Huilun Pharmaceutical R&D Institute and Clinical Research Center were founded in Shanghai, responsible for all the pharmaceutical studies, preclinical & clinical studies and IND/NDA submissions of our R&D pipelines. As wholly-owned subsidiaries of Huilun, Shanghai Yidian Pharmaceutical technology development Co., LTD and Shanghai Yidi Biotech Co., LTD have their focus on the discovery of novel targets, identification of PCCs and the subsequent preclinical & clinical development. We are proud to have established a professional and regulated handling procedure from bench to bed to support the efficient translation of our R&D work. What’s more, with the implement of office automation and electronic lab notebook, our R&D workflow is paperless and highly organized with enhanced security backed up by ESAFENET and Citrix.
Huilun is devoted to the development of both generic and innovative drugs to fulfil the unmet clinical needs.
Preclinical Research Platform is responsible for the preclinical study of the pharmacology, efficacy and toxicity in research pipelines.
Pharmaceutical Research Platform is responsible for the study of API process chemistry, formulations and quality control.
Clinical Research Platform is responsible for all the clinical study in research pipelines.
Huilun is a high-tech enterprise recognized by Shanghai and the central government. We are proud to undertake multiple National Major Scientific and Technological Special Project for “Significant New Drugs Development”.
By 2022, we have filed over 100 patents, including 70 domestic patents, 20 international patents and 10 PCTs. Among them 47 patents have been granted, including 30 domestic patents and 17 international patents.
To date, Huilun has obtained over 40 clinical trial permissions approved by CFDA. 22 drugs were applied for the manufacturing licenses with 10 approved and 10+ APIs passed review. 3 Class I innovative drugs are currently undergoing clinical trials domestically and 1 of them was approved by FDA for commencing clinical trials in the United States.
Responsible for all the pilot-scale,
trial and commercialized manufacturing
of R&D projects.
Equipped with a full-fledged manufacturing
and quality management system.
Workshop:Lyophilized powder for
injection workshop, oral solid workshop.
International GMP Certification
-
Designed and being constructed in
accordance with the cGMP requirements,
and will be certified by EU and US -
Guarantees high standards of
manufacturing conditions
International Certification of APIs
-
Introduces international talents
along with globally acknowledged
instruments to improve manufacturing
quality standards. -
Aiming to pass the EU EDMF and CEP
certification to improve manufacturing
management standards. -
Applying for COS (Certificate of Suitability)
for exporting products
Quality Control System
- Emphasizes quality control systems
-
Stresses the importance of
QA training, with regular and
all-round internal and external
trainings for relevant
staffs (GMP management)
| NO. | Product | CAS No. | Category | Specification |
|---|---|---|---|---|
| 1 | Esomeprazole Sodium | 161796-78-7 | Gastrointestinal | EP |
| 2 | Sivelestat Sodium | 150374-95-1 | Respiratory | JP |
| 3 | Avanafil | 330784-47-9 | Andrology | In house |
| 4 | Silodosin | 160970-54-7 | Andrology | JP |
| 5 | Levofolinate Calcium | 80433-71-2 | Oncology | In house |
| 6 | Levofolinic Acid | 68538-85-2 | Oncology | In house |
| 7 | Temozolomide | 85622-93-1 | Oncology | USP, EP |
| 8 | Azacitidine | 320-67-2 | Oncology | In house |
| 9 | Sugammadex sodium | 343306-79-6 | Anaesthesia reversal | In house |
| 10 | Rivaroxaban | 366789-02-8 | Cardiovascular | EP |
| 11 | Ticagrelor | 274693-27-5 | Cardiovascular | EP |