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中国基本医保参保率稳定;ST苏吴或被退市|健讯Daily
2 1 Shi Ji Jing Ji Bao Dao· 2025-07-15 00:17
Policy Developments - The National Healthcare Security Administration reported that the basic medical insurance coverage rate in China remains stable at over 95%, with 1.32662 billion people insured by the end of 2024 [2] - The total income of the national basic medical insurance fund for 2024 is projected to be CNY 34,913.37 billion, while total expenditures are expected to be CNY 29,764.03 billion, resulting in a current balance of CNY 4,639.17 billion [2] - Since the establishment of the National Healthcare Security Administration in 2018, 835 new drugs have been added to the medical insurance drug list, with over 5,400 million CNY in sales from newly negotiated drugs between 2018 and 2024 [2] Drug and Device Approvals - Bayer's non-hormonal drug elinzanetant has been approved by the UK Medicines and Healthcare products Regulatory Agency for treating moderate to severe vasomotor symptoms related to menopause [5] - Innovent Biologics' new BCL2 inhibitor mesutoclax has received FDA approval to commence clinical trials for treating myeloid malignancies, including acute myeloid leukemia and myelodysplastic syndromes [6] - Tianyu Co., Ltd.'s subsidiary has passed the review for ezetimibe raw materials by the National Medical Products Administration, pending GMP compliance inspection results for market launch [7] Capital Market Activities - Innostellar Biotherapeutics has signed a ten-year exclusive promotion agreement with Golden Age Health for the commercialization of its gene therapy candidate LX101 in mainland China [9] Earnings Disclosures - Da'an Gene anticipates a net loss of CNY 140 million to 200 million for the first half of 2025 [11] - Huahai Pharmaceutical expects a net profit decline of 40% to 50% year-on-year, projecting a profit range of CNY 374 million to 449 million [12] - KingMed Diagnostics forecasts a net loss of CNY 95 million to 65 million for the first half of 2025, representing a significant year-on-year decline [13] - Xinmai Medical projects a net profit of CNY 304 million to 361 million for the first half of 2025, a decrease of 10.52% to 24.78% compared to the previous year [14] - Wantai Biological Pharmacy anticipates a net loss of CNY 130 million to 160 million for the first half of 2025 due to market pressures and policy adjustments [15] Industry Events - *ST Suwu has received a notice of administrative penalty from the China Securities Regulatory Commission for falsifying financial reports, which may lead to forced delisting [17] - This incident serves as a warning for the pharmaceutical industry to focus on genuine innovation and establish effective internal controls to mitigate risks associated with management [17] Shareholder Movements - Qihe Venture, a shareholder holding over 5% of Xuantai Pharmaceutical, plans to reduce its stake by up to 7 million shares, representing no more than 1.5441% of the company's total shares [19]
拜耳(BAYRY.US)first-in-class新药获批上市
智通财经网· 2025-07-14 06:41
Core Viewpoint - Bayer's elinzanetant has received approval from the UK's MHRA for the treatment of vasomotor symptoms (VMS) related to menopause, marking its first global approval for this indication [1][2] Group 1: Clinical Trials - Elinzanetant's approval is based on results from three Phase III clinical trials: OASIS-1, OASIS-2, and OASIS-3 [1] - OASIS-1 and OASIS-2 were double-blind, randomized, placebo-controlled studies involving 396 and 400 postmenopausal women aged 40-65 across 184 sites in 15 countries, assessing the drug's efficacy and safety over 26 weeks [1] - OASIS-3 was also a double-blind, randomized, placebo-controlled study, involving 628 postmenopausal women aged 40-65 across 83 sites in 9 countries, evaluating the drug's effects over 52 weeks [1] Group 2: Efficacy and Safety - Elinzanetant achieved all primary endpoints in the three studies, demonstrating good safety profiles [2] - In OASIS-1 and OASIS-2, elinzanetant significantly reduced the frequency and severity of VMS compared to placebo, with improvements in sleep disturbances and quality of life related to menopause [2] - OASIS-3 confirmed the results of OASIS-1 and OASIS-2, showing statistically significant reductions in VMS frequency from baseline to week 12, with sustained benefits and safety over 52 weeks [2] Group 3: Future Prospects - Bayer is continuing to pursue market applications for elinzanetant in the US, EU, and other global markets [2]
Bayer Begins Phase I Study on BAY 3670549 in Atrial Fibrillation
ZACKS· 2025-05-21 17:36
Group 1: Company Developments - Bayer AG has initiated a phase I study for its investigational GIRK4 inhibitor, BAY 3670549, aimed at treating atrial fibrillation (AFib) [1] - The study is a double-blind, placebo-controlled trial evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of BAY 3670549 in healthy participants [1] - The successful development of BAY 3670549 could enhance Bayer's cardiovascular portfolio [3] Group 2: Market Context - Atrial fibrillation affects approximately 60 million people globally and is a significant risk factor for stroke and heart failure [2] - The current standard treatment for acute AFib episodes is electric cardioversion (ECV), which poses challenges due to the need for sedation or anesthesia [2] Group 3: Financial Performance - Year to date, Bayer's shares have increased by 36.7%, contrasting with a 3.9% decline in the industry [6] - Bayer is making progress in its pipeline with clinical milestones expected later in 2025 and has engaged in notable mergers and acquisitions to diversify its drug candidate portfolio [7] Group 4: Future Drug Launches - Bayer plans to launch new drugs, including elinzanetant for menopause symptoms and acoramidis for a specific heart disease, with acoramidis receiving regulatory approval in the EU under the brand name Beyonttra [8] - Bayer acquired marketing rights for acoramidis in Europe from BridgeBio, enhancing its cardiovascular offerings [8] Group 5: Pipeline Expansion - Bayer has expanded its pipeline to include cell therapy through the acquisition of BlueRock and gene therapy through AskBio, focusing on treatments for various disorders, including congestive heart failure and Parkinson's disease [9]