SCTB39G注射液

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康哲药业拟在新加坡二次上市丨健讯Daily
2 1 Shi Ji Jing Ji Bao Dao· 2025-06-26 00:35
Group 1: Brain-Computer Interface Standards - The National Standard for Non-Invasive Medical Devices Using Brain-Computer Interface Technology is open for public consultation, aiming to establish performance indicators and testing methods for such devices [1] - The standardization is expected to enhance international cooperation and improve regulatory efficiency, addressing the rapid development in the non-invasive neural modulation sector [1] Group 2: Pharmaceutical Industry Innovation - The head of the National Medical Products Administration emphasized the importance of supporting drug and medical device R&D innovation to strengthen China's pharmaceutical industry [2] - Key strategies include early intervention, tailored guidance for enterprises, and promoting international multi-center clinical trials to synchronize the development and approval of innovative drugs and devices [2][3] Group 3: Clinical Trials and Approvals - Shenzhou Cell announced that its product SCTB39G received approval for clinical trials in advanced solid tumors [4] - Hanyu Pharmaceutical's subsidiary received approval for the listing of the raw material drug Acetate Degarelix, which is used for treating advanced prostate cancer [6] Group 4: Market Expansion and IPOs - Kangzhe Pharmaceutical plans a secondary listing in Singapore, reflecting a trend of pharmaceutical companies expanding into Southeast Asian markets [7] - Lianya Pharmaceutical's IPO application has been accepted, focusing on complex drug formulations and high-end generic drugs [9] Group 5: Strategic Collaborations - Bayer and Tsinghua University signed a strategic cooperation agreement to enhance research in various medical fields, aiming to accelerate drug innovation [11][12] Group 6: Clinical Trial Developments - Fuhong Hanlin announced the first patient enrollment in a bridging clinical trial for its drug H, which is approved for first-line treatment of small cell lung cancer in multiple countries [13] Group 7: Corporate Leadership Changes - Fosun Pharma held a shareholder meeting to elect new board members, appointing Chen Yuqing as chairman and Liu Yi as CEO [14]
太平洋医药日报:阿斯利康减重新药联合疗法在华获批临床-20250625
Tai Ping Yang Zheng Quan· 2025-06-25 15:06
Investment Rating - The industry rating is neutral, indicating that the overall return is expected to be between -5% and 5% relative to the CSI 300 index over the next six months [9]. Core Insights - The pharmaceutical sector experienced a slight increase of +0.41% on June 25, 2025, underperforming the CSI 300 index by 1.03 percentage points, ranking 23rd among 31 sub-industries in the Shenwan classification [4]. - Among sub-industries, medical consumables (+1.34%), medical devices (+1.24%), and hospitals (+1.23%) performed well, while offline pharmacies (-0.10%), blood products (+0.10%), and in vitro diagnostics (+0.12%) lagged behind [4]. - AstraZeneca's two new drugs, AZD6234 and AZD9550, received clinical trial approval in China for long-term weight management in overweight or obese adults with at least one obesity-related comorbidity [5]. Summary by Sections Market Performance - On June 25, 2025, the pharmaceutical sector's performance was +0.41%, underperforming the CSI 300 index by 1.03 percentage points [4]. - The top three gainers were Huachang Technology (+13.48%), Shuyuan Pingmin (+6.80%), and Huitai Medical (+6.07%), while the top three losers were Yiming Pharmaceutical (-8.56%), Yong'an Pharmaceutical (-7.87%), and Beilu Pharmaceutical (-7.35%) [4]. Industry News - AstraZeneca's AZD6234 is a long-acting insulin receptor agonist approved for clinical trials in China, while AZD9550 is a synthetic GLP-1/glucagon dual receptor agonist, marking its first clinical approval in China [5]. - Yifan Pharmaceutical announced the approval for clinical trials of its biosimilar insulin injection [6]. - Shenzhou Cell and Hanyu Pharmaceutical also received approvals for their respective clinical trials and drug listings [6].
神州细胞:SCTB39G获得药物临床试验批准
news flash· 2025-06-25 09:50
Core Viewpoint - The company Shenzhou Cell has received approval from the National Medical Products Administration for clinical trials of its self-developed product SCTB39G injection in patients with advanced solid tumors [1] Group 1: Product Development - SCTB39G is a multi-target immune therapy trispecific antibody injection [1] - The clinical trial will focus on the efficacy of SCTB39G as a monotherapy in late-stage solid tumor patients [1] Group 2: Regulatory Approval - The approval includes a "Drug Clinical Trial Approval Notification" which allows the company to proceed with the clinical trials [1] - The timeline and outcomes of the clinical trials, reviews, and approvals are subject to unpredictability and uncertainty [1]