Group 1 - Changchun High-tech's subsidiary Brillian Pharma INC. received FDA approval for the oral solution of benzenesulfonic acid amlodipine, targeting hypertension in individuals aged 6 and above, as well as chronic stable angina and vasospastic angina in adults [1] - The prevalence of hypertension among adults in the U.S. was reported at 47.7% from August 2021 to August 2023, while the prevalence among children aged 6-17 was 3.8% [1] - Amlodipine is recommended as a first-line treatment for hypertension in children, aiming to reduce the risk of organ damage and cardiovascular diseases [1] Group 2 - The benzenesulfonic acid amlodipine oral solution is a 505B2 modified innovative drug developed for children over 6 and adults with swallowing difficulties, designed to lower blood pressure and reduce cardiovascular event risks [2] - The product is based on existing FDA-approved formulations, offering ease of use, accurate dosing, and palatability, which enhances medication adherence among pediatric patients [2] - The approval of this product is expected to strengthen Brillian Pharma's product portfolio in the U.S. market, enhancing the company's competitiveness in the pharmaceutical sector [2] Group 3 - Changchun High-tech's subsidiary, Changchun Jinsai Pharmaceutical, received approval for the injection of Fushen Qibai monoclonal antibody, a new biological product for treating acute gouty arthritis in adults [3] - The company has diversified its business into various pharmaceutical segments, including gene engineering, biological vaccines, antibody drugs, and modern traditional Chinese medicine [3] Group 4 - The company is advancing clinical trials for several new drugs, including GenSci098 for thyroid eye disease and GenSci122 for advanced solid tumors, both of which have received FDA clinical trial permissions [4] - The company plans to issue H-shares and list on the Hong Kong Stock Exchange to enhance its global strategy and international financing capabilities [4]

Core Viewpoint - The leading companies in the growth hormone sector, Changchun High-tech and Anke Bio, are facing declining revenues and are seeking new growth avenues through diversification into other therapeutic areas [1][2][3]. Group 1: Company Performance - Both Changchun High-tech and Anke Bio reported a decline in revenue and net profit for 2024, with Changchun High-tech experiencing its first annual revenue drop in nearly 20 years, showing a 5.66% decrease in revenue and a 44.95% drop in net profit for Q1 2025 [2][3]. - Anke Bio's revenue and net profit also fell by over 10% in the previous year, with a 4% decline in both metrics for Q1 2025 [2][3]. Group 2: Market Dynamics - The growth hormone market in China has expanded significantly, from $600 million in 2018 to $1.7 billion in 2022, capturing 34% of the global market share, surpassing the United States [2]. - The introduction of price-cutting measures in 2022 has pressured the revenues of the two leading companies, leading to a contraction in their growth hormone business [2][3]. Group 3: Product Development and Diversification - Changchun High-tech and Anke Bio are both attempting to diversify their product lines beyond growth hormones, with Changchun High-tech planning to expand into pediatrics, women's health, and anti-aging sectors [4][5]. - Changchun High-tech's subsidiary, GenSci, has seen over 76% of its revenue coming from growth hormones, while Anke Bio's growth hormone sales account for nearly 70% of its total revenue [3]. - Both companies have initiated clinical trials for new products, with Changchun High-tech focusing on innovative drugs and Anke Bio expanding into antiviral and oncology treatments [5].

近日，长春高新（000661）(000661.SZ)在披露2024年年报后召开投资者电话交流会，吸引东吴证券、 格林基金、摩根士丹利、易方达基金等96家机构参与。会上，公司财务总监及董秘围绕2024年公司业绩 表现及业务经营情况展开了详细的介绍，尤其突出了金赛药业伏欣奇拜单抗等多个在研管线的进展。 具体而言，用于成年痛风性关节炎的伏欣奇拜单抗，作为有望成为国内首款获批上市的IL-1β单抗，其 Ⅲ期临床数据显示出急性发作期非劣于复方倍他米松的疼痛缓解功效和更优的安全性，以及缓解期在用 药12周及24周内对降低痛风复发风险的显著疗效。据公告，该药品粉剂及水针剂上市申报分别于2024年 4月及2025年1月获得受理，其粉剂预计今年内能够获批上市。 公司提及的另一在研化药1类新药GS1-144片，是公司自主研发的NK3R小分子拮抗剂，该产品作为绝经 期血管舒缩症的非激素口服疗法，可为患者提供更好的治疗选择。据悉，国内暂无该靶点药物上市，公 司的GS1-144片研发在境内已至Ⅱ期临床阶段，在澳洲处于I期临床阶段，在美国处于Ⅱ期临床试验申请 获得FDA默示许可状态。 GenSci120注射液同样值得关注。该药品是公司自主 ...