Janssen Receives Positive CHMP Opinion for RYBREVANT® (amivantamab) for the Treatment of Patients with Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations After Failure of Platinum-Based Therapy
FOR EU TRADE AND MEDICAL MEDIA ONLY. NOT TO BE DISTRIBUTED TO UK AND BENELUX BASED MEDIA
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product amivantamab, intended for the treatment of adult patients with advanced NSCLC with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations, after failure of platinum-based therapy.3 If approved, amivantamab will be the first treatment in the European Union specifically targeting EGFR exon 20 insertion mutations for advanced NSCLC.1
“This group of patients often face a poor prognosis as there are currently no targeted therapy options for this specific mutation nor does it typically respond to existing therapies used to treat more common EGFR mutations,” 1,4,5 commented Catherine Taylor, M.D., Vice President, Medical Affairs Therapeutic Area Strategy, Europe, Middle East and Africa (EMEA), Janssen-Cilag AG. “The decision today by the CHMP recognises amivantamab has the potential to provide an urgently required, effective and tolerable new treatment option specifically targeted for patients diagnosed with non-small cell lung cancer who have EGFR exon 20 insertion mutations.”
Amivantamab is a fully-human EGFR and MET bispecific antibody with immune cell-directing activity that targets tumours with activating and resistant EGFR and MET mutations and amplifications.6,7,8,9 The European marketing authorisation application (MAA) is based on results from the Phase 1 CHRYSALIS study, a multicentre, open-label, clinical study evaluating amivantamab as a monotherapy in patients after previous treatment with platinum-based therapy, which demonstrated efficacy and a generally well-tolerated safety profile.10 Confirmed complete or partial responses were observed in 32 out of 81 patients, resulting in an overall response rate of 40 percent (95 percent CI, 29% – 51%), with a median duration of response of 11.1 months (95 percent CI, 6.9 – not reached).10 The median progression free survival (time experienced without progression or death) was 8.3 months (95 percent CI, 6.5 – 10.9) and the median overall survival in patients treated with amivantamab was 22.8 months (95 percent CI, 14.6 – not reached).10
The most common adverse events (AEs) were predominantly Grade 1-2 and included infusion-related reactions (66 percent), rash (86 percent) and paronychia (45 percent). Sixteen percent of patients experienced treatment-related Grade ≥3 AEs.10 Treatment-related discontinuations were seen in four percent and treatment-related dose reductions in 13 percent of patients.10 There were no treatment-related deaths.10 Ninety-four percent of infusion related reactions (IRRs) occurred with the first infusions and rarely impacted the ability to continue with subsequent treatments.10 Initial study results from the CHRYSALIS EGFR exon 20 insertion mutation population were presented at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program11 and updated results were presented at the IASLC World Conference on Lung Cancer (WCLC) 2020.12
“Amivantamab has the potential to address the high unmet need in the treatment of people with EGFR exon 20 insertion mutations in non-small cell lung cancer,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. “At Janssen, we are committed to delivering innovative therapies and making a meaningful impact in areas of high unmet need and in the lives of patients. With the development of a novel bispecific antibody like amivantamab, we believe advancing medicines targeting specific pathways can bring the greatest benefits and improve outcomes for patients with tumour alterations, such as EGFR and MET.”
The CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission, which is expected later this year.13 The U.S. Food and Drug Administration (FDA) approved amivantamab in May 2021 for the treatment of adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.14 Additional regulatory applications have been submitted and are being reviewed by other regulatory bodies worldwide.
Amivantamab is a fully-human EGFR-MET bispecific antibody with immune cell-directing activity that targets tumours with activating and resistance EGFR mutations and MET mutations and amplifications.6,7,8,9 Amivantamab is being studied in multiple clinical trials, including:15
- the Phase 1/1b, CHRYSALIS-2, (NCT04077463) study assessing the combination of amivantamab and lazertinib in patients who have progressed after treatment with osimertinib and chemotherapy, as well as lazertinib as a monotherapy16
- as first-line therapy in the Phase 3 MARIPOSA (NCT04487080) study assessing amivantamab in combination with lazertinib,* a novel third-generation EGFR tyrosine kinase inhibitor (TKI), against osimertinib in untreated advanced EGFR-mutated NSCLC17
- the Phase 3 MARIPOSA-2 (NCT04988295) study assessing the efficacy of lazertinib, amivantamab, carboplatin-pemetrexed vs. with carboplatin-pemetrexed in participants with locally advanced or metastatic EGFR Exon 19del or Exon 21 L858R substitution NSCLC after osimertinib failure18
- the Phase 3 PAPILLON (NCT04538664)study assessing amivantamab in combination with carboplatin-pemetrexed for patients with advanced or metastatic EGFR-mutated NSCLC with exon 20 insertion mutations19
- the Phase 1 PALOMA (NCT04606381) study assessing the feasibility of subcutaneous (SC) administration of amivantamab based on safety and pharmacokinetics and to determine a dose, dose regimen and formulation for amivantamab SC delivery with the aim to find effective solutions that positively impact patient management.20
About the CHRYSALIS Study
CHRYSALIS (NCT02609776) is an open-label, multicentre, first-in-human Phase 1 study to evaluate the safety, pharmacokinetics and preliminary efficacy of amivantamab as a monotherapy, in combinations with lazertinib and in combination with platinum-based chemotherapy, in patients with advanced NSCLC with various EGFR mutations.2 In the study, investigators assessed efficacy using overall response rate per Response Evaluation Criteria in Solid Tumours Version 1.1* (RECIST v1.1), clinical benefit rate, median duration of response and median progression-free survival, as well as the safety profile of amivantamab.2,21
The study will enrol 460 patients with advanced NSCLC.2 The study consists of two parts: the first consists of amivantamab monotherapy and combination dose escalations, and the second consists of amivantamab monotherapy and combination dose expansions.2
*RECIST (version 1.1) refers to Response Evaluation Criteria in Solid Tumours, which is a standard way to measure how well solid tumours respond to treatment and is based on whether tumours shrink, stay the same or get bigger.2
About Non-Small Cell Lung Cancer (NSCLC)
In Europe, it is estimated that 477,534 patients were diagnosed with lung cancer in 2020, with around 85 percent diagnosed with NSCLC.22,25 Lung cancer is Europe’s biggest cancer killer, with more deaths than breast cancer and prostate cancer combined.24
The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma and large cell carcinoma.23 Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase supporting cell growth and division.24 EGFR mutations are present in 16 to 19 percent of Caucasian patients with NSCLC and present in 37 to 41 percent of Asian patients who have NSCLC adenocarcinoma.25 The five-year survival rate for all people with metastatic NSCLC and EGFR mutations who are treated with EGFR TKIs is less than 20 percent.26 Patients with EGFR exon 20 insertion mutations have a real-world five-year overall survival (OS) of 8 percent in the frontline setting, which is worse than patients with EGFR exon 19 deletions or L858R mutations, who have a real-world five-year OS of 19 percent.27
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology and Pulmonary Hypertension.
Learn more at www.janssen.com/emea/. Follow us at www.twitter.com/JanssenEMEA for our latest news. Janssen Research & Development, LLC; Janssen-Cilag, S.A. and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
# # #
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding amivantamab and lazertinib. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC any of the other Janssen Pharmaceutical Companies, and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2021, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
1 Remon, J et al. EGFR exon 20 insertions in advanced non-small cell lung cancer: A new history begins. Cancer Treatment Reviews. 90 (2020).
2 ClinicalTrials.gov. Study of JNJ-61186372, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer. Available at: https://clinicaltrials.gov/ct2/show/NCT02609776. Accessed October 2021.
3 Committee of Medicinal Products for Human Use (CHMP) meeting highlights. Available at: https://www.ema.europa.eu/en/medicines/human/summaries-opinion/rybrevant Accessed 15 October 2021.
4 Crossland V et al. HSR19-082: Epidemiological Findings and Outcomes in Non-Small Cell Lung Cancer Patients with Exon 20 Insertion Mutations: A Meta-Analysis. JNCCN 2019; 17(3.5): HSR19-08.
5 Hirano T et al. In Vitro Modeling to Determine Mutation Specificity of EGFR Tyrosine Kinase Inhibitors Against Clinically Relevant EGFR Mutants in Non-Small-Cell Lung Cancer Oncotarget 2015; 6(36): 38789–38803.
6 Grugan et al. Fc-mediated activity of EGFR x c-Met bispecific antibody JNJ-61186372 enhanced killing of lung cancer cells. MAbs. 2017;9(1):114-126.
7 Moores et al. A Novel Bispecific Antibody Targeting EGFR and cMet Is Effective against EGFR Inhibitor-Resistant Lung Tumors. Cancer Res. 2016;76(13)(suppl 27216193):3942-3953.
8 Yun et al. Antitumor Activity of Amivantamab (JNJ-61186372), an EGFR–MET Bispecific Antibody, in Diverse Models of EGFR Exon 20 Insertion–Driven NSCLC. Cancer Discov. 2020;10(8):1194-1209.
9 Vijayaraghavan et al. Amivantamab (JNJ-61186372), an Fc Enhanced EGFR/cMet Bispecific Antibody, Induces Receptor Downmodulation and Antitumor Activity by Monocyte/Macrophage Trogocytosis. Mol Cancer Ther. 2020;19(10):2044-2056.
10Sabari, J. et al. Amivantamab in Post-platinum EGFR Exon 20 Insertion Mutant Non-Small Cell Lung Cancer. WCLC Oral Presentation #3031. January 2021 .
11 Janssen Announces Phase 1 Results for Bispecific Antibody Amivantamab in the Treatment of Patients with Advanced Non-Small Cell Lung Cancer Harboring Exon 20 Insertion Mutations. Available at: https://www.businesswire.com/news/home/20200518005380/en/Janssen-Announces-Phase-1-Results-for-Bispecific-Antibody-Amivantamab-in-the-Treatment-of-Patients-with-Advanced-Non-Small-Cell-Lung-Cancer-Harbouring-Exon-20-Insertion-Mutations. Accessed October 2021.
12 Janssen: New Amivantamab Data from CHRYSALIS Study Show Robust Clinical Activity and Durable Responses in Patients with Metastatic or Unresectable Non-Small Cell Lung Cancer and EGFR Exon 20 Insertion Mutations. Available at: https://www.businesswire.com/news/home/20210128005929/en/Janssen-New-Amivantamab-Data-from-CHRYSALIS-Study-Show-Robust-Clinical-Activity-and-Durable-Responses-in-Patients-with-Metastatic-or-Unresectable-Non-Small-Cell-Lung-Cancer-and-EGFR-Exon-20-Insertion-Mutations. Accessed October 2021.
13 Janssen Submits European Marketing Authorisation Application for Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations. https://www.janssen.com/janssen-submits-european-marketing-authorisation-application-amivantamab-treatment-patients. Accessed October 2021.
14Johnnson and Johnson. RYBREVANT® (amivantamab-vmjw) Receives FDA Approval as the First Targeted Treatment for Patients with Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations. Available at: https://www.jnj.com/rybrevanttm-amivantamab-vmjw-receives-fda-approval-as-the-first-targeted-treatment-for-patients-with-non-small-cell-lung-cancer-with-egfr-exon-20-insertion-mutations. Accessed October 2021.
15 ClinicalTrials.gov. Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer. Available at: https://clinicaltrials.gov/ct2/show/NCT02609776. Accessed October 2021
16 A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer. Available at: https://clinicaltrials.gov/ct2/show/NCT04077463. Accessed October 2021
17 ClinicalTrials.gov. A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (MARIPOSA). Available at: https://clinicaltrials.gov/ct2/show/NCT04487080. Accessed October 2021
18 ClinicalTrials.gov. A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure (MARIPOSA-2). Available at https://clinicaltrials.gov/ct2/show/NCT04988295 Accessed October 2021
19 ClinicalTrials.gov. A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions
(PAPILLON). Available at: https://clinicaltrials.gov/ct2/show/NCT04538664?term=PAPILLON&cond=NSCLC&draw=2&rank=1. Accessed October 2021.
20 ClinicalTrials.gov. A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies. Available at: https://clinicaltrials.gov/ct2/show/NCT04606381. Accessed October 2021.
21 Park et al, Amivantamab (JNJ-61186372), an anti-EGFR-MET bispecific antibody, in patients with EGFR exon 20 insertion (exon20ins)-mutated non-small cell lung cancer (NSCLC). Available at https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.9512. Accessed October 2021.
22 Globocan 2020. Estimated number of incident cases deaths in 2020, Europe, both sexes, all ages. Available at: www.gco.iarc.fr. Accessed October 2021.
23 Zappa C et al. Non-small cell lung cancer: current treatment and future advances. Transl Lung Cancer Res 2016; 5(3): 288–300.
24 Wee,P, Wang, Z. Epidermal Growth Factor Receptor Cell Proliferation Signaling Pathways. Cancers (Basel). 2017 May; 9(5): 52.
25 Zhang et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget 2016. 7 (48): 78985 – 78993.
26 Lin JJ, Cardarella S, Lydon CA, Dahlberg SE, Jackman DM, Jänne PA, et al. Five-Year Survival in EGFR-Mutant Metastatic Lung Adenocarcinoma Treated with EGFR-TKIs. J Thorac Oncol. 2016 Apr;11(4):556-65.
27 Girard N, BazhenovaL, MinchomA, OuSI, GadgeelSM, Trigo J, et al. Comparative clinical outcomes for patients with NSCLC harboring EGFR exon 20 insertion mutations and common EGFR mutations. Abstract presented at: World Conference on Lung Cancer Annual Meeting; January 29, 2021; Singapore.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Phone: +31 621 38 5718
Phone: +44 7917 849 211
Phone: +1 732-524-3922
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
NextSense Emerges to Unlock Brain Health with Key Partners UCB, Heraeus, UC San Diego, and Emory University3.12.2021 18:00:00 EET | Press release
NextSense, the foundation of brain health, came out of stealth with an announcement made from the AES (American Epilepsy Society) Annual Meeting in Chicago, where NextSense and its partners are presenting the results of their research on seizure detection to peers in academia and industry for the first time. NextSense unlocks brain health with real world data insights and practical, scientific wisdom for daily living. Traditional brain health monitoring technology like EEG machines and polysomnograms are too bulky for home use, requiring patients to stay overnight at hospitals or sleep study clinics for observation. The high cost of care and lack of comfort of these devices makes long-term and continuous monitoring nearly impossible. Not only are these data based on a single timeframe, they observe what is anything but an ordinary night’s sleep. And for anyone living with epilepsy, the unpredictability of seizures makes direct observation and high-quality data-gathering exceedingly rar
Healthcare+ Expo Taiwan to Build an Ecosystem of Digital Transformation in Healthcare3.12.2021 17:15:00 EET | Press release
One of the largest trade fairs in the APAC region- the Healthcare+ Expo Taiwan- takes place on 2 to 5 December in Taipei. The Expo displays Taiwan’s strength in AI, Cloud-based Applications, Flat Panels, IoT and Technologies that make up Metaverse, reflecting the trend on digital transformation in healthcare driven by the global pandemic. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211203005002/en/ Expand Businesses into growing markets in the APAC region, with Healthcare+ B2B. Join medical institutes and companies in the fields of pharmaceuticals, biotechnology, health/ information technology, electronics and manufacturing to promote products, build partnerships and seize supply-demand opportunities. (Graphic: Business Wire) The Expo has an all-star lineup of corporates, including Acer, Asus, AUO, Delta Electronics, Innolux, Quanta and Wistron, demonstrate their technologies and solutions tailored to digital transformati
Eurofins Technologies Launches a New Multiplex RT-PCR Assay for Combined SARS-CoV-2 Screening and Rapid Detection of the Omicron (B.1.1.529) Variant of Concern3.12.2021 16:05:00 EET | Press release
Eurofins Technologies (Paris:ERF) announces the launch of the multiplex RT-PCR assay GSD NovaType Detect + Select K417N SARS-CoV-2. Within just one week since the first reports on the Omicron variant of concern, this kit has been developed as a quick response to identify its presence. The assay is designed for the simultaneous qualitative detection of SARS-CoV-2 genomic RNA and identification of the spike (S) mutation K417N in one reaction. The results of this RT-PCR assay can be obtained within 1 hour, which makes it a fast and cost-effective solution to identifying the presence of the Omicron variant before samples are confirmed by whole genome sequencing. Eurofins Technologies is constantly working to adapt its product offering to meet the challenges of the ongoing COVID-19 pandemic.. For more information, please visit Eurofins Technologies website. About Eurofins Technologies – a fast growing provider of diagnostic technologies in the field of immunoassays and molecular detection m
How Can Chinese Cities Increase Their Global Communications Impact? Joint Report and Index from CCG and Xinhuanet Sizes up Strategies and Offers Valuable Suggestions3.12.2021 15:53:00 EET | Press release
The Center for China and Globalization (CCG) and Xinhuanet, China’s leading online news portal, recently released a joint report evaluating the global communications impact of Chinese cities, analyzing the problems with their communication strategies, and offering suggestions on improving their ability to “go global”. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211203005279/en/ Report on the Chinese Cities Global Communications Impact Index (CCGCII) & Ranking of Chinese Cities by Global Communications Impact (Graphic: Business Wire) The study covered the top 100 cities in China as ranked by GDP in 2019, including Shanghai, Beijing, Shenzhen, Guangzhou, Chongqing, Chengdu, Wuhan, Tianjin, Dalian, and Xiamen . Based on big data from the Xinhua RIS data bank, which has collated over 10 million items of public information from overseas mainstream media and international social media platforms, the Chinese Cities Global Commun
Valuence Japan Nanboya, BRAND CONCIER Recognized as No.1 in Five Categories in Japan, Including for Overall Purchase Volume, for Luxury Brand Goods and Other Items!3.12.2021 12:55:00 EET | Press release
Valuence Japan Inc. (Tokyo; Susumu Muguruma, representative director), a member of the Valuence Group (TOKYO:9270), which operates 135 offices in Japan and 23 other countries(*1) specializing in the purchase of watches, bags, jewelry, precious metals, antiques, and art objects has announced the results of a survey on the purchase volume of brand goods conducted by ESP Research Institute, Inc. According to the survey, the company’s Nanboya and BRAND CONCIER brands placed in the top position in Japan in terms of overall annual purchase volume of luxury brand goods. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211203005167/en/ Valuence Japan Nanboya, BRAND CONCIER Recognized as No.1 in Five Categories in Japan, Including for Overall Purchase Volume, for Luxury Brand Goods and Other Items! Also Recognized as No.1 in Japan for Purchase Volume of Rolex and Other Watches, Jewelry, Apparel, and Accessories (Graphic: Business Wire)
Moody’s Acquires PassFort and Agrees to Acquire kompany, Expanding KYC and Compliance Capabilities3.12.2021 12:00:00 EET | Press release
Moody’s Corporation (NYSE:MCO) announced today that it has acquired PassFort Limited and entered into an agreement to acquire 360kompany AG (kompany), two European providers of onboarding and Know Your Customer (KYC) technology solutions. The acquisitions complement Moody’s technology, data, and analytical capabilities, and enhance its industry-leading customer solutions for KYC, anti-money laundering, compliance, and counterparty risk. “Our customers rely on our data and analytical tools to make decisions about who they do business with,” said Keith Berry, General Manager of Moody’s KYC business unit. “PassFort and kompany are innovators in the compliance and regulatory space, and their technologies will upgrade and accelerate our customers’ onboarding and monitoring processes.” PassFort is a U.K. SaaS-based workflow platform for identity verification, customer onboarding, and risk analysis. Its software delivers data from over 25 third-party providers and automates the collection, ve
DEXLEVO's Liquid Polymer Filler Raises KRW 26 Billion in Pre-IPO Funding3.12.2021 10:41:00 EET | Press release
DEXLEVO has completed its pre-IPO funding of KRW 26 billion. It thus increased its valuation by six times compared to the Series B funding in 2018 thanks to its commercialization performance such as obtaining the European Union’s CE certification on the liquid polymer filler (product name: GOURI) in May of this year. The company plans to build a new cGMP-grade (current Good Manufacturing Practice) production facility in Songdo with the proceeds raised this time and start marketing its flagship product. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211202006086/en/ DEXLEVO's GOURI, the world's 1st Fully Liquid type PCL Injectable. (Graphic: Business Wire) According to industry sources on November 25, DEXLEVO has completed a total of KRW 26 billion in pre-IPO funding from existing investors such as Magna Investment, Smilegate Investment, Hyundai Venture Investment Corp., and Shinhan Capital. Magna Investment and Smilegate Inv
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom