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- 2026-03-17 19:30:53
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- Pfizer applies for reimbursement of 3rd-gen ALKi Lorviqua
- by Eo, Yun-Ho Oct 20, 2021 05:56am
- Pfizer is aiming to introduce a second ALK inhibitor after ‘Xalkori’ into Korea’s prescription market. According to industry sources, Pfizer Korea has recently submitted a reimbursement listing application for its anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI), ‘Lorviqua (lorlatinib),’ which is in progress. Pfizer received the orphan drug designation for Lorviqua last March, then in July, the drug was approved as monotherapy to treat adult patients with ALK-positive advanced non-small-cell lung cancer (NSCLC) whose disease has progressed after - Alecensa (alectinib) or Zykadia (ceritinib) as the first ALK tyrosine kinase inhibitor (TKI) therapy; or Xalkori (crizotinib) and at least one other ALK TKI. Lorviqua is a third-generation drug that arose as an alternative option in patients who developed resistance to the first-generation drug Xalkori and the second-generation drugs Zykadia, Alecensa, or Alunbrig. In other words, patients who used Xalkori first-line may use second-generation drugs as second-line, then use Lorviqua; patients who used second-generation drugs as first-line may use Lorviqua as second-line treatment. Until now, patients who developed resistance to the drugs in the second-line had no available targeted therapies and therefore had to opt for chemotherapy in later-line treatments. ALK G1202R solvent front mutation is the most common ALK resistance mutation after being treated with second-generation drugs, and other ALK mutations also occur by drug, such as F1174L(Zykadia), I1171T/N/S(Alecensa), E1210K(Alunbrig), etc. Lorviqua (lorlatinib) has shown to be effective against all known resistance mutations. With such strengths to resistance, Lorviqua is expected to quickly attract prescriptions if listed for reimbursement. Whether Pfizer, the pioneer of ALK targeted anticancer therapy, will be able to increase its share in the market remains to be seen. Meanwhile, the approval of Lorviqua was based on an open-label, single-arm, multinational, multicenter Phase II study that was conducted on various 275 NSCLC patients with ALK-positive and ROS1-positive advanced NSCLC, from treatment-naïve patients to those who had been treated with up to three ALK inhibitors. In the study, the ORR (Objective response rate) - the primary endpoint - of patients who have been previously treated with 1 or more ALK inhibitors including second-generation ALK inhibitors was 47%, and the patients’ intracranial objective response rate (IC-ORR) was 63%. The median duration of response was yet to be reached at the time of analysis, as 63 out of 93 patients with a confirmed response at the time of analysis showed a continued response. The lower bound of the 95% confidence interval for the response period was 11.1 months.
- Company
- Moderna Korea speeds up group organization
- by Oct 20, 2021 05:56am
- Moderna Korea, which had shown little activity for almost 6 months after establishing its Korean subsidiary, is busy recruiting members in secrecy. With the active hiring and imminent production of Moderna vaccines, officials predict that the company will be starting its official activity soon. According to industry sources on the 19th, Moderna Korea has completed hiring executives for some of its departments including those for Medical, Pharmacovigilance, and Regulatory Affairs. For the PV Head, an official with global CRO experience has moved to Moderna Korea in July, and a former BMS official has been serving as the Quality Head since last August. The company has been speeding up its organizational process, recruiting executives and employees for various departments including the Supply Chain, Customer Services and Logistics, and Commercial Legal. The General Manager (GM) for the Korean subsidiary has also been appointed, however, who the GM is remains unknown. Only rumors that the GM is a vaccine expert from a specific multinational pharmaceutical company are abound. A representative of a multinational pharmaceutical company who wished to remain anonymous said, “Under the premise that the GM was already hired, it is possible that the new head may have been recruited from a different country since so little is still known.” Over 60 candidates had applied for the position, and although most were residing in Korea some have applied from other regions such as Hong Kong, etc. Looking at Moderna Korea’s organization chart, the Korean subsidiary’s role is expected to be concentrated around the supply and quality control of its products. An industry official said, “Looking at the areas in hiring, I believe the company’s work will focus on drug-related tasks such as the side effects of its vaccines rather than drug development. However, as Moderna is one of the few companies that can implement mRNA products as a platform, what role the branch will play remains to be seen.” This adds strength to expectations that Moderna Korea will start its official activities in line with Samsung Biologics' consignment production of the Moderna vaccines. According to the remarks made by the Minister of Food and Drug Safety Gang-lip Kim at the NA’s Health and Welfare Committee audit, Samsung Biologics is expected to receive GMP certification within this month. Samsung Biologics has begun production of the Moderna COVID-19 vaccine in line with this. After Moderna Korea finishes organizing its group, the company is expected to be in charge of the regulatory procedures necessary to supply the Moderna products produced by Samsung Biologics to Korea and the Asia Pacifica region.
- Company
- Hugel’s Geodu BTX plant completes EMA inspection
- by Lee, Seok-Jun Oct 19, 2021 06:00am
- [Hugel announced that the European Medicines Agency completed the on-site inspection of its ‘Geodu plant’ in Chuncheon on the 18th. The Geodu plant has a fully automated state-of-the-art system that can manufacture over five million botulinum toxin vials a year. EMA conducted an on-site inspection on the Geodu plant’s manufacturing facilities and quality control system for 3 days, from the 12th to the 14th, to verify whether the facility complies with the EU-GMP standards. With the on-site inspection complete, the company expects to acquire the EU GMP certification soon. The company had previously completed FDA’s on-site inspection for cGMP in August. A Hugel official said, “ With the recent inspection of EMA’s Geodu plant complete, the company expects to be able to soon emerge into the European market in addition to its entry into the Chinese market last year. By entering the European market this year, and the US market next year, we aim to continue our endeavors to become a global company that covers 95% of the world’s botulinum toxin market. The European market, combined with the US market accounts for 70% of the world’s botulinum toxin market. With the aim to emerge into the European market, Hugel completed its Phase III clinical trials(Bless 1 and Bless 2) in Poland and Germany with an Austrian medical aesthetics pharma company ‘Croma,’ and submitted an application for marketing authorization in June 2020.
- Company
- Hugel's Letybo benefits from FDA delay of Revance's DAXI
- by Nho, Byung Chul Oct 18, 2021 05:54am
- The U.S. Food and Drug Administration’s disclosure of the official document outlining concerns in the DAXI manufacturing plant of the botulinum toxin company, Revance Therapeutics (hereinafter ‘Revance’), raised industry concerns about the uncertainty of the company’s approval. Revance is a new medical aesthetics company that sells botulinum toxin and HA filler products. The company had submitted a Biologic License Application to the FDA for its botulinum toxin product DAXI in 2020 and expected to receive marketing authorization by 2021. The FDA conducted an on-site inspection of the company's manufacturing plant from late June to early July. The document that was disclosed this time had pointed to 4 issues of concern, which includes the issues that the actual manufacturing process is not the same as in the application for the marketing authorization, and the verification of the Working Cell Bank is inadequate. Upon disclosure of such concerns, Revance announced that it still expects to receive approval within the year. However, the industry expects that it would take considerable time before the company can make up for the serious issues discussed by the FDA. Currently, Allergan’s Botox accounts for 75% of the 2 trillion dollar botulinum toxin market, virtually dominating the market. The US market, therefore, has a high need for a new company that has a premium botulinum toxin product with a reasonable price. Companies that have recently submitted a marketing approval to the FDA for their botulinum toxin and underwent review include the US company Revance and Korean company Hugel. An industry official said, “Expectations for Hugel’s entry in the US market is increasing as the competition between the new companies, Revance and Hugel, has fallen apart with the FDA’s document that rendered the date of Revance’s marketing approval uncertain. Hugel has smoothly completed its on-site inspection and mid-cycle meeting. The official added, “Hugel completed submission of the supplementary material requested by the FDA after its inspection and is expected to pass review without issue." The FDA had conducted a cGMP inspection for nine days from August 12-20 to verify the manufacturing facilities and the quality management system of Hugel’s second plant that is in charge of the production of Letybo.
- Company
- Novartis applies for another gene therapy, Luxturna
- by Eo, Yun-Ho Oct 18, 2021 05:54am
- Novartis has applied for the registration of insurance benefits for another new one-shot gene therapy drug. According to related industries, Novartis Korea recently submitted an application for benefits for the Inherited Retinal Dystrophy (IRD) treatment "Luxturna (Voregenene Neparvovec). Luxturna restores its function by replacing the deficiency and defective RPE65 gene, one of the causes of IRD, with a normal gene with just one administration. In other words, fundamental treatment of diseases is possible. The drug was designated by the U.S. FDA as a target for Breakthrough Therapy in 2014, Orphan Drug in 2016, and Priority Review in 2017, and obtained rapid approval in 2017. IRD is a rare refractory disease that causes visual loss due to mutations in genes responsible for retinal optic cell structures and functions. It contains more than 20 various eye diseases and has about 300 causative genes. IRD, caused by RPE65 gene mutation, causes abnormalities in the visual cycle in the retina that converts visual information into neural signals and transmits it to the brain. The RPE65 gene mutation can reduce the RPE65 protein essential for visual circuits and gradually narrow the field of view as retinal cells are destroyed, which can eventually lead to blindness. Kang Se-woong, chairman of The Korean Retina Society (Professor of Ophthalmology at Samsung Medical Center), said, "Luxturna can expect recovery to the extent that independent walking is possible without the help of a guardian with a single injection." Luxturna proved its effectiveness through phase 3 clinical trials conducted in patients with hereditary retinal disease whose double confrontational trait mutation of the RPE65 gene was confirmed. Clinical results show that the patient group who received Luxurna treatment at 1 year of treatment had statistically functional vision than the control group who did not receive treatment. It has improved significantly. As a result of evaluating the average score of the Multi-Luminance Mobility Test (MLMT) at the time of 1 year of treatment as a primary evaluation variable, the score change of the Luxturna treatment group was 1.8 points, 1.6 points higher than the control group's score change of 0.2 points. In the darkest 1lux (Lux), 65% (n=13/20) of the Luxturna treatment group reported the maximum improvement in MLMT scores, while none of the controls passed.
- Company
- Bayer·Viatris·Pfizer settles in new locations
- by Eo, Yun-Ho Oct 18, 2021 05:54am
- News of multinational pharmaceutical companies’ relocations continue. According to industry sources, Korean subsidiaries of multinational pharmaceutical companies including Bayer, Viatris, and Pfizer have decided on their new offices and are working on relocation projects. Bayer Korea, which had been located in Boramae, Dongjak-Ku for a long period of time, will move to Yeouido next month (in November). Bayer’s new company building will be located in Yeoido’s hot place, Parc1 Tower. With the relocation, the company’s new headquarters will become a smart office with improved transport access, which was one of the disadvantages of the existing office building. Yeoido has risen as a strategic core in the pharmaceutical industry since 2018 when Novartis Korea has moved into the IFC building. With Bayer’s relocation, a total of 4 pharmaceutical companies – Bayer Korea, Biogen Korea, Alvogen Korea, and Novartis Korea – will be in Yeoido. Viatris Korea, a spinoff of Pfizer Korea, has confirmed its relocation to the Grand Central Tower near the Seoul Station earlier next year. Viatris had been using the shared office ‘FAST FIVE Myeong-dong’ as a temporary office from August until the end of this year. Viatris plans to actively reflect the various experiences it accumulated in the shared office to establish a smart working environment in the new headquarters so that employees can work at ease. At FAST FIVE Myeong-dong, employees were able to choose from the open space where they can perform individual tasks, one-person independent space for virtual meetings, and meeting space for 2-3 to 10 or more people, to meet the employee’s individual needs. After selling Myeongdong’s landmark Pfizer Tower at ₩112 billion, Pfizer opted to maintain its geographic legacy. The company sold its building to GRE Partners 15 months after the building was put on sale. After discussing various options, the company had decided on Namsan State Tower as its new home and plans to move in next year. The new office is located within a walking distance of the existing Pfizer Tower and will be moving into the new building in the second half of next year. Meanwhile, new Korean subsidies of multinational pharmaceutical companies are being established this year. The promising Chinese pharmaceutical company ‘BeiGene’ established a new subsidiary in Korea, and Moderna, one of the COVID-19 vaccine developers, has also registered its corporation and is awaiting launch in Korea.
- Company
- Rediscovery of Clopidogrel brings back generic boom
- by Kim, Jin-Gu Oct 15, 2021 05:57am
- Picture of Plavix, a clopidogrel original Development of generics using ‘clopidogrel,’ an antiplatelet drug, is regaining momentum. A company that already owned a clopidogrel generic has released a new dose product in 16 years. And the generic companies have been showing positive responses after the effect of clopidogrel was reilluminated in a study on stent-inserted patients, raising expectations that competition in clopidogrel will intensify again in the future. According to industry sources on the 13th, 13 bioequivalence tests on clopidogrel were approved just this year, 9 of which were approved after May this year. Compared to the average of 4.3 cases that were approved in the 3 years from 2018 to 2020, the number of tests increased significantly. Currently, 145 single compound clopidogrel products are approved in Korea. Most of the approvals were concentrated between 2005 and 2007. Around 40 products including Handok’s ‘Plavix,’ and Samjin’s ‘Platless’ were approved in this period. Since then, approvals continued sporadically until the second wave of approvals rushed in 2012-2013. A total of 35 items were approved during the period. And the atrial fibrillation prevention indication was added at the end of 2011, and the release of the aspirin combination has also increased approval of the single-ingredient clopidogrel. In addition, one of the reasons why bioequivalence tests are increasing for clopidogrel this year is because of the study results that were released last May. In May, Hyo-Soo Kim, Professor of Cardiology at the Seoul National University Hospital, presented the results of his study on patients who had undergone percutaneous coronary intervention (PCI) with a drug-eluting stent (DES) comparing aspirin vs. clopidogrel as an antiplatelet agent. Professor Kim had directly compared the effect of clopidogrel and aspirin as a long-term maintenance therapy on patients who underwent PCI with a dual antiplatelet therapy (DAPT) regimen for 6 to 18 months. The study was conducted for 2 years in 37 hospitals in Korea, on 5,500 patients who underwent PCI. The results, which confirmed that clopidogrel is superior to aspirin, gained attention as all existing major treatment guidelines recommended aspirin as maintenance therapy after PCI. Professor Kim announced the results above at ACC 2021. As around 70,000-80,000 patients receive PCIs every year, and clopidogrel demonstrated a superior effect in Korean patients compared with aspirin, the front-line pharmaceutical companies have been positively responding to the study results. In fact, 9 of the 13 clopidogrel bioequivalence tests newly approved this year were submitted after the study was presented. And industry sources believe Samjin Pharmaceutical’s recent release of the high-dose product is not unrelated to the study results as well. Samjin Pharmaceutical was the first to release a 300mg clopidogrel product on the 12th. This was the first product line extension made by the company, 16 years after the 75mg dose was approved. Only 75mg products including the original are currently approved in Korea. However, the inconvenience of the ACS patients needing to take 4 tablets as the initial loading dose before receiving PCI was pointed out. The high-dose Platless that was released recently has improved this convenience with a single tablet, once-daily dose. An industry official said, “The clopidogrel ingredient treatment market has been continuously growing for the 20 years since its release with the popularization of PCIs. Also, with the latest study results demonstrating that clopidogrel is superior to aspirin as a long-term maintenance therapy, the competition in the clopidogrel treatment market will continue to intensify in the future.” According to the market research institution UBIST, the clopidogrel market last year sold ₩360 billion. In the market, the original Plavix was prescribed the most with ₩91.6 billion. Among the generics, Samjin’s Platless sold ₩61.2 billion, and Chong Kun Dang’s Pregrel sold ₩25.8 billion last year.
- Company
- ‘Ibrance’ opens new horizon as the lead CDK4/6 inhibitor
- by Oct 14, 2021 05:38am
- The breast cancer treatment ‘Ibrance (palbociclib)’ was what established Pfizer Korea as the ‘anticancer drug power’ in Korea. The company had other excellent anticancer drugs such as ‘Xalkori,’ and ‘Sutene,’ but none had received as much spotlight as Ibrance. As the ‘first CDK4/6 inhibitor,’ and ‘the first new breast cancer drug in 50 years,’ Ibrance had quickly rose to the ranks and became a blockbuster drug. ◆ The first CDK4/6 inhibitor, unrivaled status despite controversy Ibrance selectively inhibits Cyclin-dependent kinases (CDK) 4/6 that regulate cell division and cell growth to block the proliferation of tumor cells. Lilly’s Verzenio (abemaciclib),’ and Novartis’s ‘Kisqali (ribociclib)’ belong to CDK4/6 inhibitor class drugs. Among these drugs, Ibrance is the first drug in its class, the ‘first-in-class’ CDK 4/6 inhibitor. Ibrance is indicated for the treatment of breast cancer in combination with an aromatase inhibitor as first-line endocrine therapy in postmenopausal women or combination with fulvestrant in pre-and post-menopausal women with disease progression following endocrine therapy. For a year Ibrance was launched in Korea in August 2016, the field was full of expectations, disappointment, longing, and appeals. The introduction of a new drug with a new mechanism of action was blissful news. In particular, the patient population for Ibrance was wider than other drugs, as it targeted f hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, which accounts for 60% of all breast cancers. These patients had to use anti-hormonal drugs such as aromatase inhibitors or chemotherapy, which had many systemic side effects if not managed until Ibrance appeared. Before the introduction of Ibrance, this patient group had to use antihormonal therapy such as aromatase inhibitors, and if their condition was not managed with such therapies, use chemotherapy, which had many systemic side effects Korea was the fifth country to approve the drug. In December of the same year, the drug's efficacy and safety in Asian patients were verified through a clinical trial and rose as the drug that could change the breast cancer treatment paradigm. The National Comprehensive Cancer Network’s ‘Category 1’ recommendation of CDK4/6 inhibitors as combination therapy for the treatment of HR+/HER2- advanced/metastatic breast cancer had also contributed greatly to establishing the drug as standard care in breast cancer. However, Ibrance did not immediately rise and become the star after its release. The drug had suffered receiving reimbursement due to its high drug price, costing over ₩5 million per month. In particular, 2017 was the time when many high-price anticancer drugs were introduced and rejected reimbursement, and Pfizer Korea was put at a difficult price due to its difficulty in demonstrating cost-effectiveness, and the issue that Ibrance was more expensive in Korea than abroad. The Health Insurance Review and Assessment Service recognized Ibrance’s feasibility of reimbursement in July 2017, after rounds of review. However, the approval left much to be desired among patients because the reimbursement was only allowed as first-line endocrine therapy in postmenopausal women in combination with letrozole. Its use as second-line therapy in combination with fulvestrant was non-reimbursed, and premenopausal patients, which are much more prevalent in the East than in the West, were unable to receive the reimbursement benefit at all. The 2nd-line reimbursement of Ibrance+fulvestrant was only approved last July, 4 years after Ibrance’s approval. In addition, the fact that the drug was reimbursed at the same time with the CDK4/6 class latecomer Verzenio, left much to be desired for Ibrance. However still, Ibrance is fully exerting its strength as the ‘first’ introduced to its market. Among the three products in the CDK4/6 market, Ibrance has been dominating the market as the second drug, Verzenio, was approved in Korea three years later than Ibrance, in May 2019. The third CDK4/6 inhibitor Kisqali was approved 5 months after Verzenio, in October 2019 and listed for reimbursement in November last year. 자료: 아이큐비아 Ibrance raised annual sales of ₩40 billion in three years in the competitor-free market. According to the market research institution IQVIA, sales of Ibrance, which was ₩6.6 billion in 2017, surged 283% in 2018 to reach ₩25.3 billion after being listed for reimbursement. Then, sales rose 73% again to record ₩43.7 billion in 2019. Last year, Ibrance sold around ₩60 billion and is expected to sell near ₩70 billion this year. Compared to Ibrance’s quarterly sales, which is around ₩15 billion, Verzenio’s sold ₩3 billion, and Kisqali sold mid-₩1 billion range. ◆Three-way competition starts now… data will decide the winner With all three products now approved for reimbursement, the competition is finally in full pace. Of course, the other two drugs have a long way to go because they need to break down the solid position held by Ibrance in the market. Therefore, the latecomer drugs are betting in areas where Ibrance has not reached, as preoccupying new areas is easier than breaking down Ibrance's established position. The attempt will also support the expansion of the overall CDK4/6 inhibitor market amid the increased introduction of new-class drugs. One of the areas being targeted is early breast cancer. Despite its strength in metastatic breast cancer, Ibrance did not show as a good result in early breast cancer. In both the PALLAS study that tested Ibrance+endoctrine therapy as adjuvant therapy in hormone receptor-positive (HR+)/HER-2 negative (HER2-) metastatic breast cancer and the PENELOPE-B study that tested Ibrance+endoctrine therapy after neoadjuvant chemotherapy, Ibrance did not show a difference in invasive disease-free survival (iDFS) compared to placebo (primary endpoint). Pfizer believed the high early discontinuation rate due to the strict dose restriction and the short period of administration had an effect. On the other hand, Verzenio achieved its primary endpoint in a median follow-up period of 15.5 months as adjuvant therapy, suggesting the potential for scope expansion. Of course, whether using CDK4/6 inhibitor as adjuvant therapy in early breast cancer patients is more beneficial, remains a question that needs to be addressed. Kisqali can be used in combination with an aromatase inhibitor as first-line endocrine therapy in pre/perimenopausal women that cannot use Ibrance, and therefore may resolve the unmet needs of Ibrance. Also, Kisqali has demonstrated the longest overall survival period among all drugs, threatening Ibrance’s sole lead in the market.
- Company
- Korea Otsuka Pharma’s Hyangnam Plant rises as a global hub
- by Nho, Byung Chul Oct 14, 2021 05:38am
- Pic. of Korea Otsuka Pharmaceutical Korea Otsuka Pharmaceutical, which is soon to face its 40th anniversary in Korea, is receiving attention with its Hyangnam Plant rising as a forward base for global exports and production. Korea Otsuka Pharmaceutical is a global total healthcare enterprise that covers a wide range of businesses from clinical research, R&D, manufacturing, and export of pharmaceuticals. The company will celebrate its 40th anniversary in Korea in 2022. It is one of the rare multinational pharmaceutical companies in Korea that owns and operates a large-scale production facility locally in the Hyangnam Pharmaceutical Industrial Complex in Gyeonggi-do. 99% of the company’s pharmaceutical products released in Korea are supplied through the local Hyangnam plant, and Korea Otsuka Pharmaceutical has continuously invested in the manufacturing facility to expand the facility's role as Otsuka’s global hub. Established in 1989, Korea Otsuka Pharmaceutical’s Hyangnam Plant obtained KGMP approval in December 1990, and BGMP approval in December 1999. By obtaining approval from the US FDA as an API manufacturing facility in July 2000, the plant had grown into a production facility that covers the entire process of drug production from raw material synthesis to the finished product. Ever since its establishment, the company has been continuously investing in the production facility, gradually transforming the plant into a world-class production facility that can produce pharmaceuticals that meet global quality standards. In 2018, the plant was also selected as the first-ever Digital Medicine (DM) manufacturing site, raising expectations of expanding exports to North America after obtaining cGMP approval from the US FDA as well as contributing to further progressing the domestic pharmaceutical industry's production capability. Since the company started to reexport its products to Japan in 1991, Korea Otsuka Pharmaceutical has expanded exports to 13 countries in Asia including China, the Philippines, and Indonesia. In 2014, the company’s facility obtained EU-GMP approval and expanded its exports to 44 countries including those in Europe, raising over 40 billion won in annual exports. Based on the growing export sales, the company had been awarded the ‘$10 million export Tower’ in 1998, ‘$20 million export Tower’ in 2009, and ‘$30 million export Tower’ in 2015 for its outstanding export performance, contributing to the development of Korea's pharmaceutical industry through continuous job creation and the development of the domestic economy. Also, through continuous R&D investment and its independent R&D activity, the company has obtained new indications and developed new formulations, demonstrating the superior development capability of domestic researchers while increasing exports and expanding global approvals. In April this year, Korea Otsuka Pharmaceutical had succeeded in developing a global product- ‘Mucosta SR Tab.’ - for the treatment of gastric mucosal lesions using only domestic infrastructure through open innovation development with a domestic venture company, IMD Pharm, and Aju University Industry-Academic cooperation foundation. Such R&D investment activities are not irrelevant to the virtualization of its Hyangnam plant. The development of various new items with new indications and formulations led to expanded approvals in Korea and nearby countries, based on which the company has expanded exports of pharmaceuticals produced at its Hyangnam plant in Asia, Arab, and Europe regions. With the increased exports, the Hyangnam plant has been exerting its influence as a well-established production base of Otsuka Pharmaceutical. Meanwhile, Korea Otsuka Pharmaceutical has been the only multinational pharmaceutical company to be nominated as an ‘innovative pharmaceutical company’ for 4 consecutive years in recognition of its continuous investment in production facilities and activation of the domestic pharmaceutical industry.
- Company
- Tabrecta/ Rybrevant are expected to enter the market
- by Eo, Yun-Ho Oct 13, 2021 05:47am
- Two types of anticancer drugs targeting MET gene mutations are expected to enter the domestic market. According to related industries, Novartis Korea and Janssen Korea submitted applications to the MFDS for approval of the new anticancer drugs Tabrecta (Capmatinib) and Rybrevant (Amivantamab), respectively, and are currently undergoing screening. MET mutations are rare types that account for about 3% to 4% of metastatic non-small cell lung cancer, and interest in these new drugs is increasing as there have been no treatments. The two drugs have something in common that they target hepatocellular growth factor receptors (c-Met), but the indications are somewhat different. Tabrecta was first approved in the United States in May last year as a treatment for MET Exon14 mutated non-small cell lung cancer (NSCLC). In the case of Rybrevant, it obtained US approval in May, blocking epithelial cell growth factor (EGFR) and MET mutation at the same time. The first indication of this drug is non-small cell lung cancer with EGFR Exon20 mutation. Tabrecta and Rybrevant are 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, Tabrecta is conducting a clinical trial in combination with AstraZeneca's third-generation EGFR TKI Tabrecta (Osimertinib), while Rybrevant is conducting a study in combination with Yuhan's 'Leclaza(Lazertinib), a domestic new drug. Meanwhile, Tabrecta confirmed its validity 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, DoR of previously untreated patients was 12.6 months and the patients treated were 9.7 months. Leclaza proved its efficacy through CHRYSALIS, a phase 1 clinical trial. According to the study, the objective response rate (ORR) was 40% when 81 patients with non-small cell lung cancer with 20 mutations of EGFR Exon were administered with Rybrevant. There were three patients with complete response (CR) with complete tumor disappearance, and 29 patients reached partial response (PR) with tumor size decreasing by more than 30%.
