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- 2026-03-17 19:30:53
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- Five companies give up challenging Dukarb’s patent
- by Kim, Jin-Gu Dec 06, 2021 05:54am
- Pic. of Boryung Pharmaceutical Five out of the 45 companies that set out to evade the patent of Boryung Pharmaceutical's antihypertensive combination drug ‘Dukarb Tab. (fimasartan+amlodipine)’ decided to give up challenging the patent. The industry has pointed to the fierce competition in the two-drug fixed-dose combination market as one of the causes for the companies’ decision to give up their patent challenge. According to industry sources on the 6th, PharmGen Science voluntarily withdrew the trial to confirm the passive scope of patent rights that it had recently filed for the Dukarb composition patent. If the companies succeed in avoiding the composition patent for Dukarb which is set to expire on August 2031, the companies may release their latecomer drugs for Dukarb after February 2023 after the substance patent for the Kanarb ingredient expires. According to the pharmaceutical market research institution UBIST, outpatient prescription for Dukarb recorrect 36.1 billion last year. Prescriptions amounted to 30.2 billion won by Q3 this year. Other than the single-drug pill Kanarb, Dukarb has made the most prescription performance among the Kanarb family. Due to the outstanding performance of the drug, many companies have filed challenges to the drug’s composition patent. Starting with Arlico Pharm, a total of 45 companies have filed a trial to confirm the passive scope of patent rights. However, Yuyu Pharmaceutical was the first to drop the suit on August 24th. Since then, Hanwha Pharma, Daehan New Pharm, Kims Pharma, PharmGen Science voluntarily dropped their challenges. As a result, a total of 5 companies have now given up challenging Dukarb’s composition patent. The industry’s focus is now on whether more companies will follow suit. Due to the ongoing fierce competition in the antihypertensive drug market for the ARB+CCB class two-drug combo, there is still the possibility that more companies will be giving up patent challenges. In this context, the companies may have determined that the release of a latecomer Dukab generic may not have great marketability. Also, with the strong presence held by Boryung Pharmaceutical, some predicted that the market will be hard to penetrate with the release of several same-ingredient generics at the same time. However, one variable that remains is the impurity issue in the sartan ingredients. In addition to the growing concern over azido impurities in the losartan ingredient in Korea, azido impurities have also been found in irbesartan and valsartan ingredients abroad. If the impurity issue grows to exceed expectations, some expect that this will increase demand for a different ARB-class drug, fimasartan. No impurity has been detected in fimasartan up to date.
- Company
- Moderna Korea appoints Ji-Young Sohn as new GM
- by Dec 03, 2021 05:55am
- Ji-Young Sohn, General Manager of Moderna Korea Ji-Young Sohn, the former GM of CSL Behring Korea, was appointed as the General Manager of the Korean subsidiary of the COVID-19 vaccine developer Moderna. The new GM will be leading Moderna’s business in Korea and is seeking executives to organize teams that can perform various tasks for the company. The company is currently hiring new executives and employees. Sohn majored in Pharmacy at Ewha University and holds an MBA degree from Korea University Business School. Since then, she has accumulated over 20 years of experience in various global pharmaceutical companies. Before Moderna, the new GM had served as the General Manager of CSL Behring Korea and led the establishment of its Korean subsidiary and the launch of its new products. She started her pharmaceutical career at Pfizer Korea, then expanded her scope of business in the industry at Roche Korea and Roche Headquarters. At Pfizer Korea, Sohn had led various marketing and strategy teams and served as the Head/Director of the company’s first Specialty Care Business Unit. At Roche Korea, she had served as the Head of the Oncology Business Unit, driving strong growth of the oncology business and people development. After then, Sohn moved on to become an international portfolio business leader at Roche Headquarters Switzerland and successfully implemented a global strategy of a mature product portfolio worth 1 trillion won. Patrick Bergstedt, SVP of Commercial Vaccines at Moderna, said, “Sohn is a recognized innovative and strategic leader in Korea and global markets, and we look forward to working with her to reinforce Moderna’s place in Korea.” Sohn said, “Korea is a very important market for Moderna, and Moderna has already made various strategic partnerships and considerable investments in Korea. We will work to build major relations and introduce Moderna’s mRNA science technology to Korea, increase stakeholder trust, and strive to help promote the people's health with Moderna’s excellent vaccines and other future treatments to come."
- Company
- COVID-19 vaccinations freeze up the premium vaccine market
- by Chon, Seung-Hyun Dec 02, 2021 05:54am
- The premium vaccine market that consists of vaccines used to prevent diseases like shingles, pneumococcal vaccines, etc has contracted greatly. Analysts believe that the demand for other vaccines had decreased due to medical institutions prioritizing COVID-19 vaccinations. However, the cervical cancer vaccine market continued to show growth due to the increase in demand for Gardasil 9. On the 1st, according to the medical research institution IQVIA, the shingles vaccine market size in Q3 was ₩8.9 billion, down 56.1% from the same period of last year. The cumulative sales by Q3 in the market was ₩29 billion, also a 47.3% drop from last year. Currently, two products - MSD's ‘Zostavax’ and SK Bioscience's ‘Skyzoster’ – are competing in the domestic shingles vaccine market. Since Skyzoster broke the monopoly of Zostavax and entered the market at the end of 2017, the market had recorded rapid growth. The market size had increased to record ₩27.9 billion by Q4 in 2019. Quarterly sales of shingles vaccines (Unit: ₩1 million, Source:IQVIA) However, the market had fluctuated after the full outbreak of COVID-19. In Q1 last year, the shingles vaccine market decreased by 37.8% and recorded ₩12.2 billion. The market size had contracted with patients avoiding visits to medical institutions earlier on during the outbreak. Although the market showed recovery, increasing to ₩22.6 billion in Q2, ₩20.3 billion in Q2, then ₩17.3 in Q4, sales have once again made a downward turn entering this year. Sales in Q3 had fallen 68.1% compared to two years ago, in Q4 2019. Sales of Zostavax and Skyzoster have fallen together. Zostavax sold ₩5.7 billion in Q3, a 53% drop YoY. In the same period, Skyzoster sold ₩3.2 billion and dropped by 60.7%. compared to Q4 2019, when the two vaccines peaked in their sales, Zostavax and Skyzoster’s sales both fell by 66.2% and 70.9%, respectively. The sluggish performance of the shingles vaccine market is analyzed to be an effect of the increased COVID-19 vaccinations. That the medical institutions’ tendency to administer COVID-19 vaccines first had resulted in a relative neglection of other vaccine products, is most convincing. The pneumococcal vaccine ‘Prevenar 13’ that had temporarily enjoyed an upsurge in sales with COVID-19 is also seeing prolonged sluggish sales. Prevenar 13 sold ₩7.4 billion in Q3, which was a 69.6% decrease from the same period of last year. Its cumulative sales by Q3 were ₩24.9 billion, which was also an immense 58.5% drop from the previous year. Quarterly sales of Prevenar 13 (Unit: ₩1 million, Source:IQVIA) ‘Prevenar 13’ is a PCV13 that prevents infection from 13 Streptococcus pneumoniae serotypes (3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F). It may be administered to all those aged 6 weeks or older. Prevenar 13 for adults is being distributed in Korea by Chong Kun Dang, and for infants by Korea Vaccine. Prevenar 13’s performance this year is in stark contrast to the sharp rise in sales it made last year with the COVID-19 outbreak. Its sales in Q1 last year was ₩17.6 billion, a 52.2% increase from the previous year, which rose to ₩24.2 billion by Q3 last year. Prevenar13 sold ₩81.2 billion last year and made a 64.8% YoY increase. Demand for Prevenar 13 among adults had surged temporarily earlier in the COVID-19 outbreak with the expectation that while Prevenar13 cannot prevent COVID-19, it can weaken the pneumonia symptoms from COVID-19. However, its sales had greatly dropped entering this year. Sales of the vaccine in Q1 was ₩9.4 billion, a 55.5% decrease from the previous quarter, and continued to drop in the following quarters. Prevenar13’s sales dropped 32.8% compared to the pre-COVID-19 period 2 years ago. In other words, the vaccine, which enjoyed reflective benefits in the early phases of the COVID-19 pandemic, has been on the contrary, been negatively affected by COVID-19 and the increase of its vaccinations this year. Among the various products in the premium vaccine market, the cervical cancer vaccines market solely showed growth. In Q3, the cervical cancer vaccine market increased 22.7% from the previous year and recorded ₩21.9 billion. Cumulative sales by Q3 was ₩66.9 billion, increasing 42.3% from the previous year. Three products – MSD’s ‘Gardasil,’ ‘Gardasil 9,’ and GSK’s ‘Cervarix’ – are competing in the domestic cervical cancer vaccine market. The rapid rise of the relatively expensive Gardasil 9 is analyzed to have driven the growth of the market’s size. Quarterly sales of cervical cancer vaccines (Unit: ₩1 million, Source:IQVIA) Gardasil sold ₩5.4 billion in Q3, which was only a 3.9% increase from the previous year. However, Gardasil 9’s sales rose 37.2% in the same period, recording ₩16.1 billion. Cumulative sales of Gardasil 9 by Q3 was ₩50.8 billion, a 72.6% increase from the previous year. Cervarix’s sales in Q3 were only in the ₩0.3 billion range. Gardasil 9 is a vaccine is an HPV vaccine product that contains 5 additional serotypes (31, 33, 45, 52, 58) to the 4 serotypes (6·11·16·18) contained in Gardasil. It is being distributed at a higher price Among cervical cancer vaccines, it is being distributed at a high price with the distinction that it contains the most HPV types. Based on Q3 numbers, Gardasil 9's accounts for 73.6% of the cervical cancer vaccine market. Unlike Gardasil and Cervarix, Gardasil 9 is not part of the National Immunization Program in Korea. However, its effect in preventing other HPV-related diseases such as anal cancer, genital warts, and precancerous lesions in addition to cervical cancer has spread by word of mouth, increasing the annual number of male vaccinations. The age for its vaccination had also been extended to cover up to 45 years of age, increasing the rate of adult revaccinations.
- Company
- Prevenar 13 sales take ‘roller-coaster’ ride with COVID-19
- by Chon, Seung-Hyun Dec 01, 2021 05:56am
- Sales of the pneumococcal vaccine ‘Prevenar 13’ took a rollercoaster ride in one year, enjoying an upsurge for a short period of time then plummeting in just a single year. The vaccine enjoyed reflective benefits in the early phases of the COVID-19 pandemic but dropped sharply after COVID-19 vaccinations began in earnest. According to the pharmaceutical research institution IQVIA on the 30th, Q3 sales of Prevenar 13 dropped 69.6% compared to the same quarter of the previous year and recorded 7.4 billion won. The cumulative sales by Q3 was 24.9 billion won, also a 58.5% decrease from last year, indicating sluggish sales. Such cases where sales of a product suddenly drops after making unprecedented records just a year ago are rarely observed. ‘Prevenar 13’ is a PCV13 that prevents infection from 13 Streptococcus pneumoniae serotypes. It may be administered to all those aged 6 weeks or older. Prevenar 13 for adults is being distributed in Korea by Chong Kun Dang, and for infants by Korea Vaccine. Quarterly Prevenar 13 sales trend (Unit: 1 million KRW, Source: IQVIA) Sales of Prevenar13 had been steadily rising before the COVID-19 pandemic, recording approximately 10 billion in quarterly sales. Then, its sales surged with the spread of COVID-19. Its sales in Q1 last year was 17.6 billion, a 52.2% increase from the previous year, and rose to 24.2 billion won by Q3 last year. Prevenar13 sold 81.2 billion last year, which was a 64.8% YoY increase. With the claim of some experts that although Prevenar13 cannot prevent COVID-19, it can weaken the pneumonia symptoms of COVID-19 gaining credibility, demand for Prevenar 13 among adults surged temporarily. However, entering this year, its sales had greatly dropped. Sales of the vaccine in Q1 was 9.4 billion won, a 55.5% decrease from the previous quarter, and continued to drop across the following quarters. Analysts believe the rise in demand for Prevenar13 has been watered down due to the prolonged COVID-19 pandemic. Also, the start of COVID-19 vaccinations in earnest had affected the number of other vaccine recipients. Most of the vaccine market for adults is slow this year because of the priority given to COVID-19 vaccines. Also, other analysts see that the temporary surge in demand for COVID-19 vaccines last year lead to the relative gap in demand this year, and the demand for vaccination to reduce pneumonia symptoms has also decreased. The sluggish sales of Prevenar 13 also affected the performance of its distributor, Chong Kun Dang. Chong Kin Dang’s Q3 operating profit fell 23.7% from the same quarter of the previous year and recorded 37 billion won, and its sales recorded 341.3 billion won, a 4.5% YoY decrease.
- Company
- SGLT-2i Jardiance adds chronic heart failure indication
- by Eo, Yun-Ho Nov 30, 2021 05:52am
- The SGLT-2 inhibitor ‘Jardiance’ may now be prescribed for chronic heart failure in Korea as well. According to industry sources, the Ministry of Food and Drug Safety had additionally approved a new indication for Jardiance (empagliflozin),' the SGLT-2 inhibitor used for the treatment of diabetes, to be used for adults with chronic heart failure with reduced left ventricular ejection fraction, regardless of their diabetes status. With the approval, Jardiance became the second SGLT-2 inhibitor following ‘Forxiga (dapagliflozin)’ allowed to be prescribed for chronic heart failure. Forxiga had been approved for the same indication in December last year. Jardiance's heart failure indication was granted Fast Track designation, then approved by the US FDA in June. Its heart failure-related efficacy was confirmed through the Phase III EMPEROR-Reduced clinical trial. Results showed that Jardiance met the primary endpoint, composite of cardiovascular death or hospitalization for heart failure in adults, by reducing the risk by 25% compared to placebo, demonstrating statistical significance. In the analysis of key secondary endpoint, Jardiance reduced the risk of first and recurrent hospitalization for heart failure by 30% and significantly delayed the kidney function index, eGFR, compared to placebo. Also, the sub-analysis results of the EMPEROR-Reduced trial that were presented at the American Society of Nephrology (ASN) ‘Kidney Week 2020’ last year showed that Jardiance’s benefit was consistent across various patient subgroups including patients with severe renal dysfunction, regardless of chronic kidney disease status at baseline in the analysis for the overall population. Meanwhile, Jardiance also made remarkable achievements in acute heart failure. The Phase III EMPULSE study demonstrated Jardiance’s treatment benefit in patients who were hospitalized for acute heart failure. In the EMPULSE study which evaluated the efficacy and safety of Jardiance in adults with and without diabetes that were hospitalized for acute heart failure and have been stabilized, Jardiance demonstrated its clinical benefit by improving all-cause mortality, reducing cases of heart failure, and improving heart failure symptoms.
- Company
- Ildong started developing a treatment for COVID-19
- by Nho, Byung Chul Nov 29, 2021 05:58am
- Ildong Pharmaceutical and Shionogi Pharmaceutical have begun joint development of oral COVID-19 treatments, drawing keen attention to whether they will succeed in commercializing them in the future. Ildong Pharmaceutical officially announced on the 17th that it will participate in the development of S-217622 as a candidate for oral COVID-19 treatment along with Shionogi Pharmaceutical, and attention is being paid to whether it will create the third drug in the world to contribute to the end of the pandemic after Pfizer and MSD. Accordingly, Ildong Pharmaceutical plans to start the development process as soon as the recruitment of patients is completed after obtaining IND approval for the domestic clinical trial (P2/3) of S-217622 from the Ministry of Food and Drug Safety in Korea. According to Ildong Pharmaceutical, it aims to become the EUA of the Ministry of Food and Drug Safety within the first half of 2022. Although Pfizer and MSD, two global big pharmas, are already set to commercialize oral treatments for COVID-19, the pipeline should be expanded in terms of high drug costs worth nearly 850,000 won and protection of doctors and patients' drug options. In particular, S-217622 is a candidate substance for a new drug targeting the COVID-19 virus from the beginning, so it is different from drug re-creation development cases that utilize existing substances that have already been licensed or developed with other indications. According to previous studies, S-217622 prevents virus proliferation by inhibiting protease (3CL-protase), which exists only in the SARS-CoV-2 virus, the source of infection that causes COVID-19. It has also been confirmed that alpha, beta, gamma, and delta COVID-19 mutations all have similar levels of virus proliferation inhibition capabilities. More efficient medication convenience is also drawing attention. Pfizer's Paxlovid requires a total of 30 tablets, twice a day for 5 days, and the 5-day dose of MSD's Lagevrio reaches 40. On the other hand, S-217622 is being developed once a day for 5 days. It is expected to be smaller than the previous two treatments. The prospect that localization of treatments according to the terms of the joint development contract and improvement of access to domestic patients will have an advantage over other competitive drugs is also receiving positive reviews. If Ildong Pharmaceutical succeeds in developing the S-217622, it is planning domestic production through technology transfer. An official from Ildong Pharmaceutical said, "Korea's clinical design aims at more than 200 asymptomatic, mild, and severe patients. If development is successful, stable drug production and supply are expected by establishing sovereignty over treatments. Considering the data so far, it shows excellent safety, he said. Ildong Pharmaceutical and Shionogi Pharmaceutical have maintained a partnership for 40 years since the 1980s. Japan Pharmaceutical introduces and sells Shionogi Pharmaceutical's antibiotic Flumarin and Pirespa, a treatment for idiopathic pulmonary fibrosis, in Korea, and cooperates in the clinical phase for the first time. Shionogi is the world's top 50 pharmaceutical company that has focused on developing innovative treatments by focusing on treatment areas in the fields of anti-infectious diseases and central nervous system disorders, including antibiotics and antiviral drugs, for 144 years since its foundation in 1878. It has also developed large global new drugs such as flu treatment Xofluza, antibiotic Petroja, and hyperlipidemia treatment Crestor.
- Company
- Samsung BIOEPIS set a new sales record in a year
- by Chon, Seung-Hyun Nov 29, 2021 05:58am
- Samsung BIOEPIS has generated the largest quarterly sales since its launch. Overseas sales of biosimilars have increased, and milestones have flowed in due to overseas permits for subsequent biosimilar products. According to the Financial Supervisory Service on the 23rd, SAMSUNG BIOEPIS saw its sales rise 14.4% year-on-year to 271 billion won in the third quarter. It surpassed the previous maximum sales of 236.9 billion won recorded in the third quarter of last year in a year, breaking a new quarterly sales record. The company's cumulative sales in the third quarter were 625.2 billion won, up 9.2% from the previous year. Samsung Bioepis Most of Samsung BIOEPIS sales are generated through overseas sales of its own biosimilar products. SAMSUNG BIOEPIS succeeded in commercializing biosimilars of six products, including Enbrel, Remicade, Herceptin, Humira, Avastin and Lucentis. In Europe, all six products were approved, and in the United States, five products excluding Avastin were approved for sale. SAMSUNG BIOEPIS's performance has slowed slightly as sales have been on the decline for the second consecutive quarter since the third quarter of last year. Sales in the first quarter of this year amounted to KRW 166.7 billion, down 29.6% from the third quarter of last year. With the aim of securing inventory in preparation for the prolonged COVID-19, pre-orders from hospitals and wholesalers in Europe have recovered their performance. However, it rebounded in the second quarter and broke a new sales record in the third quarter, recovering from the sluggishness caused by COVID-19. Overseas sales sold by Biogen and Organon showed growth. Samsung Bioepis biosimilar's overseas sales in the third quarter were $342.8 million (about 406 billion won), up 11% from $369.9 million a year earlier. SAMSUNG BIOEPIS is selling five biosimilars in global markets excluding Korea through marketing partnerships with Biogen and Organon. Quarterly SAMSUNG BIOEPIS sales (unit: 1 million won, data: Financial Supervisory Service) Biogen is in charge of distributing and selling three types of autoimmune disease treatments in Europe, including Enbrel biosimilar Benepali, Remicaid biosimilar Flixabi, and Humira biosimilar Imraldi. Organon (formerly MSD) sells these three products under the product names Renflexis (Remicade biosimilar), Brenzys (Enbrel biosimilar), and Hadlima (Humira biosimilar) in the rest of the world except the United States, Korea, and China. Organon is also in charge of overseas sales of two types of anticancer drugs, Herceptin biosimilar Ontruzant and Avastin biosimilar Aybintio. Sales of biosimilars sold by Biogen reached $22.8 million in the third quarter, up 2% from the previous year. Organon's biosimilar sales in the third quarter rose 41% year-on-year to $140 million. The combined sales of biosimilars sold by Biogen and Organon in the third quarter amounted to $916.2 million (about 1.8 trillion won), up 11% from the previous year. In the third quarter, additional milestones were also introduced with the overseas approval of biosimilars. Lucentis biosimilar Byooviz, developed by Samsung Bioepis in August, was approved for sale by the European Commission (EC), and a month later, it was approved by the U.S. Food and Drug Administration (FDA).
- Company
- Keytruda's sales have been leading for two consecutive years
- by Chon, Seung-Hyun Nov 26, 2021 05:54am
- Keytruda, an immuno-cancer drug, has been leading the domestic pharmaceutical market for the second consecutive year. K-CAB continued to soar among new drugs from multinational pharmaceutical companies. According to IQVIA, a pharmaceutical research institute on the 26th, Keytruda of MSD Korea recorded 145.5 billion won in sales in the third quarter of this year, the largest number of all medicines. It recorded a high growth rate of 27.8% year-on-year, widening the gap with the second-ranked Lipitor by more than 30 billion won. Until the first half of the year, the gap between Keytruda and Lipitor was 19.9 billion won. Keytruda ranked first among all medicines for the first time with sales of 155.7 billion won last year. Keytruda, released in Korea in 2015, is an immune checkpoint inhibitor that treats cancer through activation of immune cells by inhibiting "PD-1" protein on the surface of immune cells T cells to prevent binding with PD-L1 receptors. In Korea, 18 indications were approved for 14 carcinomas, including melanoma, lung cancer, and head and neck cancer. Keytruda's quarterly sales remained around 3 billion won immediately after its release, but sales began to rise rapidly since August 2017 when insurance benefits were applied as a secondary treatment for non-small cell lung cancer. Keytruda surpassed 50 billion won in sales in the third quarter. If this trend continues, sales are expected to surpass 200 billion won this year. Keytruda also posted cumulative sales of $12.6 billion in the third quarter of this year in the global market. Perjeta and Prolia, new drugs from multinational pharmaceutical companies, also showed high sales growth. Roche's Perjeta recorded 69.1 billion won in cumulative sales in the third quarter, up 29.9% from the previous year. Perjeta is a drug administered in combination with Docetaxel and Trastuzumab in metastatic or localized HER2 positive breast cancer patients who are not operable and have never received HER2 targeted anticancer drugs or chemotherapy. Amgen's Prolia's cumulative sales in the third quarter amounted to 65.2 billion won, up 18.7% from the same period last year. Prolia, released in Korea in November 2016, is a biopharmaceutical osteoporosis treatment targeting protein RANKL. Since 2017, sales of Prolia have started to rise since salaries were applied only to secondary treatment therapy. Since April 2019, sales of Prolia have increased rapidly as insurance benefits have been recognized for primary treatment therapy. Chong Kun Dang is jointly selling Prolia with Amgen. It is an interesting phenomenon that Sanofi's antithrombotic drug Plavix increased 18.6% year-on-year to 46.8 billion won in cumulative sales in the third quarter. Plavix's patent expired in 2007, and more than 100 generics have entered. More than 10 years have passed since the patent expired, and sales have rather increased despite competing with more than 100 generics.
- Company
- Will the sale of impurity Losartan be okay?
- by Kim, Jin-Gu Nov 26, 2021 05:53am
- It is focusing on announcing the results of the MFDS. Anxiety in production and sales sites surrounding Losartan impurities is rising. As self-inspection results begin to come out for each manufacturer, consignment companies that received these results are agonizing over whether to preemptively suspend sales or continue sales. According to the pharmaceutical industry on the 24th, Arlico Pharmaceutical, Aju, and CTC Bio decided to stop selling Losartan-containing products. In the case of Arlico, the company decided to voluntarily withdraw along with the suspension of sales. At least five companies are confirmed to have officially decided to suspend sales about a week after concerns over Losartan impurities arose in earnest on the 16th. In addition to the three companies that decided to suspend sales on the 24th, Hutecs Pharmaceutical has begun to suspend sales. Mothers Pharmaceutical has not stopped selling Losartan, but has temporarily suspended the supply to new customers. On top of that, it is confirmed that many companies have unofficially suspended sales and supply. It is predicted that the number of companies suspended from sales is likely to increase further in the future. An official from the pharmaceutical industry said, "We have virtually stopped supplying it. "We don't know what measures the MFDS will take later, but it's to reduce the burden of voluntary recovery just in case," he said. Another company official said, "We have not yet received results from the consignee. However, if there is a problem, we plan to preemptively suspend sales", he explained. On the contrary, some pharmaceutical companies say they will continue to sell and supply until the MFDS announces. In this regard, a company official said, "There are many requests from suppliers. Since it has become difficult to obtain the product as several companies have stopped selling on their own, we will continue to supply it for now, even if we recover it later."
- Company
- Tabrecta and Tepmetko are approved simultaneously for NSCLC
- by Nov 25, 2021 05:56am
- Two new anticancer drugs that target the MET gene to treat non-small cell lung cancer have entered the Korean market. The two drugs are Novartis’ ‘Tabrecta (capmatinib)’ and Merck’s ‘Tepmetko (tepotinib)’ The Ministry of Food and Drug Safety approved Tabrecta and Tepmetko together on the 23rd. Both are targeted therapies that target MET mutations and have the same indications. Tabrecta and Tepmetko may both be used to treat locally advanced or metastatic NSCLC harboring MET exon 14 skipping mutations. Various mutations that induce cancer cell growth occur in NSCLC. Dysregulation in the proto-oncogene MET that is located in the long arm of chromosome 7 is also one of such many mutations. MET dysregulation can largely be divided into MET amplification or MET mutation. The MET exon 14 skipping mutation that is targeted by Tabrecta is one of the most commonly reported oncogenic MET mutations. MET exon 14 skipping mutation overstimulates the MET pathway that plays a key role in the signaling, proliferation, and survival of cells, resulting in the proliferation of cancer cells. MET exon 14 skipping (METex14) alterations are rare, occurring in only around 3% of all patients with metastatic NSCLC. However, its prognosis is poor due to its aggressive nature. In particular, retrospective analysis on patients with MET exon 14 skipping mutations showed that 37% of the patients had brain metastasis and 49% had bone metastasis at diagnosis. Tabrecta and Tepmetko are drugs that selectively inhibit the MET receptor tyrosine kinase. It blocks the MET phosphorylation response by binding to the intracellular kinase domain. In the US, Novartis’ Tabrecta was first approved and listed as the first MET targeted anticancer therapy. Tabrecta was approved in May last year, and Tepmetko in February of this year by the US FDA. In Korea, both were authorized simultaneously and are on an equal footing. At the pivotal GEOMETRY mono-1 trial, Tabrecta demonstrated a 68% objective response rate (ORR) and 41% ORR in treatment-naïve and previously treated patients, respectively. The duration of response (DoR) was 12.6 months and 9.7 months, respectively. Tepmetko demonstrated a 43% ORR in patients regardless of treatment experience, and DoR was 10.8 months ORR in treatment-naïve patients and 11.1 months in previously treated patients Both companies are also actively studying the combined use of their respective drugs with EGFR-targeted therapies with the hope that it could address the issue of resistance that patients acquire after treatment with EGFR inhibitors. MET mutation or amplification are key mutations that cause EGFR-TKI resistance. In this context, the companies are studying the combination of Tabrecta with Iressa, Tagrisso, etc, and Tepmetko with Tagrisso.
