Biocytogen(02315)
Search documents
百奥赛图-B(02315)业务合作伙伴IDEAYA取得美国食品药品监督管理局对IDE034的IND批准
智通财经网· 2025-12-05 00:14
Core Viewpoint - IDEAYA Biosciences has received IND approval from the FDA for its dual-target B7H3/PTK7 ADC project, IDE034, marking a significant milestone in its collaboration with 百奥赛图-B [1][2] Group 1: Clinical Development - IDEAYA plans to initiate patient enrollment for the Phase I clinical trial of IDE034 in Q1 2026, targeting solid tumors co-expressing B7H3 and PTK7, including lung cancer, colorectal cancer, head and neck cancer, and ovarian/gynecological tumors [1] - The IND approval signifies a crucial step in advancing the clinical development of IDE034, showcasing the company's technical strength in the dual-antibody ADC discovery and development field [1][2] Group 2: Research and Development Progress - The approval of IDE034's IND represents an important R&D advancement for IDEAYA, validating its RenLite® platform and proprietary linker-payload technology in the discovery and optimization of dual-antibody ADCs [2] - Preclinical studies indicate that IDE034 demonstrates deep and durable tumor shrinkage in various B7H3/PTK7 positive tumor models, highlighting its strong anti-tumor activity [2] Group 3: Future Plans and Collaborations - IDEAYA intends to explore combination therapy strategies with its PARG inhibitor IDE161 to enhance the durability of treatment effects, with plans to present supporting data at major medical conferences in the first half of 2026 [2] - The co-expression rates of B7H3 and PTK7 in lung cancer, colorectal cancer, and head and neck cancer are approximately 30%, 46%, and 27%, respectively, indicating the broad clinical applicability of IDE034 [2] - The company aims to provide high-quality source molecules to partners and actively seek external licensing opportunities for early-stage potential assets [2]
百奥赛图-B(02315.HK):业务合作伙伴IDEAYA取得美国FDA对IDE034的IND批准
Ge Long Hui· 2025-12-05 00:13
Core Insights - IDEAYA Biosciences has received IND approval from the FDA for its first-in-class B7H3/PTK7 bispecific antibody-drug conjugate (ADC) project, IDE034, marking a significant milestone in its collaboration with 百奥赛图-B [1][2] - The clinical trial for IDE034 is expected to begin patient enrollment in Q1 2026, targeting solid tumors co-expressing B7H3 and PTK7, including lung cancer, colorectal cancer, head and neck cancer, and ovarian/gynecological tumors [1][2] Group 1 - The IND approval represents an important advancement in IDEAYA's strategy to expand its first-in-class TOP1 ADC pipeline into bispecific, precision-targeted therapies [2] - The approval validates the company's RenLite® platform and proprietary linker-payload technology in the discovery and optimization of bispecific ADCs [2] - IDE034 has shown deep and durable tumor shrinkage in various B7H3/PTK7 positive tumor models, indicating strong anti-tumor activity [2] Group 2 - IDEAYA plans to explore combination therapy strategies with its PARG inhibitor IDE161 to enhance the durability of treatment effects [2] - The company intends to present more data supporting the combination treatment mechanism of PARG and TOP1 ADC at major medical conferences in the first half of 2026 [2] - The co-expression rates of B7H3 and PTK7 in solid tumors such as lung cancer, colorectal cancer, and head and neck cancer are approximately 30%, 46%, and 27%, respectively, highlighting the broad clinical applicability of IDE034 [2] Group 3 - The company aims to provide high-quality source molecules to partners under its "千鼠万抗" initiative, facilitating the clinical translation of licensed projects [2] - IDEAYA is actively exploring additional external licensing opportunities for early-stage potential assets [2]
IDE034, a Bispecific ADC Licensed by Biocytogen to IDEAYA, Receives FDA IND Clearance
Businesswire· 2025-12-05 00:00
Core Insights - Biocytogen's partner IDEAYA Biosciences has received FDA IND clearance for IDE034, a bispecific antibody-drug conjugate targeting B7H3 and PTK7, marking a significant milestone in its clinical development [1][2][3] Group 1: Product Development - IDE034 is a bispecific B7H3/PTK7 TOP1 ADC, independently developed by Biocytogen and licensed to IDEAYA in July 2024 [2] - The IND clearance allows IDEAYA to initiate a Phase 1 clinical trial, with patient enrollment expected to begin in Q1 2026, focusing on solid tumors expressing B7H3 and PTK7 [1][3] - Preclinical studies indicate that IDE034 monotherapy shows strong anti-tumor activity, inducing deep and durable tumor regressions in multiple tumor models [3] Group 2: Clinical Strategy - IDEAYA plans to explore combination strategies with its PARG inhibitor IDE161 to enhance the durability of response, with additional preclinical data to be presented at a major medical conference in H1 2026 [3] - B7H3 and PTK7 are co-expressed in various cancers, with expression rates of approximately 30% in lung, 46% in colorectal, and 27% in head and neck cancers, indicating broad clinical potential for IDE034 [3] Group 3: Company Capabilities - The IND clearance validates Biocytogen's RenLite platform and proprietary linker-payload technologies, showcasing its capabilities in bispecific ADC discovery and development [2][3] - Biocytogen continues to provide high-quality source antibodies through its RenBiologics platform to support clinical translation and is actively seeking additional early-stage assets for licensing opportunities [4]
百奥赛图(02315) - 自愿性公告业务合作伙伴IDEAYA取得美国食品药品监督管理局对IDE03...
2025-12-04 23:59
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示,概不就因本公告全部或任何部份內容而產生或因依 賴該等內容而引致的任何損失承擔任何責任。 BIOCYTOGEN PHARMACEUTICALS (BEIJING) CO., LTD. 百奧賽圖(北京)醫藥科技股份有限公司 (股份代號:2315) (於中華人民共和國註冊成立的股份有限公司) 自願性公告 業務合作夥伴IDEAYA取得美國食品藥品 監督管理局對IDE034的IND批准 百奧賽圖(北京)醫藥科技股份有限公司(以下簡稱「本公司」)欣然宣佈,其合 作夥伴IDEAYA Biosciences, Inc. (Nasdaq: IDYA)(「IDEAYA」),一家專注於腫 瘤精準治療藥物研發的公司,已獲得美國食品藥品監督管理局的臨床試驗用新 藥(「IND」)批准,推進同類首創B7H3/PTK7雙特異性抗體偶聯物(「ADC」)項目 IDE034的I期臨床試驗。IDEAYA預計將在2026年第一季度開始患者入組,初步 評估B7H3和PTK7共表達的實體瘤類型,包括肺癌、結直腸癌、頭頸癌及卵巢╱ 婦科 ...
百奥赛图(02315) - 截至二零二五年十一月三十日止月份之股份发行人的证券变动月报表
2025-12-04 12:34
股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年11月30日 狀態: 新提交 致:香港交易及結算所有限公司 公司名稱: 百奧賽圖(北京)醫藥科技股份有限公司 呈交日期: 2025年12月4日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02315 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 110,781,920 | RMB | | 1 RMB | | 110,781,920 | | 增加 / 減少 (-) | | | 0 | | | RMB | | | | 本月底結存 | | | 110,781,920 | RMB | | 1 RMB | | 110,781,920 | | 2. 股份分類 | 普通股 | 股份類別 | 其 ...
百奥赛图(02315) - 海外监管公告 - 百奥赛图(北京)医药科技股份有限公司《首次公开发行股票...
2025-12-04 00:03
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示,概不就因本公告全部或任何部份內容而產生或因依 賴該等內容而引致的任何損失承擔任何責任。 BIOCYTOGEN PHARMACEUTICALS (BEIJING) CO., LTD. 百奧賽圖(北京)醫藥科技股份有限公司 (於中華人民共和國註冊成立的股份有限公司) (股份代號:2315) 海外監管公告 本公告乃百奧賽圖(北京)醫藥科技股份有限公司(「本公司」)根據香港聯合交易所 有限公司證券上市規則第13.10B條的規定刊發。茲載列本公司於上海證券交易所 網站刊發的《首次公開發行股票並在科創板上市招股說明書》,僅供參閱。 承董事會命 百奧賽圖(北京)醫藥科技股份有限公司 董事長、首席執行官兼執行董事 沈月雷 香港,2025年12月4日 於本公告日期,本公司董事會包括董事長、首席執行官兼執行董事沈月雷博士、 執行董事倪健博士及張海超博士;非執行董事魏義良先生、周可祥博士及張蕾娣 女士;獨立非執行董事華風茂先生、喻長遠博士及梁曉燕女士。 1.4980D ,a。 科创板投资风险提示:本次股票发行后 ...
百奥赛图(02315) - 海外监管公告 - 百奥赛图(北京)医药科技股份有限公司《首次公开发行股票...
2025-12-04 00:02
(於中華人民共和國註冊成立的股份有限公司) 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示,概不就因本公告全部或任何部份內容而產生或因依 賴該等內容而引致的任何損失承擔任何責任。 BIOCYTOGEN PHARMACEUTICALS (BEIJING) CO., LTD. 百奧賽圖(北京)醫藥科技股份有限公司 (股份代號:2315) 海外監管公告 本公告乃百奧賽圖(北京)醫藥科技股份有限公司(「本公司」)根據香港聯合交易所 有限公司證券上市規則第13.10B條的規定刊發。茲載列本公司於上海證券交易所 網站刊發的《首次公開發行股票並在科創板上市招股說明書提示性公告》,僅供參 閱。 承董事會命 百奧賽圖(北京)醫藥科技股份有限公司 董事長、首席執行官兼執行董事 沈月雷 香港,2025年12月4日 於本公告日期,本公司董事會包括董事長、首席執行官兼執行董事沈月雷博士、 執行董事倪健博士及張海超博士;非執行董事魏義良先生、周可祥博士及張蕾娣 女士;獨立非執行董事華風茂先生、喻長遠博士及梁曉燕女士。 百奥赛图(北京)医药科技股份有限公司 首次公开 ...
百奥赛图(02315) - 海外监管公告 - 百奥赛图(北京)医药科技股份有限公司《首次公开发行股票...
2025-12-04 00:01
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示,概不就因本公告全部或任何部份內容而產生或因依 賴該等內容而引致的任何損失承擔任何責任。 百奧賽圖(北京)醫藥科技股份有限公司 (於中華人民共和國註冊成立的股份有限公司) (股份代號:2315) 海外監管公告 本公告乃百奧賽圖(北京)醫藥科技股份有限公司(「本公司」)根據香港聯合交易所 有限公司證券上市規則第13.10B條的規定刊發。茲載列本公司於上海證券交易所 網站刊發的《首次公開發行股票並在科創板上市發行結果公告》,僅供參閱。 承董事會命 百奧賽圖(北京)醫藥科技股份有限公司 董事長、首席執行官兼執行董事 BIOCYTOGEN PHARMACEUTICALS (BEIJING) CO., LTD. 沈月雷 香港,2025年12月4日 於本公告日期,本公司董事會包括董事長、首席執行官兼執行董事沈月雷博士、 執行董事倪健博士及張海超博士;非執行董事魏義良先生、周可祥博士及張蕾娣 女士;獨立非執行董事華風茂先生、喻長遠博士及梁曉燕女士。 百奥赛图(北京)医药科技股份有限公司 首次公开发行股票并 ...
百奥赛图(北京)医药科技股份有限公司首次公开发行股票并在科创板上市招股说明书提示性公告
Shang Hai Zheng Quan Bao· 2025-12-03 19:08
Core Viewpoint - Baiaosaitu (Beijing) Pharmaceutical Technology Co., Ltd. has received approval for its initial public offering (IPO) of ordinary shares in RMB and listing on the Sci-Tech Innovation Board [1] Group 1: Company Information - The issuer is Baiaosaitu (Beijing) Pharmaceutical Technology Co., Ltd. [1] - The main underwriter for the IPO is China International Capital Corporation Limited [1] Group 2: Regulatory Approval - The application for the IPO has been approved by the Sci-Tech Innovation Board Committee of the Shanghai Stock Exchange [1] - The registration has been authorized by the China Securities Regulatory Commission (CSRC) under license number 2025〔2296〕 [1] Group 3: Disclosure Information - The prospectus for the IPO is available on the Shanghai Stock Exchange website and other specified platforms [1] - The prospectus can also be accessed at the issuer's location and that of the main underwriter [1]
百奥赛图新股发行结果出炉
Zheng Quan Shi Bao Wang· 2025-12-03 15:04
Core Viewpoint - The new share issuance results of Bai'ao Saitou indicate strong demand from offline investors, while online investors showed a low abandonment rate, reflecting overall positive market sentiment towards the company’s stock [1][2][3] Summary by Category Share Issuance Results - The total number of shares issued by the company was 47.50 million, with an issuance price of 26.68 yuan per share [3] - Online investors subscribed for 11.42 million shares, amounting to 304.68 million yuan, while offline investors subscribed for 27.15 million shares, totaling 724.27 million yuan [2][3] - The abandonment rate for online subscriptions was 0.36%, with 4.12 thousand shares abandoned, amounting to 109.98 thousand yuan [1][2] Subscription Details - The final online issuance volume accounted for 24.13% of the total issuance, with a final online winning rate of 0.028% [3] - Offline investors fully subscribed, and the number of shares abandoned by online investors was fully underwritten by the lead underwriter, representing 0.09% of the total issuance [1][3] Recent Trends in New Share Issuance - In the past month, notable companies with high online subscription abandonment included C China Uranium, Nanfang Digital, and Hai'an Group, with abandonment rates of 0.71%, 0.40%, and 0.38% respectively [3] - Bai'ao Saitou's abandonment rate of 0.36% places it among the companies with lower abandonment rates in recent new share issuances [3]