深圳市海普瑞药业集团股份有限公司-k8凯发国际娱乐大厅

pipeline

thanks to the sound logic of hepalink’s new drug layout, we now boast dozens of first-in-class pipeline drugs for cardiovascular diseases and tumors and the equity of several mid and late stage clinical drugs in greater china.

equity drugs under research in greater china

based on hepalink’s logic of screening and distributing pipeline drugs, and to meet the significant yet unsatisfied clinical demand, we have made strategic investment in several biotechnology companies with first-in-class drug candidates and attained exclusive rights in greater china to develop and commercialize several drug candidates. among these are two at ph3 clinical trials, two at ph2 clinical trials, and one at ph1 clinical trials. moreover, a self-discovered proprietary oncology drug candidate is at the pre-clinical stage.

multi-regional clinical trials (mrct)

as for drug candidates that we have exclusive rights to develop and commercialize in greater china, hepalink plans to establish clinical stations in china to join corresponding multi-regional clinical trials (mrct), such as oregovomab and the ph3 trial of ar-301, which has been approved by the national medical products administration. mrct data can be submitted to international conference on harmonization (ich) and many regulators of non-ich countries. mrct can help us release drug candidates more quickly in china.

overview of innovative drugs

hepalink initiated the trials the companies hepalink invested initiated the clinical trials the company hepalink invested plans to initiate the clinical trials for new indication based on the ph3 clinical data of type 2 diabetes with coronary heart disease hepalink has initiated the china portion mrct hepalink plans to initiate the respective china portion mrcts once entered pivotal phase

candidate drugs
target / mechanism of action
indication
partner
business interests
ind phase i clinical phase ii clinical phase ⅲ clinical
mrct

oregovomab
immunological stimulation after binding to ca125 antigen
primary late-stage ovarian cancer

recurrent late-stage ovarian cancer
((oregovomab hiltonol))

recurrent late-stage ovarian cancer
((oregovomab pd-1inhibitor nivolumab))

recurrent late-stage ovarian cancer
((oregovomab pd-1 inhibitor nivolumab))
oncoquest(hepalink shareholding 35.18%)
greater china(owned by oncovent)

mab-ar20.5
immunological stimulation after binding to muc1 antigen
pancreatic cancer
oncoquest(hepalink shareholding 35.18%)
greater china(owned by oncovent)

ar-301
α-toxin released by gram-positive staphylococcus aureus
staphylococcus aureus pneumonia
aridis(hepalink shareholding 8.73%)
greater china(owned by shenzhen aridis)

ar-101
gram-negative pseudomonas aeruginosa o11 serum
pseudomonas aeruginosa pneumonia
aridis(hepalink shareholding 8.73%)
greater china(owned by shenzhen aridis)

rvx-208
domain of bet family member
type 2 diabetes with coronary heart disease

chronic kidney disease

new indication
resverlogix(hepalink shareholding 36.30%)
greater china(owned by hepalink)

h1710
heparanase (hpa)
pancreatic cancer
hepalink (in-house)
global(owned by hepalink)

tip：slide right to see more

1. mrct refers to multiregional clinical trials, which involves more than one independent center in enrolling and following clinical trial participants. it is widely conducted by many global pharmaceutical companies to reduce the time lag
of launching innovative drugs in different regions.

2. we directly hold 54.00% equity interest in oncovent and are entitled to additional economic interest through our 38.74% equity interest in oncoquest and our 14.94% equity interest in quest pharma tech, which together hold 40.00% equity interest in oncovent.

3. we directly hold 51.00% equity interest in shenzhen arimab and are entitled to additional economic interest through our 9.86% equity interest in aridis, which holds the remaining 49.00% equity interest in shenzhen arimab.

oregovomab

clinical progress
variety introduction

indication
ind phase i clinical phase ii clinical phase ⅲ clinical
mrct

primary late-stage ovarian cancer

recurrent late-stage ovarian cancer ((oregovomab hiltonol))

recurrent late-stage ovarian cancer ((oregovomab pd-1inhibitor nivolumab))

recurrent late-stage ovarian cancer ((oregovomab pd-1 inhibitor nivolumab))

tip：slide right to see more

brief introduction：

oregovomab, a first-in-class experimental immunotherapy against ca125, will be used for the first-line treatment of primary and recurrent late-stage ovarian cancer. as of today, the world has not seen approved or commercialized immunotherapy or monoclonal antibody against ca125 for ovarian cancer. thanks to the indication to primary late-stage ovarian cancer, oregovomab was granted orphan drug designation by fda and ema, making it the leader of the global pipeline.

commercial rights：greater china(owned by oncovent)
cooperative partner：oncoquest(hepalink shareholding 35.18%)

mab-ar20.5

clinical progress
variety introduction

indication
ind phase i clinical phase ii clinical phase ⅲ clinical
mrct

pancreatic cancer

tip：slide right to see more

brief introduction：

mab-ar20.5, a first-in-class immunotherapy drug, is an active mouse monoclonal antibody igg1. the drug, with strong affinity, can be bound to muc1 antigen and will be used to treating pancreatic cancer and muc1 expression tumor. currently, the world has not seen approved or commercialized immunotherapy or antibody against muc1 for pancreatic cancer.

commercial rights：greater china(owned by oncovent)
cooperative partner：oncoquest(hepalink shareholding 35.18%)

ar-301

clinical progress
variety introduction

indication
ind phase i clinical phase ii clinical phase ⅲ clinical
mrct

staphylococcus aureus pneumonia

tip：slide right to see more

brief introduction：

ar-301 is a fully human monoclonal igg1 antibody (mab) that specifically targets s. aureus alpha-toxin. it is used as an adjunctive therapy to standard of care antibiotics to treat patients diagnosed with ventilator associated pneumonia (vap) caused by s. aureus. it was granted fast track designation by fda and orphan drug designation by ema.

commercial rights：greater china(owned by shenzhen aridis)
cooperative partner：aridis(hepalink shareholding 8.73%)

ar-101

clinical progress
variety introduction

indication
ind phase i clinical phase ii clinical phase ⅲ clinical
mrct

pseudomonas aeruginosa pneumonia

tip：slide right to see more

brief introduction：

ar-101 is a first-in-class human body igm monoclonal antibody that targets the lps on the surface of pseudomonas aeruginosa serotype o11. it is used to treat serious vap or hap patients. it serves as an adjunctive therapy to pseudomonas aeruginosa pneumonia germs to promote complement fixation. this antibody-complement compound leaves germs to be engulfed and killed by improving the recognition capability of the immune cells of hosts. ar-101 is a first-in-class anti-infection monoclonal antibody to which no approved, commercialized or clinical drugs shares similar mechanism. compared to traditional therapies, it is a lot safer and much less resistant to drugs. therefore, it may one day become the best standard of care.

commercial rights：greater china(owned by shenzhen aridis)
cooperative partner：aridis(hepalink shareholding 8.73%)

rvx-208

clinical progress
variety introduction

indication
ind phase i clinical phase ii clinical phase ⅲ clinical
mrct

type 2 diabetes with coronary heart disease

chronic kidney disease

new indication

tip：slide right to see more

brief introduction：

rvx-208 is a first-in-class experimental oral bet inhibitor that preferentially targets the second bromodomain (bd2) of bet proteins. when binding to bd2, it influences the biological process of chronic vascular diseases such as the coronary heart disease (chd) by impacting the expression of several genes that play a role in multiple cellular processes. it can be used to treat type 2 diabetes patients with chd and patients with chronic kidney disease, and reduce the risk of bad cardiovascular events for type 2 diabetes patients with high-risk cardiovascular disease and patients with acute coronary syndrome and high density lipoprotein cholesterol (hdl).

commercial rights：greater china(owned by hepalink)
cooperative partner：resverlogix(hepalink shareholding 36.30%)

h1710

clinical progress
variety introduction

indication
ind phase i clinical phase ii clinical phase ⅲ clinical
mrct

pancreatic cancer

tip：slide right to see more

brief introduction：

h1710 is a fully self-developed effective heparinase inhibitor. based on innovative anticancer mechanism, the drug enjoys potential significant scientific breakthrough. with unique structure and characteristics, it can effectively inhibit the activity of heparinase and the growth and metastasis of tumors, and reduce the heparinase expression outside tumor cells and inside tumors. besides, it can generate synergistic effects with cytotoxic drugs, target treatment or immunotherapy. by far, the world has not witnessed approved or commercialized heparinase inhibitor.

commercial rights：global(owned by hepalink)
cooperative partner：hepalink (in-house)