[Raw Materials]
The Peptide Engineering Center of Shenzhen JYMed Technology Co., Ltd. possesses robust capabilities in raw material development. Led by a research team of 130 scientists, including 12 PhDs, the center has extensive expertise in peptide synthesis and process optimization. Utilizing advanced solid-phase peptide synthesis (SPPS) and liquid-phase peptide synthesis (LPPS) technologies, combined with fully automated production equipment, we ensure high-purity and high-activity peptide products. Our R&D team offers comprehensive services spanning from molecular design to process development, providing tailored solutions to meet diverse client needs.
All activities are carried out under stringent cGMP standards, supported by state-of-the-art analytical instrumentation such as HPLC and mass spectrometry (MS), ensuring that product quality complies with global pharmacopeial requirements. At JYMed, we are committed to empowering customers in the successful development and commercialization of innovative therapeutics through excellence in technology and service.
Process Development
JYMed’s process development team specializes in the optimization and scale-up of peptide API manufacturing, offering efficient and reliable customized solutions driven by technological innovation. With deep expertise in SPPS, LPPS, and continuous flow synthesis, we provide end-to-end development services from milligram-scale screening to hundred-kilogram-scale production.
Through our proprietary green chemistry platform for peptides, we have overcome challenges in synthesizing complex sequences, significantly improving both purity and yield. This enables us to meet the stringent requirements of high-potency peptides used in oncology, metabolic diseases, and other advanced therapies.
Our manufacturing system strictly adheres to cGMP guidelines and is equipped with fully automated synthesis units and advanced analytical tools such as UPLC and high-resolution MS. Coupled with internally developed process optimization models, we ensure process robustness and batch-to-batch consistency. JYMed has successfully completed multiple peptide API development projects across preclinical to commercial stages, delivering rapid, data-driven solutions to accelerate global pharmaceutical innovation.
Manufacturing
Our production site spans 300 mu (approximately 200,000 square meters) with a total built-up area of around 54,000 square meters. The facility comprises peptide manufacturing workshops, QC and R&D buildings, Class A and B warehouses, a solvent recovery center, utility centers, a solid waste collection area, and a wastewater treatment station.
Hubei Jianxiang Biopharmaceutical Co., Ltd. operates 10 peptide API production lines (including pilot-scale lines) compliant with cGMP standards of the U.S., EU, and China. These are equipped with dozens of solid-phase and liquid-phase peptide synthesis reactors, totaling over 30,000 liters in reactor volume.
With a well-established pharmaceutical quality management system and EHS compliance system, Hubei Jianxiang has passed official NMPA GMP inspections, multiple third-party audits, and EHS audits from leading global clients. Its annual peptide production capacity has reached multi-ton scale. Notably, the production of GLP-1 analogs ranks among the largest in China by single-batch volume, and some cosmetic peptides exceed 100 kg per batch, positioning the company as a competitive chemical synthesis peptide API manufacturer in both domestic and international markets.
High-Potency Peptide APIs
Jianxiang’s high-potency peptide API production lines represent a core competitive advantage, offering safe and efficient solutions to global customers. The facility includes two OEB4-level and two OEB5-level high-containment units designed to meet the demanding manufacturing requirements of highly potent compounds such as anti-tumor and cytotoxic peptides, ensuring safety for personnel and the environment.
The production lines employ industry-leading SPPS and LPPS technologies with fully automated control systems, enabling scalable manufacturing of high-purity and high-potency peptides from gram to kilogram scale. Batch consistency and product quality are fully compliant with international pharmacopeial standards.
Built on a cGMP-compliant quality management system, the entire production process—from raw material selection, synthesis, purification to final testing—is fully traceable. Advanced analytical instruments such as HPLC and MS ensure product purity ≥99% with controlled impurity profiles. To address the unique safety requirements of high-potency APIs, the OEB5-level units adopt closed-isolation systems, independent negative-pressure environments, and intelligent leakage monitoring systems, along with strict PPE protocols for comprehensive safety assurance.
Our R&D team also offers customized process development and optimization services covering the entire value chain from molecular design and scale-up to quality studies, supporting rapid advancement of innovative peptide-based therapeutics.
[Formulation]
Our core technical team is composed of experienced researchers specializing in formulation and analytical science. With extensive expertise across the entire formulation development value chain, we offer end-to-end services from preclinical research to commercial manufacturing. We have established unique technological strengths in frontier fields such as GLP-1 drugs, peptides and peptide formulations, sustained-release peptide formulations, and radiopharmaceutical (RDC) development.
Leveraging our globally distributed R&D and manufacturing facilities, we have built a comprehensive formulation development system. In the peptide formulation field, we provide diverse solutions including multi-dose/single-dose cartridge injectable solutions, lyophilized powder for injection, and inhalation solutions. In RDC development, our team has mastered optimized conjugation techniques for radionuclides and targeting vectors, offering innovative technologies to support precision oncology diagnostics and therapy. As of the end of 2024, our team has supported over 100 new drug development projects (covering preclinical to Phase III stages), primarily focused on GLP-1 analogs, other peptide drugs, and RDCs. We have also successfully completed 5 generic drug consistency evaluation projects involving injectable and other formulations.
As a technology-driven team, we remain committed to innovation and continuous translation of research into real-world solutions. Our efforts not only provide safe and effective formulation solutions to the global pharmaceutical market, promoting the clinical and industrial application of peptide and RDC drugs, but also establish a strong competitive edge in the field of generic drug consistency evaluation.
Pre-formulation Research
As a key preliminary step in drug development, pre-formulation research serves as a critical link between drug discovery and formulation design. Its technical quality directly impacts dosage form development and process feasibility.
For new drug development, we systematically conduct studies on the key properties of APIs — including solubility testing, polymorph screening, forced degradation analysis, and preliminary stability assessments — to accurately identify physicochemical characteristics and potential degradation pathways. These insights serve as the foundation for formulation design, process optimization, and quality standard development, ultimately reducing R&D risks and improving druggability from the outset
In generic drug development, in-depth analysis of the reference listed drug (RLD) is a central focus of pre-formulation research. Through reverse engineering, we decode the formulation composition, manufacturing process, and critical quality attributes (CQAs) of the originator drug. This enables targeted guidance for formulation matching and process reproduction, and, in line with the Quality by Design (QbD) approach, ensures that the generic product achieves equivalence in safety, efficacy, and quality control—laying a solid technical foundation for successful consistency evaluation.
Formulation Development
As a vital bridge between drug development and industrialization, formulation development plays a key role in translating lab results into clinical applications. Our team focuses on innovative formulation technologies and scalable industrial requirements, building a full-process development system covering formulation design, process optimization, quality research, and pilot-scale production. We offer customized solutions tailored to different drug types (small molecules, peptides, radiopharmaceuticals) and dosage forms (injectables, inhalation products, sustained-release formulations).
In new drug formulation development, we base our work on pre-formulation data and consider the intended indication and administration route for dosage form and process design. For the stability challenges of peptide drugs, we have developed multi-dose/single-dose cartridge injectable solutions and lyophilized powder injections. By optimizing buffer systems and lyophilization processes, we significantly improve product stability. For RDCs, we have established precise conjugation processes between targeting vectors and radionuclides along with quality control systems to ensure effective and safe radiolabeling. Using computer-aided formulation design (CADD) and QbD principles, we systematically optimize formulations and process parameters to precisely control key performance indicators such as dissolution, release profiles, and targeting behavior.
In generic drug development, we combine reverse engineering of RLDs with forward process optimization to achieve formulation and process equivalency. For complex dosage forms like injectables and inhalation solutions, we accurately match CQAs such as particle size distribution, purity, and impurity profiles. Through process scale-up and pilot-scale validation, we ensure that generics match the reference drug in safety, efficacy, and manufacturing controllability—enabling efficient regulatory approval.
To date, we have successfully supported over 30 formulation development projects for both new and generic drugs, including GLP-1 drugs, peptide sustained-release formulations, and RDCs. We have overcome technical bottlenecks such as peptide degradation, low radiolabeling efficiency, and scale-up challenges in complex dosage forms. From lab-scale trials to GMP-compliant pilot production, we are powered by dual engines of “technological innovation + industrial translation,” providing comprehensive support for new drug development from concept to clinic, and enabling high-quality, cost-effective mass production of generics that drive efficient transformation from R&D results to clinical value.
Formulation Manufacturing
As the final step in translating drug R&D into clinical use, formulation manufacturing is the critical link that connects laboratory innovation with commercial products. Relying on our globally integrated production facilities and intelligent manufacturing lines, we have established a full-chain production system covering pilot scale-up, process validation, and commercial-scale production. With strong capabilities across multiple dosage forms, products, and specifications, we meet the capacity needs of innovative drugs from clinical development to commercialization, while supporting the high-quality, large-scale production of generic drugs.
1. Technical Capabilities & Manufacturing Infrastructure
Diversified dosage form capabilities: For complex drugs such as peptides and RDCs, we have established GMP-compliant specialized production systems for multi-dose/single-dose cartridge injectable solutions and lyophilized powder injections. Equipped with automated filling, lyophilization, and sterile filtration technologies, we ensure end-to-end automated control from raw material input to finished product packaging.
For peptide formulations, we address stability challenges through buffer system optimization, tailored lyophilization profiles, and cold chain storage solutions. Our full-process scale-up platform, built on the QbD framework, enables smooth transition from lab-scale trials to pilot-scale manufacturing (10L–100L), ensuring process reproducibility and batch-to-batch consistency via systematic evaluation and validation of critical process parameters (CPPs).
Innovative drug support: Our production system covers clinical Phase I–III sample manufacturing and registration batch submissions, accelerating new drug development timelines.
Generic drug production: We offer rapid process transfer and scale-up solutions to meet global demand for cost-effective, high-quality generics.
2. Quality Control & Compliance
We have established a comprehensive lifecycle quality management system covering raw material inspection, in-process monitoring, and final product release. Our facilities are equipped with advanced analytical instruments such as HPLC, LC-MS, and radio-TLC scanners, enabling accurate assessment of CQAs including impurity profiles, content uniformity, sterility, and radiolabeling efficiency.
Our manufacturing sites are certified by the China NMPA for GMP compliance and adhere strictly to ICH guidelines, ensuring full traceability and international regulatory alignment for our global clients.
3. Industrial Value & Achievements
To date, we have successfully scaled up and commercialized over 100 formulation products, including GLP-1 injectables, peptide sustained-release formulations, and targeted RDC drugs. Our annual production capacity reaches tens of millions of doses/vials. We provide “one-stop” manufacturing services that support innovative drugs from clinical samples to market launch, significantly shortening time-to-market. Through process optimization and automation upgrades, we help generic drug clients achieve cost control and quality improvement, enhancing the global accessibility of high-value therapeutics.
From technology translation to mass production, we uphold the principles of “quality first, efficiency driven,” seamlessly integrating R&D with manufacturing to become a trusted partner in turning pharmaceutical innovations into clinical solutions worldwide.
