Pipeline & science

Pipeline of seven novel assets in clinical development targeting nine indications.

Cardiovascular

Asset
Indication
Preclinical
Phase 1
Phase 2
Phase 3
Approval
  • China studies conducted by JIXING
  • Global studies conducted by partner

Omecamtiv Mecarbil

(cardiac myosin activator)
Preclinical
Phase 1
Phase 2
Phase 3
Approval
China participated the global multi-center Ph3 studies, China NDA submission accepted
FDA acceptance of NDA with PDUFA target action date of Feb.28, 2023

Omecamtiv Mecarbil

There is no cure for heart failure but there are various options to actively manage the disease and slow down progression. Unfortunately, current therapies all have limitations so that heart failure remains a leading cause of hospitalization and readmission in elderly people. Omecamtiv Mecarbil is a novel, selective cardiac myosin activator for the potential treatment for heart failure with reduced ejection fraction (HFrEF) by increasing cardiac contractility.

For further information about our partner, Cytokinetics, please visit cytokinetics.com

Aficamten

formerly CK274 (cardiac myosin inhibitor)
Preclinical
Phase 1
Phase 2
Phase 3
Approval
Ph1 completed | Joining global Ph3 in Q3 2022
Initiated global Ph3 (SEQUOIA-HCM) in Q1 2022
Preclinical
Phase 1
Phase 2
Phase 3
Approval
To be initiated
To be initiated
Preclinical
Phase 1
Phase 2
Phase 3
Approval
To be initiated
To be initiated

Aficamten

Aficamten (previously called CK-274) is a novel investigational small molecule cardiac myosin inhibitor that targets the underlying hypercontractility in HCM. In individuals with HCM, an excessive number of actin-myosin-cross bridges are formed in the sarcomere. Aficamten prevents a portion of active cross-bridges from forming with the aim to decrease contractility, reduce the left ventricular outflow gradient (LVOTG), and improve the symptoms of heart failure. Our partner, Cytokinetics, completed a Phase 2 study for aficamten in oHCM and is preparing to start a global Phase 3 study (SEQUOIA-HCM) by end of 2021. Following the successful completion of the China Phase 1 clinical study, JIXING will conduct the China cohort of SEQUOIA-HCM under its collaboration and license agreement with Cytokinetics starting in 2022.

For further information about our partner, Cytokinetics, please visit cytokinetics.com

Etripamil Nasal Spray

(short-acting calcium channel blocker)
Preclinical
Phase 1
Phase 2
Phase 3
Approval
Initiated Ph3 study in July 2022, parallel Ph1 study to be initiated 2H 2022
Ph3 completion in Q3 2022
Preclinical
Phase 1
Phase 2
Phase 3
Approval
To be initiated
Ph2 initiated in Q2 2021

Etripamil Nasal Spray

Etripamil nasal spray is a disruptive calcium channel blocker designed to keep patients out of the emergency room (ER) and operating room (OR). Etripamil can be self-administered, enabling a convenient and effective rapid treatment outside of the hospital setting. Etripamil is positioned to significantly alter the acute treatment of PSVT, allowing patients to quickly terminate episodes without the fear or inconvenience of having to rush to the ER for treatment.

Our partner, Milestone Pharmaceuticals, is currently conducting a second registrational Phase 3 trial in PSVT. In China, JIXING will conduct a Phase 1 study to evaluate the safety and tolerability of etripamil in healthy Chinese subjects and a Phase 3 study to evaluate the efficacy and safety of etripamil nasal spray self-administration in PSVT. Both clinical trials will start in 2022. 

For further information about our partner, Milestone Pharmaceuticals, please visit milestonepharma.com

Ophthalmology

Asset
Indication
Preclinical
Phase 1
Phase 2
Phase 3
Approval
  • China studies conducted by JIXING
  • Global studies conducted by partner

OC-01 Nasal Spray

(nAChR agonist in preservative-free formulation, US brand name TYRVAYA)
Preclinical
Phase 1
Phase 2
Phase 3
Approval
Initiated Ph3 study in July 2022, parallel Ph1 study to be initiated 2H 2022
FDA Approval received October 2021

OC-01 Nasal Spray

OC-01 (varenicline tartrate) nasal spray, approved in the U.S. with the brand name of Tyrvaya contains nicotinic agonists, that bind to specific receptors in the nasal mucosa to elicit production of natural tears. Delivering Tyrvaya directly to the target tissue via a nasal spray is an innovative approach to the treatment of DED. The nasal spray delivery platform can provide both preservative free and preserved product formulations.

Our partner, Oyster Point Pharma, announced NDA approval of OC-01 Nasal Spray for the treatment of the signs and symptoms of dry eye disease in October 2021. As part of the dry eye disease clinical development pathway in China, JIXING will initiate Phase 1 and Phase 3 clinical studies for OC-01 starting in 2H 2022.

For further information about our partner, Oyster Point Pharma, please visit oysterpointrx.com

OC-02 Nasal Spray

(nAChR agonist)
Preclinical
Phase 1
Phase 2
Phase 3
Approval
Initiate Ph3 and parallel Ph1 study in 1H 2024
Ph2b studies completed

OC-02 Nasal Spray

OC-02 (simpinicline) nasal spray contains nicotinic agonists, that bind to specific receptors in the nasal mucosa to elicit production of natural tears. Delivering OC-02 directly to the target tissue via a nasal spray is an innovative approach to the treatment of DED. The nasal spray delivery platform can provide both preservative free and preserved product formulations.

OC-02 has been previously studied by our partner, Oyster Point Pharma in two Phase 2b clinical trials for dry eye disease. As part of the dry eye disease clinical development pathway in China, JIXING will initiate Phase 1 and Phase 3 clinical studies for OC-02 starting in 1H 2024.

For further information about our partner, Oyster Point Pharma, please visit oysterpointrx.com

LNZ100/101

(parasympathomimetic miotic agent)
Preclinical
Phase 1
Phase 2
Phase 3
Approval
Joining global Ph3 in 2023 or initiate standalone Ph3 in 2023
Ph2b studies completed; initiating Ph3

LNZ100/101

Aceclidine is a small molecule acetylcholine receptor agonist that causes pupil contraction, or miosis, creating a pinhole effect that improves near vision. Studies have shown that aceclidine’s mechanism of action (MOA) is ideally positioned to create a pinhole pupil effect while avoiding myopic shift. It is crucial to minimize myopic shift as it can significantly impair distance vision for a majority of presbyopes.

Aceclidine’s unique MOA, in which miosis is decoupled from myopic shift, is expected to allow it to target the broadest patient population.

In clinical trials, LENZ has shown that near-vision improvement correlates to aceclidine’s ability to maintain a pinhole pupil sweet spot of 1.5 mm to 2 mm for at least seven hours. There was no loss and a slight trend toward net gain in best corrected distance vision. In addition, aceclidine was well tolerated with no serious adverse events and with mild discomfort on instillation as the most common side effect.

LENZ’s INSIGHT clinical trial will serve as a confirmatory lead-in for its Phase 3 trial that is planned for 2H 2022.

JX08

(a preclinical ophthalmology program)
Preclinical
Phase 1
Phase 2
Phase 3
Approval
Preclinical program
Preclinical program

JX08

A preclinical ophthalmology program