Beijing Merson Pharmaceutical Co. Ltd.

2022年11月18日，复旦张江发布公告称，近日收到国家药监局核准签发的《受理通知书》，马来酸噻吗洛尔乳膏（规格：0.5%）I期临床试验申请获得受理，用于治疗婴幼儿血管瘤（Infantile  Hemangioma，IH）。婴幼儿血管瘤婴幼儿血管瘤（IH）是以内皮细胞增殖及新生血管形成为基础的血管源性肿瘤，为婴幼儿最常见的良性肿瘤。其自然病程较为特殊，多数患儿在出生时瘤体并不可见，出生后数日至数周内突然出现，而后迅速增长，该过程可持续六个月至一年不等。后逐渐自行进入消退期，并持续五至十年，约 50%的瘤体可消退完全。正是这一独特的生长特性，使其有别于其它血管肿瘤和血管畸形。据相关研究文献显示，IH在我国的发病率约为1~3%，多发于头面颈部，尽管部分血管瘤可自行消退， 但仍有约10%的患儿出现溃疡、感染、疼痛，甚至失明、窒息等严重并发症，使之成为患儿家长的严重心理负担。婴幼儿血管瘤的治疗方法有多种， 包括口服或局部应用糖皮质激素、局部注射平阳霉素、手术、激光和冷冻等，口服盐酸普萘洛尔目前是IH的主流治疗方式。然而，口服普萘洛尔后肝脏首过效应强，生物利用度低，并且有一定的全身不良反应，包括心动过缓、低血压、支气管痉挛、低血糖、嗜睡或失眠、梦魇、食欲降低、手足发凉等。对于面积较小和位置表浅的病变，使用盐酸普萘洛尔的收益并不明显。因此，IH患者亟需新的治疗药物或者剂型来满足不同程度病症的需求。 马来酸噻吗洛尔马来酸噻吗洛尔是Valeant原研的一款β-肾上腺素受体拮抗剂，最早于1978年7月18日获FDA批准上市，是一种滴眼剂，用于治疗开角型青光眼和高眼压。作为儿科青光眼一线治疗药物，，临床使用已超过30年，安全性已经得到证实。相关研究结果表明，局部使用马来酸噻吗洛尔滴眼液治疗婴幼儿血管瘤具有安全、 有效且价格便宜等优势。目前，国内多家公司的马来酸噻吗洛尔多种剂型（乳膏/凝胶）的临床研究正在进行中。其中，进展最快的是北京梅尔森医药的马来酸噻吗洛尔凝胶，最高研发状态处于临床III期（CTR20221992）；其次是上海奥科达医药马来酸噻吗洛尔凝胶，I期临床研究已经完成并取得积极结果（CTR20181638）。来源：药渡数据库目前国内尚无马来酸噻吗洛尔乳膏/凝胶制剂上市，市售马来酸噻吗洛尔滴眼液为水溶液制剂，使用不方便，敷药后容易蒸发，剂量不容易掌握，长期使用会致皮肤干燥、脱皮。作为纳入「临床急需儿童用药」目录的药品，希望马来酸噻吗洛尔乳膏/凝胶制剂临床研究顺利开展，将来为IH患者提供更优效的治疗选择。参考来源复旦张江官网、公告药渡数据库

Johnson & Johnson on Tuesday unveiled a new research and development facility in San Francisco, aiming to grow its presence in one of the top biotechnology hubs in the U.S.J&J has had a presence in the city for years. In 2013, the pharmaceutical company opened up the California Innovation Center, hoping to build ties with scientists and entrepreneurs. Two years later, it broadened another startup-focused initiative, expanding its JLABS program to South San Francisco.The new facility, a 200,000-square-foot campus located in Brisbane, Calif., has a broader scope. It is meant to be the main site for J&Js R&D in the San Francisco Bay Area, said James Merson, the site head of the campus and leader of infectious disease work at its Janssen subsidiary.According to Merson, the campus will bring three major J&J units and their existing employees under one roof: Janssen R&D, J&J Technology and J&J Innovation. The site can hold up to 400 workers, and people began relocating from their previous work sites in San Francisco last month, he said. The campus will work on gene and RNA therapies as well as experimental treatments for infectious and retinal diseases. Itll also focus on digital health and data science, the company said in a statement.Having all of the groups in one facility will help the companys divisions collaborate and develop innovative medicines faster and more efficiently, Merson said.The new campus is also meant to expand J&Js contact with academic institutions and entrepreneurs, serving as an additional arm to invest in new research and partner with emerging companies.Merson wouldnt specify how much money J&J put into the facility. '