JIXING and Wuzhou Announce Distribution Agreement
Wuzhou will provide commercialization support for varenicline solution nasal spray in Macau Special Administrative Region (SAR)
SHANGHAI, China, September 28, 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 announces that it has entered into a distribution agreement with Wuzhou Drug International Trading Limited (Wuzhou). Under the agreement, Wuzhou will provide commercialization support for varenicline solution nasal spray (US brand name TYRVAYA®) in Macau SAR. Wuzhou is a healthcare service provider headquartered in Macau SAR.
“We are very pleased to build a partnership with Wuzhou. This is another important step to expand our commercialization footprint in Mauca SAR after receiving the approval for varenicline solution nasal spray earlier this year.” said Sandy Mou, Chief Executive Officer of JIXING. “We believe Wuzhou’s industry expertise will provide strong support for the commercialization of varenicline solution nasal spray in Mauca SAR. We will work closely with Wuzhou to offer a new treatment option for local dry eye disease patients.”
"Over the past 6 years, we have been committed to providing professional services to healthcare industry and have established long lasting close relationships with leading companies. “ said Guoshan Zhen, CEO of Wuzhou. "We are very pleased to enter into a partnership with JIXING to jointly bring innovative ophthalmic drugs to the Macau market. We look forward to expanding more collaboration opportunities with JIXING in the future."
Varenicline solution nasal spray, developed by JIXING’s partner Oyster Point Pharma, is a highly selective cholinergic agonist indicated for the treatment of the signs and symptoms of dry eye disease as a preservative-free nasal spray. Varenicline solution nasal spray is designed to activate the trigeminal parasympathetic pathway to increase the production of natural tears. JIXING has the exclusive rights to develop and commercialize this product in Greater China. In October 2021, varenicline solution nasal spray was approved by the U.S. Food and Drug Administration (FDA) for the treatment of the signs and symptoms of dry eye disease. It is the first and only nasal spray approved by the FDA for the treatment of the signs and symptoms of dry eye disease. In February 2023, varenicline solution nasal spray was approved in Macau SAR. In July 2023, the New Drug Application (NDA) for varenicline solution nasal spray in China was accepted by the National Medical Products Administration (NMPA).
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 2 assets in late-stage clinical development (Aficamten, Etripamil) 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.jixing.com.
Wuzhou International Trading Limited (Wuzhou) is one of the leading Macao specialist in the parallel import and parallel export of branded pharmaceuticals, generic medicines, m edical appliances, clinical dressings, diagnostics, nutritional drinks and unlicensed medicines. Over the past 6 years,Wuzhou has developed long lasting close relationships with suppliers and customers to develop our highly successful export and import business. Wuzhou specialises in global supply to wholesalers, pharmacy groups, hospitals, private hospitals, specialist clinics, clinical trial providers, charities , NGO’s and many other healthcare providers. For more information, please visit www.droga.cn .
Contacts:
References:
- Wirta, D., Vollmer, P., Paauw, J., et al.& ONSET-2 Study Group. Efficacy and Safety of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease: the ONSET-2 Phase 3, Randomized Trial. Ophthalmology 2021:1-9. https: //doi.org/10.1016/j.ophtha.2021.11.004.
- Wirta, D., Torkildsen, G. L., Boehmer, B., Hollander, D. A., Bendert, E., Zeng, L., ... & Nau, J. (2022). ONSET-1 phase 2b randomized trial to evaluate the safety and efficacy of OC-01 (varenicline solution) nasal spray on signs and symptoms of dry eye disease. Cornea.
- Market-Scope. 2020 Dry Eye Products Report: A Global Market Analysis for 2019 to 2025. October 2020.
- Uchino M., Schaumberg D.A. Dry Eye Disease: Impact on Quality of Life and Vision. Curr. Ophthalmol. Rep. 2013; 1:51–57. doi: 10.1007/s40135-013-0009-1.
- Tsubota K, Pflugfelder S, Liu Z, et al. Defining dry eye from a clinical perspective. Int J Mol Sci 2020; 21 (23):9271. doi: 10.3390/ijms21239271.
- Song P, Xia W, Wang M, et al. Variations of dry eye disease prevalence by age, sex, and geographic characteristics in China: a systematic review and meta-analysis. Journal of global health (2018); 8(2):020503. doi: 10.7189/jogh.08.020503.
- Liu, Ning-ning, et al. Prevalence of and Risk Factors for Dry Eye Symptom in Mainland China: A Systematic Review and Meta-Analysis. Journal of Ophthalmology (2014); 2014(3):748654–8.
- Jie Y, Xu L, Wu YY, Jonas JB. Prevalence of dry eye among adult Chinese in the Beijing Eye Study. Eye (Lond) (2009); 23(3):688-93.
