chenkaijie@csmspharm.com
Founded in 2019, Morning Shine is a technology - driven company specializing in high - quality raw materials, pharmaceutical intermediates, and CRO services for the global markets. Staying true to our mission - "Technology Shapes Quality" - we continue to drive innovation to elevate pharmaceutical product quality worldwide.
Our R&D team includes over 200 highly skilled professionals with master's and doctoral degrees in chemical synthesis, separation & purification, quality research and biotechnology. With an investment exceeding $25 million in advanced R&D instrumentation - including: 600 MHz and 400 MHz NMR spectrometers, and multiple high - resolution mass spectrometers such as Orbitrap Fusion™ Q Exactive™, and Triple TOF™ - we are equipped to support cutting - edge pharmaceutical innovation. With a multidisciplinary technology platform, we have built strong capabilities in the chemical synthesis, separation and purification and comprehensive quality research of challenging compounds.
We operate a 33,000 m² GMP factory with reactor volumes ranging from 200L to 10,000L. The facility is capable of handling a variety of challenging chemical reactions—including low/high - temperature, hydrogenation, and high - pressure processes—ensuring a seamless transition from lab - scale development to commercial production, guaranteeing both product quality and service reliability.
Our key offerings include fatty acid side chains and short peptides for GLP-1 drugs manufacture. We have achieved single-batch production >300 kg with inventory >100 kg for key side chains, and single impurity level consistently below 0.10%. Backed by comprehensive quality research, our products fully support global regulatory submissions. Morning Shine is the No.1 supplier of fatty acid side chains for GLP-1 drugs such as semaglutide and tirzepatide in China by market share.
We offer PEG derivatives manufactured through proprietary synthesis and purification processes, ensuring ultra-low levels of chain length variants (e.g., ≤0.10% in PEG8, ≤0.15% in PEG12, and ≤0.4% in PEG24). Custom end-group modifications are available to meet specific drug design needs.
We provide high-purity building blocks for nucleic acid therapeutics, including cap analogs, GalNAc (with purity >99.5% and single impurity <0.10%), and linkers.
Our offerings span both small-molecule and biologic pipelines, with core strengths in end-to-end API development, regulatory support and supplemental studies, impurity profiling and genotoxicity assessments. In the biologics, we specialize in the development of antibodies, ADCs, peptides, and nucleic acid drugs, including proteomics-based research. Backed by an advanced technology plat-form and a proven track record, we are a trusted CRO/CDMO partner to pharmaceutical innovators.
Read MoreCurrently in a phase of rapid and robust development, Changsha Morning Shine Co., Ltd. has, since its founding, established in-depth collaborations with over 1,000 domestic and international pharmaceutical companies, ranging from large-scale enterprises to mid-sized innovators. Leveraging strong technical capabilities and exceptional service quality, the company has built an extensive and stable global partnership network.
Each partnership reflects a vote of confidence in our capabilities and a shared commitment to innovation and excellence in pharmaceutical development. We consistently prioritize our partners’ needs, offering innovative solutions, outstanding technical expertise, and full lifecycle support to safeguard project outcomes. This commitment has earned us wide acclaim and a strong reputation across the pharmaceutical industry.
Looking ahead, we will continue to deepen existing collaborations and forge new partnerships, jointly advancing the high-quality development of the global pharmaceutical industry.
The core team members have been engaged in new drug research and development for over a decade, with extensive experience in synthesis. We are familiar with GMP production and have a deep understanding of regulatory requirements.
We have the top-level analysis team in China to ensure that we can develop high-quality products. The head of the department has been responsible for over 100 generic drug R&D projects and has a deep understanding of product quality research.
We have developed a series of technical means such as liquid-liquid extraction, normal phase/reverse phase preparative separation, and recrystallization.
We have implemented a comprehensive and integrated Environment, Health, and Safety Management System (EHS-MS) and ISO9001 Quality Management System (QMS)
our capabilities have been accredited by China National Accreditation Service for Con - formity Assessment (CNAS) (registration number: CNAS L16409). We strive to ensure the compliance of all research activities and the stability of product quality.
We have employed an Electronic Laboratory Notebook (ELN) integrated within the Laboratory Information Management System (LIMS), ensuring data integrity and providing clearer, more accurate, and more efficient standardized records compared to traditional paper-based documentation.
The network-based database can realize hierarchical permission management, audit tracking, real-time data backup, and ensures security and compliance.
Since 2020, we have successfully passed over 100 official and client audits, and received unanimous praise from our clients.
We have 2 sets NMR, 5 sets HRMS, 16 sets LC-MS and MS/MS, 4 sets GC-MS and MS/MS, 60+ sets HPLC, 30+ sets Pre-HPLC. Additionally, we are equipped with other advanced instruments including SFC, ICP-MS, ICS, IR, Ultramicro UV-Vis, Protein Purifier, Multimode Microplate Reader, and more to support comprehensive analytical needs.
