JIXING Announces First Subject Successfully Dosed in Australian Phase I Clinical Trial of JX09

SHANGHAI, China, February 19, 2024 – 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, announced today the successful dosing of the first subject in the Phase I clinical trial of the cardiovascular investigational product JX09 (formerly PB6440) in Australia. Previously, JX09 received ethical clearance for Phase I clinical trial from the Human Research Ethics Committees (HRECs) in Australia.

JX09 is a next-generation, highly selective aldosterone synthase inhibitor. Aldosterone plays an important role in the development of hypertension, heart failure and chronic kidney disease. Directly targeting the synthesis of aldosterone has been developed as a novel alternative strategy. Preclinical data suggest that JX09 offers strong potency inhibiting aldosterone synthase, with very little impact on the biological functions of a homologous enzyme that is key to cortisol synthesis. The high potency and selectivity make JX09 a potential best-in-class drug candidate.

Yuan Li, MD, Chief Medical Officer of Cardiovascular at JIXING，said, " The clinical phase I trial of JX09 will investigate the safety, pharmacokinetics, and pharmacodynamics of single and multi-dose JX09 administration in healthy subjects. Currently, there is no approved aldosterone synthase inhibitor drug for hypertension. We are excited to accelerate the clinical development of JX09 and resolve the unmet global therapeutic need for refractory hypertension as soon as possible.”

JIXING acquired the global rights of JX09 in February 2023 and completed the necessary pharmacological and preclinical safety assessments before entering the clinic in less than a year. As the first investigational product in the cardiovascular field and ownership of global rights, JX09 is critical to JIXING's development as an innovative biopharmaceutical company based in China and expanding globally.

Sandy Mou, Board Executive Director and Chief Executive Officer of JIXING，said:” JIXING will continue to enrich the pipeline through a combination of license-in model and in-house development , thereby advancing clinical development in the global market. We are committed to building JIXING as a leading global biopharmaceutical company."

About JIXING

JIXING is a biopharmaceutical company headquartered in Shanghai committed to bringing innovative science and medicines to underserved patients in China and around the world 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 and around the world.

JIXING’s cardiovascular portfolio includes 5 assets in late-stage clinical development (Aficamten, Etripamil, Omecamtiv Mecarbil，JX09 and JX10). 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.

Reference：

• Lee J, Schotzinger J, et al. The Selective Aldosterone Synthase Inhibitor PB6440 Normalizes Blood Pressure In A Human Aldosterone Synthase-Transgenic Mouse Model Of Hypertension, Hypertension 2022, 79, A121.
• Pitt B, Bhatt D, et al, Inhibition Of Aldosterone Synthesis In Non-human Primates By PB6440, The Novel Highly Selective And Potent CYP11B2 Inhibitor, Hypertension 2020, 76, AP233.
• NCD Risk Factor Collaboration (NCD-RisC), Worldwide trends in hypertension prevalence and progress in treatment and control from 1990 to 2019: a pooled analysis of 1201 population-representative studies with 104 million participants, The Lancet 2021, 398, 10304, 957-980.
• 国家心血管病中心, 中国医师协会, 中国医师协会高血压专业委员会等. 中国高血压临床实践指南[J]. 中华心血管病杂志, 2022, 50(11): 1050-1095. DOI: 10.3760/cma.j.cn112148-20220809-00613.
• Wang Z, Chen Z, Zhang L, et al. Status of Hypertension in China: results from the China hypertension survey, 2012– 2015. Circulation 2018; 137: 2344–2356.

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