<p>歡迎來到 <em>Pharmaceutical Executive Daily</em>，這是您快速瞭解製藥和生命科學行業最新動態的簡報。</p>
<p>在今天的 <em>Pharmaceutical Executive Daily</em> 中，Cellenkos 宣佈其 CK0802 的研究性新藥申請獲得 FDA 批准，這將啓動其首個針對類固醇耐藥性移植物抗宿主病的 1b/2a 階段臨牀試驗；BioNTech 發佈了 2026 年第一季度財務結果，顯示 Covid-19 疫苗收入持續下降，同時在腫瘤學領域的投資加速；Peter Harbin 認為生物製藥行業長期以來基於銷售目標的衰退模型亟需進行根本性的重新思考。</p>
<p>Cellenkos 已獲得其研究性新藥申請，以啓動 CK0802 的 1b/2a 臨牀試驗，這是一種首創的即用型異體調節性 T 細胞療法，適用於類固醇耐藥性移植物抗宿主病患者。CK0802 的 Treg 細胞經過工程設計，以保持細胞的初始狀態，從而實現快速的體內增殖和針對性抑制驅動疾病的失調炎症，計劃於 2026 年下半年開始多中心開放標籤試驗，預計在 2027 年初獲得臨牀結果。</p>
<p>BioNTech 2026 年的收入為 1.38 億美元，較去年同期的 2.138 億美元下降，下降主要是由於 Covid-19 疫苗銷售減少，淨虧損為 6.223 億美元，因為公司在腫瘤學和抗體藥物偶聯物項目上的研發支出持續增加。研發費用上升至 6.516 億美元，主要是由於推進主要腫瘤資產 pumitamig 和 gotistobart，BioNTech 在本季度啓動了五項針對 pumitamig 的新關鍵試驗，涵蓋三陰性乳腺癌、微衞星穩定性結直腸癌、胃癌和兩個非小細胞肺癌的適應症。</p>
<p>最後，Peter Harbin 認為，基於歷史處方量對醫生目標進行細分和優先排序的幾十年做法，已經不再適合作為生物製藥行業主要的銷售目標模型。Harbin 認為該模型根本上是向後看的，衡量的是上個季度誰開處方最多，而不是誰最有可能在下個季度推動增長，靜態細分使每個競爭對手都朝着相同的高分位醫生靠攏，而有意義的機會則變得不可見。他估計，約 40% 的潛在處方機會在基於分位數的模型中低於可見性閾值。他呼籲轉向動態評分模型，結合實時行為信號、患者羣體數據和促銷響應，以及歷史量，認為正確的目標不僅是提高現場效率，更是每個下游商業決策的基礎。</p>
<p>感謝您收聽 <em>Pharmaceutical Executive Daily</em>。欲獲取更多更新和深入分析，請訪問 PharmExec.com。</p>

BNTX

標普生物技術 3 倍做多 - Direxion

<p>在今天的《製藥執行日報》中，Cellenkos 宣佈其 CK0802 獲得 FDA 批准，這是一種用於類固醇難治性移植物抗宿主病的調節性 T 細胞療法，計劃於 2026 年底進行 1b/2a 期臨牀試驗。BioNTech 報告 2026 年第一季度收入為 1.38 億美元，較 2.138 億美元下降，因 Covid-19 疫苗銷售下降和腫瘤學研發支出增加，淨虧損為 6.223 億美元。Peter Harbin 批評生物製藥行業中過時的基於遞減的銷售目標模型，提倡使用動態評分模型以更好地識別增長機會</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>歡迎來到 <em>Pharmaceutical Executive Daily</em>，這是您快速瞭解製藥和生命科學行業最新動態的簡報。</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 宣佈其 CK0802 的研究性新藥申請獲得 FDA 批准，這將啓動其首個針對類固醇耐藥性移植物抗宿主病的 1b/2a 階段臨牀試驗；BioNTech 發佈了 2026 年第一季度財務結果，顯示 Covid-19 疫苗收入持續下降，同時在腫瘤學領域的投資加速；Peter Harbin 認為生物製藥行業長期以來基於銷售目標的衰退模型亟需進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 已獲得其研究性新藥申請，以啓動 CK0802 的 1b/2a 臨牀試驗，這是一種首創的即用型異體調節性 T 細胞療法，適用於類固醇耐藥性移植物抗宿主病患者。CK0802 的 Treg 細胞經過工程設計，以保持細胞的初始狀態，從而實現快速的體內增殖和針對性抑制驅動疾病的失調炎症，計劃於 2026 年下半年開始多中心開放標籤試驗，預計在 2027 年初獲得臨牀結果。</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 年的收入為 1.38 億美元，較去年同期的 2.138 億美元下降，下降主要是由於 Covid-19 疫苗銷售減少，淨虧損為 6.223 億美元，因為公司在腫瘤學和抗體藥物偶聯物項目上的研發支出持續增加。研發費用上升至 6.516 億美元，主要是由於推進主要腫瘤資產 pumitamig 和 gotistobart，BioNTech 在本季度啓動了五項針對 pumitamig 的新關鍵試驗，涵蓋三陰性乳腺癌、微衞星穩定性結直腸癌、胃癌和兩個非小細胞肺癌的適應症。</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>最後，Peter Harbin 認為，基於歷史處方量對醫生目標進行細分和優先排序的幾十年做法，已經不再適合作為生物製藥行業主要的銷售目標模型。Harbin 認為該模型根本上是向後看的，衡量的是上個季度誰開處方最多，而不是誰最有可能在下個季度推動增長，靜態細分使每個競爭對手都朝着相同的高分位醫生靠攏，而有意義的機會則變得不可見。他估計，約 40% 的潛在處方機會在基於分位數的模型中低於可見性閾值。他呼籲轉向動態評分模型，結合實時行為信號、患者羣體數據和促銷響應，以及歷史量，認為正確的目標不僅是提高現場效率，更是每個下游商業決策的基礎。</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>感謝您收聽 <em>Pharmaceutical Executive Daily</em>。欲獲取更多更新和深入分析，請訪問 PharmExec.com。</p>
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製藥高管日報：BioNTech SE 公佈 2026 年第一季度財報