About

Founded in 2001, we are the third largest peptide-focused contract research, development, and manufacturing organization (“CRDMO”) worldwide in terms of sales revenue in 2023, according to Frost & Sullivan. We are also considered one of the most comprehensive peptide-focused CRDMO globally (Frost & Sullivan), offering complete life-cycle support from early-discovery, pre-clinical research and clinical development to commercial production.

We mainly provide (i) contract research organization (“CRO”) services, including peptide new chemical entity (“NCE”) discovery synthesis; (ii) contract development and manufacturing organization (“CDMO”) services, including peptide chemistry, manufacturing, and controls (“CMC”) development; and (iii) contract manufacturing organization (“CMO”) services, including peptide NCE and generic drug commercial manufacturing. We have established global operations, with projects covering over 50 countries, including major markets in the United States, China, Japan, Europe, South Korea, and Australia. We also provide customers wit peptide drug development, production, and CMC filing support services that meet regulatory requirements in major markets worldwide.
We are a full-service peptide-focused CRDMO with vertically integrated capabilities in peptide drug development and manufacturing. Given the increasing complexity of new peptide drugs, which makes the development and manufacturing of peptides a time- and capital-intensive process, our tailored services are ideally suited for pharmaceutical and biotechnology companies seeking outsourcing solutions for their development and manufacturing needs.
Current Manufacturing Facilities

Our operations in China are conducted in our facility located at No. 69, Street 12 of Qiantang District, Hangzhou (“Qiantang Site”), situated on our approximately 26,000 square meter CGMP campus. The constructed manufacturing CGMP facility has a gross floor area (“GFA”) of over 15,000 square meters. Our production facilities adhere rigorously to CGMP as mandated by major regulatory authorities globally, including the U.S. Food and Drug Administration (“FDA”), National Medical Products Administration (“NMPA”), European Medicines Agency (“EMA”), Therapeutic Goods Administration (“TGA”), and Korean Ministry of Food and Drug Safety (“MFDA”). We have successfully passed four FDA audits without receiving FDA-483 observations (FDA notice highlighting regulatory violations found during an inspection) as of the Latest Practicable Date (“LPD”). In addition, our facility holds ISO9001 and ISO13485 certifications for quality management systems. As of the Latest Practicable Date, our Qiantang Site contains 19 peptide synthetic production suites with reactor volumes ranging from 20 to 1,000 liters, and 16 purification suites with HPLC column sizes of up to 30 inches. This site has an annual API production capacity of 500 kilograms and per-batch capacity of 20 kilograms with a utilization rate of 49% in 2023 and is capable of handling multiple 100 kilogram-level purchase orders. More recently, the Qiantang Site has been adapted to enable the manufacturing of 1-17 kilograms of oligonucleotides per year.

In addition to the Qiantang Site, we also have GMP production facilities under construction in the United States and Hangzhou, China, with a total GFA of 4,000 and 26,700 square meters, respectively. All our production facilities are equipped with advanced equipment and instrumentation supplied by top-tier equipment suppliers such as Agilent, Waters, Thermo Fisher, Cytiva, Jianbang, and Hanbang.