Core Viewpoint - Changchun High New's subsidiary Brillian Pharma INC. has received FDA approval for the freeze-dried powder of Amlodipine Besylate oral solution, indicating a significant advancement in its product portfolio and potential market expansion [1] Group 1: Product Approval - The FDA has approved the freeze-dried powder of Amlodipine Besylate oral solution for marketing [1] - The product is indicated for hypertension in patients aged 6 and older, as well as for chronic stable angina and vasospastic angina in adults [1] - The approval supports the treatment of coronary heart disease confirmed by angiography [1]

苯磺酸氨氯地平口服溶液用冻干粉适用于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。 长春高新（000661）(000661.SZ)公告，公司控股子公司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。 ...

人民财讯7月29日电，长春高新（000661）7月29日晚间公告，近日，公司获悉，控股子公司Brillian Pharma INC.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。 ...

格隆汇7月29日丨长春高新(000661.SZ)公布，近日，长春高新技术产业(集团)股份有限公司获悉，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。 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血管 事件的风险。 ...

长春高新(000661.SZ)公告称，公司控股子公司Brillian Pharma INC.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。该产品适用于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。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。 ...

证券代码：000661 证券简称：长春高新 公告编号：2025-068 长春高新技术产业（集团）股份有限公司 关于境外子公司苯磺酸氨氯地平口服溶液用冻干粉 在美国获批上市的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假记 载、误导性陈述或重大遗漏。 近日，长春高新技术产业（集团）股份有限公司（以下简称"公司"）获悉， 控股子公司 Brillian Pharma INC.（以下简称"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。现就相关情 况公告如下： 产品名称：苯磺酸氨氯地平口服溶液用冻干粉 商品名称：Sdamlo 获批适应症：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。 二、药品的其它情况 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%， ...

Investment Rating - The report rates the mother and baby consumption industry as "Overweight" [2][9] Core Insights - The introduction of a national childcare subsidy of 3,600 yuan per child per year, totaling up to 10,800 yuan per child, is expected to improve consumption expectations in the mother and baby sector [3] - The report highlights that despite a decline in birth rates over the past seven years, the overall mother and baby market has experienced a compound annual growth rate (CAGR) of over 15% from 2018 to 2024 due to consumption upgrades and refined parenting [3] - The report emphasizes the rise of domestic brands in the mother and baby sector, with significant market share gains and a return of industry influence to local brands [3] Summary by Sections National Childcare Subsidy - The national childcare subsidy program will start on January 1, 2025, providing cash subsidies to families with children under three years old, with a basic standard of 3,600 yuan per year [3] - Local governments are expected to introduce additional subsidies, creating a wave of local support for childbirth [3] Market Growth and Opportunities - The mother and baby market is projected to rebound due to improved policies and an anticipated increase in birth rates in 2024 [3] - Key sectors and companies recommended for investment include: - Fertility and reproductive health: Focus on companies like Jinxin Reproductive and Livzon Pharmaceutical [3] - Infant nutrition: Recommendations include China Feihe and Yili Group [3] - Baby appliances: Suggested investment in Bear Electric [3] - Apparel and home textiles: Companies like Semir and Anta are highlighted [3] - Baby care products: Brands such as Runben and New Page are recommended [3] Valuation Table - The report includes a valuation table with various companies in the mother and baby sector, indicating their stock prices, market capitalization, and profit forecasts for 2025, 2026, and 2027, along with corresponding investment ratings [4]

Core Viewpoint - Changchun High-tech has experienced a significant decline in stock price and market value, reflecting the challenges faced by the Chinese pharmaceutical industry as it transitions from a reliance on "miracle drugs" to a focus on innovation [2] Financial Performance - In 2024, Changchun High-tech reported its first revenue decline in nearly 20 years, with revenue of 13.466 billion yuan, a year-on-year decrease of 7.55%, and net profit of 2.708 billion yuan, down 43.01% [3] - The company's performance continued to deteriorate in Q1 2025, with net profit of 469 million yuan, a year-on-year decline of 47.36% [4] - From 2020 to 2023, the company saw revenue grow from 8.577 billion yuan to 14.566 billion yuan, and net profit increase from 3.308 billion yuan to 4.776 billion yuan, but 2024 marked a turning point with revenue dropping to 13.466 billion yuan and net profit plummeting to 2.583 billion yuan [5] Factors Affecting Performance - The decline in performance is attributed to three main factors: centralized procurement policies, a decrease in birth rates, and price wars with competitors [6] - Centralized procurement significantly impacted the company's main product, growth hormone, which saw prices drop from approximately 1,000 yuan to 300 yuan, a reduction of 70%, leading to a 40.67% profit drop for its subsidiary, Jinsai Pharmaceutical [6] - The decline in birth rates has reduced the potential market for growth hormone, with newborn numbers dropping from 17.23 million in 2017 to 9.02 million in 2023 [7] - Increased competition in the long-acting growth hormone market has led to price wars, further squeezing profit margins [7] Sales and Expenses - In response to market challenges, the company increased its sales team by 58% in 2024, raising the number of sales personnel from 3,155 to 4,995, resulting in an 11.8% increase in sales expenses to 4.439 billion yuan [7][10] - Despite the increase in sales personnel, average salaries for sales staff decreased by approximately 15,000 yuan, reflecting higher work intensity as evidenced by significant increases in travel and entertainment expenses [10] Vaccine Business Challenges - Changchun High-tech's subsidiary, Baike Biotechnology, faced severe challenges, with 2024 revenue dropping to 1.229 billion yuan, a year-on-year decline of 32.64%, and net profit halving to 232 million yuan [11] - The decline in vaccine sales was attributed to reduced public willingness to get vaccinated and decreased market demand, with sales volume for its shingles vaccine dropping by 69.8% [11] - The company's vaccine product, "Ganwei," has a lower efficacy rate compared to international competitors, further impacting its market position [11] Innovation and Future Outlook - The company is attempting to explore new growth avenues through its innovation pipeline, but faces challenges with only 24 key products in clinical stages compared to over 300 by competitors [12] - Key projects have experienced delays, with the completion date for a significant product pushed back from June 30, 2025, to June 30, 2026 [12] - Early-stage products are expected to take 5-8 years to commercialize, indicating a long road ahead for the company to regain market competitiveness [13]

Core Insights - The report maintains a positive outlook on small molecule drug conjugates (SMDCs) and related companies, highlighting their potential in cancer treatment due to their ability to enhance efficacy while reducing toxicity [1][5][17] - The report emphasizes the clinical advantages of SMDCs, including better tumor penetration, reduced toxicity to normal cells, and easier control over synthesis and costs compared to antibody-drug conjugates (ADCs) [5][11][12] - The report identifies domestic biopharmaceutical companies, particularly Affinivax, as leaders in the SMDC space, showcasing significant advancements in innovative cancer drug development [5][12][17] Industry Overview - The pharmaceutical and biotechnology sector has shown a relative price-to-earnings (P/E) ratio of 51.14 as of July 25, 2025, which is significantly higher than its historical low of 24.38, indicating a premium valuation compared to the broader market [19] - The report notes that the healthcare sector's valuation is 279% higher than the Shanghai Composite Index, reflecting strong investor interest and confidence in the industry [19] - Recent market performance indicates a 1.90% increase in the pharmaceutical and biotechnology sector from July 21 to July 25, 2025, ranking it 16th among 27 sub-industries [26][29] Company Focus - The report suggests monitoring companies involved in the SMDC space, including Affinivax, and those collaborating with them, such as Innovent Biologics and others, which are expected to benefit from the growing interest in innovative cancer therapies [5][17][18] - Specific companies highlighted for their innovative drug development capabilities include Innovent Biologics, Shunyi Pharmaceutical, and others, which are positioned to capitalize on the advancements in SMDC technology [5][18]

Group 1: Biovaccine ETFs - There are two ETFs named Biovaccine ETF, one managed by Penghua Fund tracking the Guozhen Vaccine and Biotechnology Index, consisting of 50 companies with an average market capitalization of approximately 53.9 billion yuan [1][3] - The second Biovaccine ETF is managed by Harvest Fund, tracking the Zhongzheng Vaccine and Biotechnology Index, which includes up to 50 companies involved in vaccine research and production, with an average market capitalization of about 22 billion yuan [3][5] - The two indices share 19 overlapping constituent stocks, with the Guozhen index having 31 unique stocks and the Zhongzheng index having 24 unique stocks [5][6] - In terms of past performance, the Zhongzheng Vaccine and Biotechnology Index has outperformed the Guozhen index over one, three, and five years, with a notably higher increase in the past year [6][7] Group 2: Biopharmaceutical ETFs - There are two ETFs named Biopharmaceutical ETF, one managed by Tianhong Fund tracking the Guozhen Biopharmaceutical Index, which includes the top 30 companies based on market capitalization and liquidity, with an average market capitalization of around 45.2 billion yuan [11][13] - The second Biopharmaceutical ETF is managed by Guotai Fund, tracking the Zhongzheng Biopharmaceutical Index, which selects companies providing cell therapy, gene sequencing, and other biopharmaceutical services, with an average market capitalization of approximately 71.9 billion yuan [13][15] - The two indices have 18 overlapping constituent stocks, with each index having 12 unique stocks [15][16] - The Zhongzheng Biopharmaceutical Index has consistently outperformed the Guozhen index over one, three, and five years, while the Guozhen index exhibits higher annualized volatility [15][17]