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- 2025-12-24 19:51:19
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- Moderna's Spikevax bivalent Original/Omicron BA.1
- by Oct 05, 2022 06:11am
- Moderna announced on the 4th that it conducted Spikevax bivalent Original/Omicron BA.1 launch Webinar, a divalent vaccine containing omicron, on September 29. At the event, Jin Beom-sik, head of the Infectious Medicine Center at the National Medical Center, was the chairperson, and Kim Hee-soo, vice president of Moderna Korea's medical department, was the speaker. With a total of 2,124 participants, the next generation of COVID-19 showed keen interest in the vaccine by domestic medical staff. Spikevax bivalent Original/Omicron BA.1 is a next-generation bivalent vaccine that combines 25μg of the existing Moderna COVID-19 vaccine and 25μg of a vaccine candidate substance targeting the omicron mutation (BA1). On the 8th of last month, it was approved for emergency use by the Ministry of Food and Drug Safety as a vaccine to prevent COVID-19 over the age of 18. From the 11th, a divalent vaccine can be vaccinated. The main announcement on this day is phase 2/3 clinical data that evaluated the efficacy of Spikevax bivalent Original/Omicron BA.1. In this clinical trial, Spikevax bivalent Original/Omicron BA.1 met all major evaluation variables, including neutralizing antibody responses, compared to existing COVID-19 vaccines in participants without a history of COVID-19. The divalent vaccine booster shot increased the GMT for Omicron by eight times. Spikevax bivalent Original/Omicron BA.1 induced stronger neutralizing antibody transliteration for omicron sub mutants BA.4 and BA.5. Based on pre-vaccination, the geometric mean multiple increases (GMFR) for BA.4 and BA.5 mutations was 6.3 times that of the divalent vaccine, which was 3.5 times greater than that of the conventional vaccine. These results were consistent regardless of the presence or absence of COVID-19, including those aged 65 or older. Spikevax bivalent Original/Omicron BA.1 showed an effect consistent with the reactivity and safety profile of the currently approved booster. An official from Moderna Korea said, "According to the recently announced government's COVID-19 vaccination plan, timely vaccination with the latest vaccine is an effective way to protect the health of the public from the potential re-proliferation of COVID-19 this winter."
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- Il-Yang “has not exaggerated COVID-19 trial results
- by Kim, Jin-Gu Oct 04, 2022 06:07am
- On the 29th, Il-Yang Pharmaceutical announced that it “has not exaggerated clinical trial results” regarding the ongoing police investigation on the company’s COVID-19 drug candidate ‘Supect.’ This announcement was made in response to one media report that Il-Yang Pharmaceutical is being investigated for exaggerating the clinical trial results for its COVID-19 drug to raise the stock price. According to the report, the police saw that the company had provided misleading information to investors, claiming that ‘Supect reduced COVID-19 infection by 70% within 48 hours of administration compared to the control group’ based on its non-clinical (in-vitro) trial results. With the news, the media added that Il-Yang Pharmaceutical’s stock price soared fivefold in four months, and the company's management sold a large number of company stocks in July 2020 at the peak price. During a phone interview with Daily Pharm, an official from Il-Yang Pharmaceuticals’ explained, “The investigation is currently complete, and the results are expected to come out soon. We have fully explained the company's position to the police." The official emphasized, “We have never exaggerated clinical data nor misled the public. Also, our management has never sold a large amount of stock.” “The manipulation of clinical data or sales of stock by management are all just accusations that were made unilaterally by some investors. The investigation was carried out because these investors repeatedly filed claims to the police.” “All clinical trials have the potential to fail. Failing a trial is not a crime. Also, we are not the only COVID-19 treatment developer that failed its clinical trial.” In March, in the early stages of the COVID-19 pandemic, Il-Yang Pharmaceutical announced in-vitro trial results that showed that the company’s leukemia treatment Supect reduced COVID-19 infection. Then, the company received approval to initiate a Phase III trial in Russia through the local pharmaceutical company, R-Pharm. In March of the following year, Il-Yang Pharmaceutical officially announced that it will abandon development as the company wasn’t able to demonstrate the drug’s efficacy in its Phase III trial in Russia.
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- Pharmaceuticals trying to dominate Saxenda obesity market
- by Moon, sung-ho Oct 04, 2022 06:07am
- The pharmaceutical and bio industries' offensive toward the obesity treatment market is getting stronger day by day. It is making all-out efforts to judge obesity as a second "endocrine" market such as diabetes. Domestic pharmaceutical companies are also continuing to move beyond Saxenda and Qsymia, which are active in the domestic obesity treatment market. As it is related to other endocrine markets such as diabetes, pharmaceutical companies are more actively courting endocrine physicians who directly prescribe it, judging it as a market that can never be missed. According to IQVIA, a drug research institute on the 13th, Saxenda, and Qsymia are still active amid the growth of the obesity treatment market. The growth of Saxenda, which is at the forefront of sales, was remarkable. Sales of Saxenda in the first half of last year were 25.8 billion won, up 55% from the same period last year (16.7 billion won). If this continues until the second half of the year, it is worth expecting sales of more than 50 billion won as a single item. Qsymia, which used to threaten Saxenda, also recorded sales of nearly 14.2 billion won in the first half of this year, up 10% from 12.9 billion won a year earlier. However, the growth rate is relatively slow compared to Saxenda. Sales of the remaining obesity treatments such as Dietamin and Hutermine have rather slowed down. Focusing on the opening price, it was pointed out that the reason behind the surge in Saxenda sales was the influence of Corona and the cheaper price. Obesity treatment is a representative non-reimbursed market, and the average price of Saxenda has been up to 150,000 won, but recently, 70,000 to 80,000 won has been formed depending on the region, said the internal medicine director, who asked not to be identified. Hwang Hee-jin, a professor at the International St. Mary's Hospital (Family Medicine), an executive of the DAOR, said, "The Ministry of Food and Drug Safety has taken precautions against some doctors as it strengthened the management of psychotropic drugs," stressing, "It has no choice but to affect doctors' prescriptions." Amid the formation of obesity treatments centered on Saxenda and Qsymia, pharmaceutical companies are actively courting clinical field doctors to enter the market. As obesity is the cause of endocrine diseases such as diabetes, various measures are being devised to target endocrine doctors who are in charge of related treatment. # ICOMES 2022, which was recently held in a hybrid form, also revealed the will of pharmaceutical companies to the treatment market. Although most of the sessions were centered on online viewing, 37 domestic and foreign pharmaceutical companies, including Novonordisk Pharmaceutical and Chong Kun Dang, are actively setting up on-site booths and promoting the company's products. In addition to obesity treatments such as Saxenda, other diabetes treatments or treatment devices such as continuous blood glucose meters were set up to explain the product. In the case of booths by on-site pharmaceutical companies, the ratings were divided and arranged according to the level of sponsorship, according to pharmaceutical company officials who participated on the site. In other words, the higher the sponsorship rating, the better the location in the exhibition hall and the booth was installed. The pharmaceutical industry called the Obesity Society the "Second Endocrine Society" and evaluated it as a representative domestic society that has grown rapidly in a short period of time. At the same time, it is predicted that pharmaceutical companies' competition to sponsor academic organizations will intensify day by day due to the expansion of the obesity-related treatment market. Recently, it is specifying strategies for domestic companies to enter the market as well as Lilly's Tirzepatide, which is expected to be a new drug for diabetes and obesity centered on domestic academia. Starting with Hanmi Pharmaceutical's GLP-1 treatment Efpeglenatide, YH34160 of Yuhan Corporation GLP-1 series is also undergoing preclinical treatment. Kwangdong Pharmaceutical, which has Contrave, recently started joint development of an obesity treatment with QuadMedicine, a microneedle platform company. It is administered with a patch.
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- Industry requests re-revision of the PE exemption standards
- by Eo, Yun-Ho Sep 30, 2022 05:54am
- The pharmaceutical industry raised opposition to the government’s proposed amendment to the insurance reimbursement system. According to industry sources, the Korea-Research Based Pharmaceutical Industry Association (KRPIA) submitted an opinion statement to the government regarding the pre-announced ‘Proposal for Partial Amendment to the Regulations on the Evaluation Standards and Procedures to Determine Eligibility for Reimbursement Benefits.’ In the statement, KRPIA requested revisions to the special exemption of pharmacoeconomic evaluations exemption system’s ▲‘few patient’ requirement ▲benefits for pediatric patients, etc. Korea Pharmaceutical and Bio-Pharma Manufacturers Association is also expected to submit a written opinion by the deadline, which is today (30th) to relay the same opinion as KRPIA. The two associations, which usually had different positions on government policies, seem to agree on this case. First, the KRPIA clearly expressed its opposition to the improvement plan that includes the "few subject patients" as a prerequisite. The improvement plan brought concern in the industry due to the fact that a major premise for the PE exemptions has also been changed. The condition had previously been an “OR” clause included in Article 2(c) of eligibility for PE exemption regulations, along with other clauses such as ‘if a single-arm study was conducted,’ etc. The association requested the government to maintain the regulation in its current state. KRPIA said, “Drugs that fall under Item 2(a) and 2(b) that have difficulty generating evidence were eligible for PE exemptions even if they were not used to treat ‘few’ patients. However, the revision mandates the ‘few’ condition to be met. This will only reduce the scope of eligible subjects.” The association also added that expanding the scope of PE exemption to pediatric patients, which the government had heralded as the purpose of the revision, also needs additional improvements. The government added a clause allowing PE exemption for ‘drugs used to treat pediatric patients that are therapeutically equivalent or has no available treatment option; and demonstrates improvement in quality of life or is otherwise approved by the committee.’ In essence, the added clause excluded the “life-threatening disease” condition for PE exemptions just for pediatric patients. In other words, if drugs used for pediatric patients satisfy the remaining conditions, the PE exemption may be applied even if the condition is not life-threatening. However, the industry’s opinion is that the application of the standard should be extended. Through the written opinion, the KRPIA stated, “The government had first discussed expanding coverage to diseases that affect a small number of patients and bring a very poor quality of life even if they are not life-threatening in consideration of the characteristics of rare diseases. However, the benefit expansions made to pediatric patients or just main indications is limited and does not align with the government’s initial purpose.” To what extent the KRPIA and KPBMA’s opinions will be reflected remains to be seen. The Ministry of Health and Welfare and other subordinate institutions have been cautious about expanding the scope of the PE exemption system.
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- development of Korea-Japan, the efficacy of COVID-19 drugs
- by Kim, Jin-Gu Sep 30, 2022 05:53am
- Capture the Shionogi homepage. The difference in clinical design from Lagevrio and Paxlovid and the stop of the spread of COVID-19 are also variables. The results of phase 3 clinical trials of Xocova, a candidate for oral COVID-19 treatment under joint development by Ildong Pharmaceutical with Shionogi, Japan, have been announced. In the pharmaceutical industry, it is interpreted that it is one step closer to approval for emergency use in that it has produced meaningful results in shortening the period of symptom improvement, the primary evaluation variable. Some predict that it is difficult to guarantee Emergency Use Authorization because there is a difference in clinical design from Emergency Use Authorized MSD's Lagevrio and Pfizer's Paxlovid, and there was no permission or approval from the U.S. and Europe. ◆Xocova, similar mechanism to Paxlovid, clinical design is different Shionogi announced the results of phase 3 clinical trials of Xocova on its website on the 28th. In a clinical trial of 1,821 mild and moderate patients in Korea, Japan, and Vietnam, patients who administered Xocova showed significantly lower time than those who administered placebo until the five major symptoms of COVID-19 (nose congestion, runny nose, sore throat, cough, and fever) subsided. The time to suppress symptoms was 167.9 hours (about 7 days) in the group administered low dose Ensitrelvir and 192.2 hours (about 8 days) in the group administered placebo. The results of examining how much viral RNA was reduced on the 4th day of administration also showed that the Ensitrelvir administration group decreased significantly compared to placebo. Xocova is designed to block the activity of 3CL protease, a key enzyme needed when the COVID-19 virus (SARS-CoV-2) proliferates in cells. The mechanism is similar to Xocova and Paxlovid, but there is a large difference in clinical design. In the case of Paxlovid, the risk of hospitalization and death decreased by 89% as of the 28th day of administration. As of the 29th day of administration, Lagevrio's risk of hospitalization and death decreased by 30%. There is also a result that additional clinical trials conducted in India and other countries showed 65% effect. Xocova is expected to be less burdened by taking drugs than Paxlovid and Lagevrio. Paxlovid and Lagevrio have many drugs to take at once. Paxlovid is taken twice a day for a total of 5 days as a set of Nirmatrelvir and Litonavir. The total number of pills to be taken for five days is 30. 4 capsules of Lagevrio is taken twice a day for 5 days. The total number of pills taken during the treatment period amounts to 40 capsules. Xocova is taken once a day for a total of 5 days. The number of pills to be taken per episode has not been clearly determined, but it is known that three tablets are taken on the first day and one tablet is taken every day since then. If Xocova is approved EUA in Korea, it will be the third drug for oral COVID-19. The Ministry of Food and Drug Safety conducted EUA on Paxlovid in December last year and Lagevrio in March this year. In the case of Paxlovid, the EUA was decided five days after the request of the Korea Centers for Disease Control and Prevention (December 22, 2021). It is only 48 days, including the period of preliminary review by the Ministry of Food and Drug Safety. Lagevrio took a total of 127 days from the request of the Korea Centers for Disease Control and Prevention (November 17, 2021) to the EUA decision of the Ministry of Food and Drug Safety. Considering the previous cases, Xocova is also expected to take two to four months to make the EUA decision. However, the pharmaceutical industry's prospects are mixed as to whether the Ministry of Food and Drug Safety will finally decide Xocova's EUA. A pharmaceutical industry official said, "When Japan withheld its judgment on EUA in July, we agreed to wait for phase 3 results to see more accurate data and make a final decision," adding, "We confirmed the effect of improving symptoms through large-scale clinical trials, so the possibility of EUA in Japan has increased. If the EUA is decided in Japan, it will also help the EUA in Korea, he predicted. Some predict that the EUA will be difficult considering the domestic COVID-19 epidemic. Paxlovid & Lagevrio Shionogi applied for Xocova's conditional permission to the Japanese Ministry of Health, Labor and Welfare in February this year. Since then, the EUA application bill in Japan has been passed, and in June and July, the Ministry of Health, Labor and Welfare and Food Sanitation Council discussed whether to do so. The Pharmaceutical Affairs Council mainly said, "It is effective in reducing the amount of the virus, but there is not enough data to improve clinical symptoms." In Korea, Ildong Pharmaceutical plans to launch EUA regardless of Shionogi. In August, domestic clinical trials were completed. Ildong Pharmaceutical plans to apply for EUA in Korea by submitting the results of phase 3 clinical trials in Japan along with domestic clinical results.
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- 1st KRAS drug Lumakras can be prescribed at general hospital
- by Eo, Yun-Ho Sep 29, 2022 05:50am
- Lumakras, the first targeted anticancer therapy to target the KRAS mutation, can now be prescribed at general hospitals in Korea. According to industry sources, Lumakras (sotorasib), Amgen Korea’s treatment for locally advanced or metastatic non-small cell lung cancer with KRAS G12C mutations, passed the drug committees of the Big 5 tertiary hospitals in Korea including the Samsung Medical Center, Seoul National University Hospital, Seoul Asan Medical Center, and Sinchon Severance Hospital, as well as other medical institutions nationwide, such as the Gangnam Severance Hospital, Korea University Anam Hospital, National Cancer Center, Seoul National University Bundang Hospital, Chungnam National University Hospital, Kyungpook National University Chilgok Hospital, and Chonnam National University Hwasun Hospital. Considering that the drug was approved in Korea in February and not listed for reimbursement yet, the drug is quickly settling in medical institutions in Korea. Amgen is currently preparing for its reimbursement in Korea. Lumakras is approved for use as second-line or subsequent treatment in adult patients with KRAS G12C-mutated, locally advanced, or metastatic non-small cell lung cancer. Lumakras is the first targeted therapy to be approved by the Ministry of Food and Drug Safety for KRAS G12C NSCLC patients. KRAS is one of the major oncogenes is found in various cancers including NSCLC and is present in 25% of all NSCLCs. It is the second-most common mutation that occurs in Asian patients after EGFR mutations. NSCLC patients with the KRAS G12C mutation have shown a lower relative survival rate than other lung cancer patients in surgery or chemotherapy as many are resistant to existing standard therapies. Lumakras is the first-ever oral treatment that selectively inhibits the KRAS G12C mutant protein that is involved with the development of lung cancer. It inactivates the KRAS G12C mutant protein that promotes tumor growth to effectively block the signaling oncogenic activity without affecting the wild-type KRAS. Professor Myung Ju Ahn from the Samsung Medical Center said, “KRAS G12C-mutated NSCLC is an area where a dire need remained for a new treatment option. The domestic approval of Lumakras, the first targeted therapy for KRAS G12C mutated NSCLC, is news that both the patients and the field have been long awaiting for. Based on the excellent treatment effect and safety profile confirmed in clinical trials, Lumakras is expected greatly contribute to improving the prognosis of patients if introduced to the field.” Meanwhile, the efficacy of Lumakras was demonstrated through the Phase II CodeBreaK100 trial that included 124 patients with KRAS G12C-mutated locally advanced or metastatic NSCLC. Patients enrolled in the trial had all progressed after chemotherapy or immunotherapy. Results showed that the overall response rate (ORR) that includes both partial and complete responses was 36%. Also, 82.3% of the patients treated with Lumakras showed tumor shrinkage, with a media maximum tumor shrinkage of 60% in all responsive patients, showing a consistently high treatment effect.
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- Ildong applies to change trial protocol after completion
- by Kim, Jin-Gu Sep 29, 2022 05:50am
- Ildong Pharmaceutical and Shionogi Pharmaceutical submitted an application to modify their clinical trial protocol after completing the Phase 3 trial for their COVID-19 treatment. The industry saw this as Shionogi Pharmaceutical’s intent to reinterpret the clinical trial results around the Omicron variant. On the 27th, Ildong Pharmaceutical publicly announced that it applied to modify the Phase 2/3 clinical trial protocol for its oral COVID-19 treatment candidate 'S-217622 (brand name: Xocova).’ According to the public announcement, the biggest change was made in Cohort A’s Phase III trial size that is being conducted on moderate-to-severe COVID-19 patients. Cohort A’s Phase 2b trial size had been 428, and Phase 3 1821. Through the modification, Ildong and Shionogi decided to increase the Phase 2b trial size for Cohort A to 435, and reduce the Phase 3 trial size to 780. The size of Phase 2b and Phase 3 trials for Cohort B, which are being conducted concurrently and enrolled asymptomatic and mild COVID-19 patients, will also be reduced from 605 to 495. However, the number of participants enrolled in Cohort A and Cohort B are not that different in Korea, 204 and 200, respectively. The reason why the modification application had been receiving interest was that the two companies had already completed the global Phase III trial for Xocova. The two companies completed observation of the final trial participant on August 14th and submitted the clinical trial completion report to regulatory authorities. This is why the industry analyzes the companies’ applied for the change to reinterpret the clinical trial results, focusing on the Omicron variant. When the clinical trial was first designed, the company enrolled COVID-19 patients infected with the original (Wuhan) strain and Omicron variant in Korea. However, as time went by, the Omicron variant became the dominant strain, which naturally shifted the treatment target to the Omicron variant as well. At the same time, some industry experts analyzed that the reinterpretation of clinical trial results was Shionogi’s strategy to raise the possibility of receiving Special Approval for Emergency in Japan. Shionogi submitted an application for the conditional approval of Xocova to Japan’s Ministry of Health, Labor and Welfare in February this year. After the bill for the Special Approval for Emergency was passed in Japan, emergency use of Xocova had been discussed by MHLW’s expert committee. However, the conclusion was for the agenda to be redeliberated by MHLW’s Pharmaceutical Affairs and Food Sanitation Council. Although a second discussion was made by the council in July, the council decided to further discuss the issue in the future. An official from Ildong Pharmaceutical said, “The application for modification that was submitted this time was led by Shionogi. The company is known to have filed the application to re-review the result around subjects affected by the Omicron variant in line with the current situation where the Omicron variant is the dominant strain.”
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- FDA approved Celltrion's anticancer drug Avastin biosimilar
- by Chon, Seung-Hyun Sep 29, 2022 05:50am
- The 3.6 trillion won U.S. market has begun in earnest. Celltrion announced on the 27th that it has obtained a license from the Food and Drug Administration (FDA) to sell the Avastin biosimilar Vegzelma. Vegzelma has been approved for Avastin's indications, including metastatic direct bowel cancer, non-small cell lung cancer, metastatic renal cell cancer, cervical cancer, epithelial ovarian cancer, ovarian cancer, ovary cancer (uterine cancer), primary peritoneal cancer, and circulating glioblastoma. Since August, Celltrion has sequentially obtained sales licenses for Vegzelma from regulators in major global countries such as Europe, the United Kingdom, and Japan. According to IQVIA, a global pharmaceutical market research firm, Avastin's global market reached $6.43 billion last year. The U.S. market is about $2.62 billion, the largest in the world, on a single scale. Celltrion plans to quickly settle Vegzelma in the global market with cost competitiveness from its own drug development and production know-how. Celltrion completed a global patent agreement with Genentech, the developer of original drug Avastin, in May and laid the foundation for stable launch of Vegzelma in the global market. Celltrion Healthcare, which is in charge of selling and marketing Celltrion products, plans to launch Vegzelma in the global market sequentially, including major European countries in the second half of this year. An official from Celltrion explained, "We have obtained all the permits from major countries such as Europe, the United States, and Japan, and are ready to target Vegzelma's global market." He said, "We will do our best to settle in the global market as soon as possible with Vegzelma's cost competitiveness, and to proceed with clinical trials and permits of other biosimilar products currently being developed."
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- Daewoong Pharmaceutical SGLT-2 Diabetes New Envlo
- by Kim, Jin-Gu Sep 28, 2022 06:06am
- Daewoong Pharmaceutical has registered a trademark of Enavogliflozin, which is being developed as a new drug for treating diabetes in the line of SGLT-2 inhibitors. Daewoong Pharmaceutical temporarily confirmed the name of the single, second, and third complex series centered on Enavogliflozin as Envlo, and began the last-minute work with the aim of approving items in the first half of next year. According to the pharmaceutical industry on the 28th, the Korean Intellectual Property Office recently decided to register the trademark Envlo applied for by Daewoong Pharmaceutical. Daewoong Pharmaceutical applied for this trademark late last year. At that time, Daewoong Pharmaceutical also applied for the brand ENAZIN, ENAVOX, and BENAVO at the same time. This year, it applied for additional trademarks such as Enaflo, Eaglex, Glucut, Imabec, Imatin, and Imatide. All of these trademarks are confirmed to have applied for "drugs for treating diabetes" as designated products No. 1. Among them, Daewoong Pharmaceutical finally decided to use the name Envlo after an internal review. The rest of the applied trademarks are expected to be used as the names of drugs with the same ingredients of related companies such as Daewoong Bio and Hanol Biopharma. Daewoong Pharmaceutical recently applied for the trademarks ENVLOMET and ENVLOJEM. It is interpreted that Daewoong Pharmaceutical is likely to be a strong brand name in that it is conducting clinical trials of Metformin combi and Metformin and Gemigliptin 3 combi drugs at the same time with Enavogliflozin. Daewoong Pharmaceutical plans to continue its plan to license items and release products after trademark registration. Daewoong Pharmaceutical applied for an item permit for Enavogliflozin in April. It then plans to release a single and complex system in the first half of next year after obtaining an item license in the second half of this year. Earlier, in the first quarter of this year, the results of the phase 3 clinical top-line for Enavogliflozin and combination therapy were announced, and statistical significance of the difference in HbA1c change in monotherapy and safety in combination therapy were confirmed.
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- 4th JAKi Cibinqo makes a step towards reimbursement
- by Eo, Yun-Ho Sep 28, 2022 06:06am
- The 4th JAK inhibitor, Cibinqo, is nearing insurance reimbursement in Korea. According to industry sources, Pfizer Korea’s new Janus kinases (JAK) inhibitor ‘Cibinqo (abrocitinib)’ passed the review of the National Health Insurance Review and Assessment Service’s Drug Reimbursement Standard Subcommittee. The company applied for Cibinqo’s reimbursement in April. Its competitors -’ Lilly Korea’s ‘Olumiant (baricitinib)' and Abbvie’s ‘Rinvoq (upadacitinib)’ – have already been receiving reimbursement for the atopic dermatitis indication since May. Considering how the company made the strategic move to accept the weighted average price of its alternative drugs, its progress is not on the faster side. However, as the remaining steps to reimbursement can be accelerated with the will of the pharmaceutical company, Cibinqo’s may be launched with reimbursement within this year. Cibinqo is a JAK1 inhibitor that modulates multiple cytokines involved in the pathophysiology of atopic dermatitis, including interleukin IL-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP), etc. It is indicated for the treatment of adults and adolescents over the age of 12 with moderate-to-severe atopic dermatitis. Cibinqo demonstrated its efficacy through the Phase III trials JADE MONO-1, MONO-2, COMPARE, etc. The drug reduced the Eczema Area and Severity Index (EASI) by over 70% at Week 12 and demonstrated improvement in itch relief within 2 weeks after initiating treatment. Its pivotal study, JADE Mono-1, was designed to evaluate the efficacy and safety of two doses (100 mg and 200 mg once daily) of Cibinqo monotherapy vs placebo in randomly assigned patients 12 years of age and older with moderate-to-severe AD for 12 weeks. Results showed that 63% of the Cibinqo 200 mg administered group had achieved EASI-75 (improvement of at least 75% in lesion extent and severity) at week 12, which was a significant improvement compared to the 12% in the placebo group. Also, the rate of patients that achieved EASI-90 at week 12 had been 39% in the Cibinqo group, 5% higher than the placebo group
