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Pipeline & Platform 66 record(s)；
Pilot scale up development and manufacturing
The R&D Center has a testing center and various laboratories specializing in drug formulation, Chinese medicine, microorganisms, and cellular and molecular biochemical functions. By using precision instruments and technologies and gathering experts from different fields, the R&D Center offers a comprehensive range of services for product inspection, research and development, and improvement
Scale up development & manufacturing
The production platform is fully compliant with medical regulations (Good Tissue Practice, GTP) in Taiwan. We have three clinical trials are going in Taiwan by now including GXHPC1, GXNPC1 and GXCPC1, indications of liver cirrhosis, stroke and osteoarthritis, respectively. In addition, we currently have a clinical trial is going in Vietnam, which is called GXIPC1 that be applied for type I diabetes
EG12014 Trastuzumab Biosimilar
Eirgenix aims to commercialize the first biosimilar product manufactured in Taiwan for the global market.Indication: HER2 Breast CancerExpected Product Launch: 2020Status: Phase 1 completed, BE established between EG12014 / EU & US HerceptinAdvantages of EG12014- The development of EG12014 follows EMA/FDA published guidance and past experience- EirGenix clinical study set up is considered an asset
Clinical & Regulatory Expertise
Maximize lead discovery efficiency using multiple approaches such as proprietary naïve human phage display library with a diversity of 1.5E+10, and conventional hybridoma technology. Developed robust screening criteria utilizing multiple in vitro assays established for each project to evaluate selectivity, affinity and potency of multiple leads.
Multiple-Phasic Release Technology (MPRT)
Through Orient Pharma's patented technology, incompatible ingredients or drugs with different release profiles can be enclosed in a single capsule or tablet for the development of new drugs.
1.Highly productive integrated antibody discovery and development platform2.Research to preclinical candidate selection in less than 2 years3.Target to file 1 IND per year for the initial 2 years starting in 2015
Establish target product profile (TPP) to establish go/no go criteria for IND enabling studies. We adopt a reiterative evaluation process using multiple in vitro and in vivo SC xenograft models, transgenic and humanized mouse models and/or syngeneic models to conduct PK/PD and toxicology studies to identify the best preclinical candidates.
Chemistry Manufacturing and Controls (CMC)
1. Cell line development2. Process development3. Analytical method development4. Quality control and quality assurance system development5. Production technology, purification techniques, quality analysis and stability studies
Deploy multiple strategies to improve binding affinity and efficacy of lead antibodies. Utilize biochemical and biophysical characterization to profile the lead antibodies. Conduct exploratory in vivo experiments to rank order potential leads for optimization. Utilize multiple in vivo PK/PD models and a broad range of tumor models to benchmark our lead antibodies with current standard of care and/or
Multi-day Transdermal Drug Delivery (MTDD)
Matrix type of design resolves API to form API/Adhesive patch, which is embedded in between Backing Layer and Release Liner. The API containing side of the patch can be adhered to the skin by tearing off the Release Liner. The patch can be designed as double layers for 1-2 days use or single layer for multiple days use.
New combination for treating Sialorrhea
• Combination of two compounds with different Mechnism of Action to reduce the secreting of saliva.• First oral treatment for sialorrhoea of Parkinson's Disease.• Results of Phase IIa study, published in the 17th International Congress of Parkinson's Disease and Movement Disorders, shows efficacy and safety.
OB318- New drug for anti-liver cancer
Liver is the largest and the most complex organ in human body. Liver cancer is more prevalent among Oriental people; it is a Top 3 cancer in Taiwan and China. Doctors’ treatment options, e.g. surgery, chemotherapy, radiotherapy, biological preparations, or combination therapy, etc., usually depend on disease staging, liver function, patient’s age, and physical condition. Compared to other
INNOPHARMAX has extensive pharmaceutical R&D experience, with former researchers who worked for the Medical and Pharmaceutical Industry Technology and Development Center in Taiwan (which is the most influential pharmaceutical technology developing organization funded by the Taiwan government), INNOPHARMAX's R&D team has been highly praised by numerous pharmaceutical
SB04 is a conventional drug in new use to treat patients with dry AMD. SB04 has many different mechanisms to treat patients without invasive way; even patient self-applied medication. Eye drop formulation505(b)(2) regulatory pathwayFast Track Pathway for IND in Phase II/IIIPhase II/III clinical trial is ongoing in the US and Taiwan.
Burixafor( TG-3000) , is a novel, potent and selective chemokine receptor antagonist discovered by TaiGen. Burixafor rapidly mobilizes stem cells and progenitor cells from the bone marrow into peripheral circulation. Burixafor has completed Phase 2 study in autologous stem cell transplantation in the US. Another Phase 1 study in chemosensitization has also completed in China by 2018. Other potential
CHAP™ is a self-owned technology of SciVision Biotech Inc. which provides the unique viscoelasticity of HYADERMIS™ Facial Dermal Implant series and HYAJOINT Plus™ Synovial Fluid Supplement. CHAP™ gel with water-retention characteristic, acts as a kind of natural sponge. It creates volume in the tissue, lubricates, and transports nutrients to and from cells.
CVM-1118 is a small molecule NCE (new chemical entity). It has high anti-cancer activity, good safety margin, and multiple mechanisms of action targeting cancer, especially its unique ability to inhibit vasculogenic mimicry (VM). CVM-1118 is currently being developed into a next generation oral anti-cancer drug. CVM-1118 has great potential showing inhibitory effect towards breast, ovarian, colon,
CX-4945: CK2 Inhibitor Program
CK2 (Casein kinase 2) is a protein kinase that has elevated activity in many cancers and has a direct role in DNA damage repair. The DNA repair pathways enable tumor cells to survive damage induced by treatment with chemotherapeutic agents. Inhibitors of DNA repair pathways have been shown to increase the efficacy of DNA-damaging chemotherapeutic drugs when these are used in combination
Synthetic lethality (SL) is a concept in which cell death is induced by the combination of two non-lethal mutations, while mutation alone is not sufficient to affect cell survival. Recently, SL has been proposed as a novel anticancer strategy that is promising to be highly selective. If a cancer-specific mutation combined with a drug-induced mutation have SL interactions, it will selectively
CX-5461: RNA Polymerase I (Pol I) Inhibitor Program
The p53 protein normally functions as a tumor suppressor by causing cancer cells to self-destruct. Activating p53 to kill cancer cells is a well validated anticancer strategy and many approaches are being employed to exploit this pathway. By targeting RNA Polymerase I (Pol I) to activate p53 in cancer cells but not normal cells, through the nucleolar stress pathway, Senhwa's first-in-class
FB317, a biosimilar of omalizumab, inhibits the binding of IgE to the FcεRI on the surface of mast cells and basophils by neutralizing free IgE in the blood. Reduction of surface bound IgE on FcεRI-bearing cells decreases the release of mediators and prevents allergic responses.Mostly on the clinical treatment with antihistamines, sympathomimetic drugs, corticosteroids and
FB704A is a fully human monoclonal antibody against human Interleukin-6 (IL6) and developed by Fountain's proprietary fully-human antibody library and affinity maturation technology.IL6 is a multifunctional cytokine that regulates pleiotropic roles in immune system, inflammation and hematopoiesis. Therapeutic targeting on the IL6 is therefore considered to be a potential treatment strategy for
FB825 is a humanized monoclonal antibody that binds to the CεmX domain, leading to death of the membrane IgE+ B lymphocytes by inducing apoptosis and antibody-dependent cellular cytotoxicity (ADCC) in a dosing-dependent manner. FB825 can stand alone as a monotherapy or in combination with Xolair for the treatment of allergic asthma and IgE-mediated diseases.
FB825 (Anti-CεmX;h4B12) was developed by the same inventor who developed anti-IgE therapeutics. FB825 is a humanized monoclonal antibody that targets to the the CεmX domain and kills the membrane IgE+ B lymphocytes by ways of apoptosis and antibody-dependent cellular cytotoxicity (ADCC).By targeting to mIgE+B lymphocytes, FB825 has a long-lasting effect in down-regulating
Furaprevir is a novel inhibitor of Hepatitis C virus (HCV) NS3/4A protease. This protease is essential for HCV replication and inhibitors have been shown to be effective in reducing viral load. TaiGen's goal is to develop a highly effective and affordable combination regimen with TG-2349 as the anchor.TG-2349 possesses the following unique characteristics that differentiate it from the competitors:Active
Good Agriculture Practice Cultivation Platform
The GAP cultivation platform utilizes the quality and efficacy technique in ecological environmental study, original plant identification, seedlings preservation, nursing and standardized cultivation.
Vitamin D Analogs (up to 500 gram batch size)Steroids (up to 65 kilo batch size)Cytotoxics (up to 16 kilo batch size)
Isoniazid without liver toxicity
1. The common Tuberculosis (TB) drug Isoniazid has the most side effect of hepatotoxicity among all drugs, which is considered to be the major barrier of TB treatment.2. Isoniazid with new formulation has no hepatotoxicity due to the special excipient.
LT1001 is the first long-acting analgesic injection containing dinalbuphine sebacate, a prodrug of nalbuphine, in an oil-based formulation intended for sustained release of the drug. Nalbuphine is a κ-agonist / partial μ-antagonist analgesic with an analgesic effect comparable to that of morphine, yet it has a ceiling effect on respiratory depression. LT1001 was designed to take advantages
LT3001 contains a new chemical entity which is composed of a thrombolytic polypeptide and a small molecule moiety with anti-oxidation activity. In rodent disease models where LT3001 was administered outside of the “golden (3) hours” post- stroke when tPA cannot be used, it significantly reduced brain infarction, restored blood flow and improved neuronal behavior score without hemorrhage
MS-20 is a mixture of soy fermentation metabolites which is produced in strictly controlled fermenter and with carefully chosen microorganisms that mimics human intestinal environment.The manufacturing and R&D procedures of Chemo Young follow the international regulations.MS-20 was approved as new drug by TFDA in 2011.MS-20 acts as an immunemodulator and probiotics to improve immunity and
There are 415 million diabetes patients in the world by 2015 and 10-15% of them have DFU which may lead to amputation or even death.ON101 is the first botanic drug for diabetic foot ulcer (DFU). Target Chronic DFU with Grade 1 or 2 per Wagner Ulcer Classification SystemFulfill the Global Unmet Medical Need in DFUClinical Status: Phase III Interim Analysis (2016)In compliance to US FDA &ldquo
ON101- New drug for diabetic foot ulcer healing
When a wound heals, it usually has three phases, the inflammatory phase, proliferative phase, and remodeling phase. The diabetes patients usually have multiple dysfunctional factors such as growth factors, cytokines, and collagen synthesis and these factors are crucial to wound healing. Furthermore, these patients often develop vascular stenosis or obstruction. As a result, blood supply to the wound
Tmax of the current extended release tablets is too long, so children lose attention in learning when they start classes in the early morning.With both advantages of immediate and extended release, the unique multi-stages hot melt capsule releasing technology is able to become effective in early stage and sustainably release the drug to maintain the efficacy.The patented Oradur® formulation
PEP503 (A Radio-enhancer)
Radiation therapy is a common treatment modality for varies of cancers and may apply to more than 60% of cancer patients. It is often used alone or in combination with chemotherapy. However, radiation therapy also has notable disadvantages, such as a longer treatment period and unavoidable side effects. In order to treat the cancer many technologies and methods have been developed to ameliorate radiotherapy
PHN013 (Orphan drug;ITP)
Advantages of the productPG2 Injection is originally extracted, isolated and purified from the "superior" Tranditional Chinese Medicine (TCM) and it has been confirmed with high safety because of the over 600 cases clinical practice.PG2 Injection meets the current trend of new drug developmentPG2 Injection synchronously modulates the WBCs, RBCs and Platelets.PG2 Injection has been granted
PHN014 (Acute ischemia stroke)
Advantages of the productPHN014 is extracted, isolated and refined with high purity from the Astragalus membranaceus (黃耆) , which has been described in the classical texts as a qi-supplementing medicine.Long-term human experience show no drug- related toxicityPHN014 meet the current trend of new drug development ,with two-way immune regulationIt's very safe and without the risk for inducing the
PHN015 (Hemorrhage stroke)
Advantages of the productPHN015 is extracted, isolated, and high purified from the Astragalus membranaceus (黃耆) , which has been described in the classical texts as a qi-supplementing Traditional Chinese Medicine(TCM).PHN015 meets the current trend of new drug development ,with bidirectional immunomodulatory functionPHN015 meet the current trend of new drug development ,with two-way immune regulationThere
PHN031 (Osteoporosis prevention)
Advantages of the productSelection of native plants for control the medicinal origin and qualityLong-term human experience show no drug- related toxicityThere are dual affects in enhancing bone formation index and restraining bone loss indexCharacteristic fingerprint to ensure superior quality controlWell-defined specifications to prove the consistency of quality among batches
PHN033 (Diabetic Nephropathy treatment)
Advantages of the productSelection of native plants for control the medicinal origin and qualityLong-term human experience show no drug- related toxicityDecreases serum AGEs and urine albumin concentration, The new drug with new mechanism of action .Characteristic fingerprint to ensure superior quality controlWell-defined specifications to prove the consistency of quality among batches
PHN131 (Treat moderate to severe pain)
Advantages of the productNew oral formulation derived from an approved analgesic injectable - NalbuphinePatented technology inhibits first-pass metabolism to improve oral bioavailabilityPotency equivalent to Morphine per milligram basisLow physical dependence and addictionConvenience with oral administrationCeiling effect for side-effect of respiratory depressionNotable achievementsCo-development with
Core Technology: Pegylation PlatformIn the field of protein drug design, the process of pegylation of the therapeutic protein preserves its biological activity by targeting the PEG polymer (polyethylene glycol) at a specific and defined region on the protein. PharmaEssentia's pegylation technology platform is designed to increase the protein drug's efficacy by prolonging its circulation in
TLC is using antibodies and antibody fragments attached to lipid encapsulated drugs to develop more effective therapies in oncology. These antibody-linked nanomedicines actively target specific tissues using binding interactions between a specific antibody and a target antigen on the surface of a particular cell type. Compared with passively targeted therapies, these nanomedicines are better able to
By encapsulating molecules with poor solubility in polymeric micelle nanoparticles, TLC's technology can increase the solubility of a drug. This allows a larger quantity to be delivered in a single dose, which can enable new forms of administration. For molecules that are too insoluble to be practical as stand-alone therapies, lipid encapsulation may be the key to generating an entirely new type
Rexis® is being developed as an add-on injection therapy for patients with sepsis. Several studies have demonstrated a reduction in mortality rate with the addition of Rexis® compared to the standard treatment. Rexis® will soon initiate pivotal clinical trials follow by regulatory registrations in 2016. We hope to increase the survival rate of sepsis and bring hope to patients
SB01 is a new drug originated in Taiwan, from discovery, research and development, preclinical ADME, API and finished product manufactured to the USFDA IND. SB01 is an injectable anti-cancer NCE with multiple anti-tumor MOATreatement of cholangiocarcinoma has FDA Orphan Drug Designation clearancePhase I results show a favorable safety profilePhase II clinical trial of SB01 has
SB02 is a new drug originated in Taiwan, from discovery, research and development, preclinical ADME.SB02 is an oral active anti-tumor drug NCEProven with multiple anti-cancer MOAReady for IND
SB05 is an innovative composition of the established cytostatic drug paclitaxel combined with neutral and positive lipids. Due to the positively charged lipids, SB05 interacts with newly developing, negatively charged endothelial cells, which are especially required for the growth of tumor blood vessels. The SB05 paclitaxel component attacks the activated endothelial cells as they divide, thus targeting
IndicationNon-alcoholic steatohepatitis (NASH)Advantages Over Current ProductNo standard treatment availableFirst-in-classFor NASH and ASH bothGreat safety profilePotential MarketThe estimated global market for NASH: 35-40 B per yearCompetitive EdgeMultiple mechanisms of actionDirect action on liverGreat safety profile, US Phase IIApply orphan drug for acute fatty liver in pregnancyStatusUSFDA and
IndicationNon-alcoholic steatohepatitis (NASH)Advantages Over Current ProductOptimized New Chemical EntityFirst-in-classFor NASH and ASH bothPotential MarketThe estimated global market for NASH: 35-40 B per yearCompetitive EdgeMultiple mechanisms of actionDirect action on liverOptimal potencyGreat safety profileStatusPre-clinicalSNP-630 and/or its active metabolites: some human experiencePlan to apply
Six Genomic Technology Platforms
IVD Sequencing & NGS analysisSNP genotyping analysisGene Chip analysisFunctional genomics analysisClinical genomics analysisBioinformatics analysis
TABP's transcriptional factor protein drugs are developed based on the fact that transcription factors can specifically act on the promoter of a gene. Comparable to monoclonal antibodies' specificity, the TABP's protein drugs can target to and regulate individual gene whose function people wish to change and by this means we can determined the proliferation and differentiation fate of cells. Advanced
TLC178 is a formulation of vinorelbine loaded into liposomes, designed to reduce toxicity and improve efficacy with fewer administrations.We are initially developing TLC178 for pediatric RMS. The increased specificity of TLC178 for tumor versus non tumor tissue through the use of our NanoX technology, which utilizes enhanced permeability and retention effects, will enable greater dose intensity
Poor solubility and high toxicity are significant problems with many new promising therapeutic approaches in oncology. By using TLC's lipid-based technology to improve solubility characteristics of a new derivative from a well-known chemotherapeutic drug (camptothecin), we were able to enhance its clinical development potential. In addition, TLC388 shows
TLC399 is our proprietary BioSeizer formulation of dexamethasone sodium phosphate (DSP) intended as an intravitreal, or in-eye, injection for the treatment of macular edema due to retinal vein occlusion. TLC399 in preclinical models has been shown to provide therapeutic levels of DSP in the eye for at least six months after a single administration. A Phase I/II safety trial has demonstrated encouraging
TLC590 brings sustained release delivery technology to the common anesthetic ropivacaine, with the goal of reducing the frequency of administration for local anesthesia for post-surgical pain. More effective pain relief may also allow patients to avoid the problems of opioid therapies often used for the treatment of post-surgical pain.
TLC599 is our proprietary BioSeizer formulation of dexamethasone sodium phosphate (DSP) designed to provide sustained pain management over an extended period of three months or more. TLC599 has the potential to enable patients to receive both immediate and sustained benefit from the local delivery of a highly potent and clinically validated steroid that typically has a very short half-life. Our
TRIA11 is a biosimilar indicated for osteoporosis. The current global sales of the original product reaches to $1.7 billion. An injection pen is also developed to enhance the convenience of use. TRIA11 is planned to launch in EU first, and TSH Biopharm has consulted EMA for the development plan. TRIA11 is expected to move into clinical stage by the end of 2019.
Taigexyn® (Nemonoxacin) is a novel broad spectrum antibiotic for treatment of bacterial infections. It belongs to a new class of antibiotics known as non-fluorinated quinolone. Taigexyn® was discovered by screening against antibiotic-resistant bacteria and thus has intrinsic activity against the resistant infection which is an increasingly severe problem worldwide.Launched in Taiwan in Dec