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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

4 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

Drug Candidate	Target / Pathway	Indication	Partner	Rights Holder in China	Preclinical
The progress in the research and development of Hepalink's first/best-in-class drug candidates
Oregovomab	CA125	Primary advanced ovarian cancer	OncoQuest	OncoVent² （Greater China incl. HK, Macau and TW)
Oregovomab	CA125	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）	Aridis	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	Aridis	Shenzhen Aridis³ （Greater China incl. HK, Macau and TW）
Apabetalone (RVX-208)	BD2 domain of BET family proteins	Reduction of major adverse cardiovascular events (MACE) in patients with Type II diabetes	Resverlogix	Hepalink （Greater China incl. HK, Macau and TW）	BETonMACE BETonMACE2
		Diabetic nephropathy
		Fabry disease
H1710	Heparanase (HPA)	Solid tumors	In-house discovered	Hepalink（Global）

Trials to be 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

oregovomab

Mechanism：

A monoclonal antibody that activates CA123-specific T cell immune response

Designation：

Fast Track Designation by the U.S. FDA; Orphan Drug Designations by the U.S. FDA and EMA of the EU

Indication：

The first-line treatment of patients with advanced primary ovarian cancer

Clinical Progress：

As of June 30, 2022, clinical study was initiated at 130 trial sites around the world, having enrolled a total of 330 patients. OncoQuest is currently preparing for adding the non-clinical tests required by the CDE and will soon submit an IND to the CDE in order to expand the multi-regional clinical trial (MRCT) to China.

apabetalone（RVX-208）

Mechanism：

BET bromodomain protein inhibitor

Designation：

Breakthrough Therapy designation by the US FDA

Indication：

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：

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. Hepalink is poised to accelerate the development of this drug candidate, including those planned clinical trials as well as the implementation of its overall drug development strategy.

tosatoxumab（AR-301）

Mechanism：

A fully human IgG1 monoclonal antibody targeting S aureus α-toxin

Designation：

A Fast Track Designation from the U.S. FDA, and Orphan Drug Designations from both the U.S. FDA and EMA of the EU

Indication：

The treatment of ventilator associated pneumonia (VAP) caused by S. aureus

Clinical Progress：

As of June 30, 2022, the study has enrolled a total of 166 patients globally. Among them, 104 patients met the criteria for modified intention-to-treat (mITT).

H1710

Mechanism：

Heparanase (HPA) inhibitor preparation

Indication：

The non-clinical pharmacodynamic studies of H1710 have already observed promising antitumor activity in multiple tumor models in comparison with standard of care therapies.

Clinical Progress：

As of June 30, 2022, Hepalink has completed the production of H1710 API and preparation. The stability studies of the API and preparation are still on-going, and the stability study of the H1710 preparation is expected to last three months. The compatible stability study and impurity analysis of the H1710 preparation have already been completed.