YolTech Therapeutics
YolTech Therapeutics has raised $45M in Series B funding to advance its in vivo CRISPR therapies. Lead candidate YOLT-101, for familial hypercholesterolemia, shows strong LDL-C reduction in early trials, with a Phase 3 study on the horizon—a milestone for Chinese gene editing.
BNT327
At WCLC 2025, pumitamig (BioNTech/BMS) demonstrated 76% ORR and 100% disease control in ES-SCLC, outperforming current PD-L1 monotherapies. The bispecific antibody combines checkpoint blockade and anti-angiogenesis for enhanced efficacy.
Pacibekitug
Novartis acquired Tourmaline Bio for $1.4B, gaining pacibekitug (TOUR006), a Phase 3-ready anti-IL-6 IgG2 mAb. Discovered via Pfizer and Medarex’s UltiMAb® platform, it shows up to 86% hs-CRP reduction and targets residual inflammatory risk in ASCVD.
SHR-8068
Hengrui’s CTLA-4 antibody SHR‑8068, licensed from CStone in a 1.3B RMB deal, is now in Phase III trials for lung cancer, competing in a space dominated globally by ipilimumab and tremelimumab. Innovent’s IBI310 is under review.
HLX17
hanghai Fosun Pharmaceutical is making strides in oncology with FDA approval for phase 1 trials of HLX17, a PD-1 biosimilar, and NMPA approval for phase 3 trials of SAF-189, an ALK/ROS1 inhibitor.
IDE849
IDEAYA and Hengrui’s IDE849 (SHR-4849) showed strong Phase 1 efficacy and manageable safety in relapsed/refractory SCLC at WCLC 2025. This report covers trial outcomes, CNS activity, dosing, licensing, regulatory status, and the DLL3 competitive landscape.
CN-Only
在西班牙巴塞罗那召开的2025年世界肺癌大会（WCLC）上，贝达药业公布了MCLA-129的最新1期研究结果。这是一款同时靶向EGFR和c-MET的双特异性抗体。由中国医学科学院肿瘤医院王洁教授牵头的研究入选Poster Tour，并首次披露了无进展生存期（PFS）和总生存期（OS）数据。 研究设计 本研究为中国首次人体试验，入组对象为携带以下突变的晚期**非小细胞肺癌（NSCLC）**患者： * MET外显子14跳跃突变（队列A） * EGFR外显子20插入突变（队列B） * EGFR非外显子20突变（队列C） 患者接受MCLA-129静脉输注（1500 mg或2000 mg，每两周一次）。研究I期的主要终点为安全性和耐受性，次要终点包括客观缓解率（ORR）、PFS和OS。 关键结果 * 入组情况： 共263例患者（其中260例为NSCLC）。 * 安全性： 最常见治疗相关不良事件为输液反应（71.1%）、低白蛋白血症（57.0%）、中性粒细胞减少（46.8%）、白细胞减少（41.8%
Iza-Bren
Iza-Bren (BL-B01D1) is a bispecific EGFR/HER3 ADC for EGFR-mutated NSCLC. At IASLC WCLC 2025, Phase II combo with osimertinib showed 100% ORR and 92% 12-mo PFS; monotherapy in pretreated patients had 66% ORR and 80% 12-mo OS, with manageable safety.
Ivonescimab
Summit Therapeutics’ Ivonescimab demonstrates statistically significant PFS improvement in the global HARMONi trial. OS did not meet the pre-specified threshold in the primary analysis, but longer follow-up in Western patients shows a nominal supportive trend for regulatory review.
DB-1303
DB-1303 (BNT323) achieved a positive Phase III readout in HER2-positive breast cancer, reinforcing DualityBio’s ADC platform and BioNTech’s oncology expansion beyond immunotherapy. The trial shows potential for global commercialization, including a planned China BLA filing.
HRS-1893
Hengrui’s HRS-1893, out-licensed to Braveheart Bio, enters the global oHCM race with aficamten and mavacamten. ESC 2025 Phase I showed safety and PK; Phase III (NCT07021976) is ongoing. This review covers HRS-1893 chemical structure, patents, preclinical PK, and trial data.
Aficamten vs Mavacamten
From discovery to clinical development, aficamten outperforms mavacamten in PK, safety, and therapeutic margin. SEQUOIA-HCM, MAPLE-HCM, and ongoing ACACIA-HCM highlight its potential in obstructive and non-obstructive HCM.