Explore our certified laboratory and cGMP manufacturing capabilities designed to satisfy stringent NMPA, US FDA Botanical Drug Guidance, and EMA regulatory benchmarks.
Full GCP-compliant multi-center human trials, PK/PD profiling, and patient cohort trials tailored for botanical drug regulatory filings.
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Developing and validating HPTLC, HPLC-MS/MS, GC-FID, and chromatographic fingerprinting methodologies to establish authoritative reference standards.
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Comprehensive GLP-compliant in vivo disease models, acute/sub-chronic toxicity, bioavailability, and safety pharmacology evaluation.
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Targeted bioassays across mammalian cell lines, enzymatic cascades, receptor affinity screens, and inflammatory cascade validation.
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Quantifying seasonal and geographic chemical variations in botanical actives to lock in dependable raw material supply channels.
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Bioassay-guided fractionation to isolate alkaloids, polyphenols, flavonoids, and active polysaccharides for lead candidate optimization.
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Pilot-to-commercial extraction, purification, and crystallization producing concentrated liquids, standardized powders, and volatile oils.
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Turnkey industrialization for softgels, micro-tablets, enteric capsules, oral liquids, and soluble granules conforming to pharmacopeial monographs.
Explore Dosage SolutionsDeconstructing the complexity of botanical mixtures through chemical consistency, modern pharmacological elucidation, and strict ICH-aligned data packages.
Unlike single-molecule synthetic new chemical entities (NCEs), botanical drug substances are complex multi-component matrices derived from plant tissues. Historically, health regulatory bodies viewed complex phytomedicines with skepticism due to challenges in establishing definitive batch-to-batch chemical equivalence.
Today, regulatory frameworks like the US FDA's Guidance for Industry: Botanical Drug Development and NMPA Class 1/Class 2 Traditional Chinese Medicine designations accept that therapeutic synergy stems from the orchestrating effect of multiple compounds. Demonstrating therapeutic reproducibility without isolating a single active molecule requires establishing strict biological assays, chromatographic fingerprinting, and rigorous raw material provenance control.
Modern botanical NDAs necessitate a Quality by Design (QbD) mindset. Quality cannot be merely tested into the final dosage form; it must be built into each stage of agricultural sourcing, fractional extraction, purification, and final compounding.
Navigating an NDA requires an interconnected Common Technical Document (CTD) compilation where every non-clinical study and CMC parameter connects directly to safety margins established in human trials.
At MedGence (Yineng Pharma), our integrated team unifies Module 3 (CMC), Module 4 (Nonclinical Study Reports), and Module 5 (Clinical Study Reports). By handling both wet-lab preclinical science and full-scale pilot cGMP production internally, we eliminate the operational and regulatory friction typical when handoffs occur between distinct contract research organizations and toll manufacturing entities.
Combining the world's most extensive botanical biodiversity with cutting-edge analytical instrumentation, accelerated clinical patient recruitment, and cost-effective scaling.
China is home to over 11,000 medicinal plant species with millennia of recorded therapeutic utilization. Our headquarters in Changsha, Hunan, puts our scientists at the epicenter of historic botanic origins. We maintain strict botanical traceability back to specific geographical origins (Daodi), monitoring altitude, soil mineral composition, and microclimate variations.
By mapping active constituent density across seasonal harvesting cycles, we lock in baseline plant biomass yields that reduce raw ingredient input volumes and guarantee stability throughout 36-month shelf-life evaluations.
Translating an active phytochemical from a 20-gram laboratory fraction into a metric-ton commercial cGMP batch is where many international botanical NDA candidates fail. Chinese manufacturing leads the global pharmaceutical sector in industrial-scale extraction machinery.
Clinical study bottlenecks frequently delay NDA filings in Western markets due to slow participant recruitment and restrictive trial parameters. In China, Grade-A tertiary medical institutions and national TCM clinical research bases manage high outpatient and inpatient volumes with extensive clinical registries.
Our long-standing partnerships with institutions such as the First Hospital of Hunan University of Chinese Medicine and Shuguang Hospital allow rapid stratification and enrollment for Phase I dose-escalation, Phase II proof-of-concept, and Phase III pivotal multi-center randomized controlled trials.
Over 14 years of wet-lab validation and commercial scale-up for top pharmaceutical groups, medical universities, and global nutraceutical innovators.
A transparent, milestone-gated operational methodology designed to minimize R&D expenditure risk while maximizing scientific and regulatory certainty.
Extracting, isolating, and screening target phytoconstituents. We correlate high-affinity active principles against specific biological targets using in vitro enzymatic and cell-based bioassays.
Deliverable: Target Screen & Botanical Origin ReportEstablishment of HPLC, GC, and HPTLC testing standards alongside chromatographic fingerprinting. Creation of raw material monographs including ash, moisture, and microbial limitations.
Deliverable: Validated Analytical Test ProtocolsParameter optimization for industrial extraction, chromatography columns, concentration, and crystallization. Establishing critical process parameters (CPPs) for commercial scalability.
Deliverable: Pilot Batch Records & CPP ValidationExecution of GLP acute toxicity (LD50), 28-day/90-day repeat-dose subchronic toxicity, Ames mutagenicity, and chromosomal aberration assays to define therapeutic safety windows.
Deliverable: IND Safety Dossier (Module 4)Protocol authoring, ethics committee approvals, patient recruitment, electronic data capture (EDC), and medical monitoring across Phase I, II, and pivotal Phase III multi-center trials.
Deliverable: Clinical Study Reports (Module 5)Full commercial CDMO production of validated active botanical ingredients or finished dosage formulations (capsules, liquids, tablets) accompanied by regulatory dossier eCTD submission data.
Deliverable: Commercial Batches & DMF FileBridging traditional empirical validation with rigorous clinical biomarkers across high-growth international drug discovery pipelines.
Chronic lifestyle disorders benefit significantly from multi-target botanical mechanisms. We develop standardized polyphenol and alkaloid fractions (such as optimized berberine and mulberry leaf 1-deoxynojirimycin conjugates) that simultaneously influence AMPK phosphorylation, intestinal alpha-glucosidase activity, and hepatic gluconeogenesis.
In China, hospital preparations (in-hospital proprietary formulations) possess unique regulatory utility. Used legally within designated clinical hospital environments, these formulas accumulate extensive real-world safety and human efficacy data across tens of thousands of registered patients.
MedGence has successfully formulated and registered 56 hospital preparations. We support clients by transitioning these clinically documented formulas into formal IND candidates, bypassing early trial safety ambiguities and drastically reducing pipeline cycle duration.
Botanical polysaccharides and triterpenoid saponins demonstrate complex immunomodulatory profiles. Leveraging modernized formulas based on Astragalus and Scutellaria baicalensis, we have developed standardized extracts that modulate cytokine storms and stimulate macrophage phagocytosis without hyper-inflammatory overactivation.
Meeting the operational, technical, and regulatory requirements of international pharmaceutical sourcing executives and external QA audit boards.
For multinational drug originators, intellectual property integrity is paramount. MedGence operates on a pure entrusted contract research and contract manufacturing organization (CRO/CDMO) basis. Our contractual agreements provide comprehensive non-disclosure and guarantee that all discovered synthesis pathways, active fraction assays, and formula compositions remain the exclusive asset of the client.
All laboratory notebooks, spectrometer raw files, and instrument audit logs are governed by 21 CFR Part 11 compliant data management frameworks with encrypted offsite mirroring.
Our pilot plant and production facilities operate in strict compliance with Chinese cGMP, EU GMP (Annex 7 for Herbal Medicinal Products), and US 21 CFR 210/211. Quality assurance infrastructure includes:
Sourcing an active botanical ingredient for an NDA requires full DMF (Drug Master File) accessibility. MedGence prepares Open and Closed DMF packages formatted for direct submission to the US FDA, Health Canada, and European Directorate for the Quality of Medicines (EDQM).
Our regulatory affairs division provides active audit defense, responding promptly to regulatory requests for additional information (RAIs) to keep your submission timeline on schedule.
Our natural medicine R&D and commercial CDMO infrastructure supplies top pharmaceutical corporations and university research hospitals across China.
Tongrentang Group
CR Sanjiu
Sunflower Pharma
Livzon Pharma
Dihon Pharma
Golden Throat
Yangtzi River Pharma
Humanwell Group
Apeloa Pharma
Shuguang Hospital
First Hospital of HUCM
Second Xiangya Hospital
Essential guidance covering technical requirements, regulatory classifications, analytical methods, and CDMO engagement terms.
Select individual research work packages or commission end-to-end turnkey drug manufacturing programs supported by comprehensive documentation packages.
Rigorous GCP clinical trial designs tailored to provide human efficacy and pharmacokinetic data necessary for global drug filings.
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Developing tailored HPTLC, HPLC, and GC analytical validation packages meeting international pharmacopeial criteria.
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Animal modeling, in vivo efficacy validation, acute and chronic toxicity profiling, and pharmacokinetic evaluation.
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Targeted bioassays on cellular pathways, receptor binding, and enzymatic models delivering rapid proof-of-mechanism data.
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Comparative chemical and bioactivity profiling of natural herbs harvested across multiple geographical microclimates.
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High-efficiency isolation, fractionation, and screening across complex plant matrices to discover high-potency drug candidates.
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Targeted biophysical characterization and chemical fingerprinting of secondary plant metabolites for global pharmaceutical applications.
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Turnkey clinical trial orchestration, supply of matching double-blind placebos, and electronic data capture for NDA regulatory dossiers.
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