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- 2026-05-10 01:23:39
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- PD-1 inhibitors enhance future value of anticancer treatment
- by Jun 22, 2021 05:50am
- Professor Eui-Cheol ShinSince its first appearance in 2011, cancer immunotherapies have opened a new paradigm in the field of cancer treatment. Moving on from the era of targeted therapies that target specific gene mutation, the new era had opened where a patient’s immune system is activated to remove the malignant tumor. The immunotherapies that have been commercialized until now, such as Opdivo, Yervoy, and Keytruda, are all immune checkpoint inhibitors that target immunomodulators such as CTLA-4 or PD-(L)1. Immunologists Professor James P. Allison and Professor Tasuku Honjo were jointly awarded the Nobel Prize in Physiology or Medicine in 2018 for their discovery of this mechanism. In the wide and complex field of immunity, much is still left to be identified and remains uncharted territory. This is why cancer immunotherapies work according to theory in 30% of the patients, but not as expected in the other patients. To increase the response rate, pharmaceutical companies have been attempting to combine their immunotherapy with other immunotherapies that have different MOAs, or with existing targeted therapies or chemotherapies. Finding a good biomarker to predict the response rate also remains an important task. So how do immunologists view the present and future of cancer immunotherapies? Eui-Cheol Shin, Professor of Graduate School of Medical Science and Engineering at Korea Advanced Institute of Science and Technology (KAIST), said, “PD-1/PD-L1 inhibitors will be essential in all combination therapies that will be established for cancer treatment in the future. The PD-(L)1 and CTLA-4 immune checkpoint inhibitors can also be used in combination to complement the shortcomings of each other.” Professor Shin also added that treatment methods will be established for each cancer type and stage using viable biomarkers and that personalized cancer vaccines may become the next-generation anticancer therapy. The following is the question and answers from an interview with Professor Shin. -The paradigm that was dominated by targeted cancer therapies had shifted with the introduction of cancer immunotherapies. How is immunotherapy different from targeted anticancer drugs in terms of its mechanism of action? =The main difference between cancer immunotherapy drugs and targeted cancer therapies is in the durability of response. Strictly speaking, it is different, but a cancer immunotherapy drug is similar to a vaccine. Both use immunological memory to fight diseases. Just as people can live without concern of a certain disease after vaccination as many vaccines have a lifelong effect, treatment with immunotherapy will allow the immunologic memory to remove cancer even after it starts spreading again. The effect of the drug can last for the rest of the patient's life, even after discontinuing administration of the immunotherapy drug. -The cancer immunotherapies that have been released until now are PD-1/PD-L1 and CTLA-4 inhibitors. I know research is being conducted for new markers, how much progress has been made in this regard? =No one knows how many undiscovered mechanisms remain in the field of cancer immunotherapy. So, it is difficult to say how much progress has been made. Also, how many mechanisms were discovered is not important. Although CTLA-4 inhibitors and various PD-1/PD-L1 inhibitors have been introduced to the market, research results have reported that they work differently from the originally expected principle of action. This means that you do not need to know all the mechanisms to develop a drug. In some cases, the mechanism that you thought you knew well cannot be developed into a drug, and in other cases, you luckily find a drug another way. Research is of course conducted with sufficient theoretical grounds, but even with a solid theoretical base, clinical success cannot be guaranteed 100%. -Is there a reason why many of the developed drugs are PD-1/PD-L1 inhibitors? =In my research, I found PD-1 was the best anticancer immunotherapy target that can be modulated in the process of fighting cancer. Of course, the effect may be different for each cancer type and patient, but as PD-1 has a good effect and has the least side effects, much study has been focused on PD-1. Even in 50 years when cancer immunotherapies that target various other mechanisms are introduced in the market, I (strongly) believe PD-1 and PD-L1 inhibitors will hold their ground as a basic cancer immunotherapy drug. -Studies of combination therapies are also being conducted actively to enhance the effect of cancer immunotherapies. Some studies have been investigating the use of two immunotherapies. Mechanism-wise, is it effective to combine the use of a PD-1 inhibitor and a CTLA-4 inhibitor? =Well, the two are the only immune checkpoint inhibitors that were formally approved as of now, and using the two in combination does have a better effect. Separately, CTLA-4 inhibitors were introduced before PD-(L)1 inhibitor, but have relatively more side effects than the latter. In this sense, response in using the two drugs with the different MOAs has been unexpectedly good in general. It is rare, but using PD-(L)1 inhibitors may trigger hyperprogression of cancer in the treated patient. However, fundamental research findings have shown that hyperprogression may not show up when a CTLA-4 inhibitor is used in combination with a PD-(L)1 inhibitor. Much still needs to be verified, but I believe the immunotherapies may be able to complement each other’s shortcomings. -Patients may develop resistance to cancer immunotherapies as well. What alternatives could the patients use? =One of the reasons for ‘secondary resistance’ is mutation. The body needs to perceive the tumor as a foreign cell, however, the tumor antigen mutates and develops resistance. Cancer cells mutate just as well as viruses. Although it has not been commercialized yet, I expect ‘personalized cancer vaccines’ fit for each patient to become the next-generation anticancer therapy that would address the issue of resistance. These ‘cancer vaccines’ would be different from conventional vaccines that are administered in a healthy state, these are therapeutic vaccines that will prevent growth or recurrence of cancer in patients who have undergone surgeries for cancer removal. In other words, a vaccine that is made based on the changes identified in the mutated cancer cell of each patient to contain new antigens will allow patients to overcome resistance in the future. Of course, these cancer vaccines would also need to be used in combination with PD-1 inhibitors. As such, PD-1 is and will continue to be essential in the field of cancer immunotherapies.
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- Gifticon to MDs attending online sessions might be illegal
- by Kim, Jin-Gu Jun 22, 2021 05:50am
- It has been interpreted that it is illegal to provide economic benefits, including gifticon, to doctors who participated in the online product briefing session, which has recently emerged as a major marketing tool for pharmaceutical companies. Park Sung-min, a lawyer at the HnL Legal OfficePark Sung-min, a lawyer at the HnL Law Office, made the explanation through a presentation on "legal issues on digital marketing" at the KFDC Legal Society's Spring Conference held online on the 18th. According to him, digital marketing has emerged as a major marketing tool in the pharmaceutical industry since the Corona crisis. However, almost all economic benefits related to digital marketing are highly likely to be illegal for the reasons for the lack of relevant regulations. In the case of online product briefing sessions, it is highly likely to be illegal to provide food and beverage to participating doctors. The same is true for posting comments, giving points to doctors who participated in surveys and events, and allowing them to purchase goods. Lawyer Park Sung-min said, "If the law is interpreted strictly, it is likely to be judged as a violation under the current law." In the case of exceptionally allowing economic benefits to doctors, "a salesperson may visit individual medical institutions and provide food and beverage not exceeding ₩100,000 once a day. However, economic benefits of the online product briefing session should not be provided because salespeople did not visit it in person. The same is true of doctors from various medical institutions who participated in online product briefing sessions. This is because it is difficult to apply the concept of "place" legally, although the regulation "if a salesperson visits" is not specified at this time. "This is what the KPBMA stated in the guidebook."There has been no judgment by the prosecution and the court regarding this matter. However, since the KPBMA was consulted by two law firms, there is a high possibility of illegality at the moment." However, he pointed out that the current situation is "because there are no related regulations." "The current regulations that allow doctors to provide exceptional economic benefits were made in an era when digital marketing was not active," he said. "Since Corona, digital marketing has emerged as a new means, we need to come up with relevant regulations." He cited the "detailed standards for supporting online academic conferences" temporarily prepared by the MOHW. "The MOHW's creation of the rule greatly reduced the scope of violations by pharmaceutical companies and doctors, at least in connection with online academic conferences," he said. "In addition, regulations on overall online marketing will reduce confusion in the field." "There are no rules at the moment," he said. "If the current situation continues, there is a high possibility of many violations.The government and the KPBMA should come forward to make very specific and explicit rules. Only then can we do fair marketing in a changed world."
- Company
- Competition between PCSK9 Inhibitors has just begun
- by Eo, Yun-Ho Jun 21, 2021 05:51am
- The competition for prescription of PCSK 9 inhibitors began more than four years after the domestic approval. Sanofi-Aventis' Allepatadine (Olopatadine) was listed on the 7th. It was approved in January 2017. This was the first time in South Korea that PCSK's 9th suppression system was introduced. Later in April of the same year, Amgen's Repatha (Evolocumab) was approved, with a stronger willingness to register benefits. Repatha was first registered as Homozygous Family Hypercholesterolmia (HOFH) in August 2018. Although there were two drugs in PCSK 9 inhibitors, Repatha was the only option. PCSK 9 inhibitors are drugs that have excellent efficacy but had price issues. There were problems not only at home but also at a global level, and Amgen lowered the price of drugs held by 60% in October 2018 and Sanofi in February 2019. Sanofi voluntarily withdrew Praluent's application for registration in October 2018, before the drug price was lowered, and it was registered about two years later. PCSK.9 inhibitors had a wide range of requirements for HOFH and in January 2020, Repatha succeeded in extending the reimbursement standard to patients with atherosclerotic cardiovascular disease (ASCVD) high risk, Heterozygous Family (HeFH), and Statinability. The two drugs are believed to compete in the ASCVD and HeFH. Praluent added HoFH in the United States in April. Praluent has tended to reduce the risk of all-cause death, and is a licensed drug with Praluent 75 mg and Praluent 150 mg, allowing patient-specific dose selection with reference to patient status and LDL-C levels. Repatha, which is first listed, is already prescribed by medical institutions. It can be prescribed at major medical institutions across the country, including the Big 5 general hospitals, including Samsung Medical Center l, Seoul St. Mary's Hospital, AMC, and Sinchon Severance Hospital.
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- JAK inhibitor ‘Olumiant’ seeks reimb for atopic dermatitis
- by Eo, Yun-Ho Jun 18, 2021 05:54am
- The JAK inhibitor ‘Olumiant’ is seeking extended reimbursement benefit in atopic dermatitis. According to industry sources, Lilly Korea has submitted an application for the reimbursement of Olumiant (baricitinib) in ‘the treatment of adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy’. The company had rapidly carried out the listing application process after receiving approval for this additional indication last month. As a new drug for moderate to severe atopic dermatitis, Olumiant’s reimbursed price is expected to be set at a more economic price than recently listed new treatment for atopic dermatitis, ‘Dupixent (dupilumab).’ Olumiant selectively and reversibly inhibits JAK1 and JAK2 to reduce the expression of inflammatory cytokines and has an anti-inflammatory effect. Olumiant demonstrated significant treatment effect as well as safety as monotherapy and as combination therapy with a topical corticosteroid (TCS) in adult patients with moderate to severe atopic dermatitis compared to placebo in 3 clinical trials - BREEZE-AD1, BREEZE-AD2, and BREEZE-AD7. In the three studies, patients treated with Olumiant showed an improvement in their symptoms such as itching, which severely deteriorates the patients' overall health state and quality of life, as early as in the second day of treatment. Dr. Chang-Wook Park, Professor of Dermatology at the Severance Hospital said, “The rapid improvement of symptoms that were observed from the second day of Olumiant treatment in the patient-reported outcome gives hope to atopic dermatitis patients in Korea who previously had limited treatment options.” Park added, “With its strengths in rapidly improving itch symptoms, convenient oral administration that improves patient compliance, and long-term safety profile that has been confirmed as a rheumatoid arthritis treatment, I expect Olumiant will be able to address patients' unmet needs in the field of atopic dermatitis.”
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- Cancer immunotherapy combo seeks 1st-line reimbursement
- by Eo, Yun-Ho Jun 17, 2021 06:04am
- Activity to reimburse ‘Opdivo’ has begun again after a long standstill. According to industry sources, Ono and BMS recently submitted an application to extend reimbursement for the PD-1 inhibitor ‘Opdivo (nivolumab)’ in combination with the CTLA-4 inhibitor ‘Yervoy (ipilimumab)’ to first-line treatment of non-small cell lung cancer (NSCLC). This is the first time in a long while that a discussion for listing Opdivo is being resumed in the field of lung cancer since Opdivo’s reimbursement attempt to receive reimbursement ‘as monotherapy for second-and third-line treatment of lung cancer regardless of PD-L1 expression’ was turned down by the authorities in 2019. The Opdivo and Yervoy combination has initially been approved in Korea for the renal cell carcinoma indication, and its listing process is currently underway. As with MSD’s ‘Keytruda (pembrolizumab),' Ono and BMS had discontinued the reimbursement extension discussions as they were unable to accept the condition set by the government requesting the company to ‘cover the initial 3 cycles’ worth of administration cost.' Whether Opdivo will be able to be listed for reimbursement with the new ‘cancer immunotherapy combination' card is receiving attention. Also, with the PD-L1 inhibitor ‘Tecentriq (atezolizumab)’ and Keytruda’s reimbursement as first-line treatment for lung cancer expected to be discussed in July at HIRA’s Review Committee for Cancer Diseases meeting, whether Opdivo will also be put as an agenda for deliberation then remains to be seen. Opdivo in NSCLC was approved in Korea ▲ as first-line treatment of advanced or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations, in combination with Yervoy and 2 cycles of platinum-based chemotherapy; and ▲as first-line treatment of metastatic or recurrent NSCLC expressing PD-L1 (≥1%) with no EGFR or ALK genomic tumor aberrations, in combination with Yervoy. Opdivo’s efficacy in lung cancer was confirmed through the two Phase III trials, CheckMate-227 and CheckMate-9LA. Dr. Dae-ho Lee, Professor of Oncology at the Asan Medical Center, said, “The newly approved combination therapies that use Opdivo have clinical significance not only because it raises the treatment response rate and improves the period of survival in NSCLC patients, but because it also provides more treatment strategy options to first-line NSCLC patients. However, one thing left to be desired is that we lack discovery of appropriate biomarkers that can guide us through the various treatment strategies." he said.
- Company
- Drug exports in May amounted to ₩650 billion
- by Kim, Jin-Gu Jun 17, 2021 06:04am
- Korea's drug exports reached ₩650 billion in May. Exports are still export boom following last year. However, as imports increased, the trade balance posted in deficit for the second straight month from April. Monthly drug exports for the last two years (unit: $1 million, data: Korea Custom Service) By country, drug exports to Germany surpassed ₩1 trillion in five months. Pharmaceutical exports to Germany exceeded ₩2 trillion last year, reaching an all-time high, and exports are increasing more steeply this year. According to the Korea Customs Service on the 15th, Korea exported $585.07 million (about ₩650 billion) in May. Compared to $588.43 million in May last year, there is little difference. Last year's exports of medicines were the highest ever. The export boom continues until May. Monthly exports of medicines include $696.56 million in January, $714.57 million in February, $816.6 million in March, $468.19 million in April and $585.57 million in May. Drug imports include $634.76 million in January, $519.61 million in February, $727.51 million in March, 652.37 million dollars in April, and 689.42 million dollars in May. Compared to January-May of last year, it increased by 6%. Exports are similar to the previous year, and as imports increase, the drug trade balance has been in deficit since April. Korea's drug trade balance hit surplus for five consecutive months from November last year to March this year. However, it was $184.18 million in April and $14.35 million in May, respectively. By May, Germany had the largest cumulative export volume of $1210.77 million. Germany has become the largest exporter of medicines since 2019. In particular, exports increased even more this year. The figure has more than doubled from $553.39 million during the same period last year. From January to May, exports of medicines to Japan ranked second with US$197.24 million. It increased 40% from $141.04 million (₩160 billion) in exports from January to May last year. Exports to Netherlands also increased significantly. It was only $42.81 million (about ₩50 billion) until May last year, but it more than quadrupled to $189 million (about ₩210 billion) this year. Exports to the United States declined significantly. By May, exports to the U.S. amounted to $163.75 million (about ₩180 billion), down by half from $331.17 million (about ₩370 billion) during the same period last year. By 2018, Korea had been the largest exporter of medicines to the United States.
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- Companies are nervous about investigating Varenicline
- by An, Kyung-Jin Jun 16, 2021 05:42am
- ChampixCompanies selling anti-smoking drugs, generic for Champix are on alert. Health authorities are investigating Nitrosamines impurities in Varenicline. It seems that sales are facing difficulties due to unfavorable factors such as COVID-19 incident and follow-up measures of impurities after passing the patent dispute in Korea. According to an industry on the 15th, pharmaceutical companies that manufacture and sell generics for Champix (Varenicline) are preparing documents related to testing impurities in Nitrosamine. This is because the MFDS identified the possibility of Nitrosamines impurities in Varenicline and ordered follow-up measures. As the possibility of detection of Nitrosamine impurities has been confirmed by Varenicline, it has taken follow-up measures of domestic products. Varenicline is the main active ingredient in Pfizer's anti-smoking drug, Champix. 34 domestic pharmaceutical companies that own generics for Champix, including Pfizer Korea, which sells original product, CTC Bio, The U, Medic Pharm, AusKorea, Hanmi, Jeil, PharmGen Science, Joonghun, Litepharm, Genuonesciences, TELCON RF, Ahn-gook, Ilhwa, Theragen Etex, Daewon, Whanin, Daewoong Bio, Crystallifescience, Alvogen Korea, JW Shinyak, Kyongbo, Kwang Dong, Vivozon, Korean Drug, Hutecs, Samjin, Mcnulty, Boryung, Yuyu, Hana, Ildong, and Pharvis are included. According to IQVIA, which is a pharmaceutical market research institute, Varenicline market formed ₩4.8 billion in first quarter of last year. Sales of Pfizer Korea's Champix are ₩4 billion, accounting for 83.9% of the total market. Only 12 generic companies, including Hanmi, Hutecs, Whanin, Alvogen Korea, Vivozon, CTC Bio, Boryung, Daewoong Bio, Mcnulty, and Jeil, generated sales in the first quarter. Sales of Hanmi's Nocotin S amounted to ₩500 million, the highest among Varenicline products. Other products were less than ₩100 million in quarterly sales. Sales of Hutecs' Nicopix are ₩76 million, while Hwanin's Nicover and Alvogen Korea's Topfix are in the top sales list with ₩50 million. Quarterly sales of Champix fell below ₩3 billion until 2014, but it surpassed ₩5 billion for the first time in the first quarter of 2015 and quarterly sales soared to ₩21.4 billion in the first quarter of 2017. As the market size decreased following the reduction in drug prices in 2018, Korean companies actively wanted to enter the Varenicline market. Some companies, including Hanmi, Chong Kun Dang, and Kyung Dong, started selling generics before the expiration of the patents, but lost the lawsuit of material patent avoidance, and were dismissed from the market. The generic market reopened in July last year with the expiration of the patent of Champix, but it has rarely recovered in the aftermath of COVID-19. Domestic pharmaceutical companies are concerned that the anti-smoking drug market will be further reduced if measures such as suspension of sales are taken due to the detection of excess impurities at a time when new cash cow excavation is urgently needed. Related companies are anxious because the MFDS' investigation of impurities has not been confirmed in detail. It is known that measures such as recovery due to the detection of impurities in Varenicline have not been taken overseas. "The Champix market is not large, but it is an area that is recently expected as a new cash cow," an official from a pharmaceutical company said. "There are many concerns that the market may be hit by unexpected detection of impurities."
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- Daewoong registers patient for Phase 3 trial of Coviblock
- by Nho, Byung Chul Jun 16, 2021 05:42am
- Clinical trial approval status of Daewoong Pharmaceutical’s COVID-19 treatment Coviblock as registered on the Pharmaceutical Integrated intelligence system (image: screen capture of the Pharmaceutical Integrated intelligence system webpage) The first patient for the Phase III trial of Daewoong Pharmaceutical's COVID-19 treatment candidate 'DWJ1248 (brand name: Coviblock)’ has been registered. According to the clinical trial approval status disclosed on the Pharmaceutical Integrated intelligence system webpage, Daewoong Pharmaceuticals had registered its first patient on the 7th this month for its double-blind, randomized, controlled Phase III clinical trial for Coviblock to assess its effectiveness in preventing infections after exposure to the COVID-19 virus. The clinical trial will investigate the efficacy of Coviblock in preventing infections in people in self-isolation due to exposure to the COVID-19 virus. This is the only treatment study in Korea that investigates the preventive effect of a treatment after exposure to the COVID-19 virus. Coviblock contains the same active ingredient as Foistar, camostat mesylate. According to the eligibility criteria disclosed by the clinical trial patient recruitment company E.Jo Connections, subjects are selected among those exposed to the COVID-19 virus who are in self-isolation or have been tested negative for COVID-19 at an RT-PCR test; those that have been in contact with a COVID-19 confirmed individual within 5 days; those who do not have the 14 types of symptoms that suggest COVID-19 such as fever, cough, chills, muscle pain, etc. Camostat, the active ingredient of Coviblock, inhibits the multiplication of the COVID-19 virus by blocking the viral host cell entry and improves inflammation. Based on this mechanism of action, Coviblock is expected to prevent a person who was in close contact with the COVID-19 virus from being infected with COVID-19 by blocking the virus from entering the body's cells. On the 4th, Daewoong Pharmaceutical had completed the administration of Coviblock in a phase-2b trial that was conducted on mild COVID-19 patients. A total of 300 patients were recruited for the trial, and the company will start data analysis after observing the patients’ conditions for a certain period. If the company obtains positive results, it plans to seek conditional approval in the third quarter and consecutively conduct the phase 3 trial. An official from Daewoong Pharmaceutical said, “We will do our best to develop Coviblock as a treatment for COVID-19. We have implemented multiple approaches for the development of Coviblock to fulfill our social responsibility in overcoming COVID-19 as a pharmaceutical company." Coviblock’s main ingredient, camostat, has also been shown to be effective in various variants of the COVID-19 virus in several efficacy tests. In April, Institut Pasteur Korea (IPK) announced study results on the effects of camostat and niclosamide among others on Covid-19 virus variants in cell tests. Results showed that the drugs inhibited cell infection to a similar level in the Covid-19 virus, the U.K. variant (B.1.1.7) and the South African variant (B.1.351)." Various countries including the U.S. and Japan have been developing treatments, with some using camostat’s COVID-19 treatment effect. The Korean government is also making active efforts to overcome COVID-19 by providing support for the development of an oral treatment that is easy to administer, etc. Whether these global efforts will bring a breakthrough in the development of a treatment for COVID-19 is receiving attention.
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- '100 Tylenols per pharmacy' provided to relieve shortage
- by Jun 16, 2021 05:41am
- Tylenols awaiting shipment at a pharmaceutical distribution company The shortage of Tylenol in pharmacies will be somewhat relieved with one hundred Tylenol 500mg being supplied to each pharmacy starting today. This measure to relieve the Tylenol shortage was made under the government’s request to Johnson & Johnson to release the 5 million the company stockpiled for next year, and Johnson & Johnson shipped the products to the wholesalers in charge of distributions yesterday, on the 14th. The first shipment contains 2.4 million Tylenols. The Korean Pharmaceuticals Distribution Association divided the pharmacies by region to allow ‘fair distribution to all pharmacies’ and selected 40 wholesale companies to cover the regions. The 40 wholesalers in charge of distribution started taking preorders last week. An official from one wholesale company said, “We started taking orders from last week, and as of the 14th, some wholesalers have already started receiving their supply. So companies will be able to distribute the supply from today (15th).” In the second supply, 2.6 million more Tylenols will be released. Therefore, the 23,000 pharmacies that have ordered its 100 Tylenols from the first supply will be able to order additional Tylenols on an as-needed basis. An official from the pharmaceuticals distribution industry said, “The equal supply of Tylenol to pharmacies in all regions rather than in some pharmacies will improve patient access to the drug.” On this, the Ministry of Food and Drug Safety said, “With support from relevant organizations, the ministry will work to enable smooth supply of acetaminophen to the people in need at the right time in line with the government's vaccination plan. Also, we will share the supply and demand status with relevant institutions through regular monitoring and immediately support the administrative matters necessary to suppliers to increase production of acetaminophen products.” Earlier, the Ministry of Food and Drug Safety, Korean Pharmacists’ association, Korea Pharmaceutical and Bio-Pharma Manufacturers Association, Korea Pharmaceuticals Distribution Association, and Tylenol’s manufacturer Johnson & Johnson had met to discuss measures to stabilize the supply of acetaminophen that has faced shortage following COVID-19 vaccinations. The organizations decided to designate 40 pharmaceutical distributors by region to ensure a stable supply of Tylenol in all regions.
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- Jeil Pharma's new OAB treatment ‘vibegron’ nears release
- by Kim, Jin-Gu Jun 16, 2021 05:41am
- Vibegron product that is being sold by Kyorin Pharmaceutical ‘Vibegron,' a new drug indicated for the treatment of overactive bladder (OAB) that Jeil Pharmaceutical acquired a domestic license for from Kyorin Pharmaceutical, is soon to be approved in Korea. Two clinical trials related to the domestic approval and manufacturing of Vibegron have been completed or are near completion. At the earliest, it is expected that the drug may be released within this year. According to industry sources on the 14th, Jeil Pharmaceutical had recently completed its Phase I clinical trial on vibegron. The trial investigated the safety and pharmacokinetics of JLP-2002 in comparison with the original drug. The trial was conducted for the purpose of receiving approval for Jeil Pharmaceutical's direct manufacturing of Vibegron in Korea. Prior to this study, Jeil Pharmaceutical had received approval for its IND application and conducted the trial on 33 patients in Korea in January this year. In addition, the bridging study (Phase III trial) for the domestic approval of Vibegron is also in its final stages of completion. Jeil Pharmaceutical had started the bridging study for the domestic approval of Vibegron in May last year. The study was conducted on 201 patients in 20 hospitals in Korea, including the Seoul Asan Medical Center. The company enrolled its final subject mid-last month. The investigation for the last participant is expected to be completed near the end of this month. Jeil Pharmaceutical plans to proceed with the domestic production and marketing approval procedures as soon as the clinical trial results are released. This raises the possibility that the product may be released in the market within this year at the earliest. Jeil Pharmaceutical had signed an exclusive domestic licensing agreement for vibegron with Japan's Kyorin Pharmaceuticals in 2019. Vibegron, Kyorin’s new overactive bladder (OAB) treatment, was in-licensed by Kyorin from MSD, and released as ‘Beova’ in Japan in November 2018. The drug received U.S. FDA's approval last December. In the U.S., Urovant Sciences received approval for the drug under ‘Gemtesa.’ Urovant Sciences is a subsidiary of Japan’s Sumitomo Dainippon Pharma. After vibegron is released, the OAB market in Korea is expected to heat up from its full-scale competition with the existing market leader ‘mirabegron (Betmiga).’ Betmiga is the most-prescribed treatment for overactive bladder in Korea. According to the pharmaceutical market research frim UBIST, out-patient prescription sales of Betmiga recorded 65.1 billion won last year. Also, Betigma's prescriptions recorded 15.4 billion won in the first quarter of this year. Vibegron's mechanism of action is similar to mirabegron's as the two drugs are both selective β3-adrenoceptor agonists. The recommended dosage is also 50mg once daily for both. However, medication adherence is known to be higher for vibegron as it has fewer adverse events than existing treatments. Vibegron's has also shown positive sales in Japan. According to Kyorin Pharmaceutical's annual report, sales of vibegron recorded 4.3 billion yen (about 43.8 billion won) in 2019 and 7.3 billion yen (about 74.3 billion won) in 2020 in Japan.
