Register Now: From Clinical to Commercial: Accelerating ADC Late-Stage Development with Technology Innovation and Integrated Platform
News|Podcasts|August 13, 2026 (Updated: August 13, 2026)

The BioPharm Brief: Approval, Investment, and Antibodies

Listen
0:00 / 0:00

Today’s BioPharm Brief covers NMPA approval of ivonescimab plus chemotherapy for first-line squamous NSCLC, a $175 million financing for Silence Therapeutics, and Infinimmune’s $75 million Series A for its human-derived antibody pipeline.

Welcome to The BioPharm Brief, your daily snapshot of developments shaping the biopharmaceutical industry.

We’ll start with a significant regulatory milestone in oncology.

China’s National Medical Products Administration has approved ivonescimab in combination with chemotherapy for first-line treatment of advanced squamous non-small cell lung cancer, based on results from the phase 3 HARMONi-6 trial. The bispecific antibody targets both PD-1 and VEGF, combining immune checkpoint inhibition and anti-angiogenic activity in a single molecule. The 532-patient study showed a 34% reduction in the risk of death compared with tislelizumab plus chemotherapy and, most notably, demonstrated superiority over an established PD-1-based regimen in a phase 3 head-to-head trial.

Next, Silence Therapeutics is raising $175 million through a public offering to support its siRNA pipeline and broader development activities. The company’s pipeline includes divesiran, its siRNA therapy targeting TMPRSS6, which recently generated positive phase 2 data in polycythemia vera. The financing gives Silence additional capital to advance that program and its broader RNAi platform.

And finally, Infinimmune has raised $75 million in a Series A financing to advance a pipeline of human-derived antibodies, including programs targeting atopic dermatitis. The company is developing antibodies derived from human immune responses, with the goal of identifying therapeutics against disease targets that may be difficult to address through conventional antibody discovery approaches.

And that’s where we’ll leave it for today.

Thanks for listening to The BioPharm Brief. For analysis and expert insights, please visit BioPharmInternational.com.

Key takeaways:

  • Ivonescimab plus chemotherapy received NMPA approval for first-line squamous NSCLC after demonstrating an overall survival benefit in phase 3.
  • Silence Therapeutics is raising $175 million to advance its siRNA pipeline.
  • Infinimmune secured $75 million to advance human-derived antibody programs, including candidates for atopic dermatitis.

Related to this article

The BioPharm Brief: An AI-Designed Multibody ADC Enters the Clinic, Blackstone Backs Pfizer’s Monthly GLP-1, and enGene Readies a Bladder Cancer BLA
FDA clears the IND for Biolojic Design’s BD200, an AI-designed Trop2/Nectin-4 multibody ADC; Blackstone Life Sciences agrees to provide Pfizer up to $1.5 billion to develop its monthly GLP-1 receptor agonist berobenatide; and enGene Therapeutics plans a year-end BLA for detalimogene voraplasmid in BCG-unresponsive non-muscle invasive bladder cancer.
The BioPharm Brief: FDA Designations for a Bispecific CAR-T, a BLA for Friedreich’s Ataxia, and Phase 2b MASH Data for Efinopegdutide
FDA grants RMAT and Fast Track designations to AbelZeta’s CD20/CD19 bispecific CAR-T prizlon-cel in relapsed or refractory large B-cell lymphoma, Larimar Therapeutics completes a BLA seeking accelerated approval of nomlabofusp for Friedreich’s ataxia, and Merck’s GLP-1/glucagon receptor agonist efinopegdutide meets its primary endpoint in a phase 2b MASH trial.
The BioPharm Brief: argenx Bets on Peptides, a Two-Bispecific Regimen in Prostate Cancer, and a New Take on T-Cell Engagers
argenx agrees to acquire macrocyclic peptide developer Unnatural Products for up to about $1.15 billion, Johnson & Johnson’s pasritamig and JNJ-9401 bispecific regimen achieves a 73% PSA response in phase 1 in metastatic castration-resistant prostate cancer, and Janux Therapeutics’ TRBV6-targeted T-cell engager JANX011 shows deep B-cell depletion in healthy volunteers.
The BioPharm Brief: A Bispecific Approval in Head and Neck Cancer, TCR Bispecifics Head to the Clinic, and a New Antibody Target in Essential Thrombocythemia
FDA grants accelerated approval to Johnson & Johnson’s subcutaneous EGFR/MET bispecific Rybrevant Faspro for previously treated head and neck squamous cell carcinoma, T-Therapeutics raises a $133 million Series B to take TCR-CD3 bispecifics into clinical trials, and Alethio Therapeutics raises a $90 million Series A to advance its first-in-class G6B antibody for essential thrombocythemia.
The BioPharm Brief: Ivonescimab Priority Review in China, Stargardt Gene Therapy Moves Toward Phase 3, and Longer Dosing Intervals for an IBD Bispecific
China’s NMPA grants priority review to Akeso’s PD-1/VEGF bispecific ivonescimab with chemotherapy for first-line biliary tract cancer, VeonGen Therapeutics aligns with FDA on a phase 3 design for its dual-AAV Stargardt gene therapy VG801, and Caldera Therapeutics’ IL-23p19×TL1A bispecific CLD-423 shows a half-life of more than 40 days in a phase 1a trial.
The BioPharm Brief: A $7 Billion Oncology Option Deal, a TL1A Pivot, and Oral Adalimumab Heads to the Clinic
Boehringer Ingelheim licenses six preclinical ADC and T-cell engager programs from Sino Biopharmaceutical in a deal worth up to $7 billion, Spyre Therapeutics drops anti-TL1A antibody SPY072 in rheumatic diseases after phase 2 misses and turns to hidradenitis suppurativa, and Biora Therapeutics gets ethics approval for a first-in-human trial of its BioJet oral adalimumab capsule.