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- 2026-04-17 04:42:17
- Company
- GC Pharma: all capacity focused on COVID-19
- by Kim, Jin-Gu Apr 06, 2020 06:26am
- The GC Corporations Group says ‘all hands on deck’ to fight against COVID-19. The group has a plan to cover all—from diagnostics to preventive and treatment—with the group’s test kit, vaccine and specialized treatment. On Apr. 2, GC Pharma disseminated a press release and announced “The company would commercialize a plasma-derived treatment for patients with severe case of COVID-19 in later this year.” The press release supported a former Prime Minister and the Chair of COVID-19 Response Committee of the Democratic Party, Lee Nak-yeon’s comment regarding ‘developing a treatment within this year.’ GC Pharma introduced a plasma treatment for COVID-19 in development, ‘GC5131A’ that fractionally extracts hyperimmune globulin from blood plasma of patients who have recovered from COVID-19. Unlike typical new drug, GC Pharma expects the development of the plasma treatment would take shorter time as it only extracts hyperimmune globulin. The company said the treatment would be released in the second half of the year. However, the treatment would be used on treating patients with severe symptoms and as a preventive measure for the high-risk group due to the limited access to blood plasma of completely recovered patients and the yet-to-be confirmed treatment effect. President Heo Eun-cheol of GC Pharma commented, “The treatment is in development to treat patients with severe symptoms requiring urgent care and to prevent infection in high-risk group, such as front-line healthcare workers (through passive immunization),” and accordingly, “a clinical trial would be initiated soon to confirm the treatment effect.” GC Pharma is also in development of a COVID-19 vaccine. The company has announced on Mar. 9 that “Answering Korea Centers for Disease Control and Prevention’s (KCDC) call for state initiative against the outbreak, GC Pharma has started developing COVID-19 related vaccine and treatments.” The vaccine would be developed in subunit vaccine style. A fragment of a pathogen on a surface of coronavirus would be extracted as candidate substance and it would be mass produced through genetic recombinant technology. Compared to live-attenuated vaccine using weakened virus or germs, subunit vaccine is considered safer as it is protein-based. Besides, GC Pharma noted the vaccine would use vaccine adjuvant to boost the effect. GC Pharma’s affiliate, GC LabCell has announced it would use natural killer (NK) cell to develop a COVID-19 treatment. GC LabCell official stated on Mar. 31, the company and the U.S.-based biotech company KLEO Pharmaceuticals are collaborating on a research for the COVID-19 treatment development project. The Korean company is tentatively planning to start a clinical trial in Korea and the U.S. later this year. The project is based on a two-track approach. First, the NK cell-based COVID-19 treatment would be developed to let the cells attack the infected cells and activate other immunocytes to induce their long-term immune response. And another COVID-19 treatment development would utilize the ARMs’ function of neutralizing antibody along with NK cell’s function. Another affiliate, GCMS is well-into developing a test kit. On Mar. 23, GCMS official said “The company has signed a partnership deal to collaborate with a liquid biopsy-specialized company, Genecast.” GCMS would be in charge of commercialization, production and sales, whereas Genecast would develop the product. The COVID-19 test kit in development, 'GCare SARS-coV-2,' is based on RT-qPCR. A sample would be taken from upper and lower respiratory tract to amplify specific gene sequencing of the COVID-19 virus.
- Policy
- The first generic for Afinitor & Betmiga will be released
- by Lee, Tak-Sun Apr 06, 2020 06:26am
- Afinitor by NovartisGuangdong Pharmaceutical is licensed for the first generic version of the breast cancer treatment drug Afinitor (Everolimus, Novartis) and is expected to launch this year. In addition, Hanmi Pharm and Chong Kun Dang also received the first generic approval of the overactive bladder treatment drug 'Betmiga' (Mirabegron, Astellas). These products are also expected to be released this year. This is because they all solved the patent problem. The Ministry of Food and Drug Safety (MFDS) approved the product of Everolimus, Erinito 5mg, for breast cancer treatment by Guangdong Pharmaceutical on March 31. This drug is imported from the Chilean pharmaceutical company 'Synthon Chile Ltda.' Earlier, in March of last year, Guangdong Pharmaceuticals was also permitted to receive Erinito 10mg, which has a different dose. The original drug for breast cancer treatment Everolimus is Novartis' Afinitor. Afinitor is a blockbuster drug that raised sales of ₩20.4 billion based on IQVIA last year. It is used not only for breast cancer but also for various cancer diseases such as pancreatic, gastrointestinal tract, neuroendocrine tumor of lung origin, kidney cancer. Guangdong Pharmaceutical has long filed a patent lawsuit with Novartis, a patent holder, to enter Afinitor's first generic market. However, on Jan. 28, Guangdong Pharmaceutical won the patent invalidation trial for the treatment of cancer. In addition to winning the patent lawsuit, Guangdong also obtained generic exclusivity. As a result, Erinito 5mg was recognized for its monopoly in the generic market by December 31st. During this period, no other generic drug can be released. Guangdong Pharmaceutical has a high proportion of OTC businesses such as Ssangwhatang and Vita500, but has recently strengthened its anti-cancer drug business. It is the first time that the generic for Afinitor has obtained an exclusive right by the end of this year, so it is noteworthy whether Guangdong will compete with the original and achieve meaningful results. Meanwhile, on the same day, the first generic version of the sensitization bladder treatment drug 'Betmiga' was also approved. The generics are Chong Kun Dang's ChongKunDang Mirabegron SR 50mg and Hanmi Pharm's Mirabeg SR 50mg. Betmiga is also an ultra-large blockbuster that posted sales of ₩54.6 billion based on IQVIA last year. Many domestic generics have filed an omnidirectional patent lawsuit to enter the market early. As a result, they succeeded in avoiding all other patents (agents) except the material patent that ended on May 3rd. Accordingly, Chong Kun Dang and Hanmi are expected to launch a generic item in July after undergoing a three-month reimbursed procedure. Since Chong Kun Dang and Hanmi are exerting influence in the clinic market through a large-scale sales network, high sales are expected. However, as Astellas is trusted in the urology department, it is unlikely that Hanmi and Chong Kun Dang will be able to take their original share for a short period of time.
- Policy
- Will Hanmi and Chong Kun Dang's generic exclusivity effect?
- by Lee, Tak-Sun Apr 03, 2020 06:35am
- It is noteworthy whether Hanmi Pharm or Chong Kun Dang among the domestic pharmaceutical companies will be able to achieve the performance in the market while acquiring generic exclusivity, which is the most outstanding pharmaceutical company. In particular, attention has been focused on Hanmi and Chong Kun Dang in that there are no successful cases among the products that have obtained a generic drug exclusivity introduced in 2012. Mirabeg SR 50mg Chongkundang Mirabegron SR Tab 50mg On the 1st, the Ministry of Food and Drug Safety designated Hanmi Pharm's 'Mirabeg SR 50mg' and Chong Kun Dang's 'Chongkundang Mirabegron SR Tab 50mg' as generic drug exclusivity. Accordingly, the two products obtained the right to monopolize in the generic market for 9 months from May 4 to February 3 of next year, when the material patent of the original product expires. This is because generic drugs cannot be put on the market during this period. In addition to the two drugs, it was found that there were no products to receive additional generic exclusivity. The Ministry of Food and Drug Safety explained that there are only two products that have obtained a right to generic exclusivity in the Mirabegron, which is used as an overactive bladder treatment. Of course, there were many other pharmaceutical companies that participated in product development and patent litigation aimed at generic exclusivity in addition to Hanmi and Chong Kun Dang. However, it was reported that most of the bioequivalence tests did not prove the equivalence with the original. An official from the related company said that the original product, Betmiga, is a sustained-release preparation in which the drug is slowly released from the body, so that the generic drugs with the same ingredients were found to have difficulty in equivalence. In addition, he said that there are no pharmaceutical companies applying for permission immediately after PMS ends, except Hanmi and Chong Kun Dang. Betmiga's PMS expired on December 30 of last year, and only Hanmi and Chong Kun Dang appear to have submitted the ANDA(Abbreviated New Drug Application) on December 31, the next day. This is the explanation that the first patent challenge, the patent lawsuit win, and the conditions for the first license application are satisfied, and the products of Hanmi and Chong Kun Dang have obtained generic exclusivity. Eleven companies, including Hanmi and Chong Kun Dang, participated in the patent challenge, and the nine companies did not appear to meet the requirements for the initial permit application. As a result, Hanmi and Chong Kun Dang, which are known to have the largest number of salespeople in Korea, gained exclusive rights to the generic market of Betmiga. Hanmi has approximately 1000 salespeople and Chong Kun Dang has approximately 900 salespeople, and both companies have a number of hospitals clients in Korea. Accordingly, it is expected that the market share can be increased as much as possible during the period of monopoly. Betmiga's outpatient prescription last year was ₩54.7 billion. Even if they take 20% of the share of the two pharmaceutical companies, they will be able to exceed the ₩10 billion market. Because Astellas' influence is so great, there are many prospects that even Hanmi and Chong Kun Dang will not be easily taken away. This was also seen in the case of Vesicare (Solifenacin), an irritable bladder treatment in 2017. Ahn-gook Pharm and Hanmi Pharm, which have salt-changing products, succeeded in avoiding patent expiration and came out 7 months and 3 months before generics, respectively, but were insufficient to threaten the original. Looking at the outpatient prescription amount (Source: UBIST) last year, Ahngook's A-Care was promoted to ₩3 billion and Hanmi’s Besigum amounted to ₩2.1 billion, but it was less than Vesicare’s ₩13.4 billion. Nonetheless, the two pharmaceutical companies are expecting 9 months of monopoly. An official of the related company said that although there is a patent appeal with the original company, it is expected to enforce the launch because it has obtained generic exclusivity and it is expected to monopolize the market once there is no representative generic drug itself. Meanwhile, so far, 328 generics have won generic exclusivity. However, no case has ever grown into a large-sized product that exceeds ₩10 billion annually. This is analyzed because there are many products from the same ingredient, and because of illegal marketing regulation, it is not able to exert the sales power of generic drugs as before.
- Company
- FMC-Korea, names Hee-gyeong Kim as new CEO
- by An, Kyung-Jin Apr 03, 2020 06:34am
- CEO Hee-gyeong Kim of FMC-KoreaFMC Korea has replaced its representative for the first time since its establishment in Korea. FMC Korea said that it has appointed Hee-gyeong Kim as the new chief executive officer effective on April 1. This is the first time the company has replaced the CEO since the establishment of a domestic corporation in 1997. Former CEO Seong-ok Choi (65), who had worked for 23 years, retired and appointed Kim as his successor. The new CEO Kim graduated from Yonsei University and earned an MBA from Duke University. Since then, she has gained extensive experience in the domestic and foreign healthcare and medical device industries. She has held various roles in sales and marketing in Johnson & Johnson Medical Korea and Johnson & Johnson Korea Vision Care for 16 years and after that, she served as representative in Johnson & Johnson Korea Vision Care (2014-2018) and in Johnson & Johnson China Vision Care (2018-2020). When she served as CEO of Johnson & Johnson Vision Care in China, she was evaluated to have successfully built new organizational capabilities in the big data and e-commerce sectors through strengthening external partnerships. Jean DeSombre, President of FMC in North Asia, the new representative, Hee-kyung Kim, has a proven track record of success and leadership capabilities. He was convinced that she would contribute to leading Fresenius Medical Care Korea to the next level of growth.
- Product
- Does Tylenol prevent COVID-19 infection?
- by Kim JiEun Apr 03, 2020 06:34am
- Tylenol stockpiles are showing signs of prolongation which were initiated by the World Health Organization (WHO) According to pharmacies on the 1st, there are more customers who want to buy Tylenol, and many of them want to buy in bulk. Tylenol's full-scale hoarding began after WHO recently advised patients with suspicion of COVID-19 to use antipyretic analgesic “Acetaminophen” instead of anti-inflammatory analgesic “Ibuprofen”. Two days after the recommendation, the WHO withdrew its content on the grounds of lack of grounds. but pharmacists say that the purchase of nominations for acetaminophen-based tylenol is increasing. Since the first occurrence of COVID-19 confirmed patients, purchases of ready-to-use medicines increased and Tylenol stockpiling overlapped, making it difficult for pharmacists to secure inventory immediately. Currently, most of the Tylenol products are sold out in the online shopping malls used by pharmacists, and it is not easy to order separately through wholesalers. The number of patients seeking Tylenol suddenly increased, and a pharmacist in Seoul confirmed that there was a WHO recommendation. The pharmacist also said that some patients bought a lot of Tylenol at a time and took it regularly every day, even turning to fake news that Tyrenol has a COVID-19 preventive effect. A local pharmacist said, “Since the spread of COVID-19, there have been some shortage of OTC medications, as well as Tylenol. Tylenol has become more intense in recent years. Some hospitals even recommend or take prescriptions as a preventive measure. Pharmacists are concerned that such an overdose of acetaminophen-based tylenol may cause side effects such as gastrointestinal disorders. In addition, the hypothesis that some of the Acetaminophen that are currently being raised alleviate or prevent the early symptoms of COVID-19, an infectious disease, is an unconfirmed part and warns that it can be dangerous if patients believe it Another pharmacist in Seoul said that Acetaminophen may cause side effects such as gastrointestinal disorders when taken in excess, and may conceal fever when taken for a long time, so it is more likely to cause disease if patients do social activities for a long time while it is hidden. Reflecting this situation, the Ministry of Health and Welfare also advised frontline pharmacies to provide adequate medication guidance regarding the sale of antipyretics. The government recommends that people who have fever or respiratory symptoms (cough, sore throat, muscle pain, etc.) do not go to work and get enough rest through a strong social distance. When selling antipyretic drugs such as acetaminophen and ibuprofen, the government hopes to cooperate so that sufficient medication guidance such as efficacy, effectiveness, and precautions for use can be achieved.
- Policy
- Rumor: Chief Yang as new Pharmaceutical Benefits Director
- by Kim, Jung-Ju Apr 03, 2020 06:33am
- Apparently, a rumor is circulating about the new director of Pharmaceutical Benefits Division at Ministry of Health and Welfare (MOHW), who would lead the Moon Jae-in Care-initiated drug pricing system revision. According to pharmaceutical industry sources on Mar. 31, Chief Yang Yoon Seok of Smart Healthcare Regulation Revision Planning Team (Graduated from Department of Consumer Science and Child Development Family Studies at Seoul National University) is speculated as a new director of Pharmaceutical Benefits Division and take over the major tasks on MOHW’s pharmaceutical insurance benefit policies. Within the welfare sector of the ministry, Chief Yang used to serve at Aging Society Policy Division and Division of Basic Livelihood Security, and in the health sector, he served at Healthcare Policy Division and as a Chief of Primary Healthcare Improvement Team. In 2014, he participated in talks between the government and medical organization about remote medicine. Then after, he has served as an Administrator of Health and Welfare at the Cheong Wae Dae and a Director of National Pension Finance Division back in MOHW. Even a month after former Director of Pharmaceutical Benefits Division, Kwak Myeong-seop, was transferred in February, the position is still vacant and the division is proceeding with the pharmaceutical policies slowly, but steadily. Although Lee Seon-joo has been newly appointed as a Senior Deputy Director, she was temporarily transferred to COVID-19 response team. Concerns of overloaded work on two deputy directors of the division have been raised internally and externally, but the industry is patiently waiting for the MOHW’s regular personnel changes to be announced amid the outbreak. The government is committed to base the groundbreaking coverage enhancement initiative Moon Care to provide better accessibility on high-cost drugs and to manage listed drugs. Accordingly, the industry expects an official willing to firmly press on with the policy projects would be appointed. And considering all planned initiatives, MOHW has internally agreed on selecting a well-experienced director from other division as the next Director of Pharmaceutical Benefits Division. In other words, the ministry would not gamble on promoting an inexperienced official as the new director. MOHW would likely to finalize the new Director of Pharmaceutical Benefits Division and announce the successor this week at earliest. Meanwhile, former Director Kwak Myeong-seop was dispatched to the South Korea Consulate in Guangzhou, China.
- Policy
- New drug reimbursement review costs KRW 39 million
- by Lee, Hye-Kyung Apr 02, 2020 06:26am
- Experts recommend the Korean government should review implementing service fee system for reimbursement review to enhance speed and efficiency of pharmaceutical reimbursement listing procedure, and to provide quality service through sufficient financial and human resources. While the Health Insurance Review and Assessment Service (HIRA) does not currently collect service fee for the insurance reimbursement listing procedure, a study claims the reimbursement review costs about 39 million won. According to the HIRA’s cosigned research on ‘Appropriate Service Fee for NHI Pharmaceutical Reimbursement Listing Procedure (Principle Investigator: Lee Sang-Hoon at Korea Productivity Center (KPC))’ on Apr. 1, government bodies of Australia, Canada, Switzerland, the U.K., Japan and many other countries are charging for the pharmaceutical listing service. Specifically for reviewing new drug, the service charge apparently goes up over 100 million won. In Korea, the pharmaceutical reimbursement listing is dealt by New Drug Listing Division under the Pharmaceutical Benefit Department at HIRA, and the subject for reimbursed pricing is selected by Drug Pricing Calculation Division. And other additional support is provided by the Pharmaceutical Management Division. The research team surveyed HIRA organization and human resource capacity to calculate the cost of reimbursement review and deduced that each case of review would cost 39 million won, based on the salary class (last three years) of 17 officials in Pharmaceutical Management Division, 28 officials in New Drug Listing Division, 21 officials in Drug Pricing Calculation Division and 32 officials in Pharmaceutical Benefit Standard Division. The researchers explained, “The implementation of service fee system could be justified through the principles of specialty (compensation for the service provided by a specialized individual), the principles of expense compensation (compensation for the cost of time and physical expense spent on an individual’s benefit) and the principles of beneficiary (compensation for the financial profit provided through administrative service).” As for the administration service fee systems in Korea, HIRA charges service fee for pharmaceutical distribution information and big data provision, which comes down to basic salary of fourth level government officials and five percent of general maintenance fee. Ministry of Food and Drug Safety’s (MFDS) pharmaceutical approval service fee has not been changed since 2008. But it would be raised before July 2020, followed by a raise in 2016 based on a cosigned research outcome. Although the 2016 research has assessed and suggested an adequate service fee, 60 percent of the suggested fee was reflected. The research team stated, “The deduced cost of a new drug review case in Korea is expensive at approximately 39 million won, however, it would be not be considered excessively high compared to other countries,” regardless, “the public may be resistant to the system implementation, so the service fee should be set under the prime cost, taking in account the generated public benefit.” At the initial phase of the system implementation, the researchers recommended the government to introduce the system by charging basic administration fee and gradually increasing the fee to avoid clash with pharmaceutical companies. The researchers also emphasized, “However, the possibility of gradual increase of service fee is very low and charging the basic administration fee only could become permanent. As the service fee gap between new drug and other drugs is significantly big that charging the basic fee could be as meaningless as not charging any fee at all.” The study concluded the government should prioritize assessing the actual cost based on the current operation system to accurately deduce appropriate service fee.
- Company
- Daxas' generic by Sama succeeded in patenting
- by Kim, Jin-Gu Apr 02, 2020 06:26am
- Sama Pharm succeeded in avoiding the patent for Daxas (Roflumilast), a treatment for chronic obstructive respiratory disease (COPD). Sama Pharm's success in avoiding this patent attracts attention because large companies have failed in succession. The IPT took the side of a generic company in a trial to confirm the passive scope of the patent for Daxas that was patented by Sama Pharm against AstraZeneca on the 31st of last month. Daxas is the only oral medication used for COPD. Most COPD treatments are in the form of inhalers. However, the sales were not excellent because it is used only for severe patients. Last year, the outpatient prescription amounted to ₩900 million. Daxas, developed by Takeda, was taken over by AstraZeneca in 2015. Dong-A ST Hanmi Chong Kun Dang Yuhan Yungjin BCWorld Pharm, Ahn-gook, Boryung Daxas has received patent challenges from many domestic pharmaceutical companies. In 2015, Dong-A ST, Hanmi Pharm, Chong Kun Dang, Yuhan Corporation, Yungjin Pharm, BCWorld Pharm, Ahn-gook, and Boryung Pharm challenged. As a result, in the patent dispute that lasted for over 2 years, all pharmaceutical companies failed to attack. they were denied the claim, or withdrew theirselves. In this situation, Sama attempted a patent in May, later than other pharmaceutical companies. However, the approach method was different from the previous pharmaceutical companies. Dong-A ST, etc., challenged the formulation patent through an invalidation trial. Sama attempted to evade formulation patents through defensive confirmation trial for the scope of a right. Sama's strategy was right. Although the trial has not been released yet, it is presumed to have succeeded in overcoming some patent items in a narrower range than the invalidation trial. As a result, Sama succeeded in half done of the early launch of generic for Daxas. As the substance patent expires in July, it will be able to be a generic if it exceeds two formulation patents. This is one of the two patents that Sama succeeded. The other one is currently proceeding with trial. If Sama succeeds in evading the remaining one patent, it will be possible to release generics two and a half years before the expiration of the formulation patent (February 19, 2023).
- Policy
- Marketing approval for major Ranitidines have been renewed
- by Lee, Tak-Sun Apr 02, 2020 06:26am
- The approval of Ranitidine formulations, such as Albis, Curan, and Zantac, which have been banned from the end of September last year due to the detection of carcinogenic substances NDMA, has been renewed. Accordingly, permits will remain in effect until March 31, 2025. It is noted whether sales can be resumed during this period. According to the Ministry of Food and Drug Safety, major items containing Ranitidine such as Albis (Daewoong), Curan (Ildong), and Zantac (GSK), whose expiration date was originally set until today (March 31, 2020), were successfully updated. As a result, the validity period for the next 5 years is granted and the permit is maintained until March 31, 2025. The renewal will continue the possibility of resuming sales. Some companies, such as Daewoong, are known to be preparing safety data for resuming sales. However, the MFDS believes that it is difficult to judge the safety for a long period of time because it is considered a problem with the structure of drugs because of concerns about carcinogenesis of Ranitidine. Therefore, there is much interest in the decision of the MFDS when the related companies apply for resumption of sales. This renewal is expected to pass if the company applied without returning the permit. When reviewing the existing renewal, whether or not to register for an overseas formulary is the key, The most important thing is whether or not to list in the foreign formularies, Ranitidine, which has passed the existing renewal review, is already listed in the foreign formularies. However, it is expected to act as a variable in the next update audit, as it plans to strengthen the renewal audit, such as mandatory regular reporting of safety information. If sales are not resumed within 5 years of validity, the marketing approval will likely be canceled.
- Policy
- NHIS to act on growing number of administrative litigations
- by Lee, Hye-Kyung Apr 02, 2020 06:26am
- National Health Insurance Service (NHIS) is setting down administrative litigation response strategy to handle pharmaceutical companies’ taking legal action against drug pricing reduction. NHIS has recently started a cosigned research on ‘Drug Pricing Reduction Related Litigation Case Study and Response Plan.’ The research would be conducted for four months with the budget of 50 million won. From 2015 to 2019, total 24 cases of drug pricing reduction-associated litigations have been filed by pharmaceutical companies against the Korean government. Only three cases were filed every year from 2015 to 2017, but the number soared to 13 cases in 2018 and eight cases in 2019 since the start of a case regarding pricing reduction on single-use eye drop. In last year, most of those litigations were filed due to the 30 percent cut in maximum reimbursed price from the point of a first generic launch. NHIS official said, “As the number of administration litigations against drug pricing reductions has surged, the government agency requires in-depth analysis of precedent cases,” so “the aim of the research is to seek improvements in legal principles and administration for the pricing reduction litigations.” The cosigned research would consist of analysis on drug pricing reduction related litigation in last ten years (litigation type, cause, outcome, ruling and impact on health insurance), proposed legislative revision based on litigation analysis, and legal response against litigation through case analysis and practical persuasion strategy for pharmaceutical industry.
