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 | ph1 | ph2 | ph3 | mrcts1 participated by hepalink |
|---|---|---|---|---|---|---|---|---|---|
| oregovomab | ca125 |
primary advanced ovarian cancer
|
oncoquest |
oncovent2
（greater china incl. hk, macau and tw) |
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pancreatic cancer (ca125 ）
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| ar20.5 | muc1 |
pancreatic cancer (anti-muc1 ar20.5)
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| 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） |
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| ar-101 | gram-negative pseudomonas aeruginosa o11 serum |
ventilator-associated pneumonia (hap/vap) due to pseudomonas aeruginosa infection
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| 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） |
betonmace1
betonmace2
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| diabetic nephropathy |
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| fabry disease |
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| h1710 | heparanase (hpa) | solid tumors | in-house discovered | hepalink（global） |
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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
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.