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兆科眼科-B再涨超5% 老花眼新药获 FDA 批准上市
Zhi Tong Cai Jing· 2026-01-30 07:33
公告指,就兆科眼科而言,此批准乃其制定商业化策略前的强大催化剂。公司已为BRIMOCHOL PF建 立伙伴关系网络,现时包罗亚太区(包括南韩、澳洲、新西兰、泰国、印尼、台湾╱香港╱澳门地区、 新加坡及越南)及中东内的八名商业伙伴。凭借FDA的认可,兆科预料可加快该药物面世,标志着一项 重要的全球里程碑。 兆科眼科-B(06622)再涨超5%,截至发稿,涨5.28%,报3.79港元,成交额611.9万港元。 消息面上,1月29日晚,兆科眼科公布,公司的伙伴Tenpoint Therapeutics,Ltd.已接获美国FDA批准商业 化卡巴胆硷及酒石酸溴莫尼丁滴眼液(2.75%/0.1%)的监管批准。此滴眼液于临床试验期间名为 BRIMOCHOL PF,在美国的商用名称将为YUVEZZI,作为用于治疗老花眼的创新药物。 ...
止吐新药Nereus获FDA批准 万达生物制药(VNDA.US)涨超32%
Zhi Tong Cai Jing· 2025-12-31 15:50
Core Viewpoint - Vanda Pharmaceuticals (VNDA.US) shares surged over 32% to $9.33 following FDA approval of its new drug Nereus, aimed at preventing exercise-induced vomiting [1] Group 1: FDA Approval and Drug Details - The FDA approval of Nereus is based on results from three clinical studies comparing the drug group to a placebo group to assess vomiting occurrences [1] - Data indicates that Nereus achieved a "significant reduction" in vomiting events and demonstrated "good safety characteristics" in short-term, acute use scenarios [1] Group 2: Market Implications - The approval is expected to provide a new commercialization growth point for the company and enhance its product portfolio in the central nervous system and related indications [1]
德琪医药-B涨近6% 希维奥两项补充新药申请获香港卫生署批准
Zhi Tong Cai Jing· 2025-12-04 07:09
Core Viewpoint - The approval of two supplemental new drug applications for Selinexor (希维奥) by the Hong Kong Department of Health marks a significant expansion for the company in the Hong Kong market, enhancing its competitiveness in the biopharmaceutical industry [1] Group 1: Company Developments - The stock price of Dechra Pharmaceuticals-B (德琪医药-B) increased by approximately 6%, reaching HKD 4.34, with a trading volume of HKD 9.4944 million [1] - The approved applications are for the treatment of multiple myeloma (in combination with bortezomib and dexamethasone for adult patients who have received at least one prior therapy) and relapsed or refractory diffuse large B-cell lymphoma (as a monotherapy for adults who have undergone at least two lines of systemic therapy and are not eligible for hematopoietic stem cell transplantation) [1] Group 2: Industry Implications - The approval signifies the company's ongoing enhancement in research and market promotion capabilities within the biopharmaceutical sector [1] - The introduction of Selinexor is expected to meet the treatment needs for relevant diseases in the Hong Kong market, thereby improving the company's competitive position in the biotechnology industry [1]
济川药业:合作产品玛硒洛沙韦片获得药品注册证书
news flash· 2025-07-20 07:42
Core Viewpoint - Jichuan Pharmaceutical's subsidiary has received approval for a new drug, which is expected to positively impact the company's future development [1] Group 1: Drug Approval - Jichuan Pharmaceutical announced that its wholly-owned subsidiary, Jichuan Limited, has received a drug registration certificate from the National Medical Products Administration for the drug Marcilosavir Tablets [1] - The drug is classified as a Class 1 new drug and is a next-generation polymerase acidic protein (PA) nuclease inhibitor with broad-spectrum antiviral properties against influenza viruses [1] - The approved indication is for the treatment of previously healthy adults with uncomplicated influenza A and B [1] Group 2: Market Development and Uncertainties - The approval of this cooperative product is expected to have a positive effect on the company's future development [1] - However, the drug's market launch will require a development cycle and is subject to uncertainties influenced by pharmaceutical industry policies and procurement bidding [1]