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- 2026-03-16 21:30:23
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- GC Pharma sells GSK's new shingles vaccine Shingrix together
- by Kim, Jin-Gu Oct 07, 2022 06:03am
- ShingrixGC Pharma and GSK will jointly sell the shingles vaccine Shingrix. The two companies are expected to sell a new shingles vaccine as early as the end of this year. According to the pharmaceutical industry on the 6th, GC Pharma and GSK recently signed a co-promotion contract for Shingrix and started product training for salespeople before its full-scale release. It is expected that the product will be released at the end of this year. GSK obtained Shingrix permission from the Ministry of Food and Drug Safety in September last year. It was originally planned to be released in February this year, but the schedule was delayed. Shingrix is a vaccine used to prevent herpes zoster in adults over the age of 50 and immunocompromised people over the age of 18. When Shingrix is released, it is expected to be the third shingles vaccine in Korea after MSD Zostavax and SK Bioscience's Sky Zoster. It is evaluated that the effect of preventing shingles confirmed in clinical trials is superior to that of the two existing vaccines. In Shingrix clinical trials (ZOE-50) for adults over the age of 50, the effect of preventing shingles was 97% at 3.2 years after vaccination. In clinical trials (ZOE-70) for those aged 70 or older, it was 90% at 3.7 years after vaccination. In the case of Zostavax, a competitive product, it has a preventive effect of 51% for those over 50 and 41% for those over 70. Sky Zoster demonstrated Zostavax and specific heat in clinical practice. It is analyzed that there is no significant difference from Zostavax in terms of prevention rate. GC Pharma has experience in co-selling MSD's shingles vaccine Zostavax in the past. Since 2013, GC Pharma has co-sold Zostavax for eight years until 2020 through a contract extension once after signing a co-promotion contract with MSD. In the process, Zostavax has grown into a large item with annual sales of 80 billion won. However, SK Bioscience launched its competitive product Sky Zoster at the end of 2017, and sales have decreased significantly since 2020 due to the prolonged Corona crisis. According to IQVIA, a pharmaceutical market research firm, Zostavax sales last year amounted to 27 billion won, down 68% in four years from 83.7 billion won in 2017. This year, sales were only 11.6 billion won until the first half of the year. The pharmaceutical industry expects Shingrix to lead the domestic shingles vaccine market to rebound. In the global market, Shingrix's sales, which had already been dampened by the Corona crisis, began to recover in the second half of last year. In the first half of this year, Shingrix's global sales were £1.429 billion, more than doubling compared to the same period last year. An official from GC Pharma and GSK Korea said, "There is nothing to mention regarding Shingrix's domestic sales."
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- Daewoong Pharmaceutical launches botulinum drug in the UK
- by Chon, Seung-Hyun Oct 06, 2022 06:05am
- The botulinum toxin drug developed by Daewoong Pharmaceutical has been released in earnest in the European market. Daewoong Pharmaceutical announced on the 5th that Nabota, a botulinum toxin drug, was officially released in the UK under the product name Nuceiva. It started selling in the UK last month through Daewoong Pharmaceutical's overseas partner Evolus. The UK is the largest single market in Europe, accounting for about 30% of the European botulinum toxin market worth 650 billion won per year. Evolus, a North American and European beauty indication partner of Daewoong Pharmaceutical, is in charge of Nuceiva's distribution and marketing in the UK. Evolus formed a strategic partnership with Wigmore, a local British distributor with a history of more than 35 years, and established a specialized distribution network. Since the beginning of this month, the latest knowledge and Nuceiva product training have been conducted for local medical personnel. Daewoong Pharmaceutical and Evolus will also enter other European countries with high marketability, such as Germany and Austria, to target the European market in earnest. Park Sung-soo, vice president of Daewoong Pharmaceutical, explained, "With the release of Nuceiva in the UK, we have officially entered the U.S. and Europe, the world's No. 1 and No. 2 botulinum pharmaceutical markets." "We will actively promote Nabota's excellent product power in the global market and contribute to enhancing K-Bio's status," he said.
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- ILSUNG signs 3rd generation CCB HTN tx co-promotion
- by Lee, Seok-Jun Oct 06, 2022 06:05am
- ILSUNG, Intro Bio Pharma, and Pharmavision, have signed a partnership for Azelnidipine copromotion. According to ILSUNG on the 4th, Intro Bio Pharma received the first approval in Korea for Azelnidipine-based medicine in September 2021. Azelnidipine is a third-generation CCB hypertension treatment (Calblock) developed by Daiichi Sankyo Korea in Japan. Compared to Amlodipine, it has excellent blood pressure drop effect and fewer side effects, so it is most commonly used in Japan along with ARB hypertension treatment. It is known to have an excellent blood pressure control effect when used in combination with ARB series. Intro Bio Pharma and Pharmavision selected ILSUNG, which has strength in general hospitals, as a partner for Azelnidipine. Amlodipine has recently passed the Pharmaceutical Affairs Evaluation Committee and is expected to be listed. What is unique about this three-way contract is that Pharmavision, a research, and development venture that was established in 2019 and has completed the transfer of about 20 pharmaceutical technologies to many pharmaceutical companies so far. Based on R&D technology, Azelnidipine cooperation between Intro Bio Pharma, a pharmaceutical R&D venture company Pharmavision, and ILSUNG, which is taking a leap forward through innovation, can be a new B2B model. Kim Byung-jo, head of ILSUNG's development division (executive director, Ph.D. ), said, "Azelnidipine can be a new alternative for hypertension patients who have difficulty controlling blood pressure with Amlodipine or Lercanidipine HCl CCB hypertension treatment." Through three-way cooperation, it will become a necessary and differentiated item for patients.
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- Koselugo is keen to discuss the registration of benefits
- by Eo, Yun-Ho Oct 05, 2022 06:11am
- Attention is focusing on whether Koselugo, a drug-free treatment for neurofibroma, will succeed in registering insurance benefits. According to related industries, AstraZeneca's new neurofibromatosis drug Koselugo is under final coordination at the Drug Benefit Standards Subcommittee. AstraZeneca quickly supplemented the data in May and resumed discussions on registration at the HIRA Drug Benefit Evaluation Committee in March. As it is a rare disease area where there were no treatment options, it remains to be seen whether Koselugo will be able to draw a decision this time. Neurofibroma has relied on symptomatic treatment without proper treatment. Neurofibroma is a rare disease in which tumors occur in nerve tissue, bones, and skin, and about 85% are type 1 in which the NF1 gene of the 17th chromosome long arm is mutated. This disease begins with 1~3cm sized cafe au lait macules appearing in children. It experiences symptoms such as brain tumors at the age of 6 and scoliosis at the age of 6 to 10. In adults, Lisch nodule, which occurs in the iris, is mostly found. It is a method of removing possible areas through surgery or chemotherapy and radiation treatment. However, most of the surgeries recur, and most of them are major surgeries, so both medical staff and patients are burdened. In particular, pediatric patients often have to take painkillers even after several surgeries and suffer from speech and motor disorders. Koselugo is a treatment jointly developed by AstraZeneca and MSD. It blocks MEK activity and inhibits cell line growth. In the SPRINT phase 2 clinical trial on which the permit was based, Koselugo reduced tumor size by more than 20% in 68% of administered patients, achieving the primary evaluation index, ORR. In addition, 82% of patients who showed partial reactions continued to respond for more than 12 months. Half of the patients who did not receive treatment suffered from disease progression after 1.5 years, and only 15% of the patients who used Koselugo developed the disease up to three years ago.
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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.
