Direct contract access to specialized botanical active ingredient screening, chemical standardization, bioassay evaluations, and turnkey clinical support.
Overcoming the structural bottleneck of botanical heterogeneity through standardized molecular characterization and industrial-scale precision extraction.
The worldwide commercial demand for naturally derived bioactive molecules—spanning high-efficacy pharmaceutical APIs, standardized dietary nutraceuticals, and clean-label dermocosmetics—is undergoing unprecedented expansion. Historically, botanical commercialization has faced persistent vulnerabilities: seasonal potency variance, soil contamination, batch inconsistencies, and ambiguous therapeutic mechanisms. Regulators worldwide, including the US FDA, European Medicines Agency (EMA), and National Medical Products Administration (NMPA), have continually heightened criteria for natural ingredient registration. Phytochemical products are no longer evaluated merely as crude plant derivatives; they must satisfy rigorous criteria regarding batch-to-batch chromatographic fingerprints, quantitative secondary metabolite assays, full-profile genotoxic documentation, and defined modes of action.
Traditional herbal supply chains rely heavily on basic extraction metrics, leading to critical failures during late-stage clinical evaluation or international customs auditing. MedGence (Yineng Pharma) disrupts this legacy model by integrating modern Contract Research Organization (CRO) analytics directly with precision Contract Development and Manufacturing Organization (CDMO) infrastructure. We convert unstandardized traditional herbal formulas into chemically quantified, clinically defensible, and reproducible active pharmaceutical ingredients (APIs).
By mapping multi-target phytochemical interactions across 83 classic Traditional Chinese Medicine (TCM) formulas and over 400 single-herb monographs, our research architecture provides pharmaceutical innovators with the analytical clarity required to achieve predictable pharmacokinetics, validated target binding, and reliable therapeutic outcomes across global populations.
A unified execution pipeline covering target screening, origin analytics, process intensification, toxicological clearance, and multi-ton scale production.
Utilizing high-content screening, affinity ultrafiltration-mass spectrometry, and proprietary phytochemical metabolomic libraries to isolate target alkaloids, saponins, flavonoids, and polysaccharides with maximal therapeutic specificity.
Comprehensive comparative quantification of secondary metabolites across geographic provenances, soil mineralogies, altitude zones, and specific phenological harvest windows to lock down high-potency raw material sourcing.
Development and validation of robust HPLC, HPTLC, GC-MS, and LC-MS/MS analytical protocols in strict concordance with ICH Q2(R1) guidelines, establishing definitive chromatographic fingerprints and assay boundaries.
Optimizing critical process parameters (CPPs) across green solvent extraction, macroporous resin adsorption, nanofiltration, and flash evaporation to maximize active recovery while drastically reducing industrial carbon footprint.
Engineering formulation stability solutions addressing hygroscopicity, poor aqueous solubility, thermal degradation, and unpleasant organoleptic qualities, ensuring finished oral delivery forms retain bioactive integrity.
Safety profiling according to OECD and GLP principles: acute oral toxicity (LD50), 28-day/90-day subchronic toxicity, Ames bacterial reverse mutation test, in vitro micronucleus test, and chromosomal aberration assays.
Primary cell and immortalized cell line platforms evaluating glucose metabolism, inflammatory cascades (NF-κB, COX-2 inhibition), reactive oxygen species (ROS) quenching, and viral replication suppression.
Translational animal efficacy models spanning metabolic syndromes, neuroprotection, hepatic injury mitigation, and immune modulation to substantiate preclinical claims prior to clinical protocol submission.
GCP-compliant clinical design and monitoring: pilot human nutritional intervention trials for functional foods alongside Phase I to Phase IV multicenter randomized clinical trials for botanical New Drug Applications (NDA).
Synergistic pairing of classical herbal philosophy with contemporary pharmacokinetics. Developing complex multi-herbal matrices with enhanced bioavailability, verified chemical compatibility, and reduced excipient load.
Dedicated industrial manufacturing of active botanical ingredients delivered in diverse physical forms: vacuum-dried fine powders, standardized concentrated liquids, dense fluid extracts, and pure supercritical CO2 volatile oils.
High-capacity packaging and dosage conversions: automated manufacturing lines for enteric-coated softgels, vegetarian two-piece hard capsules, compressed tablets, oral liquid ampoules, and multi-layer sachet granules.
Aligning phytochemical research dossiers with the exact evidentiary expectations of regional health authorities.
Navigating the rigorous boundaries between NDI (New Dietary Ingredient Notifications), GRAS (Generally Recognized As Safe) dossiers, and investigational Botanical Drug Applications under FDA CDER guidance. We provide full quantitative traceability for pesticide residues, heavy metals (ICP-MS), and residual solvent thresholds below USP <467> limits.
Support for Traditional Herbal Medicinal Products (THMPD) according to Committee on Herbal Medicinal Products (HMPC) monographs. Complete chemical profile consistency ensuring active content does not drift outside defined safety margins, alongside EFSA Novel Food dossier compilation for innovative botanical concentrates.
Capitalizing on our record of 56 registered hospital preparations and 22 innovative modern natural medicines. We prepare complete registration filings for China NMPA Class 1 (innovative natural medicines) and Class 2 (improved TCM drugs), including classic formula standardization and modern clinical outcome substantiation.
How international pharmaceutical enterprises, dietary supplement developers, and cosmeceutical innovators implement our OEM R&D pipeline.
For biopharma programs developing novel treatments for metabolic dysfunction, chronic inflammation, or oncology adjunctive therapy. We handle fraction-guided bioactive isolation, molecular assay screening, and human Phase I–IV clinical designs that fulfill NDA evidentiary requirements.
For premium supplement brands needing differentiated market protection against commodity extracts. We build custom-engineered actives with proprietary chromatographic profiles, backed by small-group human clinical efficacy trials to substantiate consumer label claims.
For clinical skincare brands formulating anti-aging, barrier repair, and melanogenesis-inhibiting regimens. We screen plant extracts for cellular safety, evaluate anti-tyrosinase or antioxidant activity in keratinocyte models, and deliver stabilized, decolorized, non-allergenic actives.
Pioneering the synthesis of artificial intelligence, continuous-flow processing, and biotransformation in botanical active ingredient engineering.
Integrating deep learning molecular docking algorithms with our database of hundreds of thousands of research batches to predict target receptor affinity before beginning wet-lab extraction.
Phasing out large-volume solvent batch reactors in favor of automated continuous micro-channel extraction, dynamic microwave intensification, and subcritical water extraction systems.
Employing immobilized stereospecific enzymes to modify naturally occurring triterpenoid saponins and polyphenols, enhancing intestinal cellular bioavailability by up to 500%.
Bridging traditional agricultural plant sources with microbial fermentation chassis, validating rare plant secondary metabolites through comparative bio-equivalence frameworks.
Direct technical answers for Chief Scientific Officers, R&D Directors, and Global Procurement Executives.
MedGence (Yineng Pharma) provides end-to-end R&D and supply services for plant-derived ingredients: botanical active ingredient screening, origin- and seasonal-potency evaluation, analytical method establishment (HPLC, HPTLC, GC, LC-MS), extraction process development, GLP toxicity studies, in vitro cell assays, preclinical animal models, GCP Phase I–IV clinical trials, formulation design, and OEM/CDMO production of both active ingredients and finished drug/supplement dosage forms.
Yes. We operate our own pilot research facilities and fully integrated commercial production plants directly managed by our internal scientific team. This unified chain prevents the communication gaps, yield drops, and analytical discrepancies that often happen when handing over laboratory protocols to uncoordinated contract manufacturers.
Depending on target chemical classes, we employ High-Performance Thin-Layer Chromatography (HPTLC) for multi-constituent identification, High-Performance Liquid Chromatography with DAD/ELSD/CAD detection (HPLC) for quantification, Gas Chromatography (GC-FID/MS) for volatile terpenes, and chromatographic fingerprinting (similarity evaluation) to ensure batch-to-batch uniformity across multi-compound botanicals.
We work exclusively under strict bilateral Non-Disclosure Agreements (NDAs) and custom-contract R&D structures. All project formulas, purification parameters, proprietary yields, and assay dossiers remain the sole, uncompromised intellectual property of the entrusting client, preserving your long-term market advantage.
Active ingredients can be provided as concentrated aqueous liquids, standardized spray-dried powders, viscous pastes, or volatile essential oils. Finished product manufacturing covers hard gelatin/vegetable capsules, liquid softgels, compressed tablets, oral liquids in glass/PET containers, and moisture-barrier granules.
Yes. Our team conducts small-group human intervention trials for dietary substantiation, as well as Phase I safety/pharmacokinetic trials, Phase II dose-finding studies, Phase III confirmatory trials, and Phase IV post-market evaluations required by health authorities for new drug approval.
Over 14+ years of specialized contract research delivered for leading healthcare institutions, multinational brands, and university hospitals.
Beijing Tongrentang Group
China Resources Sanjiu
Sunflower Pharmaceutical
Livzon Pharmaceutical
Dihon Pharmaceutical
Golden Throat Group
Yangtzi River Pharma
Beihai Gofar Chuanshan
Humanwell Healthcare
SCIMYTH Pharmaceutical
Shandong Hanfang
Luoxin Pharmaceutical
Guangdong Zhongsheng
Brilliance & Abundance
Apeloa Pharmaceutical
Hunan Heng Chang Pharma
Baotou TCM Co.
Kamp Medicine Co.
Guangxi Santo Pharma
Hunan Kangshou Pharma
Jiangxi Juwang Pharma
Beijing Tcmages Pharma
Guizhou Ruihe Pharma
CR Jinchan Pharma
Kangmei Pharmaceutical
Tianjicaotang Pharma
Jiangxi Kingstone Pharma
Shuguang Hospital (Shanghai)
Hunan Directly Affiliated TCM
1st Hospital of Hunan TCM
2nd Xiangya Hospital (CSU)
2nd Hospital of Hunan TCM
TCM Orthopedics Zhuzhou
Select a dedicated CRO study track or CDMO manufacturing package to request comprehensive study protocols and quotation parameters.
