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- 2026-03-17 19:30:54
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- Shionogi's stock price is soaring
- by Eo, Yun-Ho Nov 25, 2021 05:56am
- Shares of Japan's Shionogi Pharmaceutical, which is developing a treatment for COVID-19 with Ildong Pharmaceutical, are on the rise day after day. According to related industries, Shionogi's stock price has steadily risen since August, breaking this year's highest price. As of the 24th, Shionogi Pharmaceutical's stock price is trading at around 8,100 yen, up nearly 40% from 5,950 yen on July 27, when it announced the launch of phase 1 clinical trial for COVID-19. This is analyzed due to expectations for the oral COVID-19 treatment S-217622, which is being developed by Shionogi. In particular, in the case of the 17th, it has been on the rise since the announcement that domestic pharmaceutical company Ildong Pharmaceutical has started joint development of S-217622. On the 17th, Ildong Pharmaceutical announced in a media report that it received IND approval from the Ministry of Food and Drug Safety for phase 2/3 clinical trials of S-217622 and that it would immediately begin clinical trials. S-217622 clinical trials will be conducted simultaneously in Japan, Korea, and Singapore, and its strategy is to shorten the development period and secure sufficient data through multinational clinical and joint development to prove the value of drugs. According to previous studies, S-217622 showed excellent safety and drug resistance, and it prevents virus proliferation by inhibiting protease (3CL-protase) present only in SARS-CoV-2, the source of infection that causes COVID-19. It was confirmed that alpha, beta, gamma, and delta corona-19 mutations all have similar levels of viral proliferation inhibition capabilities. Above all, the convenience of taking oral medicine once a day is drawing attention as a strength over the selective treatment. Meanwhile, if commercialization of S-217622 is successful, Ildong Pharmaceutical is expected to promote its own production and distribution.
- Company
- Opdivo combo in review for esophageal cancer indication
- by Eo, Yun-Ho Nov 24, 2021 05:53am
- The cancer immunotherapy ‘Opdivo’ is attempting to add another esophageal cancer indication as a combination therapy in Korea. According to industry sources, the Ministry of Food and Drug Safety is reviewing expanding the indication for Ono·BMS’s PD-1 inhibitor Opdivo (nivolumab) in combination with Yervoy (ipilimumab) or chemotherapy as first-line treatment for unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma. The combinations are under review by the EU EMA for the same esophageal cancer indication. The efficacy of the Opdivo-based combination therapy as first-line treatment in esophageal cancer was demonstrated through the Phase III CheckMate-648 trial. In the trial, the two Opdivo-based treatment combinations (Opdivo+chemotherapy and Opdivo+Yervoy) demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit compared to chemotherapy in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma with tumor cell PD-L1 expression ≥1%, as well as in the all-randomized population. The CheckMate-648 trial was the first global Phase III trial that evaluated the immunotherapy and chemotherapy combination and a dual immunotherapy combination in advanced esophageal squamous cell carcinoma. Also, the Opdivo+Yervoy combination was the first dual immunotherapy combination to demonstrate a superior survival benefit compared to chemotherapy in this setting. The primary endpoints of the trial, overall survival (median OS) in patients whose tumors expressed PD-L1 was 15.4 months for the Opdivo+chemotherapy group and 9.1 months for the chemotherapy group. The secondary endpoint, median OS in the all-randomized patient population, was 13.2 months and 10.7 months respectively. The Opdivo+chemotherapy combination also demonstrated a statistically significant PFS improvement in patients whose tumors expressed PD-L1. The median PFS by blinded independent central review (BICR) was 6.9 months in the Opdivo+chemotherapy group, which was longer than the 4.4 months in the chemotherapy alone group. The primary endpoint, median OS of patients whose tumors expressed PD-L1 was 13.7 months for the Opdivo+Yervoy group compared to the 9.1 months in the chemotherapy alone group. The secondary endpoint, median OS in the all-randomized patient population, was 12.8 months vs. 10.7 months, respectively. The Opdivo-Yervoy combination did not meet its other primary endpoint of PFS by BICR, recording 4.0 months and 4.4 months, respectively. The median duration of response (DoR) per BICR was 8.4 months for Opdivo+chemotherapy, 11.8 months for Opdivo+Yervoy, and 5.7 months for chemotherapy alone in patients whose tumors expressed PD-L1, and 8.2 months, 11.1 months, and 7.1 months, respectively, in the all-randomized population. Opdivo+chemotherapy also showed a clinically meaningful increase in objective response rate (ORR). The ORR per BICR was 53% for Opdivo+chemotherapy, 35% for Opdivo+Yervoy, and 20% for chemotherapy alone in patients whose tumors express PD-L1 and 47%, 28% and 27%, respectively, in the all-randomized population. Meanwhile, Opdivo as monotherapy was approved in April 2020 for patients with unresectable advanced or recurrent esophageal squamous cell carcinoma that were refractory or intolerant to fluoropyrimidine and platinum-based chemotherapy.
- Company
- Bavencio cost support provided in non-reimbursed areas
- by Eo, Yun-Ho Nov 23, 2021 05:54am
- Pharmaceutical expense support for the cancer immunotherapy drug ‘Bavencio’ in non-reimbursed areas has begun. According to industry sources, Merck and Pfizer have started a patient support program to refund part of the expenses patients spend on Bavencio (avelumab) as first-line monotherapy for metastatic Merkel cell carcinoma and as first-line maintenance treatment for the recently approved locally advanced or metastatic urothelial carcinoma. Both companies plan to support part of the pharmaceutical expenses borne by patients who were prescribed Bavencio without reimbursement and must bear the full price. In particular, the Early Access Program (EAP) gained attention as it supports the recently approved urothelial carcinoma indication that lacks treatment options. Bavencio is an anti-PD-L1 immunotherapy that was first authorized in 2019 to treat Merkel cell carcinoma, then as a first-line maintenance therapy last August for patients with locally advanced or metastatic urothelial carcinoma who have not progressed after using platinum-based chemotherapy by the Ministry of Food and Drug Safety. The indication was approved based on the Phase III JAVELIN Bladder 100 trial that compared the outcomes between the best supportive care (BSC) and Bavencio+BSC. Study results showed the median overall survival (OS) was extended by over 7 months for patients who received Bavencio+BSC compared to BSC care alone, and the risk of death was also reduced by around 31%. Jae-lyun Lee, professor of Oncology at Seoul Asan Medical Center, said, “Urothelial carcinoma, which is the most common type of bladder cancer, accounts for around 90% of all diagnosed cases. Around 12% of patients are diagnosed at an advanced stage, and the 5-year survival rate of patients who have distant metastasis is only around 6%, showing the dire need for a suitable treatment that could treat or extend the life of these patients.” Bavencio was approved as second-line treatment for Merkel cell carcinoma in March 2019 and was first listed for reimbursement last October for the same indication.
- Company
- Myungin signed an exclusive license agreement for Parkinson
- by Nov 23, 2021 05:54am
- Myungin announced on the 22nd that it has signed a license and investment contract with Israeli pharmaceutical company Pharma Two B (P2B) for commercialization of Parkinson's disease treatment in Korea. P2B001, which is being developed by P2B, is a new combination of low-dose sustained-release drug Rasagilin and sustained-release drug Pramipexole, which is widely used for Parkinson's disease. It is manufactured to solve unmet demand while minimizing side effects by combining two drugs that act as different pharmacological mechanisms. P2B001 is taken only once a day, and dose control is not required. P2B completed multinational phase 3 clinical trials of P2B001 in 70 regions of North America and Europe. It is planning to announce the results of phase 3 top line within this year. The goal is to release the product in 2023 after applying for permission in the U.S. and Europe in the second quarter of next year. With this contract, Myungin has the right to commercialize and manufacture P2B001 exclusively in Korea. To this end, Myungin will invest $5 million (about 5.9 billion won) to make equity investments. "P2B001 has the potential to become a new treatment that combines different mechanisms for patients suffering from Parkinson's disease," said Lee Hae-myung, chairman of Myungin. "We hope that cooperation with P2B will provide necessary treatment for patients with Parkinson's disease in Korea."
- Company
- Maven Clad can be prescribed in Big 5
- by Eo, Yun-Ho Nov 23, 2021 05:54am
- Maven Clad, a new drug for multiple sclerosis, has completed its entry into the Big 5 Advanced General Hospitals. According to related industries, Merck's highly active multiple sclerosis treatment Maven Clad (Cladribine) has currently passed DC of medical institutions such as Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, AMC, and Sinchon Severance Hospital. MavenClad is the first short-term oral treatment to show overall significant effects in terms of the degree of progression of physical disability, annual recurrence rate, and number of active lesions shown in MRI (magnetic resonance imaging) tests. The efficacy of this drug was confirmed through long-term follow-up data of the 8-year prospective observational registry PREMIERE study, along with CLARITY Phase III study and CLARITY Phase II study, which corresponds to CLARITY expansion clinical trials. In a two-year CLARITY 2 and 3 study, post-analysis of patients with high disease activity showed a 67% reduction in annual recurrence rate in patients with Maven Clad, and an 82% reduction in extended disability status scale (EDSS) indicating disability progression in the Maven Clad administration group. However, lymphocytopenia and shingles can occur as significant adverse reactions when administered with Maven Clad, so patients' lymphocyte levels must be measured before and during administration of Maven Clad to patients with multiple sclerosis. Maven Clad administration is prohibited in certain groups, including patients with impaired immune function and pregnant women. Maven Clad recently released retrospective observational study data and analysis results related to COVID-19 vaccination in patients with multiple sclerosis. In the case of patients receiving immunosuppressive treatment for autoimmune diseases such as multiple sclerosis, vaccination is recommended because they are more vulnerable to COVID-19 infection and are more likely to be severely transmitted if infected. A recent independent study in Israel targeted 23 patients with recurrent dysplasia (at least 4.4 months after treatment) treated with Maven Clad. As a result of the study, all 23 patients were confirmed to have a protective IgG antibody response to the COVID-19. Dimitrios M. Karussis, a neurologist at Hebrew University in Israel, explained, "If immunity is reduced due to immunosuppressants, the immune response of the COVID-19 vaccine may decrease or affect its efficacy, so patients and medical staff were deeply concerned." In addition, he added, "This study is very encouraging data for multiple sclerosis patients and medical staff in such a situation, and it is also meaningful because no unexpected safety problems were found compared to healthy ordinary people when vaccinated with Maven Clad."
- Company
- Prolonged delay in GSK vaccine supply may cost ₩30 bil
- by Nov 22, 2021 05:52am
- The discontinuation in the supply of many GSK vaccines is causing greater ripples. With the rising possibility that the situation may be prolonged, concerns continue over the sales gap, and procurement of substitutes is rising. GSK had announced the supply setbacks of 9 of its vaccines to primary clinics and hospitals on the 25th. The vaccines that were discontinued include: ▲Rotarix (rotavirus vaccine), ▲Cervarix (cervical cancer vaccine), ▲Synflorix (Pneumococcal conjugate vaccine), ▲Manveo (meningococcal conjugate vaccine), ▲Havrix (Hepatitis A vaccine), ▲Priorix (MMR vaccine), ▲Boostrix (Tdap vaccine), ▲Infanrix-IPV, IPV/Hib (DTaP vaccine) The supply of the vaccines was suspended due to errors found in the Common Technical Document while reviewing registration logs. Since the errors are documentation-related and unrelated to quality, GSK had said it will resume shipment after submitting supplementary documents. The problem lies in the possibility of the prolonged GSK supply gap. In the field, it is said that the delay may last up to 6 months at most considering the time necessary to prepare the supplementary documents and the MFDS review period. GSK’s revenue gap from the suspended products also seems inevitable. Annual sales of its main product, Rotarix, was ₩11.7 billion. In addition, Havrix sold ₩6.8 billion, Manveo ₩4.6 billion, Synfloris ₩4.1 billion, Cervarix ₩3.3 billion, and the annual sales of all 9 vaccines grossed to approximately ₩30 billion Also, many of the vaccines that were suspended supply belong to the National Immunization Program and may interfere with essential immunizations for infants and young children. To address this concern, the Korea Disease Control and Prevention Agency advised cross-vaccination with vaccines from other manufacturers. In general, cross-inoculation of vaccines that require multiple doses is not recommended, however, due to the delay that may occur for those who already received their first dose with GSK products, the cross-inoculation was approved as an exception. The situation is better for the DTaP vaccine Infanrix-IPV and IPV/Hib, and they can be substituted with Sanofi’s ‘Pnetaxim,’ ‘Tetraxim,’ Boryung’s ‘Boryung DTaP, IPV.’ However, other vaccines have only one option each as a substitute. The pneumococcal conjugate vaccine Synflorix can be substituted with Pfizer’s ‘Prevenar 13,’ cervical cancer vaccine Cervarix with MSD’s ‘Gardasil.’ The rotavirus vaccine Rotarix can be substituted with MSD’s ‘RotaTeq.’ The concern is that since most are imported products, procurement of the substitutes may be difficult. On this, GSK said, “We are unclear on how long the process will take, but the company will make the most effort to close the gap as soon as possible.” Also, MSD, which owns RotaTeq and Garadsil said, “We are closely monitoring the situation, and will do our best to prevent any disruptions arising in the domestic vaccine supply. Also, we will work closely with the government if necessary.”
- Company
- Yuhan has secured 260 billion won in technology fee in 3 yrs
- by Chon, Seung-Hyun Nov 22, 2021 05:52am
- Yuhan Corporation is creating a case of securing additional technology fees by advancing to the development stage even after exporting new drug technologies. It has secured a total of 260 billion won in new drug technology exports over the past 3 years. It has secured more money with additional technology fees than the down payment secured by exporting new drug technologies. According to the industry on the 17th, Yuhan Corporation will receive $10 million milestone for entering phase 1 clinical trials of YH25724, NASH treatment transferred to Beringer Ingelheim. YH25724 is a drug that Yuhan Corporation exported up to $870 million in technology to Beringer Ingelheim in July 2019. Under the terms of the contract, the down payment that is not obliged to return is $40 million. Yuhan Corporation received a total of $50 million in technology exports of YH25724. Yuhan Corporation is achieving results in acquiring additional technology fees by advancing to the development stage of technology export tasks. Yuhan Corporation has signed a total of five new drug technology export contracts since July 2018. In July 2018, it transferred YH14618 technology to Spine Biopharma, a treatment for degenerative disc disease. It received a down payment of $650,000 and was guaranteed $2175 million with step-by-step milestones based on development, permission and sales. Yuhan Corporation launched Janssen Biotech's anticancer drug in November 2018. Lazertinib' technology was exported. The total contract size, including $50 million in down payment, which is not obligated to return, is up to $1.25 billion. In January 2019, Gilead Science signed a license and joint development contract for new drug candidates acting on two drug targets for NASH treatment. It is a condition that receives a down payment of $15 million and receives $777 million milestones according to development, permission and sales. In August last year, it signed a technology transfer contract with Processa Pharmaceuticals in the United States for YH12852, a candidate for treating functional gastrointestinal diseases. Yuhan Corporation received a down payment of $2 million as a stock that was not obliged to return. Yuhan has secured additional technology fees four times due to progress in the development stage after exporting new drug technologies. Yuhan Corporation received Lazertinib's milestone of $35 million from Janssen in April last year. Janssen provided additional milestones to Yuhan Corporation at the time, starting clinical trials of combination therapy between Amivantamab and Lazertinib. Yuhan Corporation received an additional $65 million in additional milestones in November last year when it began recruiting subjects for a phase 3 clinical trial of Janssen's own anticancer drug Amivantamab and Lazertinib. YH25724, which Beringer Ingelheim started clinical trials this time, agreed to receive $10 million out of the $40 million down payment when the non-clinical toxicity test was completed, but received the remaining down payment last year. As a result, Yuhan Corporation has secured $2176.5 million (about 260 billion won), including additional milestones over the past three years. Of the technical fees received by Yuhan Corporation, milestones exceeded the down payment of $110 million. The technology fees secured by Yuhan Corporation are contributing to improving its performance. Yuhan Corporation has recognized technology fee profits for 11 consecutive quarters since the first quarter of 2019. The cumulative technology fee revenue reflected for two years and nine months amounted to 217.3 billion won.
- Company
- Viatris Korea will participate in the IMPACT WEEK
- by Eo, Yun-Ho Nov 22, 2021 05:52am
- Vitris Korea celebrated its first anniversary. On the 16th, Viatris announced that it will participate in the IMPACT WEEK designated by the world to mark the first anniversary of its launch, reflect on the past year, and carry out activities to commemorate the first anniversary with executives and employees. During Impact Week, Viartris will hold various events with executives and employees around the world under the theme of "Advancing Access: Everywhere Health Matters." On November 16th, U.S. time, an opening bell event and an outdoor advertisement campaign for the New York Times Square electronic display are scheduled to mark the first anniversary on the New York Stock Exchange. Linkedin Live discussion will also be held with various stakeholders to discuss ways to strengthen drug accessibility and events with the U.S. media the Hill. In addition, it plans to celebrate its first anniversary by communicating with Viatris employees around the world through the application. They will have time to express gratitude to employees around the world for their hard work over the past year and draw the future of Viatris together. In particular, Viatris Korea has time to express gratitude to employees and colleagues who have created our new journey together over the past year. Viatris Korea obtained domestic approval for MDR-TB tx Doveprella (Pretomanid) in October this year to increase access to patients in areas where unmet medical needs exist. Since domestic MDR-TB tx options have been limited over the past 50 years, it is meaningful in that it provides new treatment options to patients through the introduction of new treatments. In addition to Lipitor, Novasc, and Lyrica, Viatris Korea plans to realize its vision by expanding its portfolio to new treatment areas and enhancing accessibility. Lee Hye-young, CEO of Viatris Korea, said, "During the year of launch, the company has successfully adapted to the rapidly changing environment and has shown various results, and both the company and its employees are continuing a rewarding journey to become a 'company they want to work' with a new and healthy culture." In addition, she stressed, "As a new type of healthcare company, we will continue to do our best to contribute to the development of the domestic health care environment through active collaboration with various stakeholders." Meanwhile, Viatris is a global healthcare company launched in November 2020 by the combination of Upjohn and Mylan companies, which were Pfizer's business divisions, and was selected as Fortune Journal's 2021 Change the World in recognition of its accessibility to innovative HIV treatments over a decade.
- Company
- All-round prostate cancer treatment Xtandi with solid growth
- by Nov 18, 2021 05:55am
- Xtandi (enzalutamide)' rose to the ranks and became a blockbuster drug last year after continuously extending its indication in prostate cancer, a field that lacked treatment options. Although the drug was approved later than its competitor, through its continuous expansion effort, Xtandi became the only single-agent drug that is approved for use in both metastatic and nonmetastatic prostate cancer. Enzalutamide inhibits the AR signaling pathway by binding to the male hormone Androgen receptor (AR) to suppress the proliferation of cancer cells. Although the drug was approved later than its competitors such as ‘Zytiga (Janssen)’ or ‘Jevtana (Sanofi),’ in June 2013, Xtandi was the first to be approved for reimbursement. Xtandi was listed for reimbursement in November 2014 under the refund-type Risk-Sharing Agreement (RSA) scheme. During the 3.5 years that other drugs it took for the other drugs to receive reimbursement, Xtandi gradually took over the market as a second-line treatment for metastatic castrate-resistant prostate cancer. Xtandi sold over 10 billion to 20 billion in sales according to IQVIA from 2015 to 2017, when it was the only drug approved for reimbursement, while Zytiga sold 1 billion won and Jevtana 0.4-0.5 billion won in the same period. The multinational pharmaceutical company Pfizer recognized the potential of Xtandi and added it to its portfolio through an M&A with its original developer, Medivation. In Korea, Xtandi is continuously being supplied by Astellas, which had entered into a sales agreement with Medivation. It is distributed by Pfizer and Astellas in the U.S. ◆Used for all castration-resistant prostate cancer regardless of metastasis…Rises to the rank as No.18 blockbuster drug Xtandi gradually expanded its indications from its first indication as second-line treatment for metastatic castration-resistant prostate cancer to first-line, then to non-metastatic castration-resistant prostate cancer, and metastatic castration-sensitive prostate cancer. Through its continuous expansion effort, Xtandi became the only single-agent drug that covers all metastatic and nonmetastatic, hormone-sensitive (castration-sensitive), and castration-resistant prostate cancer. The NCCN recommends Xtandi as a first-line treatment in metastatic castration-resistant prostate cancer, and as Category 1 in metastatic hormone-sensitive prostate cancer. With the recommendations, Xtandi has established its position as a leading prostate cancer treatment. Source: IQVIA In terms of domestic sales (based on IQVIA), Xtandi’s sales increased continuously since receiving reimbursement in November 2014 to record 13.9 billion won in 2015 to 18.8 billion won in 2016, 20 billion won in 2017 and 23.8 billion won in 2018. It is the highest-grossing new prostate cancer drug. It recorded the highest sales among new prostate cancer drugs. Although its sales briefly slowed down to 23 billion won in 2019, it rebounded last year to record nearly 30 billion won. Globally, Xtandi also outperformed the other drugs and rose to the ranks to become one of the top 20 blockbuster drugs for the first time last year. Last year, Xtandi sold 4.39 billion dollars (approx. 5.19 trillion won) in global sales and became the 18th best-selling drug in the world. Projected sales per Xtandi Furthermore, Astellas expressed its ambition to maximize Xtandi’s sales over the next five years. In the new strategic planning meeting that was held in May, Astellas projected that Xtandi will sell 600 billion to 700 billion yen (approx. 6.20 trillion-7.24 trillion won) at maximum by the fiscal year 2025 (March 2026). Astellas also plans to extend the indication to high-risk non-metastatic hormone-sensitive prostate cancer next year. ◆The introduction of new latecomer drugs and Zytiga’s late but rapid chase … use of PARP inhibitors allows for more specified treatment strategies The competition in the prostate cancer treatment market is intensifying. New drugs such as ‘Erleada (Janssen),’ ‘Nubeqa (Bayer)’ etc. are continuing to be introduced while PARP inhibitors that target BRCA mutation like ‘Lynparza (AstraZeneca)’ is expanding their scope to cover prostate cancer as well. Erleada is approved for non-metastatic hormone-sensitive and nonmetastatic castration-resistant prostate cancer in the US, and Nubeqa is approved for the high-risk nonmetastatic castration-resistant prostate cancer indication. Also, a PARP inhibitor was recently approved for prostate cancer and settled as a new treatment strategy and option for castration-resistant prostate cancer patients with BRCA 1/2 and DNA Damage Response (DDR). In particular, Lynparza in combination with Zytiga emerged as a stronger option by meeting the primary endpoint of radiological progression-free survival. The Lynparza+Zytiga combination aims to become a first-line treatment for metastatic castration-resistant prostate cancer regardless of genetic mutations. In Korea, the fact that Xtandi’s sales fell short in metastatic hormone-sensitive prostate cancer, which is the second-most on-demand area after metastatic castration-resistant prostate cancer, also leaves much to be desired in terms of expanding Xtandi sales. Zytiga added the indication in June 2018, and the latecomer Erleada was also approved for the indication at the end of last year, Xtandi only received approval for the indication in September this year. While Xtandi made no further progress since expanding reimbursement to first-line treatment in metastatic castration-resistant prostate cancer in May 2019, Zytiga persisted on the path to be approved for selective reimbursement in high-risk groups among metastatic hormone-sensitive prostate cancer patients in April this year. Although Xtandi was approved for both the high-risk and low-risk groups, Zytiga, which received limited approval for the high-risk group, holds the immediate upper hand in prescriptions. After the reimbursement expansion, Zytiga’s quarterly sales surged from 2 billion won to approximately 4 billion won. In response, Astellas is seeking a way to extend its indication and expand reimbursement of Xtandi from the current metastatic hormone-sensitive indication to cover all patients. In addition, the company is seeking a new treatment strategy through a clinical trial in combination with Pfizer’s PARP inhibitor ‘Talzenna.’ The clinical trial is expected to end in three years. Astella said, “We expect sales of Xtandi is to continue to grow due to its competitive price and the yearly increase of prostate cancer, the fourth most common cancer in men. Depending on the domestic situation, we are also considering adding further indications, and are planning to expand reimbursement to the treatment of metastatic hormone-sensitive prostate cancer regardless of the degree of risk.”
- Company
- Domestic approval of Tabrecta is imminent
- by Eo, Yun-Ho Nov 18, 2021 05:54am
- According to related industries, the MFDS is conducting a final review for marketing approval of Tabrecta (Capmatinib) of Novartis Korea. Approval is possible within this year. MET mutations account for about 3% to 4% of metastatic non-small cell lung cancer, and as there have been no treatments, interest in these new drugs is increasing. Tabrecta targets hepatocyte growth factor receptor (c-Met) and was first approved in the United States in May last year as a treatment for MET exon14 mutated metastatic non-small cell lung cancer (NSCLC). It was confirmed to be effective through a phase 2 GEOMETRY mono-1 study of 97 patients with METex14. As a result of the study, the overall response rate was 68% in patients who had never been treated and 41% in patients who had previously been treated. Among the patients who took Tabrecta, the median response duration (DoR) of previously untreated patients was 12.6 months and the patients treated were 9.7 months. Tabrecta is also spurring research for future combination therapy. In particular, it is expected to be able to solve the resistance problem of EGFR TKI in lung cancer. In fact, Tabrexta is conducting a clinical trial in combination with AstraZeneca's third-generation EGFR TKI Tagrisso. Combination therapy of Tabrecta and Tagrisso are compared with platinum-based chemotherapy in patients with EGFR mutated non-small cell lung cancer with T790M negative and amplified MET genes during treatment with 1st and 2nd generation EGFR TKI or Tagrisso. Janssen Korea has also applied for permission for Rybrevant (Amivantamab) to lower the MET. In the case of Rybrevant, it obtained US permission in May, blocking EGFR and MET mutations at the same time. The first indication of this drug is non-small cell lung cancer with EGFR Exon20 mutation.Rybrevant is conducting a study in combination with Leclaza (Lazertinib) of Yuhan Corporation, a new domestic drug.
