Ivonescimab

iStock, U. J. Alexander BNT327, a PD-L1/VEGF therapy, is still currently being manufactured in China, but BioNTech is working to establish a diversified supply chain, executives said during the company’s Q1 investor call. BioNTech has big plans for the investigational PD-L1/VEGF therapy BNT327, which is being tested in a sprawling Phase III program for a variety of cancer types. There’s just one problem: President Donald Trump’s escalating trade war—particularly his targeted tariffs on China. “Manufacturing is currently supplied [from] China,” Chief Strategic Officer Ryan Richardson said during a first quarter earnings call Monday, adding that BioNTech is “reliant on a China-based CDMO.” Richardson was quick to allay investors’ concerns, however, saying on the call that BioNTech is currently “diversifying our supply base and our plans over the next couple of years are to establish multiple supply nodes, including outside of China.” The company has acquired multiple assets from Chinese companies. BNT327 came to BioNTech when it bought Chinese partner Biotheus in late 2024 for about $950 million. Multiple antibody-drug conjugates in the biotech’s pipeline also came from Shanghai-based DualityBio for $1.5 billion in biobucks . BioNTech CFO Jens Holstein said that tariffs could affect BioNTech’s vaccine business. “Potential changes in law or government policy, including tariffs and public health policy, and evolving public sentiment around vaccines and mRNA technology worldwide could further negatively impact our anticipated COVID 19 vaccine revenues and expenses,” he said. Richardson continued to downplay concerns, however. “We have the ability to produce [Comirnaty, BioNTech’s mRNA-based COVID 19 vaccine] in the United States. We also have the ability to produce it in Europe.” BNT327 is part of an emerging and closely watched class of cancer therapies addressing two of the most widely targeted pathways in cancer: PD-1, which allows malignant cells to suppress and evade the immune system, and VEGF, which tumors use to create new vasculature to supply nutrients and oxygen. Uniquely, however, BNT327 targets the PD-L1 ligand, as opposed to the PD-1 receptor, which the current VEGF bispecific frontrunner ivonescimab—developed by Summit Therapeutics and Chinese partner Akeso—targets. Investors questioned BNT327’s particular binding target on the call, noting that anti-PD-L1 antibodies have typically underperformed in the clinic. In response, Chief Medical Officer Özlem Türeci pointed out that BioNTech “deliberately” chose to target PD-L1 over PD-1, because the ligand “might be superior” to the receptor “in anchoring [BNT327] in the tumor microenvironment, where we want to have the bispecific.” BioNTech plans to move rapidly with BNT327, according to its investor presentation on Monday. The company is currently running several mid-stage trials in solid tumors, including the Phase II ROSETTA Lung-01 study in small cell lung cancer and the Phase II/III ROSETTA Lung-02 study in non-small cell lung cancer. Seeking to carve a different niche from Summit and Akeso’s ivonescimab, BioNTech is planning to develop BNT327 into novel cancer types, “a couple of those where we think [we’ll be] positioned, if we can execute well, to be potentially first-to-market,” Richardson said on the call. These include triple-negative breast cancer and small cell lung cancer. Further down the line, BioNTech is also looking to combine BNT327 with other anti-cancer agents, including antibody-drug conjugates. “And there we think we have a differentiated strategy by virtue of our broad pipeline . . . that we have in-house that could be combined with [BNT327],” Richardson added. In the first quarter of 2025, BioNTech made €182.8 million (approximately $207 million), representing a €415.8 million, or nearly $472 million, net loss. During the same period last year, BioNTech lost €315.1 million (around $357 million). Looking ahead to the rest of the year, BioNTech reiterated its 2025 revenue guidance despite continued macro-level pressures. The company anticipates bringing in between €1.7 billion and €2.2 billion (approximately $1.7 billion to $2.5 billion) this year, while R&D expenditure is projected to hit €2.6 billion to €2.8 billion, or roughly $2.95 billion to $3.18 billion.

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。NMPA发布2025年04月25日药品批准证明文件送达信息，本批次共有104个受理号获批，多款重磅新药新适应症获准上市，其中：奥赛康药业的利厄替尼片新适应症获批上市，用于具有表皮生长因子受体（EGFR）外显子 19 缺失（19DEL）或外显子 21置换突变（L858R）的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的一线治疗。利厄替尼是一款口服的第三代 EGFR-TKI，于 2025 年 1 月首次在国内获批上市，用于既往经 EGFR TKI 治疗时或治疗后出现疾病进展，并且经检测确认存在 EGFR T790M突变阳性的局部晚期或转移性 NSCLC 成人患者的治疗。2024 年 9 月 30 日，奥赛康与信达就利厄替尼达成独家商业化合作。信达取得合作产品在中国大陆地区的独家推广销售权，将按合作协议约定向奥赛康支付首付款、注册里程碑和销售里程碑款项。诺诚健华的奥布替尼片新适应症获批上市，一线治疗慢性淋巴细胞白血病（CLL）/小淋巴细胞淋巴瘤 （SLL）。奥布替尼是诺诚健华研发的一款不可逆布鲁顿酪氨酸激酶（BTK）抑制剂，可用于治疗淋巴瘤及自身免疫性疾病。2020年12月，奥布替尼在中国获批用于治疗复发/难治慢性淋巴细胞白血病（CLL）/小淋巴细胞淋巴瘤（SLL）、以及复发/难治性套细胞淋巴瘤（MCL）两项适应症。2023年4月，奥布替尼获批用于既往至少接受过一次治疗的边缘区淋巴瘤（MZL）患者。康方生物的依沃西单抗注射液新适应症获批上市，单药用于 PD-L1 表达阳性（PD-L1 TPS≥1%）的局部晚期或转移性非小细胞肺癌（NSCLC）的一线治疗依沃西单抗是一款 PD-1/VEGF 双特异性抗体，2024 年 5 月，依沃西单抗首次获批上市，适应症为联合培美曲塞和卡铂用于经 EGFR-TKI 治疗后进展的 EGFR 基因突变阳性的局部晚期或转移性非鳞状 NSCLC 患者的二线治疗。君实生物的特瑞普利单抗注射液新适应症获批上市，用于不可切除或转移性黑色素瘤一线治疗。特瑞普利单抗作为我国批准上市的首个国产 PD-1 单抗，已在国内获批 12 项适应症，包括黑色素瘤、鼻咽癌、尿路上皮癌/膀胱癌、食管鳞癌、非鳞状非小细胞肺癌、非小细胞肺癌、肾细胞癌、小细胞肺癌、三阴性乳腺癌、肝癌等适应症。锐康迪医药（Recordati集团中国全资子公司）申报的注射用双羟萘酸帕瑞肽微球获批上市，用于治疗无法手术或手术后未治愈和通过另一种生长抑素类似物治疗控制不佳的成人肢端肥大症患者。双羟萘酸帕瑞肽为第二代生长抑素类似物（SRL），生长抑素正是GH分泌的生理抑制剂。此前，双羟萘酸帕瑞肽已获得欧洲药品管理局（EMA）和美国FDA批准治疗成人肢端肥大症患者。辉瑞的阿昔替尼片新适应症获批上市，具体适应症尚未披露。公开资料显示，阿昔替尼是一种口服的，作用于血管内皮生长因子受体1，2和3的强效和高选择性酪氨酸激酶抑制剂，通过抑制血管内皮生长因子受体信号系统，全面阻止肿瘤进展。该产品最初于2012年获美国FDA批准上市，于2015年在中国获批，首个适应症为治疗既往接受过一种酪氨酸激酶抑制剂或细胞因子治疗失败的进展期肾细胞癌(RCC)的成人患者。阿斯利康的马来酸阿可替尼片新适应症获批上市，具体适应症尚未披露。阿可替尼是阿斯利康自主研发的第二代选择性BTK抑制剂。2024年11月，阿可替尼片剂剂型首次在中国获批，用于治疗既往至少接受过一种治疗的成人套细胞淋巴瘤（MCL）患者。强生的埃万妥单抗注射液新适应症获批上市，与卡铂和培美曲塞联合给药，适用于治疗携带表皮生长因子受体（EGFR）19号外显子缺失或21号外显子L858R置换突变且在EGFR酪氨酸激酶抑制剂治疗期间或之后疾病进展的局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）成人患者。埃万妥单抗是一款全人源双特异性抗体，同时针对EGFR和MET两个靶点。这是埃万妥单抗今年在中国获批的第二个肺癌适应症，此前，埃万妥单抗已于今年2月获批用于治疗携带EGFR 20号外显子插入突变的局部晚期或转移性非小细胞肺癌成人患者的一线治疗。完整批件信息如下：