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- 2026-05-07 16:55:51
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- Rolontis and Leclaza make their place in Korea
- by Chon, Seung-Hyun Nov 29, 2022 05:54am
- Leclaza and Rolontis, the homegrown drugs that have gained attention as promising new global drugs, have made a smooth start in the domestic market. Yuhan Corp’s Leclaza’s annual sales exceeded KRW 10 billion in the second year of release, and Hanmi Pharmaceutical’s Rolontis has also started making sales in earnest in the Korean market. ◆Yuhan’s Leclaza’s sales exceed KRW 10 billion in only 3 quarters... nears FDA approval According to the market research institution IQVIA on the 28th, Leclaza’s sales in Q3 were KRW 4.6 billion, a threefold increase from the KRW 1.5 billion in the same period of the previous year. Leclaza is the 31st novel drug to be developed in Korea. It received approval as a non-small-cell lung cancer treatment for patients with EGFR T790M mutation-positive, locally advanced or metastatic NSCLC who were previously treated with an EGFR-TKI. It inhibits the signal transduction that is involved in lung cancer cell proliferation and growth to inhibit the proliferation and growth of lung cancer cells. Leclaza entered the Korean prescription market in earnest with its reimbursement listing in July last year. It first made sales of KRW 1.5 billion in Q3 last year and then sold KRW 2.6 billion in Q4. Its sales continued to rise further this year. In Q1 and Q2 this year, it raised sales of KRW 3.2 billion and KRW 3.7 billion and continued its growth in Q3. Leclaza recorded cumulative sales of KRW 11.5 billion in Q3 this year and then exceeded KRW 10 billion in its second year of release. Among new anticancer drugs developed in Korea, Leclaza is the first to raise annual sales that exceed KRW 10 billion. Other homegrown new anticancer drugs that were approved before Leclaza include Il-Yang Pharmaceuticals’ Supect, Dongwha Pharm’s Milican, Chong Kun Dang’s Camtobell, Sam Sung Pharmaceutical’s Riavax, Hanmi Pharmaceutical’s Olita. None of the products have exceeded annual sales of KRW 10 billion. In the early stages of its release, Leclaza is evaluated to have made a smooth start. As anticancer drugs are usually used in large medical institutions, they are only allowed to make prescriptions only after passing drug committee reviews in their respective institutions. Also, as the new drugs need to directly compete with promising new drugs from multinational pharmaceutical companies, it is not easy for local homegrown new anticancer drugs to achieve commercial results. Leclaza passed reviews in drugs committees of major large-scale medical institutions in Korea and started speeding up market penetration. Leclaza is also speeding up entry to the US market. Yuhan Corp made a licensing deal with Janssen biotech in November 2018. Since then, Janssen has been developing the drug in combination with its own EGFR-MET bispecific antibody ‘amivantamab.’ The CHRYSALIS trial which had been the first trial initiated after the agreement was signed, has been now expanded to study its combination with other platinum-based anticancer therapies including ‘carboplatin,’ ‘pemetrexed.’ Janssen is also expected to apply for FDA approval for such combinations within the year at the earliest. The global Phase III trial for the first-line therapy is also in smooth progress. According to a phase III trial recently announced by Yuhan Corp, Leclaza reduce the risk of disease progression or death by 55% compared to Iressa and statistically significantly improved progression-free survival, the primary endpoint. PFS is an important evaluation index used to confirm the efficacy of anticancer drugs and refers to the period that a patient lives with the disease without progression or death. The Phase III trial has been conducted on 393 treatment-naive patients with EGFR-positive locally advanced or metastatic non-small-cell lung cancer. Yuhan Corp received approval to conduct the clinical trial in December 2019 from the Ministry of Food and Drug Safety, and 119 institutions in 13 countries participated in the trial. Based on the trial results, the company plans to apply for its use as a first-line treatment. ◆Hanmi’s Rolontis first makes KRW 1.5 billion this year... starts sales in the US market Hanmi Pharmaceutical’s Rolontis which recently entered the US market started to raise sales in earnest in Korea. 2 Rolontis recorded KRW 1 billion in the Korean market in Q3. It made sales for the first time in Q1 this year and then sold KRW 0.4 billion in Q2. As of Q3, its cumulative sales reached KRW 1.5 billion. Rolontis is a new biological drug that Hanmi Pharmaceutical transferred the technology to Spectrum in 2012. It is administered to prevent or treat neutropenia in cancer patients that receive myelosuppressive chemotherapy. The drug has a similar mechanism of action to Amgen’s blockbuster drug ‘Neulasta (pegfilgrastim),’ by increasing the G-CSF receptor to stimulate neutrophil production. The drug was approved as the 33rd homegrown new drug in March and started to be sold in Korea after receiving reimbursement in November last year. Rolontis was approved under the brand name Rolvedon by the US FDA in September this year and succeeded in commercialization 10 years after its technology transfer. Rolvedon is now recorded as the 6th product to pass FDA review among new drugs developed with a Korean company’s technology. LG Chem’s Factive was the first among homegrown new drugs to pass the US gates in 2003. Then, Sivextro that Dong-A ST licensed out was approved by the FDA in 2014. Then, in 2016, SK Chemical’s hemophilia drug Abstyla received FDA approval. In 2019, SK Biopharmaceutical’s narcolepsy drug Sunosi and new epilepsy drug Xcopri received FDA approval. Rolontis is the first drug to receive marekting approval from the FDA among Hanmi Pharmaceutical’s products. It is the first new drug to be produced in the US market and produced at a domestic plant (Pyeongtaek Bio Plant) that has received on-site inspections from the FDA. It is the first new drug to be produced in the U.S. market and produced at a domestic plant (Pyeongtaek Bio Plant) that has received an on-site FDA inspection. Rolontis started selling in the US market in earnest last month. The US neutropenia treatment market is worth KRW 3 trillion a year. With Spectrum failing to introduce another anticancer drug it brought in from Hanmi Pharmaceutical, poziotinib, to the US, the company has expressed aims to focus on the commercial success of Rolontis. After failing to receive approval for poziotinib, Spectrum planned to start restructuring, including a 75% reduction in R&D personnel by the end of the year, and concentrate the saved operating funds on Rolontis.
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- Keytruda has booked high sales in the domestic market
- by Chon, Seung-Hyun Nov 29, 2022 05:53am
- Keytruda, an immuno-cancer drug, has reserved a leading position in the domestic pharmaceutical market for 3 consecutive years. New drug products recently released by multinational pharmaceutical companies such as Gardasil 9 and Dupixent continued to be high. According to IQVIA, a pharmaceutical research firm, MSD Keytruda posted 161.6 billion won in sales in the first three quarters of this year, the largest among all medicines. Compared to the same period last year, it increased by 11.1%, firmly maintaining its leading position. Keytruda's sales in the first quarter were 40.4 billion won, down 8.4% from the previous year. At that time, the decline in sales was blamed for the drug price cut. Keytruda's insurance upper limit was lowered by 25.6% in March as the scope of health insurance benefits was expanded to primary treatment for non-small cell lung cancer. However, Keytruda recovered its upward trend from the second quarter. Sales in the second quarter rose 9.7% year-on-year to 53.9 billion won, and sales in the third quarter rose 28.8% to 67.2 billion won. It is analyzed that Keytruda's primary treatment benefit application effect occurred in earnest. In the case of sales in the third quarter, considering the drug price cut rate, it is calculated that usage increased by more than 60% compared to the same period last year. Keytruda, released in Korea in 2015, is an immune checkpoint inhibitor that treats cancer by inhibiting PD-1 protein on the surface of immune cell T cells to prevent binding to PD-L1 receptors and activate immune cells. In Korea, 21 indications were granted in 16 carcinomas, including melanoma, lung cancer, and head and neck cancer. Currently, the cancers that can use Keytruda have reached ▲ lung cancer, ▲ head and neck cancer, ▲ Hodgkin lymphoma, ▲ urinary epithelial cancer (Bladder cancer), ▲ esophageal cancer, ▲ melanoma, ▲ renal cell cancer, ▲ endometrial cancer, ▲ gastric cancer, ▲ small intestine cancer, ▲ pancreatic cancer, ▲ biliary cancer, ▲ cervical cancer 16, ▲ cervical cancer. It can be used in the largest number of cancer types among immuno-cancer drugs licensed in Korea. Keytruda's sales began to rise rapidly after insurance benefits were applied as a secondary treatment for non-small cell lung cancer in August 2017. Sales exceeded 10 billion won in the first quarter of 2018 and 30 billion won in the second quarter of 2019. In the first quarter of 2020, Lippito was brought down to the second place and ranked first overall, and since then, he has maintained the lead for 11 consecutive quarters. New drug products recently released by multinational pharmaceutical companies were strong at the top of drug sales. MSD's cervical cancer vaccine Gardasil 9 ranked third overall, with cumulative sales of 85.3 billion won in the third quarter, up 68.0% from the same period last year. Gardasil 9 saw its sales rise 39.2% year-on-year to 24.3 billion won in the first quarter, while sales in the second and third quarters grew 98.9% and 66.1% year-on-year, respectively. Gardasil 9 is an HPV (human papillomavirus) vaccine product that adds five serum types (31, 33, 45, 52, 58) to four serum types (6, 11, 16, and 18 types) owned by Gardasil. It includes most HPV types of cervical cancer vaccines. In addition to cervical cancer, the number of male vaccinations is also increasing every year due to word of mouth that Gardasil 9 can prevent HPV-related diseases such as anal cancer, reproductive demons, and precancerous lesions. Since July 2020, the recommended age for vaccination has expanded from 9 to 26 years old women to 27 to 45 years old women, and the rate of re-vaccination of adults who have previously been vaccinated against cervical cancer has also increased significantly. Sanofi's atopic dermatitis treatment Dupixent recorded 75.9 billion won in cumulative sales until the third quarter, up 45.2% from the previous year. Sales in the first and second quarters increased 77.0% and 47.6% year-on-year, respectively, while sales in the third quarter increased 23.8% from the previous year. Dupixent is the first targeted biological drug developed for the treatment of moderate to severe atopic dermatitis, where topical treatments are not recommended or symptoms are not properly controlled. It acts as a mechanism that selectively suppresses the signal transmission of interleukin-4 and interleukin-13, which are known to be the causes of atopic dermatitis. Dupixent, which received domestic permission in March 2018, has seen its sales expand rapidly since January 2020 when it was covered by salaries for severe atopic dermatitis. Dupixent's sales were only 3.3 billion won in the first quarter of 2020, but quadrupled to 13.5 billion won in the first quarter of last year. It has recorded sales of 20 billion won since the third quarter of last year. Ono's immuno-cancer drug Opdivo's cumulative sales in the third quarter were 79.8 billion won, up 32.6% from the previous year. Opdivo, which was licensed in 2015, began to see a significant increase in sales after it was listed as an insurance benefit in 2017. Opdivo surpassed 10 billion won in quarterly sales for the first time in the first quarter of 2018 and has recorded sales of 20 billion won since the third quarter of last year. Amgen's Prolia ranked fourth overall, with sales rising 28.6% from the previous year to 83.8 billion won in the first and third quarters. Released in Korea in November 2016, Prolia is a biomedical osteoporosis treatment that targets the protein RANKL, which is essential for the formation, activation, and survival of bone-destroying osteoporosis. Prolia began to see an upward trend in sales after salaries were applied only to secondary treatment therapy in 2017. Since April 2019, Prolia's sales have exploded as insurance benefits have been recognized in primary treatment. Among the new drugs developed by Korean companies, HK inno.N's anti-ulcer drug K-CAB ranked seventh overall with sales of 77.9 billion won in the third quarter, up 20.1% from the previous year. K-CAB, released in March 2019, is a new mechanism of action that inhibits gastric acid secretion by competitively combining proton pumps and potassium ions located in the final stage of acid secretion.
- Company
- First targeted PIK3CA Piqray reapplies for reimb
- by Eo, Yun-Ho Nov 28, 2022 05:51am
- An anticancer drug that targets the PIK3CA gene will once again attempt reimbursement listing in Korea. According to industry sources, Novartis Korea submitted a reimbursement application for the reimbursement of its breast cancer treatment Piqray (alpelisib) recently. The drug was unable to pass deliberations by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee in February this year. Piqray, which was approved in Korea in May last year, is a 'PIK3Caα-inhibitor that blocks the overactivation of the PI3K enzyme which, when overactivated because of a mutation in the PIK3CA gene, stimulates cancer cells to divide and grow in an uncontrolled fashion. The targeted cancer therapy is prescribed in combination with Faslodex (fulvestrant) to treat metastatic and advanced-stage, hormone-receptor-positive/ HER2-negative breast cancer in patients who failed previous treatment. Piqray’s safety and efficacy were demonstrated in the SOLAR-1 trial, which was conducted on 572 postmenopausal women, and men, with HR+, HER2- advanced (locoregionally recurrent or metastatic) breast cancer whose disease had progressed or recurred on or after an aromatase-inhibitor-based treatment (with or without CDK4/6 combination) Results showed when used in combination with Faslodex, Piqray improved the median PFS (Progression- Free survival) of cancer patients with the PIK3CA mutation from 5.7 months to 11 months. The Objective Response Rate (ORR), which indicates the proportion of patients whose tumor size was reduced by over 30%, was 35.7% for the combination therapy group, which is twice more than the 16.2% in the fulvestrant monotherapy group. The secondary endpoint, Overall Survival (OS) in patients with PIK3CA mutations, was 39.3 months in the combination therapy group. This was 8 months longer than the 31.4 months in the fulvestrant monotherapy group but did not have statistical significance.
- Company
- K-similars compete for Canada's ₩31 tril market
- by Nov 25, 2022 06:05am
- Biosimilars manufactured by domestic bio companies are targeting Canada, the world's 10th largest pharmaceutical market With an increasing number of provinces in Canada actively implementing policies to mandate the use of biosimilars, usage of biosimilars in the country, which had been in the 10% range, is expected to increase significantly. According to industry sources on the 25th, Samsung Bioepis launched its oncology drug ‘Avastin’ biosimilar ‘Aybintio’ through its partner company Organon. Aybintio is a VEGF inhibitor prescribed for metastatic colorectal cancer, metastatic or recurrent non-small-cell lung cancer, platinum-sensitive recurrent ovarian cancer, etc. With the approval, a total of 5 Samsung Bioepis biosimilar products have been released in Canada as of this month. When including the 4 Celltrion biosimilars, a total of 9 biosimilars from Korea are now in the Canadian market. Starting with its Enbrel biosimilar ‘Brenzys’ in 2016, Samsung Bioepis received approval for 6 biosimilars including its Remicade biosimilar ‘Renflxis’ in 2017, Humira biosimilar ‘Hadlima’ in 2018, Avastin biosimilar ‘Aybintio’ in 2021, Herceptin biosimilar ‘Ontruzant’ and Lucentis biosimilar ‘Byooviz’ in 2022. Among the products, Byooviz has not been released to the market yet due to patent issues. In the case of Celltrion, it received approval and has marketed 4 biosimilars including its Remicade biosimilar ‘Remsima,' Rituxan biosimilar ‘Truxima,’ and Herceptin biosimilar ‘Herzuma’ in 2014, and Humira biosimilar ‘Yuflyma’ in 2021. Among the 50 biosimilar products approved by the health authorities in Canada, 10 are Korean products. ◆Canada ranks 10th in the global market...receives attention for its policy pro-biosimilar policy The Canadian pharmaceutical market is worth UDS 23.8 billion (KRW 31.58 trillion) based on IQVIA in 2020, and is the 10th largest market in the world. The country has been pointed to as the ‘land of opportunity' by domestic biopharmaceutical companies with the government’s recent implementation of biosimilar-friendly policies in provinces to reduce the cost of prescription drugs. The Province of British Columbia after implemented a policy three years ago that only allows the use of biosimilars for certain diseases, with exceptions, to raise the usage of biosimilars that remained at the 8% level at the time. British Columbia has mandated that prescriptions be switched to biosimilars, except in exceptional cases for indications for autoimmune diseases such as plaque psoriasis, psoriatic arthritis, and Crohn's disease. Some provinces in Canada have a policy that mandates the use of biosimilars instead of originals for certain diseases. (Source: Northwest Territories website) The unconventional policy significantly increased the use of biosimilars in the province. As of the end of last year, the share of biosimilars in the private biopharmaceutical market, which had been 12% in other provinces, had reached 65% in the Province of British Columbia. From December last year to this year, other provinces including Alberta, New Brunswick, Quebec, Nova Scotia, Northwest Territory, and Saskatchewan also adopted policies to encourage the use of biosimilars, therefore, the biosimilar market is expected to grow further. The number of biosimilar approvals has also increased. Since approving 9 biosimilars last year, Health Canada additionally approved 7 products by November this year. In total, 50 biosimilars have now been approved in Canada so far, which is more than the 39 approved in the US. The Canadian government projects that it will be able to save about KRW 1 trillion (USD 768.7 million) a year with the implementation of the pro-biosimilar policy. An official from Samsung Bioepis said, “We have established a diverse product portfolio in Canada, the world's 10th largest pharmaceutical market, and plan to work more closely with our partners to expand their sales in the North American market."
- Company
- Janssen Korea to reduce workforce...conducts VSP
- by Eo, Yun-Ho Nov 25, 2022 06:05am
- Janssen Korea plans to restructure its labor force. According to industry sources, Janssen finalized its decision to conduct a Volunteer Separate Program (VSP) in its town hall meeting. The company will receive applications for VSP until the 30th of this month and does not have a fixed number of reductions planned. The specific terms of compensation for the VSP have not been disclosed. While conducting the VSP in 2015, the company had proposed ‘'years of service X2+2 months (average wage)+2 months (normal wage)' as compensation for early retirement. Also, Janssen’s VSP will exclude those in charge of market access (MA) and regulatory affairs (RA). Other multinational pharmaceutical companies including Novartis Korea, GSK Korea, and Sanofi Korea have also implemented early retirement programs in the second half of this year.
- Company
- First ASMD treatment Xenpozyme to land in Korea
- by Eo, Yun-Ho Nov 24, 2022 05:51am
- The first-ever pediatric storage disorder treatment is expected to be introduced to Korea. According to industry sources, Sanofi Genzyme’s treatment for acid sphingomyelinase deficiency (ASMD) ‘Xenpozyme (olipudase alfa)’ is undergoing processes for marketing authorization by the Ministry of Food and Drug Safety. Starting with Japan in March, the drug was also approved in Europe in July and by the US FDA in August and received Breakthrough Therapy designation in the countries. The efficacy of Xenpozyme, the only existing ASMD treatment, was identified through the ASCEND and ASCEND-Peds trials. The ASCEND trial evaluated the efficacy and safety of Xenpozyme in 36 adult patients with ASMD type A/B or type B. The patients were randomized to receive Xenpozyme or placebo for 52 weeks (primary analysis). At Week 52, Xenpozyme improved lung function from baseline by 22% in terms of the predicted diffusing capacity of the lung for carbon monoxide (DLco). Compared with the 3% improvement shown in the placebo group, the difference between the two treatment arms of 19% was statistically significant. Also, at Week 52, patients treated with Xenpozyme had a mean reduction in spleen volume by 39.5% compared with the 0.5% increase in the placebo group. All patients that were treated with Xenpozyme showed an improvement in one or two primary endpoints. The single-arm ASCEND-Peds trial studied 20 pediatric patients younger than 12 years of age with ASMD type A/B or type B. The primary objective of the trial was to evaluate the safety and tolerability of Xenpozyme for 64 weeks, and the explored efficacy endpoints of progressive lung disease, spleen, and liver enlargement, and platelet count were also explored in the trial. 9 patients who could take the test for diffusing capacity of the lung for carbon monoxide in the trial showed a 33% improvement in diffusing capacity after 1 year. The patients also showed a mean reduction in spleen volume of 49%. ASMD is caused by the lack of an enzyme needed to break down a complex lipid, called sphingomyelin, which accumulates in the liver, spleen, lung, and brain. Patients with ASMD experience enlarged abdomens that can cause pain, vomiting, feeding difficulties, and falls at 3 to 6 months of birth. The most severely affected patients have profound neurologic symptoms and rarely survive beyond two to three years of age.
- Company
- Shaperon applies for a patent for biomarkers,
- by Lee, Seok-Jun Nov 24, 2022 05:50am
- Shaperone announced on the 23rd that it has applied for a patent to prove the correlation between NuGel, an atopic dermatitis treatment under development, and biomarkers (biological markers). The patent is the result of analyzing the data of phase 2 patients with atopic dermatitis in Korea and confirming that biomarkers in the blood can be effectively used to predict the treatment reactivity of atopic dermatitis patients to NuGel. It is also a new technology that has revealed that the biomarkers can be used in Companion Diagnostics, which is required to maximize the therapeutic effect. Until now, most of the development of biomarkers for companion diagnosis has been focused on the field of anticancer drug development. It is evaluated that the Shaperon patent is meaningful because it has discovered a biomarker that can predict drug reactivity of new drugs in the field of atopic dermatitis for the first time in the world. It proposed a new paradigm that the diagnosis criteria for "Type A" (tentative name) atopic dermatitis can be prepared and the treatment effect can be maximized in the patient group. It is the same as requiring a different approach to the treatment of type 1 and type 2 diabetes. It is evaluated that it has developed a new personalized treatment technology based on NuGel for individual atopic patients through a patented technology that can differentiate between A-type atopic and non-atopic atopic patients with biomarkers discovered by Shaperon. The precision medical technology used in the patent is not limited to atopic dermatitis but plans to expand it to patients with intractable inflammatory diseases who have high market demand for accompanying diagnosis. In particular, it is expected that it can be used to develop new drugs that can increase the treatment effect by selecting patients with good treatment prognoses early. An official from Shaperon said, "In order to increase the success rate of new drug development in the era of precision medicine, it is important to develop joint diagnostic technology. The discovery of biomarkers has re-proven technology. "We will provide customized treatment options to patients with patent-based atopic dermatitis."
- Company
- Chong Kun Dang CKD-701, equivalent to Lucentis' original
- by Chon, Seung-Hyun Nov 24, 2022 05:50am
- A panoramic view of Chong Kun DangChong Kun Dang announced on the 23rd that the results of phase 3 clinical trials of the macular degeneration treatment Lucentis biosimilar CKD-701 were published in the SCI-level international academic journal PLoS One. Chong Kun Dang conducted phase 3 clinical trials of CKD-701 in 312 patients with neovascular age-related macular degeneration at 25 hospitals, including Seoul National University Hospital, from September 2018 to March 2021. In phase 3 clinical trials, the percentage of patients with vision loss of fewer than 15 characters in the primary efficacy evaluation index comparing the maximum calibration vision (BCVA) at 3 months after drug administration was 97.95% (143/146) in the CKD-701 administration group and 98.62% (143/145) in the original drug administration group. The change in maximum corrected vision (BCVA) improved by 7.14 characters in the CKD-701 administration group and 6.28 characters in the original administration group, showing no significant difference between the two drugs. It was confirmed that drug efficacy, safety, immunogenicity, and pharmacokinetic characteristics were clinically equivalent to the original drug through indicators such as the ratio of patients with less than 15 characters of vision loss and vision improvement, respectively, after 3, 6, and 12 months of drug administration. CKD-701, which was approved by the Ministry of Food and Drug Safety last month, is a high-purity Lucentis biosimilar mainly composed of Ranibizumab. Chong Kun Dang's pure independent technology, which is an antibody fragment raw material manufacturing technology, has been applied. CKD-701 is a drug with clinical equivalence compared to Lucentis, the original drug, in significant indicators, including maximum calibration vision, the primary evaluation index, said Professor Hyung-gon. "Pro Re Nata (PRN) is expected to stabilize the condition of macular degeneration disease and reduce the patient's burden of treatment." PLoS One is an online journal specializing in science and medicine published by the Public Library of Science (PLoS) since 2006. It has been listed on SCIE and SCOPUS, a global academic paper database platform for the past five consecutive years.
- Company
- SK Bio "hasn't manufactured SKYCovione after first batch"
- by Kim, Jin-Gu Nov 24, 2022 05:50am
- SK Bioscience On the 23rd, SK Bioscience publicly announced that the manufacture and supply of its self-developed COVID-19 vaccine ‘SKYCovione’ have currently been discontinued. SK Bioscience received marketing authorization for SKYCovione in Korea in July this year. In September, the company supplied an initial batch of 60 thousand doses of the 10 million doses that the government pre-purchased through an agreement. However, further manufacture and supply of the vaccine have been discontinued. One reason is that the overall vaccination rate has fallen with the slowdown of the COVID-19 outbreak and the increasing number of people with immunity. According to the Korea Disease Control and Prevention Agency, the cumulative number of people vaccinated with SKYCovione in Korea as of November 22nd was only 3,787. In other words, only 0.6% of the 600,000 doses supplied to the government were used. Its performance is sluggish compared to its competitors. The government has been recommending winter season COVID-19 vaccinations from October 11. People can choose from vaccines including SKYCovione, Pfizer’s BA1·BA.4/5-adapted vaccines, Moderna’s BA.1-adapted vaccine, and Novavax’s winter season vaccine. Among these, a cumulative 1,530,332 people received vaccination with Moderna’s vaccine. 754,058 received Pfizer’s vaccine, and 23,156 received Novavax’s vaccine. In the same period, only 1,759 people opted to receive SKYCovione. Due to such circumstances, SK Bioscience plans to continue producing the vaccine solution and wait for additional orders from the government. An official from SK Bioscience said, “Basically, the finished vaccine product is manufactured when requested by the government. We are not producing additional finished vaccines because we have not received additional requests after the initial supply." “Apart from the finished product, we have been manufacturing the vaccine solution. We will resume production and supply the request of the government in the future” The official added, “We are also undergoing global approval processes.” In July, the company applied for a Conditional Marketing Authorization (CMA) of SKYCovione (SKYCovion™ in Europe) to the Medicine and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA), and then submitted an Emergency Use Listing (EUL) application to the World Health Organization in September. However, the applications have not been approved yet.
- Company
- Kadcyla can be prescribed after registering benefit
- by Eo, Yun-Ho Nov 23, 2022 06:04am
- According to related industries, anticancer drugs such as ADC and Antibody-drug conjugate Kadcyla and CDK4/600 inhibitor Verzenio are entering the early breast cancer area in Korea. Kadcyla was already listed on the insurance benefit list in July, and the actual prescription began. The drug, which was used for the second or more treatment of HER2-positive metastatic breast cancer, has expanded access to postoperative adjunct therapy in HER2-positive early breast cancer patients with invasive residual lesions after receiving prior chemotherapy, including Taxane and Trastuzumab. The effectiveness of Kadcyla's early breast cancer was confirmed through an open-label study in phase 3 (KATHERINE). KATHERINE is a study comparing the efficacy and safety of the Kadcyla-only and Trastuzumab-based preoperative adjuvant group in 1,486 HER2-positive early breast cancer patients who were confirmed to have invasive residual lesions in the surgical site or armpit lymph nodes even after undergoing taxane and Trastuzumab-based preoperative adjuvant therapy. As a result of the study, the 3-year invasive disease-free survival (iDFS) of the Kadcyla solo administration group was 88.3%, an 11.3% improvement over the Trastuzumab solo administration group (77.0%), and a 50% reduction in the risk of disease recurrence or death. Verzenio succeeded in securing HER2-negative early breast cancer indication. This drug obtained additional approval from the Ministry of Food and Drug Safety on the 19th for HR+/HER2-, high-risk early breast cancer with lymph node-positive recurrence. The enlargement of the indication was based on the results of the Phase III clinical study cohort 1 of Verzenio's monarchE in 5,637 adult women and men at high risk of lymph node-positive type HR+/HER2- who underwent resection. As a result of the monarchE study, both IDFS (Invisible Disaster-Free Survival) and DRFS (Distant Relapse-Free Survival) at the time of follow-up 3 years showed significant improvement compared to the control group in the Verzenio administration group. The Verzenio administration group showed a 30% reduction in risk of recurrence and death within 3 years compared to the control group (88.8% of the 3-year IDFS ratio with Verzenio+endocrine therapy, 83.4% of the endocrine therapy alone), and a 31% decrease in risk of remote recurrence and death. The proportion of early breast cancer patients, which is between 0 and 1, accounts for more than half of the total breast cancer patients (as of 2018), emphasizing the importance of reducing recurrence rates through optimal treatment.
