| 序号 | 受理号 | 药品名称 | 申请人 | 批准文号 | 批准日期 | | --- | --- | --- | --- | --- | --- | | 98 | IXSS2400017 | 注射用隆培生长激素 | 维异药业(上海)有限公司 | 国药准字SJ20260003 | 2026年01月20日 | | də mərkəzi və qalında çəkilməsi və qalınmışdır. Bu mənist və bir mənist və bir mənist | .TXSS2400018 | 注射用隆培生长激素 | 维异药业(上海)有限公司 | 国药准字SJ20260004 | 2026年01月20日 | | 100 | JXSS2400019 | 注射用隆培生长激素 | 维异药业（上海）有限公司 | 国药准字SJ20260005 | 2026年01月20日 | | 101 | JXSS2400020 | 注射用隆培生长激素 | 维科药业（上海）有限公司 | 国药准字SJ20260006 | 2026年01月20日 | | 102 | IXSS2400021 | 注射用隆培生长激素 ...

Group 1 - The core product of Weisheng Pharmaceutical-B, Longpei Growth Hormone, is expected to be approved soon, having completed its supplementary data task on January 12, 2026 [1] - Longpei Growth Hormone is the first long-acting growth hormone prodrug approved for use in children with Growth Hormone Deficiency (GHD) in the US and Europe, which could significantly enhance patient compliance compared to daily formulations [1][2] - The stock of Weisheng Pharmaceutical-B has risen over 16% this year, outperforming the Hang Seng Index, which has increased by over 4% during the same period [1] Group 2 - Longpei Growth Hormone, introduced by Weisheng Pharmaceutical from Ascendis Pharma, utilizes TransCon technology for long-acting delivery, showing superior efficacy and equivalent safety compared to short-acting growth hormones [2] - The drug has completed critical Phase III trials in China, demonstrating its effectiveness in comparison to short-acting growth hormones [2]

国海证券曾发研报指，基于TransCon技术的长效生长激素隆培预计上市在即，其相比于短效人生长激素显示出优效性及同等安全性。隆培生长激素为维昇药 业于2018年11月自Ascendis Pharma授权引入，凭借TransCon"暂时连接技术"长效路径，隆培生长激素是唯一一款于每周给药之间在体内持续释放未经修饰的 人生长激素的长效生长激素，经已完成的中国Ⅲ期关键性试验所验证，隆培生长激素是唯一一款在与短效人生长激素的阳性药物对照及平行组试验比较中显 示出优效性及同等安全性的长效生长激素。(格隆汇) 消息面上，Insight数据库显示，维昇药业-B核心产品隆培促生长素已于2026年1月12日离开补充资料任务，预计即将获批。据悉，隆培促生长素是维昇药业- B从Ascendis Pharma引进的长效生长激素前药，是全球首个在美国及欧洲获批用于儿童生长激素缺乏症(GHD)的长效周制剂。国内生长激素市场以日制剂为 主，周制剂可大幅提升患者依从性，上市后有望重塑竞争格局，满足未被充分满足的临床需求。 维昇药业-B(2561.HK)今日高开高走，盘中一度大涨9.9%至38.2港元，股价创去年12月19日以来逾一个月新高。 ...

Core Viewpoint - Viesheng Pharmaceutical-B (02561) has seen a significant stock price increase, with a rise of over 9% during trading, currently up 7.13% at HKD 37.24, driven by the anticipated approval of its core product, Lonapegsomatropin, expected on January 12, 2026 [1] Company Summary - Lonapegsomatropin is a long-acting growth hormone prodrug developed by Viesheng Pharmaceutical-B, licensed from Ascendis Pharma, utilizing TransCon technology for the treatment of Growth Hormone Deficiency (GHD) in children [1] - The product is designed for once-weekly subcutaneous injection, releasing unmodified natural growth hormone, and has already received approval in Europe and the United States [1] Industry Summary - The domestic growth hormone market primarily consists of daily formulations, and the introduction of a weekly formulation is expected to significantly enhance patient compliance [1] - The anticipated launch of Lonapegsomatropin is likely to reshape the competitive landscape and address unmet clinical needs in the market [1]

消息面上，据Insight数据库显示，维昇药业-B核心产品隆培促生长素已于2026年1月12日离开补充资料 任务，预计即将获批。 据公开资料显示，隆培促生长素是维昇药业-B从Ascendis Pharma引进的长效生长激素前药，基于 TransCon暂时连接技术研发，用于治疗儿童生长激素缺乏症(GHD)，每周皮下注射一次，可释放未经修 饰的天然人生长激素，欧美此前已获批。国内生长激素市场以日制剂为主，周制剂可大幅提升患者依从 性，上市后有望重塑竞争格局，满足未被充分满足的临床需求。 智通财经APP获悉，维昇药业-B(02561)盘中涨超9%，截至发稿，涨7.13%，报37.24港元。 ...

Core Viewpoint - The new National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalog will be implemented on January 1, 2026, leading to price reductions for several drugs, including long-acting growth hormone products from Jinsai Pharmaceutical and Tebao Biological [1][6]. Group 1: Market Impact - The inclusion of long-acting growth hormones in the national medical insurance will fundamentally change the market dynamics by significantly lowering annual treatment costs, thus releasing previously suppressed demand [7][18]. - The annual treatment cost for a child weighing 30 kg will drop to around 30,000 yuan after the inclusion of long-acting growth hormones in the insurance [6][10]. - The domestic growth hormone market size has grown from 4 billion yuan in 2018 to 11.6 billion yuan in 2023, with a compound annual growth rate (CAGR) of 23.9%, expected to reach 28.6 billion yuan by 2030 [14]. Group 2: Product Competition - Jinsai Pharmaceutical's Jinsai Growth Hormone and Tebao Biological's Yipeisheng are the only two long-acting products included in the new insurance catalog, leading to direct competition [20][21]. - Jinsai Growth Hormone's price has reportedly dropped to approximately 900 yuan per 9 mg after negotiations, a reduction of about 75% from its previous price of 3,500 yuan [6][10]. - Tebao Biological's Yipeisheng has seen a price reduction of about 53%, with new insurance payment prices ranging from 418.11 yuan to 853.20 yuan [5][6]. Group 3: Future Trends - The long-acting growth hormone market is expected to capture 73.8% of the overall growth hormone market by 2030, while short-acting products are projected to decline [17]. - The market penetration of long-acting growth hormones is anticipated to increase significantly due to their improved patient compliance and lower injection frequency [10][18]. - New entrants, such as Novo Nordisk and Weisheng Pharmaceutical, are expected to face challenges in gaining market share due to the already low pricing established by Jinsai Growth Hormone [23][24].

Core Viewpoint - Anhui Anke Biotechnology (Group) Co., Ltd. is set to experience a peak in new drug launches in 2026, with a dual focus on self-developed innovative drugs and agency-represented blockbuster products, covering key therapeutic areas such as oncology, rare diseases, and assisted reproduction, which will reshape the company's performance growth pattern [1] Group 1: Self-Developed Drugs - The long-acting growth hormone pipeline is expanding, with the collaboration with Weisheng Pharmaceutical on Longpei Growth Hormone entering the production review stage, expected to launch between late 2025 and early 2026, significantly improving patient compliance with a once-weekly dosing frequency [1] - Two major self-developed products are anticipated to achieve market breakthroughs in 2026: PA3-17 injection, a CD7 CAR-T therapy for T-lymphoblastic leukemia/lymphoma, is included in the CDE's breakthrough therapy category, with a pivotal Phase II trial starting in October 2025 and a conditional market application expected around 2026 [2] - An anti-VEGF humanized monoclonal antibody has completed Phase III clinical trials and plans to submit for market approval in 2026, providing an important treatment option for advanced malignant tumors [2] - The HER2-targeted innovative drug HuA21 injection has completed Phase Ib/II clinical trials and aims to advance to Phase III clinical application in 2026, potentially overcoming existing treatment resistance in HER2-positive breast cancer [2] Group 2: Agency-Represented Drugs - The long-acting follicle-stimulating hormone "Shengnuo" is highlighted as China's first approved long-acting follicle-stimulating hormone injection, developed through a collaboration between Anke Biotechnology and Baoji Pharmaceutical, achieving a convenient "one injection covers one week" treatment [3] - Phase III clinical trials show that key indicators such as the number of eggs retrieved and live birth rates are comparable to short-acting formulations, with the average injection frequency reduced to 2.6 times [3] - A dedicated promotion team of 300 has been established, with expectations for significant revenue contributions in 2026, filling a market gap in the domestic long-acting follicle-stimulating hormone sector, which has a market size exceeding 6 billion yuan [3] Group 3: Overall Impact - Anke Biotechnology's robust positioning in growth hormones, anti-tumor, and assisted reproduction fields has established a dual product matrix of "self-developed + agency" [3] - The concentrated launch of multiple new drugs in 2026 is expected to enrich clinical treatment options, enhance the accessibility of domestic drugs, and potentially drive the company's performance to achieve exponential growth, solidifying its core competitiveness in the biopharmaceutical niche [3]

消息面上，安科生物近期披露合作进展，与维昇药业合作的隆培促生长素即将获批。据悉，7月14日， 安科生物宣布，公司与维昇药业签订战略合作框架协议，共同推动隆培促生长素在中国市场的普及。 智通财经获悉，维昇药业-B(02561)再涨超12%，截至发稿，涨7.11%，报35.26港元，成交额190.82万港 元。 值得注意的是，11月6日，第八届进博会期间，维昇药业与国内制药装备龙头企业东富龙达成双腔冻干 制剂技术战略合作，并与临港新片区管委会、临港集团物贸平台签署产业协同协议，标志着其在"全球 创新、中国加速"的战略实践进一步落地。 本文源自：智通财经网 ...

消息面上，安科生物近期披露合作进展，与维昇药业合作的隆培促生长素即将获批。据悉，7月14日， 安科生物宣布，公司与维昇药业签订战略合作框架协议，共同推动隆培促生长素在中国市场的普及。 值得注意的是，11月6日，第八届进博会期间，维昇药业与国内制药装备龙头企业东富龙达成双腔冻干 制剂技术战略合作，并与临港新片区管委会、临港集团物贸平台签署产业协同协议，标志着其在"全球 创新、中国加速"的战略实践进一步落地。 智通财经APP获悉，维昇药业-B(02561)再涨超12%，截至发稿，涨7.11%，报35.26港元，成交额190.82 万港元。 ...

Core Viewpoint - Vison Pharma-B (02561) experienced a significant stock price increase, rising over 7% during trading and currently up 3.64% at HKD 31.88, driven by recent collaboration news with Anke Bio [1] Group 1: Company Developments - Anke Bio recently disclosed progress in its collaboration with Vison Pharma regarding the growth-promoting factor, Longpei, which is expected to receive approval soon [1] - On July 14, Anke Bio announced the signing of a strategic cooperation framework agreement with Vison Pharma to promote the market penetration of Longpei in China [1] - Vison Pharma's core product, Longpei, had its application for market approval accepted by the National Medical Products Administration of China in March 2024, with expectations for market launch in the second half of 2025 [1]