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- 2026-03-17 09:48:44
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- Expanding Entresto benefits/maximizing tx for inpatients
- by Mar 29, 2022 05:53am
- Entresto, Novartis' chronic heart failure treatment, has expanded both indications and benefits. Enresto can be used even in patients with more than 40% and less than 60% of the ejection fraction, which has been in great demand. In addition, it is expected that Entresto's position will be further strengthened as hospitalized heart failure patients can use Entresto as a primary drug. Novartis Korea held an online press conference on the 24th to commemorate the expansion of Entresto benefits and indications. Kang Seok-min, a professor of cardiology at Yonsei University's Sinchon Severance Hospital, and Cho Hyun-jae, a professor of circulatory medicine at Seoul National University Hospital, attended to share the meaning of expanding benefits. rom the left, Park Soo-jin, director of the Cardiovascular Metabolism Division of Novartis Korea, Kang Seok-min, professor of cardiology at Yonsei University Sinchon Severance Hospital, and Cho Hyun-jae, professor of circulatory medicine at Seoul National University Hospital Entresto is the first Angiotensin receptor-Neprilsysin inhibitor (ARNI) treatment in Korea and the only new drug that works directly on the heart. It acts on cardiac nerve hormones in two ways to activate NP nerve hormones that are beneficial to cardiovascular systems, while suppressing RAAS that is harmful to cardiovascular systems. In February, Entresto added an indication of 'reducing the risk of death from cardiovascular disease and hospitalization due to heart failure' in patients with chronic heart failure with lower left ventricular systolic function than normal. Starting this month, for patients who have been hemodynamically stabilized after hospitalization due to acute non-compensatory heart failure, salaries have also been expanded to those without ACE inhibitors or angiotensin II receptor blocking. Entresto can be reimbursed as a primary drug for inpatients. According to Professor Kang Seok-min, 83% of patients with chronic heart failure are hospitalized more than once for acute heart failure, and one in four patients is hospitalized again for 30 days after discharge. Up to 10% die. Effective initial treatment that can reduce re-hospitalization is important. Entresto is recommended as a standard treatment in domestic and foreign heart failure treatment guidelines, but it was difficult to use it initially in Korea as a limited standard. Professor Kang said, "Inpatients have not been able to use Entresto in the first round, but clinical studies have supported the importance of using drugs that can reduce mortality at the time of hospitalization," adding, "Now domestic inpatients are expected to use Entresto to significantly reduce re-entry and mortality." Entresto has also expanded its use in patients with a heart rate of more than 40% to less than normal (about 60%), which has been in unmet demand. Reduced hardness of ejection rate and some conservative patients can be treated with Entresto. Throughout this, Entresto has become the drug with the widest range of chronic heart failure indications in Korea. Entresto showed the greatest clinical effect in patients with a heart rate of 60% or less. Professor Cho Hyun-jae said, "When looking at the left ventricular ejection rate according to the quintile, it showed a consistent positive effect from less than 25% to less than 60%," adding, "9.6% of patients who preserved the ejection rate were progressing heart failure a year later. There have been many studies so far, but Entresto is expected to benefit from proving its effectiveness for the first time." Professor Cho then said, "Recently, SGLT-2 inhibitors have also shown some effects in preserving the ejection rate," adding, "Entresto and SGLT-2 inhibitors play different roles in three axes of heart failure treatment. Therefore, since the two drugs are not in a substitute relationship, but in a complementary relationship, standard treatment will move toward using Entresto and SGLT-2 together in the future, he added. Entresto surpassed 30 billion won in outpatient prescriptions within five years of its launch. Last year, prescriptions amounted to 32.3 billion won, up 37.3% from the previous year.
- Company
- Four types of PE exemption drugs listed in one month…
- by Eo, Yun-Ho Mar 28, 2022 06:10am
- Coverage expansions of new drugs continue to be reported. In fact, four new drugs were successfully listed last month. According to industry sources, starting with Astellas’ ‘Xospata (gilteritinib)’ in March, Novartis’s ‘Kymirah (tisagenlecleucel),’ Roche’s ‘Rozlytrek (entrectinib),’ Bayer’s ‘Vitrakvi (larotrectinib)’ were listed as new drugs under the pharmacoevaluation exemption track. Despite the difficulties faced during discussions, all the drugs were successfully listed in the end. ◆'Xospata’ resolves the unmet needs in leukemia Xospata is the first treatment approved for FLT3mut+ relapsed/refractory Acute Myeloid Leukemia (AML). The drug, which was approved in March 2020, passed the Health and Insurance Review Service’s Drug Reimbursement Evaluation Committee on the 9th last year, and then started negotiations with the National Health Insurance Service in October of the same year, Although the parties were unable to reach an agreement within the set negotiation period (60 days) and extended the period once more to reach an agreement. Xospata was approved early this month. As a newly introduced treatment option, the public’s interest in on Xostapa’s reimbursement. In fact, the Korea Organization for Patient Group had delivered the opinion on the accelerated reimbursement of new drugs including Xostapa at a roundtable meeting with the MOHW’s Department of Pharmaceutical Benefits. ◆ GOV and company promptly works for the reimbursement of ' Kymriah' The reimbursement of the ultra-high-priced one-shot CAR-T therapy Kymriah has been successfully achieved with the efforts of the government, pharmaceutical company, and the patient. This drug started its reimbursement listing process with the MFDS approval through the approval-reimbursement evaluation linkage system in March last year. Although the agenda was listed for review by the Cancer Disease Deliberation Committee six months later, it was deferred at the time. As soon as the deferral was disclosed by the press, the Korean Alliance of Patient Organization issued a statement criticizing the government and the company. KAPO had previously criticized the delay in deliberations of the agenda by the Cancer Disease Deliberation Committee. As a result, Kymriah passed CDDC in the October of the same year. This was also the first day HIRA had disclosed the CDDC deliberation results. Also, Kymriah passed the review of the first Drug Reimbursement Review and Assessment Service meeting in 2022. And after extending negotiations once, the company succeeded in completing its negotiations and is set to be listed in April. Of course, this is a frustrating period of wait for the patients who long for reimbursement. However, considering the time usually consumed in the registration process for innovative new drugs in Korea, Kymriah’s reimbursement was quick. ◆'Rozlytrek' and 'Vitrakvi’ pave the road for tumor-agnostic drugs Rozlytrek and Vitrakvi had also overcome many obstacles. The two drugs passed the HIRA DREC review but their listing were deferred in the final stages, with the drug pricing negotiations being extended. As these drugs can be applied to many solid cancers that have specific genetic mutations, the authorities had difficulty applying one specific evaluation system and are judged that it will take a while for discussions to be made between the government and the pharmaceutical company. Rozlytrek and Vitrakvi are indicated for the treatment of patients that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic, or where surgical resection is likely to result in severe morbidity and have progressed following treatment or have no satisfactory alternative therapy. In other words, the drugs can be used in most tumors with identified NTRK gene fusions. However still, conservative restrictions remain for the use of the drugs. The use of the two drugs was limited to cancer types mentioned in the NCCN guidelines.
- Company
- Sanofi Launches 3rd Generation Antihistamine Alllegra
- by Nho, Byung Chul Mar 28, 2022 06:10am
- Sanofi Korea announced on the 23rd that it released Allegra 120mg, an allergic rhinitis treatment with 3rd generation antihistamine ingredients, in February. Most 3rd generation antihistamines are Rx drugs, which can only be taken after prescription at clinics, but Allegra can be purchased without prescription at pharmacies with permission from OTC for a dose of 120mg. Fexofenadine, the actvie ingredient of Alllegra, is a third-generation antihistamine component. Antihistamines are classified from 1st to 3rd generations according to the development order, and have gradually improved in terms of effects and side effects as generations evolve. The newly launched Alllegra is a next-generation ingredient that improves/complementes the advantages and disadvantages of first- and second-generation antihistamines, and it is a third-generation antihistamine allergy drug that is effective quickly, reduces sleepiness, and lasts 24 hours. Allegra is 10 tablets per pack, and one tablet (120 mg) can be taken once a day with sufficient water before meals. It is expected to improve the quality of life of busy modern people such as drivers, office workers, and students who usually suffer from allergic rhinitis, as the effect is rapidly expressed within 60 minutes on average and the effect lasts for 24 hours. In addition, there is no interaction through hepatic metabolism, so patients taking other drugs can also take them according to the advice of medical experts. Allergic rhinitis, classified as a chronic disease, is mainly caused by allergic antigens such as house dust, mold, cockroaches, and pollen, or by rapid temperature changes, air pollution, and pet hair, and is classified as the most common disease type worldwide. Symptoms of allergic rhinitis are similar to colds, such as stuffy nose, clear runny nose, sneezing, and itchy eyes and nose. Advertising for the new Alllegra will be on-air through TV and digital platforms from March. Under the theme of house dust, pet fur, change of seasons, and air pollution, the advertisement plans to actively promote allergic rhinitis and improve the quality of life through Allegra, a third-generation antihistamine drug, even in various daily situations.
- Company
- Antengene’s first new drug Xpovio lands in hospitals
- by Eo, Yun-Ho Mar 25, 2022 05:48am
- ‘Xpovio, the first drug introduced by the Chinese pharma company Antengene, has landed in general hospitals. According to industry sources, the company’s anticancer drug Xpovio (Selinexor) has passed the review of drug committees (DCs) at 4 of the Big 5 tertiary hospitals - Samsung Medical Center (SMC), Seoul National University Hospital (SNUH), Seoul St.Mary’s hospital, Seoul Asan Medical Center (AMC) – and has been added for prescriptions through an emergency DC at the Severance Hospital. Xpovio, which had been designated as an orphan drug and then approved in August last year, is a drug with a new mechanism of action that selectively inhibits the nuclear export protein XPO1. The drug was approved for two indications: ▲ for use in combination with dexamethasone for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least 4 prior therapies and whose disease is refractory to at least 2 proteasome inhibitors (PI), at least two immunomodulatory medicinal products (IMiD), and an anti-CD38 monoclonal antibody (mAb); and ▲ as a monotherapy for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) who have received at least two prior lines of treatment. XPO1 inhibitors are expected to be used to improve outcomes of various diseases in combination with other regimens (drugs) in the future. The National Comprehensive Cancer Network (NCCN) guidelines currently recommend 5 treatment regimens including Xpovio. Most multiple myeloma recurs and is refractory to treatment, and diffuse large B-cell lymphoma that has failed systemic treatment also has less chance of being cured or achieving long-term progression-free survival every time the disease progresses after treatments. As a result, a dire need has existed for a more safe and effective treatment method in relapsed and/or refractory multiple myeloma and relapsed/refractory diffuse large B-cell lymphoma. However, experts expect that it will take some more time for the drug to be listed for reimbursement. Xpovio had undergone review by HIRA’s Cancer Disease Deliberation Committee in January but had failed to set reimbursement standards. The reason for the failure is known to be that the company wasn’t able to satisfy ‘the number of A7 country released’ requirement. Therefore, the company needs to wait for the drug’s results in other countries to attempt reimbursement in Korea. Meanwhile, the drug’s efficacy was demonstrated through two Phase II trials – the STORM and SANDAL trials. In the STORM study, Xpovio achieved an objective response rate (ORR) of 26% and a clinical benefit rate (CRB) of 39.9% in combination with dexamethasone in patients with relapsed and/or refractory multiple myeloma who have received at least 4 prior therapies In the SADAL study that was conducted on patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) who have received at least two prior lines of treatment, Xpovio as monotherapy had achieved an ORR of 28.3% and a CR of 11.8%.
- Company
- SK Biopharm targets US sales of Xcopri
- by Kim, Jin-Gu Mar 25, 2022 05:48am
- SK Biopharm announced that it will double U.S. sales of Cenobamate (Xcopri) this year. Cho Jung-woo, CEO of SK Biopharm, presented this year's goal at an online press conference on the 24th. SK Biopharm generated 78.2 billion won in sales from Cenobamate in the U.S. last year. Sales have more than increased seven times compared to 10.6 billion won in 2020, the first year of its launch. SK Biopharm plans to double its sales to 160 billion won this year. New marketing plan has been drawn up this year. First of all, the government plans to double the annual number of prescriptions from 90,000 last year to about 90,000 this year. If the company focused on increasing the new prescription rate of doctors who mainly deal with CNS diseases until last year, it plans to expand marketing to target various doctors from this year. It plans to focus on raising awareness of SK Biopharm and Cenobamate in the epilepsy treatment market. It has set a goal to achieve No. 1 recognition of products and companies in the epilepsy treatment market within this year. CEO Cho Jung-woo said, "Cenobamate is growing into a top tier in the U.S. epilepsy treatment market. Considering that patents for major competitors will expire next year, it will be able to establish itself as the only new drug for epilepsy. We will expand face-to-face sales and marketing to double sales in the U.S.," adding, "In the U.S., quarantine guidelines have been eased until the stage of taking off masks." In the second half of this year, face-to-face activities are expected to recover to around 90%." He added, "We will improve awareness of diseases through TV advertisements and SNS marketing, and increase brand awareness of companies and products."
- Company
- Why Vemlidy's patent dispute took 3 years to win the 1st tri
- by Kim, Jin-Gu Mar 24, 2022 05:54am
- Generics, which challenged the patent of Gilead Science's hepatitis B treatment Vemlidy (Tenofovir Alafenamide HemiFumarate), won the first trial in about three years. According to the pharmaceutical industry on the 21st, Intellectual Property recently made a "claim establishment" trial on the passive scope of the Vemliddy salt patent filed by Dong-A ST, Daewoong Pharmaceutical, and Chong Kun Dang against Gilead. The patent expires in August 2032. Pharmaceutical companies that won the first trial have been qualified to release generic products after September, when Vemlidy's PMS period expires. Attention is drawn to this by the referee. Dong-A ST and others requested a trial in December 2018. It took more than three years for the decision to be reached. Generics usually apply for a "priority trial" at the same time when requesting a trial, so it is unusual for the decision to take three years. ◆The conclusion was reached 3 years after the request for trial The pharmaceutical industry explains that Vemlidy's remaining PMS expiration period had a decisive impact on the prolonged dispute. Vemlidy's PMS expires on September 12. As of December 2018, when generics requested a trial, Vemlidy's PMS expiration date was about three years and nine months away. However, Intellectual Property did not immediately look into the incident. This is due to Intellectual Property's regulations on preferential trials. Article 31 of the Administrative Rules of Intellectual Property's "Patent Trial Handling" stipulates that the claimant's application for a priority trial must be judged before other cases.This regulation stipulates that "the trial case for patent rights related to drugs whose expiration date of the retrial period is one year after the date of application for priority trial is excluded." When generics filed a patent trial in 2018, Vemlidy's PMS did not expire within a year, so it was excluded from the priority trial, and only recently, when the PMS expiration date was within a year. An official from the pharmaceutical industry explained, "With the implementation of the patent-approval linkage system, there have been more requests for patent trials by generics to accept generic for exclusivity, and I understand that Intellectual Property has set these regulations to prioritize." He said, "Under this regulation, hearings have not been conducted for a while since the request for a trial, but only recently have the Patent Tribunal begun to look into the case," adding, "The rest of the Vemlidy salt patents that have yet to be concluded are expected to come out soon." Vemliddy is another hepatitis B drug from Gilead, generic for Viread. The active ingredient is Tenofovir Disoproxil Fumarate, but Gilead has newly developed the drug in pro-drug form. This improved drug resistance and kidney toxicity side effects. Vemlidy is rapidly replacing existing Viread in the hepatitis B treatment market. According to IQVIA, pharmaceutical market research firm, Vemlidy's sales surged in four years from 500 million won in 2017 to 28 billion won last year, the first year of its launch. During the same period, Viread's sales fell nearly half from 129.3 billion won to 63.1 billion won.
- Company
- Samsung Bioepis makes ₩847 billion expanding overseas
- by Chon, Seung-Hyun Mar 23, 2022 05:51am
- Samsung Bioepis made a new sales record last year. With the global expansion of its biosimilars well on track, the company had made over ₩800 billion last year. According to the Korea Financial Supervisory Service, Samsung Bioepis’s sales recorded ₩847 billion last year, a 9.0% increase from the previous year. This is the largest record ever since the company was established in 2012. Sales have increased 129.7% in just 3 years from ₩368.7 billion in 2018, and have been breaking its sales record ever since. Annual Sales of Samsung Bioepis (Unit: million won, Data: Financial Supervisory Service) After recording ₩765.9 billion in sales in 2019, the company’s growth rate had fallen to 1.5% the next year. The reduced growth has been due to the temporary market contraction that occurred in the early stages of the COVID-19 crisis. The company’s quarterly performance had then showed ups and downs with preorders from hospitals and wholesalers in Europe to secure a supply. However, the company’s recovered growth last year was driven by the increased sales of biosimilars in the US and Europe. Samsung Bioepis’ sales are mostly generated by overseas sales of biosimilars that were developed by the company. Samsung Bioepis had succeeded in commercializing biosimilars of 6 products - Enbrel, Remicade, Herceptin, Humira, Avastin, and Lucentis. All 6 products were approved in Europe, and 5 products less the Avastin biosimilar achieved marketing authorization in the US. The five biosimilars from the company had recorded $1,255,100,000 (approx. ₩1.5 trillion) in overseas sales last year. This is an 11% increase and a new record from the $1,125,800,000 it made in 2020. Samsung Bioepis’ biosimilar is sold abroad by its partners Biogen and Organon. Biogen sells the company’s biosimilars of Enbrel, Remicade, Humira for autoimmune diseases in Europe. Organon sells the mentioned products in countries other than Europe and Korea, and the Remicade biosimilar in the US. Organon is also in charge of overseas sales of Samsung’s two anticancer drugs, the biosimilars of Herceptin and Avastin. Last year, Biogen’s sales of Samsung Bioepis’ biosimilars recorded $831,100,000 (approx. ₩1 trillion), which was a 4% increase from the previous year. Organon’s sales of Bioepis’ products also increased 28% from the previous year to record $424,000,000 (approx. ₩500 billion). Also, the approval of the biosimilars abroad has added new milestones. In August last year, the company’s Lucentis biosimilar ‘Byooviz’ that it developed received marketing authorization from the European Commission (EC) and the U.S. Food and Drug Administration (FDA) a month later. Samsung Bioepis will be converted into a wholly-owned subsidiary of Samsung Biologics. At the time of its establishment, Samsung Bioepis was established as a joint venture between Samsung Biologics and Biogen. Samsung Bioepis was launched in February 2012 with a capital of ₩164.7 billion, and Biogen initially invested 15% of the capital, 24.7 billion won. With Biogen only partially participating in the paid-in capital increase, its share fell to 5.4% in 2017. In 2018, Biogen had exercised its call option over Samsung Epis and increased its shares to 50%. Previously, the company had signed a call option agreement under which the company may acquire ‘50% less 1 share’ of Bioepis’s stock by June 29th, 2018. And upon the date of expiry, Biogen decided to acquire the stocks. In June 2018, the company acquired 9,226,068 of the 19,567,921 shares of Bioepis that were owned by Samsung Biologics for $700 million (₩748.6 billion). In January, Samsung Biologics decided to acquire 10,341,852 shares (50% stake) of Samsung Bioepis that was owned by Biogen for ₩2.765 trillion. Samsung Biologics plans to pay the remaining amount of the acquisition price in installments over the next two years. After the acquisition, Samsung Biologics will own 100% of Samsung Bioepis’s shares.
- Company
- Gov purchased ₩200 billion worth of COVID-19 vaccines
- by Chon, Seung-Hyun Mar 23, 2022 05:51am
- The COVID-19 vaccine, which incorporates technology from domestic bio companies, will be supplied for the first time in Korea. SK Bioscience announced on the 21st that it has signed a pre-purchase contract with the KDCA for the COVID-19 vaccine worth 200 billion won. The contract volume is 10 million inoculations, and SK Bioscience will sequentially supply the amount according to the Korea Centers for Disease Control and Prevention's inoculation plan when the development of GBP510 is completed. GBP510 is a candidate substance for the COVID-19 vaccine jointly developed by SK Bioscience with IPD. GSK's immune-enhancing technology was also used. Phase 3 clinical trials are currently underway. SK Bioscience self-evaluated, "Korea's No. 1 COVID-19 vaccine, which checks the safety and effectiveness of Phase III clinical trials including Koreans, will be supplied in Korea." SK Bioscience independently produces and supplies two of the five major COVID-19 vaccines licensed in advanced countries such as the United States and the EU (AstraZeneca and Novavax) in Korea. SK Bioscience began consignment production of the undiluted and finished product of the COVID-19 vaccine AZD1222 developed by AstraZeneca last year, and this year, it supplied Nuvaxovid, a synthetic antigen-type COVID-19 vaccine with high safety and proven efficacy. GBP510 was selected for the Wave2 project of the international organization CEPI and is undergoing clinical trials with a total development cost of $213.7 million. In the first half of this year, it is planning to obtain a domestic item license, the WHO emergency license, and the EUA by overseas country. Recently, Rolling Review documents have been submitted to the MHRA for prompt approval. Ahn Jae-yong, president of SK Bioscience, said, GBP510 is the result of SK technology, the government's willingness to leap forward as a biopower, and the cooperation of global organizations supporting vaccine development for public health rights." Starting with GBP510, we will develop products to prepare for various viral infectious diseases and establish ourselves as a leading company in the global vaccine market, he said.
- Company
- Seqirus 'will introduce the first adjuvanted flu vaccine'
- by Mar 22, 2022 05:53am
- A multinational pharmaceutical company has bravely thrown its hat into the domestic influenza vaccine ring that is led by Korean companies such as GC Pharma and SK Bioscience, etc. The company, named Seqirus, is attempting to enter the Korean market equipped with the solid technology it accumulated through its sole focus on influenza vaccines. Seqirus is a vaccine company specializing in influenza vaccines that became the company it is after the influenza department of the Australia-based pharmaceutical company CSL acquired Novartis’s influenza vaccine business. The company has pursued vaccines, only influenza vaccines for over a century, and is known for its extensive influenza vaccine portfolio that covers a wide range of egg-based, cell culture-based, and adjuvanted vaccines. Its annual sales amount to ₩2 trillion. Seqirus's entrance into the Korean market was prompted by the rise of the COVID-19 pandemic after the sole manufacturer of cell-based vaccines in Korea, SK Bioscience, was unable to manufacture its influenza vaccines due to its manufacture of consigned COVID-19 vaccines. Thus, the Korean government granted emergency use authorization for Seqirus's cell culture-based flu vaccine ‘Flucelvax’ in Korea. Also, using the opportunity as momentum, Seqirus made the decision to start the direct supply of its egg-based Afluria that had been marketed through Boryung Biopharma until then. During an interview with Dailpharm, Jonathan Anderson, Medical Head of the International Region of Seqirus, said, “Although there are many excellent companies in Korea that already focus on the development and manufacture of influenza vaccines, Seqirus has strengths of owning various platforms in the area. As a research-based company, we are developing technology for cell culture-based vaccines, adjuvanted vaccines, and self-amplifying mRNA vaccines.” [Interview] Jonathan Anderson Medical Head of the International Region of Seqirus Among its various products, Seqirus has high expectations for its adjuvanted influenza vaccine ‘Fluad’ General flu vaccines can be less effective in immunocompromised elderly, or when the vaccine strain does not coincide with the epidemic, or due to egg-adaptations, etc. In such cases, adjuvanted flu vaccines can improve immune reaction and increase prevention. The ‘MF59’ used in Fluad is an adjuvant that had also been used in 2009 during the swine flu. ‘MF59’ is made using squalene that is produced in the liver, which induces an immune response in the injection site and promotes antigen uptake to increase immune response by activating T cells and B cells. In other words, the adjuvanted vaccine can achieve a strong antibody response even with a small amount. Anderson said, “Real-world results showed that the adjuvanted vaccine showed a better effect in elderly patients over the age of 65.” He added, “Many still get infected with influenza during the influenza season and progress to hospitalization or even death. With the social burden still high for influenza, adjuvanted vaccines could rise as a new alternative.” Anderson added that in terms of safety, the adjuvanted vaccine showed a higher rate of local reactions such as injection site pain than general vaccines, but the reactions were mostly mild or moderate and were resolved naturally over time. Based on its efficacy and safety data, Fluad was approved in 2020 in the US as the world’s first adjuvanted influenza vaccine allowed for use in people aged 65 years or older. Seqirus’s Korea, the Korean subsidiary of Seqirus is working to speed up the introduction of Fluad in Korea. As no adjuvanted flu vaccine exists in the Korean market yet, Fluad's approval by the MFDS is expected to change the domestic flu vaccine market. As Fluad has been introduced to Korea in the past, no separate clinical trial will be required for its introduction to Korea. Anderson said, “Seqirus plans to promptly introduce its vaccine portfolio to Korea. We will make the most effort to fully explain our data through close discussions with the healthcare authorities.
- Company
- GSK’s immuno-oncology drug Jemperli applies for approval
- by Eo, Yun-Ho Mar 22, 2022 05:53am
- Another immuno-oncology drug is set to soon be introduced to Korea. According to industry sources, GSK Korea has applied for the approval of its PD-1 inhibitor ‘Jemperli (dostarlimab),’ and is undergoing discussions with relevant authorities. If approved, Jemperli will become the third PD-1 inhibitor to be approved in Korea after ‘Opdivo (nivolumab),’ and ‘Keytruda (pembrolizumab).’ Unlike the other two drugs that started as a melanoma treatment, Jemperli was approved for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen by the FDA in April last year. In addition, Jemperli was additionally approved for adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumors in August of the same year. GSK plans to continue adding indications to endometrial cancer in Korea as well. Meanwhile, Jemperli demonstrated its efficacy through the multi-cohort GARNET trial that enrolled patients with dMMR recurrent or advanced endometrial cancer who have progressed on or following prior treatment with a platinum-containing regimen. In the trial, treatment with Jemperli resulted in an objective response rate (ORR) of 43.5%) and a disease control rate of 55.6%. The median duration of response (DoR) had not been reached in these patients, and the probability of maintaining response at six months and 12 months was 97.9% and 90.9%, respectively.
