CORXEL Announces TFDA Approval of New Drug Application for Varenicline Solution Nasal Spray for the Taiwan Region
SHANGHAI, China, November 22, 2024 – Corxel Pharmaceuticals (CORXEL), formerly named Ji Xing Pharmaceuticals, a leading biotech company committed to bringing innovative science and medicines to underserved 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 TYRVAYA® varenicline solution nasal spray for the treatment of signs and symptoms of dry eye disease (DED). CORXEL has been in 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.
“We are very pleased to announce that TYRVAYA® varenicline solution nasal spray has been approved in Taiwan, which will provide a new treatment option for the nearly 3 million dry eye patients in Taiwan, helping them to effectively alleviate their eye discomfort, restore their bright and comfortable eye condition, and return to a healthy lifestyle.” Sandy Mou, Board Executive Director and Chief Executive Officer of CORXEL，“ TYRVAYA® Varenicline solution nasal spray is CORXEL's first product to be successfully approved in Taiwan, and it represents a significant milestone for us. This achievement not only demonstrate an important regional collaborative step on our journey to drug development and commercialization, but also provides us with the opportunity to drive the development of more high-quality product pipelines globally to better address unmet clinical needs worldwide.”
TYRVAYA® Varenicline solution nasal spray was developed by CORXEL’s partner Oyster Point Pharma, a Viatris company. for the treatment of signs and symptoms of dry eye disease (DED). In February 2023, TYRVAYA® 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.
Additional information
Dry Eye 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 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 TYRVAYA is the first and only nasal spray approved for the treatment of the signs and symptoms of dry eye disease. 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 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. 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.
CORXEL, formerly named Ji Xing Pharmaceuticals, is a leading biotech company headquartered in US and China committed to bringing innovative science and medicines to underserved patients with serious and life-threatening cardiometabolic diseases. Backed by RTW Investments, LP, CORXEL was founded in 2019 to develop and commercialize novel, innovative therapeutics to treat unmet medical needs in cardiometabolic diseases. With a strong and further developing asset pipeline, industry leading talent, and patient-centric focus, CORXEL is dedicated to deliver a meaningful and lasting impact on patients.
The full portfolio of CORXEL consists of 2 assets with global rights and 4 assets with Greater China rights in late-stage clinical development. The portfolio with global rights are JX09 for hypertension and JX10 for acute ischemic stroke (AIS), while the portfolio with Greater China rights include aficamten, etripamil, varenicline solution nasal spray/US brand name TYRVAYA®, and LNZ100.
For further information about CORXEL, please visit www.corxelbio.com.
