Core Viewpoint - The stock of Baiaosaitu-B (02315) has seen an increase of over 3%, currently trading at 31.86 HKD, following the announcement of FDA approval for a clinical trial by its partner IDEAYA Biosciences, Inc. for a novel dual-targeting antibody-drug conjugate project [1][2]. Group 1: Company Developments - IDEAYA Biosciences has received FDA approval for its Investigational New Drug (IND) application to advance the Phase I clinical trial of the B7H3/PTK7 dual-specific antibody-drug conjugate (ADC) [1]. - The patient enrollment for the trial is expected to begin in Q1 2026, focusing on solid tumors co-expressing B7H3 and PTK7, including lung cancer, colorectal cancer, head and neck cancer, and ovarian/gynecological tumors [1][2]. Group 2: Clinical Research Insights - Preclinical studies indicate that IDE034 monotherapy shows deep and durable tumor shrinkage in various B7H3/PTK7 positive tumor models, demonstrating strong anti-tumor activity [2]. - IDEAYA plans to explore a combination treatment strategy of IDE034 with its PARG inhibitor IDE161 to enhance the durability of efficacy, with data supporting the combination treatment mechanism to be shared at a major medical conference in H1 2026 [2]. - The co-expression rates of B7H3/PTK7 in solid tumors are approximately 30% for lung cancer, 46% for colorectal cancer, and 27% for head and neck cancer, indicating broad clinical applicability [2].

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]

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]

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]

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 ...

Summary of IDEAYA Biosciences FY Conference Call Company Overview - **Company**: IDEAYA Biosciences (NasdaqGS:IDYA) - **Industry**: Precision medicine oncology Key Points Lead Program: Darovasertib - **Current Status**: In first-line registrational study for metastatic uveal melanoma - **Upcoming Milestones**: Randomized median progression-free survival (PFS) results expected by year-end 2025, with full enrollment for median overall survival (OS) component nearly complete, targeting over 450 patients [2][3][4] - **Breakthrough Therapy Designation**: Received for a phase 3 randomized neoadjuvant trial, which is now active with patients in screening [3][4] Patient Journey in Uveal Melanoma - **Lack of Approved Therapies**: No systemic approved therapies in neoadjuvant or adjuvant settings, with most metastatic patients also lacking approved options [5][6] - **Treatment Options**: Initial treatments include eye resection or plaque therapy, followed by adjuvant phase with no available therapies [7][8] Objectives for Neoadjuvant and Adjuvant Trials - **Primary Endpoint**: Eye preservation rate exceeding 10% with 95% confidence interval for the enucleation cohort [9][10] - **Visual Acuity Goals**: Aim for 20% or more patients in treatment arm passing a 15-letter BCVA vision test [10] DLL3 Topo ADC Program - **Efficacy Data**: Confirmed response rate of 70% in second-line small cell lung cancer at a dose of 2.4 mg/kg [15] - **Safety Profile**: Grade three or higher adverse events (AEs) below 20%, indicating potential for dose escalation [16] Future Development Plans - **Focus Areas**: Small cell lung cancer and neuroendocrine tumors (NETs) with plans to share more data in 2026 [20][23] - **MAT2A and MTAP Pathway**: Ongoing phase two trials for IDE397 (MAT2A inhibitor) and phase one for PRMT5 inhibitor, with updates expected in the first half of next year [24][25] Bispecific ADC Development - **B7-H3 and PTK7**: First-in-class bispecific ADC targeting co-expressed antigens in various tumor types, including non-small cell lung cancer and colorectal cancer [32][34] - **Patient Population**: Approximately one-third of lung cancer patients and 40%-50% of colorectal cancer patients are expected to express both antigens [34] Key Takeaways - **Upcoming Focus**: Randomized PFS results are critical for transitioning towards commercialization [38] - **Overall Strategy**: Emphasis on combination therapies and targeting co-alterations to enhance treatment efficacy [29][30] This summary encapsulates the essential insights from the IDEAYA Biosciences FY Conference Call, highlighting the company's strategic focus, ongoing clinical trials, and future development plans in the oncology sector.

Group 1 - The article does not contain any relevant content regarding company or industry insights [1]

Financial Data and Key Metrics Changes - The company is approaching top line results for its lead program, darovasertib, with guidance for an accelerated approval filing in the U.S. by year-end this year to Q1 next year [3][4] - Historical median progression-free survival (PFS) for metastatic uveal melanoma is about 2-3 months, while the company has reported a PFS of approximately 7 months in its trials, indicating a significant improvement [6][7] Business Line Data and Key Metrics Changes - The company has eight programs in clinical development, with darovasertib being the lead program in a registrational trial for metastatic uveal melanoma [3] - The company has received breakthrough therapy designation for darovasertib in the neoadjuvant setting, indicating a strong pipeline and potential for accelerated development [4] Market Data and Key Metrics Changes - The market for darovasertib targets approximately 4,000-5,000 patients, with a significant portion being HLA negative, which the company aims to address [9] - The annual incidence of neoadjuvant uveal melanoma is estimated to be 10,000-12,000 patients, highlighting a substantial unmet need in this area [12] Company Strategy and Development Direction - The company is focusing on expanding its pipeline in the MTAP deletion space, with a phase two MAT2A inhibitor and a phase one PRMT5 inhibitor, aiming to position itself as a leader in this competitive area [36] - The company is also exploring the DLL3 program for small cell lung cancer, with plans to differentiate based on efficacy and durability compared to competitors [53] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming data readouts, particularly for darovasertib, and believes that the combination of strong efficacy data and a robust pipeline will position the company favorably in the market [19][20] - The company is optimistic about the potential for its adjuvant study to become a blockbuster opportunity, targeting patients earlier in their treatment journey [29] Other Important Information - The company is preparing to initiate an adjuvant study in collaboration with Servier, targeting high and high medium metastatic risk populations [27] - The company has a unique bispecific ADC targeting B7-H3 and PTK7, which is expected to amplify efficacy in dual expression populations [66] Q&A Session Summary Question: What is the expected timeline for the neoadjuvant study? - The company anticipates enrolling the study in roughly five quarters, with the first eye preservation data expected in about six months [19][20] Question: How does the company plan to differentiate its DLL3 program? - The company believes it can differentiate based on response rates and durability, leveraging a unique linker system that allows for higher dosing [53][54] Question: What is the competitive landscape for the MTAP deletion space? - The company sees itself as an industry leader in the MTAP deletion area, with a diverse pipeline that includes multiple clinical stage assets [36][37]

Financial Data and Key Metrics Changes - The company is approaching top line results for its lead program, darovasertib, with guidance for an accelerated approval filing in the U.S. by year-end this year to Q1 next year [3][4] - Historical median progression-free survival (PFS) for metastatic uveal melanoma is about 2 to 3 months, while the company has reported a PFS of approximately 7 months in their studies, indicating a significant improvement [6][7] Business Line Data and Key Metrics Changes - The company has eight programs in clinical development, with darovasertib being the lead program in a registrational trial for metastatic uveal melanoma [3] - The company has received breakthrough therapy designation for darovasertib in the neoadjuvant setting, indicating a strong focus on this area [4] - The next key program is DLL3, with recent data presented at the World Conference on Lung Cancer, highlighting its potential in small cell lung cancer [4][55] Market Data and Key Metrics Changes - The market for darovasertib targets approximately 4,000-5,000 patients, with a significant portion being HLA negative, which the company aims to address [9] - The annual incidence of neoadjuvant uveal melanoma is estimated to be 10,000-12,000 patients, indicating a substantial unmet need in this market [12] Company Strategy and Development Direction - The company is focusing on a diversified pipeline, with plans to initiate an adjuvant study in collaboration with Servier in the first half of next year, targeting high-risk metastatic patients [28] - The company aims to implement rational combinations in the MTAP deletion space, positioning itself as a leader in this area with multiple clinical stage assets [37][38] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming data readouts, particularly for eye preservation rates and event-free survival in the neoadjuvant setting [19][13] - The company believes it is well-positioned to address the unmet needs in the neoadjuvant space due to limited competition [15][17] Other Important Information - The company is developing a bispecific ADC targeting B7H3 and PTK7, which is unique in its AND format, aiming to enhance efficacy in dual expression populations [68][69] - The company is also advancing its KAT6/7 inhibitor program, which targets chromatin remodeling, with a focus on breast cancer and potentially other indications [76][77] Q&A Session Summary Question: What is the timeline for the neoadjuvant study? - The company plans to enroll the study in roughly five quarters, with the first eye preservation data expected in about six months [19][20] Question: How does the company plan to differentiate its DLL3 program? - The company believes its linker system allows for higher dosing and reduced toxicity compared to competitors, which could lead to better efficacy and durability [55][56] Question: What is the market potential for the adjuvant study? - The adjuvant market could potentially be the largest of the three indications, with a path to becoming a blockbuster opportunity [30]

Financial Data and Key Metrics Changes - The company is approaching top line results for its lead program, darovasertib, with guidance for an accelerated approval filing in the U.S. by year-end this year to Q1 next year [3][4] - Historical median progression-free survival (PFS) for metastatic uveal melanoma is about 2.5 months, while the company has reported a PFS of approximately 7 months in its trials, indicating a significant improvement [6][8] Business Line Data and Key Metrics Changes - The company has eight programs in clinical development, with darovasertib being the lead program in a registrational trial for metastatic uveal melanoma [3] - The company received breakthrough therapy designation for darovasertib in the neoadjuvant setting, indicating a strong pipeline and potential for accelerated development [4] Market Data and Key Metrics Changes - The target market for darovasertib includes approximately 4,000-5,000 patients, with a significant portion being HLA negative, which the company aims to address [10] - The annual incidence of neoadjuvant uveal melanoma is estimated to be 10,000-12,000 patients, highlighting a substantial unmet need in this area [14] Company Strategy and Development Direction - The company is focusing on expanding its pipeline in the MTAP deletion space, which represents about 10% of all solid tumors, and is pursuing rational combinations to enhance treatment efficacy [39] - The company is also exploring the DLL3 program for small cell lung cancer, aiming to differentiate based on efficacy and durability compared to competitors [57] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming data readouts, particularly for darovasertib, and highlighted the potential for further upside based on patient baseline characteristics [11][12] - The company is optimistic about the adjuvant study, which is expected to target high-risk populations and could potentially be the largest market segment among its three indications [32] Other Important Information - The company is preparing to initiate an adjuvant study in collaboration with Servier, targeting approximately 450 patients and focusing on relapse-free survival as the primary endpoint [30] - The company is also advancing its KAT6/7 inhibitor program, which aims to enhance activity and durability in cancer treatment [75] Q&A Session Summary Question: What are the expected timelines for the neoadjuvant and adjuvant studies? - The company anticipates eye preservation data in about six months and expects to enroll the neoadjuvant study in roughly five quarters [21][20] Question: How does the company plan to differentiate its DLL3 program? - The company believes its linker system allows for higher dosing and reduced toxicity compared to competitors, which could lead to better efficacy and durability [58] Question: What is the strategy for the MTAP deletion program? - The company aims to implement rational combinations and believes it is an industry leader in this area with multiple clinical stage assets [39]