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1年长高11厘米!维昇药业生长激素周制剂获批上市
Xin Lang Cai Jing· 2026-01-26 11:09
Core Viewpoint - Lonapegsomatropin, developed by Ascendis Pharma in collaboration with Weisheng Pharma, has been approved for market release in China for the treatment of growth hormone deficiency in children [1][5]. Group 1: Product Approval and Details - The National Medical Products Administration (NMPA) approved the injection of Lonapegsomatropin on January 20, 2026, under multiple registration numbers [3][7]. - Lonapegsomatropin is designed using the innovative TransCon (Transient Conjugation) technology platform, allowing for weekly administration, unlike most existing growth hormone products that require daily injections [3][7]. Group 2: Clinical Research and Efficacy - In 2021, Lonapegsomatropin was approved in the U.S. for children weighing at least 11.5 kg (25.4 lbs) with growth disorders due to endogenous growth hormone deficiency [4][8]. - A Phase III study in 2022 for Chinese children with growth hormone deficiency showed that after 52 weeks of treatment, the annualized height velocity (AHV) for Lonapegsomatropin was 10.66 cm/year compared to 9.75 cm/year for daily growth hormone formulations, demonstrating non-inferiority [4][8].
维昇药业-B大涨10% 股价创逾一个月新高 隆培促生长素上市在即
Ge Long Hui· 2026-01-23 08:01
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]
港股异动|维昇药业-B大涨10% 股价创逾一个月新高 隆培促生长素上市在即
Ge Long Hui· 2026-01-23 07:19
Core Viewpoint - Viesheng Pharmaceutical-B (2561.HK) has seen a significant stock price increase, reaching a new high since December 19 of the previous year, driven by the anticipated approval of its core product, Lonapegsomatropin, which is expected to reshape the growth hormone market [1][2] Group 1: Stock Performance - Viesheng Pharmaceutical-B opened high and surged by 9.9% to HKD 38.2, marking a year-to-date increase of over 16%, outperforming the Hang Seng Index, which rose over 4% during the same period [1] Group 2: Product Development - The Insight database indicates that Lonapegsomatropin is set to exit the supplementary data task on January 12, 2026, and is expected to receive approval soon [1] - Lonapegsomatropin, a long-acting growth hormone prodrug introduced from Ascendis Pharma, is the first long-acting weekly formulation approved for pediatric growth hormone deficiency (GHD) in the U.S. and Europe [1] - The domestic growth hormone market primarily consists of daily formulations, and the introduction of a weekly formulation is anticipated to significantly enhance patient compliance and address unmet clinical needs [1] Group 3: Competitive Advantage - According to Guohai Securities, Lonapegsomatropin, based on TransCon technology, is expected to be launched soon and demonstrates superior efficacy and equivalent safety compared to short-acting growth hormones [2] - Lonapegsomatropin is the only long-acting growth hormone that continuously releases unmodified human growth hormone in the body between weekly doses, validated by completed Phase III trials in China [2] - It has shown superior efficacy and equivalent safety in positive drug control and parallel group trials compared to short-acting growth hormones [2]
维昇药业-B盘中涨超9% 核心产品隆培促生长素预计即将获批
Zhi Tong Cai Jing· 2026-01-23 04:02
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]
港股异动 | 维昇药业-B(02561)盘中涨超9% 核心产品隆培促生长素预计即将获批
智通财经网· 2026-01-23 04:01
Core Viewpoint - Viesheng Pharmaceutical-B (02561) has seen a significant stock price increase, with a rise of over 9% during trading, currently at 37.24 HKD, 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 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, while weekly formulations like Lonapegsomatropin are expected to significantly enhance patient compliance [1] - The introduction of Lonapegsomatropin is anticipated to reshape the competitive landscape and address unmet clinical needs in the market [1]
生长激素行业要变了
3 6 Ke· 2026-01-08 08:10
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].
安科生物与维昇药业合作的隆培促生长素2026年即将上市,自研与代理双线突破
Quan Jing Wang· 2025-12-29 10:19
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]
港股异动 维昇药业-B(02561)再涨超12% 隆培促生长素即将获批 公司近期与东富龙达成战略合作
Jin Rong Jie· 2025-12-02 04:06
Group 1 - The core viewpoint of the article highlights the significant stock price increase of Vison Pharmaceutical-B (02561), which rose over 12% and is currently trading at 35.26 HKD with a transaction volume of 1.9082 million HKD [1] - Anke Bio recently disclosed progress in its collaboration with Vison Pharmaceutical, indicating that the growth-promoting factor, Longpei, is about to receive approval [1] - On November 6, during the 8th China International Import Expo, Vison Pharmaceutical established a strategic cooperation on dual-chamber freeze-drying technology with Dongfulong, a leading domestic pharmaceutical equipment company, and signed an industrial collaboration agreement with the Lingang New Area Management Committee and Lingang Group's trade platform, further implementing its strategy of "Global Innovation, China Acceleration" [1]
港股异动 | 维昇药业-B(02561)再涨超12% 隆培促生长素即将获批 公司近期与东富龙达成战略合作
智通财经网· 2025-12-02 03:09
Core Viewpoint - Vison Pharmaceutical-B (02561) has seen a significant stock increase of over 12%, currently trading at 35.26 HKD with a transaction volume of 1.9082 million HKD, driven by recent collaboration announcements and strategic partnerships [1] Group 1: Company Developments - Anke Bio recently disclosed progress in its collaboration with Vison Pharmaceutical, indicating that the growth-promoting agent Longpei is nearing approval [1] - On November 6, during the 8th China International Import Expo, Vison Pharmaceutical established a strategic cooperation on dual-chamber freeze-drying technology with leading domestic pharmaceutical equipment company Dongfulong [1] - Vison Pharmaceutical signed an industrial collaboration agreement with the Lingang New Area Management Committee and Lingang Group's trade platform, further advancing its strategy of "Global Innovation, China Acceleration" [1]
港股异动 维昇药业-B(02561)盘中涨超7% 公司核心产品隆培促生长素即将获批
Jin Rong Jie· 2025-12-01 03:14
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]