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- 2026-03-16 23:45:11
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- Vyzulta reimbursed and prescribed at general hospitals
- by Eo, Yun-Ho Jul 12, 2022 05:53am
- The glaucoma treatment ‘Vyzulta’ has received approval for insurance benefits and is landing at general hospitals in Korea. According to industry sources, Baush + Lomb Korea’s ophthalmic solution Vyzulta (latanoprostene bunod) has passed the drug committees of various medical institutions including the Seoul National University Hospital and Gangnam Severance Hospital. Vyzulta, which was approved in Korea in February last year, passed the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee (DREC) deliberations in the August of the same year and was listed for reimbursement starting February this year. Vyzulta is an ophthalmic solution that reduces intraocular pressure (IOP), which is a risk factor of glaucoma, and is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Drug treatment to reduce IOP is currently considered the most effective treatment for glaucoma. Vyzulta has two separate MOAs for drainage and is metabolized into two moieties1 – its API Latanoprost acid and nitric oxide –to reduce IOP through by increasing the outflow of aqueous humor through both uveoscleral and trabecular meshwork channels Also, Vyzulta demonstrated a superior mean IOP reduction effect over latanoprost 0.005%, a common glaucoma treatment, and demonstrated statistically significantly greater mean IOP reduction over Timolol 0.5% in clinical trials. Meanwhile, Vyzulta’s had costed around ₩110,000 per year without reimbursement, but the patient’s out-of-pocket cost was reduced to around ₩30,000 per year with reimbursement, being applied a 30% coinsurance rate.
- Company
- Johnson & Johnson Medical Devices changed its name
- by Eo, Yun-Ho Jul 12, 2022 05:53am
- Director Oh Jin-yong Johnson & Johnson Medical of Korea announced a new start with a change of name. The company held a press conference explaining the "J&J MedTech" rebranding at The Plaza Hotel in Jung-gu, Seoul on the 11th and announced its vision to lead innovation in the future medical market combined with digital as a global leading company. Johnson & Johnson's medical device division, a U.S.-based global healthcare company, changed its name from Johnson & Johnson Medical Devices to Johnson & Johnson MedTech in March. The name of the Korean branch will be maintained by the existing Johnson & Johnson Medical Center. The event was announced by Oh Jin-yong, president of North Asia, and introduced a new corporate vision and business direction focusing on digital transformation. President Oh pointed out the recent rapid development of digital transformation throughout the industry, and in line with this, Johnson & Johnson Medical Korea will make a new leap forward as a medtech company that encompasses not only medical devices but also digital solutions such as robotic surgery and medical software. As a specific strategy, it plans to develop new models of future healthcare in the digital era, contribute to improving human health through state-of-the-art technology and innovation, and present integrated solutions for optimal treatment away from existing products to focus on overall health. "The transition to &J MedTech is part of efforts to provide innovative treatment solutions to meet the rapidly digitizing medical environment and patient demand. "Our vision is to provide smarter, less invasive, and more customized treatment for patients by utilizing advanced technologies such as AI, machine learning, data science, and virtual reality," he said. To this end, three future directions were presented, leading the healthcare innovation, developing digital healthcare solutions that encompass the entire process of patient treatment, and optimal treatment using data science. It will also continue to cooperate closely with medical personnel to reflect the demand of clinical sites and to create a better medical environment. President Oh Jin-yong said, "The Korean medical device market is emerging as a center of Meditec innovation in the Asia-Pacific region thanks to continuous growth and the emergence of ventures with innovative technologies and global competitiveness." Johnson & Johnson Medical Korea is a global company that has provided medical devices and digital solutions for 34 years since its establishment in 1988, and consists of major business units such as ETHICON, which provides surgical medical devices and digital solutions, DePuy Syntes, and CSS (Cardiovascular & Specialty Solutions).
- Company
- NPS buys Samsung Biologics and SD Biosensor shares
- by Kim, Jin-Gu Jul 12, 2022 05:52am
- In the midst of the prolonged contraction observed in the Korean stock market, Korea’s largest institutional investor, the National Pension Service (NPS), was found to have expanded its investment in biotech/pharma companies by nearly ₩500 billion. NPS net purchased ₩140 billion worth of Samsung Biologics shares and increased investment in SD Biosensor, Celltrion, Hanmi Pharmaceutical, Celltrion Healthcare, and Daewoong Pharmacuetical by over ₩50 billion. Also, NPS net sold over ₩50 billion worth of Yuhan Corp’s shares and over ₩40 billion worth of SK Bioscience shares during the same period. ◆NPS increases investment in Samsung Biologics and SD Biosensor again this year… turns to net purchases from net selling According to the Korea Exchange on the 11th, NPS net sold ₩417.3 billion worth of shares in the domestic securities market and the KOSDAQ market in the first half of this year. However, no large-scale net sales like the ones made last year were observed. Last year, NPS had net sold shares worth ₩2.4 trillion after deciding to curtail local equity exposure to 16.8%. In the Pharma/Bio industry, NPS was found to have made more purchases than sales. It sold a total of ₩2.43 trillion and bought ₩2.89 trillion, resulting in net sales of ₩459.2 billion. In particular, NPS increased investment in Samsung Biologics, SD Biosensor, Celltrion, Hanmi Pharmaceutical, Celltrion Healthcare, and Daewoong Pharmacuetical by over ₩50 billion. NPS net purchased Samsung Biologics shares worth around ₩140.1 billion in only the first half of this year. This is analyzed to be NPS’s decision to continuously expand investment in Samsung Biologics this year. NPS had net bought ₩917.9 billion shares of Samsung Biologics’ stocks last year. NPS is also continuously increasing investment in SD Biosensor and had net purchased shares worth ₩95.3 billion in the first half of this year. NPS had net purchased ₩124.3 billion worth of SD Biosensor’s shares last year. In addition, NPS had net purchased over ₩70 billion worth of shares in Celltrion, Hanmi Pharmaceutical, and Celltrion Healthcare each in the first half of this year. The institution’s decision to purchase Celltrion’s shares again is a focus of interest as it had net sold ₩648.6 billion of Celltrion’s shares last year. NPS had net sold over ₩600 billion last year and then turned to net purchase over ₩70 billion in the first half of this year. NPS had also net purchased shares over ₩10 billion in 18 companies including Daewoong Pharmacuetical, ST Pharm, SK Biopharmaceuticals, Hanmi Science, Lutronic, Osten Implant, Daewoong, GC Pharma, Jeisys Medical, Dentium, Ray Pharma, PharmaResearch, and Pharmicell. ◆NPS net buys ₩280 billion of SK Bioscience shares last year but net sells ₩43 billion in 2022 1H On the other hand, NPS sold a large number of shares it owned in Yuhan Corp, SK Bioscience, Bukwang Pharmaceutical, Mezzion, Hugel, and GC Cell. In particular, SK Bioscience and GC Cell moved from the top net bought shares last year to the top net sold shares in the first half of this year. In the case of Yuhan Corp, NPS bought ₩86.2 billion and sold ₩140.3 billion in 1H this year, resulting in net sales worth ₩54.1 billion. Also, NPS net sold ₩43 billion worth of SK Bioscience’s shares in the first half of this year. This is in stark contrast to how the company net bought ₩280.3 billion last year. Also, NPS net purchased ₩112.2 billion last year, but net sold ₩11.9 billion of SK Bioscience’s shares in the first half of this year. NPS also net sold over ₩10 billion worth of shares from Bukwang Pharmaceutical (₩26.5 billion), Mezzion (₩19.8 billion), and Hugel (₩19.3 billion).
- Company
- Will Celltrion Pharmaceutical voluntarily cut down on Godex?
- by Nho, Byung Chul Jul 12, 2022 05:52am
- Celltrion Pharmaceutical's Godex is on the verge of being expelled from insurance registration, and it is expected to cut voluntary drug prices at the level of comparative drugs as the last defense measure to maintain benefits. The reason why Celltrion Pharmaceutical's strategy is drawing attention is that if Godex, which looks like 60 billion won, is deleted, it is inevitable to lose about 20% of its total sales, which is expected to make every effort to maintain insurance drugs through clinical utility proof. Godex was not recognized for the appropriateness of the benefit at the 7th review of the Pharmaceutical Benefit Evaluation Committee held on the 7th, but the final results may change depending on the evaluation of the objection. This re-evaluation project is planned for five years from 2021 to 2025, and it is difficult to overcome obstacles in this way because it contains more than 20 billion won, or less than one country among A8 countries, or drugs pointed out by the committee due to insufficient policy, social needs and usefulness. It is insufficient to judge the HIRA's expression of its willingness to derive reasonable drug prices by comparing clinical usefulness and drug prices in excluded countries with domestic released drugs as simply proof of usefulness. The most effective means is the voluntary reduction of drug prices to the level of a single drug (or Pennel Cap ( 312 won ) with the same main ingredient). Godex capsules contain 25mg of Biphenyl Dimethyl Dicarboxylate, 500μg of Riboflavin, 125μg of Cyanoborate, 2.5mg of Adenine HCl, 25mg of Pyridoxynate, and 150mg of Carnitine Orotate. A comparative drug with the same main ingredient is Pharmaking's Nissel (144 won). Despite the expiration of Godex patents, many pharmaceutical bio companies failed to release generics because they could not successfully derive biological equivalence test data for other auxiliary substances except biphenyl dimethyl Dicharboxylate, the main ingredient. It is true that even though Godex is a composite agent, if the drug price is the same as the single drug Nissel by giving up the drug price value for the rest of the ingredient combination except for the main ingredient, the HIRA lacks the reasonable logic to prevent it. Sales of Godex could be halved due to a benefit cut of 371 won → 144 won, but it can actually prevent it from leaving the market and restore it to its original state according to its sales strategy, which is likely to reduce its weakness. It is logical that Celltrion Pharmaceutical's the HIRA limit is unfair to reduce the benefit of Godex capsules, a composite drug, at a time when insurance registration and benefits continue due to the clear effect of a single product. In addition, under the current regulations, drug prices fall only when generics enter, but there is a logic that it is unreasonable to target them for re-evaluation even though generics has not been released.
- Company
- 4th JAKi Cibinqo to be prescribed in general hospitals
- by Eo, Yun-Ho Jul 11, 2022 06:03am
- The fourth JAK inhibitor ‘Cibinqo ‘ has landed at general hospitals in Korea. According to industry sources, Pfizer Korea’s new Janus kinases (JAK) inhibitor ‘Cibinqo (abrocitinib)’ passed the drug committees (DCs) of various medical institutions in Korea, including the Seoul National University Hospital. The drug, which is approved for atopic dermatitis, is Pfizer’s follow-up of ‘Xeljanz (tofacitinib)’ that is set to compete with ‘’ Lilly Korea’s ‘Olumiant (baricitinib),’ ‘Abbvie’s ‘Rinvoq (upadacitinib)' for the same indication. Olumiant and Rinvoq were approved for reimbursement in May this year, and the reimbursement listing process for Cibinqo is also in progress. Cibinqo received marketing authorization in November last year when the reimbursement listing for Olumiant and Rinvoq was under review. As a JAK1 inhibitor, the drug modulates multiple cytokines involved in the pathophysiology of atopic dermatitis, including interleukin IL-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP). It is indicated for the treatment of adults and adolescents over the age of 12 with moderate-to-severe atopic dermatitis. Cibinqo demonstrated its efficacy through the Phase III trials JADE MONO-1, MONO-2, COMPARE, etc. The drug reduced the Eczema Area and Severity Index (EASI) by over 70% at Week 12 and demonstrated an improvement in itch relief 2 weeks after initiating treatment. Its pivotal study, JADE Mono-1, was designed to evaluate the efficacy and safety of two doses (100 mg and 200 mg once daily) of Cibinqo monotherapy in patients 12 years of age and older with moderate-to-severe AD for 12 weeks. Results showed that 63% of the Cibinqo 200 mg administered group had achieved an EASI-75 (improvement of at least 75% in lesion extent and severity) at Week 12, which was a significant improvement compared to the 12% in the placebo group. Also, the rate of patients that achieved EASI-90 at week 12 had been 39% in the Cibinqo group and was higher than the 5% in the placebo group.
- Company
- ER contraceptive market battles over original & generics
- by Nho, Byung Chul Jul 11, 2022 06:03am
- Norevo (Levonorostrel 0.75mg) and Elaone (Ulipristal Acetate 30mg), which Hyundai Pharmaceutical received import licenses from HRA Pharma in 2001 and 2011, by a 10-year gap, are emerging as icons of changes in the emergency contraceptive market. Emergency contraceptives have been submitted to the Central Pharmaceutical Review Committee of the MFDS and classified and maintained as Rx drugs during the reclassification process of Rx drugs vs OTC. In 2014, seven years after Norevo, the first product of this series, was approved, the emergency contraceptive market showed box-office performance after forming about 8.7 billion won in appearance. In the past five years, the CAGR has been showing a gradual decline, with -2.6% based on market value and -4.9% based on prescription quantity. It is observed that the market of Levonorgestrel, where each brand's products were licensed and generic appeared less than a year after patents were not protected, has been bisected by the launch of Ulipristal in 2011. The share of Ulipristal products, which was 21% in 2013, the third year of its launch, has remained at 45% until last year since entering the 40% range in 2016. Ulipristal preparations have the advantage of extending the emergency contraceptive effect from 72 hours (3 days) to 120 hours (5 days) after the relationship. As mentioned above, the size of the oral emergency contraceptive market itself is stagnant, but new changes are also expected under the surface. Pharmaceutical companies that have oral hormone preparation facilities include Myungmoon Pharm, Dalim Biotech, and GL Pharma. GL Pharma, which entered the market last, is expanding its market share to 28% by manufacturing a total of six items, including its own product, Sexcon One. Hyundai Pharmaceutical's 5-year CAGR of Norevo one was -6.5%, and GI Medics' Phostino-1 sold by Bayer Korea had a CAGR of -20.4% during the same period, and its market share also decreased by more than half from 22% to 10%. Given this situation, the challenge of emergency contraception by Ulipristal's first generic, Ellaoil (authorized on June 13, 2022/GL Pharma), is drawing attention from the industry. Attention is being paid to THEU's move, which quickly rose to second place (23%) in market share from Levonorgestrel. The price change due to the shift in market flow from monopoly to oligopoly is also another point to watch. Four first generics companies, including GL Pharma, are competing with HRA Pharma, a French emergency contraceptive developer, to determine the scope of rights and to sue for patent infringement.
- Company
- The pharmaceutical union of 2,500 people has been launched
- by Jul 11, 2022 06:03am
- The first chairman is Ahn Deok-hwan, head of the Korea Novartis union. Fifteen multinational companies and one domestic company participated in the NPU launch ceremony after three years of discussion "Working conditions are deteriorating despite increased sales in the pharmaceutical industry. Active response to common issues" The nation's largest pharmaceutical labor union has been newly created. The new labor union, which consists of a total of 2,500 pharmaceutical workers, expressed its willingness to jointly respond to the pharmaceutical company's restructuring moves. The NPU held a launching ceremony at the FKTU on the morning of the 5th. Kim Dong-myung, chairman of the FKTU, Hwang In-seok, chairman of the FKTU, Kim Ki-chul, chairman of FKTU's Seoul regional headquarters, Nam Sung-hee, chairman of FKCU's pharmaceutical cosmetics division, and Yoo Byung-jae, CEO of Novartis Korea, attended the meeting. A total of 16 domestic and foreign pharmaceutical labor unions, including ▲Novonodisc Pharmaceutical, ▲Bayer Korea, ▲Amgen Korea, ▲Ipsen Korea, ▲Novatis Korea, ▲Viatris Korea, ▲ Janssen Korea, ▲ Pfizer Pharmaceutical, ▲ Sanofi Aventis Korea, ▲Alvogen Korea, ▲Opella Healthcare Korea, ▲Merck, ▲Beringer Ingelheim, ▲AstraZeneca, ▲GSK, and ▲Hyundai Pharmaceutical. Eight unions, including Novonodisc Pharmaceutical and Pfizer Pharmaceutical Korea, have already decided to switch to industrial unions. Eight unions, including the AstraZeneca Korea Union, are preparing to switch industries. The total number of union members was about 2,500. Those who have been preparing for a new union of pharmaceutical unions for about two years since 2019 formed an integrated promotion committee for some unions and non-affiliated unions that left the KDPU, and officially established the NPU last year. In a declaration of launch, Ahn Deok-hwan, the first chairman of Novartis Korea, said, "The Korean pharmaceutical industry is suffering from job insecurity and a real decrease in wage income through the fourth revolution and COVID-19." "I felt the need for solidarity as I recognized these problems as the same problems that appeared in the pharmaceutical industry as a whole, not in a specific company," he said. He then stressed, "The NPU will firmly maintain employment stability, raise wages and welfare, and respond intensively to common problems arising from low growth and non-face-to-face operations in the name of voluntary retirement." Yoo Byung-jae, CEO of pharmaceutical industry, said in a congratulatory speech, "Congratulations on the launch of NPU. The pharmaceutical bio industry is facing a reorganization of its organizational structure to improve innovation and productivity, he said. "I think trust between employees and companies is more important than anything else for companies to grow continuously and stably." There may be conflicts of interest between each subject, but we hope to establish a constructive relationship with the NPU," he said. The NPU is closely watching the reduction of personnel due to the recent reorganization at the global level. For example, Pfizer, which is in the process of reorganizing its sales department, is likely to implement additional Voluntary Early Retirement Programs. In addition, Novartis recently announced plans to reduce the number of people worldwide by integrating the organization at a global level. In addition to the overlapping number of people due to department integration, additional personnel reduction can be made in Korea. Chairman Ahn said, "The Voluntary Early Retirement Programs have been doing ERP due to a lack of trust that the union can protect itself, even though the subject has to be a worker. The NPU will try to gain confidence in its members that it can protect them."
- Company
- Byung-Jae Yoo to head integrated Novartis Korea
- by Eo, Yun-Ho Jul 08, 2022 06:25am
- General Manager Byung-Jae Yoo Byung-Jae Yoo (49) was appointed the head of the integrated Novartis Korea. Suhee Shin, General Manager of the Oncology Business Unit at Novartis submitted her resignation. According to industry sources, Novartis Korea has been integrating its Pharmaceuticals and Oncology Business Unit with the goal of completing the integration within the year. The company had been operating 2 business units independently under one name, but the two units have operated separate support departments, including marketing·sales as well as drug pricing·government relations·approval departments. In the integration process, the business units will be competing for the head position of each department. As Yoo was nominated as the head of the integrated business unit, how the structure of Novartis Korea would change remains to be seen. Novartis’s Asia-Pacific Region also appointed the former head of its Pharmaceutical Business Unit as Head of the integrated Novartis Asia-Pacific. Meanwhile, Yoo joined J&J in 2006 after completing his MBA at Harvard Business School through the company’s International Recruitment & Development Program. Since then, Yoo had held various roles in the company, including at North America’s Endovascular team, DePuy UK, and DePuy Australia. In Korea, he served at North Asia’s Cardiovascular Care Business Unit and was appointed the Managing Director of Johnson & Johnson North Asia to oversee Korea, Taiwan, and Hong Kong in 2017. In October last year, Yoo was appointed General Manager of Novartis Korea.
- Company
- Dong-A ST prepares to make another leap with Actonel
- by Eo, Yun-Ho Jul 07, 2022 05:55am
- Dong-A ST is attempting to make another leap with ‘Actonel,’ a bisphosphonate drug that is now sold exclusively by the company. According to industry sources, Dong-A ST has been working to land Sanofi’s bisphosphonate osteoporosis treatment Actonel (risedronate) at major medical institutions in Korea after it started to exclusively supply the drug in October last year. As of now, the drug has passed the drug committees (DCs) of 64 medical institutions including the ‘Big 5 tertiary hospitals’ of Korea - the Seoul National University Hospital, Seoul Asan Medical Center, Sinchon Severance Hospital, etc. Actonel, which is one of the representative bisphosphonate bone resorption inhibitors, has ruled the ranks in the Korean osteoporosis treatment market after its release in 2003, but then lost its share to new drugs such as Amgen’s ‘Prolia (denosumab).’ Therefore, what performance Dong-A ST will make with Actonel remains to be seen. With additional landings made, Actonel’s various strengths such as the 150mg formulation have been newly or additionally listed at hospitals. Sanofi discontinued the supply of its 5mg and 35mg strengths last year, and Dong-A ST plans to attract prescriptions while stabilizing the supply. Actonel has demonstrated its efficacy by reducing the relative risk reduction (RRR) of osteoporotic fractures and the risk of vertebral, hip, and nonvertebral fractures over its competitors from six months after intake. Meanwhile, Actonel EC 35mg is an enteric-coated tablet that can be taken once a week regardless of meal intake to treat osteoporosis in postmenopausal women. Actonel 150mg is taken 30 minutes before or 2 hours after meals monthly to treat osteoporosis in postmenopausal women.
- Company
- Two pharmaceutical unions unite with each other
- by Jul 07, 2022 05:54am
- NPU Launching CeremonyWith the birth of the nation's largest pharmaceutical industry union, the number of unions affiliated with the Federation of Korean Trade Unions in the pharmaceutical industry has increased to two. This includes corporate unions that have withdrawn from the existing industrial unions, drawing keen attention to the background. The NPU was launched on the 5th as an industrial union under the Federation of Korean Chemical Worker's Union (KCTU). The NPU has ▲ Novonodisc, ▲Bayer Korea, ▲Amgen Korea, ▲Ipsen Korea, ▲Novartis, ▲Viatris Korea, ▲Janssen, ▲Pfizer Pharmaceutical, ▲Sanofi Aventis Korea, ▲Alvogen Korea, ▲Opella Healthcare Korea, ▲Beringer Ingelheim, and ▲Hyundai. It is the largest union group in the pharmaceutical industry with a total number of 2,500 members. Among them, some corporate unions, including Novartis Korea, Merck Korea, AstraZeneca Korea, and Pfizer Korea, have belonged to the KDPU in the past. It is the first union in the pharmaceutical industry established in 2012 and is also affiliated with the Federation of Korean Chemical Workers' Union. With the introduction of new NPUs into existing KDPUs, two types have existed in the pharmaceutical industry. Some corporate unions that have been active in the KDPU left the union between 2019 and 2020, and formed an integrated promotion committee to devise a new coalition. On top of that, the current NPU started with the participation of unaffiliated unions. In the current KDPU, where some corporate unions have escaped, branches such as Allergan, Mundipharma, Zuellig Pharma Korea, and BMS Korea remain. NPU's first chairman, Ahn Deok-hwan, explained that the reason why he moved from the KDPU is "a difference in philosophy aimed at." It is interpreted that there was a difference of opinion with the existing executive in the process of preparing countermeasures for one agenda. It is understood that opinions will also be mixed in detailed operation plans. The new coalition considered a coalition that recognizes independence as each corporate union in the initial phase of the initiative. However, as the discussion materialized, it was judged that industrial unions were appropriate to increase bargaining power and legal recognition. Kang Seung-wook, secretary-general of the NPU, said, "As the discussion progressed, I chose the current industrial union because I thought acting as a coalition and acting as a industrial union were different." "As a pharmaceutical industry union, I am determined to do it properly," he explained. He also expressed his willingness to join forces with the KDPU. Chairman Ahn said, "Just as unions do not have to be one, I think various types of unions can compete or complement each other and produce better results." "We will be solidarity with the KDPU and help each other with what we need and have a complementary relationship," he said.
