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长效生长激素首次纳入国家医保,700万矮小患儿迎来“普惠曙光”
Xin Lang Cai Jing· 2026-01-01 01:16
2026年1月1日,新版国家医保药品目录在全国范围内正式落地实施。 根据国家医保局公布的数据,此次调整新增114种药品。其中针对内源性生长激素缺乏(GHD)引起儿 童生长缓慢的长效生长激素——金培生长激素注射液,为全球原研第一支PEG长效生长激素,更是填补 了国家医保目录内无长效生长激素可用的空白。 回顾过往,金赛药业在1998年就研制出第一支国产短效生长激素粉剂,一举打破进口垄断;2014 年,"金赛增"获批上市,成为全球首款长效生长激素。经过10年超15万患者临床验证安全优效,已是当 前临床使用时间最长、治疗患者数最多的长效生长激素。如今,响应国家政策进入医保目录,它还有望 成为患者治疗负担最低的生长激素长效制剂,实现中国儿童生长发育治疗领域的里程碑式跨越。 一、中国700万矮小患儿,治疗率却不足5% 中国家长对身高的关注度从未像如今这般高涨,尽管有时感觉"自己在被贩卖焦虑",但大数据揭露的一 个残酷事实是:中国矮小症患儿的实际治疗率严重不足。 2021年《国务院关于印发中国妇女发展纲要和中国儿童发展纲要的通知》提出,5岁以下生长迟缓率控 制在5%以下。对于儿科内分泌门诊或生长发育门诊的医生而言,每年寒暑 ...
速递|中国首款周制生长激素落地!诺和诺德生长激素获批上市
GLP1减重宝典· 2025-12-28 15:17
整理 | GLP1减重宝典内容团队 | 序号 | 受理号 | 药品名称 | 申请人 | 批准文号 | 批准日期 | | --- | --- | --- | --- | --- | --- | | 90 | JXSS2400073 | 帕西生长激素注射液 | 诺和诺德(中国)制药有限 公司 | 国药准字SJ20250030 | 2025年12月22日 | | 91 | JXSS2400074 | 帕西生长激素注射液 | 诺和诺德(中国)制药有限 | 国药准字SJ20250031 | 2025年12月22日 | | | | | 公司 | | | 帕西生长激素是一种长效生长激素类似物,通过对分子结构进行优化,在替换一个氨基酸的基础上偶联脂肪酸侧链,使药物能够以高亲 和力与人血白蛋白可逆性结合,从而显著延长体内半衰期,实现每周一次给药。该产品早在2020年8月即已获得美国FDA批准,用于治 疗成人生长激素缺乏症,并于2023年4月进一步扩展适应症,成为全球首款同时覆盖儿童和成人生长激素缺乏症的周制剂生长激素产 品。 2025年12月25日,国家药品监督管理局官网公示,诺和诺德旗下长效生长激素(LAGH)注射液帕西生长 ...
特宝生物半年报:营收净利均创新高
Core Insights - The company reported strong growth in its semi-annual report, with a revenue of 1.511 billion yuan, representing a year-on-year increase of 26.96%, and a net profit of 428 million yuan, up 40.60% [1] - The core product, Pegbivac, has gained recognition for its effectiveness in improving clinical cure rates for chronic hepatitis B and significantly reducing the risk of liver cancer, driving both revenue and profit growth [1] Financial Performance - In the first half of 2025, the company achieved a record high in both revenue and net profit, with revenue reaching 1.511 billion yuan and net profit at 428 million yuan [1] - The growth rates of 26.96% in revenue and 40.60% in net profit indicate robust financial health and operational efficiency [1] Market Context - China has approximately 75 million chronic hepatitis B virus carriers, with 20 to 30 million suffering from chronic hepatitis B, highlighting a significant market opportunity for the company's products [1] - The annual incidence rate of liver cirrhosis among chronic hepatitis B patients is between 2% and 10%, and the progression from cirrhosis to liver cancer has an annual incidence rate of 3% to 6%, underscoring the critical need for effective treatments [1] Research and Development Initiatives - The company is actively involved in various public welfare and research projects aimed at hepatitis B clinical cure and liver cancer prevention, including the "Everest" project, which is the largest real-world study on chronic hepatitis B [2] - As of May 2025, the "Everest" project has enrolled 33,466 patients and achieved surface antigen clearance in 10,240 cases, with a clearance rate exceeding 30% for patients treated for over 36 weeks [2] Technological Advancements - The company has developed three core technology platforms related to polyethylene glycol (PEG) modification, protein drug production, and drug screening and optimization, establishing itself as a leader in the PEG long-acting protein field in China [3] - The recent approval of a new long-acting growth hormone, Yipeisheng, for treating growth hormone deficiency in children, positions the company to capture a share of the growing growth hormone market, projected to reach 28.6 billion yuan by 2030 [3] Future Outlook - The company plans to continue focusing on the fields of immunology and metabolism, accelerating innovation to produce more "China-made" products and services for human health [3]
维昇药业的独立性与生长激素困局
3 6 Ke· 2025-06-12 23:15
Core Viewpoint - The innovative drug company Weisheng Pharmaceutical has faced significant market challenges post-IPO, with a 30% drop in stock price and a market capitalization loss exceeding 2 billion HKD, despite a booming market for new listings in Hong Kong [1][14]. Company Overview - Weisheng Pharmaceutical, known as the "first growth and development stock" in Hong Kong, has struggled to attract investor interest, reflected in its poor stock performance [1]. - The company reported a cumulative loss of 1.3 billion HKD over five years, with zero revenue generated in the past four years, which is unusual in the relatively tolerant Hong Kong market [3][14]. Financial Performance - The company has a cash balance of only 200 million HKD as of the end of 2024, raising concerns about its financial sustainability if it fails to achieve timely product approvals [5]. - Weisheng's IPO valuation was nearly 20% lower than its 2021 Series B financing valuation, indicating a lack of confidence from investors [1][14]. Product Pipeline - The flagship product, Longpei Growth Hormone, has completed Phase III clinical trials and is expected to receive market approval in 2025 [2]. - The company has two additional products in development, but it has yet to commercialize any products since its establishment over six years ago [3][14]. Market Competition - Longpei Growth Hormone faces stiff competition from established players like Changchun High-tech, which has dominated the market for over a decade with its product JinSaiZeng [11][13]. - The competitive landscape includes several other companies with products at various stages of clinical trials, which could further dilute Weisheng's market share upon its product launch [11][13]. Operational Independence - Weisheng Pharmaceutical's operational independence is questioned, as it appears to function more as a local agent for Danish biopharmaceutical giant Ascendis Pharma, with over 70% of shares held by Ascendis and Vivo Capital [7][9]. - The company relies heavily on external partners for production and technology transfer, raising concerns about its ability to independently develop and manufacture pharmaceutical products [9][10]. Future Challenges - Even with a successful product launch, Weisheng Pharmaceutical will face ongoing operational challenges, including potential price pressures from centralized procurement policies that could significantly impact profit margins [13][14]. - The market's skepticism regarding Weisheng's future profitability is evident, as reflected in its low market valuation despite the potential for its flagship product [14].
孩子矮是因为“晚长”?儿童长个最快的季节,先戳破五个长个谣言
Bei Ke Cai Jing· 2025-05-19 10:36
Core Viewpoint - The article addresses common misconceptions regarding children's height growth and provides expert advice on how parents can support their children's growth effectively [1][2][3][4][5][6][9][10][11][12][13][14]. Group 1: Misconceptions and Truths - Misconception 1: Tall parents will have tall children. Truth: Height is influenced by genetics but also by environmental factors, with studies showing that genetic factors account for approximately 80% of height in Western populations and 65% in Asian populations [2]. - Misconception 2: A child is short because they are "late bloomers." Truth: Only 2.0%-2.5% of children experience delayed puberty, and most children with this condition do not exceed their parents' height [3]. - Misconception 3: Being shorter than peers means a child has dwarfism. Truth: "Short stature" is defined as being below the 3rd percentile for height, and not all children who are shorter than their peers meet this criterion [4]. - Misconception 4: A larger bone age means a child will stop growing soon. Truth: Bone age is a dynamic measure and a single test cannot predict future height [5]. - Misconception 5: Administering growth hormones will solve height issues. Truth: Growth hormones should only be used under medical supervision and are not effective for all children [6][8]. Group 2: Recommendations for Parents - Regularly monitor height and weight, and create growth charts to track trends over time [9]. - Create a healthy growth environment by ensuring a balanced diet, adequate sleep, regular exercise, and sufficient outdoor activity for vitamin D synthesis [10][11][12]. - Encourage a positive psychological environment by fostering self-esteem and avoiding undue pressure regarding height [13]. - Seek medical advice promptly if any growth abnormalities are observed, including assessments of bone age and hormone levels [14].