Directory of Peptide API Manufacturing Plants

Sinopep-Allsino Biopharmaceutical is a global commercial API provider and full-service CDMO focused on end-to-end CMC development and commercial production of peptides, oligonucleotides and small molecule APIs. Serving global innovative pharmaceutical companies since 2009, it has passed four US FDA inspections and strictly follows FDA and ich guidelines. The peptide production capacity reaches 20–30 metric tons per year; a large-scale GMP oligonucleotide base has been built in Lianyungang, Jiangsu Province (annual output can reach thousands of kilograms, containing ASO, siRNA, GalNAc, AOC, liposomes and other conjugates). Services cover polypeptide/oligonucleotide CDMO, FTE, discovery services, generic APIs and preparations (oral solid preparations, lyophilized powder injections, etc.), providing process development, analytical method development and validation, stability research, and IND/NDA regulatory support to achieve a seamless connection from early development to commercial supply.

Teide Pharmaceutical (Zhejiang) Co., Ltd. (stock code 03880.HK) is a contract research, development and production organization (CRDMO) specializing in polypeptides, providing full-cycle services from early discovery, pre-clinical, clinical development to commercial production. Headquartered in Hangzhou, China, it has commercial production bases and offices in China and the United States, and has been deeply engaged in the field of polypeptides for more than 20 years. Provides CRO (polypeptide new chemical molecular entity discovery synthesis) and CDMO (polypeptide CMC development and commercial production) services, and has extended to oligonucleotide CDMO since 2021. It has provided more than 1,000 customers worldwide with support for the synthesis, development, production and CMC declaration of polypeptides that meet the regulatory requirements of major markets around the world. The project covers more than 50 countries such as China, the United States, Japan, Europe, South Korea and Australia. Clients include large pharmaceutical companies, biotech companies, virtual pharmaceuticals and start-ups. The peptide biochemical tirpopeptide drug substance in the subsidiary has completed the US FDA DMF registration.

Founded in 2000, Suzhou Tianma Pharmaceutical Group Tianji Biopharmaceutical Co., Ltd. is a high-tech enterprise and enterprise technology center in Jiangsu Province. The company's new industrial base has been completed and put into operation in Jiangsu Changshu New Material Industrial Park. It is planned to be built according to the high standards of the pharmaceutical industry at home and abroad, and is the core carrier for the integration of polypeptide and small molecule drug research and development and commercial production. Representative peptide/polypeptide preparation products include: cortisol ® terlipressin for injection, Amgas ® octreotide acetate injection, Anqi ® carbetocin injection, lidine ® thymus method for injection, etc. The base can meet the needs of capacity upgrades and business development, and provide reliable products and professional technology solutions for domestic and foreign pharmaceutical partners. (Note: Group subordinates contain a small amount of non-pharmaceutical sectors such as hotels, etc., which have been omitted.)

Zhejiang Peptide Biotechnology Co., Ltd. (a national-level specialized and new key "small giant" enterprise) focuses on the research and development, production and application of polypeptides. It has a national post-doctoral scientific research station, Shaoxing academician expert workstation and provincial enterprise research institute. It is the first polypeptide synthesis engineering research center in Zhejiang Province. It has obtained 108 relevant invention patents and is one of the domestic leaders in the large-scale production of polypeptides. The company builds a "one main two-wing, two-wheel drive" strategy: mainly pharmaceutical polypeptides and technical services, and cosmetic polypeptides and other polypeptides are two wings. The product line includes more than 60 kinds of peptide APIs, covering obesity, diabetes, gastrointestinal diseases and other fields. Many core products have been filed/approved in many countries; more than 40 kinds of cosmetic peptide raw materials cover anti-wrinkle, anti-aging, repair, whitening and so on. The production system has passed FDA certification in the United States and has been certified by halal, EcoVadis, ISO and other management systems. With large-scale production capacity: the annual output of polypeptide powder is 8000kg, and the annual output of polypeptide bulk solution is 2000t. Products are exported to the United States, the European Union, Canada, South Korea, Japan, Russia, etc., and establish stable cooperation with internationally renowned companies.

Shenzhen Han Yu Pharmaceutical Co., Ltd. (listed on the Shenzhen Stock Exchange, 300199, listed in 2011) is a national high-tech enterprise specializing in the R&D, production and sales of polypeptide drugs and small nucleic acids. Founded in 1998, it is an early listed polypeptide drug enterprise in China. The company has built a national and local joint engineering laboratory for polypeptide drugs, a national public experimental center for innovative polypeptide drugs, and a national pilot technology platform for the preparation of polypeptide drugs. It has undertaken a number of national-level projects and won the second prize of the National Technology Invention Award. It has passed the GMP/cGMP certification in China, the United States, the European Union, Brazil, Australia, South Korea and other countries, and has four major production bases: Shenzhen Pingshan Preparation Base, Wuhan Peptide Featured API Base (through the China/United States/Australia GMP certification, which is being expanded), Gansu Chengji Pharmaceutical Intermediates Base, Yunnan Dali Industrial Hemp Base, etc., to open up the whole chain control from raw materials to drugs. The APIs are sold to 20 + countries and regions, and the preparations are sold to 90 + countries and regions. The polypeptide products include GLP-1 injections such as liraglutide, smeclutide, tirpotide, etc., atoxiban, etibapeptide, etc., and have CRDMO (custom R&D + custom production) capabilities. The monomer reactor capacity is 100L-10000L.

Shenzhen Jianxiang Biotechnology (JYMed/Jianyuan Pharmaceutical) is a CDMO enterprise specializing in polypeptides, providing polypeptide API R&D and GMP production from milligrams to tons. With 13 cGMP production lines and 85,000 L spps/LPPS reactor volumes, the Hubei base has an annual production capacity of 10 + tons and has passed FDA, NMPA, and EDQM inspections. Employees of 650 + are located in Shenzhen (7,000 ㎡ R&D center), Hubei (52,000 ㎡ API production base, OEB-5 isolation), and Shenzhen (formulation FDF base). Services cover custom synthesis, polypeptide API manufacturing (long chain, unnatural amino acids, conjugates), cosmetics/veterinary drugs/health peptides and CDMO, supporting 1 g R&D to 100 kg commercial batches. With 20 + years of experience in peptide chemistry and CDMO, we provide peptide intermediates, APIs and CDMO services to pharmaceutical companies worldwide.

Nortex Biotech (stock code 688076) focuses on polypeptide drugs and small molecule drugs, adopts the combination of independent R&D and custom R&D and production, and forms self-developed and customized two-wheel drive in the fields of advanced pharmaceutical intermediates, APIs and preparations. The company was established in Lianyungang in 2009 and listed on the Science and Technology Innovation Board in 2021. Its Hangzhou Aosino focuses on the R&D and production of new small molecule drugs, advanced intermediates and peptide fragments (Zhejiang Hangzhou R&D Center + Jiande GMP Commercialization Base). In terms of peptide APIs, there is a large production capacity of side chain chemically modified peptides and long chain modified peptides with a single batch of 10 kg or more, and the production capacity of peptide APIs has reached tonnage (expected to reach several tonnage by the end of 2025). A quality management system in line with USFDA/EDQM/NMPA has been established. The Lianyungang factory has successively passed the US FDA on-site inspection/flight inspection, South Korea MFDS, Brazil ANVISA and other inspections. The R&D team is led by experts such as the "100 Talents Program" of the Chinese Academy of Sciences, and provides CDMO/CMO services from advanced intermediates and APIs to preparations for innovative pharmaceutical companies around the world. It has R&D centers and production bases in Hangzhou/Lianyungang/Jiande and more than 2,000 employees.

Sinopep-Allsino Biopharmaceutical is a global supplier of commercial grade APIs and a full range of polypeptide/oligonucleotide CDMOs. Providing end-to-end CMC development and cGMP production from early R&D to commercialization for new drugs (NCE) and innovative pharmaceutical companies since 2009. The company's current production capacity of polypeptides is about 20–30 tons/year. It has built a large-scale GMP oligonucleotide (ASO, siRNA and GalNAc, AOC, liposome and other conjugates) production facility that can produce thousands of kilograms per year in Lianyungang, Jiangsu Province. At the same time, it has small molecule generic drugs and NCE commercial production capacity. The quality and regulatory system is mature. It has passed four FDA on-site inspections, strictly follows FDA and ich guidelines, and provides process development, analytical method development and verification, stability research, and global IND/NDA declaration support.