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Lizhu Pharmaceutical has reached an exclusive development and commercialization licensing agreement with Xuanzhu Bio for its product, Fudanafi (XZP-5849).
Published Time：
2024-06-13
Recently, Lizhu Pharmaceutical Group Co., Ltd.'s wholly-owned subsidiary, Lizhu Pharmaceutical Factory (hereinafter referred to as "Lizhu Pharmaceutical"), and Xuanzhu Biotechnology Co., Ltd., a non-wholly-owned subsidiary of Four Rings Pharmaceutical Holdings Group Co., Ltd. (hereinafter referred to as "Xuanzhu Bio"), jointly announced that the two parties have reached an exclusive authorization and licensing cooperation agreement for Xuanzhu Bio's independently developed highly selective PDE-5 inhibitor, Vardenafil (product code: XZP-5849).
According to the authorization and licensing agreement signed by both parties, Lizhu Pharmaceutical will obtain the exclusive rights to develop, produce, and commercialize Vardenafil (XZP-5849) raw materials and preparations in the Greater China region and non-standard markets. Xuanzhu Bio will retain the rights to develop, produce, and commercialize Vardenafil in Europe, the United States, Canada, Japan, South Korea, Australia, and Brazil. According to the agreement, Xuanzhu Bio will receive an upfront payment and is entitled to milestone payments and tiered royalties up to double digits.
Vardenafil is a highly selective phosphodiesterase 5 (PDE5) inhibitor independently developed by Xuanzhu Bio, a Class 1 new chemical drug with independent intellectual property rights. Product effects include: 1) Inhibiting benign prostatic hyperplasia and significantly improving lower urinary tract symptoms caused by benign prostatic hyperplasia; 2) Relaxing the smooth muscles of the corpus cavernosum, increasing penile arterial blood flow, and improving erectile dysfunction; 3) Dilating the pulmonary artery and reducing pulmonary artery pressure. More importantly, it overcomes the adverse reactions such as visual impairment and back pain that occur with similar drugs such as sildenafil, vardenafil, and tadalafil. Preclinical studies have also shown that Vardenafil has a significantly lower clearance rate than avanafil, sildenafil, and vardenafil, and is expected to have a longer half-life in the human body. In addition to meeting the treatment needs of patients with erectile dysfunction (ED), it can also meet the clinical needs of patients with benign prostatic hyperplasia-induced lower urinary tract symptoms (BPH/LUTS) and pulmonary arterial hypertension (PAH) for once-daily, long-term medication. The product is currently in Phase I clinical trials, with indications under investigation including ED, BPH/LUTS, BPH/LUTS combined with ED, and PAH.
Phosphodiesterase -5(PDE5), as an intracellular phosphodiesterase, is mainly present in the corpus cavernosum tissue in the human body and can catalyze the degradation of cyclic adenosine monophosphate (cAMP) and cyclic guanosine monophosphate (cGMP). cAMP and cGMP, as intracellular second messengers, can participate in and regulate various cellular activities through specific receptors. Their intracellular content is mainly determined by the dynamic balance between the synthesis of adenylate (guanylate) cyclase and the hydrolysis of phosphodiesterase (PDE). In cells, it uses 3,5-cyclic nucleotides as substrates to catalyze the hydrolysis of intracellular cGMP and cAMP, generating corresponding substrates, thereby changing the body's metabolism. PDE5 inhibitors can reduce the activity of PDE5, thereby inhibiting the hydrolysis of cAMP or cGMP, increasing the intracellular concentration of cAMP or cGMP, amplifying the activity of the NO/cGMP signaling pathway, and ultimately exerting physiological effects.
Mr. Tang Yanggang, Executive Director and President of Lizhu Pharmaceutical, said: This cooperation with Xuanzhu Bio will further enrich Lizhu Pharmaceutical's existing male reproductive health drug pipeline and expand Lizhu Pharmaceutical's OTC product layout. Based on the good research foundation of Vardenafil in the early stage, we will accelerate the later clinical development and strive to achieve commercialization as soon as possible.
Dr. Li Jiakui, Vice President and General Manager of Shandong Xuanzhu, Xuanzhu Bio, said: “We are very pleased to reach a strategic cooperation with Lizhu Pharmaceutical. We believe that under the leadership of Lizhu Pharmaceutical's strong R&D, production, and commercialization team, Vardenafil will be able to accelerate the clinical trial development process and achieve commercial sales as soon as possible, helping China's innovative drugs bring new hope to patients' treatment and life health.”
About Lizhu Pharmaceutical: Lizhu Pharmaceutical Group Co., Ltd. ( 000513.SZ, 01513.HK) was founded in 1985, with a registered capital of 928 million yuan. It is a comprehensive pharmaceutical group company integrating pharmaceutical R&D, production, and sales, with nearly 9,000 employees. Lizhu is committed to the R&D, production, and sales of raw materials, small molecule drugs, large molecule drugs, and diagnostic reagents. Its key therapeutic areas cover anti-tumor, assisted reproduction, digestive tract, anti-infection, and mental/nervous systems.
About Xuanzhu Bio: Xuanzhu Bio focuses on major disease areas such as tumors, digestion, and non-alcoholic fatty liver disease, and is committed to the R&D, production, and commercialization of innovative drugs with core independent intellectual property rights Class 1 innovative drugs to address unmet clinical needs. The company has a team with rich experience in innovative drug R&D and industrialization, and has formed a complete new drug R&D system with the ability for continuous innovation and continuous output. The company also has two major R&D systems for small molecule chemical drugs and large molecule biological drugs, driving the company's innovative development with a dual-engine approach, forming a product pipeline with a variety of types, including small molecules, monoclonal antibodies, bispecific antibodies, antibody-drug conjugates, and fusion proteins, which is rare in China. With the strategic concept of "innovation-driven, promoting the development of new drugs in China and serving human health," Xuanzhu Bio is currently transforming from a biotechnology company to an integrated biopharmaceutical company covering R&D, production, and sales.
This article is from: Lizhu Pharmaceutical
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