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海思科:HSK36357胶囊新适应症IND申请获受理
Xin Lang Cai Jing· 2025-10-09 08:22
海思科公告,子公司上海海思盛诺医药科技有限公司于近日收到国家药品监督管理局下发的《受理通知 书》。该通知涉及药品HSK36357胶囊,适应症为拟用于治疗肌营养不良症,申请事项为境内生产药品 注册临床试验,受理号分别为CXHL2501059和CXHL2501060。HSK36357是公司自主研发的一个全新小 分子药物,临床拟用于治疗肌营养不良症(包括贝氏肌营养不良症和杜氏型肌营养不良症)。 ...
华润双鹤药业股份有限公司关于全资子公司华润双鹤利民药业(济南)有限公司波生坦分散片获得药品注册证书的公告
Core Viewpoint - The company announced that its wholly-owned subsidiary, Huaren Shuanghe Limin Pharmaceutical (Jinan) Co., Ltd., has received a drug registration certificate for Bosentan dispersible tablets from the National Medical Products Administration (NMPA) [1][2]. Group 1: Drug Registration and Development - The drug Bosentan dispersible tablets are indicated for pulmonary arterial hypertension (PAH) in pediatric patients aged 3 years and older, as well as for adult patients classified as WHO functional class II to IV [1][2]. - The development of this generic drug began in 2022, with the application for marketing authorization submitted on June 14, 2024, and approval granted on September 23, 2025 [2]. Group 2: Market Situation - Bosentan dispersible tablets were developed by Actelion Pharmaceuticals Ltd and were approved for sale in the EU in 2009 under the brand name "Tracleer." The drug was imported into China in September 2019 under the brand name "Quankeli" [3]. - In 2024, the global sales of Bosentan dispersible tablets reached approximately $35.9 million, with "Tracleer" accounting for about $31.3 million of that total [3]. - In the Chinese market, the total sales of Bosentan dispersible tablets were approximately 2.126 million yuan in 2024, with Johnson & Johnson holding a 100% market share [3]. Group 3: Impact on the Company - The acquisition of the drug registration certificate is expected to enhance the company's product line and market competitiveness, while also providing valuable experience for future product development [4].
20cm涨停!盟科药业定增落地,海鲸药业10亿入主
Feng Huang Wang· 2025-09-23 06:25
Core Viewpoint - Mengke Pharmaceutical (688373.SH) experienced a significant stock price increase following the announcement of a private placement plan to issue shares to Nanjing Haiqing Pharmaceutical Co., Ltd, which will result in Haiqing becoming the controlling shareholder of Mengke [1][3]. Group 1: Share Issuance Details - Mengke Pharmaceutical plans to issue 163,901,373 shares at a price of 6.30 CNY per share, raising a total of 1.033 billion CNY [1]. - After the issuance, Haiqing Pharmaceutical will hold 20% of Mengke's shares, making it the controlling shareholder, with Zhang Xiantao becoming the actual controller [1][2]. Group 2: Financial Structure and Use of Proceeds - The funds raised will be used for ongoing R&D investments and to improve the company's financial structure by reducing the debt-to-asset ratio and increasing liquidity [3]. - Mengke's debt-to-asset ratio is projected to rise from 18.91% at the end of 2022 to 59.45% by mid-2025 [3]. Group 3: Strategic Collaboration - The partnership with Haiqing Pharmaceutical is expected to enhance Mengke's sales revenue and reduce costs through strategic cooperation in commercialization, pharmaceutical research, and production processes [3]. - Mengke anticipates that if market resource integration is successful, sales revenue from products could reach 260 million CNY, 388 million CNY, and 600 million CNY from 2026 to 2028 [3]. Group 4: Product Portfolio and Market Position - Mengke's only commercialized product, Contizolam, has faced slow market uptake despite being approved in June 2021 and included in the national medical insurance directory in December 2021 [5]. - Sales figures for Contizolam have shown gradual improvement, with revenues of 4.82 million CNY in 2022, 9.08 million CNY in 2023, and projected 13 million CNY in 2024 [5][7]. Group 5: Clinical Development and Future Prospects - Mengke is expanding the indications for Contizolam into pediatric use and is conducting clinical trials for new drugs targeting resistant bacteria [7]. - The company has not yet achieved profitability, with net losses of 220 million CNY, 421 million CNY, 441 million CNY, and 139 million CNY from 2022 to mid-2025 [7].
智飞生物:CA111注射液获得临床试验批准通知书
Mei Ri Jing Ji Xin Wen· 2025-09-17 09:41
每经AI快讯,9月17日,智飞生物(300122)(300122.SZ)公告称,公司控股子公司宸安生物研发的 CA111注射液获得国家药品监督管理局药物临床试验批准通知书,同意在成人超重或肥胖患者中开展临 床试验。该注射液是一款葡萄糖依赖性胰岛素释放肽(GIP)受体和胰高血糖素样肽-1(GLP-1)受体的双重 激动剂,拥有广阔的市场前景。但需注意的是,药品研发具有投入大、周期长、风险高的特点,且后续 临床试验进度、结果及产品上市情况存在不确定性。 ...
泽璟制药:注射用ZG006开展关键性临床试验并完成首例受试者入组
Core Viewpoint - Zai Lab (688266) has received feedback from the National Medical Products Administration (NMPA) regarding the conditional approval for the clinical trial of its investigational product, ZG006 injection, indicating progress in its development for advanced small cell lung cancer patients [1] Group 1 - The NMPA's Center for Drug Evaluation (CDE) has agreed to allow ZG006 to proceed with critical clinical trials based on current safety and efficacy data [1] - ZG006 has been included in the CDE's list of breakthrough therapies, targeting patients with advanced small cell lung cancer who have previously undergone platinum-based chemotherapy and at least one other systemic treatment [1] - The company has successfully completed the enrollment of the first subject in the critical clinical trial for ZG006 [1]
北京初一女生HPV疫苗免费接种全面启动;赛诺菲创新药在华获批
Group 1: Pharmaceutical Companies and Products - 63 pharmaceutical companies have been exposed for serious credit violations, with 63 companies rated as "particularly serious" or "serious" by the National Medical Insurance Administration [1] - Junshi Biosciences announced positive results from a Phase III clinical trial of JS005 for moderate to severe plaque psoriasis, planning to submit a marketing application soon [1] - Sanofi's teplizumab injection has been approved in China for delaying the progression of type 1 diabetes in patients aged 8 and above [2] Group 2: Corporate Actions - Yingke Medical adjusted its share repurchase price limit from RMB 26.51 to RMB 41.88 per share, effective from September 8, 2025, with a total repurchase fund of RMB 80 million to 120 million [3] - Qidi Pharmaceutical plans to change its name to "Guhan Health Industry Group Co., Ltd." and will revise its articles of association accordingly [4] - Jiuan Medical intends to cancel 9.77 million shares, which is 2.06% of its total share capital, as part of a strategy to enhance shareholder returns [5] Group 3: Market Movements and Regulations - Xiangrikui is planning to acquire controlling stakes in Xi Pu Materials and 40% of Beid Pharmaceutical, leading to a temporary suspension of its stock [6] - Beijing has launched a free HPV vaccination program for new first-year junior high school girls, aiming to increase vaccination rates [7][8] - Two studies on iza-bren (EGFR×HER3 dual antibody ADC) have been selected for the official news release program at the 2025 WCLC, highlighting its clinical significance [9] Group 4: Shareholder Actions - Chengda Pharmaceutical announced that a shareholder plans to reduce their stake by up to 7.27% within three months [10] - Kangchen Pharmaceutical's controlling shareholder plans to reduce their stake by up to 3% between September 29 and December 28, 2025, due to personal funding needs [11]
每周股票复盘:泽璟制药(688266)上半年营收3.76亿元同比增56.07%
Sou Hu Cai Jing· 2025-09-06 18:56
Group 1 - The stock price of Zai Jian Pharmaceutical (688266) closed at 120.84 yuan on September 5, 2025, an increase of 18.46% from the previous week's 102.01 yuan [1] - The company's market capitalization is currently 31.987 billion yuan, ranking 18th out of 150 in the chemical pharmaceutical sector and 553rd out of 5152 in the A-share market [1] Group 2 - Zai Jian Pharmaceutical reported a revenue of 376 million yuan for the first half of 2025, representing a year-on-year growth of 56.07%, primarily driven by increased drug sales [2][3] - The company recorded a net loss of 72.8035 million yuan in the same period, with losses slightly widening compared to the previous year [2][3] - Research and development expenses amounted to 197 million yuan, accounting for 52.31% of total revenue [2][3]
陈德康为何频频减持亲手带上市的莎普爱思?
Sou Hu Cai Jing· 2025-09-05 07:04
Core Viewpoint - The major shareholder of Zhejiang Shapuaisi Pharmaceutical Co., Ltd., Chen Dekang, plans to reduce his stake in the company due to personal financial needs, which raises concerns about the company's future performance and governance [2][3]. Shareholder Changes - Chen Dekang, who currently holds 11.67% of the shares, intends to reduce his holdings by up to 2% of the total share capital within three months starting from September 25, 2025 [2]. - Chen Dekang has a long history with the company, having been its founder and former controlling shareholder, but he lost control in late 2018 when he transferred shares to the Lin brothers [3][4]. - Since losing control, Chen has been on a continuous selling spree, reducing his stake from 16.3% in 2021 to the current 11.67% [4][6]. Company Performance - Shapuaisi has faced financial difficulties, with losses reported in 2020 and 2024, totaling 1.79 billion and 1.23 billion respectively, leading to cumulative losses of 1.96 billion over five years [4][7]. - The company managed to achieve a profit of 0.22 billion in the first half of the current year, but this is minimal compared to its historical performance [4][7]. Market Position and Stock Performance - The company's stock price has significantly declined from over 50 yuan per share at its peak to below 10 yuan currently, indicating a lack of upward momentum [7][8]. - Despite attempts to integrate hospitals controlled by the Lin brothers into Shapuaisi, these acquisitions have not resulted in improved financial performance, with core product sales dropping by 80% from 2017 to 2024 [7].
深度*公司*3SBIO INC(1530.HK):FLATTISH 1H25 MISSED; PFIZER’S TRIAL INITIATION OF 707 COULD BE KEY CATALYST
Ge Long Hui· 2025-09-04 03:17
Core Viewpoint - 1H25 results were disappointing with a revenue decline of 0.8% YoY to RMB4.36 billion, while adjusted net profits to shareholders increased by 2.1% YoY to RMB1.36 billion, missing expectations [1][2] Revenue Performance - Revenue from legacy products TPIAO and EPO, which accounted for 54% and 16% of total revenue respectively, declined by 4% YoY and 12% YoY due to high base effects, stricter medical insurance controls, increased competition, and negative impacts from province-level VBP [2][3] - Revenue from Sunshine Guojian increased by 8% YoY, driven by its CDMO business, while sales from the alopecia area increased by 24% YoY, attributed to new SKUs and effective digital promotions [3] Profitability - Adjusted net profits to shareholders rose by 2.1% YoY to RMB1.36 billion, although management did not update guidance post-results, indicating challenges in meeting previous double-digit growth expectations [3] Future Developments - The company is closely monitoring Pfizer's development plan for 707, with a focus on its Phase II data in colorectal cancer to be presented at the 2025 ESMO conference [1][3] - Pfizer's near-term objectives include initiating global Phase III development for 707 in various cancers and exploring its potential in combination with Pfizer's ADC therapies [3] Pipeline Updates - The company anticipates new product approvals between 2026-28, including candidates for psoriasis, acute gouty arthritis, adult atopic dermatitis, and asthma, with several in late-stage trials [3] Sales Forecast Adjustments - Post-results, the company revised its 2025-27 sales forecasts, decreasing estimates for legacy products while increasing projections for Mandi due to strong sales momentum [3] - The target price was raised to HK$38.20 based on updated sales forecasts and a revised WACC from 10.6% to 9.7% [3]
浙江莎普爱思药业股份有限公司 关于全资子公司获得盐酸毛果芸香碱滴眼液临床试验批准通知书的公告
Group 1 - The core point of the announcement is that Zhejiang Shapuaisi Pharmaceutical Co., Ltd.'s wholly-owned subsidiary has received approval for clinical trials of a new eye drop medication, which is intended for the treatment of presbyopia in adults [1][2]. - The drug, named Pilocarpine Hydrochloride Eye Drops, is classified as a Class 3 chemical drug and is currently in the clinical trial phase [1][3]. - The total research and development investment for the Pilocarpine Hydrochloride Eye Drops project has reached approximately 6.4457 million RMB [3]. Group 2 - The major shareholder, Mr. Chen Dekang, holds 43,871,004 shares, accounting for 11.67% of the total share capital of the company [7]. - Mr. Chen plans to reduce his holdings by up to 3,759,250 shares through centralized bidding and another 3,759,250 shares through block trading, totaling a maximum of 7,518,500 shares, which is 2.00% of the total share capital [7][8]. - The reduction plan is due to personal financial needs and will take place from September 25, 2025, to December 24, 2025 [7].