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- 2026-04-14 13:28:25
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- ASCO 2021 preview: News drugs from Yuhan, Genexin, and Hanmi
- by An, Kyung-Jin May 21, 2021 05:27am
- ASCO 2019 학회 전경(자료: ASCO) The organizers of the 2021 ASCO Annual Meeting (ASCO 2021) released the accepted abstracts on the 19th (local time), two weeks ahead of the virtual event that will be held next month, from June 4-8. The ASCO meeting is considered one of the most important events for biopharmaceutical companies around the world in introducing the latest clinical data on anticancer drugs. Due to the COVID-19 pandemic, all schedules in the 5-day event, including its keynote lectures, poster sessions, and exhibitions will be held virtually, non-face-to-face, for the second consecutive year. The abstracts of Korean biopharmaceutical companies including Yuhan Corporation, Hanmi Pharmaceutical, MedPacto, and Genexin that have been developing new anticancer drugs have also been unveiled with the pre-release. Whether the long-awaited international event will be able to rekindle investors’ interest in the biopharmaceutical industry is drawing attention. At the event, the multinational pharmaceutical company Janssen will be presenting 2 studies on the combination of its EGFR/cMET dual antibody ‘amivantamab’ and Yuhan Corporation’s new drug ‘Leclaza (lasertinib).’ The abstracts are an update from the Phase 1b CHRYSALIS study that received much attention at the ESMO 2020 Meeting last year. The abstract focuses on the potential of the combination in overcoming the resistance issue of its competitor ‘Tagrisso (osimertinib).’ The study focused on delaying cancer progression through treatment with amivantamab in combination with Leclaza in patients with non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) exon 19 deletion or L858R mutations who have acquired resistance to Tagrisso. The study focused on analyzing the biomarkers while conducting genetic testing through next-generation sequencing (NGS) in circulating tumor DNA (ctDNA) to profile each patient’s tumor. If each patient’s response rate could be predicted in advance, this could maximize the response rate of the amivantamab and Leclaza combination therapy. Results showed that among the 45 patients whose disease had progressed on osimertinib that were administered 240mg of Leclaza and 1050mg or 1400mg of the amivantamab and Leclaza combination, the ORR(objective response rate) was 36% (95% CI, 22–51), with 1 patient showing complete response and 15 showing partial responses. Up to this, the data presented were similar to those presented at the ESMO 2020 last year. However, the investigators additionally presented an analysis of potential biomarkers of response. According to the analysis, 8 out of the 17 patients with EGFR and/or MET-based mutations – which is known to be the cause of resistance to Tagrisso – showed a confirmed tumor response. The median progression-free survival (PFS) of these patients was 6.7 months (3.4months- not reached). However, as some (8 patients) of the 18 patients who had unknown mechanisms of Tagrisso-resistance also showed a partial response to the regimen, grounds for its use as a biomarker was seen to be insufficient. 9 out of 10 Immunohistochemistry (IHC) high patients (90%) showed a high response rate to treatment, but the abstract determined that further investigation is warranted. More progressed data on the study will be shared at the oral abstract session for metastatic non-small cell lung cancer on the 5th, the second day of the meeting. The principal investigator of the Phase III LASER301 trial, Professor Byoung Chul Cho (Director of the Lung cancer center, Yonsei Cancer Center), will be presenting the session. Genexin released an abstract on the interim results of its Phase 2 clinical trial that evaluated the combination of its cervical cancer DNA vaccine 'GX-188E' with Merck(MSD)’s immunotherapy ‘Keytruda(pembrolizumab).’ The abstract contained results of the efficacy group of patients with late-stage recurrent or advanced HPV-positive (HPV-16 or HPV-18) cervical cancer. 5 of the 48 patients had a complete response (CR) where the target lesion completely disappeared, and 10 had a partial response (PR) where the target lesion was reduced by 30% or more. The objective response rate (ORR) was 31.3%. Subanalysis results showed that the ORR of patients with PD-L1 positive, HPV-16, and squamous cell carcinoma was highest, being 48%. The combination therapy showed an improved median PFS of 4.1 months, and OS of 16.7 months compared to Keytruda monotherapy. Most of the patients who experienced adverse events showed grade 1 or 2 adverse events, demonstrating that there were no safety issues concerning to the combination therapy. The details of the GX-188E and Keytruda combination will be introduced at the oral abstract session on the first day of the ASCO meeting, on the 4th (local time). MedPacto released the Phase 1b/2a trial results of ‘vactosertib’ (capecitabine)’ combined with ‘Keytruda’ in microsatellite stable (MSS) metastatic colorectal cancer (mCRC) patients. According to the abstract, 5 of the 33 patients enrolled in the trial reached PR, and the ORR was 15.2%. 7 patients had stable disease where the tumor did not grow further. Industry has seen that the study fully demonstrated the potential of vactosertib as a combination option in MSS mCRC as the response rate of Keytruda monotherapy is near 0% for the disease. Further clinical data on more patients and the OS data and doses will also be released in the final poster that will be released on the 4th (local time). Hanmi Pharmaceutical has released the latest update on ‘belvarafenib,’ which was licensed to Genentech. The results are from a Phase I trial of belvarafenib in combination with cobimetinib in patients with BRAF- and NRAS-mutant melanoma. The abstract shows further progress that had been made since the last presentation at the 2019 ASCO meeting. According to the abstract, 5 of the 13 NRAS-mutant melanoma patients reached PR, giving an ORR of 38.5%. Currently, no approved standard of care exists for NRAS-mutant melanoma. According to clinicaltrials.gov, a clinical trial registration website operated by the U.S. National Institute of Health (NIH), Genentech had recently registered a new global Phase I clinical trial on belvarafenib. The Phase 1b study will evaluate the safety, pharmacokinetics, and activity of belvarafenib as a single agent and in combination with either ‘Cotelic (cobimetinib) or Cotelic plus ‘Tecentriq (atezolizumab)’ in patients with NRAS-mutant advanced melanoma who have previously received anti-PD-1/PD-L1 therapy. As this is the first clinical trial initiated for a belvarfenib combination therapy by Genetech in 5 years since singing the technology transfer deal with Hanmi Pharmaceutical, concerns over the deal cancellation have been said to be resolved. Analysts predict that if the three-dug combo including belvarafenib shows a superior response rate over ‘Zelboraf,’ the new drug’s value may increase additionally.
- Policy
- Samsung & Pfizer compete in Avastin biosimilar market
- by Lee, Tak-Sun May 21, 2021 05:26am
- Samsung Bioepis and Pfizer will compete in the domestic market for anti-cancer drug Avastin (Bevacizumab, Roche Korea). There will be a rare competition between domestic companies and global companies over generics. The MFDS approved Jairabeve of Pfizer Korea on the 18th. Jairabeve (Bevacizumab) is biosimilar for Avastin in Roche, Korea. Equivalence between Jairabeve and Avastin has been demonstrated. Clinical trials were conducted to assess the equivalence of drug in a total of 388 patients with progressive or metastatic non-small cell lung cancer with healthy adult male volunteers, demonstrating statistical equivalence. Avastin recorded sales of ₩118 billion in South Korea last year. It is ranked third in sales. It is used for metastatic direct connective bowel cancer, metastatic breast cancer, non-small cell lung cancer, progressive or metastatic kidney cell cancer, glioblastoma, epithelial ovarian cancer, ovarian or primary peritoneal cancer, and cervical cancer. Earlier in March, Samsung Bioepis was first licensed for biosimilar for Onbevey in Korea. Onbevey is not yet on the list. Industries predict that the two drugs will compete in the second half of this year. As Samsung Bioepis has been targeting the domestic market in partnership with large domestic pharmaceutical companies such as Yuhan and Daewoong , chances are high that it will form partnerships with domestic pharmaceutical companies again this time. Pfizer has a well-established distribution network for large hospitals in Korea, so the release of biosimilar will also affect Roche's Avastin, the original drug. In the biosimilar market, not only Samsung Bioepis and Celltrion but also global pharmaceutical companies are releasing products one after another, which is expected to compete with domestic pharmaceutical companies.
- Company
- Tylenol is in short supply for a long time
- by Kim, Jin-Gu May 21, 2021 05:26am
- Along with the issue of side effects of COVID-19 vaccines in pharmacies, the shortage of Tylenol is intensifying. Domestic companies with generic products are expecting reflective profits. Several companies are said to have started marketing related to Tylenol shortages so that they can lead to increased sales of other generics of acetaminophen. Tylenol According to the pharmaceutical industry on the 14th, Tylenol has become more scarce in outpatient pharmacies over the past month. In the case of Tylenol and Tylenol 8-hour ER, it is confirmed that they are completely out of stock at online malls exclusively for major pharmacies. Analysts say that the issue of side effects of COVID-19 vaccine and the government's guidance have caused a shortage. As the number of people vaccinated against COVID-19 increased, the side effects of fever and muscle pain increased, and more people wanted to buy Tylenol. In addition, the quarantine authorities guided, "If fever occurs after vaccination, it is recommended to take fever reducer such as Tylenol," and most pharmacies are now unable to find Tylenol. Pharmacists are recommending generic products instead of original Tylenol. A pharmacist who runs a pharmacy in Seoul said, "The number of people looking for Tylenol has more than doubled than usual," adding, "We recommend generics because Tylenol is not available." "If the number of people vaccinated against COVID-19 increases in the future, sales of generic products will increase." Another pharmacist in Daejeon said, "We're barely getting Tylenol. I think it's been about a month. Wholesale stores offer limited supplies to each pharmacy. If generics are recommended, one to two out of 10 people buy the drug." As the shortage of Tylenol intensifies, its effects are gradually expanding to other generics. Sales of Samjin's Geworin, Jong Kun Dang's PENZAL-Q, Dong-A's Panpyrin, and Daewoong's EZN6 Ace, which include the same ingredients as Tylenol, are reportedly increasing little by little. Geworin Cooldown Korean companies are also starting related marketing in line with this trend. Emphasizing that it is the generics for those who have not obtained Tylenol, it is necessary to prepare for the possibility of side effects after vaccination. In the case of Geworin, sales volume is said to have increased slightly last month due to the issue of side effects of vaccines. "We are pushing for Geworin Cooldown as a product to prepare for side effects of the vaccine," said a representative for Samjin. "It is true that sales have increased compared to the past." "In the case of Geworin Cooldown, the number of new businesses is increasing just after its release. "We understand the impact of this, the issue of side effects of vaccines, and the result of marketing." An official from Dong-A said, "Panpyrin's sales have increased a little compared to last year," adding, "However, it is too much to blame only the issue of side effects of vaccines." "It's Acetaminophen, but it's more widely known as a cold medicine than a pain reliever. "In case of PENZAL, there is little change in sales compared to the past," said a representative for Chong Kun Dang. "There is a possibility that sales will increase as the number of people vaccinated against COVID-19 increases."
- InterView
- IQVIA provides a total solution based on big data
- by Eo, Yun-Ho May 20, 2021 05:41pm
- CEO Jeong Su-Yong IQVIA(CRO Quintiles & IMS Healths) is much bigger than before. In addition to simply providing clinical referral and sales data, IQVIA includes development, release, and subsequent marketing and Rx management. IQVIA Korea, a so-called 'Human Data Science Company', recently acquired CoreZetta, a sample big data analysis company of the HIRA, and MMK Communications, a healthcare marketing company, to upgrade the reliability and service area of the data. The number of executives and employees of Korean subsidiaries has already surpassed 780. Dailypharm met with CEO Jeong Su-Yong (48 yrs old), who has been leading IQVIA Korea since 2017, and heard about IQVIA's vision and strategy. - About five years have passed since the merger of Quintiles and IMS. What has been the change? The most noticeable change is the diversity of IQVIA customers. In the past, if it was a global clinical trial and market data and analysis business with multinational pharmaceutical companies, domestic pharmaceutical companies, biotech, investment companies such as medical devices and venture capital, consumer companies, private insurers, governments, hospitals, and wholesalers. Last year alone, it has expanded its ties with more than 100 companies as customers and partners. Specifically, the role of helping Korean customers globalize (strategies for overseas expansion, providing overseas market data and insights, supporting overseas clinical, commercialization, and selecting overseas partners) is growing. Companies that enter overseas markets need people by connecting overseas workers with a high understanding of the regulatory environment in overseas markets, and it supports related consulting and advice services. - It is also notable that it has acquired two domestic companies. As far as I know, it was led by a Korean corporation. Yes, IQVIA's Korean subsidiary is continuing its efforts to specialize in the domestic market. First, CoreZetta is a company that analyzes data from the HIRA. The HIRA's data are assets of our country with the NHIS system, but it is important how they can be analyzed and shown well. The cycle is slow and limited, and if it is supplemented with the advantages of IQVIA data, it will be possible to create new insights. Last month, it acquired MMK Communications, which provides medical communication and marketing, digital detailing, and nurse counseling services. Due to the COVID-19 situation, the need for digital detailing has increased and the importance of medical information contents has increased. It is trying to develop the data that doctors need and provide major contents in accordance with the Korean regulatory situation. IQVIA is a total healthcare solution company. -Due to the nature of acquisition companies, services to attract domestic customers are drawing attention. Recently, interest in the domestic biopharmaceutical industry has been increasing, how is it viewed by global consulting firms? I think we should look at it from an overall infrastructure perspective rather than from a technical or scientific perspective. It is possible and necessary to grow a step in line with the capital market's interest in the pharmaceutical bio market and the size of investment. This requires the technological superiority of individual companies, the establishment of an ecosystem for feasible growth, or globalization as much as the performance of each project. Domestic biotech and venture companies grow through investment, and IPO is almost the only way to recover investment in Korea. That is why there is a limit to the recovery market. I think there is a limit to growth in the domestic market alone. It is also important to have a competitive pharmaceutical company that can lead large projects. This seems to require a large merger within the pharmaceutical bio industry. Cases of expansion in overseas markets such as Celltrion's acquisition of Takeda and SK's acquisition of global CMO will have positive results. - Are you trying to combine 'big data' with diversified services? The importance of big data is essential for the development of healthcare industries. Clinical trials are essential for the pharmaceutical industry, but they have to take huge amounts of capital and high risks. However, we expect Real World Data to be able to convert substantially efficiently. South Korea's pharmaceutical industry still lacks large capital capacity. I think data is the driving force behind the growth of these conditions. If it wisely uses it while dispeling concerns about personal information leakage, IQVIA can do this, thinking it could be a big opportunity for the development of the domestic pharmaceutical industry. In addition to managing the risk of data, it is necessary to balance and develop the benefits that real data can give.
- Policy
- GSK’s dutasteride+tamsulosin combo finally enters Korea
- by Lee, Tak-Sun May 20, 2021 05:57am
- GSK will be introducing its fixed-dose ‘Avodart(dutasteride)’ and tamsulosin combination for the treatment of prostatic hyperplasia for the first time in Korea. The domestic approval has come 10 years after the approval by EMA and FDA. Considering that the combined prescription of the abovementioned two drugs is common in the prostatic hyperplasia treatment market, whether the introduction of this combination drug will change the market structure is the focus of interest. The Ministry of Food and Drug Safety (MFDS) granted GSK’s ‘Duodart capsule’ marketing approval on the 18th. Duodart capsule is a fixed-dose combination of dutasteride and tamsulosin used for the treatment of moderate-to-severe symptoms of Benign Prostatic Hyperplasia (BPH). The recommended dose of Duodart is one capsule taken orally approximately 30 minutes after the same meal each day. Duodart is a combination of two drugs - dutasteride, a dual 5α-reductase inhibitor (5-ARI), and tamsulosin hydrochloride, an antagonist of α1a-adrenoreceptors - with complementary mechanisms of action to improve symptoms in patients with benign prostatic hyperplasia (BPH). In a 4-year clinical trial of 4,844 men with BPH (the CombAT study), the group that was co-administered with dutasteride-tamsulosin showed superior symptom improvement over monotherapy of either drug at year 2. Based on the results, EMA had approved the drug in April 2010, and the FDA in June 2010. In other words, the Duodart cap, is being approved in Korea 10 years after being approved by leading authorities abroad. Also, the MFDS assigned a re-examination period for Duodart capsule until May 17th, 2027. During the re-examination period, generics made with the same ingredient cannot enter the market. Companies in Korea have also been working hard to develop a combination treatment for prostatic hyperplasia, but no products have been commercialized so far. Chong Kun Dang is conducting a Phase III trial on its tamsulosin+tadalafil combination, and Dongkook Pharmaceuticals’s dutasteride+tadalafil combination has also entered a Phase III trial. Also, Ildong Pharmaceutical and Jeil Pharmaceutical has completed the clinical trial for their tamsulosin+solifenacin combination. More recently, Dongkoo Bio&Pharma and KyungDong Pharm have entered a Phase III trial to develop their tamsulosin+mirabegron combination. However, perhaps due to GSK’s early success with the dutasteride and tamsulosin combination in 2010, the same combination has not been studied in Korea. Hanmi Pharmaceutical had received export approval for the same combination in 2017 but withdrew the approval in August last year. Pharmaceutical companies have been keen to develop a combination drug since a high proportion of patients use two drugs in combination for the treatment of prostatic hyperplasia. In particular, prescription of the tamsulosin and dutasteride combination is very common in the field, drawing more attention to the approval of GSK’s combination drug. The market for prostatic hyperplasia treatment is estimated to be around 400 billion won. Currently, Astellas has a strong influence over the market as it owns the original drugs such as tamsulosin, etc. Whether GSK will rise as the new dark horse with its combination drug is receiving much interest. Meanwhile, GSK’s dutasteride is also indicated for the treatment of hair loss among men in addition to symptomatic benign prostatic hyperplasia.
- Policy
- Generic for Madopar by Myungin was first licensed
- by Lee, Tak-Sun May 20, 2021 05:56am
- Madopar (Benserazide HCl/Levodopa) by Roche is the treatment for Parkinson's syndrome, and the generic was approved in Korea. Myungin, which is drawing attention in related markets for Perkin and Trilevo, is expected to expand its sales with the joining of generic for Madopar . The MFDS approved Myungdopar by Myungin on the 14th. Myungdopar is a drug used in Parkinson's syndrome that is generic for Roche's Madopar. It is the first generic to be introduced in Korea. After receiving approval for the first biological equivalence test plan in May 2019, Myungin began developing generic for Madopar . A single oral administration of Myungdopar to healthy adults was conducted to measure Levodopa in the blood of 57 people, demonstrating that the mean 90% confidence interval with Madopar was biological equivalent from log 0.8 to log 1.25. Madopar is a combination of dopamine precursors Levodopa and Benserazide. Levodopa reaches the brain region and increases dopamine levels. It is also a drug with Benserazide added to help sufficient amounts of Levodopa leap into the brain. This treats symptoms associated with Parkinson's disease dance and tonic. Madopar recorded ₩9 billion in outpatient Rx (UBIST) last year, ranking second after Lundbeck's Azilect (₩9.9 billion) among Parkinson's disease treatments. Myungin stands out in the treatment of Parkinson's disease as a generic company. Myungin has several treatments for Parkinson's disease, including Trilevo (generic for Stalevo) and Perkin (generic for Sinemet). Trilevo was ranked No. 1 in the generic market with ₩6 billion last year, while Perkin was ranked No. 3 with ₩3.6 billion. Rasalin, the No. 1 product in the market, was also released last year. Myungdopar, first generic for Madopar, is expected to serve as a new opportunity for Parkinson's disease treatment market.
- Company
- Zopista for insomnia to be prescribed at general hospitals
- by Eo, Yun-Ho May 20, 2021 05:56am
- The insomnia treatment ‘Zopista,’ which can be prescribed long-term, is now cleared for prescription at general hospitals. According to industry officials, Huons’ Zopista(eszopiclone) passed the Drug Committees (DCs) of the Big-5s - Seoul National University Hospital (SNUH), Asan Medical Center (AMC), Seoul St. Mary’s Hospital, Samsung Medical Center (SMC), and Severance Hospital – and many other major medical institutions in the nation. Zopista was first introduced in Korea along with its reimbursement approval in November 2019. However, as the drug has been prescribed in the U.S. since 2004, its generics have also soon entered the Korean market, expanding the competition. With no domestic patent or Post Market Surveillance (PMS) period set for the drug, there was no way for the company to deter or block the entrance of its generics. However, with Huons successfully landing its product in general hospitals, whether Zolpidem can maintain its share in the market as the leading product remains to be seen. Contrary to other existing insomnia treatments like ‘Zolpidem,’ Zopista can be used long-term. In case of Zolpidem, its long-term use is not recommended, and the treatment period is regulated to not exceed 4 weeks. However, according to a survey by the Health Insurance Review and Assessment Service, insomnia is a common condition that 1 out of 3 adults in Korea experience, with its market rapidly growing as the number of insomnia patients rose 48.3% from 2013 to 2017. Considering that a relatively small number of patients currently receive treatment for insomnia due to low recognition of the disease, the potential for growth in the market is high.
- Company
- Piqray has been released in Korea
- by May 20, 2021 05:56am
- The first new drug targeting the PIK3 gene in breast cancer has been released in Korea. The MFDS approved Piqray (Alpelisib/50·150·200 mg' by Novartis on the 13th. Piqray is HR- (+)/HER2 (-) and may be combined with the endocrine treatment Faslodex (Fulvestrant) in postmenopausal women and men with progressive or metastatic breast cancer. PIK3CA positive diagnostic tests are evaluated using in vitro diagnostic medical devices licensed by the MFDS. It is the first domestic PIK3 inhibitor. It also obtained permission from the U.S. and Europe in May 2019 and July 2020, respectively. PIK3CA genetic variation is known to be a common pattern in about 40% of patients with HR+/HER2- breast cancer. Sporadic genetic mutations can mutate independently of family history. If PIK3CA mutations are latent, they can lead to cancer proliferation as well as resistance to endocrine therapy and poor prognosis. In a three-phase SOLAR-1 study conducted by Novartis, Piqray and Fulvestrant combined therapy approximately doubled the primary evaluation variable, Progressive Survival Period (PFS). The median survival period for the combined therapy group was 11.0 months and 5.7 months for the sole therapy group. Overall response rate (ORR), an indicator of the proportion of patients who experience at least a 30% reduction in overall tumor size (in patients with measurable disease), was more than doubled when Piqray was added to Fulvestrant in patients with a PIK3CA mutation, (ORR= 35.7% vs 16.2% for fulvestrant alone, p=0.0002). There was a clinically relevant improvement in OS of eight months for patients with a PIK3CA mutation taking Piqray plus Fulvestrant compared to Fulvestrant alone (median OS 39.3 months vs. 31.4 months). This difference did not reach the prespecified threshold of statistical significance set for the secondary objective of OS in patients with PIK3CA-mutated breast cancer. In terms of safety, most of them were mildly reactive, which can be managed by dose control, and the rate that led to discontinuation of medication was similar to that of the sole therapy group. However, during the administration period, patients may experience severe skin irritation due to drugs, which requires management. The MFDS recommended that Piqray be stopped if the skin is more than 30% toxic to the body surface. As the first PIK3CA-targeted treatment that can meet unmet demand has crossed the licensing threshold, attention is expected to be focused on whether to be reimbursed for combined therapy.
- Company
- IQVIA acquires Korean healthcare marketing firm MMK
- by Eo, Yun-Ho May 18, 2021 05:52am
- The healthcare big data company IQVIA has acquired MMK Communications. Industry sources said that IQVIA Korea had completed the merger and acquisition of MMK communications, expanding its business area to digital consulting services. MMK Communications is a company that provides digital detailing services including webinars and call center medication counseling services with nurses. It has been providing customized services in the COVID-19 pandemic during which the need for non-face-to-face communication had been rising. Through the M&A, IQVIA plans to transform into a comprehensive healthcare service provider that offers a wide range of services from Contract Research Organization (CRO) to healthcare data analytics. In 2019, the company had acquired CoreZetta, a firm that analyzes big data provided by the Health Insurance Review and Assessment Service (HIRA). After a merger between IMS Health and Quintiles, the company adopted the new name of IQVIA in 2017. Powered by IQVIA CORE, IQVIA provides customized solutions for its clients leveraging the world’s largest curated healthcare information source, advanced analytics, leading technologies, and extensive industry knowledge across diseases, geographies, and scientific methods.
- Policy
- Generic exclusivity of Alicoxib has been extended by one mon
- by Lee, Tak-Sun May 18, 2021 05:52am
- Korea Arlico PharmArlico Pharm's "Alicoxib," which acquired generic exclusivity, has been extended for one month. The MFDS allowed the application for extension in consideration of the listing period. According to the MFDS on the 17th, Alicoxib will be guaranteed exclusive rights until January 30 next year. It was extended by about a month from December 25. The entry period for the same ingredient was postponed by one month. This is because when generic exclusivity is acquired, products of the same active ingredient are not allowed to enter within 9 months. The MFDS grants a nine-month effective period, but if sales are delayed within the effective period due to registration, it is extending the period at the request of pharmaceutical companies. Alicoxib has been effective since March 26, but it was not until May 1. However, the generic exclusivity item has a registration period of two months after the application month, which is shorter than 3 months. Arlico Pharm also produces three other ingredients in addition to Alicoxib. They also acquired a generic exclusivity. In addition, six other pharmaceutical products also received generic exclusivity. They are also expected to extend the generic exclusivity period. Alicoxib (Etoricoxib) is a COX-2 inhibitor that, unlike non-selective NSAID (COX-1), selectively inhibits COX-2 induced by inflammatory reactions to relieve pain, and does not inhibit COX-1, which is associated with GIl complications. The original is MSD's Arcoxia, and recorded ₩1.7 billion (based on UBIST) in sales of outpatient Rx last year.
