Azenosertib

4月全球获批新药清单       2026年4月全球共有90款新药获批（含新适应症），其中19款为改良新药，10款为生物类似药。中国澳门、中国内地及美国是获批活跃区，统计数据包含首次获批、新适应症获批及同适应症在不同地区获批。 •肿瘤领域：包括治疗非小细胞肺癌的新药他雷替尼、塞伐艾替尼、安达艾替尼、度伐利尤单抗等；治疗原发纵隔大B细胞淋巴瘤|弥漫性大B细胞淋巴瘤的新药安基奥仑赛；治疗卵巢上皮癌|宫颈癌|结直肠癌|胶质母细胞瘤|非小细胞肺癌的新药贝伐珠单抗-TAB008以及治疗HR阳性、HER2阴性乳腺癌的新药氟维司群(新适应症)、库莫西利等多款重要药物。 •其他重要领域： ⭐免疫系统疾病：治疗慢性自发性荨麻疹的新药度普利尤单抗伊；治疗克罗恩病|银屑病|银屑病关节炎的新药乌司奴单抗-CT-P43；治疗斑块状银屑病的新药卡泊三醇+倍他米松-LEO90100等获批。 ⭐内分泌代谢系统疾病：治疗肥胖的新药奥氟格列隆，治疗1型糖尿病|2型糖尿病的新药甘精胰岛素和治疗肾上腺功能不全的新药氢化可的松缓释硬胶囊-Efmody肾等获批。 ⭐其他：治疗射血分数保持的心力衰竭|射血分数轻度降低的心力衰竭的新药非奈利酮、治疗OTOF突变相关的听觉障碍的新药lunsotogene parvec-cwha、治疗阿尔兹海默症激越的新药安非他酮+右美沙芬-AXS-05、治疗精神分裂症的新药卢美哌隆等也获得批准。 4月全球提交申请新药清单        4月全球71款新药提交上市申请（含11款改良新），ADC药物和JAK抑制剂是申报主力。统计范围涵盖首次申请、新适应症申请及同适应症在多地申请。 •肿瘤领域：包括治疗慢性淋巴细胞白血病/小淋巴细胞淋巴瘤的新药阿可替尼、维奈克拉；治疗弥漫性大B细胞淋巴瘤| 原发纵隔大B细胞淋巴瘤的新药；治疗小细胞肺癌的新药ifinatamab deruxtecan（B7-H3 ADC）；治疗实体瘤的新药德曲妥珠单抗（HER2 ADC），治疗胃癌的新药泽尼达妥单抗（HER2双抗）；治疗淋巴瘤的新药万基奥仑赛（CD19 CAR-T）等。 •其他重要领域： ⭐免疫系统疾病：治疗温抗体型自身免疫性溶血性贫血的新药索乐匹尼布；治疗系统性红斑狼疮的新药奥妥珠单抗和治疗季节性过敏性鼻炎的新药Povetacicept等申请上市。 ⭐内分泌和代谢系统疾病：治疗苯丙酮尿症|高苯丙氨酸血症的新药塞匹蝶呤；治疗X连锁低磷血症的新药布罗索尤单抗和治疗肥胖的新药司美格鲁肽(诺泰澳赛诺）在中国申请上市。 ⭐罕见病与其他：治疗年龄相关性黄斑变性|湿性年龄相关性黄斑变性|糖尿病黄斑水肿|脉络膜新生血管|视网膜静脉阻塞继发黄斑水肿的新药Zilganersen，治疗HIV感染的新药 来那帕韦+比克替拉韦等前沿疗法提交申请。 4月首次进入 Ⅲ 期临床的新药清单        4月全球共有29个项目首次进入III期，其中19款为新药。血液肿瘤和慢性疾病是主要战场。 •肿瘤领域：是III期临床最集中的领域，治疗多发性骨髓瘤的新药ARI0002H（CAR-T）、泽沃斯妥单抗（CD3/FCRL5双抗）；治疗卵巢上皮癌的新药Azenosertib；治疗慢性淋巴细胞白血病/小淋巴细胞淋巴瘤的新药TQB3909等。 •其他重要领域： ⭐代谢与慢性病：治疗2型糖尿病，原发性高血压的新药HL1113、HL1113R1、HL1113R2；治疗弗里德赖希共济失调的新药Nomlabofusp；治疗斑块状银屑病的新药RSS0393（PDE4）等。 4月研发进度终止新药        4月全球共有21款新药研发终止，3款适应症终止。临床I/II期是淘汰最集中的阶段。 终止原因： 在明确原因中，研发策略调整是首要原因，其次是疗效未达预期。基因治疗（安斯泰来）和新型免疫疗法（ISAC）的高风险性在本月数据中尤为突出。 终止阶段与领域： •终止项目覆盖多集中在临床I/II期，反映了早期研发的高淘汰率；CAR-T、双抗等前沿技术同样面临失败风险 END

Appointments enhance commercialization readiness as Zentalis advances registrational program for azenosertib in Cyclin-E1 positive platinum-resistant ovarian cancer SAN DIEGO, May 27, 2026 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical oncology innovator advancing late-stage development of investigational first-in-class WEE1 inhibitor azenosertib as a biomarker-driven treatment approach for ovarian cancer, today announced the appointments of Shannon Campbell to its Board of Directors and Sarah Kelly as the Company’s Senior Vice President of Commercial Strategy. These appointments reflect Zentalis’ continued commitment to developing commercial and operational capabilities as the Company advances registration-intended Phase 2 and Phase 3 trials of azenosertib for patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC). “Shannon Campbell brings deep experience helping oncology companies successfully navigate the transition from clinical to commercial-stage,” said Julie Eastland, Chief Executive Officer of Zentalis. “Shannon’s commercial scale-up leadership will help us achieve our vision as we continue advancing azenosertib through late-stage development for patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC). Simultaneously, the appointment of Sarah Kelly brings a broad set of experience in building launch readiness for both companion diagnostics and therapeutics. Together, these roles provide the strategic, operational, and commercial foundation needed to support launch readiness and long-term growth.” Ms. Campbell is a seasoned biopharmaceutical executive with more than 30 years of experience, leading global commercial strategy and building oncology franchises. Her proven track record will support Zentalis as it advances toward the potential commercialization of azenosertib for Cyclin E1 positive PROC patients, as well as, evaluating azenosertib in earlier lines of ovarian cancer, as a combination therapy, and in other tumor types. Most recently, Ms. Campbell served as Executive Vice President and Chief Commercial Officer at Merus, where she led the company’s evolution toward becoming a commercial-stage organization, including launch preparedness efforts for its portfolio of multiclonic antibodies. Prior to Merus, she held senior oncology leadership roles at Novartis Pharmaceuticals and Bayer Healthcare Pharmaceuticals, where she supported the launch and growth of innovative therapies across solid tumors and rare diseases. Ms. Campbell currently serves on the board of Black Diamond Therapeutics and is an advisory board member for Verix. “I am excited to join Zentalis’ Board at an important time for the Company as it prepares to bring a potential first-in-class therapy to market for patients with platinum-resistant ovarian cancer, a population with significant unmet need,” said Ms. Campbell. “I look forward to working with the Zentalis Board and the leadership team to help build the strategic and commercial infrastructure needed to ultimately bring this important potential new treatment option to the community.” Sarah Kelly joins Zentalis as Senior Vice President of Commercial Strategy to lead launch readiness. Throughout Ms. Kelly’s 30-year career, she has held senior leadership positions in commercial and business development at companies including Amgen, Turning Point, Spectrum and Agilent. Ms. Kelly’s extensive experience in oncology includes building and leading commercial organizations in preparation for therapeutic and companion diagnostic launches. Ms. Kelly’s focus on commercial strategy, market access, companion diagnostics, field leadership, and business development provides operational expertise to prepare Zentalis for the potential to bring azenosertib to patients. Zentalis is advancing azenosertib through a late-stage registrational development program in Cyclin E1-positive PROC, with an anticipated year-end 2026 topline readout from the DENALI Phase 2 trial, which is designed to support a potential accelerated approval pathway, pending data outcomes and U.S. FDA feedback. Additionally, Zentalis recently announced dosing of the first patient in the ASPENOVA Phase 3 confirmatory trial in Cyclin E1-positive PROC, which is designed to support conversion from accelerated to full approval, as well as potential ex-U.S. registrations. About Azenosertib Azenosertib is an investigational, potentially first-in-class, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated in clinical studies in ovarian cancer and additional tumor types. WEE1 acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent replication of cells with damaged DNA. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death. Azenosertib is in late-stage development as a potential treatment for Cyclin E1-positive platinum-resistant ovarian cancer (PROC). There is currently no approved treatment option specifically for this biomarker-selected population which comprises approximately 50% of PROC patients. Cyclin E1 protein overexpression has been established as a sensitive and specific predictive biomarker for identifying patients who could potentially derive benefit from azenosertib treatment, based on retrospective analysis of azenosertib studies in PROC. Validation of the Cyclin E1 companion diagnostic assay is ongoing in the DENALI and ASPENOVA trials. Azenosertib has been granted Fast Track Designation by the U.S. FDA for the treatment of patients with Cyclin E1-positive platinum-resistant ovarian cancer. Fast Track Designation is intended to facilitate the development and expedite the review of therapies that have the potential to treat serious conditions and address unmet medical needs. About Zentalis Pharmaceuticals Zentalis is a clinical oncology innovator developing a treatment approach for ovarian cancer and multiple tumor types. Leveraging therapeutics development and biomarker expertise, Zentalis is advancing monotherapy and combination studies of its investigational first-in-class WEE1 inhibitor, azenosertib. Focused on translating WEE1 science into clinical practice, we aim to equip physicians with a targeted, non-chemo, orally available medicine that enhances treatment experience, choice, and outcomes. Our mission: to unburden cancer patients with more convenience and care. For more information, please visit . Follow Zentalis on LinkedIn at . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the continued development of azenosertib; the clinical and therapeutic potential of azenosertib as a monotherapy and as a combination agent; the potential for azenosertib to be first-in-class; the potential benefits of azenosertib across multiple lines of ovarian cancer and other tumor types; the combinability of azenosertib with other agents and the potential benefits thereof; the broad franchise potential of azenosertib; the Company’s biomarker-driven strategy for azenosertib; the potential regulatory approval and commercialization of azenosertib; the Company’s anticipated milestones and the timing thereof, including the anticipated timing of the topline readout from DENALI Part 2; the Company’s launch readiness and long-term growth; and the building of the Company’s the strategic and commercial infrastructure. The terms “achieve,” “anticipate,” “advance,” “build,” “design,” “develop,” “expect,” “focus,” “growth,” “look forward,” “potential,” “strategy,” “strengthen,” “support,” “target,” and “will” and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history, which may make it difficult to evaluate our current business and predict our future success and viability; we have and expect to continue to incur significant losses; our need for additional funding, which may not be available; our substantial dependence on the success of azenosertib; our plans, including the costs thereof, of development of companion diagnostics; the outcome of preclinical testing and early trials may not be predictive of the success of later clinical trials; potential unforeseen events during clinical trials could cause delays or other adverse consequences; risks relating to the regulatory approval process or ongoing regulatory obligations; our product candidates may cause serious adverse side effects; the interim, initial, “topline,” and preliminary data from our clinical trials may change as more patient data becomes available, and are subject to audit and verification procedures that could result in material changes in the final data; our reliance on third parties; effects of significant competition; the possibility of system failures or security breaches; risks relating to intellectual property; our ability to attract, retain and motivate qualified personnel, and risks relating to management transitions; significant costs as a result of operating as a public company; and the other important factors discussed under the caption “Risk Factors” in our most recently filed periodic report on Form 10-K or 10-Q and subsequent filings with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. ZENTALIS ® and its associated logo are trademarks of Zentalis and/or its affiliates. All website addresses and other links in this press release are for information only and are not intended to be an active link or to incorporate any website or other information into this press release. Contact: Aron Feingold VP, Investor Relations & Corporate Communications ir@zentalis.com