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一周医药速览(06.23-06.27)
Cai Jing Wang· 2025-06-27 08:43
Group 1 - Xiansheng Pharmaceutical announced that its insomnia treatment drug Daridorexant (brand name: Kewiko®) has been approved for marketing in China, enhancing patient access and supporting long-term use [1] - HAP Pharmaceutical entered a global strategic collaboration with Otsuka Pharmaceutical to develop a BCMAxCD3 bispecific T-cell engager, receiving an upfront payment of $47 million and potential additional payments up to $623 million based on future milestones [1] - Baotai announced a licensing agreement with Stein for the commercialization rights of BAT2406 (Dupilumab) in Latin America, with total upfront and milestone payments potentially reaching $10 million [1] Group 2 - David Medical received a medical device registration certificate for its electric stretcher, which offers significant advantages over traditional manual devices, improving operational efficiency and reducing the burden on healthcare personnel [2] - Hanyu Pharmaceutical's subsidiary received approval for the listing of its active pharmaceutical ingredient Acetate Degarelix, which is used to treat advanced prostate cancer [3] - China Traditional Chinese Medicine reported that its innovative TCM drug Yushudapin's registration application has been accepted, showing significant efficacy in improving early symptoms of depressive disorders [4]
百奥泰(688177) - 百奥泰 自愿披露关于与SteinCares就BAT2406(度普利尤单抗)注射液签署授权许可及生产、供货和商业化协议的公告
2025-06-23 09:15
证券代码:688177 证券简称:百奥泰 公告编号:2025-042 百奥泰生物制药股份有限公司 自愿披露关于与 SteinCares 就 BAT2406(度普利尤 单抗)注射液签署授权许可及生产、供货和商业化 协议的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性依法承担法律责任。 重要内容提示: 协议内容摘要: 百奥泰生物制药股份有限公司(以下简称"百奥泰"或"公司")与SteinCares (注册名:Logistics Business Services, S.R.L,以下简称"Stein")签署授权许可及 生产、供货和商业化协议,将公司的BAT2406(度普利尤单抗)注射液在巴西以 及其余拉丁美洲地区市场的独占的产品商业化权益有偿许可给Stein(以下简称 "协议")。 交易标的名称:BAT2406(度普利尤单抗)注射液在巴西以及其余拉丁美洲 地区市场独占的产品商业化权益。 交易金额:首付款及里程碑款总金额最高至 1,000 万美元,其中包括 100 万 美元首付款、累计不超过 900 万美元里程碑付款,以及净销售额的两位数百分 ...
百奥泰:与SteinCares签署BAT2406许可及商业化协议 金额最高1000万美元
news flash· 2025-06-23 08:58
Core Viewpoint - The company Baiotai has signed a licensing and commercialization agreement with SteinCares for the exclusive rights to commercialize BAT2406 injection in Brazil and other Latin American markets, with a total agreement value of up to $10 million [1] Group 1 - The agreement includes an upfront payment of $1 million and milestone payments not exceeding $9 million [1] - Baiotai will receive a revenue share based on a double-digit percentage of net sales as per the agreement [1] - The agreement is effective upon signing and has an initial term of fifteen years [1] Group 2 - The signing of this agreement is expected to have a positive impact on the company's future performance [1]
百奥泰(688177) - 百奥泰 自愿披露关于Usymro(乌司奴单抗注射液)获欧洲药品管理局人用药品委员会积极意见的公告
2025-06-20 07:45
证券代码: 688177 证券简称: 百奥泰 公告编号:2025-041 百奥泰生物制药股份有限公司 自愿披露关于 Usymro ®(乌司奴单抗注射液)获欧 洲药品管理局人用药品委员会积极意见的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈 述或者重大遗漏,并对其内容的真实性、准确性和完整性依法承担法律责任。 百奥泰生物制药股份有限公司(以下简称"百奥泰"或"公司")于近日收到 了欧洲药品管理局(以下简称"EMA")的通知,Usymro ®(BAT2206,乌司奴 单抗注射液)获得EMA人用药品委员会(以下简称"CHMP")积极意见。 CHMP建议欧盟委员会(EC)批准Usymro ®上市,用于治疗成人及儿童的:中 重度斑块状银屑病(PsO),活动性银屑病关节炎(PsA),中重度活动性克罗 恩病(CD)。 现将相关情况公告如下: 一、 药品相关情况 (一) 药品名称:乌司奴单抗注射液 (二) 商品名称:Usymro ® (三) 剂型规格:输注溶液浓缩液:130 mg/瓶;注射溶液:45 mg/支;预 充式注射器注射液:45 mg/支、90 mg/支 (四) 适应症:中重度斑块状银屑病( ...
科创医药指数ETF(588700)盘中交投活跃,机构:国产创新药投资机会值得重视
Sou Hu Cai Jing· 2025-06-11 06:13
Group 1: Liquidity and Performance of Sci-Tech Pharmaceutical Index ETF - The Sci-Tech Pharmaceutical Index ETF had a turnover rate of 16.48% during the trading session, with a transaction volume of 37.98 million yuan, indicating active market trading [2] - Over the past week, the average daily transaction volume of the ETF reached 48.92 million yuan, ranking first among comparable funds [2] - In the past year, the ETF's scale increased by 154 million yuan, achieving significant growth and ranking first in new scale among comparable funds [2] - The ETF's shares grew by 130 million units in the past year, also ranking first in new shares among comparable funds [2] - As of June 10, the net value of the ETF increased by 25.51% over the past year [2] - The highest monthly return since inception was 23.29%, with the longest consecutive monthly gains being 4 months and a maximum increase of 21.76% [2] - The average monthly return during the rising months was 8.18%, with a historical one-year profit probability of 69.81% [2] Group 2: Market Trends and Investment Opportunities - The Central Committee of the Communist Party of China and the State Council issued opinions to improve the basic medical insurance drug catalog adjustment mechanism and to develop a commercial health insurance innovative drug catalog [3] - A report from Dongwu Securities indicated that there were 73 oral presentations from China at the 2025 ASCO, marking a historical high, with 89 out of 184 ADC pipeline studies coming from China, accounting for approximately 48.4% of the total [3] - The agency believes that the competitiveness of domestic innovative drugs in the global market is continuously improving, and international investors' confidence in Chinese innovative drug companies is increasing [3] - Domestic innovative drugs are transitioning from "catching up" to "leading," presenting significant investment opportunities [3] - Investors without stock accounts can access the Sci-Tech Biopharmaceutical ETF linked fund (021061) to capitalize on opportunities in the Sci-Tech Board biopharmaceutical sector [3]
百奥泰董事长李胜峰:聚焦研发创新与全球化 推动企业稳健发展
Zheng Quan Ri Bao· 2025-06-03 16:46
Core Viewpoint - The Chinese biopharmaceutical industry, represented by Baotai Biopharmaceutical Co., Ltd., is enhancing its international competitiveness through innovation amidst a restructuring global medical technology landscape [2]. Group 1: Company Overview - Baotai, established in 2003, focuses on the research and development of innovative drugs and biosimilars, targeting diseases such as cancer and autoimmune disorders [3]. - The company has shown steady revenue growth from 455 million yuan in 2022 to 743 million yuan in 2024, with a compound annual growth rate of 27.8% [3]. Group 2: Product Portfolio and Globalization - Baotai has several marketed products, including Adalimumab injection and Bevacizumab injection, contributing significantly to its revenue [3]. - The company has established commercial partnerships for six products across over 92 countries, with its products receiving regulatory approvals from the FDA and EMA [4]. - Baotai aims to have four products launched globally by 2027, indicating a strong pipeline for future growth [4]. Group 3: Research and Development Strategy - R&D expenditures from 2022 to 2024 were 616 million yuan, 769 million yuan, and 778 million yuan, respectively, reflecting a commitment to maintaining competitive positioning through innovation [6]. - The company is focusing on developing next-generation antibody-drug conjugates (ADCs) and bispecific antibodies in oncology and autoimmune fields [6]. - Baotai emphasizes a dual-track strategy of innovative drugs and biosimilars to drive long-term growth [6]. Group 4: Technological Integration and Future Outlook - Baotai's BAT2206 is expected to receive FDA approval in May 2025, with other products also progressing through regulatory pathways [7]. - The company is integrating AI technology into various stages of drug development, aiming to make it a foundational aspect of R&D and production [7]. - Baotai's supply chain remains resilient against global trade tensions, primarily sourcing raw materials domestically [8].
百奥泰终止帕博利珠单抗生物类似药关键研究,项目已投入逾2亿元
Bei Ke Cai Jing· 2025-05-24 02:36
Core Viewpoint - Company plans to adjust the development strategy of BAT3306 (a biosimilar of Pembrolizumab) and terminate the ongoing BAT3306-002 study, with future decisions pending careful evaluation [1][2][3] Development Strategy Adjustment - BAT3306 is currently involved in a Phase I/III study (BAT3306-002) assessing its pharmacokinetics, efficacy, and safety in combination with chemotherapy for stage IV non-small cell lung cancer [2] - The adjustment in development strategy is influenced by recent communications from the FDA and EMA, indicating a reduced necessity for comparative efficacy studies for biosimilars in the approval process [2][3] - Two other companies developing Pembrolizumab biosimilars have also halted their Phase III efficacy studies, opting for submissions based on Phase I and analytical data [2] Financial Implications - The total investment in the BAT3306 project has reached 224 million yuan, with all R&D expenses accounted for in the respective accounting periods, indicating no substantial impact on current or future financial performance [4] - The company has incurred cumulative losses exceeding 1.8 billion yuan since its listing, with only one profitable year in 2021 due to licensing income [5] Revenue and R&D Expenditure - Revenue figures from 2020 to 2024 show fluctuations, with revenues of 185 million yuan, 837 million yuan, 456 million yuan, 705 million yuan, and 743 million yuan respectively, while net profits remained negative [6] - R&D expenses have consistently exceeded revenue, with ratios of R&D expenditure to revenue ranging from 304% to 104.7% over the same period [6] Market Context - Pembrolizumab (Keytruda) is a leading PD-1 inhibitor with over 30 approved indications and sales reaching 25.011 billion USD in 2023, with its key patent expiring in 2028, potentially opening a significant market for biosimilars [4] - The company will continue to monitor regulatory developments and evaluate the future of the BAT3306 project based on the latest policy dynamics [4] Competitive Risks - The company faces risks from centralized procurement policies, as three of its four approved products are biosimilars, which are a major source of revenue [7]
百奥泰(688177) - 百奥泰 关于BAT2206(乌司奴单抗)注射液获得美国FDA上市批准的公告
2025-05-23 08:15
证券代码: 688177 证券简称: 百奥泰 公告编号:2025-040 百奥泰生物制药股份有限公司 关于 BAT2206(乌司奴单抗)注射液获得 美国 FDA 上市批准的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈 述或者重大遗漏,并对其内容的真实性、准确性和完整性依法承担法律责任。 百奥泰生物制药股份有限公司(以下简称"百奥泰"或"公司")于近日收到 了美国食品药品监督管理局(以下简称"美国FDA")签发的关于BAT2206(乌 司奴单抗)注射液(美国商品名称:STARJEMZA)上市批准的通知,现将相 关情况公告如下: 胞因子,能够参与炎症和免疫应答过程,可以与 p40 亚基以高亲和力特异性地 结合,阻断其与细胞表面受体结合,从而破坏 IL-12 和 IL-23 介导的信号传导和 细胞因子的效应。 一、药品相关情况 皮下制剂:45mg/0.5mL、90mg/mL,静脉注射剂:130mg/26mL (五) 适应症:成人适应症:中重度斑块状银屑病(PsO),活动性银屑 病关节炎(PsA),中重度活动性克罗恩病(CD),中重度活动性溃疡性结肠 炎(UC);儿童适应症:中重度斑块状银屑 ...
百奥泰:BAT2206(乌司奴单抗)注射液获美国FDA上市批准
news flash· 2025-05-23 08:01
Core Viewpoint - Baiotai has received FDA approval for BAT2206 (Ustinumab) injection, indicating a significant milestone for the company in the biopharmaceutical sector [1] Group 1: Product Approval - The FDA has approved BAT2206 (Ustinumab) injection, marketed in the U.S. as STARJEMZA [1] - The drug is indicated for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, moderate to severe active Crohn's disease, and moderate to severe active ulcerative colitis in both adults and children [1] Group 2: Commercialization Efforts - Baiotai is actively pursuing the commercialization of BAT2206 in multiple global regions [1] - The company has submitted marketing authorization applications to the NMPA in China and the EMA in Europe [1]
荣昌生物配售融资8亿港元;百奥泰调整开发策略并终止一项研究
Policy Developments - The total amount of personal accounts for employee medical insurance mutual aid reached 17.792 billion yuan from January to April 2025, with 133 million participants [2] Drug and Device Approvals - The KRAS G12C inhibitor, Gozai Lese, developed by Jako and Ailis, has been approved for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have previously received at least one line of systemic therapy [3] - Heng Rui Medicine's innovative drug, Regaglitin Metformin Tablets, has been approved for use in adults with type 2 diabetes to improve blood sugar control [4] Capital Markets - Boyin Hearing announced a B-round financing of several tens of millions, aimed at increasing investment in domestic hearing aid research and development [5] - Lid Health Technology has completed nearly 100 million yuan in angel round financing, with funds allocated for accelerating technology research and product commercialization [6] Major Industry Events - Rongchang Bio plans to place 19 million new H-shares at a price of 42.44 HKD per share, raising approximately 796 million HKD for core product pipeline expansion [7] - Haoyuan Pharmaceutical announced that its shareholder, Zhenjin Investment, has reduced its holdings by approximately 3.2 million shares, accounting for 1.51% of the total share capital [8] - Baiyatai has decided to terminate the BAT3306-002 study, which evaluated the pharmacokinetics, efficacy, and safety of BAT3306 in combination with chemotherapy in IV-stage NSCLC patients, after an investment of 224 million yuan in the project [9]