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- 2026-03-17 09:48:45
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- Rising COVID-19 cases impede progress of bioequivalence test
- by Chon, Seung-Hyun Apr 08, 2022 06:08am
- Pharmaceutical companies are having trouble conducting bioequivalence tests for the development of generics due to COVID-19. The spread of COVID-19 has made it difficult for companies to recruit subjects, and even those recruited are dropping out after being confirmed with COVID-19, causing disruptions in the companies’ schedules. With delays inevitable due to the unexpected pandemic, pharmaceutical companies have been asking authorities to extend the drug pricing reevaluation deadlines that were set for February next year. According to industry sources on the 8th, several pharmaceutical companies have expressed their difficulties in progressing their ongoing bioequivalence tests due to the surge of COVID-19 cases. With hundreds of thousands of people being confirmed with COVID-19 every day, recruiting patients for the bioequivalence test itself is difficult. According to KDCA, 1,683,111 people were confirmed with COVID-19 over the past 1 week since the 6th. With over a million people in self-isolation due to COVID-19, the companies are complaining of difficulties in recruiting necessary subjects. With subject requirements are already stricter than before, difficulties in recruiting subjects for bioequivalent tests have been ongoing for some time. In accordance with the revised Pharmaceutical Affairs Act passed by the National Assembly in November 2018, people who have no experience participating in a clinical trial within 6 months prior to the trial date should be selected as subjects for clinical trials. With the restriction period extended from 3 months to 6 months. the number of participants viable for the tests has also decreased significantly. Also, even the registered subjects are frequently leaving trials to COVID-19. This renders it difficult to conduct a normal bioequivalence test due to the lack of subjects. The drug equivalence standards require 12 or more people in each group -the test group and control group for bioequivalence tests. This means the bioequivalence tests cannot be conducted unless over 24 people register for the tests. If subjects in the test group or control group are reduced to less than 12 due to COVID-19, the bioequivalence test itself may turn to waste. The companies can increase the test group or control group can by recruiting additional subjects, but this would inevitably push back the schedule. An official from a pharmaceutical company said, “We are planning to recruit more subjects than originally planned due to the rapid increase in the number of confirmed COVID-19 cases, but it isn’t easy. Even those who already registered are leaving trials after being confirmed with COVID-19, so we’re having much difficulty conducting the required bioequivalence test” Also, if the fallouts are concentrated in a specific group, such as the control or test group, the test itself may not derive significant results. For example, if 30 people were recruited for each group but 15 people from the test group leave due to COVID-19, the reliability of the test statistics may be undermined. Pharmaceutical companies have also had difficulty conducting bioequivalence tests in the early stages of the COVID-19 pandemic. In the early stages of the outbreak in 2020, the tests had been delayed with medical institutions discontinuing face-to-face work related to bioequivalence tests such as administration, screening, and monitoring. The main reason why pharmaceutical companies are expressing concern over their difficulties is because of the pressing deadline of the drug pricing re-evaluations for generic drugs. The Ministry of Health and Welfare announced a plan to re-evaluate the price ceiling of drugs, under which generics that do not meet the highest-price requirements in June 2020 are required to submit data on their ‘performance of bioequivalence tests’ and ‘use of registered APIs’ by February 28th, 2023 to maintain their previous drug price. This is a follow-up measure to apply the new drug pricing system which took effect in July 2020 to registered generic products. Under the revised drug pricing system, generic products can only be priced at the maximum price, which is 53.55% of the original drug’s price before patent expiry only when it satisfies both the requirements – directly-conducted bioequivalence tests and the use of registered raw materials. If either of the requirements is not met, the price cap is lowered by 15%. This means that a generic, which is approved by consigning the entire process to other companies without developing or producing it, will receive a drug price discount and be set at 72.25% of the previous price cap. The requirement of using a registered raw material can be met by switching the API. Due to the revised law, companies were left to decide between accepting the drug pricing discounts or maintaining the previous price by conducting bioequivalence tests. This is why companies have been actively conducting bioequivalence tests on their registered generics. According to the Ministry of Food and Drug Safety, a total of 768 plans for bioequivalence tests were approved in 1.8 years from July 2020 to February this year, which averages at 38 plans per month. Compared to 445 (22 per month on average) that were approved during the 1.8 years prior to July 2020 (November 2018 to June 2020), this is a 72.6% increase. Over half of the bioequivalence test plans approved recently are for registered generics. Of the 51 bioequivalence test plans approved in February, 39 were already on sale as registered generic products. Most of the bioequivalence tests are being conducted for ‘'in-house conversion' of the generics to manufacture in their own companies. If the companies make generics through formulation research and conduct bioequivalence tests that demonstrate bioequivalence, the companies can avoid the price cuts by obtaining change approvals. If companies convert consigned manufacturing to in-house manufacturing while applying for license changes, the companies can satisfy the ‘conducting bioequivalence test’ condition. Whichever way, it is said that it takes up to six months or more for bioequivalence tests to be imitated and render results. However, if the bioequivalence test data cannot be submitted by February next year due to a delay in the test schedules caused by the surge in confirmed COVID-19 cases, generic drugs will have no choice but to bear the drug price cuts. This means that the price of generic drugs may be reduced by 15%, even after the companies spent a lot of money and effort to avoid such discounts.
- Company
- GC Pharma’s Hunterase ICV approved for P1T in Korea
- by Kim, Jin-Gu Apr 08, 2022 06:08am
- On the 7th, GC Pharma announced that it had received approval for a Phase I trial of its severe Hunter syndrome treatment ‘Hunterase ICV’ in Korea from the Ministry of Food and Drug Safety. Hunterase ICV comes in a new formulation that is inserted as a device in the head, through which a drug is directly administered into a patient’s cerebral ventricle. It overcomes the limitations of existing IV-type formulations that were unable to penetrate the blood brain barrier (BBB) and reach the cerebral parenchyma. The clinical trial will be conducted in 3 institutions in Korea - the Samsun Medical Center, Seoul National University Hospital, and Pusan National University Yangsan Hospital – on 12 patients with a severe type of Hunter syndrome to evaluate the safety and efficacy of the drug. GC Pharma said that the unmet medical need is high in the area as 70% of the patients have the severe, neuropathic form of Hunter syndrome. An official from GC Pharma said, “We will continue our efforts to improve the quality of life of our rare disease patients. As the product has already been successfully commercialized abroad, we will make the best effort so that the drug could be supplied to our patients in Korea as soon as possible.” GC Pharma received marketing authorization for ‘Hunterase ICV,’ the world’s first treatment for sever-type Hunter syndrome in Japan in January last year. In a clinical trial conducted in Japan, "Hunterase ICV" significantly reduced ‘heparan sulfate (HS),’ a key substance that causes central nerve damage, and demonstrated an effect in maintaining and improving the developmental age.
- Company
- Yuhan's gastric atony tx has completed the registration
- by Nho, Byung Chul Apr 08, 2022 06:08am
- Yuhan Corporation (CEO Cho Wook-je) announced on the 6th that it has completed the first patient registration in phase 2A of clinical trial for patients with gastric atony of the new drug candidate "YH12852 (PCS12852)" exported by Technology to Processa Pharmaceuticals. Gastric atony is a chronic gastric motor disorder that causes severe heartburn, nausea, vomiting, and bloating due to delayed gastric emptying. In the United States, millions of patients suffer from dysentery, and there is a high demand for more effective treatment development. Currently, the only FDA-approved gastric atony treatment is Metoclopramide, a dopamine D2 receptor antagonist. However, the drug has been approved only for diabatic gastric atony and has a limited duration of up to 12 weeks due to serious potential side effects. Although past 5-HT4 agonists are effective, they bind non-selectively to other 5-HT receptors, resulting in serious side effects. YH12852 developed by Yuhan shows more than 200 times higher binding power to 5-HT4 receptors than other 5-HT receptors and has excellent selectivity and efficacy. Preclinical and clinical studies using YH12852 also showed minimal side effects in effective doses, so more clinical results are expected. Dr. Sian Bigora, head of development at Processa Pharmaceuticals, said, "We expect that this clinical 2A will have a similar effect on the gastric emptying rate of patients with gastric atony, as we confirmed that the gastrostomy rate was significantly improved while using YH12852 for constipation patients." He said, "The results of this study will provide important data to confirm the effect of YH12852 on the symptoms of patients with idiopathic and diabatic gastric atony, and will be useful for further designing clinical phase 2B." This clinical trial is a phase 2A clinical trial aimed at evaluating safety, pharmacokinetic properties, and efficacy of 13C-Spirulina Gastric Emptying Breath Test (GEBT) according to the dose of YH12852 in moderate or severe gastric atony patients, and will be conducted in a total of 24 patients in the U.S.
- Company
- Organon Korea "No NDPA detected in Singulair”
- by Apr 07, 2022 06:10am
- Organon Korea announced on the 6th that no impurities were detected in ‘montelukast,’ the active ingredient of the allergic rhinitis and asthma treatment ‘Singulair.’ Organon Korea had conducted an impurity investigation for N- nitrosodipropylamine (NDPA) in January after the Ministry of Food and Drug Safety ordered companies to investigate the possibility of impurities. The company had brought in the active pharmaceutical ingredient used for the manufacture of Singulair for investigations in Korea. The company used a liquid chromatography-mass spectrometry device (LC-MS/MS) that could detect minimal amounts of the impurity. The results of the investigation and assessment data will be submitted to the MFDS soon. NDPA is a type of nitrosamine impurity that can be formed in the presence of amines or amine sources together with nitrite or nitrite equivalent reagents. The company explained, "The process was not included in the montelukast synthesis process, and it was found that there is no possibility of cross-contamination in the final manufacturing process." The company had also reached the same conclusion in an impurity investigation conducted at the request of the European Medicines Agency (EMA) in 2019. Keon-Young Jung, Managing Director of Marketing at Organon, said, “Organon Korea has confirmed the safety of its products from impurities through evaluation of the manufacturing process and quantitative analysis on the API of all its formulations. We hope that the tests will help HCPs and patients to resolve concerns about impurities in the original Singulair.”
- Company
- Competition for Pelubi's generics worth ₩30 billion
- by Kim, Jin-Gu Apr 07, 2022 06:10am
- Pelubi It is expected that generic competition will take place in earnest in the Pelubi market, a osteoarthritis treatment worth 30 billion won per year. Following Youngjin Pharmaceutical, which launched generic alone, Huons and Chong Kun Dang are predicting their entry into the market. Daewon Pharmaceutical, which faces the challenge of generic, is in a situation where it is confronting each other by releasing follow-up drugs such as original formulation change and salt change products. ◆Generic for exclusivity of first generics ends According to the pharmaceutical industry on the 6th, the period of Youngjin's Pelubi will end on the 25th of this month. Phelps is the first generic of Daewon Pharmaceutical. Youngjin Pharmaceutical received generic for exclusivity. Accordingly, except for Youngjin Pharmaceutical, the other generic companies were not able to release the same-active ingredients within the generic for exclusivity period. Huons and Chong Kun Dang are expected to release Generics in earnest when Phelps' priority sales period expires on the 25th of this month. Like Youngjin Pharmaceutical, the two companies have surpassed patent of Pelubi. In April and May last year, generics for Pelubi received product approval, respectively. Huons has already received insurance benefits. When generic for exclusivity expires, generic can be released immediately within this month. Daewon Pharmaceutical, the original company, is developing strategies such as developing follow-up drugs and adding indications. Daewon Pharmaceutical plans to release Pelubi S, which was approved as a salt-changing product last year, soon. Daewon Pharmaceutical explained that it improved drug solubility and side effects of GI disorders through salt changes. In the case of Pelubi SR, which was released earlier, it already has more performance than Pelubi. According to UBIST, a pharmaceutical market research firm, Pelubi and Pelubi SR's outpatient prescriptions amounted to 32.5 billion won last year. Among them, Pelubi SR's prescription performance is said to account for about 70% of the total. It is analyzed that the addition of indications had a significant impact on the expansion of Pelubi SR's prescription performance. Daewon Pharmaceutical added "post-traumatic pain" as an indication of Pelubi SR in May 2020. It is an indication that Pelubi does not have. ◆ Unfinished patent dispute, Pelubi SR's New Patent Challenge Variables There are two main variables of generic competition in Pelubiprofen market in the future. One is the Pelubi patent dispute. Youngjin Pharmaceutical, Huons, and Chong Kun Dang won in the first trial, but Daewon Pharmaceutical objected to the decision. If Daewon Pharmaceutical wins, sales of Pelubi generic will be discontinued. Generics companies are also forced to compensate for damages caused by patent infringement is inevitable. There is a possibility that Daewon Pharmaceutical's delayed drug price reduction may be executed according to the subsequent ruling. Daewon Pharmaceutical filed a lawsuit with the Seoul Administrative Court to cancel the drug price reduction, dragging the patent dispute against Pelubi to the second trial. If Daewon Pharmaceutical loses in the second trial, the drug price of Pelubi will be reduced by 30%. Another variable is the new patent challenge for Pelubi SR. With Pelubi SR performing more than Pelubi, Huons, Chong Kun Dang, and Mothers are reportedly preparing to challenge composition patent of Pelubi SR . Mothers Pharmaceutical has already begun BA test of generics for Pelubi SR. Mothers Pharmaceutical was approved by the MFDS in July 2020 for a clinical trial for BA evaluation of Pelubi SR and Pelum SR.
- Company
- Sales of AZ COVID vaccine increased 32% to 655.3 billion won
- by Apr 06, 2022 06:05am
- AstraZeneca Korea surpassed 600 billion won in sales last year by supplying the COVID-19 vaccine. According to an audit report by AstraZeneca Korea, the company recorded 655.3 billion won in sales last year. The figure is up 31.6 percent from the previous year's 498.1 billion won. Operating profit was 26 billion won, up 7.5% from 24.2 billion won a year earlier. It is analyzed that the increase in operating profit was relatively small because there was little difference between the purchase amount and domestic sales amount purchased globally. AstraZeneca Korea, which has improved its performance with anticancer drug Tagrisso, saw its performance jump significantly last year when it supplied the COVID-19 vaccine AZD1222 in Korea. After gradually increasing sales to 383.1 billion won in 2018, 438.9 billion won in 2019, and 498.1 billion won in 2020, sales jumped more than 100 billion won last year when the COVID-19 vaccine was introduced in earnest. AstraZeneca started researching vaccines with a research team at Oxford University in the UK as COVID-19 spread around the world. In particular, it received attention by signing a contract with SK Bioscience, a Korean company, to produce the COVID-19 vaccine on consignment. Last year, SK Bioscience commissioned the production of AstraZeneca vaccine extract and the complement and supplied them to the global and domestic markets. The Korean government signed a purchase contract with AstraZeneca early last year and introduced the vaccine in earnest. At the beginning of the inoculation, when the supply and demand of the Pfizer vaccine were not smooth, AstraZeneca supplied most of the supplies. Although it received the EUA around the same time as Pfizer, the increase in AstraZeneca sales is relatively small. In the case of Pfizer Pharmaceutical Korea, which supplied the COVID-19 vaccine, sales reached a record high of 1.69 trillion won last year. The figure increased by 332.3% from 391.9 billion won in the previous year. Pfizer Pharmaceutical Korea generated about 1.3 trillion won worth of vaccine sales. The difference in vaccine supply had a significant impact on the performance of the two companies. This is because the use of the Astrazeneca vaccine has gradually declined as the number of vaccinations in Korea has been limited due to rare side effects, and the volume of modern and Pfizer vaccines has increased. According to the Korea Centers for Disease Control and Prevention, the total amount of Astrazeneca vaccinations over the first to third rounds is 20.32 million doses, which is one-third of Pfizer's 74.23 million doses. In the first inoculation, about 25% of the total were vaccinated against Astrazeneca, but in the third inoculation, only 4% were vaccinated against Astrazeneca. Vaccine prices have also led to differences in sales. According to the company's stance that it will not make profits from the COVID-19 vaccine, the price of the AstraZeneca vaccine was set at $4 per dose, the cheapest. It is only one-sixth the price of a Pfizer vaccine ($24).
- Company
- Sales of MSD in Korea exceeded 500 billion won
- by Apr 05, 2022 09:32am
- MSD Korea surpassed 500 billion won in sales last year. Keytruda's effect increased 1% year-on-year. Analysts say that it will be able to quickly recover its past sales of 800 billion won before Organon's spin-off. According to MSD audit report, the company recorded 541.9 billion won in sales last year. The figure is up 11.8% from the previous year's 486.8 billion won. During the same period, operating profit shifted from a deficit of 5.8 billion won to a surplus of 58 billion won. Sales of Keytruda, an immuno-cancer drug of MSD Korea, are evaluated to have been good. Keytruda's sales were not specified, but according to pharmaceutical research firm IQVIA, Keytruda surpassed 200 billion won in annual sales for the first time last year. The figure rose 28.5% to 2.1 billion won from the previous year's 155.7 billion won. The growth of Gardasil 9 and others also contributed to the expansion of sales. Based on IQVIA, Gardasil 9 recorded 72.6 billion won last year, up 70.9% from 42.5 billion won a year earlier. Another representative item of MSD Korea, the Januvia, reached 171 billion won in outpatient prescriptions last year. The expansion of MSD's performance is expected to continue in the future. This is because Keytruda's indication continues to expand, and from this year, it will be paid in the primary treatment of non-small cell lung cancer and the secondary treatment of Hodgkin's lymphoma. In fact, even when it was first listed in August 2017, Keytruda's sales rose vertically from 10 billion won to 100 billion won. At this rate, it is expected that the scale before the organon spin-off will be restored within a few years. According to an audit report by MSD Korea two years ago, when the obligation to disclose audit reports of limited companies was implemented, the sales of all companies of Organon spin off are estimated to be about 800 billion won. In the calculation of discontinued business profit and loss due to the division, the sales of organon products in the sales of organon products amounted to 326.8 billion won as of 2019. As of 2019, product sales of MSD accounted for 98% of total sales, and product sales are total sales. At that time, MSD's total sales amounted to 471.6 billion won. Operating profit turned into a surplus last year as other sales increased and management costs due to spin-off decreased. MSD Korea lost 18.4 billion won in 2019 and 5.8 billion won in 2020. Last year, other sales rose 42.8% year-on-year to 15.8 billion won, while sales and administrative costs fell 2.9% to 97.2 billion won. MSD Korea said, "Representative items such as Keytruda, Gardasil 9, and Januvia have driven sales growth, and we invested about 74.6 billion won in clinical research last year, up 33% from the previous year, which accounts for 13% of total sales."
- Company
- Imbruvica fails CDDC twice and reattempts 1st-line reimb.
- by Eo, Yun-Ho Apr 05, 2022 05:59am
- Once again, the blood cancer drug ‘Imbruvica’ is attempting to expand reimbursement to first-line treatment. According to industry sources, Janssen Korea has applied for the reimbursement extension of its Imbruvica (ibrutinib) as a first-line treatment for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Leukemia (SLL) to once again attempt at deliberations by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee. Imbruvica’s first-line indication was unable to pass deliberation by the CDDC twice, one of which was held in October last year. The company was able to receive reimbursement extensions to the second line after being listed through the PE exemption pathway but is having trouble extending its indication further into the first line. Therefore, how Janssen will progress discussions on reimbursement based on what adjustments remain to be seen. Imbruvica is a first-in-class oral Bruton's Tyrosine Kinase (BTK) inhibitor that is taken once daily. With its oral formulation, the drug has the strength of being able to be administered in the outpatient setting. Since it was approved in April 2018, the drug is being used as ▲ a second-line treatment for adult patients with CLL, ▲monotherapy for the treatment of adult patients over the age of 65 with previously untreated CLL, ▲in combination with obinutuzumab for the treatment of adult CLL patients over the age of 65 or those who have comorbidities or at high-risk and those under the age of 65 with previously untreated CLL. Meanwhile, CLL is a type of blood cancer that occurs mainly in adults over the age of 60, characterized by increased production of mature but dysfunctional B lymphocytes Around 120 to 130 patients are newly diagnosed with CLL every year, and 60-70% of the CLL patients in Korea are discovered in a state that does not require treatment. Like its name, this “chronic” condition progresses slowly, sometimes insignificantly for several years.
- Company
- AZ starts next-gen ADC dev with confidence from Enhertu
- by Apr 04, 2022 06:07am
- AstraZeneca is leading the next-generation ADC development environment. The company, which has successfully commercialized ‘Enhertu’ in partnership with Daiichi Sankyo, is targeting areas slow in development such as triple-negative breast cancer. On the 31st, AstraZeneca received approval for its Phase III trial of a new ADC drug last month. The new ADC drug subject to the trial is ‘datopotamab deruxtecan (DS-1062, hereafter datopotamab),’ a TROP2 targeting ADC that is being co-developed by AstraZeneca and Daiichi Sankyo. The Phase III trial for datopotamab will be conducted on patients with unresectable locally advanced or metastatic triple-negative breast cancer. The trial will evaluate the drug’s efficacy as a first-line treatment in patients who are not eligible for treatment using PD-(L)1 immunotherapies in comparison to chemotherapy. MoA of datopotamab(Source: Daiichi Sankyo) ADC is a next-generation drug that is produced by coupling a potent cytotoxic agent to a monoclonal antibody that binds to a specific antigen on the surface of a tumor cell. It minimizes the side effects while increasing the treatment effect by selectively working on cancer cells. Although ‘Kadcyla’ marked the start of the commercialization of ADC drugs, the drugs were unable to make significant performance in the earlier stages due to technical limitations. Since then, the development of next-generation ADCs, such as linkers that control the drug-antibody ratio (DAR) or enhance blood stability, is being developed in earnest. AstraZeneca already has experience commercializing an HER-2 targeted ADC, ‘Enhertu’ after signing a joint development agreement with Daiichi Sankyo. Enhertu had demonstrated superior efficacy over the early-generation ADC drug ‘Kadcyla’ as a second-line treatment in HER2-positive breast cancer. According to results from the DESTINY-Breast03 that was presented last year, Enhertu reduced the risk of disease progression and deaths by 72% compared to Kadcyla in the head-to-head trial. Also, the objective response rate (ORR) was significantly higher, 80% in the Enhertu group as compared to 34% in the Kadcyla group. The new ADC therapy that will be presented by AstraZeneca will target the field of triple-negative breast cancer that has poor prognosis. In the Phase I trial, datopotamab showed positive results with an ORR of 43% and DCR of 95%. If significant results continue on in the follow-up trials, AstraZeneca’s new ADC will likely compete with Gilead’s ADC therapy. Like datopotamab, Gilead’s ADC drug ‘Trodelvy’ also targets TROP2. Trodelvy was approved by the US FDA as a treatment for triple-negative breast cancer last April. AstraZeneca paid Daiichi Sankyo $1 billion (₩1.22 trillion) in upfront payment for the development rights of datopotamab. AstraZeneca will pay additional conditional amounts up to $6 billion according to the company’s achievement of development and commercialization milestones. In the past, AstraZeneca had signed a $6.9 billion (₩8.41 trillion) agreement with Daiichi Sankyo for the development rights of Enhertu. The company is also investigating using datopotamab in combination with its immunotherapy ‘Imfinzi’ in addition to another trial that assesses the effect of datopotamab in NSCLC. In addition to the ADC technology the company had bought from other companies, AstraZeneca is also developing a next-generation ADC using its linker technology, 'AZD8205.’ 'AZD8205 is a new drug candidate that targets overexpression of B7-H4 found in various solid cancers. The company plans to first disclose study results for AZD8205 at the ‘AACR 2022’ that will be held from the 8th.
- Company
- Keytruda, the primary treatment for esophageal cancer
- by Apr 04, 2022 06:07am
- Keytruda, an immuno-cancer drug of MSD, has become the primary option in esophageal cancer, where treatments have been limited. The medical team predicted that an immuno-cancer drug-oriented treatment strategy using Keytruda or Opdivo will be established depending on the PD-L1 expression rate. At a seminar to commemorate the expansion of Keytruda indications held online by MSD Korea on the 31st, Sun Jong-moo, a professor of hematological oncology at Samsung Medical Center, pointed out the meaning of the launch of Keytruda in esophageal cancer. He said, "As immuno-cancer drugs appear in esophageal cancer, treatment strategies are changing in the direction of considering using immuno-cancer drugs from the earliest stage possible depending on the PD-L1 expression rate of patients." Professor Sun Jong-moo of the Dept. of Hematology at SMC, who is presenting at the MSD Online Seminar in KoreaOn the 7th, the MFDS expanded indications for Keytruda in combination with chemotherapy in metastatic esophageal cancer and gastroesophageal junction cancer, which cannot be operated. Keytruda is the first immuno-cancer drug to be released in the primary treatment. Keytruda targets patients with positive PD-L1 expression. Esophageal cancer is largely divided into squamous epithelial cell cancer and adenocarcinoma, of which squamous epithelial cell cancer accounts for 90%. According to Professor Sun, esophageal cancer is considered a very difficult cancer, and if surgery is impossible, it should be treated with chemotherapy. However, when chemotherapy is used, mOS is only about 10 months. Although treatments have developed dramatically in various cancers over the past decade, esophageal cancer has continued for nearly 40 years. Keytruda significantly improved the therapeutic effect through a study on KEYNOTE-590, a licensed clinical trial. The mOS of Keytruda+anti-cancer chemotherapy group was 13.5 months, which was significantly longer than the control group (anti-cancer chemotherapy alone) of 5.5 months. Keytruda reduced the risk of death by 38%. mPFS also reduced the risk of disease progression or death by 49% compared to 5.5 months in the control group to 7.5 months in the Keytruda group. Keytruda previously put forward a distinctly different strategy from BMS's immuno-cancer drug Opdivo, which entered esophageal cancer. Opdivo can be used regardless of the PD-L1 expression rate, but can be used as a secondary treatment in patients who first used chemotherapy. Conversely, Keytruda was limited to PD-L1 positive patients, but acquired the status of primary treatment. Professor Sun said, "The current treatment that can be used in the primary esophageal cancer is a drug that has been used since the early 80s, and the demand for unmet was high." Professor Sun said, "Now that immuno-cancer drugs can be used in the first round, the treatment effect is expected to increase significantly," adding, "Medical staff also experienced that adding immuno-cancer drugs to chemotherapy does not significantly increase side effects, and the experience has been proven by clinical data."
