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亚盛医药上涨5.26%,报39.79美元/股,总市值36.99亿美元
Jin Rong Jie· 2025-07-28 13:41
资料显示,亚盛医药集团是一家立足中国、面向全球的生物医药企业,致力于在肿瘤、乙肝及与衰老相 关的疾病等治疗领域开发创新药物。2019年10月28日,亚盛医药在香港联交所主板挂牌上市,股票代 码:6855.HK。亚盛医药拥有自主构建的蛋白-蛋白相互作用靶向药物设计平台,处于细胞凋亡通路新药研 发的全球前沿。公司已建立拥有9个已进入临床开发阶段的1类小分子新药产品管线,包括抑制Bcl-2、 IAP或MDM2-p53等细胞凋亡通路关键蛋白的抑制剂;新一代针对癌症治疗中出现的激酶突变体的抑制剂 等,为全球唯一在细胞凋亡通路关键蛋白领域均有临床开发品种的创新公司。目前公司正在中国、美 国、澳大利亚及欧洲开展40多项临床试验。用于治疗慢性髓细胞白血病的核心品种奥雷巴替尼(商品名: 耐立克)曾获中国国家药品监督管理局新药审评中心(CDE)纳入优先审评和突破性治疗品种,并已在中国 获批,是公司的首个上市品种。目前,耐立克已被成功纳入《国家基本医疗保险、工伤保险和生育保险药 品目录(2022年)》。该品种还获得了美国FDA快速通道资格、孤儿药资格认定、以及欧盟孤儿药资格认 定。截至目前,公司共有4个在研新药获得16项FDA和1 ...
亚盛医药上涨4.15%,报39.9美元/股,总市值34.81亿美元
Jin Rong Jie· 2025-07-24 13:43
Core Viewpoint - As of July 24, 2023, AAPG's stock price increased by 4.15%, reaching $39.9 per share, with a total market capitalization of $3.481 billion. The company reported a total revenue of 981 million RMB for the year ending December 31, 2024, representing a year-on-year growth of 341.77%, while the net profit attributable to shareholders was -405 million RMB, showing a year-on-year increase of 56.2% [1][2]. Group 1 - AAPG is a biopharmaceutical company based in China, focusing on developing innovative drugs for cancer, hepatitis B, and age-related diseases [2]. - The company was listed on the Hong Kong Stock Exchange on October 28, 2019, under the stock code 6855.HK [2]. - AAPG has established a proprietary drug design platform targeting protein-protein interactions and is at the forefront of developing new drugs in the apoptosis pathway [2]. Group 2 - The company has a pipeline of nine clinical-stage Class 1 small molecule drugs, including inhibitors targeting key proteins in the apoptosis pathway such as Bcl-2, IAP, and MDM2-p53 [2]. - AAPG is conducting over 40 clinical trials across China, the United States, Australia, and Europe [2]. - The core product, Orebatinib (brand name: Nairike), has received priority review and breakthrough therapy designation from the Chinese National Medical Products Administration and has been approved for sale in China [2]. Group 3 - Orebatinib has been included in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List (2022) in China and has received multiple designations from the FDA, including fast track and orphan drug status [2]. - The company has been involved in several national science and technology major projects, including five under the "Major New Drug Creation" initiative [2]. - AAPG has established global collaborations with leading biotech and pharmaceutical companies and academic institutions, enhancing its research and development capabilities [2].
时隔九年全球第二款Bcl-2抑制剂上市,对慢淋白血病治疗改变多大
Di Yi Cai Jing· 2025-07-23 05:47
Core Viewpoint - The recent approval of the novel Bcl-2 selective inhibitor, Lisangtuo (generic name: Lishatoclax), by Ascentage Pharma marks a significant advancement in the treatment of high-risk chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients, particularly those with TP53 mutations, who have limited treatment options and a poor prognosis [1][2][4] Group 1: Product and Market Impact - Lisangtuo is the first domestically developed Bcl-2 inhibitor approved in China and the second globally, indicating a milestone in the development of targeted therapies for hematological malignancies [1][2] - The mechanism of Bcl-2 inhibitors involves specifically binding to and inhibiting the Bcl-2 protein, which is overexpressed in certain malignancies, thereby restoring the apoptotic pathway in cancer cells [1][3] - The global incidence of CLL/SLL exceeds 100,000 new cases annually, with an increasing trend in China due to an aging population, despite a lower incidence compared to Western countries [2][3] Group 2: Clinical and Safety Profile - Clinical trial data supporting Lisangtuo's approval demonstrated a favorable safety profile, with no reported cases of tumor lysis syndrome, a serious adverse reaction previously associated with Bcl-2 inhibitors [3][4] - Traditional treatment options for high-risk patients, such as chemotherapy, yield a progression-free survival of only about 12 months, highlighting the need for more effective therapies [2][4] Group 3: Future Directions and Industry Trends - The emergence of new-generation Bcl-2 inhibitors addresses limitations of existing therapies, such as BTK inhibitors, by reducing drug interactions and allowing for potential intermittent dosing, which can alleviate long-term economic burdens and risks of resistance [5] - There are currently 42 Bcl-2 inhibitors in development globally, indicating a growing interest and investment in this therapeutic area [5] - The future goals for blood cancer treatment include moving towards non-chemotherapy approaches and achieving clinical cures in certain patient populations [5]
研判2025!中国国际多中心临床试验(MRCT)行业发展现状、企业格局及未来趋势分析:临床试验数量创新高,本土企业市场地位不断提升[图]
Chan Ye Xin Xi Wang· 2025-07-22 01:14
Core Viewpoint - The article discusses the growth and significance of International Multi-Center Clinical Trials (MRCT) in the pharmaceutical industry, highlighting the shift towards biological drugs and the increasing participation of domestic companies in MRCTs [1][9][21]. Group 1: Overview of MRCT - MRCT refers to clinical trials conducted simultaneously at multiple centers across different regions to evaluate the efficacy, safety, and applicability of new drugs or treatments [2][3]. - MRCT has gained global recognition in the pharmaceutical and medical device industries, becoming a primary source of clinical trial data for product registration in multiple countries [9][21]. Group 2: Current Status of MRCT in China - The number of MRCTs in China peaked in 2021, saw a decline, and is projected to reach a new high of 336 in 2024, representing a 15% year-on-year increase [9][11]. - The transition from small molecule chemical drugs to large molecule biological drugs is evident, with biological trials surpassing chemical trials for the first time in 2023 [11][21]. - In 2024, 55.4% of MRCTs will be biological trials (186 trials), while chemical trials will account for 150 trials [11][13]. Group 3: MRCT Phases and Trends - The majority of MRCTs in China are Phase III trials, maintaining over 55% of the total, followed by Phase II (21.1%) and Phase I (17.0%) trials [13][21]. - The increase in Phase I trials is attributed to improved review and approval efficiency, allowing for faster market entry of drugs based on early clinical data [13][21]. Group 4: Company Landscape in MRCT - Foreign companies like AstraZeneca, Sanofi, and Merck dominate MRCTs in China, holding the top positions in trial numbers [17][19]. - Domestic companies such as BeiGene, Zai Lab, and Ascentage Pharma are increasingly active in MRCTs, with their participation rising significantly from less than 3% in 2015 to 30.1% in 2024 [15][17]. Group 5: Future Trends in MRCT - The trend towards MRCTs is expected to continue, driven by supportive policies and an improving market environment, enhancing the market position of domestic companies [21][23]. - Biotech companies are increasingly engaging in MRCTs as a first step towards internationalizing their products for overseas registration [21][23].
医药生物行业双周报:《2024年全国医疗保障事业发展统计公报》发布第十一批集采规则优化-20250721
Great Wall Glory Securities· 2025-07-21 09:24
Investment Rating - The investment rating for the industry is "Positive" and the rating has been maintained [2] Core Insights - The pharmaceutical and biotechnology industry index increased by 5.89%, ranking third among 31 primary industries, outperforming the CSI 300 index which rose by 1.92% [5][17] - The sub-industries of medical research outsourcing and chemical preparations saw significant gains of 13.94% and 8.43% respectively, while offline pharmacies experienced a decline of 3.91% [5][17] - As of July 18, 2025, the overall PE (TTM) for the pharmaceutical and biotechnology industry is 30.09x, up from 28.52x in the previous period, indicating an upward trend in valuation but still below the average [6][22] - The top three sub-industries by PE (TTM) are vaccines (57.37x), hospitals (37.75x), and other biological products (36.95x), while pharmaceutical circulation has the lowest valuation at 15.84x [6][22] Industry Review - The report highlights that 37 listed companies in the pharmaceutical and biotechnology sector experienced a net reduction in shareholder holdings amounting to 2.182 billion yuan, with 4 companies increasing their holdings by 145 million yuan and 33 companies reducing theirs by 2.328 billion yuan [6] Important Industry News - The National Medical Products Administration (NMPA) approved the BCL-2 inhibitor "Lisatinib" for market entry, marking it as the first domestic product of its kind [8] - The NMPA also approved "Recombinant Human Albumin Injection (Rice)" as the first of its kind in China [8] - The eleventh batch of national procurement rules has been optimized, significantly reducing policy uncertainty for innovative drugs [9] Investment Recommendations - The report suggests continued attention to pharmaceutical companies with innovative capabilities and those with high-end and cost advantages in generic drugs, especially in light of the optimized procurement rules that favor high-quality production and cost-effective generics [9]
港股异动 | 创新药概念再度走强 政策利好及BD预期双轮驱动 机构称板块当前估值仍具吸引力
智通财经网· 2025-07-17 02:28
Group 1 - The innovative drug sector is experiencing a strong rally, with significant stock price increases for companies such as Lepu Biopharma-B (up 11.15%), CanSino Biologics (up 9.92%), and others [1] - Recent favorable news for the innovative drug industry includes the initiation of the 11th batch of national drug centralized procurement, which will not include innovative drugs, focusing instead on mature "old drugs" [1] - The National Healthcare Security Administration and the National Health Commission have issued measures to support the high-quality development of innovative drugs, including 16 specific initiatives across R&D support, medical insurance access, and clinical application [1] Group 2 - According to Zhongyou Securities, the innovative drug sector is expected to continue its positive trend due to overseas large-scale business development (BD) expectations and supportive policy documents [2] - The core driving force behind the current Hong Kong stock market's innovative drug rally is value reassessment, with current valuations still considered attractive [2] - Domestic capital has been increasing its positions through the Hong Kong Stock Connect, while foreign capital remains at a low position in innovative drugs, indicating a preference for fundamentally solid and cost-effective stocks [2]
香港医药ETF(513700)冲击4连阳,首个商保参与制定的创新药目录有望推出
Sou Hu Cai Jing· 2025-07-16 05:41
Core Insights - The Hong Kong pharmaceutical sector is experiencing a strong rally, with the China Securities Hong Kong Stock Connect Pharmaceutical and Health Comprehensive Index (930965) rising by 1.50% as of July 16, 2025, driven by significant gains in individual stocks such as Lijun Pharmaceutical (01513) up 11.16% and Green Leaf Pharmaceutical (02186) up 8.55% [1][2] - The introduction of a commercial health insurance innovative drug directory by the National Healthcare Security Administration on July 11, 2025, marks a significant development, allowing for the inclusion of high-innovation drugs that exceed basic insurance coverage [1][2] - The first innovative drug directory involving commercial insurance is expected to be launched within 2025, potentially creating a more favorable pricing environment compared to traditional medical insurance negotiations [2] Industry Summary - The Hong Kong Medical ETF (513700) has seen a 1.72% increase, marking its fourth consecutive rise, with the latest price reported at 0.65 yuan [1] - The index reflects the performance of 50 liquid and large-cap healthcare companies within the Hong Kong Stock Connect, with the top ten weighted stocks accounting for 59.44% of the index [2] - The commercial health insurance sector is anticipated to experience significant growth, with potential for premium and innovative drug payment scales to increase by several multiples in the long term [2]
苏州工业园区今年已新增6款1类创新药 占全国同期约20%
Zheng Quan Shi Bao Wang· 2025-07-15 06:19
Core Insights - The approval of innovative drugs is a significant indicator of the new productive forces in the biopharmaceutical industry, with Suzhou Industrial Park accounting for approximately 20% of the new innovative drugs approved in China this year [1][3]. Group 1: Drug Approvals - As of July 10, 2023, Ascentage Pharma's new Bcl-2 selective inhibitor, Lisatoclax, received approval for treating adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma who have undergone prior systemic therapy [1]. - On July 8, 2023, Suzhou Wangshan Wangshui Biopharmaceutical Co., Ltd. and the Shanghai Institute of Materia Medica collaborated to launch a new drug, Semaglutide, for the treatment of erectile dysfunction [1]. - On June 27, 2023, Innovent Biologics' injection, Ma Shidu, was approved for long-term weight management in adults with obesity or overweight, being the first dual receptor agonist for weight loss globally [1]. - On May 29, 2023, the injection of Trastuzumab deruxtecan was approved for treating adult patients with HER2-mutant non-small cell lung cancer who have received prior systemic therapy, marking it as the first antibody-drug conjugate for this indication in China [2]. - On the same day, BeiGene's bispecific antibody, Zhenidamab, was approved for patients with HER2-positive advanced biliary tract cancer, providing a new treatment option [2]. - On January 10, 2023, the approval of the long-acting PCSK9 monoclonal antibody, Rucaparib, was granted for treating high cholesterol levels [2]. Group 2: Industry Development - Since 2006, Suzhou Industrial Park has focused on the biopharmaceutical and health industry, attracting over 2,000 related enterprises, with a projected output value of 165.5 billion yuan by 2024 [3]. - The park has implemented a targeted investment strategy, introducing approximately 300 biopharmaceutical and health projects annually over the past three years [3]. - In May 2023, Suzhou Industrial Park announced an action plan to accelerate the growth of the biopharmaceutical and health industry, aiming to develop over five leading enterprises with international competitiveness and achieve significant sales milestones by 2027 [3].
亚盛医药-B(06855)拟先旧后新配售最多2200万股销售股份 净筹14.93亿港元
智通财经网· 2025-07-14 22:27
Core Viewpoint - The company, Ascentage Pharma-B (06855), has entered into a placement and subscription agreement to issue up to 22 million shares at a price of HKD 68.60 per share, which represents a discount to the market price, aiming to raise approximately HKD 15.09 billion for further commercialization and development of its core products [1][2][3] Group 1: Placement and Subscription Details - The placement price of HKD 68.60 per share is approximately 8.17% lower than the closing price of HKD 74.70 on the date of the agreement [2] - The maximum number of shares to be sold represents about 6.29% of the company's existing issued share capital as of the announcement date [1] - The expected net proceeds from the subscription are estimated to be around HKD 14.93 billion, with a net price per share of approximately HKD 67.84 [2] Group 2: Use of Proceeds - Approximately 40% of the net proceeds will be allocated for commercialization efforts, including expanding coverage and improving patient access [3] - About 35% will be used for global clinical development to advance the company's core pipeline products [3] - The remaining 25% will be directed towards infrastructure and operational funding to strengthen global operations [3]