JIXING and TSH Biopharm Announce Strategic Partnership Agreement
SHANGHAI, China, July 12, 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 strategic collaboration agreement with TSH Biopharm (TSH). Under the agreement, TSH will provide commercialization support for varenicline solution nasal spray (US brand name TYRVAYA) in Taiwan. TSH is a biopharmaceutical company based in Taiwan.
“We are very pleased to build a strategic partnership with TSH. This is an important step to expand our commercialization footprint, ” said Sandy Mou, Chief Executive Officer of JIXING. “We believe TSH’s industry expertise and commercialization capability will provide strong support for the commercialization of varenicline solution nasal spray in Taiwan. We will work closely with TSH to offer a new treatment option for local dry eye disease patients.”
"TSH has achieved success in multiple disease areas, and the dry eye treatment drug, varenicline nasal spray, on which we cooperate with JIXING, will be our first product to enter the field of ophthalmology," said Grace Yang, General Manager of TSH Biopharm. "We will promptly initiate the new drug approval and commercialization preparations. We look forward to establishing further collaborations with JIXING in ophthalmology and other disease areas 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.
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 is a highly selective cholinergic agonist that is U.S. FDA approved to treat the signs and symptoms of dry eye disease as a multidose nasal spray. The parasympathetic nervous system, the "rest and digest" system of the body, 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. The exact mechanism of action is unknown at this time.
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.jixing.com.
TSH Biopharm starts in the field of chronic diseases and adheres to the principles of integrity and honesty. With a focus on innovation and excellence, our mission is to provide superior healthcare services for all stages of patient care. Our core products are centered around "patient-centric" treatments, including cardiovascular medications, gastrointestinal medications, and central nervous system medications. We cultivate the niche market of chronic diseases while simultaneously pursuing a dual-engine strategy to pioneer precision medicine and offer comprehensive treatment options. For more information, please visit www.tshbiopharm.com.
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.
