BAT1806(托珠单抗)

Search documents
百奥泰生物制药股份有限公司关于参加广东辖区2025年投资者网上集体接待日活动的公告
Shang Hai Zheng Quan Bao· 2025-09-15 20:58
Group 1 - The company will participate in the "2025 Guangdong Investor Collective Reception Day" to enhance interaction with investors [1] - The event will be held online on September 19, 2025, from 15:30 to 17:00 [1] - Company executives will discuss the 2025 semi-annual performance, corporate governance, development strategy, operational status, and sustainable development [1] Group 2 - The second extraordinary general meeting of shareholders was held on September 15, 2025 [3] - All 9 current directors attended the meeting, along with the company secretary and senior management [5] - Three resolutions were passed, including changes to the registered address and the signing of a licensing and commercialization agreement for BAT1806 [6][6]
百奥泰与STADA就托珠单抗注射液签署商业化协议,首付及里程碑款最高至1.36亿欧元
Cai Jing Wang· 2025-08-22 05:42
Core Viewpoint - Baiyoutai has signed a licensing and commercialization agreement with STADA for BAT1806 (Tocilizumab) injection, granting STADA exclusive commercialization rights in several regions, which is expected to positively impact the company's future performance and enhance its global commercialization and profitability [1][2]. Group 1: Agreement Details - The total amount of upfront and milestone payments can reach up to €136 million, including an upfront payment of €8.5 million and milestone payments not exceeding €127.5 million, along with a double-digit percentage of net sales as revenue sharing [1]. - The agreement covers the commercialization rights in the EU, Switzerland, the UK, parts of other European countries, parts of the Middle East and North Africa (MENA), and some Commonwealth of Independent States (CIS) countries [1]. Group 2: Product Information - BAT1806 (Tocilizumab) is a biosimilar developed by Baiyoutai, targeting the interleukin-6 receptor (IL-6R) and is approved by the NMPA in China, the FDA in the US, and the EMA in Europe [2]. - The product is marketed under the name Shiruili in China and TOFIDENCE in the US [2]. Group 3: STADA Overview - STADA is a well-established European pharmaceutical company headquartered in Germany, focusing on three strategic pillars: consumer health, generics, and specialty pharmaceuticals [2]. - In the fiscal year 2024, STADA achieved a group sales revenue of €4.059 billion, with an adjusted EBITDA of €886 million, and employs approximately 11,649 people globally [2].
百奥泰2024年财报:营收增长但亏损扩大,创新药研发成关键
Jin Rong Jie· 2025-04-08 15:43
Core Insights - The company reported a total revenue of 743 million yuan in 2024, representing a year-on-year growth of 5.44%, but the net profit attributable to shareholders was a loss of 510 million yuan, an increase in loss of 29.34% compared to the previous year [1] - Despite progress in innovative drug research and global market expansion, the company faces significant challenges due to ongoing losses and high R&D costs [1][5] Group 1: Innovative Drug Development - The company continued to advance its innovative drug development in 2024, achieving several milestones, including the approval of its first national Class 1 innovative drug, Beta Ning® (Citrulline Bevacizumab Injection), by NMPA for acute coronary syndrome patients [4] - BAT1706 (Bevacizumab) and BAT1806 (Tocilizumab) received marketing approvals from EMA and ANVISA, respectively, allowing for sales in the US, Europe, and Brazil [4] - However, the commercialization process for these innovative drugs remains slow, with BAT1806 generating only 1.1 million USD in revenue in the US market in 2024 [4] Group 2: Global Market Expansion - The company actively expanded its global market presence in 2024, entering into licensing agreements with several international firms, such as Macter International Limited for BAT1706 in Pakistan and Afghanistan, and STADA Arzneimittel AG for BAT2506 (Golimumab) in the EU, UK, and Switzerland [4] - These partnerships are expected to enhance the company's global product coverage, although their short-term revenue contribution is limited [4] Group 3: Financial Performance - The company's gross profit for 2024 was 514 million yuan, reflecting a year-on-year increase of 0.59%, but the net loss attributable to shareholders widened to 510 million yuan [5] - High R&D expenditures and commercialization costs are the primary reasons for the ongoing losses [5] Group 4: Production Capacity and Cost Pressure - The company continued to upgrade its production lines in 2024, with the Yonghe Phase II expansion project achieving a total production capacity of 66,500 liters, enhancing production capabilities [6] - The company has also obtained GMP certification from major global regulatory bodies, including NMPA, FDA, and EMA, ensuring access to key pharmaceutical markets [6] - However, the ongoing upgrades and GMP certification efforts have resulted in significant cost pressures, with a non-deductible net profit loss of 556 million yuan in 2024, an increase of 17.76% year-on-year [6]