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- 2026-07-03 08:28:56
- Policy
- Galvusmet latecomers face a price war since launch
- by Lee, Tak-Sun Apr 12, 2022 06:05am
- How price will affect sales of the DPP-4i antidiabetic treatment Galvusmet’s latecomers is gaining attention. Hanmi Pharmaceutical, which had been the first to release a drug to the market, had opted to set its price lower than planned, and the price of the original Galvusmet had also fallen due to the introduction of generics. The price of the generics had also been set accordingly. According to industry sources on the 11th, starting with Hanmi’s Vildaglmet, sales of Galvusmet generics had started in earnest in February, along with sales of KB Pharma’s salt-modified drug in March, all of which as latecomers of Novartis’s Galvusmet (vildagliptin/metformin). The latecomers have been eyeing the Galvusmet market as this fixed-combination drug has been prescribed more than the single-agent Galvus. According to UBIST, Galvus sold ₩8.5 billion and Galvusmet ₩38 billion last year in Korea. Among the latecomers that were newly introduced, only a generic version of the Galvusmet’s main dose - vildagliptin 50mg/metformin 500mg – was released in the market. The introduction of Galvusmet 50/500mg generic had reduced the price of the original by 25.3%, leaving no difference in price between it and the latecomer drugs. In particular, KB Pharma’s salt-modified Vildamet tab 50/500mg, and Korea United Pharm’s Healusmet tab, which received a pricing premium as an innovative pharmaceutical, were listed at ₩310, which is the same price as its original drug. However, Hanmi Pharmaceutical opted to set the price of its salt-modified Vildaglmet tab 50/500mg ₩300, and how this will affect market competition is receiving attention. 빌다글립틴(50mg)/메트포르민(500mg) 동일제제 급여등재 현황 Galvusmet latecomers were able to enter the market earlier after successful patent challenges. Although the original's substance patent was set to expire on March 4th this year, Hanmi and Ahn-gook succeeded in invalidating part of the extended term of the patent and released their generics earlier than the patent expiry date. On this, Novartis has filed an active trial to confirm the scope of its patent against companies other than Hanmi – KB Pharma, Korea United Pharm, Ahn-gook Pharmaceutical, Ahn-gook New Pharm, and Samjin Pharm – on grounds of patent infringement. With patent and drug prices so intricately intertwined, who will be the last to smile in this ₩40 billion market is expected to continue to draw attention.
- Company
- KRPIA BOD meets Oh Chang-hyun, the new head
- by Eo, Yun-Ho Apr 12, 2022 06:05am
- KRPIA BOD will hold its first face-to-face meeting with Oh Chang-hyun, director of the MOHW's insurance pharmaceutical dept. According to related industries, KRPIA Board of Director (BOD) will hold a meeting with Oh Chang-hyun, the new manager, and members of the MOHW's Insurance and Pharmaceutical Affairs on the 15th. The meeting is expected to be accompanied by Oh Dong-wook, CEO of Pfizer Korea, Lee Young-shin, a full-time vice chairman of KRPIA, and some members of the board of directors. Through the discussion meeting, KRPIA BOD is a plan to deliver grievances, policies, and pledges from the perspective of pharmaceutical companies within the agenda of "expanding new drug coverage." As the industry has recently emphasized the need for the introduction of the "post-evaluation of lights" system, it remains to be seen how to proceed with discussions with the changed head of the insurance drug department. KRPIA is also discussing with the 20th Presidential Transition Committee to expand the guarantee of new drugs.
- Company
- No. of employees decline sharply due to restructuring/reorgs
- by Apr 12, 2022 06:04am
- The number of employees at multinational pharmaceutical companies has declined sharply due to their active restructuring and reorganizations. Over 200 employees have been laid off in just 4 companies - Roche Korea, Lilly Korea, Sanofi-Aventis Korea, and Zuellig Pharma Korea. According to the Financial Supervisory Service, the number of employees at Roche Korea, Lilly Korea, Sanofi-Aventis Korea, and Zuellig Pharma Korea was 1,109, which was a 16% decrease from the 1,326 of the previous year. Approximately 80 employees left Sanofi-Aventis Korea last year. The number of employees in the company had been 492 at the end of 2020 but was reduced to 413. In the same period, the number of Zuellig Pharma Korea employees decreased by 58, from 293 to 235. Roche Korea’s employees decreased by 52 from 309 to 257. Lilly Korea’s employees decreased by 28 from 232 to 204. The companies above have all actively carried out restructuring and reorganizations last year, influenced by the business model reorganizations conducted to remove or reduce non-core departments by the companies’ global headquarters. Also, the sales department became the main target of restructuring due to the increasing preference for online-based, non-face-to-face sales activities due to COVID-19. The number of employees at Sanofi-Aventis Korea decreased greatly following the split-off and merger of its consumer healthcare business with Opella Healthcare Korea. Before the spilt-off, the company had also offered an early retirement program for its CHC and GenMed divisions. The GenMed division is in charge of non-core prescription drugs of the company other than vaccines (Pasteur), and specialty care (Genzyme). Zuellig Pharma Korea had reduced the number of employees while withdrawing its local pharmacy retail business. The company had notified employees of its plans to dissolve the pharmacy retail business and large-scale restructuring in March last year. The company had decided to undergo such measures due to continuous operating deficits brought on by the lower distribution fees and intensified market competition. The company aimed to lay off about 80 people by eliminating direct sales and leaving only a small number of personnel in online sales services, Lilly Korea had downsized its offline sales services while increasing its online sales. For this, the company had carried out a large-scale ERP since November 2020. At the time, the company explained that its purpose was “The purpose of the reorganization is to increase the productivity and efficiency of the sales division and reinforce various multi-channels including digital programs.” The company had expected 25% of the 100-something employees in its sales division to opt for the ERP, and it is analyzed that a corresponding number of employees have voluntarily retired. Roche Korea had also conducted two ERPs at the end of 2020 and in the previous year. The main subject of the ERP was the sales department. Although around 20% of the 60-70 workforce in sales were expected to opt for ERP, the number that left had exceeded expectations. The number of employees at Roche Korea, which had exceeded 300, was reduced to 250 after ERP.
- Company
- Lutathera’s partner ‘LysaKare’ may be prescribed at GHs
- by Eo, Yun-Ho Apr 11, 2022 05:58am
- ‘LysaKare’, the drug concomitantly used with the neuroendocrine tumor treatment ‘Latathera’ may soon be prescribed at general hospitals. According to industry sources, Novartis Korea’s ‘LysaKare (L-arginine hcl/L-lysine hcl) has passed the drug committee (DC) reviews at 3 of the Big 5 general hospitals – Samsung Medical Center, Seoul National University Hospital, Seoul Asan Medical Center - in Korea. LysaKare was approved as a drug to be used concomitantly with Novartis’s orphan drug Lutathera (lutetium), a neuroendocrine tumor treatment that was approved in July 2020. Lutathera is a radioactive targeted therapy that increases the dose of radiation in the tumor areas. It is an ultra-high-priced but highly effective drug used to treat a very small number of patients. The drug was listed for insurance benefit in March last year and cost ₩104 million for 4 injections before then. LysaKare is used to reduce damage caused by renal radiation exposure during the use of Lutathera. The Ministry of Food and Drug Safety had also designated LysaKare as an orphan drug recently. Specifically, LysaKare is indicated for ‘reduction of renal radiation exposure during peptide-receptor radionuclide therapy (PRRT) with lutetium (177Lu) oxodotreotide in adults.’ Meanwhile, Lutathera’s efficacy had been demonstrated through the Phase III NETTER-1 trial and Phase I/II ERASMUS studies. The primary efficacy endpoint of the NETTER-1 study was progression-free survival (PFS). At the time of primary analysis, the median PFS was not reached for Lutathera and was 8.4 months for the control group, showing that Lutathera reduced disease progression and death by 82% compared to the control group. In particular, the drug had significantly prolonged PFS in patients regardless of tumor size, including those with liver tumors, and demonstrated the possibility of effectively treating various types of patients.
- Policy
- The adverse drug reaction rate of Trulicity is 19%
- by Lee, Hye-Kyung Apr 11, 2022 05:58am
- As a result of a six-year post-marketing survey of Type 2 diabetes treatment Trulicity in Lilly Korea, 15 cases of serious adverse drug reactions that cannot be excluded from causal relationships were reported. The permit will be changed as 62 unexpected adverse drug reactions, which cannot exclude causal relationships, also occurred. The MFDS recently announced that it will pre-announce and reflect the order to change the permission according to the results of the re-examination of Trulicity 1.5 mg/0.5ml and Trulicity 0.75 mg/0.5ml disposable pens from July 6. Trulicity was developed as a disposable syringe formulation as a long-acting GLP-1 analog and obtained domestic permission in 2015. As a result of a post-marketing survey of 3,022 people for 6 years for re-examination in Korea, the incidence of abnormal cases was reported to be 19.49% (589/3,022 people, total 819 cases), regardless of causality. Significant adverse drug reactions were found to be 0.46% (14/3022 patients, 15 cases), with occasional blood sugar increases and rare dizziness, poorly controlled diabetes, diabetic gastritis, gastroesophageal reflux disease, acute kidney damage, and diabetic kidney disease. In the case of unexpected adverse drug reactions such as weight loss, weight gain, sensory degradation, and gastroenteritis, 1.99% (60/3,022 cases, 62 cases) occurred. Trulicity is administered as an adjuvant to dietary and exercise therapy to improve blood sugar control in adult type 2 diabetes patients. Among patients who have difficulty controlling sufficient blood sugar with Metformin and Sulfonylurea combination therapy, insurance benefit is being applied to the combination therapy of patients who cannot perform body mass index ≥25kg/㎡ or insulin therapy. Last year, it recorded 47 billion won in outpatient prescriptions based on UBIST, up 23% from 38.2 billion won in the previous year.
- Policy
- NHIS to study measures on improving the PVA system
- by Lee, Tak-Sun Apr 11, 2022 05:58am
- With a study on improving the price-volume agreement (PVA) system in plan, the possibility that the improvement may increase drugs subject to PVA is being raised. According to industry sources on the 8th, the National Health Insurance Service is preparing to conduct a research to ‘evaluate the performance of and improve the Price-Volume Agreement system’ and will post a bid for its research services soon. Its plan, as disclosed by the NHIS, indicates that the study will be conducted for 6 months from the period of its initiation and be completed at the end of the month. Through the study, the authorities plan to establish a mid-to-long-term roadmap for the PVA system and ensure the appropriateness of the drug expenditures to save excess resources and strengthen Korea’s NHI coverage. Feasibility reviews on alternatives that go beyond the existing agreement system and reference formulas will also be developed in the study. For example, the current system applies the rate of increased claims in the formula, but the study will review the application of a reference formula that considers the absolute claims amount and the amount of increase. In addition, the study will be used to prepare a reasonable plan that considers the fiscal impact of the selection/exclusion criteria that were already revised this month, and review diversifying the method used to make PVA. Based on the research results, NHIS also plans to hold public hearings with relevant institutions to improve the PVA system to prepare a system improvement plan that can enhance both acceptability and negotiation power, and propose a mid-to-long-term development direction for the PVA system based on legal and institutional review. NHIS announced its plan to research measures to improve the PVA system earlier this year. At a policy roundtable meeting on the ‘Rational improvement of the PVA system’ that was held by the National Assembly in January, Hyun-Deok Kim, Director-General of the Pharmaceutical Management Department, said, “We are aware of the issue caused by reviewing only the rate of increase without consideration of the absolute increase in claims amount. We agree that there is a need to conduct a comprehensive review on the PVA system and prepare improvements, and will be posting a bid for research services within the year.” As the main purpose of the study is to save NHI pharmaceutical expenses, friction with pharmaceutical companies seems inevitable in the process of its implementation. An industry official expressed regrets, "Contrary to the pharmaceutical industry’s opinion of reducing or deferring the PVA system, the government’s only plan seems to be to reduce its expenses. By the contents of the study alone, it seems that subject drugs and discount rate would only increase further."
- Policy
- National Responsibility for the Side Effects of Vaccines
- by Lee, Jeong-Hwan Apr 11, 2022 05:58am
- Ahn Cheol Soo, the chairman of the presidential transition committee/the special chairman of the COVID-19 emergency response committee said they would provide wide support for adverse reactions to the COVID-19 vaccine while significantly easing the burden of public proof. On the 7th, Chairman Ahn held the 6th meeting of the COVID-19 Special Committee at the Transition Committee in Samcheong-dong, Jongno-gu, Seoul, and discussed ways to realize a national responsibility system for adverse vaccine reactions and secure treatments. Chairman Ahn said, "We have emphasized the importance of scientific quarantine and focused on policy implementation measures based on objective data such as the national antibody positive rate and vaccine abnormalities." "From next week, we plan to release related data one by one with the KDCA and the NHIS," he said. The COVID-19 Emergency Response Special Committee asked the government to come up with measures to compensate for damage from adverse reactions to vaccines, expand diseases subject to support, and ease the burden of public proof to provide quick and fair damage compensation. The KDCA promised to strengthen support by reflecting this request. Specifically, abnormal reactions registered by pharmaceutical departments in major overseas countries will be recognized as related diseases first, and the scope of causal recognition will be expanded if the COVID-19 Vaccine Safety Committee comprehensively analyzes the causalities of related diseases. A project to be supported will also be established, and if the disease is suspected after vaccination and is treated or tested, actual expenses will be provided for the cost. In order to ease the public's burden of submitting evidentiary documents, rapid compensation procedures will also be implemented, such as simplifying submission centered on necessary evidentiary documents in the case of related diseases. The number of objections will also be expanded from one to two. The transition committee said, "We decided to provide consolation money for sudden deaths within 30 days of vaccination, where the cause of death is unknown even as a result of the autopsy." In addition, he said, "There was no support if not diagnosed as a disease subject to vaccine abnormal response compensation and support, but in the future, if the disease is suspected and treated or tested, we plan to provide actual support for the cost."
- Company
- HK inno.N's K-CAB has ended Phase 1 in US
- by Kim, Jin-Gu Apr 11, 2022 05:58am
- HK inno.N announced on the 7th that its flagship drug, "K-CAB (Tegoprazan), has successfully ended phase 1 clinical trials in the U.S., a treatment for gastroesophageal reflux disease. The clinical trial was conducted on 30 healthy adults with random assignment, double blinding, placebo control, and repeated administration. K-CAB 25 mg, 50 mg, and 100 mg were administered to clinical participants orally for 7 days, respectively, and pharmacokinetic characteristics and safety were evaluated. As a result of pharmacokinetic evaluation, the blood concentration of K-CAB was proportional according to the content, and similar profiles were maintained on both the 1st and 7th days of administration. In the pharmacological evaluation to measure the acidity (pH) in the stomach, both the 1st and 7th days of administration showed higher acidity than the placebo for 24 hours. In particular, it showed rapid medicinal effects regardless of the dose on the first day of administration. In terms of safety, all doses of K-CAB did not differ from placebo. HK inno.N has been conducting a phase 1 clinical trial of K-CAB with the aim of entering the U.S., the world's largest pharmaceutical market. HK inno.N signed a technology export contract worth about 640 billion won to Braintree Laboratories, a subsidiary of Sebela, a U.S. digestive medicine company, last year when it was undergoing local clinical trials. HK inno.N explained that Braintree Laboratories will be in charge of follow-up clinical trials in the United States and Canada. Braintree Laboratories plans to carry out follow-up clinical trials in the U.S. and Canadian markets as soon as possible. Starting with the smooth completion of the phase 1 clinical trial in the U.S., It will work closely with our local partners to ensure that the Korean new drug K-CAB can be successfully launched in the U.S. market, said Kwak Dal-won, CEO of HK inno.N. K-CAB recorded 109.6 billion won in outpatient prescriptions in Korea last year. Cumulative prescriptions amount to 236.4 billion won over the three years after release. Based on its domestic success, HK inno.N is actively seeking overseas expansion. It has made inroads into 27 countries around the world, including the U.S. In the Chinese market, Luoxin, a local partner, is planning to license and release items in the first half of this year.
- Policy
- CAR T-cell therapy has shown the disappearance of leukemia
- by Kim, Jung-Ju Apr 11, 2022 05:57am
- A research team of domestic CAR-T (Chimeric Antigen Receiver-T Cell) treatment confirmed the disappearance of leukemia cells in clinical trials of pediatric and adolescent leukemia patients. The government plans to positively evaluate the treatment of children and adolescents with leukemia through advanced regenerative medical clinical research and continue to provide related policy support. The MOHW (Minister Kwon Deok-cheol) announced on the 7th that the results of the disappearance of leukemia cells in children and adolescents through advanced regenerative medical clinical research research at Seoul National University Hospital (Director Kang Hyung-jin). CAR-T introduces a gene that combines the receptor site of an immune cell (T cell) and the characteristic antigen recognition site on the surface of a cancer cell into a patient's T cell and is a cell with a function of specifically recognizing and attacking the surface antigen of a cancer cell. This study is a high-risk clinical study, which was approved and approved as the first high-risk clinical study by the Advanced Regenerative Medical and Advanced Biopharmaceutical Review Committee and the MFDS in December. Seoul National University Hospital said it administered its own CAR-T treatment to an 18-year-old leukemia patient on February 28, and that a bone marrow test conducted on March 28 confirmed that leukemia cells completely disappeared. This project is to support research funds for clinical studies approved or approved by the Council and the MFDS. In addition to this clinical study at Seoul National University Hospital, it is also supporting clinical research conducted by Samsung Medical Center and Catholic University Industry-Academic Cooperation. Seoul National University Hospital receives 1.25 billion won in research funds from 2022 to 2023, Samsung Medical Center 1.83 billion won from March 2022 to December 2023, and Catholic University Industry-Academic Cooperation Group 1 billion won from 2022 to 2023. As of the end of March, a total of five clinical studies were finalized and approved by the Deliberation Committee and the MFDS, and one high-risk clinical study and one medium-risk clinical study will also apply for research funding to the Advanced Regenerative Clinical Research Support Group. The MOHW explained that the number of applications and applications for advanced regenerative medical clinical research has been on the rise since the Advanced Regenerative Bio Act took effect in August 2020 and the deliberation committee began to form and operate in January 2021. The deliberation committee is determining whether or not to make a decision on the suitability of clinical research in consideration of the validity and safety of the research plan, and the proportion of clinical research that has recently been approved is increasing. Among them, the number of suitable resolutions through the deliberation committee so far has been 10. Recently, the advanced regenerative medical field is attracting attention as a future food in the biohealth field, and as the number of advanced regenerative medical institutions capable of conducting clinical research continues to increase, advanced regenerative medical research is expected to be further activated. Accordingly, the government will strengthen legal essential education for clinical research personnel, R&D for virus production and human transplantation, and GMP support to promote joint research between hospitals and startups. "It is encouraging to provide treatment opportunities for pediatric leukemia patients through the first high-risk clinical study," said Kim Young-hak, head of the MOHW. "We will do our best to provide treatment opportunities to more patients through pan-ministerial regenerative medical technology development projects."
- Policy
- Chinese companies are set to debut in the domestic market
- by Lee, Tak-Sun Apr 11, 2022 05:57am
- Chinese pharmaceutical companies' new anti-cancer drugs, which were approved in Korea last year, are more likely to be listed on the Korean health insurance. Expectations for benefits are growing as BeiGene's Bruxinsa passed the HIRA's Cancer Disease Review Committee as a sole treatment for WM adult patients the previous day. Another Chinese pharmaceutical company, Antengene's Xpovio, will also continue to challenge the domestic market. On the 6th, the deliberation committee set a benefit standard for BeiGene's Brukinsa, which applied for a new benefit, for VM that have received more than one treatment before. If the HIRA's Drug Benefit Evaluation Committee recognizes the appropriateness of the benefit and if the drug price negotiation is concluded with the NHIS, it will be on the domestic health insurance benefit list so that patients can easily receive medication. This is expected to be the first case in which a new anti-cancer drug developed by a Chinese pharmaceutical company enters the domestic benefit market. Brukinsa is a target anticancer drug that inhibits the survival and spread of malignant B cells by blocking Bruton kinase protein, a signaling molecule that affects the survival and development of B cells as a Brutons Tyrosine kinase inhibitor. It was first approved as an MCL treatment by the U.S. FDA in November 2019, and was also approved as a WM treatment in September last year. To be approved as a WM treatment, Bruxinsa conducted a comparative clinical trial with Janssen's Imbruvica, the same BTK inhibitor. American businessman John V. Oyler and biochemist Xiaodong Wang, Ph.D co-founded BeiGene in 2010. As the name of BeiGene suggests, it is headquartered in Beijing, China. Brukinsa is currently in 23 countries with approval from around the world. It has established a branch office early in October 2019 and has been preparing to enter the market. Brukinsa, which was approved by the MFDS on February 25, passed the WM indication committee in less than two months, raising expectations for a high-speed listing. The Chinese pharmaceutical company's new anti-cancer drug approved prior to Brukinsa is Antengene's Xpovio. Xpovio received approval from the MFDS in July last year. This drug is a new mechanism that selectively inhibits XPO1, a nuclear export protein. In January, it was submitted to the cancer screening and discussed setting benefit standards, but failed. In recurrent or refractory polymyeloma, it applied for benefits as a combination therapy with Dexamethasone, and treatment for recurrent or refractory diffuse B-cell lymphoma, but failed to pass. Antengene is expected to continue to challenge the domestic benefit market while watching the situation of overseas registration. Xpovio has already passed the so-called Big 5 DCs such as Samsung Seoul Hospital, Seoul National University Hospital, Seoul St. Mary's Hospital, and Seoul Asan Hospital and is being used as non-reimbursement. Founded in 2017, Antengene is a major developer of anticancer drugs invested by global pharmaceutical company BMS and is headquartered in Shanghai, China. In March last year, a local corporation was established.
