Top 5 Target	Count

PCSK9(Proprotein convertase subtilisin kexin type 9)	1
SARS-CoV-2 3CLpro(SARS-CoV-2-3C-like-proteinase)	1
TLR(Toll-like receptor)	1
gp41(Transmembrane glycoprotein gp41)	1

Drugs associated with Frontier Biotechnologies, Inc. (China)

Albuvirtide

Target

gp41

Mechanism

gp41 inhibitors [+1]

Active Org.

Frontier Biotechnologies, Inc. (China)

Originator Org.

Frontier Biotechnologies, Inc. (China)

Active Indication

HIV Infections

Inactive Indication

Acquired Immunodeficiency Syndrome

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date23 May 2018

Bofutrelvir

Target

SARS-CoV-2 3CLpro

Mechanism

SARS-CoV 3CLpro inhibitors

Active Org.

Frontier Biotechnologies, Inc. (China)

Originator Org.

Shanghai Institute of Materia Medica Chinese Academy of Sci [+1]

Active Indication

COVID-19

Inactive Indication-

Drug Highest PhasePhase 2/3

First Approval Ctry. / Loc.-

First Approval Date-

Teropavimab

Target

HIV envelope protein gp120

Mechanism

HIV envelope protein gp120 inhibitors

Active Org.

National Institutes of Health [+2]

Originator Org.

The Rockefeller University [+1]

Active Indication

HIV Infections

Inactive Indication

Acquired Immunodeficiency Syndrome

Drug Highest PhasePhase 2

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with Frontier Biotechnologies, Inc. (China)

CTR20242378 / CompletedNot Applicable

洛索洛芬钠贴剂人体生物等效性研究

[Translation] Study on the bioequivalence of loxoprofen sodium patch in healthy volunteers

主要目的：采用单中心、随机、开放、两制剂、双周期交叉试验设计，比较空腹给药条件下，前沿生物药业（南京）股份有限公司提供的洛索洛芬钠贴剂（规格：100 mg/贴（10 cm×14 cm）；受试制剂T）与Lead Chemical Co., Ltd持证的洛索洛芬钠贴剂（规格：100 mg/贴（10 cm×14 cm）；参比制剂R）在中国健康人群中吸收程度和吸收速度的差异，评价两种制剂的生物等效性。次要目的：1）评价受试制剂与参比制剂在中国健康受试者中的安全性；2）评价受试制剂与参比制剂在中国健康受试者用药过程中的黏附性；3）评价受试制剂与参比制剂对中国健康受试者的皮肤刺激性。

[Translation]

Primary objective: To compare the differences in the absorption extent and absorption rate of loxoprofen sodium patch (specification: 100 mg/patch (10 cm×14 cm); test preparation T) provided by Frontier Biopharmaceuticals (Nanjing) Co., Ltd. and loxoprofen sodium patch (specification: 100 mg/patch (10 cm×14 cm); reference preparation R) certified by Lead Chemical Co., Ltd. in Chinese healthy population under fasting conditions, and to evaluate the bioequivalence of the two preparations. Secondary objectives: 1) To evaluate the safety of the test preparation and the reference preparation in Chinese healthy subjects; 2) To evaluate the adhesion of the test preparation and the reference preparation during the medication process of Chinese healthy subjects; 3) To evaluate the skin irritation of the test preparation and the reference preparation on Chinese healthy subjects.

Start Date24 Jul 2024

Sponsor / Collaborator

Frontier Biotechnologies, Inc. (China)

NCT06510413 / Not yet recruitingPhase 1

An Bioequivalence Study of Loxoprofen Sodium Patches in Chinese Healthy Volunteers

This study was a single-center, randomized, open-label, two-agent, two-cycle, double-cross bioequivalence trial.

Start Date01 Jul 2024

Sponsor / Collaborator

Frontier Biotechnologies, Inc. (China)

NCT05675072 / RecruitingPhase 2/3

A Phase II/III,Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of FB2001 for Inhalation in Patients With Mild to Moderate COVID-19

This study is a double-blind,randomized,placebo-controlled study to evaluate the efficacy and safety of FB2001 for Inhalation in patients with mild to moderate Coronavirus Disease 2019(COVID-19). A total of about 1336 subjects are planned to be enrolled. The subjects will be randomized in a 1:1 ratio to FB2001 group or placebo group while both receiving standard of care treatment.

Start Date04 Jan 2023

Sponsor / Collaborator

Frontier Biotechnologies, Inc. (China)

100 Clinical Results associated with Frontier Biotechnologies, Inc. (China)

0 Patents (Medical) associated with Frontier Biotechnologies, Inc. (China)

Literatures (Medical) associated with Frontier Biotechnologies, Inc. (China)

01 Feb 2024·Naunyn-Schmiedeberg's Archives of Pharmacology

Comparison of pharmacokinetics and safety of albuvirtide in healthy subjects after intravenous drip and bolus injection

Article

Author: Qin, Huiling ; Xie, Dong ; Yao, Cheng ; Yu, Shuchang ; Ye, Jun ; Liu, Yuantao ; Hu, Wei ; Hu, Min ; Zhang, Wei

Albuvirtide (ABT) is the first long-acting HIV fusion inhibitor developed in China, blocking the invasion of HIV-1 virus into target cells. This study aimed to compare the pharmacokinetics (PK), tolerability, and safety of ABT following a single intravenous (IV) bolus injection or intravenous drip in healthy Chinese subjects. A single-center, randomized, open-label, single-period, parallel phase I clinical trial was conducted. Thirty subjects were randomly divided into three groups in a ratio of 1:1:1. After an overnight fast, all subjects received a single dose of 320 mg ABT either by intravenous drip for 45 min (group A) or bolus injection for 0.5 min (group B), or bolus injection for 3 min (group C). ABT plasma concentrations were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Non-compartmental analysis was used to evaluate PK parameters. The median time to reach maximum concentration was 0.75 h in group A and 0.16 h in both groups B and C. Elimination half-life, mean residence time, apparent clearance, and apparent volume of distribution were similar among the three groups. The 90% confidence intervals (CI) of geometric mean ratios of PK parameters for groups B and C relative to group C were within 85-120%. All adverse events (AEs) reported in this study were mild, according to the CTCAE guidelines and the study investigator's judgement. ABT bolus injections for 0.5 min and 3 min are expected to be well tolerated and to exhibit similar PK characteristics as IV drip for 45 min, offering potential clinical benefits.

01 Dec 2022·Antiviral Research

In vitro and in vivo evaluation of the main protease inhibitor FB2001 against SARS-CoV-2

Article

Author: Yao, Cheng ; Xu, Ling ; Xie, Dong ; Li, Jian ; Tao, Xiangming ; Hu, Min ; Su, Haixia ; Xie, Xiong ; Dai, Wenhao ; Liu, Hong ; Jiang, Hualiang ; Shang, Weijuan ; Xu, Yechun ; Zhang, Leike

FB2001 is a drug candidate that targets the main protease of SARS-CoV-2 via covalently binding to cysteine 145. In this study, we evaluated the inhibitory activities of FB2001 against several SARS-CoV-2 variants in vitro and in vivo (in mice), and we also evaluated the histopathological analysis and immunostaining of FB2001 on lung and brain which have been rarely reported. The results showed that FB2001 exhibited potent antiviral efficacy against several current SARS-CoV-2 variants in Vero E6 cells, namely, B.1.1.7 (Alpha): EC₅₀ = 0.39 ± 0.01 μM, EC₉₀ = 0.75 ± 0.01 μM; B.1.351 (Beta): EC₅₀ = 0.28 ± 0.11 μM, EC₉₀ = 0.57 ± 0.21 μM; B.1.617.2 (Delta): EC₅₀ = 0.27 ± 0.05 μM, EC₉₀ = 0.81 ± 0.20 μM; B.1.1.529 (Omicron): EC₅₀ = 0.26 ± 0.06 μM and EC₅₀ = 0.042 ± 0.007 μM (in the presence of a P-glycoprotein inhibitor). FB2001 remained potent against SARS-CoV-2 replication in the presence of high concentrations of human serum, which indicating that human serum had no significant effect on the in vitro inhibitory activity. Additionally, this inhibitor exhibited an additive effect against SARS-CoV-2 when combined with Remdesivir. Furthermore, FB2001 significantly reduced the SARS-CoV-2 copy numbers and titers in the lungs and brains in vivo, and alleviated the pathological symptoms. In addition, FB2001 could alleviated local bleeding, erythrocyte overflow, edema, and inflammatory cell infiltration in brain tissue, and inhibitors reducing viral titers and improving inflammation in the brain have been rarely reported. A physiologically based pharmacokinetic model was established and verified to predict the FB2001 concentration in human lungs. When FB2001 was administered at 200 mg twice a day for 5 days, the observed C_{trough ss} in plasma and predicted C_{trough ss} of lung total concentration were 0.163 and 2.5 μg/mL, which were approximately 9 and 132-fold higher than the EC₅₀ of 0.019 μg/mL (0.042 μM) against Omicron variant. Taken together, our study suggests that FB2001 is a promising therapeutic agent in COVID-19 treatment and can be combined with remdesivir to achieve improved clinical outcomes. Owing to its good safety and tolerability in healthy human (NCT05197179 and NCT04766931), FB2001 has been approved for Phase II/III clinical trial (NCT05445934).

01 Sep 2022·Journal of Infection

Long-acting HIV fusion inhibitor albuvirtide combined with ritonavir-boosted lopinavir for HIV-1-infected patients after failing the first-line antiretroviral therapy: 48-week randomized, controlled, phase 3 non-inferiority TALENT study

Letter

Author: Wang, Hui ; Mu, Ting-Ting ; Zhang, Tong ; Wang, Hu ; Zheng, Yu-Huang ; Liu, Xia ; Lun, Wen-Hui ; Zhao, Min ; Sun, Li-Jun ; Dai, Li-Li ; Li, Ling-Hua ; Wang, Min ; Cai, Wei-Ping ; Sun, Cheng-Chen ; Chen, Yuan-Yuan ; Su, Bin ; Zhang, Fu-Jie ; Lu, Rong-Jian ; Zhao, Qing-Xia ; Sun, Yong-Tao ; Shao, Yi-Ming ; Liu, Li ; Zhu, Biao ; Xing, Hui ; Wang, Yao ; He, Yun ; Zhang, Yi-Hang ; Jiang, Tai-Yi ; Lu, Hong-Zhou ; Yao, Cheng ; Hu, Min ; Xie, Dong ; Xia, Wei ; Hu, Jian-Hua ; Wang, Mei-Xia ; Wu, Hao ; Chen, Jin-Feng ; Zheng, Qing-Shan ; Peng, Hai-Yan ; Yu, Jian-Hua

News (Medical) associated with Frontier Biotechnologies, Inc. (China)

08 Nov 2022

·www.prnewswire.com

Extremely Robust COVID-19 Clinical Trial Pipeline With 420+ Key Companies Expected to Change the Pace of the COVID-19 Treatment

COVID-19 clinical trial pipeline constitutes 420+ key companies continuously working towards developing 520+ COVID-19 vaccines and drugs, analyzes DelveInsight LAS VEGAS, Nov. 8, 2022 /PRNewswire/ -- DelveInsight's ' COVID-19 Competitive Landscape – 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline COVID-19 vaccines in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the COVID-19 competitive domain. Key Takeaways from the COVID-19 Pipeline Report Over 420+ COVID-19 companies are evaluating 520+ COVID-19 pipeline therapies in various stages of development, and their anticipated acceptance in the COVID-19 market would significantly increase market revenue. Leading COVID-19 companies such as Westvac Biopharma, Xenothera, Windtree Therapeutics, Vir Biotechnology, ViiV Healthcare, Verastem, VBL Therapeutics, Vasomune Therapeutics, Inc., Valneva, Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories, UNION Therapeutics, Trustem, Toscana Life Sciences, Throne Biotechnologies, Thirty respiratory Limited, Theravance Biopharma, TC BioPharm, Syntax for Science, S.L, SyneuRx, Swedish Orphan Biovitrum, Swedish Herbal Institute AB, Stemedica Cell Technologies, Staidson (Beijing) Biopharmaceuticals Co., Ltd, Sound Pharmaceuticals, Sorrento Therapeutics, SolAeroMed, SK Bioscience, Sinovac Biotech Co., Ltd, Sinocelltech, Shenzhen Kangtai Biological Products Co., Ltd., Shaperon, Senhwa Biosciences, Inc., Selva Therapeutics, Archivel Farma, R-Pharm, Rohto Pharmaceutical, Revimmune, Resverlogix Corporation, Restorbio, Resolve Therapeutics, Renibus Therapeutics, ReiThera, Regeneron Pharmaceuticals, RedHill Biopharma, Red de Terapia Celular, Reata Pharmaceuticals, Inc., Qurient Co, Quercis Pharma, PureTech, Pulmotect, PTC Therapeutics, Pluristem Ltd., Pliant Therapeutics, Pharming Technologies B.V., Pharmenterprises, Pharmamel S.L., Pharma Holdings, Pharco Pharmaceuticals, Pfizer, Petrovax, Paion UK Ltd., Ashvattha Therapeutics, Inc. (Orpheris), OPKO Health, Oncotelic Inc., National Resilience, Inc. (Ology Bioservices), Olatec Therapeutics LLC, Novavax, Novartis Pharmaceuticals, Notitia Biotechnologies Company, Noorik Biopharmaceuticals, Nobelpharma, Moderna, Moderna, MetrioPharm, Merck Sharp & Dohme Corp., Merck KGaA, Medicago Inc., Mallinckrodt, Mabwell (Shanghai) Bioscience Co., Ltd., Lifefactors Zona Franca, Leading BioSciences, Kiniksa Pharmaceuticals, Ltd., 3M, 4D Pharma, AbbVie, Apotex, AgelessRx, AgenTus Therapeutics, AiCuris, AlloVir, Apeiron Biologics, Bausch Health Americas, BeiGene, Biotest, Bio-Thera Solutions, Cadila Healthcare Limited, Cellenkos, Cellularity Incorporated, Chiesi Farmaceutici S.p.A., Clene Nanomedicine, Codagenix, Debiopharm, Direct Biologics, Eiger BioPharmaceuticals, Emergent Biosolutions, Enlivex Therapeutics, Evergreen Therapeutics, Faron Pharmaceuticals, Frontier Biotechnologies, FSD Pharma, Genentech, Inc., Globavir Biosciences, Grand Medical, Grifols Therapeutics LLC, Inotrem, Ionis Pharmaceuticals, Jazz Pharmaceuticals, Kamada, Kiadis Pharma, Medicine Invention, MedRegen LLC, Miltenyi Biomedicine, Natureceuticals Sdn Bhd, NeoImmune Tech, Neutrolis, Ology Bioservices, Oncovir, OPKO Health, Organicell Regenerative Medicine, and others are evaluating novel drugs for COVID-19 to improve the treatment landscape. Key COVID-19 pipeline therapies in various stages of development include XAV-19, Sinapultide, VIR-7831, Maraviroc, Duvelisib, VB 201, AV-001, VLA2001, T3 solution for injection, UNIKINON, UNI911, Umbilical cord derived mesenchymal stem cells, MAD0004J08, Stem Cell Educator therapy, RESP301, TD-0903, TCB008, Bemiparin, Pentarlandir™ UPPTA, Emapalumab, Kan Jang capsules, hMSC, BDB-001, Ebselen, COVI-DROPS| Placebo, STI-5656, COVI-AMG, PSC-04, S-1226, GBP510, SARS-COV-2 inactivated vaccine, SCTA01, SARS-CoV-2 Vaccine (Vero Cells), Inactivated, NuSepin, Silmitasertib, SLV213, RUTI® vaccine, Olokizumab + RPH-104, Mesenchymal stem cell (ADR-001), CYT107, Apabetalone, RTB101, RSLV-132, RBT-9, GRAd-COV2, REGN-COV2 Antibody Cocktail, ABC 294640, Upamostat, Mesenchymal Stromal Cells, Bardoxolone methyl, Telacebec, IQC-950AN, LYT-100, PUL-042, PTC-299, PLX-PAD, PLN-74809, Conestat alfa, Treamid, Melatonin, LTX-109, Selenium, Ramipril, PF-06650833, Polyoxidonium, Remimazolam, OP-101, Rayaldee, OT-101, ADM03820, OLT 1177, NVXCoV 2373, DFV890, Crizanlizumab, MAS-825, NBT-NM108, Ambrisentan, Sargramostim, Gam-COVID-Vac, mRNA-1283, mRNA-1273, MP1032, Molnupiravir, M5049, Covifenz, INOmax, MW33, COVID-19 convalescent plasma, LB1148, Mavrilimumab, and others. In October 2022, eFFECTOR Therapeutics announced the completion of enrollment for the second cohort of a three-cohort Phase Ib clinical trial of zotatifin in non-hospitalized adults with confirmed COVID-19 infection. In October 2022, Pfizer/BioNTech and Moderna's bivalent COVID-19 booster vaccines targeting the BA.4 and BA.5 subvariants of Omicron have been approved for use in children and adolescents in the United States. In October 2022, an intranasal formulation of AstraZeneca's widely used COVID-19 vaccine, Vaxzevria, failed at the first hurdle, with results from a phase I trial revealing that it was unable to stimulate a strong immune response to the virus. In September 2022, Bharat Biotech's Covid-19 vaccine candidate codenamed BBV154, which has now been rechristened iNCOVACC became the world's first intranasal Covid-19 vaccine to be granted emergency use authorization (EUA) after the Indian drug regulator approved it for a two-dose primary immunization of those aged 18 years and above. COVID-19 intranasal vaccine (BBV154) has proven to be safe, well-tolerated, and immunogenic in subjects in controlled clinical trials phase III In July 2022, Revive Therapeutics Ltd. is pleased to provide an update on the Company's U.S. Food & Drug Administration ("FDA") Phase III clinical trial (the "Study") (NCT04504734) to evaluate the safety and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19. The Company had unblinded the pre-dose selection data (the "Data") to potentially support the amended Study protocol with the new primary efficacy endpoints. The assigned unblinded statistician team is currently analyzing the Data, and the Company aims to submit the amended Study protocol to the FDA shortly thereafter. The proposed new primary efficacy endpoints may include the rate of sustained clinical resolution of symptoms of COVID-19, which addresses the shift in COVID-19 clinical outcomes observed over the course of the pandemic, and, therefore, to have more meaningful study endpoints for the FDA to consider for potential Emergency Use Authorization In April 2022, Direct Biologics, FDA approved the company to proceed with its Phase III clinical trial using its investigational EV drug, ExoFlo, to treat Acute Respiratory Distress Syndrome (ARDS) due to Covid-19. Direct Biologics is the first and only EV Company to receive FDA Phase III approval for an Investigational New Drug (IND) indication to date In April 2022, Direct Biologics announced that the US Food and Drug Administration (FDA) had awarded their EV drug product ExoFlo with a Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19. In March 2022, Akston Biosciences Corp and Biolexis, a division of Stelis Biopharma Ltd., entered into a licensing, manufacturing, and commercialization agreement for Akston's AKS-452, a protein subunit COVID-19 vaccine. Biolexis gained the right to manufacture and commercialize AKS-452 (branded as AmbiVax-CTM) in India and over 130 countries in Asia, Latin America, and Africa, largely covering the low-and-middle-income countries (LMICs). Biolexis will also leverage the capabilities of Strides Group for launching this vaccine across regions where the group has a deep market presence, and established relationships Request a sample and discover the recent advances in COVID-19 treatment @ COVID-19 Competitive Landscape Report COVID-19 Overview Coronavirus disease (COVID-19) is an infectious disease caused by the most recently discovered coronavirus, SARS coronavirus 2. (SARS-CoV-2). COVID-19 causes a respiratory illness similar to the flu. The COVID-19 symptoms include cough, fever, and difficulty breathing. The majority of people infected with the COVID-19 virus will experience mild to moderate respiratory illness and will recover without the need for special care. People over the age of 65 and those with underlying medical conditions such as cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illnesses. When an infected person coughs or sneezes, the COVID-19 virus is primarily transmitted through saliva or nasal discharge droplets. Discover more about COVID-19 testing @ New Treatment for COVID-19 COVID-19 Pipeline Analysis: Drug Profile Sargramostim: Nobelpharma Nobelpharma's drug Sargramostim is a synthetic version of a natural substance produced in the body. It is used to boost the body's production of white blood cells. Sargramostim is given to patients with decreased ability to produce white blood cells. It is also used in some medical procedures (for example, bone marrow/stem cell transplants). It is a supportive medication but does not aid cancer treatment. The product is currently in Phase II/III development for the treatment of COVID-19. Sotrovimab: Vir Biotechnology Vir Biotechnology's Sotrovimab is a monoclonal antibody that neutralizes SARS-CoV-2. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make resistance development more difficult. Sotrovimab, which incorporates Xencor, Inc.'s XtendTM technology, has also been designed to achieve high concentrations in the lungs for optimal penetration into SARS-CoV-2-affected airway tissues and to have an extended half-life. Discover more about the list of FDA-approved drugs for COVID-19 @ Antiviral Drugs for COVID-19 Treatment A snapshot of the COVID-19 Pipeline Drugs mentioned in the report: Learn more about the emerging COVID-19 pipeline therapies @ COVID-19 Clinical Trials Scope of the COVID-19 Competitive Landscape Report Coverage: Global Key COVID-19 Companies: Westvac Biopharma, Xenothera, Windtree Therapeutics, Vir Biotechnology, ViiV Healthcare, Verastem, VBL Therapeutics, Vasomune Therapeutics, Inc., Valneva, Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories, UNION Therapeutics, Trustem, Toscana Life Sciences, Throne Biotechnologies, Thirty respiratory Limited, Theravance Biopharma, TC BioPharm, Syntax for Science, S.L, SyneuRx, Swedish Orphan Biovitrum, Swedish Herbal Institute AB, Stemedica Cell Technologies, Staidson (Beijing) Biopharmaceuticals Co., Ltd, Sound Pharmaceuticals, Sorrento Therapeutics, SolAeroMed, SK Bioscience, Sinovac Biotech Co., Ltd, Sinocelltech, Shenzhen Kangtai Biological Products Co., Ltd., Shaperon, Senhwa Biosciences, Inc., Selva Therapeutics, Archivel Farma, R-Pharm, Rohto Pharmaceutical, Revimmune, Resverlogix Corporation, Restorbio, Resolve Therapeutics, Renibus Therapeutics, ReiThera, Regeneron Pharmaceuticals, RedHill Biopharma, Red de Terapia Celular, Reata Pharmaceuticals, Inc., Qurient Co, Quercis Pharma, PureTech, Pulmotect, PTC Therapeutics, Pluristem Ltd., Pliant Therapeutics, Pharming Technologies B.V., Pharmenterprises, Pharmamel S.L., Pharma Holdings, Pharco Pharmaceuticals, Pfizer, Petrovax, Paion UK Ltd., Ashvattha Therapeutics, Inc. (Orpheris), OPKO Health, Oncotelic Inc., National Resilience, Inc. (Ology Bioservices), Olatec Therapeutics LLC, Novavax, Novartis Pharmaceuticals, Notitia Biotechnologies Company, Noorik Biopharmaceuticals, Nobelpharma, Moderna, Moderna, MetrioPharm, Merck Sharp & Dohme Corp., Merck KGaA, Medicago Inc., Mallinckrodt, Mabwell (Shanghai) Bioscience Co., Ltd., Lifefactors Zona Franca, Leading BioSciences, Kiniksa Pharmaceuticals, Ltd., 3M, 4D Pharma, AbbVie, Apotex, AgelessRx, AgenTus Therapeutics, AiCuris, AlloVir, Apeiron Biologics, Bausch Health Americas, BeiGene, Biotest, Bio-Thera Solutions, Cadila Healthcare Limited, Cellenkos, Cellularity Incorporated, Chiesi Farmaceutici S.p.A., Clene Nanomedicine, Codagenix, Debiopharm, Direct Biologics, Eiger BioPharmaceuticals, Emergent Biosolutions, Enlivex Therapeutics, Evergreen Therapeutics, Faron Pharmaceuticals, Frontier Biotechnologies, FSD Pharma, Genentech, Inc., Globavir Biosciences, Grand Medical, Grifols Therapeutics LLC, Inotrem, Ionis Pharmaceuticals, Jazz Pharmaceuticals, Kamada, Kiadis Pharma, Medicine Invention, MedRegen LLC, Miltenyi Biomedicine, Natureceuticals Sdn Bhd, NeoImmune Tech, Neutrolis, Ology Bioservices, Oncovir, OPKO Health, Organicell Regenerative Medicine, and others Key COVID-19 Pipeline Therapies: XAV-19, Sinapultide, VIR-7831, Maraviroc, Duvelisib, VB 201, AV-001, VLA2001, T3 solution for injection, UNIKINON, UNI911, Umbilical cord derived mesenchymal stem cells, MAD0004J08, Stem Cell Educator therapy, RESP301, TD-0903, TCB008, Bemiparin, Pentarlandir™ UPPTA, Emapalumab, Kan Jang capsules, hMSC, BDB-001, Ebselen, COVI-DROPS| Placebo, STI-5656, COVI-AMG, PSC-04, S-1226, GBP510, SARS-COV-2 inactivated vaccine, SCTA01, SARS-CoV-2 Vaccine (Vero Cells), Inactivated, NuSepin, Silmitasertib, SLV213, RUTI® vaccine, Olokizumab + RPH-104, Mesenchymal stem cell (ADR-001), CYT107, Apabetalone, RTB101, RSLV-132, RBT-9, GRAd-COV2, REGN-COV2 Antibody Cocktail, ABC 294640, Upamostat, Mesenchymal Stromal Cells, Bardoxolone methyl, Telacebec, IQC-950AN, LYT-100, PUL-042, PTC-299, PLX-PAD, PLN-74809, Conestat alfa, Treamid, Melatonin, LTX-109, Selenium, Ramipril, PF-06650833, Polyoxidonium, Remimazolam, OP-101, Rayaldee, OT-101, ADM03820, OLT 1177, NVXCoV 2373, DFV890, Crizanlizumab, MAS-825, NBT-NM108, Ambrisentan, Sargramostim, Gam-COVID-Vac, mRNA-1283, mRNA-1273, MP1032, Molnupiravir, M5049, Covifenz, INOmax, MW33, COVID-19 convalescent plasma, LB1148, Mavrilimumab, and others. Dive deep into rich insights for drugs for COVID-19 treatment; visit @ COVID-19 Vaccines Table of Contents For further information on the COVID-19 guidelines, reach out @ COVID-19 Treatment Guidelines Related Reports COVID-19 Pipeline COVID-19 Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key COVID-19 companies, including Chiesi Farmaceutici S.p.A., Clene Nanomedicine, Codagenix, Debiopharm, Direct Biologics, Eiger BioPharmaceuticals, Emergent Biosolutions, Enlivex Therapeutics, Evergreen Therapeutics, Faron Pharmaceuticals, among others. Common Cold Market Common Cold Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key common cold companies, including Sanotize Research and Development, Orbis Biosciences, Exscientia, EURRUS Biotech, among others. Common Cold Pipeline Common Cold Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key common cold companies, including Sanotize Research and Development, Orbis Biosciences, Exscientia, EURRUS Biotech, among others. Common Cold Epidemiology Common Cold Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted common cold epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Acute Respiratory Distress Syndrome Market Acute Respiratory Distress Syndrome Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key acute respiratory distress syndrome companies, including MediciNova, Edesa Biotech, Light Chain Biosciences, Boehringer Ingelheim, Genentech, among others. Chronic Obstructive Pulmonary Disease Market Chronic Obstructive Pulmonary Disease Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key chronic obstructive pulmonary disease companies, including United Therapeutics, Verona Pharma PLC, AstraZeneca, Chiesi Farmaceutici S.p.A., GlaxoSmithKline, among others. Other Trending Reports Goitre Market | Thymus Cancer Market | US Healthcare Outlook Report | Venous Stenosis Market | Negative Pressure Wound Therapy Systems Market | Global Kinase Inhibitor in Autoimmune Diseases Market | Metrorrhagia Market | Dysfunctional Uterine Bleeding Market | Hypereosinophilic Syndrome Market | Age-related Vision Dysfunction Market | Dental Lasers Market | CRISPR Therapies Pipeline Insight | Cell And Gene Therapy For Multiple Myeloma Market | Drug Hypersensitivity Market | Dysthymia Market | Persistent Depressive Disorder Market | Cancer Vaccines Market | Weight Loss/Weight Management (Obesity) Market | Food Allergy Market | Obsessive-Compulsive Disorder Market | Tumor Ablation Market | Physiotherapy Equipment Market | Chimeric Antigen Receptor (CAR) T-Cell Therapy Market | Anti-hypertension Market | Radiofrequency Ablation Devices Market | Global Messenger RNA (mRNA)-based Vaccines and Therapeutics Market | Gastro Intestinal Bleeding Market | Trastuzumab Biosimilars Insight | Varicose Veins Market | Germ Cell Tumor Market | Intracardiac Echocardiography Devices Market | India Healthcare Report | Crows Feet Market | Seborrhoeic Dermatitis Market | Injectable Drug Delivery Devices Market | Structural Heart Devices Market | Substance (Drug) Abuse Market | Insulin Glargine Biosimilar Insight Related Healthcare Blogs Increasing COPD Prevalence ARDS Market Outlook Emerging ARDS Therapies About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. Connect with us at LinkedIn Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

VaccineGene TherapyAntibodyBiosimilarCell Therapy

09 Aug 2022

·www.prnewswire.com

FRONTIER BIOTECHNOLOGIES ANNOUNCES POSITIVE PHASE 1 RESULTS OF ITS FIRST CORONAVIRUS MAIN PROTEASE (MPRO) SMALL MOLECULE INHIBITOR, LAYING FOUNDATION FOR THE TREATMENT OF ACUTE AND LONG COVID

ATLANTA, Aug. 8, 2022 /PRNewswire/ -- Frontier Biotechnologies, a biopharmaceutical company focused on the discovery, development and dissemination of innovative medicines that improve patient health, announced positive results from the Phase 1 clinical trial of its drug candidate, FB2001 – a small molecule inhibitor of coronavirus main protease (Mpro) – in healthy adult volunteers. Continue Reading Presentation by Michael Hu, Chief Medical Officer of Frontier Biotechnologies Poster presented at the 11th International Conference on Emerging Infectious Diseases (ICEID) The data, presented today at the poster session of the 11th International Conference on Emerging Infectious Diseases (ICEID), showed FB2001 to be safe and well tolerated among trial participants. Adverse events reported during the trial were mostly mild-to-moderate in severity, with no significant differences observed between participants in the Chinese and American study centers. "We are pleased by the positive results from FB2001's phase 1 trial. It is a significant milestone for us and the healthcare community", said Dr CJ Wang, Chief Executive Officer of Frontier Biotechnologies. "This promising result will spur us on to strive for success in later-stage trials. We believe that the work done at Frontier Biotech can elevate our efforts in the fight against COVID-19 in China and abroad." A total of 120 participants (80 Whites in the US and 40 Chinese in China) received intravenous infusions of FB2001 at either single doses from 5 mg to 400 mg, or multiple doses of 30 mg to 400 mg daily for 5 days. The key findings from the study are as follows: FB2001 was safe and well tolerated up to 400 mg per day Without using a pharmacokinetic enhancer, FB2001 exhibited plasma and lung drug concentration above the in vitro antiviral EC50 value. No significant difference was observed between Chinese and American populations. The results from the Phase 1 trial build on preclinical in vivo data of FB2001, where the drug was observed to reduce viral loads in both the lung and brain tissues of mice. Pharmacokinetic data obtained from preclinical studies showed significantly higher concentration of FB2001 in the lung compared to plasma. "FB2001 has demonstrated in vivo antiviral activity in the lung and brain tissue of SARS-CoV-2 mouse model without the need for pharmacokinetic boosting. Therefore, it holds great promise as a treatment for acute COVID-19 as well as long-COVID, both of which will be evaluated in further follow-up studies", said Dr Jay Lalezari, MD, Medical Director of Quest Clinical Research in San Francisco. The current intravenous formulation of FB2001 is ideal for hospitalized patients with its rapid onset of action and is suited for patients with dysphagia or other problems with swallowing. Working with clinical research organizations, regional regulatory agencies, and local clinical centers, Frontier Biotechnologies has started a pivotal Phase 2/3 study (BRIGHT trial) to enroll about 1,200 hospitalized patients in hundreds of clinical centers worldwide. "The phase 1 data were really promising", said Dr Michael Hu, Chief Medical Officer of Frontier Biotechnologies, "and we are confident to carry out the pivotal trial to explore the utility of the drug in reducing the time to recovery in hospitalized patients due to COVID-19." Frontier Biotechnologies is also developing a pulmonary formulation of FB2001 that could be used in out-patient setting for the treatment of mild Covid-19, as well as for post exposure prophylaxis. When inhaled directly into the respiratory tract and lungs, the tissue concentration of FB2001 is much higher than that in plasma; hence, the onset of action and viral clearance could potentially be faster than that of oral therapy . About Frontier Biotechnologies Founded in 2013, Frontier Biotechnologies Inc. ("Frontier Biotech") is a commercial-stage biopharmaceutical company headquartered in China with global vision and world-class competitiveness. Frontier Biotech is committed to discovering, development, manufacturing, and commercialization of innovative medicines that improve patient health.

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