Atezolizumab/Hyaluronidase-tqjs

Halozyme Therapeutics said Friday that it has pulled its proposal to buy Evotec, a struggling German biotech that Halozyme said was “unwilling to engage” in deal talks. Last week, San Diego-based Halozyme said it wanted to buy Evotec for €11.00 per share in cash, which would give it an equity value of €2 billion ($2.1 billion). At the time, the announcement boosted Evotec’s shares, which have lost most of their value since a 2021 peak. “We continue to believe that a combination of Halozyme and Evotec would create a leading, differentiated, global pharma services company, benefiting shareholders, patients and employees,” Halozyme CEO Helen Torley said in a statement. “However, to date, Evotec has been unwilling to engage with us to explore a potential combination and a company spokesperson has publicly commented that its goal is to remain an independent company.” Evotec’s shares dropped about 19% and Halozyme’s rose more than 3% Friday after the update. Halozyme makes drug delivery technology and has helped turn big-name medicines into subcutaneous formulations, including Roche’s Tecentriq Hybreza, Bristol Myers Squibb’s Opdivo and argenx’s Vyvgart Hytrulo. Evotec has more than 140 partnered assets, according to Jefferies analysts. Its manufacturing unit, Just – Evotec Biologics, has lined up partnerships with biosimilars company Sandoz and the US Department of Defense. Evotec has about 10 times as many employees as Halozyme, according to headcount figures from Leerink Partners analysts. Halozyme said it conducted “extensive external diligence” in the months prior to its proposal and wanted to engage with Evotec. They had informal discussions with a supervisory board member but said its multiple requests to meet with Evotec’s supervisory board chair were “not accepted.” So instead it went to Evotec’s CEO, Halozyme said. “It has now become evident that there is no interest at this time on the part of Evotec’s Supervisory and Management Boards to engage constructively with Halozyme and explore a potential transaction.” An Evotec spokesperson didn’t immediately respond to an Endpoints News inquiry. Earlier this month, Bloomberg News reported that private equity firm Triton Partners boosted its stake in Evotec to 9.9% and was reportedly considering a takeover bid, according to anonymous sources. Novo Holdings and Mubadala Investment are Evotec’s other major shareholders. Evotec has had a bumpy year. Its new CEO, Christian Wojczewski, said in August that 2024 did not meet expectations. During 2024, the company changed CEOs, shuttered its gene therapy unit, sold an API manufacturing plant, closed facilities in Austria, France and Germany, and let go of hundreds of employees. That all came on top of a cyberattack last year.

Keytruda（K药）作为默克公司的重磅产品在疗效和销售额方面一枝独秀，但是在皮下注射的开发方面落后于其它检查点抑制剂竞争对手。但是在11月19日，默克宣布Keynote-D77试验的积极初步结果使得K药皮下给药制剂向市场迈进了一步。虽然目前还没有详细的结果披露，但默克公司表示，皮下注射的Keytruda在药代动力学终点上显示出与批准的静脉注射版本非劣效性。公司计划在即将举行的会议上展示这些数据，并与监管机构共享，并且预计该试验将支持所有实体瘤适应症。MK-3475A，即皮下注射Keytruda的代号，是默克公司的第二次尝试；在MK-3475A之前，默克公司还开发了不含透明质酸酶的皮下给药制剂，并且其研究也已经进入临床Ⅲ期（MK-3475-A86），其主要研究K药皮下给药与化疗联用，对比静脉给药与化疗联用在一线鳞状和非鳞状NSCLC中的疗效。 罗氏公司在皮下注射Tecentriq方面领先，该药物已于9月获得FDA批准，FDA批准Tecentriq Hybreza ™（阿替利珠单抗和透明质酸酶-TQJS）皮下（SC）注射，用于静脉注射阿替利珠单抗（Tecentriq ™）的所有获批适应症，包括非小细胞肺癌（NSCLC）、小细胞肺癌、肝细胞癌、黑色素瘤、肺泡软组织肉瘤。 Tecentriq皮下制剂的获批基于IMscin001临床研究结果，皮下给药 和静脉注暴露量相当。客观缓解率（ORR）和无进展生存期（PFS）方面，皮下制剂与静脉输注组的疗效相似，并且与静脉输注剂型的已知情况一致：皮下注射和静脉输注组的中位PFS分别为2.8个月和2.9个月，两者的ORR分别为11.8％和9.7％。皮下制剂的安全性也与静脉输注剂型一致。 另外，BMS正在等待12月美国对皮下注射Opdivo的决策。今年5月BMS宣布FDA已经重新调整了Opdivo皮下注射制剂的生物制品许可申请（BLA）PDUFA日期，并提前到2024年12月29日（此前为2025年2月28日），其上市申请主要是基于一项随机开放标签的III期CheckMate-67T研究（N=495）数据。 该研究旨在评估皮下注射对比静脉输注纳武利尤单抗在既往接受过全身治疗的晚期或转移性透明细胞肾细胞癌（ccRCC）患者中的疗效。结果显示与静脉输注纳武利尤单抗相比，皮下注射Opdivo在28天内平均血清浓度（Cavgd28）和稳态血清低谷浓度（Cminss）指标上均表现出非劣 效性 ，达到共同主要终点，几何平均比值分别为2.098（90% Cl: 2.001-2.200）、1.774 (90% CI: 1.633-1.927)。关键次要终点客观缓解率（ORR）也显示出非劣效性，皮下注射纳武利尤单抗组患者ORR为24.2%，而静脉输注组患者的ORR为18.2%(RR=1.33；95% CI: 0.94-1.87)，显示出非劣效性；皮下注射纳武利尤单抗组患者PFS为7.23个月，而后者该数值为5.65个月。 与此同时，辉瑞的sasanlimab预计将在2025年上半年从Crest试验中获得数据，而阿斯利康已经退出了竞争。默克公司最近开始了Keynote-F65研究，研究皮下注射Keytruda在淋巴瘤中的应用，同时公司也在进行Keynote-F84试验，测试皮下注射与静脉注射Keytruda单药治疗一线NSCLC患者中高PD-L1表达的情况。 在国内，免疫检查点相关药物皮下给药竞争也非常激烈，康宁杰瑞的PD-L1皮下给药已经获批上市，君实，百济，恒瑞等相关皮下给药也在临床开发中。 药渡媒体商务合作 媒体公关 | 新闻&会议发稿 张经理：18600036371（微信同号） 点击下方“药渡“，关注更多精彩内容 免责声明 “药渡”公众号所转载该篇文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请及时告知，我们会在24小时内删除相关信息。 微信公众号的推送规则又双叒叕改啦，如果您不点个“在看”或者没设为"星标"，我们可能就消散在茫茫文海之中~点这里，千万不要错过药渡的最新消息哦！👇👇👇