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ANDA Research and Development
Research and development of generic drugs
| Therapeutic area | Drug name | Registration category | Mechanism of action | Indications | Main characteristics | Development stage | Technology transfer |
| Tumor | Afatinib tablets | Chemical drug class 3 | EGFR tyrosine kinase inhibitor | Metastatic non-small cell lung cancer | (1) Targeted (2) Overcoming resistance. | Proposed for clinical trial | Pending technology transfer |
| Veliparib capsules | Chemical drug class 3 | PARP inhibitor | Triple-negative breast cancer and metastatic non-small cell lung cancer | (1) Targeted (2) First-in-class | Proposed for clinical trial | Pending technology transfer | |
| Methanesulfonic acid levatinib capsules | Chemical drug class 3 | Multi-targeted tyrosine kinase inhibitors for VEGFR, FGFR, and PDGFR | Thyroid cancer, renal cell carcinoma, and liver cancer | (1) Targeted (2) New standard therapy for thyroid cancer, (3) Breakthrough therapy for renal cancer, (4) Liver cancer can surpass sorafenib | Proposed for clinical trial | Pending technology transfer | |
| Cardiovascular (Anticoagulant) | Rivaroxaban tablets | Chemical drug class 4 | Factor Xa inhibitor | (1) Prevention of DVT and PE after knee and hip surgery, non-valvular atrial fibrillation-related stroke, and systemic embolism (2) Treatment of venous thrombosis and pulmonary embolism. | (1) Overcoming the disadvantages of traditional anticoagulants; (2) Efficacy superior to low molecular weight heparin; (3) National medical insurance variety. | Application for production | Technology transferred |
| Type II diabetes | Dapagliflozin tablets | Chemical drug class 3 | SGLT2 inhibitor | Type II diabetes | (1) The most active SGLT2 inhibitor, significantly lowering blood sugar; (2) Does not increase the risk of hypoglycemia and weight. | Reported for clinical trial | Technology transferred |
| Empagliflozin tablets | Chemical drug class 3 | SGLT2 inhibitor | Type II diabetes | (1) The first hypoglycemic drug that can reduce the risk of heart disease, stroke, and cardiovascular disease; (2) The only hypoglycemic drug that delays the progression of kidney disease; (3) Does not increase the risk of hypoglycemia and weight. | Reported for clinical trial | Pending technology transfer | |
| Autoimmune | Apremilast tablets | Chemical drug class 3 | PDE4 inhibitor | Psoriatic arthritis / psoriasis | (1) Long-term efficacy comparable to biological agents; (2) Good long-term safety and tolerance; (3) Excellent risk-benefit ratio. | Clinical approval obtained | Pending technology transfer |
| Tofacitinib extended-release tablets | Chemical drug class 3 | JAK1/JAK3 tyrosine protein kinase inhibitor | Moderate to severe adult rheumatoid arthritis | (1) Efficacy comparable to first-line drug adalimumab; (2) Can be used alone or in combination; (3) Once daily, good compliance. | Proposed for clinical trial | Pending technology transfer | |
| Chronic kidney disease | Carboxymaltose iron injection | Chemical drug class 3 | Iron-releasing polysaccharide | Iron deficiency when oral iron preparations are ineffective or cannot be used | (1) Efficacy superior to sucrose iron; (2) Low risk of allergy and iron toxicity. | Proposed for clinical trial | Independent industrialization |
| Citrate iron tablets | Chemical drug class 3 | Phosphate binder | Hyperphosphatemia in CKD patients; CKD iron deficiency anemia. | (1) Efficacy superior to standard drug sevelamer, can continuously lower phosphorus; (2) The only one that lowers phosphorus and supplements iron. | Proposed for clinical trial | Pending technology transfer | |
| Mental and neurological | Safinamide tablets | Chemical drug class 3 | Reversible monoamine oxidase inhibitor | Adjunctive treatment for moderate to advanced Parkinson's disease | (1) Rapid onset within 2 weeks; (2) Efficacy lasts up to 2 years; (3) Does not increase movement disorders, has neuroprotective effects. | Preclinical research | Pending technology transfer |
| Carbamazepine transdermal patch | Chemical drug class 3 | Acetylcholinesterase inhibitor | Alzheimer's disease; Parkinson's disease dementia | (1) The only patch for treating Alzheimer's disease; (2) Reduced gastrointestinal side effects, increased compliance. | Preclinical research | Pending technology transfer | |
| Pifeltro tablets | Chemical drug class 3 | 5-HT2a inverse agonist | Hallucinations and delusions related to Parkinson's psychosis | (1) FDA granted breakthrough therapy; (2) No extrapyramidal side effects, will not worsen the patient's motor function. | Preclinical research | Pending technology transfer | |
| Aripiprazole aldehyde laurate ester sustained-release injection suspension | Chemical drug class 3 | 5-HT2a receptor inhibitor, 5-HT1a and dopamine D2 partial agonist | Schizophrenia | (1) Efficacy and safety comparable to aripiprazole; (2) Long-acting formulation once a month, good compliance. | Preclinical research | Pending technology transfer | |
| Epirizole tablets | Chemical drug class 3 | Partial agonism of dopamine D2 and 5-HT receptors | Adjunctive treatment for schizophrenia and severe depression | (1) Efficacy comparable to aripiprazole; (2) Better improvement of cognitive and negative symptoms than aripiprazole; (3) Fewer extrapyramidal side effects than aripiprazole. | Preclinical research | Pending technology transfer | |
| Vortioxetine hydrochloride tablets | Chemical drug class 4 | 5-HT subtype receptor antagonists and partial agonists | Major depressive disorder | (1) Efficacy superior to agomelatine; (2) First-line drug for elderly patients; | Preclinical research | Pending technology transfer | |
| Buprenorphine tablets | Chemical drug class 3 | Highly selective binding to synaptic vesicle protein 2A (SV2A) | Adjunctive treatment for partial-onset epilepsy in patients aged 16 and older | (1) Efficacy comparable to levetiracetam; (2) Third-generation antiepileptic drug with lower toxicity; (3) Indications can be expanded to children. | Preclinical research | Pending technology transfer | |
| Pregabalin capsules | Chemical drug class 4 | Gamma-aminobutyric acid (GABA) receptor agonist | (1) Neuropathic pain; (2) Epilepsy; (3) Fibromyalgia | (1) Multiple indications; (2) Best-selling drug, highly recognized by doctors. (3) Can be exempt from clinical BE. | Pending technology transfer | ||
| Anesthesia | Remimazolam injection | Chemical drug class 3 | GABAA receptor agonist | Ultra-short-acting sedation anesthesia during colonoscopy and bronchoscopy | (1) Ultra-short-acting new benzodiazepine (BZD) sedative; (2) Can be used in ICU patients with liver and kidney dysfunction; (3) FDA approved for pediatric drug research. | Preclinical research | Pending technology transfer/self-industrialization |
| Sugammadex sodium | Chemical drug class 3 | GABAA receptor agonist | Reversal of neuromuscular blockade caused by rocuronium or vecuronium | (1) The only selective relaxant binding agent, the first major advancement in the field of anesthetics in 20 years; (2) Can be used in children or adolescents aged 2-17. | Preclinical research | Pending technology transfer/self-industrialization | |
| Urinary system | Oxybutynin gel | Chemical drug class 3 | M1, M2, and M3 muscarinic receptor antagonists | Overactive bladder | (1) Reduced adverse reactions such as dry mouth and skin irritation; (2) Increased patient compliance | Clinical approval obtained | Pending technology transfer |
| Infection | Amoxicillin pulse release tablets | Chemical drug class 3 | Ampicillin-type semi-synthetic antibiotics | Secondary to purulent streptococcal tonsillitis and/or pharyngitis | (1) Unique pulse release, significantly enhances efficacy. (2) The only long-acting formulation of amoxicillin that can be taken once daily; (3) Can be used in children aged 12 and older. | Clinical approval obtained | Pending technology transfer |
| Delafloxacin tablets and injection | Chemical drug class 3 | Broad-spectrum fluoroquinolone antibiotics | Acute bacterial skin and skin structure infections | (1) Efficacy comparable to the combination of vancomycin + aztreonam; (2) High activity against resistant bacteria. | Preclinical research | Pending technology transfer |
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E-mail: cpri@cpri.com.cn
Tel: 86-023-62505956
E-mail: cpri@cpri.com.cn
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