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Bio-Thera Solutions, Ltd. — Investor Relations & Filings

Ticker · 688177 ISIN · CNE100003R98 Shanghai Stock Exchange Manufacturing
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Filings indexed 691 across all filing types
Latest filing 2023-01-16 Regulatory Filings
Country CN China
Listing Shanghai Stock Exchange 688177

About Bio-Thera Solutions, Ltd.

https://www.bio-thera.com/

Bio-Thera Solutions, Ltd. is a biopharmaceutical company dedicated to the research and development of innovative therapeutics and high-quality biosimilars. The company focuses on addressing serious medical conditions across oncology, autoimmune, and cardiovascular therapeutic areas. Its portfolio includes several approved biosimilars, such as QLETLI (adalimumab), POBEVCY (bevacizumab), and TOFIDENCE (tocilizumab), alongside a robust pipeline of novel drug candidates, including antibody-drug conjugates (ADCs) and monoclonal antibodies. Bio-Thera utilizes advanced technology platforms to streamline the drug discovery and development process, aiming to expand global access to essential biologic medicines. The organization maintains a commitment to rigorous clinical standards and international regulatory compliance to deliver effective treatment options for patients worldwide.

Recent filings

Filing Released Lang Actions
百奥泰 自愿披露关于公司托珠单抗注射液（施瑞立）药品注册进展的公告
Regulatory Filings Classification · 95% confidence The document is a voluntary disclosure announcement by 百奥泰生物制药股份有限公司 regarding the drug registration progress of their product 托珠单抗注射液 (施瑞立®). It provides detailed information about the drug, regulatory approval status, and licensing agreements. The document is an announcement about the progress and approval status of a pharmaceutical product, not a financial report, earnings release, or management discussion. It does not contain financial statements or detailed financial data. It is a regulatory announcement related to drug approval and business updates. Therefore, it fits best under Regulatory Filings (RNS), which is the fallback category for miscellaneous regulatory announcements that do not fit other specific categories.
2023-01-16 Chinese
百奥泰 自愿披露关于BAT1806（托珠单抗）注射液在美国FDA上市许可申请获得受理的公告
Regulatory Filings Classification · 95% confidence The document is a company announcement regarding the acceptance of a drug (BAT1806) marketing application by the US FDA. It includes details about the drug, regulatory submission status, and risk warnings. The document is relatively short (1553 characters) and does not contain financial statements, management discussion, or detailed financial data. It is an update on regulatory progress rather than a financial report or detailed investor presentation. It fits best as a Regulatory Filing (RNS) because it is a general regulatory announcement about FDA acceptance of a drug application and does not fit other specific categories like Capital/Financing Update or Legal Proceedings Report.
2022-12-09 Chinese
百奥泰 关于召开2022年半年度及第三季度业绩说明会的公告
Investor Presentation Classification · 90% confidence The document is an announcement about the scheduling of an investor earnings explanation meeting (业绩说明会) for the half-year and third quarter results of 2022. It specifies the date, time, format (online interactive session), and participation details. It references that the half-year and third quarter reports have already been published on August 24 and October 27, 2022, respectively. The document does not contain actual financial data or detailed financial analysis but serves to inform investors about the upcoming earnings call event. Given the document length (1570 characters) and content, it is not the earnings release itself but an announcement of the earnings call meeting. According to the filing definitions, this fits best under Call Transcript (CT) if it were the transcript, but since it is an announcement of the meeting, it is more aligned with Investor Presentation (IP) or possibly Regulatory Filings (RNS). However, since it is specifically about an earnings explanation meeting (业绩说明会), which is a form of investor presentation focused on financial results and interaction, the best classification is Investor Presentation (IP).
2022-12-05 Chinese
百奥泰 2022年第三季度报告
Interim / Quarterly Report Classification · 100% confidence The document is titled '2022 年第三季度报告' which translates to '2022 Third Quarter Report'. It contains detailed financial data including balance sheets, profit and loss statements, cash flow statements, and notes on financial performance for the third quarter of 2022. The report includes unaudited financial statements and comprehensive financial metrics for the quarter and year-to-date periods. The length of the document is about 15,000 characters, indicating it is a full report rather than a brief announcement. The content matches the characteristics of an Interim / Quarterly Report, which provides comprehensive financial data for a period shorter than a full fiscal year. There is no indication that this is an announcement of a report or a certification document. Therefore, the appropriate classification is Interim / Quarterly Report (IR).
2022-10-26 Chinese
百奥泰 自愿披露关于BAT1806（托珠单抗）注射液在欧洲EMA上市许可申请获得受理的公告
Regulatory Filings Classification · 95% confidence The document is a company announcement regarding the acceptance of a drug (BAT1806) marketing application by the European Medicines Agency (EMA). It includes details about the drug, regulatory status, and risk warnings. The document is short (1479 characters) and serves as a formal notification of a regulatory event rather than a financial report or detailed presentation. It does not contain financial statements, management discussion, or detailed investor information. It is not an earnings release, annual report, or any form of financial filing. It is a regulatory announcement about a product approval process. Therefore, the most appropriate classification is Regulatory Filings (RNS), which covers general regulatory announcements and compliance documents that do not fit other categories.
2022-09-30 Chinese
百奥泰 关于注射用BAT8007获得临床试验批准通知书的公告
Regulatory Filings Classification · 95% confidence The document is a public announcement by 百奥泰生物制药股份有限公司 regarding the receipt of a clinical trial approval notice from the National Medical Products Administration (国家药品监督管理局) for their drug BAT8007. It details the drug's characteristics, clinical trial approval, and associated risks. The document is relatively short (1828 characters) and serves as an official notification about regulatory approval for clinical trials rather than a detailed financial or operational report. It does not contain financial statements, management discussion, or detailed data typical of annual or interim reports. It is also not a certification, voting result, or management change announcement. Therefore, it fits best as a Regulatory Filing (RNS), which is a general category for regulatory announcements and compliance documents that do not fit other specific categories.
2022-09-23 Chinese

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