<p>欢迎来到 <em>Pharmaceutical Executive Daily</em>，这是您快速了解制药和生命科学行业最新动态的简报。</p>
<p>在今天的 <em>Pharmaceutical Executive Daily</em> 中，Cellenkos 宣布其 CK0802 的研究性新药申请获得 FDA 批准，这将启动其首个针对类固醇耐药性移植物抗宿主病的 1b/2a 阶段临床试验；BioNTech 发布了 2026 年第一季度财务结果，显示 Covid-19 疫苗收入持续下降，同时在肿瘤学领域的投资加速；Peter Harbin 认为生物制药行业长期以来基于销售目标的衰退模型亟需进行根本性的重新思考。</p>
<p>Cellenkos 已获得其研究性新药申请，以启动 CK0802 的 1b/2a 临床试验，这是一种首创的即用型异体调节性 T 细胞疗法，适用于类固醇耐药性移植物抗宿主病患者。CK0802 的 Treg 细胞经过工程设计，以保持细胞的初始状态，从而实现快速的体内增殖和针对性抑制驱动疾病的失调炎症，计划于 2026 年下半年开始多中心开放标签试验，预计在 2027 年初获得临床结果。</p>
<p>BioNTech 2026 年的收入为 1.38 亿美元，较去年同期的 2.138 亿美元下降，下降主要是由于 Covid-19 疫苗销售减少，净亏损为 6.223 亿美元，因为公司在肿瘤学和抗体药物偶联物项目上的研发支出持续增加。研发费用上升至 6.516 亿美元，主要是由于推进主要肿瘤资产 pumitamig 和 gotistobart，BioNTech 在本季度启动了五项针对 pumitamig 的新关键试验，涵盖三阴性乳腺癌、微卫星稳定性结直肠癌、胃癌和两个非小细胞肺癌的适应症。</p>
<p>最后，Peter Harbin 认为，基于历史处方量对医生目标进行细分和优先排序的几十年做法，已经不再适合作为生物制药行业主要的销售目标模型。Harbin 认为该模型根本上是向后看的，衡量的是上个季度谁开处方最多，而不是谁最有可能在下个季度推动增长，静态细分使每个竞争对手都朝着相同的高分位医生靠拢，而有意义的机会则变得不可见。他估计，约 40% 的潜在处方机会在基于分位数的模型中低于可见性阈值。他呼吁转向动态评分模型，结合实时行为信号、患者群体数据和促销响应，以及历史量，认为正确的目标不仅是提高现场效率，更是每个下游商业决策的基础。</p>
<p>感谢您收听 <em>Pharmaceutical Executive Daily</em>。欲获取更多更新和深入分析，请访问 PharmExec.com。</p>

BNTX

标普生物技术 3 倍做多 - Direxion

<p>在今天的《制药执行日报》中，Cellenkos 宣布其 CK0802 获得 FDA 批准，这是一种用于类固醇难治性移植物抗宿主病的调节性 T 细胞疗法，计划于 2026 年底进行 1b/2a 期临床试验。BioNTech 报告 2026 年第一季度收入为 1.38 亿美元，较 2.138 亿美元下降，因 Covid-19 疫苗销售下降和肿瘤学研发支出增加，净亏损为 6.223 亿美元。Peter Harbin 批评生物制药行业中过时的基于递减的销售目标模型，提倡使用动态评分模型以更好地识别增长机会</p>

<p>Welcome to <em>Pharmaceutical Executive Daily</em>, your quick briefing on the top news shaping the pharmaceutical and life sciences industry.</p>
<div class="lb-trans"><p>欢迎来到 <em>Pharmaceutical Executive Daily</em>，这是您快速了解制药和生命科学行业最新动态的简报。</p>
</div><p>In today's <em>Pharmaceutical Executive Daily</em>, Cellenkos announces FDA clearance of its investigational new drug application for CK0802, enabling a Phase 1b/2a trial of its first-in-class regulatory T cell therapy in steroid-refractory graft-versus-host disease, BioNTech releases its first quarter 2026 financial results showing a continued decline in Covid-19 vaccine revenues alongside accelerating investment in oncology, and Peter Harbin argues that biopharma's longstanding deciling-based sales targeting model is overdue for a fundamental rethink.</p>
<div class="lb-trans"><p>在今天的 <em>Pharmaceutical Executive Daily</em> 中，Cellenkos 宣布其 CK0802 的研究性新药申请获得 FDA 批准，这将启动其首个针对类固醇耐药性移植物抗宿主病的 1b/2a 阶段临床试验；BioNTech 发布了 2026 年第一季度财务结果，显示 Covid-19 疫苗收入持续下降，同时在肿瘤学领域的投资加速；Peter Harbin 认为生物制药行业长期以来基于销售目标的衰退模型亟需进行根本性的重新思考。</p>
</div><p>Cellenkos has received of its investigational new drug application to initiate a Phase 1b/2a clinical trial of CK0802, a first-in-class, off-the-shelf allogeneic regulatory T cell therapy, in patients with steroid-refractory graft-versus-host disease. CK0802's Treg cells are engineered to preserve cellular naivety, enabling rapid in vivo proliferation and targeted suppression of the dysregulated inflammation driving the disease, and the multicenter, open-label trial is scheduled to commence in the second half of 2026 with a clinical readout expected in early 2027.</p>
<div class="lb-trans"><p>Cellenkos 已获得其研究性新药申请，以启动 CK0802 的 1b/2a 临床试验，这是一种首创的即用型异体调节性 T 细胞疗法，适用于类固醇耐药性移植物抗宿主病患者。CK0802 的 Treg 细胞经过工程设计，以保持细胞的初始状态，从而实现快速的体内增殖和针对性抑制驱动疾病的失调炎症，计划于 2026 年下半年开始多中心开放标签试验，预计在 2027 年初获得临床结果。</p>
</div><p>BioNTech 2026 revenues of $138 million, down from $213.8 million in the prior year period, with the decline driven primarily by lower Covid-19 vaccine sales, and posted a net loss of $622.3 million as the company's research and development spending continued to climb on the back of accelerating investment in oncology and antibody-drug conjugate programs. R&amp;D expenses rose to $651.6 million, driven by advancing lead oncology assets pumitamig and gotistobart, and BioNTech initiated five new pivotal trials for pumitamig across triple-negative breast cancer, microsatellite-stable colorectal cancer, gastric cancer, and two non-small cell lung cancer settings during the quarter..</p>
<div class="lb-trans"><p>BioNTech 2026 年的收入为 1.38 亿美元，较去年同期的 2.138 亿美元下降，下降主要是由于 Covid-19 疫苗销售减少，净亏损为 6.223 亿美元，因为公司在肿瘤学和抗体药物偶联物项目上的研发支出持续增加。研发费用上升至 6.516 亿美元，主要是由于推进主要肿瘤资产 pumitamig 和 gotistobart，BioNTech 在本季度启动了五项针对 pumitamig 的新关键试验，涵盖三阴性乳腺癌、微卫星稳定性结直肠癌、胃癌和两个非小细胞肺癌的适应症。</p>
</div><p>Finally, Peter Harbin makes the case that the decades-old practice of segmenting and prioritizing physician targets based on historical prescribing volume, has outlived its usefulness as biopharma's primary sales force targeting model. Harbin contends that the model is fundamentally backward-looking, measuring who prescribed the most last quarter rather than who is most likely to drive growth next quarter, and that static segmentation drives every competitor toward the same high-decile physicians while leaving meaningful opportunity invisible. By his estimate, roughly 40% of potential prescribing opportunity falls below the threshold of visibility in a decile-driven model. He calls for a shift to dynamic scoring models that incorporate real-time behavioral signals, patient population data, and promotional responsiveness alongside historical volume, arguing that getting the targeting right is not just a field efficiency improvement but the foundation on which every downstream commercial decision has to stand.</p>
<div class="lb-trans"><p>最后，Peter Harbin 认为，基于历史处方量对医生目标进行细分和优先排序的几十年做法，已经不再适合作为生物制药行业主要的销售目标模型。Harbin 认为该模型根本上是向后看的，衡量的是上个季度谁开处方最多，而不是谁最有可能在下个季度推动增长，静态细分使每个竞争对手都朝着相同的高分位医生靠拢，而有意义的机会则变得不可见。他估计，约 40% 的潜在处方机会在基于分位数的模型中低于可见性阈值。他呼吁转向动态评分模型，结合实时行为信号、患者群体数据和促销响应，以及历史量，认为正确的目标不仅是提高现场效率，更是每个下游商业决策的基础。</p>
</div><p>Thanks for listening to <em>Pharmaceutical Executive Daily</em>. For more updates and in-depth analysis, visit PharmExec.com.</p>
<div class="lb-trans"><p>感谢您收听 <em>Pharmaceutical Executive Daily</em>。欲获取更多更新和深入分析，请访问 PharmExec.com。</p>
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制药高管日报：BioNTech SE 公布 2026 年第一季度财报