利生妥®(利沙托克拉)

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亚盛医药2025年中报:耐立克销售大增93%,利生妥®获批撬动双引擎
Jin Rong Jie· 2025-08-21 01:17
Core Viewpoint - Asiasoft Pharmaceuticals (NASDAQ: AAPG; HKEX: 6855) reported strong financial performance for the first half of 2025, driven by significant sales growth of its innovative drugs, particularly the launch of its new product, Lisengto® [1][2]. Financial Performance - The company generated revenue of 234 million RMB in the reporting period, with sales of Nairike® (Orebatin) reaching 217 million RMB, representing a 93% year-on-year increase due to its inclusion in the medical insurance coverage [1]. - The company's cash flow has improved, with total cash exceeding 3 billion RMB as of the current date [1]. Product Development and Approval - Lisengto® (Lisatrakra) received approval from the National Medical Products Administration (NMPA) on July 10, 2025, for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have undergone at least one systemic therapy, marking it as the first domestically approved original Bcl-2 inhibitor [1][2]. - The company is actively exploring the therapeutic potential of Lisengto® in CLL/SLL, acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), and multiple myeloma (MM), with four global Phase III clinical trials currently underway, two of which have received FDA approval [3]. Commercialization Strategy - Following the approval of Lisengto®, the company has signed cooperation agreements with major pharmaceutical distribution companies to accelerate its commercialization efforts, achieving rapid prescription issuance in over 30 cities and 40 hospitals within 15 days [2]. - The launch of Lisengto® signifies the company's transition into a dual-engine growth phase, enhancing its commercial framework to maximize product synergy [2]. International Development - Asiasoft Pharmaceuticals became the first biopharmaceutical company to list on both the Hong Kong and NASDAQ stock exchanges, which supports its international development and provides financial backing for the commercialization strategies of Lisengto® and Nairike® [3].
国内首款Bcl-2抑制剂利生妥®在京东健康全网首发 助力血液肿瘤精准治疗
Zhong Jin Zai Xian· 2025-07-30 01:53
Core Insights - The article highlights the launch of a new oral Bcl-2 selective inhibitor, Lisangtuo® (generic name: Lishatoklaku), developed by Ascentage Pharma, which is now exclusively available on JD Health [1][3] - Lisangtuo® is the first domestically approved original Bcl-2 inhibitor in China and the second globally, aimed at treating adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have undergone at least one prior systemic therapy including BTK inhibitors [1][3] - The drug works by selectively inhibiting the Bcl-2 protein, restoring normal apoptosis in tumor cells, and is expected to have fewer interactions with common drugs and more controllable effects on platelets compared to traditional CLL/SLL medications [1][3] Industry Context - The development of Bcl-2 inhibitors is challenging due to complex protein-protein interactions and the need for the drug to penetrate both the cell membrane and mitochondrial membranes [3] - Prior to Lisangtuo®, no Bcl-2 inhibitors had been approved for CLL/SLL treatment in China, indicating a significant advancement in the field [3] - The successful launch of Lisangtuo® represents a major step for China in the treatment of hematological malignancies and showcases Ascentage Pharma's leading capabilities in global innovative research and development [3] Distribution Strategy - JD Health is leveraging its capabilities in pharmaceutical supply chain and healthcare services to provide comprehensive support, including drug consultation, doctor consultations, and efficient delivery for users in need [4]
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].
一周医药速览(07.07-07.11)
Cai Jing Wang· 2025-07-11 08:29
Group 1 - Jichuan Pharmaceutical's "Children's Constipation Granules" has received a registration application acceptance notice, marking it as the first innovative traditional Chinese medicine specifically for treating pediatric constipation [1] - The product is expected to be the first Class 1 pediatric-specific drug for constipation following the release of the clinical research guidelines in 2024 [1] Group 2 - Innovent Biologics' drug Daberat® has become the first KRAS G12C inhibitor approved in Macau, providing a new targeted therapy for patients with advanced non-small cell lung cancer [2] - In a Phase II clinical trial, Daberat® demonstrated an objective response rate (ORR) of 49.1%, a median progression-free survival (PFS) of 9.7 months, and a 12-month overall survival (OS) rate of 54.4% [2] Group 3 - Sinovac Biotech's special shareholders meeting approved the election of 10 new directors proposed by SAIF Partners, who committed to support the company's dividend distribution plan [3] - The new board members aim to work closely with management to restore trading of the company's common stock and enhance long-term shareholder value [3] Group 4 - Ganli Pharmaceutical expects a net profit increase of 100.73% to 114.12% for the first half of 2025, with projected profits between 600 million to 640 million yuan [4] - The company achieved market share expansion through two rounds of insulin procurement, with a significant 32.6% increase in agreement volume during the 2024 procurement [4] Group 5 - Ascentage Pharma's new Bcl-2 inhibitor, Lisangtuo® (APG-2575), has been conditionally approved for marketing in China, becoming the first Bcl-2 inhibitor for chronic lymphocytic leukemia/small lymphocytic lymphoma [5] - This marks Ascentage Pharma's second innovative drug to be approved and enter the commercialization stage [5] Group 6 - United Biomedical's UBT37034 injection has received FDA approval for clinical trials, showing significant weight reduction effects when combined with GLP-1 analogs in preclinical studies [6] - The combination therapy demonstrated superior weight loss effects compared to other investigational drugs [6]
医保目录调整进展;百济神州达成一协议|21健讯Daily
2 1 Shi Ji Jing Ji Bao Dao· 2025-07-10 23:53
Group 1: Policy and Regulatory Updates - The National Healthcare Security Administration released the adjustment plan for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance drug catalog, along with guidelines for commercial health insurance innovative drug catalog adjustments and negotiation rules for drug renewals [1] - The National Medical Products Administration held a national drug business supervision meeting, emphasizing the need for continued risk assessment and the fight against illegal activities in the pharmaceutical sector [2] Group 2: Company Developments - Novo Nordisk's 7.2mg semaglutide application for weight management has been accepted by the European Medicines Agency (EMA), based on positive results from Phase III STEP UP studies [4] - Ascentage Pharma's new drug lisatoclax has received conditional approval from the National Medical Products Administration for use in adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma [5] - Anke Bio announced a collaboration with Shengji Pharmaceutical for the exclusive agency of a recombinant human follicle-stimulating hormone-CTP fusion protein injection in mainland China and Hong Kong, Macau, and Taiwan [7] - Cornerstone Pharmaceuticals plans to place 100 million shares at a price of HKD 4.72 per share, aiming to raise a total of HKD 472 million as part of its financing plan [8] Group 3: Financial Performance - WuXi AppTec expects to achieve approximately CNY 20.799 billion in revenue for the first half of 2025, a year-on-year increase of about 20.64%, with adjusted net profit expected to be around CNY 6.315 billion, reflecting a growth of approximately 44.43% [10] - ST Sihuan anticipates a half-year revenue of CNY 180 million to CNY 190 million, representing a growth of 70.12% to 79.57%, but expects a loss of CNY 9 million to CNY 13 million [12] Group 4: Industry Collaborations - Baiao Biotechnology and BeiGene have reached a global licensing agreement for antibody molecules, which includes upfront payments and milestone payments based on development and commercialization [14]