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Eisai: Latest Findings on Lecanemab Presented at AD/PD 2022 Annual Meeting
Four key symposium presentations explored how lecanemab's clinical efficacy data, overall amyloid-related imaging abnormality (ARIA) rates, biomarker relationships to clinical outcomes, potential dosing regimens, and administration have the potential to benefit people living with early AD.
1. Science of the Amyloid Cascade and Distinct Mechanism of Action (MoA) of Lecanemab
- BioArctic's Professor Lars Lannfelt presented the science of the amyloid cascade and studies evaluating lecanemab's distinct binding profile to antibodies created from patented sequences of two other clinical antibodies, aducanumab and gantenerumab. The three antibodies have different binding profiles to Abeta species. All three antibodies bind to fibrils, but with different selectivity. Lecanemab was the strongest Abeta binder and prefers protofibrils. Lecanemab's binding profile is critical to enriching our understanding of the features in clinical outcomes and safety. BioArctic has had a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of AD.
2. Key Trial Design Aspects and Clinical Outcomes of the Lecanemab Phase 2b (Study 201) Trial and Open-Label Extension (OLE) in Early AD
- Innovative Bayesian Adaptive Randomization Design and Dose Regimen-Finding Study with OLE - Study 201 (published by Eisai in Alz Res Therapy 13;21) was prospectively designed as a blinded 18-month study. To accelerate the development program, Eisai used a Bayesian adaptive design with a prespecified 12-month Bayesian primary endpoint in addition to the prespecified traditional analysis at the end of the 18-month treatment period. The OLE evaluated the long-term safety and tolerability of lecanemab and the effect of lecanemab on amyloid PET over 12 months of treatment, which looked at treatment naive patients (those on placebo during the core study) and those patients who had previously been treated with lecanemab, including earlier time points (3 and 6 months) than in the core phase (12 and 18 months). Eisai's study design provided the opportunity to explore the biomarker and clinical effects of stopping and restarting lecanemab across five years of disease trajectory.
- Rapid and Thorough Amyloid Clearance Correlates with Clinical Benefit - By using the Bayesian study design across a broad range of doses, researchers were able to efficiently and effectively identify the most effective dose, 10 mg/kg biweekly, to produce rapid and thorough amyloid clearance and potential clinical efficacy. Of the approximately 12 treatment-naive patients in the OLE (those who received placebo in the Core study), more than 40 percent were amyloid negative as early as 3 months and more than 80% were amyloid negative by 12 months as measured by PET image (visual read).(1) The OLE results are consistent with core phase results in which 65% were amyloid negative at 12 months(1) and 81% of participants were amyloid negative at 18 months as measured by PET image (visual read) in 161 subjects treated with 10 mg/kg biweekly dose. Robust amyloid reduction in those receiving lecanemab in the Core study was maintained while off-treatment over the Gap period. Despite the small number of participants in the OLE, findings help confirm the results from the Core study: lecanemab rapidly and thoroughly cleared amyloid plaque from the brain. Study 201 established 10 mg/kg biweekly as the most effective dose of lecanemab based on ADCOMS. Lecanemab could potentially be administered at 10mg/kg on the first day of treatment and continue at biweekly intervals without titration.
ARIA Incidence, Frequency, Severity and Modeling
ARIA-E is an important adverse event of amyloid-lowering therapies that is critical to monitor and manage during treatment.
Study 201 Core ARIA-E Rates
ARIA-E was observed in allele groups administered 10 mg/kg biweekly at the following rates: overall ApoE4 carriers 14.3% (7/49), ApoE4 carriers homozygous 50.0% (5/10), ApoE4 carriers heterozygous 5.1% (2/39) and ApoE4 non-carriers 8.0% (9/112). The overall ARIA-E rate in the Core study was 9.9% (16/161) of patients treated with lecanemab 10 mg/kg biweekly compared with 0.8% (2/245) of placebo patients.
Study 201 OLE ARIA-E Rates
Although ApoE carriers were underrepresented in the 10 mg/kg biweekly group in Study 201 Core, all participants entering Study 201 OLE (69.4% of whom were ApoE4 carriers) were treated with 10 mg/kg biweekly, and ARIA rates were consistent with those in the Core study. Forty-five participants who received placebo in the Core study joined the OLE. ARIA-E was observed in allele groups newly treated with 10 mg/kg biweekly in the OLE at the following rates: overall ApoE4 carriers 12.9% (4/31), ApE4 carriers homozygous 25.0% (1/4), ApoE4 carriers heterozygous 11.1% (3/27) and ApoE4 negative 0.0% (0/14). In the OLE study, overall ARIA-E rates were as follows: ApoE4 carriers 10.4% (13/125), ApoE4 carriers homozygous 14.3% (4/28), ApoE4 carriers heterozygous 9.3% (9/97) and ApoE4 non-carriers 1.8% (1/55).
Study 201 Core and OLE Pooled ARIA-E Rates
In the Core and the OLE, ARIA-E was observed in allele groups administered 10 mg/kg biweekly at the following rates: ApoE4 carriers 13.8% (11/80), ApoE4 carriers homozygous 42.9% (6/14), ApoE4 carriers heterozygous 7.6% (5/66) and ApoE non-carriers 7.1% (9/126). The overall ARIA- E rate was 9.7% (20/206) of patients treated with lecanemab 10 mg/kg biweekly.
ARIA-E Rates Frequency and Severity
In the Core study and OLE, the majority of ARIA-E events occurred within the first 3 months of treatment (75% [12/16]) and resolved within 4 months of onset. For the majority of patients, the radiographic severity was mild or moderate; severe radiographic severity was reported in 1.2% (2/161) of patients. The majority of ARIA-E was asymptomatic; with symptomatic ARIA-E reported in 1.9% (3/161) of patients. Symptoms reported in association with ARIA-E included headache, visual disturbance, confusion, aphasia. There has been a single case of ARIA-E associated with seizure in the Core study and OLE to date.
Exposure-Response Model Predicted and Observed ARIA-E vs. Cmax for APOE 4
The PK/PD exposure-ARIA-E model was developed from the Core study utilizing data from all doses and demonstrated that ARIA-E is driven primarily by Cmax. The ApoE4 genotype is a significant covariate in the model. The PK/PD model predicted ARIA-E by Cmax at the 10 mg/kg biweekly dose in the Core study by allele group as follows: ApoE4 carriers homozygous 22.5%, ApoE4 carriers heterozygous 6.8% and ApoE4 non-carriers 5.4%. In addition to the modeling predicting ARIA-E by Cmax in the Core study, it confirmed the observed ARIA-E in the OLE. Given the small data set for ApoE4 homozygous patients, this will be evaluated in Eisai's Phase 3 Clarity AD clinical trial.
ARIA-H Rates
In the Core study, the incidence was higher in ApoE4 homozygous carriers than in ApoE4 heterozygous carriers and non-carriers. ARIA-H was observed in 6.2% (10/161) of patients treated with lecanemab 10 mg/kg biweekly compared with 4.9% (12/245) of placebo patients. The rate of ARIA-H was higher in ApoE4 carriers (12.2% [6/49] vs placebo 5.2% [9/174]), than in ApoE 4 non- carriers (3.6% [4/112] vs placebo 4.2% [3/71]). All patients with microhemorrhage or superficial siderosis were asymptomatic. There has been one report of symptomatic cerebral macrohemorrhage. These data are hypothesis-generating and will be further evaluated in Clarity AD.
3. Phase 2b (Study 201) Lecanemab Early AD Study Biomarker Results, Correlations with Clinical Outcomes and Potential Less-Frequent Maintenance Dosing
- Abeta42/40 and P-Tau181 are plasma biomarkers that signal sequential changes in AD progression. Lecanemab has an effect on these plasma biomarkers as amyloid plaque reduction is related to soluble amyloid and P-Tau. Lecanemab has a dose- and time-dependent reduction of amyloid plaques with a correlated increase in plasma Abeta42/40 and a decrease in plasma P-Tau181. Changes in plasma Abeta42/40 and P-Tau18 also correlate with change from baseline Clinical Dementia Rating scale Sum of Boxes (CDR-SB). In the Core study, a correlation in change from baseline in amyloid PET SUVR and plasma Abeta42/40 ratio and plasma P-tau181 was observed at 18 months, indicating that plasma biomarkers could potentially help with measuring clinical changes.
- When lecanemab treatment was discontinued at the end of the Core study, changes in the plasma Abeta42/40 (47%), P-Tau18 (24%), and amyloid PET SUVR (21%), gradually began to reverse, suggesting stopping therapy prematurely may potentially allow re-accumulation of pathology. Less frequent maintenance treatment to prevent re-accumulation may be possible based on data and modeling. Eisai will further explore maintenance dosing in the subcutaneous substudy of the Study 201 OLE, which will evaluate alternative dosing every 4 weeks or every 12 weeks.
- Increasing strong evidence highlights the role of amyloid plaques in triggering tau dysregulation and researchers optimize tau therapeutics by removing a key driver of tau dyshomeostasis (amyloid). For this reason, the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, selected lecanemab as the backbone anti-amyloid therapy for anti-tau combination for the ongoing component of the Tau NexGen clinical study, which continues enrollment efforts.
4. Update on Lecanemab Clinical Development, Including New Subcutaneous Formulation
Eisai's Dr. Michael Irizarry Senior VP of Clinical Research and Deputy Chief Clinical Officer presented updates on key lecanemab clinical trials.
- Clarity AD Phase 3: The innovative Bayesian design of lecanemab's robust dose-ranging Phase 2b study allowed Eisai to design the Phase 3 confirmatory Clarity AD clinical trial to verify lecanemab's clinical efficacy and safety in early AD. Enrollment is complete with 1,795 participants globally. Additionally, Eisai's recruitment strategy for the Clarity AD clinical trial ensured greater inclusion of ethnic and racial populations in the U.S., resulting in approximately 25% of the total U.S. enrollment including Hispanic (22.5%) and African American (4.5%) persons living with early AD, which mirrors the U.S. Medicare population. The readout will occur in Fall 2022.
- AHEAD3-45 Phase 3 Study in Preclinical AD: As of March 2022, there were over 2,900 people screened, resulting in 287 participants enrolled.
- Clarity AD Subcutaneous Substudy: Eisai is developing a subcutaneous formulation of lecanemab with the potential to be administered at home by the patient or caregiver via an auto-injector with a more rapid administration than the IV formulation (<15 second SC injection versus ~1h infusion). PK/PD modeling of Study 201 suggests that the average lecanemab concentration (Cave) predicts amyloid clearance while the maximal lecanemab concentration (Cmax) predicts ARIA-E rate. Since subcutaneous administration results in a blunted Cmax, the SC dose with comparable Cave to 10 mg/kg IV is hypothesized to have similar amyloid reduction with potentially reduced incidence of ARIA-E relative to IV but less than half the ARIA- E rate as IV. Eisai is evaluating the SC formulation in the Clarity AD OLE.
"The invited lecanemab presentations at AD/PD provide new and exciting insights into how the mechanism of action of late-stage anti-amyloid antibodies differ and how that may help simplify the patient journey by offering a less frequent dosing regimen while providing long-term benefit," said Lynn Kramer, M.D., Chief Clinical Officer, Neurology Business Group, Eisai. "Eisai aims to bring these potential innovations to people living with early AD and healthcare providers as quickly as possible as we work to fulfill our human health care mission."
Lecanemab was granted Breakthrough Therapy and Fast Track designations by the U.S. Food and Drug Administration (FDA) in June and December 2021, respectively. Eisai anticipates completing lecanemab's rolling submission of a Biologics License Application for the treatment of early AD to the FDA under the accelerated approval pathway. Eisai expects to complete this rolling submission in the first quarter of our fiscal year 2022, which begins April 1, 2022. Eisai initiated a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data of lecanemab under the prior assessment consultation system in Japan in March 2022. Additionally, the readout of the Phase 3 confirmatory Clarity AD clinical trial will occur in the Fall of 2022. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.
This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such an investigational agent will successfully complete clinical development or gain health authority approval.
(1) Swanson C.et all, November, 9-12, 2021, Clinical Trials On Alzheimer's Disease Annual Meeting, Lecanemab: An Assessment of the Clinical Effects, the Correlation of Plasma Abeta 42/40 Ratio With Changes in Brain Amyloid PET SUVr, and Safety from the Core and Open Label Extension of the Phase 2 Proof-of- Concept Study, BAN2401-G000-201, in Subjects With Early Alzheimer's Disease.
Contacts:
MEDIA CONTACT:
Eisai Co., Ltd.
Public Relations Department
+81-(0)3-3817-5120
Eisai Inc. (U.S.) Libby Holman
+ 1-201-753-1945
[email protected]
INVESTOR CONTACT:
Eisai Co., Ltd.
Investor Relations Department
+81-(0)70-8688-9685
MEDIA CONTACT:
Biogen Inc. Ashleigh Koss
+ 1-908-205-2572
[email protected]
INVESTOR CONTACT:
Biogen Inc. Mike Hencke
+ 1-781-464-2442
[email protected]
For more information, visit https://www.eisai.com/news/2022/pdf/enews202221pdf.pdf.
Copyright 2022 JCN Newswire. All rights reserved. www.jcnnewswire.comEisai Co., Ltd. and Biogen Inc. announced today that the latest findings on lecanemab, an investigational anti-amyloid-beta (Abeta) protofibril antibody being developed for the treatment of early Alzheimer's disease (AD), were presented at the Abeta Targeted Therapies in AD 2 Symposium at the 2022 International Conference on Alzheimer's and Parkinson's Diseases (AD/PD) March 15-20 in Barcelona, Spain and virtually.
Moderna Will Develop mRNA Vaccines for 15 of the World’s Worst Diseases
IND Application for SinoMab’s First-in-Class Asthma Therapeutic Product SM17 Accepted by FDA
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SM17 is the world's first monoclonal antibodies targeting IL17BR co-developed by SinoMab and LifeArc (a medical research charity based in the United Kingdom). SM17 has a wide range of indications, including indications with large market volumes such as asthma and diseases with high mortality rates such as idiopathic pulmonary fibrosis. Comparing to other products on the market, SM17 enjoys differentiation advantages. With the preclinical data and unique mechanism of action of SM17, Company believes that SM17 potentially has a broader and more beneficial effect on asthma treatment than other approved biologics.
In the global market, the number of asthma patients is gradually increasing and is expected to reach 247.5 million by 2023 and further increase to 267.7 million by 2030. The number of asthma patients in the PRC is increasing at a greater pace than the global rate and is forecasted to reach 25.6 million by 2023 and further increase to 27.8 million by 2030. In terms of market size, the global asthma market is projected to reach US$25.1 billion by 2023 and US$34.6 billion by 2030. However, the asthma market in the PRC is expected to reach RMB36.4 billion by 2023 and RMB65.0 billion by 2030. In terms of treatment options, traditional asthma treatment is based on inhaled corticosteroid, but they are prone to serious adverse effects, especially in adolescents. Drug resistance can also develop if used for a long time. The introduction of SM17 is expected to provide a better treatment option in terms of the balance of efficacy and safety.
Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab said that: "following the acceptance of the IND application for SN1011 for the treatment of multiple sclerosis by the NMPA, the acceptance of the SM17 IND application by the FDA fully demonstrates the efficient execution of the Company's new drug R&D program. There is still an unmet medical need for additional effective therapies, particularly for patients who do not respond to current treatments. We are therefore confident in the enormous prospects of SM17's clinical development. Our core products, including SM03, SN1011 and SM17, is making progress on the clinical R&D smoothly, driving the Company moving steadily towards commercialization. In the future, we will accelerate our projects implementation to bring benefits to patients and create value for shareholders through innovation."
About SM17
SM17 is known to be the world's first humanized, IgG4-k monoclonal antibody for new drug development, which targets IL-17RB. And IL-17RB is a type-I single transmembrane glycoprotein belonging to IL-17 receptor family. The binding of SM17 to IL-17RB could suppress Th2 immune responses induced by a category of cytokines called "alarmin", which has shown to be implicated in the pathogenesis of allergic disease and airway viral responses. Alternative approach targeting upstream mediators of the Th2 inflammatory cascade, such as "alarmins", is expected to have a broader effect on airway inflammation and to provide more effective asthma control than currently available therapies, and products with similar mechanism of action as SM17 have been approved by FDA.
About SinoMab BioScience Limited
SinoMab BioScience Limited (stock code: 3681.HK) is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases. The Company's flagship product SM03 is a potential global first-in-target mAb against CD22 for the treatment of rheumatoid arthritis (RA) and is currently in Phase III clinical trial for rheumatoid arthritis in China, which has been recognized as one of the significant special projects of Significant New Drugs Development of the Twelfth Five-Year Plan Period and the Thirteenth Five-Year Plan Period. In addition, the Company possesses other potential first-in-target and first-in-class drug candidates, some of which are already in clinical stage, with their indications covering rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), pemphigus vulgaris (PV), non-Hodgkin's lymphoma (NHL), asthma, and other diseases with major unmet clinical needs.
Copyright 2022 ACN Newswire. All rights reserved. www.acnnewswire.comSinoMab BioScience Limited ("SinoMab" or the "Company", together with its subsidiaries, the "Group", stock code: 3681.HK), a Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases
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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