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Livzon Pharmaceutical has reached an exclusive development and commercialization licensing cooperation with Xuan Bamboo Biotechnology for the product Fudanaphrine (XZP-5849).
Release time:
2024-06-18
Recently, the wholly-owned subsidiary of Livzon Pharmaceutical Group Inc., Livzon Group Livzon Pharmaceutical Factory (hereinafter referred to as "Livzon Pharmaceutical"), announced a joint exclusive licensing cooperation with Xuan Bamboo Biotechnology Co., Ltd. (hereinafter referred to as "Xuan Bamboo Bio"), a non-wholly-owned subsidiary of Sihuan Pharmaceutical Holdings Group Ltd., regarding Xuan Bamboo Bio's independently developed highly selective PDE-5 inhibitor, Ruda Na Fei (product code: XZP-5849).
According to the licensing agreement signed by both parties, Livzon Pharmaceutical will obtain exclusive development, production, and commercialization rights for the raw materials and formulations of Ruda Na Fei (XZP-5849) in the Greater China region and non-standard markets, while Xuan Bamboo Bio will retain the rights for development, production, and commercialization of Ruda Na Fei in Europe, the United States, Canada, Japan, South Korea, Australia, and Brazil. According to the agreement, Xuan Bamboo Bio will receive an advance payment and is entitled to milestone payments and a tiered royalty sales share of up to double digits.
Ruda Na Fei is a highly selective phosphodiesterase 5 (PDE5) inhibitor independently developed by Xuan Bamboo Bio, classified as a new chemical drug of Class 1, with independent intellectual property rights. The product's effects include: 1) inhibiting prostate hyperplasia and significantly improving lower urinary tract symptoms caused by prostate hyperplasia; 2) relaxing the smooth muscle of the penile corpus cavernosum, increasing blood flow in the penile arteries, and improving erectile dysfunction; 3) reducing pulmonary artery pressure by dilating the pulmonary arteries. More importantly, it overcomes adverse reactions such as visual disturbances and back pain seen with similar drugs like Sildenafil, Vardenafil, and Tadalafil. Preclinical studies have also shown that the clearance rate of Ruda Na Fei in the body is significantly lower than that of Avanafil, Sildenafil, and Vardenafil, suggesting a longer half-life in the human body, which can meet the clinical needs for daily administration and long-term use for treating erectile dysfunction (ED), as well as lower urinary tract symptoms (BPH/LUTS) caused by prostate hyperplasia and pulmonary arterial hypertension (PAH). The product is currently in Phase I clinical research, with indications under investigation including ED, BPH/LUTS, BPH/LUTS combined with ED, and PAH.
Phosphodiesterase-5 (PDE5), as an intracellular phosphodiesterase, is mainly found in the corpus cavernosum tissue of the human body, where it catalyzes the degradation of cyclic adenosine monophosphate (cAMP) and cyclic guanosine monophosphate (cGMP). cAMP and cGMP, as intracellular second messengers, participate in and regulate various cellular activities through specific receptors, with their intracellular content primarily determined by the dynamic balance between the synthesis by adenylate (guanylate) cyclase and the hydrolysis by phosphodiesterase (PDE). Within the cell, it uses 3,5-cyclic nucleotides as substrates to catalyze the hydrolysis of cGMP and cAMP, generating corresponding substrates and altering the metabolism of the organism. PDE5 inhibitors can reduce the activity of PDE5, thereby inhibiting the hydrolysis of cAMP or cGMP, increasing the concentration of cAMP or cGMP within the cell, amplifying the NO/cGMP signaling pathway activity, and ultimately exerting physiological effects.
Mr. Tang Yanggang, Executive Director and President of Livzon Pharmaceutical, stated: "This collaboration with Xuan Bamboo Bio will further enrich Livzon Pharmaceutical's existing urology drug pipeline and also expand Livzon Pharmaceutical's OTC product layout. Based on the good research foundation of Ruda Na Fei, we will accelerate the later-stage clinical development and strive to achieve commercialization as soon as possible."
Dr. Li Jiaqin, Vice President and General Manager of Shandong Xuan Bamboo, stated: "We are very pleased to reach a strategic cooperation with Livzon Pharmaceutical. We believe that under the strong R&D, production, and commercialization team of Livzon Pharmaceutical, Ruda Na Fei can accelerate the clinical trial development process and achieve commercial sales as soon as possible, helping Chinese innovative drugs bring new hope for patient treatment and life health.
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