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 primarily on PCC identification, preclinical research and clinical medical studies for Category I innovative drug candidates. 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

Target Screening Platform Our pipeline strategy for both Category I innovative drugs and Category II modified new drugs begins with identifying unmet clinical needs, then systematically evaluates potential targets based on their biological mechanisms, translational research data, and real-world evidence to select promising candidates with differentiated advantages. For each target under consideration, we conduct comprehensive evaluation — analyzing its mechanism of action, disease relevance, and therapeutic potential to predict both efficacy and safety profiles.

Innovative Drug Discovery Platform We have established a proprietary oral small-molecule drug design platform that designed to accelerate the identification and optimization of high-quality drug candidates while enhancing R&D efficiency and success rates. This platform focuses on therapeutically important target classes — including G protein-coupled receptors, kinases, and proteases — which regulate critical physiological and pathological processes, enabling the rational design of novel compounds with optimal oral bioavailability and target specificity.

Clinical Development Technology Platform Our clinical development platform oversees the end-to-end design and execution of clinical trials for innovative drugs, incorporating preclinical findings, target mechanisms, and fundamental medical research to optimize trial protocols. During trialimplementation, we address compound-specific technical challenges through close collaboration with leading hospitals and healthcare professionals.

CMC Development Platform We have established several key platform technologies: (i) API development technologies encompassing chiral drug synthesis, crystallization engineering, and salt formation; (ii) novel formulation including solubility enhancement for poorly soluble drugs,sustained-release formulations, and fixed-dose combination; and (iii)quality-focused analytical tools including analytical method development, impurity profile characterization, and genotoxic impurity detection. Our CMC development platform was instrumental to the successful commercialization of marketed products, including our Category II modified new drug, Zuoyu, and multiple first-to-market generic products in China.

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

  • Construct according to the new
    version of GMP regulations,
    construct according to the GMP
    requirements of the European
    Union and the United States,
    and plan to apply for certification
  • 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
12 Suzetrigine (VX-548) Pain control In House
13 Relugolix For treatment of advanced prostate cancer In House
14 Cabozantinib S-Malate Anti-Cancer
15 Palbociclib Anti-Cancer In House
16 Ibrutinib Anti-Cancer In House