RCH-01

雄激素性脱发（androgenetic alopecia，AGA）是一种最常见的脱发类型，是起始于青春期或青春后期的一种进行性毛囊微小化的脱发疾病。男女均可罹患，但表现为不同的脱发模式和患病率。在我国，男性患病率约为21.3%，女性患病率约为6.0%[1]。AGA是一种具有遗传倾向的多基因隐性遗传疾病。国内的流行病学调查显示，AGA患者中有家族遗传史的占53.3%~63.9%，且父系明显高于母系。目前的全基因组测序和定位研究发现了若干易感基因，但尚未明确其发病基因。目前已有的研究表明，雄激素在AGA的发病中占有决定性因素；其他包括毛囊周围炎症、生活压力的增大、紧张和焦虑、不良的生活和饮食习惯等因素均可加重AGA的症状[1]。图1 AGA的BASP分型法[1]图片来源：参考资料1AGA上市治疗药物分析目前获批雄激素性脱发适应症的药物，仅有米诺地尔（minoxidil）、非那雄胺（finasteride）和度他雄胺（dutasteride）。米诺地尔治疗雄激素性脱发早在1995年11月28日就由强生公司上市销售。非那雄胺（Finasteride）由Merck开发，代号为MK-906。1992年非那雄胺（5mg）被美国食品和药物管理局（FDA）批准用于治疗良性前列腺增生，默克公司以商品名Proscar销售该产品。1997年默克公司成功获得FDA批准非那雄胺（1mg）的雄激素性脱发适应症，该药物以Propecia品牌销售。度他雄胺（Dutasteride）由葛兰素史克（GlaxoSmithKline，GSK）研发，于2001年11月20日首次获美国食品药品管理局（FDA）批准上市后，之后于2009年7月7日获得日本医药品医疗器械综合机构（PMDA）批准，由葛兰素史克上市销售，商品名为Avodart(在美国)或Avolve（在日本）。度他雄胺属于一类5-α还原酶抑制剂，通过阻断5-α还原酶，将睾酮转化为双氢睾酮（DHT）。雄激素性脱发适应症的获批时间为2004年4月23日。AGA在研药物和技术分析目前在研适应症为雄激素性脱发的药物/技术有18个，其中处于临床Ⅲ期的有5个。涉及的治疗方式包括外用药物治疗、系统药物治疗、局部注射治疗和干细胞治疗。表1 雄激素性脱发在研药物/技术信息数据来源：药智数据，药智咨询整理福瑞他恩(furuitaen)福瑞他恩的靶点为Androgen receptor，其作用机制是通过与标靶组织者中的雄激素竞争结合雄激素受体，局部抑制雄激素及其受体所介导的信号通路的传导。在阻断信号传到刺激生发的同时，福瑞他恩避免了系统性雄激素水平的降低及因此带来的临床副作用。2023年5月11日开拓药业宣布福瑞他恩（KX-826）治疗脱发美国II期临床试验成功完成，该项II期临床试验结果显示，与基线相比，KX-826可以促进毛发生长，通过目标区域内非毳毛数（TAHC）衡量的结果具有统计学及临床意义。KX-826相对于安慰剂在TAHC变化方面呈现出数值上的优势，且不同KX-826剂量组间存在剂量效应关系。目前KX-826正在中国、美国开展用于男性、女性脱发的多项临床试验。2023年3月28日，开拓药业宣布已完成KX-826治疗男性脱发中国III期临床试验全部受试者入组，预计在2023年第四季度公布该项III期临床试验的顶线数据[2]。SM04554药物相关研究发现，毛囊发育、形成和毛发生长依赖于Wnt/β-catenin信号的激活，SM04554是一种可以激活Wnt通路的小分子，可以促进毛囊增生和头发生长。目前该药正在进行Ⅲ期临床试验。RCH-01技术干细胞是一种具有自我更新和分化能力的细胞。干细胞技术被视为“再生医学技术”，被誉为继药物治疗和手术治疗之后的第三次医学革命。毛乳头细胞在毛囊发育和周期性生长调控中起主导作用，而干细胞已被证明对毛乳头具有再生和修复的作用；同时，干细胞分泌的细胞因子可加速毛囊周期。RCH-01技术是将秃顶或头发稀疏患者头部的真皮鞘细胞，经人工培育复制后，再次注射入秃发部位，以达到修复患者受损毛囊的目的。目前正在开展Ⅲ期临床试验，据报道日本资生堂集团花上亿元购买了RepliCel公司的RCH-01毛发再生技术使用权，相信商业化的RCH-01毛发再生技术问世的日期指日可待了。参考文献：[1]中国医师协会美容与整形医师分会毛发整形美容专业委员会.中国人雄激素性脱发诊疗指南[J].中国美容整形外科杂志,2019,30(1):前插2-前插6.DOI:10.3969/j.issn.1673-7040.2019.01.001.[2]开拓药业官网：https://www.kintor.com.cn/news/300.html声明：本内容为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | summer转载开白 | 马老师 18996384680（同微信） 阅读原文，是昨天最受欢迎的文章哦

New DermaPrecise™ patent application and patents granted for tendinopathy and skin rejuvenation technologies in key markets VANCOUVER, BC / ACCESSWIRE / August 4, 2022 / RepliCel Life Sciences Inc. (OTCPK:REPCF)(TSXV:RP)(FRA:P6P2) ("RepliCel" or the "Company"), a company developing novel, next-generation injection technologies as well as cell-based regenerative medicine products in aesthetics and orthopedics, is pleased to announce the granting of several patents covering novel aspects of the DermaPrecise™ product portfolio, as well as the granting and/or allowance of four other patent applications for its skin rejuvenation and tendon regeneration technologies. RepliCel has now been granted patents for DermaPrecise™ by the patent offices in the Unites States (Patent No. 11,311,684) and Japan (Patent No. 6718472B2), both of which are key, near-term markets for RepliCel's cell therapies and the DermaPrecise™ product line. RepliCel has also received a notice of allowance in New Zealand for a corresponding patent application. "RepliCel has a growing number of allowed and granted patents globally with respect to its innovative DermaPrecise™ injector, control unit and consumables," stated RepliCel President and CEO, R. Lee Buckler. "With the positive results we are now seeing in testing of the DermaPrecise™ injection system, we continue to generate patentable innovations which serve to strengthen the clinical and commercial value of this next-generation injection technology." Additionally, RepliCel has been granted: in relation to its RCS-01, regenerative cell therapy for skin rejuvenation, a patent in New Zealand (Patent No. 715905) and a notice of allowance in Mexico on a related application; in relation to its RCT-01 cell-based regenerative medicine for the treatment of chronic tendinopathy, a patent in South Africa, and a notice of allowance on a corresponding application in China, where the product has been licensed and is being co-developed by RepliCel's partner for Greater China. About the DermaPrecise Product Line The DermaPrecise™ Injector is an electronic injection system designed to offer new levels of control over any injection into the intro-dermal and subcutaneous layers for which precision of depth, dose and/or delivery matters. About RepliCel's Skin and Tendon Programs Both RepliCel's cell-based skin rejuvenation product (RCS-01) and its cell-based tendon regeneration product (RCT-01) have been the subject of successful phase 1 clinical studies. RepliCel is currently preparing for next-phased clinical testing and commercialization of two cell-based regenerative medicines in Japan. In China, RepliCel's partner, YOFOTO China Health Company, is currently preparing for phase 2 studies in China of these same therapies in collaboration with RepliCel. About RepliCel Life Sciences RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration. These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function. These cell therapy product candidates are based on RepliCel's innovative technology, utilizing cell populations isolated from a patient's healthy hair follicles. The Company's cell therapy product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. RCH-01 has been the subject of successful safety and dose-finding clinical studies and is now the subject of its third clinical study evaluating efficacy for the treatment of male and female hair loss due to androgenetic alopecia. This ongoing study is being funded by Shiseido Company Limited pursuant to a license agreement which has now been terminated but is the subject of an arbitration regarding Shiseido's rights to the product for Asia. RepliCel maintains the undisputed rights to RCH-01 for the rest of the world. RCT-01 and RCS-01 are exclusively licensed in Greater China to YOFOTO (China) Health Company. RepliCel and YOFOTO are currently co-developing these products in China. RepliCel maintains the rights to these products outside of Greater China. RepliCel has also developed a proprietary injection device (DermaPrecise™) and related consumables, which is expected to improve the administration of its cell therapy products and certain other injectables. YOFOTO has exclusively licensed the commercial rights for the DermaPrecise™ device and consumables in Greater China for dermatology applications and is expected to first launch the product in Hong Kong upon it being approved for market launch in either the United States or Europe. Please visit replicel.com for additional information. Notable Facts: RepliCel's three cell therapy products have now been tested in over 100 patients in four countries on three continents. RepliCel now has key strategic regional partners each of which are now investing heavily in the further clinical testing and development of RepliCel's products for their markets. Data from each of the clinical programs will strengthen the product development initiatives for RepliCel and its other partners worldwide. For more information, please contact: Lee Buckler, CEO and President 604-248-8693 info@replicel.com Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. SOURCE: RepliCel Life Sciences Inc. View source version on accesswire.com: