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Fujitsu and Tokyo Medical and Dental University leverage world’s fastest supercomputer and AI technology for scientific discovery to shed light on drug resistance in...
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Fujitsu and TMDU applied this technology to gene expression level(2) data obtained from cancer cell lines in order to analyze drug resistance(3) against anticancer drugs, and succeeded in extracting a new causal mechanism of a previously unknown gene that suggests a cause of resistance to lung cancer drugs. The new technology is expected to contribute to the acceleration of drug discovery and the realization of cancer therapies individualized for each patient.
The technology was developed under the theme of "elucidation of the cause and diversity of cancer using large-scale data analysis and AI technology," an initiative supported by TMDU, Kyoto University and Fujitsu as part of the supercomputer Fugaku achievement acceleration program(4).
Background
Even if a patient receives a targeted cancer drug(5) therapy, the appearance of drug-resistant cancer cells represents an ongoing threat to full remission. The mechanism for how certain cancers become drug resistant remains unclear, however, and researchers continue to work on new methods of analysis that shed light on how cells that have multiple driver mutations(6) acquire drug resistance. In drug development and clinical trials involving drug repositioning(7), it is important to identify patients for whom drugs are anticipated to have an effect. However, the effectiveness of drugs may differ depending on the organ and the individual and variations in gene expression, and the number of patterns combining expression levels of multiple genes exceeds 1,000 trillion(8). A comprehensive search of all 20,000 genes in the human genome would thus take more than 4,000 years with a conventional computer and finding ways to accelerate the process represents a major challenge.
Newly developed technology
Fujitsu implemented parallel conditional and causal algorithms to maximize computational performance with the supercomputer Fugaku to analyze the human genome within a timeframe needed for practical research. By utilizing Fujitsu's "Wide Learning"(9) AI technology to extract combinations of potential genes relating to the emergence of drug resistance based on statistical information, Fujitsu developed a novel technology that makes it possible to conduct a comprehensive search within a day.
Results
As a result of running data of the Dependency Map (DepMap)(10) portal using this technology on the supercomputer Fugaku, Fujitsu and TMDU were able to search the entire human genome for conditions and causality within a single day and determine the genes that cause resistance to drugs used to treat lung cancer(11).
Comment from Prof. Seiji Ogawa, Graduate School of Medicine, Kyoto University
Promising technologies like Fujitsu's AI technology for scientific discovery ("Wide Learning") may one day contribute to the discovery of biomarkers, which represent an area of growing interest in drug development. The key to the success of new drug development is to identify patients who are expected to benefit from new drugs and conduct clinical trials. If the marker that predicts who will benefit from the drug is known, the cost of clinical trials can significantly be reduced and the probability of success by conducting individual clinical trials can be increased. From this point of view, pharmaceutical manufacturers and others are expected to be very interested in this technology. The fact that it has been implemented using Fugaku has also raised expectations.
Future Plans
Moving forward, Fujitsu and TMDU will conduct a multilayered and comprehensive analysis that combines various data including time axis and location data with the aim of accelerating medical research, including in the field of drug efficacy, as well as to shed light on the causes of cancer.
Fujitsu and TMDU will also collaborate in experimental research in the fields of drug discovery and medicine. TMDU will further utilize the technology developed in this research to promote research on strategies for intractable diseases such as cancer.
In addition to medical care, Fujitsu will utilize the new technology to resolve challenges in a variety of fields, including marketing, system operations and manufacturing.
Acknowledgements
This research was conducted as part of Ministry of Education, Culture, Sports, Science and Technology's Fugaku Achievement Acceleration Program "Understanding the Origin and Diversity of Cancer through Large-scale Data Analysis and Artificial Intelligence Technologies" (JPMXP 1020200102). A part of the research was conducted with the computational resources of supercomputer Fugaku (Issue #: hp 200138, hp 210167).
(1) Supercomputer "Fugaku":
A computer installed at RIKEN as a successor to the supercomputer "K." From June 2020 to November 3, it ranked first in 4 categories in the supercomputer rankings for 4 consecutive years. Full operation started on March 9, 2021.
(2) Gene expression level :
Amount of RNA copied from DNA (the same nucleic acid as DNA synthesized by transcription using some DNA sequences as templates).
(3) Drug resistance :
A phenomenon in which the effect of a drug weakens while the drug is being administered.
(4) Supercomputer Fugaku Achievement Acceleration Program :
Program started in May 2020 by the Ministry of Education, Culture, Sports, Science and Technology with the aim to achieve early results.
(5) Targeted drug :
A drug designed to act only on the molecule (protein, gene, etc.) that is causing the disease.
(6) Driver mutations :
A genetic mutation that directly causes the development or progression of cancer.
(7) Drug repositioning :
The application of existing drugs developed and approved for the treatment of one disease to the treatment of another disease.
(8) More than 1,000 trillion :
Even if the expression level of each gene is restricted to a combination of 50 major genes known to be related to cancer and the expression level of each gene is classified into 2 categories (e.g., "high" or "low" gene expression), the condition number is 2 to the power of 50, which exceeds 1,000 trillion.
(9) Wide Learning :
Official site "Hello, Wide Learning!"
(10) Dependency Map (DepMap) :
Data on the sensitivity and resistance of approximately 4,500 drugs to approximately 600 different cancer cell lines, provided by the American Broad Institute. Mutation information of cancer cell lines and expression data of all genes are included.
(11) Fujitsu and TMDU analyzed gene expression data from DepMap of approximately 300 cancer cell lines, sensitivity and resistance data of Gefitinib (molecularly targeted drug used to treat lung cancer and other cancer types), and comprehensively searched for conditions and mechanisms of cancer cell lines that do not respond to Gefitinib. Fujitsu and TMDU identified conditions under which the expression levels of three transcription factors (genes that control gene transcription (synthesis of RNA)), ZNF516, E2F6, and EMX1, were low. In lung cancer cell lines that meet these conditions, a mechanism triggered by the transcription factors SP7 and PRRX1 was discovered as further potential causes of drug resistance in cancer cells (see reference image).
About Fujitsu
Fujitsu is the leading Japanese information and communication technology (ICT) company offering a full range of technology products, solutions and services. Approximately 126,000 Fujitsu people support customers in more than 100 countries. We use our experience and the power of ICT to shape the future of society with our customers. Fujitsu Limited (TSE:6702) reported consolidated revenues of 3.6 trillion yen (US$34 billion) for the fiscal year ended March 31, 2021. For more information, please see www.fujitsu.com.
About Tokyo Medical and Dental University
Tokyo Medical and Dental University (TMDU) is Japan's only comprehensive medical university and graduate school, and has provided advanced medical treatment through a fusion of the medical and dental fields and worked to cultivate "professionals with knowledge and humanity." TMDU contributes to human health and the well-being of society by fostering outstanding healthcare professionals with a humane and global outlook.
Copyright 2022 JCN Newswire. All rights reserved. www.jcnnewswire.comFujitsu and the Tokyo Medical and Dental University (TMDU) today announced a new technology that uses AI to discover new causal mechanisms of drug resistance in cancer treatments from clinical data.
Eisai Initiates Submission of Application Data Under the Prior Assessment Consultation System in Japan with the Aim of Obtaining Early Approval for Investigational Anti-Amyloid...
The PMDA's process, known as "prior assessment consultation", is conducted at the development stage before the new drug application submission, which is based on available quality, non-clinical and clinical data. By identifying and resolving any potential issues prior to submission, the aim is to shorten application review time.
Based on discussions with the Ministry of Health, Labour and Welfare (MHLW) and PMDA, Eisai applied to PMDA for permission to utilize the "prior assessment consultation" process for lecanemab with the aim of shortening the review period. The agency approved Eisai's request and Eisai has submitted the non-clinical lecanemab data to PMDA. The additional data of the application package will be submitted hereafter. Eisai plans to obtain the primary endpoint data from Clarity AD study in the fall of 2022, and based on the results of the study, aims to file for the manufacturing and marketing approval in Japan during Eisai's fiscal year 2022.
In September 2021, Eisai initiated a rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) for lecanemab, an investigational agent under the Accelerated Approval pathway for the treatment of early AD with confirmed amyloid pathology, and expects to complete this rolling submission in the beginning of Eisai's fiscal year 2022. Based on the results of Clarity AD study as the confirmatory study, Eisai plans to submit for full approval of lecanemab to the U.S. FDA during fiscal year 2022. Eisai and Biogen are committed to providing innovative treatments to persons living with early AD, their families and healthcare professionals who are waiting for new treatment options, as early as possible.
About the Prior Assessment Consultation System
The prior assessment consultation is conducted at the development stage before new drug application submission based on available quality, non-clinical and clinical data. By identifying and resolving any potential issues prior to submission, the aim is to shorten application review time.
About Lecanemab (BAN2401)
Lecanemab is an investigational humanized monoclonal antibody for Alzheimer's disease (AD) that is the result of a strategic research alliance between Eisai and BioArctic. Lecanemab selectively binds to neutralize and eliminate soluble, toxic amyloid-beta (Aβ) aggregates (protofibrils) that are thought to contribute to the neurodegenerative process in AD. As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. Currently, lecanemab is being developed as the only anti- Aβ antibody that can be used for the treatment of early AD without the need for titration. With regard to the results from pre-specified analysis at 18 months of treatment, Study 201 demonstrated reduction of brain Abeta accumulation (P<0.0001) and slowing of disease progression measured by ADCOMS* (P<0.05) in early AD subjects. The study did not achieve its primary outcome measure** at 12 months of treatment. The Study 201 open-label extension was initiated after completion of the Core period and a Gap period off treatment of 9-59 months (average of 24 months, n=180 from core study enrolled) to evaluate safety and efficacy, and is underway.
Currently, lecanemab is being studied in a confirmatory Phase 3 clinical study in symptomatic early AD (Clarity-AD), following the outcome of the Phase 2 clinical study (Study 201). Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in Alzheimer's Disease and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Furthermore, Eisai has initiated a lecanemab subcutaneous dosing Phase 1 study. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement concluded with BioArctic in December 2007. In March 2014 Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab and the parties amended that agreement in October 2017.
* Developed by Eisai, ADCOMS (AD Composite Score) combines items from the ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive subscale), CDR (Clinical Dementia Rating) and the MMSE (Mini-Mental State Examination) scales to enable a sensitive detection of changes in clinical functions of early AD symptoms and changes in memory. The ADCOMS scale ranges from a score of 0.00 to 1.97, with higher score indicating greater impairment.
** An 80% or higher estimated probability of demonstrating 25% or greater slowing in clinical decline at 12 months treatment measured by ADCOMS from baseline compared to placebo.
About the Collaboration between Eisai and Biogen for Alzheimer's Disease
Eisai and Biogen are collaborating on the joint development and commercialization of AD treatments. Eisai serves as the lead in the co-development of lecanemab.
About the Collaboration between Eisai and BioArctic for Alzheimer's Disease
Since 2005, BioArctic has had a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of AD. The commercialization agreement on the lecanemab antibody was signed in December 2007, and the development and commercialization agreement on the antibody lecanemab back-up for AD, which was signed in May 2015. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for AD. BioArctic has no development costs for lecanemab in AD.
About Eisai Co., Ltd.
Eisai Co., Ltd. is a leading global pharmaceutical company headquartered in Japan. Eisai's corporate philosophy is based on the human health care (hhc) concept, which is to give first thought to patients and their families, and to increase the benefits that health care provides to them. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.
Leveraging the experience gained from the development and marketing of a treatment for Alzheimer's disease, Eisai aims to establish the "Eisai Dementia Platform." Through this platform, Eisai plans to deliver novel benefits to those living with dementia and their families through constructing a "Dementia Ecosystem," by collaborating with partners such as medical organizations, diagnostic development companies, research organizations, and bio-ventures in addition to private insurance agencies, finance industries, fitness clubs, automobile makers, retailers, and care facilities. For more information about Eisai Co., Ltd., please visit https://www.eisai.com.
About Biogen
As pioneers in neuroscience, Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological diseases as well as related therapeutic adjacencies. One of the world's first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Sir Kenneth Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today, Biogen has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, and is providing the first and only approved treatment to address a defining pathology of Alzheimer's disease. Biogen is also commercializing biosimilars and focusing on advancing the industry's most diversified pipeline in neuroscience that will transform the standard of care for patients in several areas of high unmet need.
In 2020, Biogen launched a bold 20-year, $250 million initiative to address the deeply interrelated issues of climate, health, and equity. Healthy Climate, Healthy Lives aims to eliminate fossil fuels across the company's operations, build collaborations with renowned institutions to advance the science to improve human health outcomes, and support underserved communities.
Biogen Safe Harbor
This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof; the expected data readout for the Clarity AD study; the treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization. These statements may be identified by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "possible," "potential," "will," "would" and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation unexpected concerns that may arise from additional data, analysis or results obtained during clinical studies, including the Clarity AD clinical trial and AHEAD 3-45 study; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen's drug candidates, including lecanemab; actual timing and content of submissions to and decisions made by the regulatory authorities regarding lecanemab; uncertainty of success in the development and potential commercialization of lecanemab; failure to protect and enforce Biogen's data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing COVID-19 pandemic on Biogen's business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen's expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen's most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen's current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
Copyright 2022 JCN Newswire. All rights reserved. www.jcnnewswire.comEisai Co., Ltd. and Biogen Inc. announced today that Eisai has initiated a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data under the prior assessment consultation system in Japan for the investigational anti-amyloid beta (Abeta) protofibril antibody lecanemab (BAN2401).
Lepu Biopharma Announces Proposed Listing on the Main Board of the Hong Kong Stock Exchange
Lepu Biopharma plans to offer 126,876,000H shares (subject to the Over-allotment Option), of which 114,188,000 H shares will be International Offer Shares (subject to reallocation and the Over-allotment Option), representing 90% of the initial offer shares; the remaining 12,688,000 H shares will be Hong Kong Offer Shares (subject to reallocation), representing 10% of the initial offer shares. Offer Price is between HK$6.87 and HK$7.38 per Offer H Share. Lepu Biopharma will open for Hong Kong Public Offering in Hong Kong at 9 a.m., 10 February 2022 (Thursday), and close at 12:00 noon, 15 February 2022 (Tuesday). Dealings in shares of Lepu Biopharma on the Main Board of the Hong Kong Stock Exchange is expected to commence on 23 February 2022 (Wednesday). The shares will be traded in board lot of 1,000 shares each. The Company's stock code is 2157.
-- China International Capital Corporation Hong Kong Securities Limited and Morgan Stanley Asia Limited are the Joint Sponsors and Joint Global Coordinators.
-- China International Capital Corporation Hong Kong Securities Limited, Morgan Stanley Asia Limited (exclusively for Hong Kong Offer Shares), Morgan Stanley & Co. International plc (exclusively for International Offer Shares), Haitong International Securities Company Limited, Huatai Financial Holdings (Hong Kong) Limited, China Galaxy International Securities (Hong Kong) Co., Limited and Valuable Capital Ltd. are the Joint Bookrunners.
-- China International Capital Corporation Hong Kong Securities Limited, Morgan Stanley Asia Limited (exclusively for Hong Kong Offer Shares), Morgan Stanley & Co. International plc (exclusively for International Offer Shares), Haitong International Securities Company Limited, Huatai Financial Holdings (Hong Kong) Limited, China Galaxy International Securities (Hong Kong) Co., Limited, Valuable Capital Ltd. and Tiger Brokers (HK) Global Limited (exclusively for International Offer Shares) are the Joint Lead Managers.
Lepu Biopharma was incorporated in 2018 and is a biopharmaceutical company focusing on oncology therapeutics. The Company has designed pipeline with a range of oncology products. As of the Latest Practicable Date, the Company had pipeline including eight clinical-stage drug candidates, three pre-clinical drug candidates and three clinical-stage combination therapies of the candidates in the pipeline. The product pipeline of Lepu Biopharma features broad-spectrum anti-tumor drugs, including primarily the anti-PD-1 antibody candidate, as the backbone, and a dual focus on ADC and oncolytic virus drug candidates, maximizing synergies in both drug efficacy and commercialization and enabling company to expand indications and addressable market. The Company takes Anti-PD-1 antibody candidate as the cornerstone of its immunotherapies, advances the research and development of related products. The Company filed an NDA of HX008 in melanoma in June 2021 with the NMPA, and filed an NDA of HX008 in MSI-H/dMMR solid tumors in October 2021 with the NMPA. In addition, the Company focus on the development of innovative drugs including ADC and oncolytic virus. According to Frost & Sullivan, the Company house the leading ADC drug candidate pipeline in China in terms of the number of clinical-stage ADC drug candidates. The comprehensive ADC and oncolytic virus pipeline of company creates synergies and maximizes its competitive strength in commercialization. As of the Latest Practicable Date, company had initiated 28 clinical trials, among which three had entered registration trial phase and two were ongoing in the U.S.
Core Product with Encouraging Clinical Trial Results and Advance R&D Smoothly
The major pipeline assets of Lepu Biopharma consist of four core products, namely, MRG003, MRG002, HX008 and LP002, and three key clinical-stage drug candidates.
Among core products, MRG003 and MRG002 are ADC drug candidates, MRG003 is the most advanced EGFR-targeted ADC in clinical-stage development in China and has the potential to seize market opportunities. The Company is conducting Phase II clinical trials of MRG003 in recurrent or metastatic advanced HNSCC, advanced NSCLC, BTC and NPC in China, and expects to initiate clinical trials in recurrent or metastatic advanced HNSCC in the U.S. and expand MRG003 indications based on the clinical data obtained, further expanding the overall addressable market with the aim of achieving international commercialization with MRG003.
MRG002 is an innovative HER2-targeted ADC. Company's pre-clinical studies revealed better efficacy as compared to T-DM1 (trastuzumab emtansine) in multiple Herceptin-resistant HER2 over- and low-expressing PDX models of the gastric cancer and breast cancer. The Company had initiated Phase II clinical trials of MRG002 in HER2 low-expressing and over-expressing breast cancer, UC (urothelial cancer) and HER2 over-expressing BTC. For HER2 over-expressing breast cancer, the Company had obtained approval from the NMPA of registration trial.
HX008 and LP002 are anti-PD-1/anti-PD-L1 drug candidates, HX008 is a humanized antagonist mAb to human PD-1, which demonstrated efficacy and a good safety profile in the completed Phase Ia clinical trial in solid tumors. As of the Latest Practicable Date, the Company was also in the process of conducting a Phase II clinical trial of HX008 in NMIBC and a Phase III clinical trial of HX008 in the second-line gastric cancer. LP002 is a humanized mAb against PD-L1, which has shown a favorable safety profile in a Phase Ia clinical study in advanced solid tumors. Lepu Biopharma are in the process of a cohort expansion trial in advanced digestive system cancer and have completed patient enrollment and entered the follow-up period for Phase II clinical trials in ES-SCLC in China.
Core Technology Platforms to Buttress Products
Lepu Biopharma has demonstrated capabilities in the development of innovative drugs spanning across early-stage molecular target identification and validation, pre-clinical development and CMC development. The Company has three synergistic core technology platforms around its pipeline specializing in ADC technology, antibody discovery and advanced process and analytical development.
The Company has fully integrated ADC technology platform covering discovery, process and analytical development and manufacturing, is able to design and create new molecules with innovative mechanisms and utilize cutting-edge technology, such as GlycoConnect(TM) site-specific conjugation technology. It has, among others, cutting-edge ADC technologies including sophisticated DAR control technology, advanced ADC conjugation technology, identification and validation of early-stage molecular targets, ADC process development and a well-established quality analysis system.
The Company has constructed a full human naive antibody library of 1011 scale, the platform reduces the reliance on animal immune systems to produce antibodies, and significantly shorten the development period of innovative drug candidates to four to six weeks compared to the traditional hybridoma technology. The Company has also constructed a trispecific antibody T cell engager platform by utilizing protein binding domains, such as nanobodies and scFv, to augment T cells' response to solid tumors.
Lepu Biophamra has an advanced process and analytical development platform for antibodies and ADCs. The Company has impl emented a comprehensive set of quality analysis methods and inspection technology to assess and control the product quality in the course of process and analytical development and production to fulfill the requirements for registration, in order to ensure a standardized process and analytical development and quality control.
Intellectual Property Promotes the Sustainable Development of Drugs
Implement Manufacturing and Commercialization Layout
Intellectual property is pivotal to the sustainable development and commercialization of drugs, the Company endeavors to ensure global full-life-cycle IP protection for drug candidates. As of the Latest Practicable Date, Company had 11 issued patents in China, 20 in the U.S., nine in Japan, seven in the European Union and one in each of South Korea, Australia, Chile, India, Colombia, Indonesia, New Zealand and Israel, and 74 pending patent applications, consisting of 15 in Mainland China and 59 in overseas jurisdictions such as the U.S., Japan, India, South Korea, Australia, Israel, and the European Union. Our patent portfolio spans across mAb structure, targeted epitope, CMC, usage, biopharmaceutical formulation and indications.
While Lepu Biopharma advancing its drug candidates, it has mapped out and is implementing the manufacturing and commercialization strategies. Company commenced the operation of a 2,000L GMP-compliant antibody production line in Beijing in 2019 in support of clinical trials for the antibody products, it is building a production line for oncolytic virus drugs in Beijing with a designed capacity of 200L, as well as a biologics manufacturing center in Shanghai Biotech Park, including production line with a designed capacity of 12,000L initially, coupled with laboratories and manufacturing facilities, and one production line with capacity of 6,000L under construction. The Company is building marketing forces in China and seeking partnership opportunities to support international expansion and commercialization.
Expedite Innovative Drugs Development
Advance Pipeline and Technology Platforms Construction
Lepu Biopharma strives to expedites immune checkpoint inhibitor therapy development, aims to achieve expedited and adequate market coverage of HX008 through both medical institutions and direct-to-patients distribution channels by leveraging the broad spectrum of indications covered by MSI-H/dMMR solid tumors. The Company expects to establish effective sales channels and strengthen the commercialization capabilities through the commercialization of HX008, which would also benefit its efforts to commercialize other drug candidates. The Company also plans to seek strategic partnerships with preeminent pharmaceutical companies internationally to maximize the clinical and commercial value of its immune checkpoint inhibitors.
Lepu Biopharma advances the clinical development of its candidates including ADC candidates, oncolytic virus candidates and combination therapies, plans to stay focused on the development of innovative products, create a pipeline for novel therapies, design and develop innovative products and build advanced technology platforms. In addition, the Company is committed to strengthening its overseas business development of pipeline, enhancing the brand awareness and continuously exploring the commercial value of its products and technology in the international market, and will make efforts to pursue out-licensing partnership opportunities in overseas markets. Furthermore, to meet the commercialization demand, the Company will expand GMP-compliant manufacturing facilities to increase capacity and enhance product quality.
The Founder, Chairman and Executive Director of Lepu Biopharma Co., Ltd. Dr. Pu Zhongjie said, "Since our inception, Lepu Biopharma focuses on the development of innovative drugs, the design and well-establishment of pipeline, we have established an integrated end-to-end platform across drug discovery, clinical development and CMC and GMP-compliant manufacturing. As an innovation-driven biopharmaceutical company leveraging an internationally integrated research and development system, we are committed to fulfilling current medical needs. Lepu Biopharma has solid R&D capabilities, advanced development platforms and comprehensive pipeline, we will the hold future trend and of the whole industry, use our competitive strengths to keep Lepu Biopharma's status in the market and maxmize the created value for shareholders and investors."
Copyright 2022 ACN Newswire. All rights reserved. www.acnnewswire.comThe biopharmaceutical company focusing on oncology therapeutics - Lepu Biopharma Co., Ltd. ("Lepu Biopharma" or the "Company", stock code: 2157), today announced the proposed listing of its shares on the Main Board of The Stock Exchange of Hong Kong Limited ("Hong Kong Stock Exchange").
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