PRESENTING COMPANIES

Targovax (OSE:TRVX, www.targovax.com) is a clinical stage biotechnology company developing immune activators to target hard to treat solid tumors. Immuno-oncology is currently one of the fastest growing therapeutic fields in medicine. Targovax’s lead product candidate, ONCOS-102, is a genetically modified oncolytic adenovirus, which has been engineered to selectively infect and replicate in cancer cells. It has been shown to activate the immune system to generate tumor-specific immune responses. In phase I trials, ONCOS-102 induced both local and systemic innate and adaptive immune activation, which has been associated with clinical benefit. ONCOS-102’s lead indication is mesothelioma, where the virus is currently being tested in a randomized phase II trial, with a phase Ib safety lead-in cohort. Another trial, in advanced melanoma, is expected to produce important proof of concept data for checkpoint inhibitor refractory patients within the next 6-12 months.

Targovax is also developing a neo-antigen cancer vaccine targeting tumors that express mutated forms of RAS – mutations known to drive cancer. The TG vaccine program has shown a signal of efficacy in a 32- patient trial with TG01 in resected pancreatic cancer. A next generation product candidate, TG02 is currently tested as monotherapy and will also be tested in combination with Keytruda® (an anti-PD1 Check point inhibitor, CPI).

Primary therapeutic area(s):  Immunotherapy

Phase of developmentPhase I/II

Product Description:  Targovax’s lead product candidate, ONCOS-102, is a genetically modified oncolytic adenovirus, which has been engineered to selectively infect and replicate in cancer cells. It has been shown to activate the immune system to generate tumor-specific immune responses. In phase I trials, ONCOS-102 induced both local and systemic innate and adaptive immune activation, which has been associated with clinical benefit. ONCOS-102’s lead indication is mesothelioma, where the virus is currently being tested in a randomized phase II trial, with a phase Ib safety lead-in cohort. Another trial, in advanced melanoma, is expected to produce important proof of concept data for checkpoint inhibitor refractory patients within the next 6-12 months.

Targovax is also developing a neo-antigen cancer vaccine targeting tumors that express mutated forms of RAS – mutations known to drive cancer. The TG vaccine program has shown a signal of efficacy in a 32- patient trial with TG01 in resected pancreatic cancer. A next generation product candidate, TG02 is currently tested as monotherapy and will also be tested in combination with Keytruda® (an anti-PD1 Check point inhibitor, CPI).

eTheRNA (www.etherna.beis a clinical stage developer of mRNA-based immunotherapies for cancer, focusing on therapies that activate the immune system by programming dentritic cells (DC) with synthetic mRNA. To date it has completed 4 clinical studies (Phase I and II) and has 3 studies underway. The company recently opened a new GMP facility which also provides contract manufacturing services. eTheRNA concluded a Series A financing in 2016 and is supported by a strong sector-specialised investor syndicate.

Primary therapeutic area(s):  eTheRNA immunotherapies is a clinical stage developer of mRNA-based immunotherapies for cancer, focusing on therapies that prepare and activate the immune system by programming dentritic cells (DC) with synthetic mRNA. It also has an interest in infectious disease therapies.

Phase of development:  Clinical Development – phase I/II.

Astrocyte (https://www.astrocytepharma.com) is a small asset-centric CNS drug development company based in Cambridge, MA, USA.  The company has raised $4.7M in private financing and been awarded $4M in NIH grants.

Primary therapeutic area(s):  Acute neurology including acute ischemic stroke (AIS), traumatic brain injury (TBI) and concussion, which are leading causes of death and disability worldwide.

Phase of development: Preclinical.  Efficacy demonstrated in porcine and rodent AIS/TBI models; exploratory toxicology studies completed; GMP manufacturing campaign in progress; US IND in Q4 2018.   AST-004 is a novel small molecule A3R agonist that activates mitochondrial energy production in astrocytes and promotes multiple intrinsic neuroprotective mechanisms.

Product DescriptionAST-004 is a novel small molecule A3R agonist that activates mitochondrial energy production in astrocytes and promotes multiple intrinsic neuroprotective mechanisms.

MVI (www.MadisonVaccines.com) MVI is a venture-funded Biotech company in Phase I and II clinical development with two DNA plasmid T-cell stimulating agents for men with all stages of prostate cancer (PC).  MVI has observed positive clinical data in a Phase I/II combination trial with anti-PD-1.   MVI plasmids also synergize with standard-of care PC drugs like Lupron and AR antagonists.  PC is the 5th leading cause of male cancer deaths in China where PC is responsible for a 5.5% mortality increase in the last decade and >60,000 new cases and >27,000 deaths from PC each year.    MVI is an ideal partner for Chinese companies seeking to differentiate their PD-1 inhibitors in the lucrative and growing PC market, where commercial anti-PD-1  monotherapies have failed to gain approval due to limited efficacy.  MVI molecules are safe, simple to administer and are manufactured at a low COG. MVI is seeking partnership with anti-PD-1 sponsors.

Primary therapeutic area(s):  Prostate Cancer

Phase of development: Phase 1, Phase 2

Product Description: MVI products are plasmid DNA molecules encoding specific antigens.  MVI-816 encodes prostatic acid phosphatase (PAP), a prostate-specific protein.  MVI-118 encodes the ligand binding domain of the human androgen receptor, the key molecular driver of prostate cancer. Both candidates are simple to manufacture and have excellent stability.  MVI agents are administered as a 100-microgram intradermal dose using a tuberculin syringe.    Both MVI plasmid agents have demonstrated excellent pre-clinical and human clinical safety.  MVI agents induce antigen-specific CD4+ and CD8+ T-cell responses to their targets when dosed intradermally and increase tumor-infiltrating lymphocytes (TILs) in prostate tumors.  MVI plasmid DNA molecules are amenable to microneedle patch delivery systems that would further improve patient convenience.

HPBio (www.hpbio.co.kris a specialty biotech company focused on innovative cutting-edge technologies for analysis of toxic metabolites, biomarker proteins, bacteria, tumor cells, rare metals (such as Neodymium, Lithium), based on our ‘AptaCut & AptaLink’ technology. HPbio has demonstrated excellent results when it comes to addressing the biomarker proteins on the surface of cells. HPbio’s aptamer product can bring microvesicle carriers (liposomes, exosomes, lisosomes and hybridosome) very specifically to the target cells. HPBio has also filed multiple patents on new aptamer technology such as Aptablotting assay that involves direct and indirect aptamer recognition. HPBio’s unique assay platform supports the screening and design of aptatope for high sensitive diagnostic use. We would like to arrange a meeting with you at JPM to update the progress of our technology, ‘AptaCut & AptaLink’, as well as internal pipeline for out-licensing discussion, including Obesity, Allergy, Wound/Scar free healing, Neurodegenerative disease programs.

Primary therapeutic area(s): Obesity, Wound/Scar treat, Allergy, Neurodegenerative disease

Phase of development:  Preclinical

Product DescriptionHPBio is actively focusing on four indications, Obesity, Allergy, Wound/Scar free healing, Neurodegenerative disease.

Obesity program:

  • PPARgamma binding RNA aptamers
  • Adipocyte differentiation was over 80% inhibited and showed very reduced lipid accumulation

Allergy program:

  • Histamine binding DNA aptamers and HDC (Histidine decarboxylase) binding DNA aptamers
  • Antihistamines DNA aptamers bind to specifically to Histamine and shows 85% reduction values in clinical samples.

Wound/Scar free healing

  • Growth factors (Insulin, EGF, PDGF) receptor binding DNA aptamer
  • Growth factor agonist DNA aptamers has demonstrated exemplary results such as growth factor induced cell signaling activation.

Neurodegenerative disease

  • Establishment of In vitro BBB (Brain blood barrier)-SELEX set-up and Aptamer-exosome complexes
  • Development of Alzheimer’s disease target (Aβ, Tau) and Parkinson’s disease target (α-synuclein) binding aptamer for inhibiting protein plaques.
  • Aptamer- Exosome complexes can cross the permeable in vitro BBB.

Elasmogen (www.elasmogen.comdelivers next generation therapeutics called soloMERs that are small, robust, single-domain (multi-functional) and bind unique epitopes (increased potency).

Primary therapeutic area(s): Ophthalmology, oncology, inflammation, auto-immune diseases

Phase of development: Late pre-clinical

Product DescriptionPlatforms for de novo soloMER isolation, potent anti-inflammatory soloMERs (superior to Humira), anti-angiogenesis products and NDure for improved systemic half-life.

MGI Tech Co., Ltd. (MGI, http://www.mgitech.cn/), is a member of the BGI Group of companies, one of the world’s largest genomics organizations. As the leading manufacturer and developer of BGI’s proprietary NGS instrumentation, the global MGI organization provides comprehensive products and services for fully-automated, real-time, whole picture and lifelong genetic analysis in life science research. With the mission to develop and commercialize advanced life science tools for future healthcare, we are devoted to bringing innovative equipment and solutions to our customers and advancing precision medicine, agriculture and healthcare around the world.

Primary therapeutic area(s):  Cancer, prenatal, all health related diagnostics

Phase of development: Products on market

Product Description:  Efficient high throughput genome and transcriptome sequencing opens the door to a new era of understanding biology. It provides foundation for our knowledge leaps in biological and medical research, analogous to broadband internet. The recent launch of sequencing platform MGISEQ-T7 with significantly reduced-cost and ultra high-throughput marks the era of “broadband sequencing” that will profoundly affect our lives.

 Technology innovations incorporated in MGISEQ-T7 include i) DNBseq technology comprising unique PCR-free error-free DNA nanoball arrays based on linear DNA amplification and cPAS sequencing chemistry with negligible signal loss in hundreds of sequencing cycles, and ii) advanced biochemical, fluidics, and optical systems resulting in the best performance to date: the highest throughput and shortest turn-around time (6Tb of PE150 reads per 1-day run). DNBseq technology delivers high quality 35-200 base single or pair-end reads with low duplicate rate, higher coverage in GC rich regions, and increased accuracy in detection of diagnostic mutations, especially indels. In addition, DNBseq has no molecular índex swapping providing index mis-assignments as low as 1 part per million even with single indexing. MGISEQ-T7 utilizes a revolutionary quadruple flow cell staging, which enables multiple flow cells with different read lengths and applications to be independently processed in a single run. This unique design allows users to combine multiple applications based on specific demands. 

A first look of the impact of MGISEQ-T7 on sequencing workflow, throughout and cost, and exceptional data quality of the underlining DNBseq technology will be discussed for a wide range of applications such as WGS, deep sequencing on WES or cfDNA, epigenome sequencing, RNAseq and large targeted clinical panels to show the benefits of “broadband sequencing”.

Histogen (www.histogen.com) is a regenerative medicine company developing patented technologies that stimulate the body’s stem cells to regenerate tissues and restore youthful function.  

Primary therapeutic area(s):  Aesthetic products including hair growth, skin care, tissue augmentation and dermal fillers. Therapeutics including orthopedic indications such as cartilage formation and spinal disk repair, and wound healing.

Phase of development:

  • HSC660: Clinical Phase 2
  • Skin Care: Market
  • Other Applications: Preclinical

Product DescriptionHistogen’s lead product application is HSC660, a soluble formulation in clinical development as an injectable for hair regrowth.  

ProMIS (www.promisneurosciences.com) is a development stage biotechnology company developing antibody therapeutics selectively targeting toxic oligomers, the root cause of neurodegenerative diseases; Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and Parkinson’s disease (PD).

Primary therapeutic area(s):  Central nervous system diseases (CNS): Alzheimer’s disease, Parkinson’s disease, ALS

Phase of development: Preclinical development for Alzheimer’s, Parkinson’s and ALS

Product Description: PMN310: lead antibody therapeutic for Alzheimer’s disease selectively neutralizes the toxic oligomers of amyloid beta, widely considered a root cause of the disease. Preclinical studies demonstrate it blocks both the neurotoxicity and propagation of the toxic oligomers, without interfering with normal, non-toxic forms of amyloid beta.

Atom Bioscience (www.atombp.com/en/) founded in 2012 in China and mainly focused on new drug discovery and development on metabolic diseases and anti-cancer. The management team members are mainly from the US and have extensive experiences on pharmaceutical industry.

Atom Bioscience has completed A and A+ Rounds of financing. Investors are KAITAI Capital, YouChoose Capital, Ch-gemstone Capital and etc.

Primary therapeutic area(s):  ABP-671 from Atom Bioscience is under Phase 1 clinical trials in the US. ABP-671 is an inhibitor of renal urate transporter 1 (URAT1) whose function is to increase the excretion of uric acid by the kidneys. ABP-671 has demonstrated excellent efficacy at low dose in lowering serum uric acid levels and showed great pharmacokinetics (PK) in recent Phase 1 study. Its pre-clinical results showed that ABP-671 did not show any toxicity at 500 mg/kg of NOAEL both in rats and monkeys tox studies. ABP-671 may become the most potent and safe drug for the treatment of gout and hyperuricemia worldwide. Besides ABP-671, ABP-6016 showed remarkable potency for treatment of NASH with the maximum tolerated dose over 3 g/kg in mice. ABP-431, which greatly inhibited three types of cancers in nude mice, is under investigation for treatment of gastric cancer, colon cancer and breast cancer. Both compounds are under pre-clinical development, will enter into the clinical trials in 2020.

Phase of development:

  • ABP-671 for gout treatment is in phase 1 clinical trials in the US.
  • ABP-6016 for NASH treatment is under pre-clinical studies.
  • ABP-431 for anti-cancer is under pre-clinical studies.

Product Description:  Gout has over 40 million patients worldwide. The current medications do not meet the requirement of treatment of gout due to the severe side effects of these drugs. ABP-671 showed a great inhibition of hURAT1 whose function is to increase the excretion of uric acid by the kidneys. ABP-671 demonstrated great efficacy in the animal models, excellent safety profiles, good enzymatic stability, good PK and several other good characteristics in its pre-clinical studies. ABP-671 is currently under Phase 1 clinical trials in the US. It shows superior lowering serum uric acid in recent first human study, which is much better than current gout drugs including URAT1 inhibitors such as Benzbromarone and Zurampic, and Xanthine oxidase inhibitors like Allopurinol and Uloric (Febuxostat). ABP-671 has showed a good human PK. The NOAEL of ABP-671 both in monkeys and rats is 500 mg/kg. ABP-671 may become the most potent and safe drug for treatment of gout and hyperuricemia worldwide.

Viriom (https://www.viriom.com/) is a commercial and late-stage biotech company developing novel therapies and prophylactic medicines against HIV-1 and Hepatitis B Virus (HBV).

Viriom is developing breakthrough medicines that are effective and affordable with the ultimate goal of curing HIV and chronic HBV infections in both developing and developed countries.

Primary therapeutic area(s):  Viral infection (HIV and Hepatitis B virus)

Phase of development

  • Elpida®: authorized to market
  • NRTI VM2500: preclinical/IND

Product DescriptionElpida® (elsulfavirine), the best-in-class NNRTI that obtained first market authorization in 2017; novel fixed doze combination single pill regimens; low frequency (weekly) oral formulations; and long-acting injectable therapy and prophylaxis.

Viriom is also developing NRTI VM2500 – a highly potent prodrug of the antiviral tenofovir to treat HIV-1 and Hepatitis B patients. Viriom combines its extended release and long-acting injectable compounds with partnered therapies projecting curative potential.

Inivata (https://www.inivata.com/) Inivata is a leader in liquid biopsy. Its InVision® platform unlocks essential genomic information from a simple blood test to transform the care of cancer patients. The Company’s technology is based on pioneering research from the Cancer Research UK Cambridge Institute, University of Cambridge and backed by multiple high calibre publications. Its lead product, InVisionFirst™-Lung, is commercially available and provides molecular insights that enable clinicians to make more informed treatment decisions for NSCLC patients. Inivata is partnering with pharmaceutical and biotechnology companies on InVisionFirst™-Lung and its wider platform, which is applicable to a range of cancer types. The Company has a CLIA laboratory in Research Triangle Park, NC and laboratories in Cambridge, UK.

Primary therapeutic area(s):  Molecular diagnostics for lung cancer and other cancers

Phase of development:  Commercially available

Product Description:  InVisionFirstTM – Lung is a qualitative laboratory developed test that uses targeted advanced sequencing technology to detect single nucleotide variants (SNVs), copy number variants (CNVs), insertions and deletions (InDels) and structural variants in selected genes from DNA isolated from plasma samples from patients with non-small cell lung cancer (NSCLC). The test is intended to aid clinicians in treatment decisions for NSCLC patients.

InVisionSeqTM is a qualitative laboratory developed test that uses targeted advanced sequencing technology to detect single nucleotide variants (SNVs), copy number variants (CNVs), insertions and deletions (InDels) in selected genes from DNA isolated from plasma samples from patients.

GLAdiator Biosciences is a therapeutic company formed in 2018 based upon broad cancer targeting platform with drug development experts from Bayer and supported by world class scientific advisory board.

Primary therapeutic area(s):  Oncology

Phase of development: Pre-clinical

Product DescriptionCurrent cancer treatments lack effective targeting and suffer from limited efficacy and unwanted off target effects.  Using a platform discovered by Bayer HealthCare in collaboration with Stanford University, GLAdiator Biosciences seeks to address this need by selectively internalizing therapeutic payloads into targeted cancer cells.  As former VP of Biologics Research at Bayer and Head of their US Innovation Center and now CEO of GLAdiator Biosciences, I would welcome the opportunity to elaborate on our company and discuss mutually beneficial opportunities to realize the value of this platform in the clinical setting.

PhaseBio (phasebio.com) is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies to treat orphan diseases, with an initial focus on cardiopulmonary indications. Our lead product candidate is PB2452, a novel reversal agent for the antiplatelet drug ticagrelor, and our second product candidate is PB1046, a once-weekly fusion protein for the treatment of pulmonary arterial hypertension. PB1046 utilizes our proprietary elastin-like polypeptide (ELP) technology, which also serves as the engine for our preclinical pipeline.

Primary therapeutic area(s): 

  • Rare disease
  • Cardiopulmonary
  • PAH

Phase of development: Phase 2

Product Description:  PB2452 is a novel recombinant human monoclonal antibody antigen-binding fragment, designed to reverse the antiplatelet activity of ticagrelor. Ticagrelor is an antiplatelet therapy widely prescribed to reduce the rates of death, heart attack and stroke in patients with acute coronary syndrome (ACS), or who have previously experienced a heart attack. Ticagrelor binds to platelets to prevent them from forming blood clots, which could restrict blood flow. Due to ticagrelor’s antiplatelet activity, patients on ticagrelor have an elevated risk of spontaneous bleeding. In addition, patients on ticagrelor who need urgent surgery cannot wait the recommended five days for ticagrelor’s effect to dissipate and are at increased risk of major bleeding during and after surgery. There are currently no known reversal agents approved or in clinical development for ticagrelor or any of the other antiplatelet drugs.

In our Phase 1 clinical trial, PB2452 achieved rapid and complete reversal of ticagrelor’s antiplatelet activity, with potential customizable duration of reversal based on the dosing regimen, which we believe has the potential to bring life-saving therapeutic benefit by increasing the safety of ticagrelor. We believe the availability of a reversal agent could expand ticagrelor’s use by mitigating concerns regarding bleeding risk and uniquely position ticagrelor as the only oral antiplatelet drug with a reversal agent.

Adocia (www.ADOCIA.comemploys its proprietary excipient library, BioChaperone®, to unlock new clinical benefits of already-approved treatments in the fields of diabetes and metabolism.

Primary therapeutic area(s): Diabetes and Metabolism

Phase of development:

  • Up to, and including, Phase 3. 
  • Seeking partners for development and ultimate commercialization.

Product DescriptionPipeline includes: Ultra-rapid insulin lispro | Modern premix of insulins glargine and lispro | Combination of pramlintide and insulin | Ready to use glucagon | Ready to use GLP2

Zynerba Pharmaceuticals (https://zynerba.com/) is the leader in pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders. We are committed to improving the lives of patients and their families living with severe, chronic health conditions including Fragile X syndrome and refractory epilepsies.

Primary therapeutic area(s): Rare and near-rare neuropsychiatric disorders

Phase of developmentPhase II

    Product DescriptionOur lead asset, ZYN002, is a pharmaceutically manufactured cannabidiol (CBD), formulated as a patent-protected permeation-enhanced gel for transdermal delivery through the skin and into the circulatory system. 

    ZYN002 is currently enrolling in a pivotal pediatric/adolescent study in Fragile X syndrome (granted orphan drug designation by the FDA). We are also enrolling a Ph2 pediatric/adolescent study in a group of rare refractory epilepsies, Developmental and Epileptic Encephalopathies (DEE). Data from both are expected in 2019.

    ALPS Global Holding Berhad (www.alps-holdings.com)

    The ALPS Global Holding Berhad (ALPS) is a fully-integrated biotechnology research, medical and wellness services group of companies. ALPS’s business focus is on the perception that the use of precision and preventive medicine as therapeutic entities will drive one of the next most important phases in medicine and wellness. Today, ALPS in Malaysia has evolved into a modern, preferred Asia Pacific destination for medical tourism providing specialized boutique precision and preventive medical and wellness services for today’s modern consumer seeking to look and feel good, aesthetically and medically for posterity. Driven by its Head Office in Malaysia, ALPS’s core service centres are the ALPS Medical Centre in the heart of Kuala Lumpur’s Central Business District and a Wellness and Anti-Aging Centre in the cool internationally renowned highlands resort of Genting Highlands. They cater to local and international clientele which has been growing significantly in recent years due to the quality of services supported by a good marketing network locally and overseas taking advantage of the growth of Malaysia as a medical tourism venue. ALPS has established the first commercialized Human Genomic Lab (MyGenome) located at ALPS Medical Centre, Malaysia. 

    To fund this exciting future, initial private equity investment funding process is already in progress and ultimately, an initial public offering (IPO) of ALPS on one of the main bourses will bring ALPS to greater heights.

    Primary therapeutic area(s)Precision and Preventive Medicine

    • Oncology: 9 Types of Cancer Disease:
    1. Blood Cancer
    2. Lung Carcinoma
    3. Hepatic Cancer
    4. Colorectal Cancer
    5. Breast Cancer
    6. Pancreatic Cancer
    7. Nasopharyngeal Cancer
    8. Ovaries/ Endometrial Cancer
    9. Cervical Cancer/ Prostate Cancer
    • Neurology
    1. Alzheimer’s Disease
    2. Parkinson Disease
    • Common Diseases
    1. Coronary Heart disease
    2. Diabetes Mellitus 1 & 2 Disease
    3. Infertility

    Phase of development: The future is exciting for ALPS and its clientele. ALPS through the establishment of an international network of professional providers, suppliers and supporting services will ensure its international clientele base will have access to state-of-the-art wellness and anti-aging products and services. Already in the development stage are in-house laboratories to produce autologous stem cells and the establishment of an international Research and Development Hub of renowned scientists and institutions involved in stem cell and related research. We are moving into Merger & Acquisition phase to look for strategic partner specialized hospitals and laboratories around the whole to cater to our clientele and business direction.

      Product Description

      Precision Medicine

      The Biomarker can detect our hidden disease from 3 years up to 30 years in future. The Biomarker results are up to 90% accuracy and above.  Currently our Biomarker Lab can detect up to 14 types of diseases via using different biomarker. Out of 14 types of disease can be detected such as blood cancer, lung carcinoma, hepatic cancer, colorectal cancer, breast cancer, pancreatic cancer, nasopharyngeal cancer, ovaries cancer, cervical cancer, coronary artery disease, diabetes mellitus, Alzheimer’s disease, Parkinson disease and infertility.

      Preventive Medicine

      Immunotherapy establish by ALPS is the effective ways for preventing, managing or preventing different cancers and diseases at early stage, for example: Natural Killer (NK) cell, Dendritic cell (DC), Cytokine-Induced Killer (CIK) cell and Chimeric Antigen Receptor (CAR) T cell. Currently, with the discovery of induced pluripotent stem (IPS) cells, ALPS can convert differentiated somatic cells into multipotent stem cells that have the capacity to generate all cell types of adult tissues. Because they’re made from a person’s own cells, they can potentially be manipulated to fix the disease-causing defect and then used to create healthy cells for transplant that won’t be rejected by the immune system. In means, ALPS can help to regenerate the damage organ cells via culture the IPS cells. 

      Zhejiang Teruisi Pharmaceutical (http://www.teruisipharm.com/is a biopharmaceutical company focuses on but not limited to mAb product development and manufacture. Company’s core technical teams came from reputable international pharmaceutical companies (J&J, BMS and GSK); they are the top-notch CMC experts with 25-28 year mAb product development and manufacture experiences. The company is on the promise of delivering quality.

      Primary therapeutic area(s): Oncology

      Phase of development: Phase I& Phase IIIProduct DescriptionCompany had established the China’s first world class large scale commercial manufacture facility (4X5000 L = 20,000L) that met US/FDA, EU/EMA, ICH & cFDA multiple cGMP standards. The facility had been successfully validated and produced the phase 3 material for US/FDA phase 3 clinical trial.  The company can provide one stop, full service CMC development and commercial manufacturing for international companies.

      Company is looking for international partners for market collaborations (biosimilars and NMEs) as well as mAb CMO clients.

      HEXAELL biotech  (www.hexaell.com) was founded in 2015 and is located in the core area of Jiading Industrial Park of Shanghai. The company possesses internationally leading cell differentiation and production technology and is focusing on developing novel therapies for severe liver diseases and cellular therapy. All the founders of the company are from international renowned scientific research institutes and top pharmaceutical companies, committed to developing the world’s leading innovative biomedical technology and products and providing better clinical solutions for patients.

      Primary therapeutic area(s): liver disease (liver failure)

      Phase of development: Pre-clinic

      Product Description: China has a large population that is affected by liver diseases. There are about 1 million new cases of liver failure each year. The 28-day mortality is as high as 50% in patients with acute liver failure. HepaCure bioartificial liver is an in vitro liver function support system, which can substitute hepatic function in a short period to prevent the manifestations of liver failure, promote the recovery of native liver function in patients with liver failure to avoid liver transplantation, or bridge patients to liver transplantation. By using such technology, Hexaell Biotech has finished pilot studies with more than 10 liver failure patients in China. Results showed reliable safety and outstanding clinical efficacy with >90% long-term survival rate.