经济观察报 记者 刘晓诺 在跨国药企纷纷来华扫货的2025年，中国这家"抗体超市"也迎来了近年最好的业绩丰收。 2月26日，百奥赛图（688796.SH/02315.HK）发布2025年业绩快报，初步会计数据显示，该公司2025年营收约13.79亿元，实现归母净利1.73亿元，分别同比 增长40.63%、416.37%。 2019年—2023年，百奥赛图处在大规模烧钱的研发阶段，收不抵支，每年都亏损数亿元。直到2024年，研发的投入开始进入商业化兑现阶段，百奥赛图实现 归母净利3354万，扭亏为盈。 百奥赛图的股价也曾长期低迷。2022年，百奥赛图在创新药资本寒冬中登陆港交所，股价从发行的25.22港元/股一路下跌，2024年11月触底5.6港元/股，市 值仅有20多亿港元。 此后，行业回暖。2025年的创新药牛市中，百奥赛图的港股股价也震荡上行，较低谷期翻了约10倍。2025年12月，百奥赛图在科创板上市，又受到资本市场 的热情迎接，网上初步超额认购约5383倍，首日股价涨幅一度冲高到146.63%。 截至发稿，百奥赛图港股股价54.05港元，A股股价77.75元，总市值314亿元。 企业自身的经营阶段与行 ...

PresentationYujiro HataFounder, President, CEO & Director Thank you so much to you and Evercore for hosting this fireside chat today with the IDEAYA management team. So IDEAYA Biosciences, we're a leading precision medicine oncology company. We have 9 programs in the clinic. So a very deep and diversified portfolio. Umer, as you know, our most advanced program is Darovasertib, which is now currently in 2 Phase III randomized studies, one in the first-line metastatic uveal melanoma indication and then next ...

Summary of IDEAYA Biosciences Update - February 23, 2026 Company Overview - **Company**: IDEAYA Biosciences (NasdaqGS:IDYA) - **Industry**: Precision medicine oncology - **Programs**: 9 clinical programs, with a focus on darovasertib in phase 3 studies for metastatic uveal melanoma [1][3] Key Points and Arguments Clinical Programs - **Darovasertib**: - Currently in two phase 3 randomized studies for first-line metastatic uveal melanoma and neoadjuvant indications [1] - Upcoming guidance on top-line results expected by the end of March 2026, focusing on median progression-free survival (PFS) as the primary endpoint [4][5] - Reported a solid 7-month PFS in previous presentations, with a follow-up of approximately 2 years [5][11] - **DLL3 Topo ADC (IDE-849)**: - Anticipated clinical data update by the end of 2026, with potential to be a best-in-class asset [2] - **MTAP Deletion Programs**: - Two clinical assets (PRMT5 and MAT2A) with opportunities for both monotherapy and combination therapy [2] - **KAT6/7 (IDE-574)**: - Entered phase 1, targeting a large patient population including breast and colorectal cancer [3] Trial Design and Expectations - **Trial Design**: - Simple randomized phase 3 comparison of darovasertib-crizotinib combination versus standard of care (checkpoint inhibitors) [15] - Control arm expected to show PFS of approximately 2-3 months based on meta-analyses [10][11] - **PFS and OS Analysis**: - The treatment arm is expected to outperform the control arm, with a significant buffer for achieving statistical significance [11][12] - Overall survival (OS) data shows a promising 21-month survival rate, with expectations for positive outcomes in the ongoing study [11][12][128] Patient Population and Disease Characteristics - **Uveal Melanoma**: - Majority of patients (over 90%) present with liver metastases, making liver-directed therapies critical [167][176] - Approximately one-third of patients have elevated LDH levels, indicating disease severity [180][181] Regulatory and Future Plans - **FDA Submission**: - Plans to file for approval based on PFS data, with OS data to be presented during the review process [136][186] - Anticipated timeline for filing and review is approximately 12 months, targeting first half of 2027 for potential approval [187] - **NCCN Guidelines**: - Plans to present data to the NCCN panel to support treatment inclusion for both HLA-A2 negative and positive patients [189] Neoadjuvant Study (OptimUM-09) - **OptimUM-09 Study**: - Focused on neoadjuvant treatment with promising results in tumor shrinkage and vision preservation [191] - Aims to change the treatment paradigm from surgical interventions to pharmacological management [195] Additional Important Information - **Safety Profile**: - Expected to be comparable to previous studies, with a focus on managing adverse events effectively [155] - Investigators are becoming more adept at handling treatment-related toxicities, which may lead to lower discontinuation rates [156] - **Data Review Process**: - The independent review of PFS is ongoing, with a target completion by the end of March 2026 [144] This summary encapsulates the key points from the IDEAYA Biosciences update, highlighting the company's focus on innovative oncology treatments, ongoing clinical trials, and strategic regulatory plans.

IDEAYA Biosciences Announces Appointment of Dr. Theodora (Theo) Ross, M.D., Ph.D., as Chief Development Officer [Accessibility Statement] Skip NavigationSOUTH SAN FRANCISCO, Calif., Feb. 23, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, today announced the appointment of Dr. Theodora (Theo) Ross into the newly created role of Chief Development Officer. In this role, Dr. Ross will be responsible for leading early clinical development for IDEAYA's ...

Core Insights - The session is part of Citi's 2026 Virtual Oncology Leadership Summit, featuring discussions with various companies in the oncology sector [1][2] - IDEAYA's senior management team, including CFOs Josh Bleharski and Michael White, and CMO Darrin Beaupre, is highlighted for their participation in the summit [2] Company Overview - IDEAYA is represented by key executives who are available for questions from the audience, indicating an open communication approach [2] - The summit includes a variety of companies, suggesting a diverse representation within the oncology industry [1]

Group 1 - Telstra Group reported a 9.4% increase in half-year profit, attributed to steady contributions from its mobile business and cost-cutting initiatives [1] - The profit attributable for the six months ended December 31 was A$1.12 billion (approximately $788.03 million), compared to A$1.03 billion in the previous year [1]

Summary of IDEAYA Biosciences Conference Call Company Overview - **Company**: IDEAYA Biosciences (NasdaqGS:IDYA) - **Industry**: Clinical-stage precision medicine oncology - **Key Programs**: Nine clinical programs, with a focus on uveal melanoma and other oncology indications Key Points and Arguments Upcoming Catalysts - **Darovasertib**: Lead molecule for uveal melanoma, with an upcoming top-line data release for the combination with crizotinib in metastatic uveal melanoma expected by the end of March 2026. The company has triggered the required 130 events for analysis [2][5] - **Neoadjuvant and Adjuvant Studies**: Enrollment in a neoadjuvant study is ongoing, with plans to begin an adjuvant study in Q2 2026 [3][4] Clinical Data Expectations - **Control Arm Expectations**: The control arm is expected to show a median progression-free survival (PFS) of 2-3 months and overall survival (OS) of about 13 months based on historical data [9][10] - **Darovasertib and Crizotinib Combination**: Previous data indicated a median PFS of about 7 months and OS of 21 months, significantly better than standard therapies [10][12] - **Response Rates**: Standard therapies show a response rate of around 10%, while the combination therapy has shown a response rate exceeding 30% [10] Study Design and Patient Demographics - The study focuses on HLA-A2 negative patients with metastatic uveal melanoma, comparing the combination therapy to standard care, which varies by region [8][9] - The study design includes frequent patient scans every six weeks, which may lead to earlier detection of progression compared to traditional three-month scans [15] Regulatory and Filing Timelines - **FDA Filing**: The company anticipates a six-month timeline to file for accelerated approval post-data release, with a review period of at least six months [30] - **HLA-A2 Positive Group**: Data from HLA-A2 positive patients will be presented in two chapters, with the first chapter expected to show early efficacy data [31][32] Other Pipeline Developments - **DLL3 TOPO1 ADC**: Currently in phase I studies, with initial data expected by the end of 2026. The U.S. study has launched, and early safety data is anticipated [47][48] - **MTAP Inhibitor IDE397**: Ongoing studies in combination with Trodelvy for MTAP-deleted urothelial cancer, with promising early data [59][60] - **Combination Strategies**: The company is exploring various combination therapies, including those targeting PRMT5 and CDKN2A, to enhance treatment efficacy in MTAP-deficient tumors [66][68] Market Position and Future Outlook - IDEAYA aims to set a new standard for uveal melanoma treatment, addressing a significant unmet medical need with limited existing therapies [22][14] - The company has a strong cash position of approximately $1.05 billion, providing a runway into 2030, positioning it well for upcoming clinical milestones [5] Additional Important Information - The company emphasizes the importance of data integrity and the potential for positive outcomes based on historical performance metrics [12][26] - Discussions with the FDA regarding potential label expansions and real-world data integration are ongoing, particularly for HLA-A2 positive patients [33] This summary encapsulates the key points discussed during the conference call, highlighting IDEAYA Biosciences' strategic focus on advancing its oncology pipeline and addressing critical patient needs in uveal melanoma and other cancer indications.

Clinical Development - The company has a pipeline of nine potential first-in-class product candidates across four clinical focus areas, including Darovasertib for Uveal Melanoma and ADC and DNA Damage Response (DDR) combinations [22]. - Darovasertib is being evaluated in a Phase 2/3 trial (OptimUM-02) for first-line metastatic Uveal Melanoma, with full enrollment of 437 patients completed in December 2025, and topline data expected in Q1 2026 [26]. - In the Phase 2 trial (OptimUM-01), darovasertib combined with crizotinib showed a confirmed objective response rate (ORR) of 34% and a disease control rate (DCR) of 90% among 41 efficacy-evaluable patients [28]. - The company plans to initiate a global Phase 3 trial (OptimUM-11) in the adjuvant setting of primary Uveal Melanoma in H1 2026, enrolling approximately 450 patients [32]. - IDE849, a DLL3 TOP1 ADC, is being evaluated in a Phase 1 clinical trial in China, with positive initial data presented from 100 patients, including 87 refractory SCLC patients [36]. - IDE397 is being evaluated in a Phase 1/2 trial in combination with Trodelvy for MTAP-deleted urothelial cancer, with initial data showing manageable safety and no serious adverse events [47][50]. - The company plans to initiate a Phase 1 clinical trial for IDE034, a B7H3/PTK7 bispecific ADC, in the first quarter of 2026, following FDA IND clearance [40][43]. - The company is targeting to initiate a Phase 1 clinical combination trial with IDE161 and IDE849 in the second quarter of 2026 [42]. - IDE574 received FDA IND clearance and is expected to begin a Phase 1 trial in the first quarter of 2026, with plans for combination trials with IDE397 [55]. - FDA granted IND clearance for IDE275, targeting Phase 1 trial in Q1 2026 for breast, lung, prostate, and colorectal cancers [56]. - The company achieved the first dosing of the first patient in the Phase 1 clinical trial for IDE849, triggering a $2 million milestone payment to Hengrui Pharma [127]. Regulatory Designations and Approvals - The FDA granted Breakthrough Therapy designation for darovasertib as a neoadjuvant treatment for primary Uveal Melanoma in March 2025, expediting its development and regulatory review [33]. - The FDA granted fast track designation to darovasertib in combination with crizotinib for the treatment of adult patients with mUM in November 2022 [164]. - In September 2023, the FDA granted two fast track designations to IDE161 for specific ovarian and breast cancer indications [164]. - The FDA may require Phase 4 clinical trials post-approval to further assess a drug's safety and effectiveness, which could impact the commercial value of the product [151]. - The FDA may issue a Complete Response Letter detailing deficiencies in an NDA, requiring resubmission to address these issues [150]. - The FDA requires substantial time and financial resources for drug regulatory approvals, with potential sanctions for non-compliance, including product recalls and fines [137]. - The NDA submission process includes a preliminary review by the FDA within the first 60 days, with a goal to review and act on applications within ten months for standard review and six months for priority review [148]. - Orphan drug designation is granted for drugs intended to treat rare diseases affecting fewer than 200,000 individuals in the U.S., providing financial incentives such as tax credits and user-fee waivers [154]. Market and Commercialization Strategy - The company plans to build its own sales force for commercialization in the U.S. and potentially Europe, supported by effective marketing and sales management [130]. - The company retains commercialization rights for darovasertib in the U.S. and worldwide rights for several other product candidates, indicating a focus on expanding its commercial capabilities [129]. - The company is targeting to nominate a development candidate for a novel program targeting MTAP and CDKN2A by the first half of 2026 [67]. - The company plans to evaluate future strategic opportunities to accelerate development timelines and maximize the commercial potential of its product candidates [91]. - The company has established collaborations with Pfizer and Gilead for clinical development of darovasertib and IDE397, respectively [67]. - The company has exclusive commercial rights worldwide for IDE397 and IDE161, and all commercial rights within the U.S. for darovasertib [85]. Financial Agreements and Partnerships - An exclusive license agreement with Servier was established in August 2025, providing an upfront payment of $210 million and potential milestone payments of up to $320 million [30]. - An upfront payment of $210 million was received from Servier for the exclusive license agreement to develop darovasertib outside the U.S. [67]. - The Hengrui Pharma License Agreement includes upfront and milestone payments totaling $1.045 billion, with a $75 million upfront fee and up to $200 million in development and regulatory milestone payments [126]. - The company paid Novartis an upfront payment of $2.5 million and issued 263,615 shares of Series B redeemable convertible preferred stock, with potential milestone payments of up to $29 million based on clinical and commercial milestones [104]. - The company entered into a collaboration with Gilead for IDE397, with Gilead providing drug supply and the company sponsoring a Phase 1 clinical trial, sharing oversight responsibilities [107]. Intellectual Property and Patent Portfolio - The company has a patent portfolio comprising approximately 71 distinct patent families, including 21 issued U.S. patents and 65 issued foreign patents, with expiration dates ranging from 2035 to 2046 [79]. - The PKC program, including darovasertib, has approximately seven issued U.S. patents and 34 issued foreign patents, with expiration dates between 2035 and 2045 [80]. - The MAT2A program, including IDE397, consists of five issued U.S. patents and nine issued foreign patents, with expiration dates between 2039 and 2045 [81]. - The PARG program, including IDE161, has four issued U.S. patents and 17 issued foreign patents, with expiration dates between 2035 and 2044 [82]. Market Environment and Regulatory Challenges - The U.S. annual incidence of MTAP-deleted tumors is estimated at approximately 62,000 patients across priority tumor types, highlighting a significant unmet medical need [53]. - The FDA may withdraw approval if compliance with regulatory standards is not maintained or if problems occur after the product reaches the market [166]. - The FDA may deny PMA approval based on deficiencies in the application, requiring additional clinical trials that can delay approval [180]. - The FDA requires that a companion diagnostic be approved contemporaneously with the therapeutic product if it is essential for safe and effective use [175]. - The FDA may impose post-approval conditions necessary to ensure the safety and effectiveness of a device, including restrictions on labeling and promotion [179]. - The FDA conducts inspections of manufacturing facilities to ensure compliance with cGMP requirements before approving an NDA [149]. Economic and Legislative Factors - The Affordable Care Act (ACA) increased Medicaid rebates from 15.1% to 23.1%, affecting revenue for pharmaceutical manufacturers [208]. - The Inflation Reduction Act of 2022 mandates price negotiations for certain drugs under Medicare, with penalties for price increases exceeding inflation, impacting future revenue forecasts [211]. - The One Big Beautiful Bill Act, enacted in July 2025, is expected to reduce Medicaid enrollment and services, adversely affecting sales of commercialized products [213]. - The U.S. government and states are increasingly implementing regulations to control pharmaceutical pricing, which may limit sales and reimbursement for products [215]. - The EU's Regulation No 2021/2282 on Health Technology Assessment (HTA) aims to enhance cooperation in assessing health technologies, potentially affecting product pricing and reimbursement decisions [217]. - Pharmaceutical companies face penalties for non-compliance with healthcare regulations, including civil and criminal penalties, which could impact operational capabilities [218]. - Data privacy laws are evolving, potentially complicating compliance and leading to significant penalties for violations, affecting operational processes [219]. - Coverage and reimbursement decisions by third-party payors are increasingly restrictive, which could adversely affect product sales and market demand [220].

Financial Performance - As of December 31, 2025, IDEAYA had approximately $1.05 billion in cash, cash equivalents, and marketable securities, down from $1.08 billion as of December 31, 2024, primarily due to net cash used in operations[12]. - The net loss for Q4 2025 was $83.3 million, compared to a net loss of $130.3 million for Q4 2024, with total stock compensation expense increasing to $11.8 million from $9.5 million[18]. - For the full year 2025, the net loss was $113.7 million, significantly reduced from a net loss of $274.5 million in 2024[19]. - Cash and cash equivalents and short-term and long-term marketable securities decreased to $1,049.685 million from $1,082.151 million[28]. - Total assets decreased to $1,109.324 million from $1,124.091 million[28]. - Total liabilities increased to $86.390 million from $64.944 million[28]. Revenue and Expenses - Collaboration revenue for Q4 2025 was $10.9 million, an increase from $7.0 million in Q4 2024, with a remaining balance of $161.8 million related to clinical trial cost reimbursements under the license agreement[13]. - Research and development expenses for Q4 2025 totaled $86.6 million, a decrease from $140.2 million in Q4 2024, driven by a prior year's upfront payment offset by higher clinical trial expenses[16]. - General and administrative expenses for Q4 2025 were $18.8 million, up from $11.0 million in Q4 2024, mainly due to increased personnel-related expenses and consulting fees[17]. Clinical Trials and Developments - IDEAYA completed full enrollment of 437 patients in the OptimUM-02 trial, with topline results expected by the last week of March 2026[5]. - The company anticipates initiating three randomized Phase 3 trials for darovasertib in uveal melanoma by H1 2026, including neoadjuvant and adjuvant settings[9]. - IDEAYA received IND clearance for IDE034 in Q4 2025 and plans to initiate a Phase 1 trial in Q1 2026, with a $5 million milestone payment triggered upon dosing the first patient[11]. - The company is targeting to provide preliminary clinical data from the IDE849 Phase 1 trial by the end of 2026 and initiate a registrational study in the second line setting for small cell lung cancer[8].

Core Insights - IDEAYA Biosciences reported strong clinical execution and pipeline expansion in Q4 and full year 2025, with a focus on advancing its oncology programs and commercial readiness activities [1] Financial Results - As of December 31, 2025, IDEAYA had approximately $1.05 billion in cash, cash equivalents, and marketable securities, a decrease from $1.08 billion in 2024, primarily due to net cash used in operations [2] - Collaboration revenue for Q4 2025 was $10.9 million, up from $7.0 million in Q4 2024, driven by research and development services under the Servier exclusive license agreement [2] - R&D expenses for Q4 2025 totaled $86.6 million, down from $140.2 million in Q4 2024, mainly due to a prior year's upfront payment under a license agreement [2] - G&A expenses for Q4 2025 were $18.8 million, an increase from $11.0 million in Q4 2024, attributed to higher personnel and consulting costs [2] - The net loss for Q4 2025 was $83.3 million, compared to a net loss of $130.3 million in Q4 2024 [2] - For the full year 2025, the net loss was $113.7 million, significantly reduced from $274.5 million in 2024 [2] Clinical Developments - IDEAYA is advancing darovasertib in uveal melanoma, with topline results from the OptimUM-02 trial expected by the end of March 2026, which may enable accelerated approval in the U.S. [1] - The company plans to initiate three Phase 3 registrational trials for darovasertib in uveal melanoma by H1 2026 [1] - IDEAYA has received IND clearance for IDE034, a bispecific ADC, and plans to initiate a Phase 1 trial in Q1 2026 [1] - The company is also targeting the initiation of several other clinical trials, including IDE574 and IDE892, in 2026 [1] Corporate Updates - In December 2025, GlaxoSmithKline notified IDEAYA of its intention to terminate a collaboration agreement, leading to the transfer of certain clinical programs back to IDEAYA [1] - The company is actively preparing for the commercial launch of darovasertib in the U.S. and globally [1]