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R & D

R & D System

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.

R & D Platform

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.

R & D Achievements

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.

Manufacturing
FDF
Responsible for all the pilot-scale, trial and commercialized manufacturing of R&D projects.

Responsible for all the pilot-scale,
trial and commercialized manufacturing
of R&D projects.

Equipped with a full-fledged manufacturing and quality management system.

Equipped with a full-fledged manufacturing
and quality management system.

Lyophilized powder for injection workshop, oral solid workshop.

Workshop:Lyophilized powder for
injection workshop, oral solid workshop.

API

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
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