Developing Highly-Innovative Drugs to

Address Patients’ Unmet Medical Needs

Innovative Drug Business

Driven by the mission of addressing patients’ unmet needs, Hepalink focuses on the acquisition, development and commercialization of highly-differentiated innovative drugs, having already built a rich pipeline of novel drug candidates.

A portfolio of over 20 first-in-class drug candidates targeting more than 30 indications
5 drug candidates are already in global Phase III studies and over 10 drug candidates are in global Phase II studies
10 of Hepalink’s pipeline assets came with full development and commercial rights for Greater China, and 3 of them are already in global Phase III studies
Target / Pathway Indication Partner Rights Holder in China Preclinical Ph1 Ph2 Ph3 MRCTs1 Participated by Hepalink
Oregovomab CA125
Primary advanced ovarian cancer

(Greater China incl. HK, Macau and TW)

Pancreatic cancer (CA125+)
AR20.5 MUC1
Pancreatic cancer (Anti-MUC1 AR20.5)
Tosatoxumab (AR-301) α-toxin released by Gram-positive staphylococcus aureus
Ventilator-associated pneumonia due to S. aureus infection(HAP/VAP)
Shenzhen Aridis3

(Greater China incl. HK, Macau and TW)

AR-101 Gram-negative pseudomonas aeruginosa O11 serum
Ventilator-associated pneumonia (HAP/VAP) due to pseudomonas aeruginosa infection
Apabetalone (RVX-208) BD2 domain of BET family proteins Reduction of major adverse cardiovascular events (MACE) in patients with Type II diabetes Resverlogix

(Greater China incl. HK, Macau and TW)

Diabetic nephropathy
Fabry disease
H1710 Heparanase (HPA) Solid tumors In-house discovered Hepalink(Global)
On-going trial initiated by Hepalink
On-going trial initiated by Hepalink’s subsidiary
MRCTs that have been initiated by Hepalink in China
MRCTs that will be initiated by Hepalink in China at pivotal stage

1. MRCT, multiregional clinical trials, which is a type of clinical trials widely adopted by global pharmaceutical companies to effectively advance novel therapies across regions

2. OncoVent is a subsidiary of which Hepalink holds controlling stake

3. Aridis is a subsidiary of which Hepalink holds controlling stake

A monoclonal antibody that activates CA123-specific T cell immune response
Fast Track Designation by the U.S. FDA; Orphan Drug Designations by the U.S. FDA and EMA of the EU
The treatment of patients with primary first-line ovarian cancer
Clinical Progress:
A global multicenter Phase III trial is currently enrolling patients, with a New Drug Application (NDA) submission in the U.S. expected in 2024.
A BET bromodomain protein inhibitor
Granted a Breakthrough Therapy Designation by the U.S. FDA (January 2020), which is the second Breakthrough Therapy Designation in the cardiovascular field in the past 5 years
In combination with standard of care therapies including high-intensity statins, for the secondary prevention of major adverse cardiac events (MACE) in patients with type 2 diabetes who have recently experienced acute coronary syndromes.
Clinical Progress:
  1. The BETonMACE 2 trial will soon be initiated and the breakthrough Phase III BETonMACE trial was already completed in September 2019. Although the Phase III BETonMACE trial did not reach its primary endpoint, the FDA has encouraged the continued exploration of the subgroups in the BETonMACE2 trial. In June 2020, the overall design for the BETonMACE 2 trial of RVX-208 was accepted by the FDA, and the FDA has agreed that if the interim analysis shows adequate efficacy and safety, then an NDA can be directly submitted to the FDA.
A fully human IgG1 monoclonal antibody targeting S aureus α-toxin
A Fast Track Designation from the U.S. FDA, and Orphan Drug Designations from both the U.S. FDA and EMA of the EU
The treatment of ventilator associated pneumonia (VAP) caused by S. aureus
Clinical Progress:
A global multicenter Phase III trial is currently enrolling patients and has already dosed patients in China.
A heparanase (HPA) inhibitor
Solid tumors, and will be first developed for the treatment of pancreatic cancer
Clinical Progress:
Currently in preclinical development with Investigational New Drug (IND) applications in China and the U.S. expected in Q4 2022 to Q1 2023