Core Viewpoint - Changchun High-tech has received approval for clinical trials of its drug, Cabergoline Tablets, aimed at treating hyperprolactinemia and pituitary prolactin adenomas, marking a significant step in addressing unmet clinical needs in this area [1][2] Group 1: Product Development - Cabergoline Tablets are a dopamine receptor agonist with effective activity on dopamine D2 receptors, classified as a chemical drug of category 3, intended for the treatment of hyperprolactinemia and pituitary prolactin adenomas [1] - The drug has been approved for clinical trials in China, which will facilitate its clinical development and address unmet clinical needs for patients [2] - The original product of Cabergoline has been approved in over 80 countries since 1992, making it a first-line treatment for hyperprolactinemia and pituitary prolactin adenomas [2] Group 2: Market Context - Hyperprolactinemia is a common endocrine disorder, particularly among young women, with an annual incidence rate of 23.9 per 100,000 for women aged 25 to 34 [1] - The condition is prevalent in 10% to 25% of patients with secondary amenorrhea and 70% to 80% of patients with amenorrhea and galactorrhea, with 20% to 30% of hyperprolactinemia patients having pituitary tumors, primarily prolactinomas [1] Group 3: Company Strategy and Other Developments - Changchun High-tech is involved in various pharmaceutical sectors, including gene engineering, biological vaccines, antibody drugs, high-end chemical drugs, and modern traditional Chinese medicine [2] - The company has also received approvals for other products, including GenSci098 for thyroid eye disease and GenSci122 for advanced solid tumors, indicating a robust pipeline of clinical trials [3] - Additionally, the company plans to issue H-shares and list on the Hong Kong Stock Exchange to enhance its international presence and financing capabilities [4]

Group 1 - Changchun High-tech announced that its subsidiary Brillian Pharma INC. received FDA approval for the oral solution of benidipine hydrochloride lyophilized powder, which is suitable for treating hypertension in patients aged 6 and above, as well as chronic stable angina and vasospastic angina in adults [1][2] - The approved product is a 505B2 modified innovative drug specifically designed for children over 6 years old and adults with swallowing difficulties, aimed at lowering blood pressure and reducing the risk of fatal and non-fatal cardiovascular events [1] - The product is developed based on existing FDA-approved original products, offering convenience in clinical use, accurate dosing, and palatable taste, enhancing medication adherence for pediatric patients [1] Group 2 - The approval of this product will enrich Brillian Pharma's product portfolio in the U.S. market and enhance the company's competitiveness in the pharmaceutical sector [2] - The company plans to actively organize market promotion, production, and sales efforts to facilitate the widespread application of the product, providing more treatment options for patients [2]

国家医保局召开医保支持创新药械系列座谈会第四场 7月29日，据国家医保局消息，为落实《支持创新药高质量发展的若干措施》，推动创新药高质量发 展，更好满足人民群众多元化就医用药需求。近日，国家医保局召开医保支持创新药械系列座谈会第四 场，10余位专家学者、企业代表结合自身专业、行业特点，聚焦创新药研发现状、难点、发展方向等深 入交流，并提出意见建议。 药械审批 长春高新：创新药苯磺酸氨氯地平口服溶液用冻干粉获美国FDA批准上市 政策动向 7月29日，长春高新(000661.SZ)公告称，公司控股子公司倍利年申报的苯磺酸氨氯地平口服溶液用冻干 粉已获美国食品药品监督管理局（FDA）批准上市。苯磺酸氨氯地平口服溶液用冻干粉是倍利年研发的 专门针对6岁以上儿童和存在吞咽困难的成人高血压患者的505B2改良型创新药，能够降低6岁以上儿童 和成人的血压，可以减少致命和非致命心血管事件的风险。该产品获批有利于丰富倍利年的美国产品布 局，增强公司在医药市场的竞争力。 尖峰集团恩格列净化学原料药获批上市 7月29日，尖峰集团(600668.SH)公告称，全资子公司尖峰药业收到国家药品监督管理局关于化学原料药 恩格列净的《化学原 ...

中央网信办决定自7月24日起，在全国范围内启动为期2个月的"清朗·整治'自媒体'发布不实信息"专项行动。通过开展专项行动，集中整治"自媒体"发布不实 信息乱象，从严打击恶意蹭炒误导公众、多种手段歪曲事实、不做标注以假乱真、专业领域信息不实等突出问题，督导网站平台建立健全技术识别发现、信 息来源标注和专业资质认证等功能机制，进一步规范"自媒体"运营行为，持续营造清朗网络空间。（新华财经） 针对食品添加剂滥用问题，市场监管总局食品抽检司司长卫国锋29日表示，将持续加大食品添加剂抽检监测力度，严管食品添加剂超范围、超限量和非法添 加问题，对任何越界、超标非法行为零容忍，让合规使用食品添加剂成为食品行业的责任底线和信誉基石。（新华社） 中美经贸会谈在瑞典斯德哥尔摩举行双方将继续推动已暂停的美方对等关税24%部分以及中方反制措施如期展期90天 中央网信办开展"清朗·整治"专项行动集中整治"自媒体"发布不实信息乱象从严打击恶意蹭炒等突出问题 IMF将2025年和2026年的世界经济增长预期分别上调至3%和3.1% 当地时间7月28日至29日，中美经贸中方牵头人、国务院副总理何立峰与美方牵头人、美国财政部长贝森特及贸易代表 ...

丨 2025年7月30日星期三丨 NO.1诺和诺德下调全年财务指引 7月29日，诺和诺德美股盘前加速下跌，跌幅扩大至25%，此前公司下调2025年展望。公司预计2025年 在固定汇率下，全财年销售额增长8%~14%，此前预期增长13%~21%。这与Wegovy在美国肥胖市场的 增长预期较低，Ozempic在美国GLP-1糖尿病市场的增长预期较低，以及Wegovy在部分IO(国际运营)市 场的渗透率低于预期有关。 点评：诺和诺德下调全年业绩指引反映出GLP-1赛道从超预期增长向理性回归的趋势，也揭示出即便是 头部企业，在高基数和激烈市场竞争下亦难以持续高速扩张。Wegovy在肥胖适应证和Ozempic在糖尿病 领域的增长放缓，可能会影响整个GLP-1赛道的投资情绪，包括前期炒作激烈的国内相关原料药企业。 NO.2恩华药业（002262）：2025年上半年归母净利润约7亿元，同比增加11.38% 7月29日，恩华药业发布2025年半年报。报告期内，公司实现营业收入30.1亿元，同比增长8.93%；归属 于上市公司股东的净利润7亿元，同比增长11.38%。实现归属于上市公司股东的扣除非经常性损益的净 利润6.99亿 ...

Group 1 - Novo Nordisk has lowered its full-year financial guidance for 2025, expecting sales growth of 8% to 14% at constant exchange rates, down from a previous forecast of 13% to 21% [1] - The downward revision is attributed to lower growth expectations for Wegovy in the U.S. obesity market and Ozempic in the U.S. GLP-1 diabetes market, as well as lower-than-expected penetration of Wegovy in certain international markets [1] - This adjustment reflects a trend of rational return in the GLP-1 sector, indicating that even leading companies face challenges in sustaining high-speed expansion amid high bases and intense market competition [1] Group 2 - Enhua Pharmaceutical reported a net profit of approximately 700 million yuan for the first half of 2025, an increase of 11.38% year-on-year, with total revenue reaching 3.01 billion yuan, up 8.93% [2] - The company's performance demonstrates steady growth in a challenging pharmaceutical industry, highlighting its solid market position in analgesics and psychiatric drugs [2] Group 3 - Changchun High-tech announced that its subsidiary has received FDA approval for the freeze-dried powder of Amlodipine Besylate oral solution, aimed at treating hypertension in children over 6 years old and adults with swallowing difficulties [3] - This product approval enhances the company's product portfolio in the U.S. market and strengthens its competitive position in the pharmaceutical sector [3] Group 4 - Zhixiang Jintai has received approval for clinical trials of its investigational product, Sluveimi Monoclonal Antibody Injection, for passive immunity in children and adolescents suspected of rabies virus exposure [4] - This product is the world's first dual-specific antibody for rabies passive immunity, indicating the company's innovative capabilities in developing biopharmaceuticals [4]

Macro News - The International Monetary Fund (IMF) has significantly raised China's economic growth forecast for this year by 0.8 percentage points to 4.8%, reflecting stronger-than-expected economic activity in the first half of the year and lower actual tariff rates compared to previous predictions [4] - In the first half of the year, state-owned enterprises in China reported total operating revenue of 4,074.96 billion yuan, a year-on-year decrease of 0.2%. Their total profit amounted to 218.25 billion yuan, down 3.1% year-on-year, and tax payments were 300.26 billion yuan, a decline of 0.8% [4] Industry News - Hong Kong's "Stablecoin Regulation" will come into effect on August 1, with the Hong Kong Monetary Authority releasing five regulatory documents for licensed stablecoin issuers [7] - The China Photovoltaic Industry Association issued a statement refuting claims made by some media regarding "anti-involution" in the photovoltaic industry, particularly concerning polysilicon, stating that the reports were severely inconsistent with actual conditions [7] Company News - WuXi AppTec announced an adjustment to its share repurchase price ceiling to no more than 114.15 yuan per share [11] - The PCB industry is experiencing a significant improvement in market conditions compared to the same period last year, especially for high-end products, with strong demand and rising prices [9] - Changchun High-tech announced that its innovative drug, Amlodipine Besylate Oral Solution, has received approval from the FDA for market launch in the United States [12]

长春高新（000661）7月29日晚公告，公司获悉，控股子公司Brillian Pharma INC.(简称"倍利年")申报的 苯磺酸氨氯地平口服溶液用冻干粉已获美国食品药品监督管理局(FDA)批准上市，获批适应症为适用于 6岁以上和成人高血压，以及成人慢性稳定性心绞痛，血管痉挛性心绞痛，经血管造影证实的冠心病。 据介绍，高血压是一种以动脉血压持续升高为特征的慢性疾病，若长期控制不佳，会对身体多个器官和 系统造成严重损害，甚至引发致命性并发症。根据美国疾病控制与预防中心2024年10月发布的数据， 2021年8月至2023年8月期间，美国18岁及以上成年人高血压患病率为47.7%，6—17岁的美国儿童高血 压患病率为3.8%。 美国高血压指南治疗指出，药物治疗儿童及青少年高血压治疗的总体目标是降低靶器官损伤的风险，最 终降低成人高血压及心血管疾病的风险，氨氯地平作为长效二氢吡啶钙通道阻滞剂，是儿童高血压治疗 初始阶段的首选药物。 苯磺酸氨氯地平口服溶液用冻干粉是倍利年研发的一款专门针对6岁以上儿童和存在吞咽困难的成人高 血压患者的505B2改良型创新药，能够降低6岁以上儿童和成人的血压，可以减少致命和非致命心 ...

Core Viewpoint - The approval of Brillian Pharma INC.'s product, a freeze-dried powder for oral solution of Amlodipine Besylate, by the FDA enhances the company's product portfolio in the U.S. market and strengthens its competitive position in the pharmaceutical industry [1][3]. Group 1: Product Information - Product Name: Amlodipine Besylate Oral Solution Freeze-Dried Powder - Brand Name: Sdamlo - Approved Indications: For hypertension in individuals aged 6 and older, and for chronic stable angina, vasospastic angina, and coronary artery disease confirmed by angiography [1][2]. Group 2: Market Context - Hypertension is a chronic condition characterized by persistently elevated arterial blood pressure, affecting 47.7% of U.S. adults aged 18 and older and 3.8% of children aged 6-17 as of August 2023 [2]. - Amlodipine is recommended as a first-line treatment for hypertension in children and adolescents, aiming to reduce the risk of organ damage and cardiovascular diseases [2]. Group 3: Impact on the Company - The product's approval will enrich Brillian Pharma's product offerings in the U.S. and enhance its competitiveness in the pharmaceutical market [3]. - The company plans to actively promote, produce, and sell the product, aiming for widespread market application and providing more treatment options for patients [3].

*ST海华（600243）公告：基于巴州鲁新鼎盛燃气有限公司（下称："鲁新鼎盛"）所处的天然气行业和 地理位置具有良好的发展前景，公司控股子公司茫崖源鑫拟与徐海波、徐瑶瑶、鲁新鼎盛签署《收购协 议》，约定控股子公司茫崖源鑫以现金4300万元取得鲁新鼎盛100%的股权。 神马电力：拟以3亿元—4亿元回购股份 药明康德：拟将回购股份价格上限调整为不超114.15元/股 *ST海华：控股子公司拟4300万元收购鲁新鼎盛100%股权 仕佳光子：上半年净利润2.17亿元，同比增长1712% 滨化股份：筹划发行H股股份并在香港联交所上市事项 恩华药业：上半年净利润7亿元，同比增11.38% 沪市重要公告： 药明康德：拟将回购股份价格上限调整为不超114.15元/股 药明康德（603259）公告：拟将2025年第一次以集中竞价交易方式回购A股股份的回购股份价格上限由 不超过90.72元/股（含）调整为不超过114.15元/股，本次回购方案的其他内容不变。 *ST海华：控股子公司拟4300万元收购鲁新鼎盛100%股权 华勤技术：拟23.93亿元协议受让晶合集成6%股份 时空科技：实控人终止筹划控制权变更的重大事项，股票明起复 ...