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CStone Pharmaceuticals — Investor Relations & Filings

Ticker · 2616 ISIN · KYG2588M1006 LEI · 300300095A57F80T2461 HKEX Manufacturing
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Filings indexed 3,374 across all filing types
Latest filing 2021-09-20 Regulatory Filings
Country KY Cayman Islands
Listing HKEX 2616

About CStone Pharmaceuticals

http://www.cstonepharma.com

CStone Pharmaceuticals is an innovation-driven biopharmaceutical company focused on the research, development, and commercialization of anti-tumor drugs. The company is dedicated to addressing the unmet medical needs of cancer patients globally. Its core therapeutic focus is on innovative immuno-oncology and molecularly targeted therapies. The R&D pipeline is strategically balanced, featuring potential first-in-class or best-in-class assets, including Antibody-Drug Conjugates (ADC) and multi-specific antibodies. CStone has successfully launched four innovative drugs and secured multiple New Drug Application and indication approvals.

Recent filings

Filing Released Lang Actions
VOLUNTARY ANNOUNCEMENT - CSTONE PRESENTS PRELIMINARY RESULTS FROM A PHASE IB STUDY OF THE ANTI-CTLA-4 MONOCLONAL ANTIBODY (MAB) CS1002 IN COMBINATION WITH THE ANTI-PD-1 MAB CS1003 IN PATIENTS WITH ADV
Regulatory Filings Classification · 90% confidence The document is a voluntary announcement by CStone Pharmaceuticals presenting preliminary clinical study results from a phase Ib trial of their monoclonal antibodies in cancer treatment. It includes detailed clinical data, safety profiles, and response rates from the study. There is no indication that this is a full financial report, regulatory filing, or earnings release. It is not an announcement of a report publication but a standalone announcement of clinical trial results. The content is scientific and clinical in nature, not financial or governance related. Therefore, it does not fit into categories like Annual Report, Earnings Release, or Regulatory Filings. Given the nature of the announcement focusing on clinical study results and not fitting other categories, the best fitting category is Regulatory Filings (RNS) as a general announcement that does not fit other specific financial or corporate filing categories.
2021-09-20 English
VOLUNTARY ANNOUNCEMENT - CSTONE WILL PRESENT REGISTRATIONAL CLINICAL STUDY DATA OF SUGEMALIMAB IN PATIENTS WITH STAGE III NON-SMALL CELL LUNG CANCER IN AN ORAL PRESENTATION AT ESMO CONGRESS 2021
Regulatory Filings Classification · 95% confidence The document is a voluntary announcement by CStone Pharmaceuticals regarding the presentation of registrational clinical study data of sugemalimab at the ESMO Congress 2021. It details clinical trial results, study design, and regulatory status such as NDA acceptance by the NMPA. The document is not a full financial report, audit report, or earnings release. It is not a transcript of a call, nor a management or governance report. It is a detailed announcement about clinical data presentation and regulatory progress, typical of a voluntary announcement or regulatory filing. The document is lengthy (over 14,000 characters) and contains substantive information about clinical trials and regulatory updates, but it is not a financial report or investor presentation. It fits best under Regulatory Filings (RNS) as it is a regulatory announcement about clinical data and NDA acceptance, not a financial or governance report or a meeting-related document.
2021-09-17 English
VOLUNTARY ANNOUNCEMENT - CSTONE RECEIVED IND APPROVAL BY THE NMPA OF CHINA FOR CS2006/NM21-1480, A PD-L1/4-1BB/HSA MULTI-SPECIFIC ANTIBODY-BASED MOLECULE, MARKING FURTHER EXPANSION OF I
Regulatory Filings Classification · 95% confidence The document is a voluntary announcement by CStone Pharmaceuticals regarding the approval of an investigational new drug (IND) application by the National Medical Products Administration (NMPA) of China. It discusses the drug candidate CS2006/NM21-1480, its clinical trial plans, and partnership details. There are no financial statements, earnings data, or detailed management analysis. The document is an announcement of a regulatory milestone related to drug development, not a financial report, earnings release, or management report. It is not a report publication announcement since it contains substantive information about the IND approval and pipeline expansion. The content fits best under a general regulatory announcement category related to compliance and regulatory updates. Therefore, the appropriate classification is Regulatory Filings (RNS).
2021-09-15 English
VOLUNTARY ANNOUNCEMENT - CSTONE PRESENTS UPDATED DATA FROM REGISTRATIONAL CLINICAL STUDY OF SUGEMALIMAB IN PATIENTS WITH STAGE IV NSCLC IN AN ORAL PRESENTATION AT IASLC 2021 WCLC
Regulatory Filings Classification · 90% confidence The document is a voluntary announcement by CStone Pharmaceuticals presenting updated clinical study data from a registrational Phase 3 clinical trial (GEMSTONE-302) of sugemalimab in patients with stage IV NSCLC. It includes detailed clinical trial results, survival rates, safety profiles, and regulatory updates such as new drug application acceptances by the National Medical Products Administration (NMPA) of China. The document is not a financial report, earnings release, or regulatory filing but rather a detailed clinical data presentation and update. It is not a report publication announcement since it contains substantive data and analysis rather than just announcing the availability of a report. The content is focused on clinical trial results and drug development progress, which is typical for a voluntary announcement or clinical update. Given the nature and content, the best fitting category is Regulatory Filings (RNS) as a general regulatory announcement and clinical data update that does not fit into other more specific financial or governance categories.
2021-09-14 English
VOLUNTARY ANNOUNCEMENT - CSTONE PRESENTS REGISTRATIONAL BRIDGING STUDY DATA FOR GAVRETO (PRALSETINIB) HIGHLIGHTING EFFICACY AND SAFETY IN CHINESE PATIENTS WITH ADVANCED RET FUSION-POSITIVE NON-SMALL C
Capital/Financing Update Classification · 90% confidence The document is a voluntary announcement by CStone Pharmaceuticals presenting clinical trial data for their drug GAVRETO (pralsetinib) in Chinese patients with RET fusion-positive non-small cell lung cancer. It includes detailed efficacy and safety data from a registrational bridging study, mentions plans to submit a supplemental new drug application (sNDA) to the National Medical Products Administration (NMPA) of China, and discusses clinical trial results and regulatory status. The document is not a full financial report, audit, or earnings release, nor is it a regulatory filing or report publication announcement. It is a corporate announcement focused on clinical trial data and regulatory plans related to drug development and approval. This fits best under the category of a Capital/Financing Update (CAP) because it relates to clinical development progress and regulatory submission plans that impact the company's capital and financing outlook, rather than financial results or governance matters. The document length (over 11,000 characters) and detailed data exclude it from being a brief announcement or a report publication announcement. Therefore, the most appropriate classification is CAP with high confidence.
2021-09-09 English
MONTHLY RETURN OF EQUITY ISSUER ON MOVEMENTS IN SECURITIES FOR THE MONTH ENDED 31 AUGUST 2021
Share Issue/Capital Change Classification · 95% confidence The document is a detailed monthly report on movements in securities, specifically focusing on share capital, issued shares, share options, and confirmations related to securities issued by CStone Pharmaceuticals. It includes data on authorized and issued shares, share option schemes, and confirmations by a director. The document is addressed to the Hong Kong Exchanges and Clearing Limited and references compliance with listing rules. It is not an annual or quarterly financial report, nor is it an earnings release or management discussion. It is not a proxy statement, AGM material, or legal proceeding. The content is focused on share capital changes and share issuance details, which aligns with announcements regarding share issues or capital changes. Therefore, the most appropriate classification is Share Issue/Capital Change (SHA). The document length and detail confirm it is the report itself, not just an announcement of a report publication or a certification letter.
2021-09-06 English

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