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- 2026-05-16 17:30:38
- Price of ‘Vesicare’ drops below its generics
- by Lee, Tak-Sun Feb 21, 2022 05:58am
- The voluntary price cut made by the overactive bladder treatment Vesicare (solifenacin succinate) is expected to reduce its drug price to a level lower than its generic versions. On what tactic the generic companies will take after losing their price competitivity remains the focus of attention. According to industry sources on the 20th, Astellas Korea has voluntarily applied to lower the reimbursement ceiling for Vesicare from ₩533 to ₩516, which will become effective as of March 1st. The price will be applied to both the 5mg and 10mg doses. The price ceiling of the discounted Vesicare 5mg will be set at the third-lowest level among the 78 products with the same active ingredient, dose, and formulation. In other words, only 2 of the 77 Vesicare generics will be cheaper than the original. Based on the February drug reimbursement list, the two drugs cheaper than Vesicare are Pharmbio Korea’s ‘OAB tab. 5mg' at ₩490, and Hanall Biopharma’s ‘Vesigad tab. 5mg’ at ₩500. The other 75 products cost between ₩532 to ₩534, priced around ₩16-18 more expensive than the ₩516 of Vesicare. The generic versions of Vesicare were released in July 2017. At the time, most generic companies in Korea have launched generic versions of Vesicare that had been leading the OAB treatment market. However, Betmiga (mirabegron), which Astellas had released in October 2015 in preparation for Vesicare’s patent expiry took over the OAB treatment market, leaving Vesicare generics little room for success. 45 products have already withdrawn from the market after revoking their licenses. Moreover, Hanmi Pharmaceutical and Ahngook Pharm had released their salt-modified drugs 7 months before other generics, so the other companies were unable to reap the benefits of preoccupying the market. According to UBIST, outpatient prescriptions of Vesicare last year recorded ₩13.7 billion, the salt-modified Hanmi’s ‘Besigum (solifenacin tartrate)’ recorded ₩1.7 billion, and Ahngook Pharm’s ‘A-care (solifenacin fumarate)’ recorded ₩2.9 billion. Other generic products have sold less than ₩1 billion and have been making an insignificant presence in the market. The reimbursement ceiling price set for Besigum and A-care is ₩698, which is relatively more expensive than the price-adjusted solifenacin succinate drugs. With the price gap widening to ₩182 with Vesicare’s voluntary price cut, Hanmi Pharmaceutical and Ahngook Pharm would also need to pay attention to consider price competitivity. Accordingly, what strategies the latecomers would take to respond to the voluntary price cut of its original is receiving attention. The industry expects generics with low competition to withdraw from the market, and those who wish to remain in the market would consider price adjustments.
- Policy
- Required PMS case reports reduced for Genvoya and Descovy
- by Lee, Hye-Kyung Feb 21, 2022 05:58am
- The number of evidence cases reported for post-marketing surveillance of HIV treatments ‘Genvoya tab (emtricitabine / tenofovir alafenamide/ cobicistat / elvitegravir)’ and ‘Descovy tab (emtricitabine / tenofovir alafenamide) that are subject to reevaluation will be adjusted. Genvoya and Descovy, which received marketing authorization from the Ministry of Food and Drug Safety in September 2016 and February 2017, respectively, are up for reexamination by September 12th and have been conducting post-marketing surveillance for 6 years since their release. The PMS cases that were required for the report are 3000 cases for Genvoya and 600 for Descovy, but the Central Pharmaceutical Affairs Council saw consensus on the need for the number of cases to be adjusted to 1,430 and 460 for each. The results were detailed in the minutes of the CPAC meeting disclosed recently by the Ministry of Food and Drug Safety. The committee members have judged that the number of evidence cases reported should be adjusted in consideration of the indications and the reduced sales for Genvoya, and the refunds and characteristics of its indication for Descovy. ◆Descovy = In detail, the committee chair of the safety and pharmaceutical reexamination review subcommittee explained that when a new standard-of-care is introduced, the number of new patients taking the drug decreases while the number of HIV-positive patients remains the same, the 600 PMS cases required for Descovy may not be realistic. The MFDS said, “The drug was not designated an orphan drug due to the availability of various alternatives. As setting a fixed number, 3,000 or 600, unilaterally on drugs rose as an issue, the company is allowed to present an appropriate number of evidence cases for the report in the process of determinations, but as the actual market situation may change, the number is often later adjusted according to the market situation. The explanation came after the inquiry on why AIDS treatments do not fall into the category of rare diseases when the number of AIDS patients was 14,000. A committee member said, “The number of PMS cases for submission should be reviewed and applied consistently within the ministry. A standard should be set internally to adjust the number of PMS cases.” Some had raised the opinion that AIDS treatments should be reviewed from a different standard than other general medicines when setting the number of required evidence cases for examinations. Another committee member said, “Due to the small number of patients and short duration of the drugs, it is hard to collect cases according to regulations. The short duration of action of the drug and the number of patients are not being considered. Since the additional investigation period will not help increase the number of collected cases, it would be better to close the re-examination within the set period and sort out the side effects as soon as possible.” ◆Genvoya = Both Descovy and Genvoya are Gilead Science Korea’s products, and the committee members focused on the fact that was the same company has been supplying improved follow-on STR formulation. The committee saw that the fact that the company supplies both the product subject to case number adjustments and follow-on products was an important factor and that the pharmaceutical company is leading the market by focusing on marketing its follow-on drug. The committee members weighted on the fact that the reason why Descovy and Genvoya cannot collect the number of required cases is that the market share has shifted with the release of its follow-on drugs. Another member said, “The follow-on drug will also be subject to reexaminations, and we should require the company to fill the number of evidence cases early on in those subject to the PMS. As the PMS should be conducted in patients who are new users of the drug, the company may apply for another adjustment without the allowance of retrospective studies." To this, some members had suggested that cases in the retrospective studies should also be included as PMS cases for submission. A member said, “There may be distortions in the retrospective survey depending on the patient's memory, but as the collection of results for the retrospective study is based on medical records, there will be no major distortions. We need to accept retrospective study results.” However, the MFDS said, “The PMS is conducted to monitor all adverse events. There is still room for data distortion with retrospective investigations.” The committee was able to reach an agreement on adjusting the number of cases, the members were unable to reach an agreement due to discord on filling the number of cases with retrospective studies. The chair of the committee said, “We ask the MFDS for more thorough supervision of the latecomer drugs developed and prepared by the pharmaceutical companies that developed the originals so that the companies could fully concentrate on PMS in the early stages after release.”
- Policy
- Pre-registration of Novavax vaccination will begin
- by Kim, Jung-Ju Feb 21, 2022 05:58am
- The quarantine authorities will start pre-registration of Novavax vaccinations for adults over the age of 18. According to the COVID-19 vaccination promotion team, adults over the age of 18 who want to receive Novavax can make reservations through (http://ncvr.kdca.go.kr). Elderly people who have difficulty making reservations on their own can make proxy reservations through the website or make phone reservations (1339, local government call centers). Those who have completed the pre-booking will be able to get vaccinated on the day of reservation at consigned medical institutions nationwide (about 12,900 locations) from March 7, and the second inoculation date will be automatically booked three weeks after the first inoculation. However, the inoculation date cannot be selected as a date two weeks before the reservation date. For example, if people make a reservation on February 21, they can choose after March 7, and if people make a reservation on February 22, they can choose after March 8. People can get vaccinated on the same day by booking a remaining vaccine on Kakao Talk and Naver, or putting the name on the preliminary list after checking by wire with a medical institution. The authorities plan to allow vaccinations on the same day through the amount held by all consignment agencies after March 7 so that vaccinations can be conveniently received without prior reservations. Cross-vaccination and 3rd vaccination using Novavax vaccine are also possible. 2nd vaccination should be inoculated with the same vaccine as primary vaccination, but cross-vaccination through Novavax vaccine is exceptionally possible if MD determines. In the case of basic vaccination with Novavax vaccine, the third vaccination is based on Novavax vaccine, and the vaccination interval is three months after the completion of the second vaccination. However, there are two exceptional cases. In the first case, a person who has received a basic vaccination with Novavax vaccine wishes to receive 3rd vaccination with mRNA vaccine, and can be vaccinated without any special reason. The second is the case where a person who received basic vaccination with a vaccine other than the Novavax vaccine has a reason for contraindication or postponement during the basic vaccination, and a third vaccination is possible with an exception under the judgment of a doctor. The authorities are conducting door-to-door vaccinations for non-invaccinated people such as ▲ hospitalized patients, ▲ residents of nursing facilities, ▲ elderly people with severe disabilities, etc. It is expected to contribute to reducing the number of severely ill patients and protecting high-risk groups by eliminating vaccination blind spots for high-risk groups that were not vaccinated due to physical constraints. The promotion team said, "As vaccination can reduce the risk of COVID-19 infection in the community and effectively prevent severe progression, we ask those who have not yet been vaccinated to actively participate in the pre-reservation for Novavax vaccination."
- Company
- Development of Xolair biosimilars is in full swing
- by Ji Yong Jun Feb 21, 2022 05:58am
- Xolair (Novartis)Domestic and foreign bio companies have started to develop Xolair (Omalizumab) biosimilars which patents expire in two years. The development stage of Celltrion, a domestic company, is the fastest. According to Clinical Trials, a clinical registration site of the NIH on the 17th, six clinical trials of Xolair biosimilars are currently registered. Three companies, Celltrion, Theba in the UK, and CSPC in China, are conducting phase 3 clinical trials, while three are in phase 1 clinical trials, including Zhejiang Huahai Pharmaceutical in China, Generium in Russia, and Syneos Health in the United States. Xolair is a treatment for allergic asthma and chronic urticaria. It was jointly developed by Genentech and Novartis, subsidiaries of Roche. Based on the two companies' earnings announcements, Xolair's sales last year amounted to 4.2 trillion won, up 10.5% from the previous year. Xolair will be challenged by biosimilars from 2024. Xolair patents expire in Europe in 2024 and in the United States in 2025, respectively. Celltrion is analyzed as the fastest place to develop Xolair biosimilars. Celltrion is conducting phase 3 clinical trials of the Xolair biosimilar CT-P39. The end of the clinical trial is expected to be January next year. Considering the period of the European licensing process, it is expected that biosimilars will be released in time for Xolair's patent expiration. Teva, a British pharmaceutical company, is closely chasing this. Teva is conducting phase 3 clinical trials of the Xolair biosimilar TEV-45779. However, the end of the clinical trial is expected to be June 2024, later than Celltrion. China's CSPC entered phase 3 clinical trials of the Xolair biosimilar SYN008 earlier than Teva, but it is still in the pre-patient recruitment stage. In addition, Generium's GNR-044 has ended phase 1 clinical trials, while Zhejiang Huahai Pharmaceutical's HS632 and Synos' BP11 are undergoing phase 1 clinical trials. Due to the clinical progress of companies, Celltrion is likely to take over the first mover of Xolair biosimilars. First mover is considered a top priority when evaluating the competitiveness of biosimilars. This is because biosimilars generate profits by bringing the market share of the original market. Celltrion's biosimilars Remsima and Truxima, which were released as first movers, are prominent in the European market. According to Celltrion, as of the third quarter of last year, the European market share was 54% for Remsima and 34% for Truxima.
- Company
- Vitrakvi's price negotiation has been extended
- by Eo, Yun-Ho Feb 18, 2022 05:55am
- According to related industries, both Roche's Rozlytrek (NTRK) anticancer drugs, Roche Korea's Rozlytrek and Bayer Korea's Vitrakvi, failed to conclude discussions with the NHIS (60 days) in January. The two drugs seeking the PE system passed the HIRA's Drug Benefit Evaluation Committee last year, but are in the final stage. If the extended negotiations are concluded as soon as possible, both drugs can be applied in March, but as they are the first drugs to be applied to multiple solid cancers only for certain genetic mutations, it remains to be seen whether the government and pharmaceutical companies can reach an agreement. Among adult and pediatric patients with NTRK gene fusion without acquisition-resistant mutations, Rozlytrek and Vitrakvi are highly likely to undergo severe morbidity during local progression, metastasis, or surgical resection, and can be used to treat solid cancer patients who have progressed after conventional therapy or do not have suitable treatments currently available. Meanwhile, Rozlytrek's approval was determined based on experimental data from phase 1/2 STARTRK-NG trials and phase 2 clinical trials in pediatric patients, STARTRK-1, and ALKA-372-001. In the STARTRK-2 study, Rozlytrek reduced tumors in more than half to 56.9% of patients with solid cancer (ORR) positive for NTRK fusion genes. Patients were conducted in 10 different solid cancer patients, and the duration of the reaction was observed to be 10.4 months. Vitrakvi's approval was based on a phase 1 test for adults aged 18 or older, a phase 2 NAVIGATE test for adults and children aged 12 or older, and a phase 1/2 SCOOT study for pediatric patients aged 1 month to 21 years old, including primary CNS tumors. According to the efficacy evaluation of a total of 55 people whose NTRK gene fusion was confirmed from three studies,Vitrakvi achieved an objective response rate (ORR) of 75% and 53% in various carcinomas (soft tissue sarcoma, infant fibroma, salivary gland cancer, lung cancer, melanoma, colon cancer, bile duct cancer, breast cancer, and pancreatic cancer).
- Policy
- Tagrisso’s succeeds in RSA renewal… 3% price cut per dose
- by Kim, Jung-Ju Feb 18, 2022 05:55am
- AstraZeneca’s NSCLC treatment Tagrisso (Osimertinib) succeeded in renewing its risk-sharing agreement (RSA) with the National Health Insurance Service, and the price of the drugs will be adjusted and discounted by 3% per dose. According to industry sources, AstraZeneca has agreed to discount the insurance price of Tagrisso during RSA renegotiations with the NHIS. With the MOHW working to amend the ‘drug reimbursement list and reimbursement ceiling price table’ to implement these changes. If the amendment is finalized, it can be applied from March 1st. Leclaza is reimbursed for second-line treatment of lung cancer, for locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with positive EGFR T790M mutation who have been previously treated with an EGFR-TKI. The drug also has indications as first-line therapy and as adjuvant therapy after complete tumor resection. With the expiry of the first RSA term, the price of the drugs will be discounted by 3% each. The 30mg dose will be discounted from ₩116,563 to ₩113,066, and the 80mg dose from ₩217,782 to ₩211,248.
- Company
- AstraZeneca wins second trial on ‘Forxiga substance patent'
- by Kim, Jin-Gu Feb 18, 2022 05:55am
- AstraZeneca, the original drug maker of the SGLT-2 inhibitor for the treatment of diabetes, ‘Forxiga,’ won the second trial over its substance patent. The ruling has abruptly put a hold on Dong-A ST’s plans for the early release of its Forxiga latecomer. The industry interpreted this as a crisis for the ‘pro-drug strategy’ that has been gaining attention as a breakthrough in overcoming the substance patent of originals. On the 17th, the Patent Court of Korea overturned the first instance court ruling and ruled in favor of AstraZeneca in its appeal against Dong-A ST to overrule the Intellectual Property Trial and Appeal Board (IPTAB)’s decision. The IPTAB had previously ruled in favor of Dong-A ST. The Patent Court of Korea judged that the Forxiga prodrug (product name Dapaflo) falls within the scope of the patent of AstraZeneca's Forxiga’s active ingredient. The ruling has put a stop to Dong-A ST’s early release strategy. Dong-A ST had planned to release a Forxiga latecomer exclusively if it wins in the appeal. However, losing the second trial, Dong-A ST can now only release its latecomer drug after April 7th 2023, after Forxiga’s substance patent expires. The prodrug strategy that gained industry interest is also in peril. Dong-A ST was the first in Korea to attempt evasion of Forxiga’s substance patent using the prodrug strategy. The industry believed that this attempt may become a new breakthrough in overcoming the 'impenetrable' substance patents of original drugs. Pro-drug is a ‘pro’ drug that is considered a similar but different drug from the original drug. Its chemical structure is partially different in its substituents with the original drug until administration. However, once administered, the drug shows the same effect as the original drug. In principle, it may seem similar to salt-modified drugs, but the difference Is clear. Salt can be changed through simple ion bonding, and the chemical structure of the drug does not change. However, prodrugs change the substituents through a more difficult covalent binding method. It has a different chemical structure to the original drug. The key issue in the patent suit was whether a prodrug could be considered a completely new substance. The Patent Court of Korea had determined prodrug partially improved form an existing substance.
- Company
- The industry is worried about the spread of Omikron
- by Kim, Jin-Gu Feb 18, 2022 05:55am
- The Omicron mutation COVID-19 virus is also hurting factories and research institutes of pharmaceutical bio companies. Concerns are growing over production disruptions as a series of confirmed cases have emerged in Hwaseong Hyangnam Pharmaceutical Industrial Complex and Cheongju Osong Life Science Complex, where pharmaceutical factories are concentrated. According to the pharmaceutical industry on the 15th, a series of COVID-19 confirmed cases have recently occurred in the Hyangnam Pharmaceutical Industrial Complex located in Hyangnam-eup, Hwaseong-si, Gyeonggi-do. It is reported that the number of confirmed cases is increasing after the Lunar New Year holiday. Currently, 40 factories of 38 pharmaceutical companies are in operation in the Hyangnam complex. There are 3,500 workers working in the complex alone. Most of them commute from Suwon or Hwaseong, Gyeonggi-do. The problem is the spread of COVID-19 in Suwon According to Gyeonggi-do, as of midnight on the 15th, there were 31,894 confirmed cases of COVID-19 in Suwon. The number of new confirmed cases is 1,387. In the case of Mars, a total of 27,039 people, including 1,589 new confirmed cases. Analysts say that the Hyangnam Pharmaceutical Industrial Complex has also been affected by the rapid spread of COVID-19 in Suwon. The pharmaceutical industry is concerned that if the spread continues, drug production will be disrupted. Currently, most of the factories in the Hyangnam Pharmaceutical Industrial Complex are reported to take self-quarantine measures for a certain period of time for COVID-19 confirmed patients and all departments. In addition to the government's guidelines for self-quarantine of COVID-19 confirmed patients for a week, it is interpreted as a measure to prevent further spread of COVID-19. An official from the pharmaceutical industry working at the Hyangnam complex said, "Unlike the early days of the COVID-19 crisis, the entire factory will not be shut down," adding, "The number of confirmed cases has been increasing recently as the Omicron mutation spreads so rapidly. In particular, there seems to be a series of confirmed cases after the Lunar New Year holiday, he said. He said, "There are places where all employees of the department are quarantined for a week when a confirmed person comes out, and some places take measures not to go to work until the infection of fellow employees is confirmed," adding, "Since the factory cannot work from home, everyone seems to be nervous about whether there will be a confirmed person." The self-quarantine rules have also been greatly strengthened recently, he added. Another pharmaceutical industry official said, "As quarantine is carried out on a team or department basis, if at least one confirmed person comes out, the operation of the line will be disrupted," adding, "Even if workers from other lines return their vacations and are put in, production delays are inevitable." Concerns are also growing at the Osong Life Science Complex located in Osong-eup, Cheongju-si, Chungcheongbuk-do. The Osong Life Science Complex currently houses more than 70 companies and research institutes related to medicines, medical devices, cosmetics, and food. About half of them are pharmaceutical bio companies. As of 8 a.m. on the 15th, 710 new COVID-19 confirmed patients were confirmed in Cheongju, Chungbuk, where Osong Complex belongs. Currently, 6,368 people have been confirmed and are in self-quarantine. The pharmaceutical industry predicts that the occurrence of confirmed cases in Osong Complex will also be a matter of time. An official from the pharmaceutical industry said, "The current spread is so fast that there is nothing strange about it even if a confirmed person comes out at any time," adding, "The problem is that it is difficult to find substitute manpower." If there are one or two confirmed cases, it will be okay, but if there are several confirmed cases, it is expected that the production schedule will be tight."
- Policy
- What is the pledge of the presidential candidates?
- by Lee, Jeong-Hwan Feb 18, 2022 05:54am
- Democratic Party of Korea Lee Jae-myung (left), the power of the people, Yoon Seok-yeolWith the 20th presidential election day just 20 days away, candidates from each party completed submitting their teenage pledges with the registration of candidates for the National Selection Commission on the 13th. The main keyword for the health care pledge of Democratic Party of Korea Lee Jae-myung, the power of the people Yoon Seok-yeol, Ahn Cheol Soo of the People's Party, and Sim Sang Jung of the Justice Party is "overcoming COVID-19." Lee Jae-myung promised to secure sovereignty in domestic development vaccines and treatments and establish a public production system for essential medicines based on the strengthening of the all-out response system to the spread of COVID-19 variants such as Omicron. Lee Jae-myung plans to strengthen his ability to respond to infectious diseases by securing sufficient public hospitals and public medical personnel. Earlier, he said he would also implement policies to apply health insurance for hair loss treatments and legislate CCTVs in operating rooms, which he had pledged to "small situations" and Lee Jae-myung's definite happiness). Candidate Yoon Seok-yeol of the People's Power pledged to immediately operate an emergency rescue program by setting up a "COVID-19 Emergency Rescue Special Headquarters" directly under the president's office. Candidate Yoon established a policy fee in the health insurance benefit system to strengthen periodic pandemic responsiveness and announced the realization of a national responsibility system for essential medical care. It also reaffirmed its pledge to strengthen the requirements for foreign health insurance subscribers to register dependents and prevent theft of their names. Candidate Yoon is also expected to apply health insurance for consecutive blood glucose meters for diabetic patients, expand mobile telemedicine for military personnel, and make it mandatory to check health insurance recipients of medical institutions. Candidate Ahn Cheol Soo The People's Party stands out in the health and medical field for pledges such as safe welfare by life cycle, lowering the price of hair loss generic drugs, and the state responsibility system for mental health. Candidate Ahn promised to raise 3 trillion won to 5 trillion won in finances used to abolish standards for livelihood and medical benefits in order to link and treat high-risk groups for depression by adding mental health checkups to the entire nation. Candidate Sim Sang Jung Justice Party put the so-called "Sim Sang Jung Care" at the forefront of the pledge, which guarantees the right to health for the people by expanding public health care and setting an annual cap of 1 million won for hospital expenses. From the cradle to the grave It is determined to ensure the care of the whole people. As a way to implement Sim Sang Jung care, the government has proposed the expansion of public health care, guaranteeing essential severe medical care by region, upper limit on hospital expenses, and realizing health advanced countries such as the family doctor system. In detail, it promised to establish a system for training public doctors and public nurses by establishing the National University of Medicine and public medicine, and to expand health care personnel to the OECD level. It also said it would conduct a health impact assessment on all government policies with the establishment of the Ministry of National Health.
- Company
- The development of next lung cancer txs is in full swing
- by Feb 17, 2022 05:53am
- From the left, Lumakras, Rybrevant & TabrectaStarting with EGFR, treatments have been released. The first dual inhibitor was also released. Non-small cell lung cancer treatment is facing a new turning point with the emergence of various targeted anticancer drugs. Precise treatment began by pioneering areas where there were no treatments, such as KRAS, MET, and EGFR Exon 20. ◆ New KRAS drug in 40 years, 8 global companies will develop For the first time in 40 years this year, a new drug targeting KRAS mutations has emerged. It is Amgen's Lumakras, approved by the MFDS on the 14th. Lumakras can be used as a secondary treatment for KRAS G12C mutation local progression or metastatic non-small cell lung cancer. Non-small cell lung cancer patients show various genetic mutations, and KRAS mutations account for the largest proportion of them. About 25% of the world represents KRAS mutations. In Korea, it is about 5 to 8%. Lumakras succeeded in entering the KRAS field for the first time. The KRAS tumor gene was discovered early in 1982, but it did not lead to the development of a treatment. This is because clinical trials have repeatedly failed due to the complex molecular biological activity mechanism of KRAS. The binding site was also very small, so the development of target materials was a challenge. Starting with Lumakras, KRAS target treatments are expected to appear one after another. This is because many global pharmaceutical companies have entered the development of KRAS-targeted anticancer drugs. Eight companies, including ▲Mirati Theraputics ▲ Novartis ▲ Roche ▲ Boehringer Ingelheim ▲ MSD ▲ Eli Lilly ▲ Sanofi ▲ InventisBio, are conducting KRAS clinical trials in Korea. Among them, Mirati is closely chasing Amgen as the most advanced step. Mirati's Adagrasib is undergoing phase 3 in Korea and is undergoing FDA approval review in the United States. The development of other pharmaceutical companies is in phase 1/2. ◆Dual inhibiton of EGFR and MET have also emerged Treatment of non-small cell lung cancer is facing a new turning point. For non-small cell lung cancer, targeted treatment began with the emergence of Iressa, the first EGFR target anticancer drug, and in 2017, immuno-cancer drugs entered and presented a new paradigm for the treatment of non-small cell lung cancer, which cannot be used. Recently, the area of anticancer drugs targeting non-small cell lung cancer has increased further. In addition to relatively common KRAS mutations, minority mutations found in less than 3% of all patients can be detected. Janssen's Rybrevant, which was approved by the MFDS on the 15th, shows a clear difference from the existing EGFR targeted anticancer drugs. It aimed at a blind spot called Exon 20 insertion mutation, not Exon 19 defect and L858R substitution mutation, which are common in EGFR. EGFR Exon20 insertion mutation non-small cell lung cancer is rarely found as the third most common mutation among EGFR mutations. Rybrevant is clearly different in that it targets not only EGFR but also MET variations. With the approval of Rybrevant, the EGFR target anticancer drug market is also expected to change. Already, in the EGFR area, third-generation drugs represented by Tagrisso and Leclaza through the first and second generations are becoming standard treatments. Although it remains in the second treatment due to clinical problems in Korea, global guidelines have already recommended the third generation Tagrisso as the top priority treatment. A new anticancer drug that directly targets MET gene mutations also appeared for the first time last year. It is Novartis' Tabrecta and Merck's Tepmeko. Both drugs, which were approved by the MFDS side by side in November last year, can be used in patients with local progressive or metastatic non-small cell lung cancer whose MET exon 14 deficiency was confirmed. MET mutation is also one of the genetic mutations caused by non-small cell lung cancer. The adverse reactions in the MET gene are largely divided into MET amplification and MET mutation, and the MET exon14 defect targeted by Tabrecta and Tepmeko is a representative MET mutation. Targeted anticancer drugs targeting RET genes are also expected to be released soon. Roche and Lilly are undergoing domestic approval procedures for their own Gavreto and Retevmo. These drugs can inhibit primary mutations in the RET gene as well as secondary mutations that cause anticancer treatment resistance. The incidence of RET mutations in non-small cell lung cancer is reported to be around 2%.
