JIXING Announces NMPA Acceptance of New Drug Application for Varenicline Solution Nasal Spray
Stimulating natural tear production through nasal spray formulation, varenicline solution nasal spray may be a paradigm-changing way to treat dry eye disease in China
SHANGHAI, China, July 17, 2023 – Ji Xing Pharmaceuticals Limited (JIXING), a clinical-stage biopharmaceutical company committed to bringing innovative medicines to underserved Chinese patients with serious and life-threatening diseases, today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the PRC has accepted the New Drug Application (NDA) for varenicline solution nasal spray (US brand name TYRVAYA®) for the treatment of signs and symptoms of dry eye disease (DED) in China. This is JIXING’s first NDA submission of an ophthalmology product.
As a highly selective cholinergic agonist, varenicline solution nasal spray is designed to activate the trigeminal parasympathetic pathway resulting in increased natural tear production. In October 2021, varenicline solution nasal spray was approved in the U.S. by the Food & Drug Administration (FDA) as the first and only nasal spray for the treatment of the signs and symptoms of dry eye disease.
“There are more than 200 million patients suffering from DED in China and current therapies have not satisfied patients’ medical needs . Stimulating natural tear film through a nasal spray formulation, varenicline solution nasal spray may be a paradigm-changing way to treat DED. We look forward to engaging with the NMPA and the medical community to bring this new ophthalmic drug with a novel mechanism of action to Chinese patients soon.” said Sandy Mou, Chief Executive Officer of JIXING. “This is another important milestone for JIXING’s business growth to become an innovative biotech company with license-in, clinical development and commercialization capabilities to bridge the innovation gap for patients in China and the world.”
The NDA is supported by the results from three global pivotal clinical studies enrolling over 1,000 DED patients as well as a Phase 1 and Phase 3 study conducted in subjects in China. The China Phase 3 study was designed as a multicenter, randomized, controlled, double-masked study to evaluate the safety and efficacy of varenicline solution nasal spray to treat signs and symptoms of dry eye disease. The study enrolled 340 subjects at 20 centers across China. The study met the pre-defined primary efficacy endpoint with varenicline nasal spray showing a statistically and clinically significant improvement at week 4 compared to the control group. The natural tear production of the subjects showed statistically significant increases from the baseline (the percentage of subjects gaining ≥ 10 mm in Schirmer’s score). Additionally, the study produced positive results for a number of secondary efficacy endpoints. Overall, it demonstrated efficacy and safety profiles consistent with previous studies.
Additional information
Dry eye disease is a chronic condition that is estimated to impact more than 200 million patients in China and is growing in prevalence, significantly influencing a person’s day-to-day quality of life. It can cause persistent stinging, scratching, burning sensations, sensitivity to light, blurred vision, and eye fatigue. Dry eye disease is a multifactorial disease of the ocular surface characterized by disruption of the tear film. Human tear film is a complex mixture of more than 1,500 different proteins, including growth factors and antibodies, as well as numerous classes of lipids and mucins. Natural tear film protects and lubricates the eyes, washes away foreign particles, contains growth factors and antimicrobial components, and creates a smooth surface that forms the primary refractive surface of the eye. Despite the large prevalence and a significant disease burden, there remains a large unmet need in dry eye disease.
Varenicline solution nasal spray (US brand name TYRVAYA® ) is a highly selective cholinergic agonist that is U.S. FDA approved to treat signs and symptoms of dry eye disease as a multidose nasal spray. The parasympathetic nervous system controls tear film homeostasis partially via the trigeminal nerve, which is accessible within the nose. The efficacy of varenicline solution nasal spray in dry eye disease is believed to be the result of varenicline's activity at heteromeric sub-type(s) of the nicotinic acetylcholine (nACh) receptor where its binding produces agonist activity and activates the trigeminal parasympathetic pathway resulting in increased production of basal tear film as a treatment for dry eye disease. Varenicline binds with high affinity and selectivity at human α4β2, α4α6β2, α3β4, α3α5β4 and α7 neuronal nicotinic acetylcholine receptors.
TYRVAYA® is a registered trademark of Oyster Point Pharma, Inc., a Viatris company.
JIXING is a biopharmaceutical company headquartered in Shanghai committed to bringing innovative science and medicines to underserved patients in China with serious and life-threatening diseases. Backed by RTW Investments, LP, JIXING was founded in 2019 and partners with global biotechnology companies to develop and commercialize novel, innovative therapeutics to treat unmet medical needs in cardiovascular and ophthalmic diseases. With a strong and further developing asset pipeline, seasoned management team, and patient-centric focus, JIXING is dedicated to delivering a meaningful and lasting impact on patients in China.
JIXING’s cardiovascular portfolio includes 3 assets in late-stage clinical development (Aficamten, Etripamil, Omecamtiv Mecarbil) and 1 in pre-clinical stage (JX09). JIXING’s ophthalmology portfolio includes 4 assets in late-stage clinical development (varenicline solution nasal spray/US brand name TYRVAYA, OC-02 nasal spray, JX06/LNZ100, JX07/LNZ101) and 1 asset in pre-clinical stage (JX08). For further information about JIXING, please visit www.jixingbio.com.
Contacts:
References:
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