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- 2026-05-07 14:20:52
- Policy
- When will domestic COVID-19 Txs be officially approved?
- by Lee, Hye-Kyung Aug 08, 2023 05:30am
- Voices calling for the approval of domestic COVID-19 treatments are rising. Petitions and heated discussions are being made on the free bulletin board of the Ministry of Food and Drug Safety’s website for the marketing authorization and accelerated review of homegrown COVID-19 treatments. The items that are receiving attention on the yay or nay of approvals are Ildong Pharmaceutical’s ‘Xocova (ensitrelvir)’ and Hyundai Bioscience’s ‘Xafty.’ Xocova was developed by Japan’s Shionogi Pharmaceutical. Ildong Pharmaceutical conducted a domestic clinical trial for the drug. The drug was unable to receive EUA in Korea last year, and the company applied for official marketing authorization for the drug in January this year. However, 8 months have passed and the drug has not even been designated as a subject for expedited review until now. On this, an MFDS official said, "It is difficult to disclose specifics on why a certain drug’s EUA review is being delayed. In some cases, the pharmaceutical company is unable to make follow-up measures after the MFDS gives feedback like insufficient supplementary data after primary review. The reason may differ by individual drug.” In the case of Xafty, a new drug candidate for COVID-19, Hyundai Bioscience submitted the results of its Phase II trial on Xafty to the Korea Disease Control and Prevention Agency in April to request emergency use approval. According to Hyundai Bioscience, in a Phase II trial conducted on 300 patients, Xafty reduced the time to improvement of COVID-19 symptoms by 4 days compared with the placebo. In particular, the company stressed that niclosamide, the main active ingredient of Xafty, has a verified profile as it has been used as an insect repellent for 60 years around the world. Xocova applied for marketing authorization in January and and Xafty for EUA in April. With their results still unknown, voices urging for results have been rising through public petitions and MFDS’s online bulletin board. One person said, “It has been 6 months since Xocova applied for approval, and 3 months since the start of the EUA review for Xafty has started. Why hasn’t the government decided upon their approval or non-approval still? We’re talking about the same authorities that approved Paxlovid in only 7 days.” Another person wrote, "3 months have passed since the drug’s Phase II trial was completed, and the drug has not been granted the EUA still. This is contrary to the purpose of granting EUAs.” Another added, "It is ironic that we seek to become a pharmaceutical powerhouse with pharmaceutical sovereignty in this state. What is the reason for the delay in approval?”
- Company
- Chong Kun Dang/Cell Biotech, big match in the MicrobiomeCDMO
- by Nho, Byung Chul Aug 08, 2023 05:30am
- It is expected that CKD Bio and Cell Biotech will compete to expand the related market in the microbiome drug CDMO (Contract Development Manufacturing) field. According to the Korea Institute of Science and Technology Information, the global market for human microbiome is expected to reach 1,743.8 billion won in 2029 with a rapid average annual growth rate of 31% from the current 343.4 billion. The size of the domestic market is expected to grow from 8 billion won last year to 48 percent annually, reaching 25.9 billion won in 2029. Chong Kun Dang Bio was the first to identify the blue ocean potential and set out to preoccupy the market. CKD Bio continues to invest in clinical trials and commercialization of various microbiome treatments based on its microorganism-related R&D and manufacturing capabilities accumulated over the past 50 years. CKD Bio is believed to have signed a business agreement with KoBioLabs in 2015 for microbiome research and customized probiotics development and is developing and producing therapeutics to be used in preclinical microbiome trials. CKD Bio has been developing probiotics products, such as acquiring a patent for a culture technology that increases the stability of lactic acid bacteria in March 2016. In November of last year, it signed a CDMO contract with Bifido, an Amicogen affiliate, for BFD1R, a candidate for rheumatoid arthritis microbiome treatment. Candidate substance strain BFD1R is a new concept treatment that can treat rheumatoid arthritis by controlling the abnormal immune function of patients with rheumatoid arthritis and is securing indications related to various autoimmune diseases (Sjogren's syndrome, lupus, ankylosing spondylitis, etc.). Cell Biotech, which has 28 years of research know-how, entered into the CDMO business in earnest by signing a business agreement with Biomi last month to develop and commercialize microbiome-based microbial treatments. Joint projects are broadly classified into various forms of cooperation for the development of new microbiome drugs, such as ▲ manufacturing and quality control tests for clinical trials,▲ sharing materials for microbial treatment, ▲ and sharing experiences for IND approval. Based on its multistrain technology, BioMe has five new drug development pipelines, including BM111, an antibiotic-resistant bacterial infection treatment, and BM109, a cardiovascular disease treatment. Cell Biotech is developing PP-P8, a colorectal cancer treatment, based on its expertise in researching various functionalities of Korean lactic acid bacteria. Cell Biotech, in particular, invests around 10% of its sales in R&D every year and is actively developing new drugs. In the meantime, Cell Biotech has been hinting at a strategy to preoccupy the CDMO business of domestic microbiome-related pharmaceutical strains, such as securing strain mass production technology and directly constructing a biologic drug factory to directly supply new drugs necessary for clinical trials.
- Company
- Union Korea Pharm agrees to export 8 drugs to Jurabek
- by Lee, Seok-Jun Aug 08, 2023 05:30am
- Union Korea Pharm signed an agreement to export 8 types of drugs with its Uzbekistan partner, Jurabek Laboratories. According to the company on the 7th, the 8 export items include the company’s representative antibiotics and injections such as Atrasen Tab, Serokfen Tab, Uni-Minoxidil Tab, Atorvan Tab, Kefodon Inj, and Amikacin Inj. The local pharmaceutical company, Jurabek Laboratories, will bear the product registration and marketing costs in Uzbekistan. Jurabek plans to expand sales to neighboring countries in Central Asia (Kazakhstan, Tajikistan, Turkmenistan, etc.). in the future. Union Korea Pharm established a joint venture with Jurabek in May last year. Due to the time required to establish the plant and manufacturing facilities, the companies decided to cooperate by exporting drugs produced in Korea first. The 8 items exported this time are a part of the agreement. Byung Ha Back, President and CEO of Union Korea Pharm, said, “We will increase our presence in the global market based on the excellent quality of our products that are recognized around the world.” Union Korea Pharm achieved a surplus for the first time in three years last year, powered by increased sales of its antibiotics and cold medicines and improved profits and losses structure due to the normalization of utilization rates of its new plant. The company’s total sales exceeded KRW 60 billion for the first time. Analysts predict that the new plant (Munmak Plant 2) that the company invested KRW 30 billion on will drive the company’s performance in the future. The Munmak Plant 2 has secured 2.5 times the production capacity of Plant 1 and owns two lines for injection manufacturing (30 million ampules/year) and one line for solid drugs (500 million tablets/year). After receiving GMP certification in 2H 2021, the company has been increasing the plant’s utilization rate since 2022. More than KRW 100 billion in new sales could be generated when the second plant is fully operated. As of the end of last year, the plant's utilization rate was 80%. At the end of Q1 this year, the rate rose to 85%, and the rate is expected to rise to 90% by the end of this year.
- Company
- Immuno-anticancer drugs have brought us closer
- by Jung, Sae-Im Aug 08, 2023 05:30am
- Product photos of Opdivo (left) and Keytruda Immuno-anticancer agents are active in early lung cancer. Following 'Opdivo (Nivolumab),' which obtained the indication for adjuvant therapy before surgery for the first time, 'Keytruda (Pembrolizumab)' is also seeking to expand its scope as adjuvant therapy before and after surgery. The data shown by immuno-anticancer drugs in early lung cancer were surprising. When chemotherapy and CCRT were used, 'pCR', which was seen in 1 or 2 out of 100 patients, increased more than 10 times. In the case of Opdivo, a pCR of 24% was recorded in CheckMate-816 phase 3, significantly improving the 2.2% of the chemotherapy alone group. At 3 years, EFS was 57%, exceeding the control group's 43%. Keytruda also had an event-free survival rate of 62.4% at 2 years, which was significantly higher than that of the control group, 40.6%. The mPR and pCR ratios were 30.2% and 18.1%, respectively, demonstrating a greater improvement than the control group of 11% and 4%. Lee Se-hoon, a professor of hemato-oncology at Samsung Seoul Hospital, said in a recent interview with Daily Pharm, "If Opdivo caused a 'frenzy' as an adjuvant therapy before surgery, Keytruda gave the answer that it is helpful for patients to use immuno-oncology for a certain period after surgery." “We are now able to take a step closer to the goal of complete cure with immuno-oncology,” he said. Lee Se-hoon, professor at Samsung Seoul Hospital The effects of immuno-anticancer drugs shown in clinical trials are being reproduced in the actual field. Professor Lee explained, "When Gefitinib, the first EGFR-targeted anti-cancer drug, came out as a fellow in the past, I was very surprised that the prognosis of patients improved significantly. I am feeling the emotions I felt then once again as I look at adjuvant therapy before and after immuno-anticancer drug surgery." He said, "The professors of the Department of Pathology were also surprised to see that there were so many 'cancer-free' cases when they did a PET scan after immuno-anticancer treatment. Not only did the pathological CR increase, but I felt that the overall response improved." If Opdivo showed significant improvement in adjuvant therapy before surgery for the first time, Keytruda could improve the prognosis even for patients who have not reached complete pathological remission if they use immuno-anticancer drugs for one more year as adjuvant therapy after surgery. Proven. While the Opdivo study used only adjuvant therapy before surgery and there was no follow-up treatment after surgery, Keytruda's KEYNOTE-671 study used up to 4 cycles of Keytruda + chemotherapy on patients before surgery and performed Keytruda alone after surgery. The design was designed to use up to 13 cycles of therapy. Opdivo EFS and pathological pCR data (source BMS) As a result of analyzing EFS, the primary endpoint, according to pathological complete remission status, EFS improved regardless of whether or not complete remission was achieved. Patients who did not achieve pCR by administering immuno-anticancer drugs before surgery and administered Keytruda after surgery reduced the risk of disease recurrence, progression, or death by 31% compared to the control group. Professor Lee said, "I knew that immunotherapy before surgery would be of great help from the Opdivo study, but there was no answer for postoperative treatment. Because the clinical design was designed to use Opdivo only as an adjuvant therapy before surgery, Treatment was a situation where clinicians had to take care of themselves, so everyone was interested in how to treat patients who did not achieve complete remission.” The Keytruda study provided answers to questions raised in the clinical field. Professor Lee said, “I was convinced through the KEYNOTE-671 study that the use of immuno-anticancer drugs after surgery is helpful even in the group that did not show pCR,” and “If you look at the EFS graph, the group that did not achieve pCR used Keytruda. You can see that the graph is clearly wider than the group that did nothing." EFS trend following pathological complete remission with Keytruda (data ASCO) There are many aspects to be discussed about adjuvant therapy before and after surgery of immuno-anticancer drugs that have just begun to be used in the field. Representative examples include use in patients with major mutations such as EGFR and ALK, and screening of patients who may experience difficulty in surgery with little improvement when using immuno-anticancer drugs before surgery. However, he said, it is self-evident that immuno-anticancer drugs are being used for early lung cancer and are getting closer to the goal of a complete cure. Professor Lee said, "The title of the 'ASCO' session, which included the KEYNOTE-671 research presentation, was 'The Promise of Neoadjuvant Immunotherapy Across Solid Tumors'. As in the usual case, this study was not included in the lung cancer session. Here, preoperative adjuvant immunotherapy for lung cancer You can notice the meaning of therapy. It means that immuno-anticancer drugs have begun to actively intervene in the goal of complete recovery with adjuvant therapy before surgery. I am happy to think that it has shown a major change in the cancer treatment paradigm."
- Policy
- The price of 6 items of Choline alfoscerate is cut
- by Lee, Tak-Sun Aug 08, 2023 05:30am
- Despite the government's decision to limit reimbursement, the brain function-improving drug Choline Alfoscerate continues to come out with price cuts due to increased usage. It was found that 6 Choline Alfoscerate items were included in the PVA type Da negotiations this year as well. According to the industry on the 7th, negotiations were conducted as Gliatamin drugs such as Gliatamin were included in the Type Da target this year. Choline Alfoscerate ingredient items that have been negotiated are Ahn-gook Kanoa Soft Cap., Korea Prime Pharmaceuticals Gria Soft, Daewoong Bio Gliatamine Soft Cap, and Gliatamine. They negotiated for the number of claims in 2022 to exceed the PVA Type Da standard. Criteria for each type is when the claim amount for the calculated drug increased by 60% or more from the previous year's claim amount or increased by 10% or more and the increase amount was 5 billion won or more. In the case of Ahn-gook Kanoa, the number of outpatient prescriptions based on UBIST was 6.8 billion won in 2022, up 68% from the previous year, Korea Prime Pharm. Gria’s sales were 29 billion won, up 17% from the previous year, and Daewoong Bio Gliatamin’s sales increased by 5% to 115.6 billion won. Kanoa and Gliatamine had their drug prices reduced last year as PVA. The use of Choline alfoscerate continues to increase despite the decision to reduce benefits in 2020. In September 2020, the government decided to allow reimbursement for Choline Alfoscerate drugs only for dementia patients and apply selective reimbursement by applying 80% patient copayment for the remaining indications. Specifically, 'secondary symptoms and degenerative or degenerative brain organic mental syndrome due to cerebrovascular defects: memory loss and confusion, disorientation due to decreased motivation and spontaneity, decreased motivation and spontaneity, and decreased concentration' in patients diagnosed with dementia It was agreed that reimbursement would be recognized for administration and 80% patient copayment would be applied to prescriptions other than the accreditation standards. The implementation has been suspended as related pharmaceutical companies filed lawsuits for suspension of execution and cancellation of benefit reduction. Since then, even the indications have been reduced in the process of clinical re-evaluation planning, but the amount of prescriptions in the field has not decreased. Even last year, the Choline Alfoscerate preparation Chongkundang Gliatirin Soft Cap. 10 items, including original drugs, were included in the PVA target, and the drug price was reduced.
- Company
- ‘Competitors eye Eylea due to its many benefits’
- by Jung, Sae-Im Aug 08, 2023 05:30am
- The fact that many companies are concentrating on the development of Eylea biosimilars is proof of the many advantages owned by Eylea. We plan to continue to make known the strengths of Eylea while developing new products to continue to deliver on our patient and HCP-centric treatment strategy.” Sangok Suh, Head of the Specialty Medicine business unit at Bayer Korea said so regarding Eylea’s off-patent strategy during an interview with DailyPharm. Sangok Suh, Specialty Medicine BU Head, Bayer Korea The anti-VEGF inhibitor Eylea is regarded as the long-standing powerhouse in the field of macular degeneration. The drug has been solidifying its lead in the market ever since it was approved in Korea in 2013. According to the market research institution IQVIA, Eylea’s annual sales reached KRW 80.4 billion last year. This is a 14% increase over the previous year. Even in the 10th year of approval, the drug has been showing off its unwavering potential, recording double-digit growth. However, like all other new drugs, Eylea is also facing challenges from competitors. This year, the first new bispecific antibody drug for macular degeneration, ‘Vabysmo’, was introduced to Korea, and the domestic patent for Eylea is set to expire in January 2024. Although no direct competition has been made between the two, changes are expected to arise at the end of the year. Vabysmo received conditional approval from the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee in July. The committee deemed the drug’s reimbursement adequate if the company accepted a price lower than the evaluated price. Therefore, if the drug pricing negotiations progress without issues, the drug is expected to be listed in 2H this year. In addition, domestic pharmaceutical and bio companies have been applying for the approval of their biosimilars that target Eylea’s patent expiry. Celltrion, Samsung Bioepis, Sam Chun Dang Pharm, and Alteogen are nearly at the end of developing their Eylea biosimilars. The imminent challenges are set to inevitably complicate the marketing strategy for Eylea. In this changing environment, Suh expressed her determination to stick to the basics. Suh plans to further appeal to the strengths of Eylea, the drug that had established the T&E(Treat&Extend) treatment regimen as a standard treatment in the field of macular degeneration. Eylea was the first drug that allowed patients to adjust their treatment interval according to the patient's condition using the T&E regimen. Suh said, “Eylea has been at the forefront of change in macular degeneration treatment trends over the past 10 years. It has contributed to establishing anti-VEGF treatment as the standard of care and established a personalized treatment environment for patients by demonstrating the efficacy of flexible injection intervals. We wanted to raise awareness of the disease itself break the ‘'macular degeneration leads to blindness’ formula, and create an environment where patients receive early treatment for the disease.” As the representative macular degeneration treatment, Eylea has shown steady growth in Korea. Recently, the prefilled syringe formulation has been newly introduced, reducing the preparation time for drug administration, and enabling a more efficient and convenient treatment experience for the patients. The prefilled syringe formulation can be used with reimbursement for all indications approved for the existing Eylea 2mg formulation. Regarding the challenges being made by biosimilar companies, Suh said, “That in itself is proof of the many advantages owned by Eylea. Although we won’t be able to prevent the price cuts made on our drug due to the introduction of its biosimilars, we are confident that competitivity-wise, the market is still in favor of the original. Biosimilars usually make a bid at the market with their lower price. However, in the case of Eylia, we have a program in place that reimburses a certain level of expenses for diabetic macular degeneration, which takes care of about half of the patient's burden. Therefore, patients can enjoy the ‘cheap price’ benefit offered by the biosimilars while using the original drug. The clinical data and trust that Eylea has built over the past 10 years is a barrier that biosimilars cannot easily break down. Based on this, Suh emphasized that the company’s best defense strategy will be to focus on the unmet needs of patients and HCPs. Suh said, “The Eylea team needs to contemplate how to address the unmet needs of patients and HCPs to ultimately create a better treatment environment for the patients. That is the best defense strategy. We will work to make Eylea more widely available for various retinal diseases, including diabetic retinopathy, retinal vein occlusion, etc.
- Policy
- Cough Syrup and Synatura Syrup complete PVA negotiations
- by Lee, Tak-Sun Aug 08, 2023 05:30am
- Respiratory drugs such as Cough Syrup and Synatrua Syrup were found to have been added as subjects for drug pricing negotiations under the Price-Volume Agreement (PVA) this year. The use of the items had increased significantly last year due to the sharp increase in confirmed COVID-19 cases last year. According to industry sources on the 7th, the National Health Insurance Service added 134 items and updated the list of drugs that completed drug pricing negotiations as ‘Type C PVA drugs’ recently. Previously, the number of items subject to PVA Type C negotiations this time was known to be 138, and a similar number of items had been added to the list as those that completed negotiations as of July 31st. Among the added items, antitussive expectorants, antibiotics, and antivirals stand out as the use of the drugs was presumed to have increased due to the increase in confirmed COVID-19 cases last year. Specifically, the drugs include Yuhan Corp’s ‘Cough Syrup,’ Daewon Pharmaceutical’s ‘Codaewon Forte Syrup,’ Ahngook Pharm’s ‘Synatrua Syrup,’ Hanmi Pharm’s ‘Cossac-L Tab,’ Hanwha Pharma’s ‘Muteran Cap. 200mg,’ Korea United Pharm’s ‘Kalomin Tab And Kalomin S Tab.’ According to UBIST, outpatient prescriptions of the Cough Syrup had increased 111% YoY to record ‘KRW 26.7 billion’ last year. Prescriptions of Codaewon Forte Syrup had also increased 88% YoY to reach KRW 21.6 billion, and Synatrua Syrup by 96% to record KRW 35 billion. Prescriptions of Cossac-L Tab increased by 121% to reach KRW 5.6 billion. Prescriptions of major items increased by around 100%, and the dominant analysis in the industry is that this is because prescriptions for respiratory drugs, such as antitussive expectorants and antibiotics increased significantly with the rise of confirmed COVID-19 patients last year. Drugs are subject to drug pricing negotiations as Type C of the PVA if its claims amount of a drug increases by over 60%, or by 10% but the increased amount exceeds KRW 5 billion. Therefore, drugs whose claims have increased by around 100% due to the influence of COVID-19 were highly likely to be included in the PVA negotiations and subject to price cuts. Regarding the issue, the pharmacuetical industry insisted that drugs whose use increased due to COVID-19 should be excluded from PVA negotiations, and the health authorities partially accepted this claim and decided to adjust the use amount of drugs related to COVID-19. For example, the government prepared a correction formula that excludes the 10 months last year when the number of COVID-19 patients surged and converts the claims amount of the 2 remaining months into 12 months to compare with the claims amount of the previous year. As a result, the use amount of 36 items of the same product group was corrected and completed negotiations with the NHIS. In addition to respiratory drugs, blockbuster drugs used to treat chronic conditions such as Boryung’s ‘Dukarb Tab,’ Hanmi Pharm’s ‘Rosuzet Tab,’ Chong Kun Dang’s ‘Telminuvo Tab,’ and AstraZeneca’s ‘Xigduo XR Tab’ were also found to have completed negotiations this time.
- Company
- Sales of the flu tx market increased due to the endemic
- by Chon, Seung-Hyun Aug 07, 2023 05:23am
- In the first half of the year, the outpatient prescription market for flu treatment exceeded 10 billion won in four years. As the number of flu patients surged after the end of the Corona 19 pandemic, the flu treatment market, which had disappeared over the past three years, expanded significantly. According to UBIST, a drug research institute on the 5th, the outpatient prescription amount for influenza (flu) treatment in the first half of last year was recorded at 11.5 billion won. It fell short of 100 million won in the first half of last year but soared more than 200 times in one year. Quarterly outpatient Rx amount of flu treatment (unit: 100 million won, source: UBIST) In the first and second quarters of last year, the flu treatment market size was only 40 million won and 4 million won, respectively. It rose sharply to 5.1 billion won in the first and second quarters of this year. It is the first time in four years since 2019 that the prescription of flu treatment in the first half of the year exceeded 10 billion won. After recording 8.2 billion won in prescriptions in the first quarter of 2020, the flu treatment market virtually disappeared by the third quarter of last year. After the spread of COVID-19 in earnest, the outbreak of infectious diseases has significantly decreased due to strengthened personal hygiene management such as washing hands and wearing masks. According to the KDCA, the number of suspected flu patients per 1,000 outpatients recorded at 6.3 in the 9th week, the first week of March 2020, and has never exceeded 5 until August of last year. This means that there has not been a single outbreak of the flu in 2 years and 6 months. Influenza tx recorded 8.2 billion won in prescriptions in the first quarter of 2020 and virtually disappeared by the third quarter of last year, but started to rebound with 10.4 billion won in the fourth quarter of last year. From the beginning of this year to last June, the number of flu patients exceeded the epidemic standard. The number of suspected influenza patients per 1,000 outpatients dropped from 52.5 in the first week to 11.7 in March. However, since April, the number of suspected flu cases has risen again. For six consecutive weeks from the 17th week of the fourth week of April to the 22nd week of the last week of May, the number of suspected influenza patients per 1,000 outpatients was more than 20. It is a level that significantly exceeds the flu prevalence standard of 4.9 set by the KDCA. In the first half of last year, the prescription market for oseltamivir ingredients was limited to 40 million won, but in the first half of this year, it expanded 191 times to 7.9 billion won. Oseltamivir is the main active ingredient in Tamiflu. The size of the prescription market for Oseltamivir never exceeded 100 million won until the third quarter of last year after recording 6.6 billion won in the first quarter of 2020. However, it succeeded in rebounding to 8.5 billion won in the fourth quarter of last year and continued its growth this year. In the first half of last year, prescriptions for Tamiflu were only 30 million won, but this increased to 5.7 billion won in one year.
- Policy
- Paxlovid and Dong-A’s Diosmin Powder were approved in July
- by Lee, Hye-Kyung Aug 07, 2023 05:23am
- The number of prescription drug approvals decreased significantly in July. The approvals, which had continuously increased from 70 in May to 93 in June, had fallen to record 29 in July. However, the drugs approved were nevertheless as significant as Pfizer Korea’s COVID-19 treatment ‘Paxlovid (nirmatrelvir, ritonavir)’, which had first been introduced to Korea through the EUA (emergency use authorization) during the COVID-19 outbreak, received formal approval as a new drug in Korea, and the Takeda-developed Celltrion-owned ‘Alo Gliptinpio Tab’ was approved for export. Drugs Approved in 2023 In July, a total of 76 drugs were approved by the Ministry of Food and Drug Safety. Compared to the previous month, the ETC approvals were reduced by 64, and OTC approvals increased to 47 and exceeded the number of ETC approvals. ◆OTC drugs== A total of 47 over-the-counter drugs were approved (registered) in July. Among those, 3 were data submission drugs(incrementally modified drugs, IMDs), which are modified versions of existing drugs that underwent safety and efficacy reviews due to changes in ingredient, salt base, or dosage form. OTCs approved in July KyungDong Pharma’s Gnal-N Ace Soft Cap (IMD, approved on July 12) Gnal-N is the first product that made KyungDong Pharm, a pharmaceutical company that had previously been focused on clinical areas, familiar to the public. The Gnal-N series was first released in 2009 with the ibuprofen combo ‘Gnal-N Tab,’ followed by ‘Gnal-N Q Tab', ‘Gnal-N Nose Soft Cap, ‘Gnal-N Cold Soft Cap,’ ‘Gnal-N Cough Soft Cap,’ ‘Gnal-N Nose Plus Soft Cap.’ The company received additional approval for ‘Gnal-N Ace Soft Cap’ which contains a combination of acetaminophen and riboflavin on July 12, and increased its Gnal-N product line-up to 13. Gnal-N Ace Soft Cap is indicated for headache, toothache, pain after tooth extraction, sore throat, ear pain, joint pain, neuralgia, back pain, muscle pain, shoulder pain (stiff shoulder), bruise pain, fracture pain, sprain pain, menstrual pain. analgesia of traumatic pain, chills, and fever. Dong-A Pharmaceutical’s Dong-A Pharm Diosmin Suspension Powder (IMD, approved on July 18) Dong-A Pharmaceutical will soon be releasing its approved ‘Dong-A Pharm Diosmin Suspension Powder’ that offers improved convenience in intake to pharmacies in Korea. Each packet of the drug contains diosmin 600mg that can be dissolved into water for intake. It is indicated to improve symptoms related to venous insufficiency (leg heaviness, pain), as supplementary treatment for disorders caused by capillary fragility, and treatment of symptoms related to hemorrhoids. It will be released to pharmacies as a box with 10 packets. Meanwhile, latecomers such as Dong-A Pharmaceutical, Hanmi Pharm, Chodang Pharm, and Samjin Pharm have increased their presence in the diosmin market by releasing high-dose oral hemorrhoids treatments one after another. Dong-A Pharmaceutical's annual sales of Diomax Tab doubled from KRW 500 million in 2020 to KRW 1 billion in 2021, based on IQVIA data. Last year, Diomax posted sales of KRW 1.1 billion, occupying 48% of the market the high-dose (600mg) oral hemorrhoids treatment market. ETCs approved in July ◆ETC=Two new prescription drugs were approved in July. 14 data submission drugs and 13 generics and others were also approved the same month. Celltrion’s ‘Celltrion Alo Gliptinpio Tab 25·15mg, 25·30mg (for export, Approved on July 6 and 7) Celltrion received approval for Celltrion Alo Gliptinpio Tab 25·15mg, and 25·30mg for export on July 6 and 7, respectively. The drug is a new combination made by the company using its rights for ‘Nesina' and 'Actos', which it acquired from the Japanese pharmaceutical company Takeda Pharmaceuticals. Takeda Pharmaceuticals had been directly selling Nesina in Korea until 2020, but in December 2020, it sold all rights, including sales rights and patents, of 12 ETC drug brands and 6 OTC drugs in 9 Asia-Pacific countries to Celltrion Pharm to adjust the size of its debt. I did. Alogliptin and pioglitazone can help patients control blood sugar levels, and patients with Type 2 diabetes can take them to control blood sugar along with diet and exercise. Since last year, Celltrion Pharm has been strengthening its product lineup receiving approval for drugs to export overseas. Sanofi-Aventis Korea’s Enjaymo Inj (new drug, Approved on July 12) Sanofi’s ‘Enjaymo Inj,’ which is indicated to treat adults with cold agglutinin disease (CAD), was also recently approved in Korea. The drug is used to treat the breakdown of red blood cells (hemolysis) in adults with cold agglutinin disease (CAD), which is a form of autoimmune hemolytic anemia (AIHA), CAD is a rare type of autoimmune hemolytic anemia caused when antibodies called cold agglutinins bind to the surface of red blood cells. When cold agglutinins bind to the surface of red blood cells, the body's immune system mistakenly attacks and destroys healthy red blood cells. Pfizer Korea’s Paxlovid Tab (new drug, Approved on July 14) Pfizer Korea’s ‘Paxlovid,’ which was first introduced in Korea through the emergency use authorization (EAU) track during the spread of COVID-19, received official approval in Korea. Paxlovid was granted EAU by the MFDS on December 27, 2021, the same year the number of confirmed and seriously ill patients with COVID-19 surged and the Omicron variant spread, raising the need for an oral treatment for COVID-19. It has been formally approved as a prescription drug 1 year and 7 months after its introduction to Korea. Patients who take Paxlovid take two tablets at the same time. Nirmatrelvir blocks protease (3CL protease) to prevent the production of proteins necessary for viral replication, thereby inhibiting the proliferation of the virus, and ritonavir inhibits the enzyme (CYP3A4) that breaks down nirmatrelvir, extending its duration of effect. After a careful review of the results of the Phase III clinical trial (therapeutic confirmatory trial) conducted on adult patients, the drug was officially approved in Korea in accordance with the 'Pharmaceutical Affairs Act,’ The EAU for Paxlovid, which has allowed patients to use the drug free of charge, will remain in place as is.
- Company
- Prescription of HA eye drops record KRW 166 bil in 1H
- by Kim, Jin-Gu Aug 07, 2023 05:23am
- The prescription market for hyaluronic acid eye drops grew to record the largest scale ever ahead of the reimbursement reevaluations set for the end of this year. In 1H alone, the market grew exceeded KRW 160 billion in prescriptions this year. The number of companies with half-year prescriptions that exceed KRW 10 billion increased from 5 in 1H last year to 7. The pharmaceutical companies that will inevitably suffer huge losses due to the expected reimbursement re-evaluations are preparing to jointly respond to the government's measures. Prescription of HA eye drops exceed KRW 160 bil in 1H, 7 companies exceed KRW 10 bil According to the market research institution UBIST, outpatient prescription of HA eye drops in 1H this year was KRW 16.6 billion. This is a 16% increase from 1H last year. This market shrunk somewhat in 2020 due to the spread of COVID-19 but has been rapidly expanding since then. Quarterly HA eye drop prescriptions(Unit: KRW 100 mil, Data: UBIST) By quarterly prescriptions, HA eye drops exceeded KRW 70 billion in Q2 last year and KRW 80 billion in Q1 this year. At this rate, the total market size may increase to exceed KRW 300 billion this year for the first time this year. The prescription performance of major companies in the market has also increased significantly. The prescription performance of Optus Pharm, which owns the Tearin series, increased by 26% from KRW 14 billion in 1H last year to KRW 17.7 billion in 1H this year. In the case of Taejoon Pharm, which owns New Hyalyuni, Hyalyuni, and New Hyaldrops, its sales increased by 21% from KRW 12.6 billion to KRW 15.3 billion. Sales at Daewoo Pharm, which owns Hyalsan, rose 36% from KRW 10.6 billion to KRW 14.4 billion. As a single product, Hyalsan recorded the highest prescription performance in 1H this year. The number of companies whos half year sales exceeded KRW 10 billion increased from 5 in 1H last year to 7 in 1H this year. As of 1H this year, Optus Pharm, Taejoon Pharm, Daewoo Pharm and SamChunDang Pharm, Huons Meditech, Hanmi Pharm, Kukje Pharm recorded prescriptions of more than KRW 10 billion. Changes in HA eye drop prescriptions in H1 (Unit: KRW 100 mil, Data: UBIST) ‘Protect the KRW 300 bil annual market’...Pharma companies jointly prepare to respond to gov't reimbursement reevaluations However, whether the companies may continue their growth next year remains unknown, because the government included HA eye drops as a subject for reimbursement reevaluations. The government has selected 8 ingredients, including HA eye drops, as targets for reimbursement revelations this year. These include rebamipide, limaprost oxiracetam, acetyl Locartinie hydrochloride, loxoprofen sodium, levosulpiride, epinastine hydrochloride, and HA eye drops Among them, oxiracetam and acetyl L-carnitine hydrochloride are expected to fail to pass the reimbursement revelations as they failed to pass the clinical reevaluations conducted by the Ministry of Food and Drug Safety. Among the 8 ingredients, HA eye drops have the largest scale in terms of number of items and market size. 46 pharmaceutical companies have been selling 77 HA eye drop products in 1H this year. The government has already received related data from each pharmaceutical company and started the practical review. The outline of HA eye drops’ adequacy of reimbursement will be revealed next month at the earliest. After holding an objection period for the pharmaceutical industry, the final result of the reimbursement reevaluation will be determined by the end of this year. From the industry’s perspective, the companies will inevitably experience serious aftermath if the government concludes that the drug lacks grounds to be determined adequate for reimbursement. This is why the companies have been jointly preparing a response to the reevaluation results. About 10 companies, centered around Optus Pharm, have been concentrating on developing a countermeasure with large law firms in Korea. As in the case of choline alfoscerate, there is a possibility that the companies will file a class action lawsuit against the government. If they do file a class action lawsuit, the suit will likely be subject to the drug expenditure refund and redemption law that passed the National Assembly this year. The law, which will be enforced on November 20th, allows for the recovery or refund of drug costs that were already paid according to the outcome of the lawsuit if a pharmaceutical company delays government actions such as drug price cuts by applying for a suspension of execution along with an administrative lawsuit. Some companies have also started to develop alternatives in preparation for the market withdrawal of HA acid eye drops. In June of last year, Samil Pharmaceutical and Kukje Pharm received permission for Reba-K eye drops and Reba-i eye drops that contain rebamipide to treat dry eye syndrome. Daewoo Pharm is also known to be developing an eye drop product with the same ingredient.
