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Pipeline & Platform 73 record(s)；
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
Vitamin D Analogs (up to 500 gram batch size)Steroids (up to 65 kilo batch size)Cytotoxics (up to 16 kilo batch size)
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.
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
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
Six Genomic Technology Platforms
IVD Sequencing & NGS analysisSNP genotyping analysisGene Chip analysisFunctional genomics analysisClinical genomics analysisBioinformatics analysis
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
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
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.
Small Molecule Drugs
ScinoPharm possesses a full range of chemistry capabilities and has extensive experience in synthesizing complex molecules. Depending on individual requirements, we develop new synthetic routes, or scale up and optimize processes based on the customer's technology. Our synthesis studies include structured Design of Experiment. (DoE) methods used to identify optimal conditions, factors that most
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
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.
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
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
Friendly GUI interface for reading and displaying 16 bit TIFF image files.GenePix Array List (GAL) file or MSK file. Optical image multi-block circular array of fluorescent spots. Tiff image generated by the automatic selection of slide bits on the fluorescence spots.Adjustable image brightness and contrast.Display histogram distribution of fluorescent reaction of wavelengths 532nm and/or
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
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,
Dual-targeted bifunctional anti-flu drug (CHO-S05)
A novel series of dual-targeted bifunctional anti-flu drugs comprising of influenza virus inhibition and pro-inflammatory cytokine suppression are designed, synthesized and evaluated. In vitro and in vivo functional analyses have shown remarkable protection of cells and mice by oral administration against H1N1 & H5N1 influenza viruses.
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
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
Glycan arrays and glycoprobes
Synthetic oligosaccharides and/or polysaccharides are immobilized on a solid supported in a spatially-defined arrangement to mimic the glycan expression on cell surface. The arrays of various glycans can be used for the diagnosis and prognosis of the disease such as cancer and infectious disease. They can also be used as research tools such as the validation of glycan binding protein and antibody,
Homogeneous antibody drugs (CHO-H01, H02, H03)
A unique glycan structure was identified for monoclonal antibodies with improved activity. With the proprietary technology developed by CHO Pharma, the Fc-glycan structure of therapeutic antibodies can be engineered to a homogeneous glycoform, which displayed enhancement of antibody-dependent cell-mediated cytotoxicity (ADCC), in vivo anti-tumor activities, and potential anti-inflammatory properties
Injectable Manufacturing Services
Already the leader in providing oncological APIs to regulated markets worldwide, ScinoPharm is poised to extend the service to offer finished dosage form of injectable products. With the completion of injectable plant in Tainan campus in Taiwan and combining the API capability, ScinoPharm is able to provide integrated solutions for one-stop shopping of injectable products in a flexible, reliable and
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.
JHL1152 Ipilimumab Biosimilar
JHL1152 is a proposed biosimilar to ipilimumab, a cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody.
JHL1178 Ramucirumab Biosimilar
JHL1178 is a proposed biosimilar to ramucirumab, a human IgG1 that binds to VEGFR2, which in turn blocks the natural ligands secreted by tumors, therefore can inhibit tumor angiogenesis.
JHL1255 Ustekinumab Biosimilar
JHL1255 is a proposed biosimilar to ustekinumab, a human monoclonal antibody that is directed against interleukin 12 and interleukin 23, naturally occurring proteins that regulate the immune system and immune-mediated inflammatory disorders.
JHL1266 Denosumab Biosimilar
JHL1266 is a proposed biosimilar to denosumab, which is a monoclonal antibody used for treatment of a range of osteoporosis.
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
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
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
Advantages of the productAdvantages include replacing complicated surgeries such as harvesting cells from bone marrow .Reducing recovery period for dental implants and alveolar bone reconstruction, and improving patient quality of life.Low immune riskNotable achievementsAwarded Advanced Medical Development and Rapid Commercialization program grant support by the Industrial Development Bureau of the
AdvantageAdvantages include replacing complicated surgical procedures, such as harvesting cells from cartilage allografting, or bone marrow .Promoting the repair and functional regeneration of cartilage affected by degenerative OA, and improving patients' quality of life.Low immune risk
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
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
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
RNTA06 is used to treat angina. R06 can response the demand from angina treatment market, with good safety profile. Considering the high entry barrier of development, we believe R06 can create significant value from the market.
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
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
IndicationAnalgesic and antipyreticAdvantages Over Current ProductHepatotoxicity-freeTo address the important and urgent unmet medical needsA patented formulation with great safety marginPotential MarketAcetaminophen sales are 1.3 billion USD a year (US only)Competitive EdgeCurrently, no hepatotoxicity-free acetaminophen on the marketGreat impact on the market share of pain controllers, especially
TAH4411 Antiemetic Oral Thin Film
TAH4411 oral dissolving film (ODF) is a new formulation of a selective 5-HT3 receptor antagonist which blocks stimulation on both peripherally located vagal nerve terminals and centrally located receptors in the chemoreceptor trigger zone of the area postrema.This new formulation provides equivalent amount of the active ingredient as in Zofran® tablets and Zofran® OD tablets, but with a potential
TAH8801 Alzheimer's Disease Transdermal Patch
TAH8801 is a once a day transdermal patch system used for the treatment of mild to moderate Alzheimer's disease and various other memory impairments. The patch releases medicine continuously over 24 hours. The medication is absorbed through the skin and may be an option for those who have trouble swallowing pills.Uniqueness• Reducing dosing frequency due to longer duration• Improved bioavailability&bull
TAH9901 ADHD Trandermal Patch
TAH9901 comprise of a ADHD treatment proven to be safe and efficacious for over 50 years, and as a stimulant, is a first line therapy for children with ADHD. TAH 9901 offers a transdermal once daily treatment for ADHD.Uniqueness:• Reducing dosing frequency due to longer duration• Improved bioavailability• Uniform plasma levels, resulting in reduced side effect• Possibility of terminating
TAH9922 ADHD Oral Solution
TAH9922 is an once-daily, liquid ADHD treatment option. It is a flavored, immediate release ADHD treatment option for patients ages 6 and above. Dosing can be tailored to the treatment's need.Uniqueness:• Better Palatability• Improved patient compliance via non-invasive, painless and simple application
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
TLC's own formulation of liposome encapsulated doxorubicin effectively reduces the side effects of doxorubicin and broadens its indications.
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.