketing of the type B hemophilia treatment drug 'Idelvion'. Janovex Korea is also registered as a license holder. Idelvion will also be transferred to CSL Behring Korea in the near future. CSL Behring is a global pharmaceutical company with hemophilia treatment and rare disease treatment, and is a subsidiary of the Australian CSL Group. It has expanded into 60 countries worldwide and is headquartered in Pennsylvania, USA. Afstyla and Idelvion, which have been licensed this time, are evaluated as drugs with a significantly improved half-life than conventional hemophilia drugs. However, it is unlikely that the domestic market will be settled. The size of the domestic hemophilia treatment market is about ₩180 billion, of which Type A treatment accounts for 80%, and the Green Cross is dominated. In the case of Shire's highest-selling Adbate, Green Cross sells, and the second-largest product, 'Greengene F', is a product of Green Cross. Pfizer's Benefix has the largest share of type B drugs. In the case of hemophilia treatment, the Koham has great influence, so pharmaceutical companies with high contribution are currently leading the market. In this situation, it is unclear whether CSL, a latecomer, will settle into the domestic market with only upgraded products. This is because SK Plasma, a sales agent, is not a very influential pharmaceutical company in the domestic hemophilia treatment market.
- Policy
- 19 new drugs & 1 new medical device were approved
- by Lee, Tak-Sun Apr 27, 2020 06:10am
- In the first quarter, 19 new drugs and 1 newly developed medical device were approved. The MFDS (Minister Eui-kyung Lee) made the announcement on the 23rd, when it released a list of new medical products that were first approved in Korea, such as new drugs and newly developed medical devices, in the first quarter of 2020. Previously, the status of new medical products could not be checked at a glance, but it will be announced quarterly so that anyone can easily check the current status of new medical products in the future,. Looking at the details, a total of 22 new medical products were approved in the first quarter, including 19 new drugs, 1 domestically developed vaccine, and 1 newly developed medical device. In the case of new drugs, the number of items increased compared to 13 items approved in the first quarter of last year, and various drugs, such as antihypertensive drugs, anticancer drugs, rheumatoid arthritis drugs, and ulcerative colitis drugs, have been approved. 'Xospata', which is used for acute myeloid leukemia, has been approved as an orphan drug, and 'Varycella shot', which was developed in Korea, is expected to contribute to the stable supply of chickenpox vaccine, which was dependent on imports. In addition, INFUSE ™ Bone Graft, a medical device used for intervertebral fusion, was designated as a newly developed medical device. This is a product that induces new bone production by soaking the genetically modified bone-forming protein in a collagen sponge and transplanting it into the intervertebral body. An official from the MFDS said that it would strengthen the right for the public to know by periodically distributing useful information, such as items of high social concern, to the public periodically in relation to the approval information for new medical products.
- Policy
- It has been successful in expanding the coverage of new drug
- by Lee, Jeong-Hwan Apr 27, 2020 06:09am
- It was evaluated that the government has achieved success in strengthening generic management, such as strengthening guarantees like new drugs for anticancer and rare diseases last year, and announcing plans to revise the generic drug pricing system. In the case of Ranitidine, a gastrointestinal drug containing carcinogenic substance NDMA, it was also diagnosed that DUR information system prevented further damage such as pre-blocking prescriptions and dispensing and shortening recovery procedures. The MOHW said in a report on the results of the self-evaluation of major policies in 2019. According to the report on the 22nd, the MOHW first gave a rating of 'slightly insufficient' for policy to advance drug distribution structure, 'regular' for strengthening insurance drug coverage and appropriate management policy for drug costs, and 'moderate' for policy strengthening pharmaceutical, medical device, and cosmetics industry competitiveness. ◆Advancement of drug distribution structure = Specifically, in the case of the policy of advancing drug distribution structure, it was mentioned that DUR information system and drug distribution information system were used to block prescribing and dispensing Ranitidine prescriptions and to shorten the recovery process. It was considered that the improvement and supplementation needs to actively collect patient and consumer opinions and develop performance indicators that will specifically include the results of the advancement of the drug distribution structure. In particular, it is said that performance indicators are needed to evaluate the advancement of the distribution structure of safety-related drugs. The intention is that there are no indicators that can actually represent the advancement of the distribution structure of safe medicines. In addition, the MOHW also considered that the rebate structure of pharmacies and hospitals was needed as a way to investigate the reality of the development of a dedicated pharmacy into hospital admission fees and cash rebates. It is not only to limit rebates between wholesalers and hospitals, but also to establish a rebate investigation method for the number of prescriptions between hospitals and pharmacies. ◆Enhancement of insurance drug coverage and appropriate management of drug costs = The MOHW evaluated that it has achieved enhanced security, such as new drugs for anticancer and rare diseases, which have high social demands and high medical expenses. Strengthening generic management by announcing plans to reorganize the generic drug pricing system was also a major achievement. However, the MOHW said there was a need to further increase the goal for policy enhancement and reducing drug costs. The MOHW says that a reduction in the proportion of drug costs may be a natural decrease as the overall rate of increase in health care increases, so it sets more aggressive goals. The MOHW said that in order to properly manage the drug cost, it is necessary to take various measures, such as managing generic drug prices, improving the irrational distribution structure of hospitals, and managing rational drug use. The ratio of drug costs was decided by the contents suggested by the evaluators, but it was necessary to raise the target. In terms of suitability for on-site monitoring and response to changes in the situation, the rapid response to NDMA detection was highly appreciated. It was diagnosed that the new drug listing guarantees were strengthened and the goals were achieved. ◆Strengthening competitiveness in the pharmaceutical and medical device industry = the MOHW cited strengthening competitiveness as enacting the 'Medical Device Industry Fostering and Innovative Medical Device Support Act', nurturing professional manpower, and opening AI new drug development support centers. However, it is said that it is necessary to strengthen the qualitative performance indicators based on the pharmaceutical and medical device industries. The MOHW said that the pharmaceutical and medical device industry is a higher value-added business and has high future-oriented importance. It was said that the expert networking was also excellent, so that the opinion gathering was appropriate when carrying out the policy. Furthermore, although the achievement index of the policy to strengthen the competitiveness of the pharmaceutical and medical device industry was achieved, it was evaluated that it was evaluated that it was not the promotion effect of last year alone. In addition, the overseas market expansion and the national recognition of the nation's technological power were raised, and the HOHW's leadership in the medical device industry across the government was highly appreciated.
- Policy
- Chong Kun Dang’s Esoduo, registered additional patents
- by Lee, Tak-Sun Apr 24, 2020 06:26am
- Chong Kun Dang’s anti-ulcer agent Esoduo (Esomeprazole magnesium trihydrate), has added an additional patent. Basically, if the original drug patent is listed on the MFDS’ patent list, late candidates must succeed in the patent challenge to ensure early release. Items that are commercially available without patent challenge may be subject to prohibition. On the 22nd, Chong Kun Dang registered a new composition patent (stable pharmaceutical composition including Esomeprazole and Sod. hydrogen carbonate) for Esoduo in the MFDS patent list. This patent expires on January 29, 2038, like the previously listed formulation patents (pharmaceutical formulations including Esomeprazole and Sod. hydrogen carbonate). As soon as it was registered on November 1, last year, Daewon Pharm, CTC Bio, Ajou, and Shinil filed a judgment to confirm the passive scope of rights to evade patents. Among them, Daewon has already been approved for bioequivalence test for generic commercialization in April of last year, and Ajou has been approved for development in October of that year. Chong Kun Dang's addition of this patent is interpreted as a measure to further strengthen the defense. This is because if latecomers want to release the generic drug early before the patent term expires, it must succeed in the patent challenge. Otherwise, if Chong Kun Dang enforces the launch, it may be prohibited from selling by a patent holder for a certain period (9 months) by the patent-linkage system . Conversely, it can be a burden for patent infringement lawsuits. Esoduo is a new drug to improve GERD released in July 2018. It is the first compound in the country to combine the PPI-based component Esomeprazole and Sod. hydrogen carbonate, which rapidly raises the hydrogen ion index (pH) in the stomach to protect the Esomeprazole component that is weak to stomach acid and takes a long time to act and protect the drug from stomach acid. After the drug is absorbed from the upper duodenum, the efficacy of the drug quickly appears. Last year, the outpatient prescription amounted to ₩9.8 billion, which is the target of late starters as it recorded sales close to blockbusters in two years after launch. In the future, attention is being paid to Chong Kun Dang, which is defending in advance, and latecomers who are promoting the early launch of generic drugs.
- Policy
- Betmiga's first generic, Hemlibra registered next month
- by Kim, Jung-Ju Apr 24, 2020 06:26am
- 2 items including Mirabeg 50mg, which are the first generic drugs for overactive bladder, and Hemlibra 30mg for hemophilia treatment (Emicizumab) by JW Pharmaceutical are confirmed to be registered next month, and are added to the drug benefit standard. In addition, oral administration of Clopidogrel is acceptable for children with Kawasaki disease who have exceeded the permit. The MOHW announced an administrative amendment on the 20th of the notice regarding ‘the Pharmaceutical Reimbursement Listing Standard and Method’ and entered the opinion inquiry until the 24th. As for the revised contents, two items, such as Mirabeg 50mg, which is an overactive bladder treatment drug, will be registered next month, the standards for insurance benefits is to be applied from the 4th of next month. Also, on the first day of next month, Hemlibra 30mg (Emicizumab), which is scheduled to be registered in patients with severe type A hemophilia with the factor 8 antibody, is recognized for up to 24 weeks. In principle, this drug is administered in-hospital at a medical institution that meets the requirements for an immunotolerance regime for safe administration. The subject to be administered is a severe hemophilia A patient with an 8th factor antibody (coagulant activity is less than 1%). ▲Over 12 years of age, weight over 40kg ▲Antibody titer has a history of 5BU (Bethesda unit)/mL or more ▲In case of bleeding in 6 or more times in the last 24 weeks, a bypass factor was administered or immunotolerance therapy failed should all be satisfied. Children with Kawasaki disease exceeding the permitted range of use will be admitted to take Clopidogrel which are Pregrel, Provic, Clovid, and Clopin. The subjects to be administered are children under 18 years of age diagnosed with Kawasaki disease. Monotherapy is applied when there are side effects or contraindications to Aspirin, and in the case of a second-line therapy (Aspirin + Clopidogrel), warfarin cannot be administered as a patient with coronary aneurysm with a diameter of more than 5 mm and less than 8 mm with a risk of thrombosis ( Hypersensitivity or contraindications to warfarin, failure to adjust the International Normalized Ratio (INR), etc.). The third-therapy regimen (Aspirin + anticoagulant + Clopidogrel) is for patients with a large aneurysm greater than 8 mm in diameter with a history of coronary thrombosis within the last 6 months. The age-related permission for Protopic ointment 0.1%, 0.03%, etc. (Tacrolimus) have been changed from 2 years old to 2 years old in full. Considering the anemia standard of iron injections such as Venoferrum and the characteristics of pregnant women, the standard of hemoglobin, serum ferritin, and transferrin saturation is relaxed to expand the standard for insurance coverage.. Hemoglobin levels change from the current 8g/dl to 10g/dL (but 11g / dL for pregnant women). Considering the anemia standard of iron injections such as Venoferrum and the characteristics of pregnant women, the criteria for hemoglobin, serum ferritin, and transferrin saturation are relaxed to expand the standard for insurance coverage. Hemoglobin levels change from the current 8g/dl to 10g/dL (but 11g/dL for pregnant women). Liquid iron preparations, such as Hemocom, also expand the benefits by relaxing the standards of hemoglobin levels, serum ferritin, and transferrin saturation as primary drugs in accordance with the expansion of the iron injection system. It is specified in the individual notice so that it is not administered at the same time or concurrently with sodium hyaluronate preparations accordance with the reimbursement standard (positive reimbursement) for the treatment material for injection in the knee joint, such as chondroid In addition, as two items of Fattiodol injection to be used for carotid artery embolization of liver cancer are scheduled to be listed from next month, the supplement is recognized by adding 'etc.' to the names of ethyl esters of the iodised fatty acids of poppyseed oil injections such as Lipiodol Ultra Liquid, and the reimbursement is recognized. As eight items, including Movizolo 1 mg are scheduled to be listed, the benefit is recognized by adding 'etc.' to the name of the oral product of Prucalopride succinate.
- Policy
- Chong Kun Dang's own brand botulinum sales countdown
- by Lee, Tak-Sun Apr 23, 2020 06:27am
- Chong Kun Dang's anti-wrinkle agent botulinum toxin will be released to the market soon after receiving national lot release. In the meantime, Chong Kun Dang has been selling Hugel's brand 'Botulax', but it ended the contract last year and prepared to sell its own brand. According to the industry on the 22nd, Chong Kun Dang secured the rights of the botulinum toxin formulation 'Wondertox 100 units' (Clostridium botulinum toxin type A) through the transfer with Huons at the end of last year. Wondertox was approved by Huons in August of last year, but the rights were transferred to Chong Kun Dang through the transfer. Instead, production is undertaken by Huons Global, a holding company. Huons Global has a separate botulinum formulation 'Liztox' (Export name: Hutox). National lot release is a system that approves sales after conducting data screening and tests for vaccines, botulinum preparations, and plasma fraction preparations. National lot release means that it can be sold on the market. As soon as Wondertox passed final step, it is expected to start selling through the hospital soon. The reason for interest in Chong Kun Dang's botulinum toxin is that Chong Kun Dang previously collaborated with Hugel to sell botulinum toxin 'Botulax', which significantly increased its market share. Since 2014, Chong Kun Dang has signed a joint sales contract for 'Botulax' with Hugel and has been selling products until June of last year. With the sale of Chong Kun Dang, Botulax won the market by surpassing Medytox with sales of about ₩50 billion in the domestic market. This is the result of taking full advantage of Chong Kun Dang's largest sales force, the largest in Korea. Sale for Botulax ended, but Chong Kun Dang gained sales experience instead. As a result, Wondertox is expecting to settle in the market early through sales staffs who have accumulated sales experience. Moreover, Medytoxin by Medytox, which had a predominant sales rate, was banned due to suspicion of manipulation. Taking advantage of this, Wondertox was able to expand its customers. The participation of Chong Kun Dang and the ban on the sale of Medytox is expected to change the market for the domestic botulinum toxin market. It is noted who will be the final winner in the domestic market worth about ₩100 billion.
- Policy
- Atnahs is insisting on infringement against generics
- by Lee, Tak-Sun Apr 23, 2020 06:26am
- Generic for Bonviva , an osteoporosis treatment drug launched in 2012, was lately caught up in a patent dispute. This is because the changed patent holder is insisting on infringement of indications and dosage patents against generics. According to the industry on the 21st, Atnahs, UK, which took over the patent right of Bonviva from Roche in 2018, filed a lawsuit against patent infringement in domestic generic company A. It is known that the patent infringement lawsuit is still ongoing. In response, domestic pharmaceutical companies have also filed a patent invalidation trial since March. Following the first judgment on March 10 by Theragen Etex, Cho-A Pharm, Wooridul Pharmaceutical, Arlico Pharmaceutical, Kolmar Korea, Huvist, Ildong Pharmaceutical, Hana Pharmaceutical, and Hyundai Pharmaceutical joined. An official at a pharmaceutical company that filed patent invalidity said that he claimed alleged patent infringement against generic company A because the new patent holder filed a patent invalidation lawsuit. This patent relates to indications and dosage of Bonviva. It is for taking 150mg once a day at least 1 hour before eating food in the morning. In Korea, the advancing indications and dosage patents are not recognized, but in the 2015 Supreme Court agreement, they are recognized as a new component of the invention of medical use. At the time of the release of generics in 2012, indications and dosage patents were not a problem for market sales. Earlier, the official said that when launching generics, it was obvious that indications and dosage patent would be invalidated, but it was in the dispute after acknowledging the patent in Korea. Currently, there are about 40 pharmaceutical companies that have the same ingredients (Ibandronate Sod.) generics such as Bonviva. Therefore, it is an analysis that the direction of patent invalidation judgment is important. Currently, Bonviva has a domestic copyright in Roche. The amount of outpatient prescriptions (Souce: UBIST) last year was ₩2.8 billion.
- Policy
- Samsung developed mobile blood pressure measurement app
- by Lee, Tak-Sun Apr 23, 2020 06:26am
- The MFDS (Chief Lee Eui-kyung) announced on the 20th that it approved the world's first software as a medical device (SaMD) that measures blood pressure using a 'mobile app'. This medical device is a 'blood pressure app' developed by 'Samsung Electronics Co., Ltd.'. It measures blood pressure easily by using a smart watch (mobile platform) on the wrist without wearing a cuff on the arm, and provides the user with a systolic/dilatolic blood pressure of the heart, and pulse rate reporting software. In particular, the MFDS explained that it satisfies both the blood pressure and pulse rate accuracy standards, which are the performance standards for medical devices of conventional automatic electronic blood pressure monitors. In order to promote the development of cutting-edge software medical device products, the MFDS held a round-table conference with mobile app companies in January of this year, listening to domestic and foreign product development trends and regulatory improvement needs. In February, the guidelines for safety management of mobile medical apps were revised so that only mobile apps can be authorized without permission for devices and devices used as mobile platforms, such as smartphones and tablet PCs. An official from the MFDS said that it expects the development of mobile platform-based software medical devices to become more active in the 4th industrial era, and will continue to support the rapid commercialization of medical devices with advanced technologies.
- Policy
- MSD, commercialize adult male oral HPV prevention vaccine
- by Lee, Tak-Sun Apr 22, 2020 06:04am
- Gardasil 9, MSDMSD conducts vaccine clinical trials to prevent oral HPV (human papillomavirus) infection in adult men. MSD has already introduced vaccines to prevent human papillomavirus through 'Gardasil · Gardasil9', but there are no indications for oral HPV prevention in adult men. The MFDS approved IND for phase III of an HPV vaccine (V503) submitted by MSD in Korea on the 20th. This clinical trial is aimed at the efficacy and immunity of the 9vHPV vaccine, a multivalent L1 virus-like particle vaccine in terms of HPV 16, 18, 31, 33, 45, 52, and 58 oral infections in adult males aged 20 to 45 years. This is a phase III, international, multicenter, randomized, double-blind, placebo-controlled clinical trial that evaluates originality and safety. The total number of subjects is 6000, and the number of domestic subjects is 250. MSD plans to conduct this clinical trial from December this year to January 2025. In Korea, Eunpyeong St. Mary's Hospital, Severance Hospital, Korea University Guro Hospital, HUMC-Kangnam Hospital, and Korea University Ansan Hospital participate. Human papillomavirus (HPV) causes papillomas in humans in the case of a virus that is infected through the skin or subcutaneous of an animal. It also causes cervical burden and testicular cancer. The most famous HPV vaccine in the world is MSD's Gardasil. The recently released Gardasil 9 prevents nine types of human papillomavirus and can be inoculated to women aged 9 to 26 and men aged 9 to 26. Gardasil is mainly used to prevent cervical disease in women, genital and anal diseases in men. However, HPV virus is also known to be the cause of infiltration into the oral cavity and larynx cancer mainly due to sexual intercourse. According to the HIRA, 2629 men were treated for oral cancer in 2018, an increase of about 33% compared to 2014. The exact cause of oral cancer is unknown, but smoking and drinking are the biggest risk factors, and are sometimes caused by the HPV virus. This clinical trial primarily evaluates vaccine efficacy against oral infections involving HPV 16, 18, 31, 33, 45, 52, and 58 that lasts more than 6 months, and secondly, it is a test to check the serum antibody titers, adverse reactions, etc. MSD's Gardasil 9 had a domestic sales of ₩40.5 billion, based on IQVIA last year, and is superior in the domestic HPV vaccine market. If indications are added, it is expected to have a significant impact on market expansion and sales growth.
- Policy
- Controversy over Rutatera's exclusion from disaster expenses
- by Lee, Jeong-Hwan Apr 22, 2020 06:02am
- It has been pointed out that the NHIS is causing economic damage to patients by not applying disaster medical expenses to anticancer drugs for the treatment of rare tumors, which has greatly increased the cost of medication due to the COVID-19 pandemic. The NHIS announced that it was unable to apply disaster medical expenses for the reason that Rutatera, a neuroendocrine tumor treatment drug, was not permitted to be marketed in Korea. The association criticized it as an unreasonable and underfounded measure. The reason for this controversy is that the cost of a single dose of the treatment is about ₩26 million, and the cost is estimated at about ₩104 million when the treatment cycle is 4 times. On the 20th, the Korea alliance of patients organization issued a statement and urged that the NHIS should support Rutatera's disaster medical expenses. Rutatera obtained a commercial license from the US Food and Drug Administration (FDA) on January 26, 2018. The MFDS designated this drug as an emergency drug on November 28, last year. However, it has not yet been officially approved, but the MFDS is designating it as a orphan drug in December of last year, according to a request for marketing permission from Novartis Korea. As a result, domestic patients receive this drug from overseas through the KOEDC. The controversy over the disaster medical expenses started with the rejection of the request by the NHIS for Rutatera's disaster medical expenses, patient A with a neuroendocrine tumor in Korea, purchased from the KOEDC. It is known that the NHIS rejected Mr. A's application because Rutatera was not officially approved and is still in clinical trials. Particularly, patients who are burdened with the cost of administering Rutatera 1 cycle (4 injections) of more than ₩104 million receive overseas expeditions to Malaysia for administration of Lutetium that are similar to Rutatera. The situation in which expedition treatment was difficult with the COVID-19 Pandemic also contributed to the controversy over the rejection of disaster medical expenses. With expedition treatment, the cost of administering Lutetium is reduced to about ₩32 million to ₩40 million per cycle, but The Korea alliance of patients organization's position is that patients have to take risks such as medical accidents and serious safety accidents, and even COVID-19 outbreak has made it difficult. As a result, the Korea alliance of patients organization strongly emphasized the need for Rutatera to support disaster medical expenses. The opinion that the decision of the NHIS is different from that of the disaster medical expenses support project and contrary to the purpose of enacting the law. The Korea alliance of patients organization pointed out that patient A was planning to do so after receiving an answer from the staff of the Siheung branch of the NHIS that the drug cost of Rutatera, which was purchased at the KOEDC, can be supported as disaster medical expenses from ₩20 million to ₩30 million a year, but the NHIS took a position that the drug cannot be applied because it is in clinical trials. The organization said that this is different from the contents of the disaster medical expenses business and does not comply with the law, and the government-issued booklet includes medicines purchased from the KOEDC as targets for support. The association stressed that Rutatera is currently completing phase II clinical trials in Korea and is in the process of reviewing permits, and the NHIS needs to reconsider its complaints about rejection. Meanwhile, this statement was jointly presented by the Korean Association of Neuroendocrine Tumor (KANT) along with the Korea alliance of patients organization.
