JIXING Announces TFDA Acceptance of New Drug Application for Varenicline Solution Nasal Spray for the Taiwan Region

SHANGHAI, China, January 3, 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 Food and Drug Administration of Taiwan's Ministry of Health and Welfare（TFDA）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). JIXING has entered into a strategic collaboration agreement with TSH Biopharm (TSH) in July 2023. Under the agreement, TSH submitted this NDA and provides commercialization support for varenicline solution nasal spray in the Taiwan region.

"Stimulating natural tear film through a nasal spray formulation, varenicline solution nasal spray may be a paradigm-changing way to treat dry eye disease and bring a new therapeutic experience to patients," said Sandy Mou, Board Executive Director and Chief Executive Officer of JIXING. " We are very pleased that TSH quickly submitted this new drug application and was accepted by TFDA in less than six months. We hope that varenicline solution nasal spray can get approval soon, providing an innovative treatment for the nearly 3 million dry eye patients in Taiwan, so that they can get free from dry eye disease so that they may be relieved from their symptoms and return to a normal life."

Varenicline solution nasal spray is a highly selective cholinergic agonist. It’s designed to activate the trigeminal parasympathetic pathway to increase the production of natural tears. Developed by JIXING’s partner Oyster Point Pharma, Varenicline solution nasal spray has been approved by the United States FDA the treatment of the signs and symptoms of dry eye disease, and JIXING has the exclusive rights to develop and commercialize this product in Greater China.

In February 2023, Varenicline solution nasal spray was approved in Macao SAR, and since April 2023, it has been available in Boao Lecheng International Medical Tourism Pilot Zone as an imported drug for patients with urgent clinical needs.In July 2023, the new drug application was formally accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the PRC.

About Dry eye disease

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.

About Varenicline solution nasal spray

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.

About JIXING

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 Greater 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 .