Norroy Bioscience Co., Ltd., a private clinical-stage radiopharmaceutical company based in Wuxi, China, announced on September 2 that China’s National Medical Products Administration (NMPA) has cleared it to begin a pivotal Phase III trial of 177Lu-NYM032, an investigational PSMA-targeted radioligand therapy for metastatic castration-resistant prostate cancer (mCRPC). Norroy is privately held and does not trade under a stock ticker, and the actual clinical data behind this trial has not yet been made public, so this article treats the company’s efficacy claims with the caution that requires.

What’s Being Tested

The Phase III trial is randomized, open-label, and multicenter, led by Peking Union Medical College Hospital, and will evaluate 177Lu-NYM032’s efficacy and safety in patients whose prostate cancer tests positive for PSMA, a protein commonly found on prostate cancer cells. Radioligand therapy works by attaching a radioactive isotope, in this case lutetium-177, to a molecule designed to bind selectively to that target, delivering radiation directly to cancer cells rather than exposing the whole body to it. Unlike an antibody-drug conjugate, which uses a full antibody as its targeting component, NYM032 is described as a small-molecule radiopharmaceutical, a chemically simpler and generally faster-clearing type of targeting agent, a design choice that can affect how quickly the drug clears from healthy tissue and how it is dosed.

The Data Isn’t Public Yet

Norroy describes its Phase I/II results for 177Lu-NYM032 as showing promising anti-tumor activity and a favorable safety profile, but this release does not include any actual data, response rates, or adverse event figures. Instead, the company says that data will be presented as a Top-Rated Oral Presentation at the European Association of Nuclear Medicine’s 2026 annual congress. Until that presentation happens and the underlying numbers become available, Norroy’s characterization of its own early results should be read as a preview of forthcoming data rather than a verified finding.

An Established Category Leader Already Exists

177Lu-NYM032 is not the first PSMA-targeted radioligand therapy for mCRPC; that distinction belongs to Novartis’ Pluvicto (lutetium Lu 177 vipivotide tetraxetan), first approved by the FDA in 2022 and since expanded to earlier treatment lines based on additional Phase III data. In one of those later trials, Pluvicto reduced the risk of disease progression or death by 59% compared with a change in hormone therapy alone, with common side effects including dry mouth, fatigue, nausea, and constipation. Pluvicto has become a meaningful commercial product for Novartis, generating hundreds of millions of dollars in quarterly sales in past years. Norroy’s program is best understood as an attempt to bring a similar class of therapy to the Chinese market and potentially compete globally, rather than as an entirely novel treatment concept; the release does not compare NYM032 directly to Pluvicto, and no head-to-head data exists between the two.

The Theranostic Pairing

Alongside the therapeutic agent, Norroy is developing a paired diagnostic version, 68Ga-NYM032, built from the same precursor molecule but labeled with a different, imaging-suited isotope, gallium-68, instead of a therapeutic one. This diagnostic-therapeutic pairing, known as a theranostic approach, lets doctors use a PET scan with the diagnostic version to confirm a patient’s tumors actually express the target before treating them with the therapeutic version, in principle helping select patients more likely to benefit and avoiding treating patients whose tumors would not respond. Norroy says the diagnostic agent has already dosed its first patient in a separate Phase III trial, and that both the diagnostic and therapeutic versions of NYM032 have received U.S. FDA Investigational New Drug clearance in addition to this NMPA clearance in China, giving the program a foothold in both regulatory systems even at this early stage.

The Disease Burden

Prostate cancer is the fifth leading cause of cancer death among men worldwide, according to figures Norroy cites, with more than 134,000 new diagnoses and roughly 47,500 deaths in China in 2022 alone. A meaningful share of patients eventually progress to mCRPC, an advanced stage where treatment options narrow considerably after standard therapies stop working, which is the specific population this trial targets.

What’s Next

Norroy, founded in July 2021, says it has radiopharmaceutical candidates in clinical development across more than 10 disease targets, and has received six FDA IND clearances and six NMPA IND approvals to date, including Breakthrough Therapy and Fast Track designations from the FDA for a separate kidney cancer imaging agent, 68Ga-NYM096, unrelated to this trial. No financial information, funding sources, or trial timeline beyond initiation were disclosed in this release. Norroy’s own release explicitly states that 177Lu-NYM032 has not been approved for marketing by any regulatory authority and that its safety and efficacy have not been fully established. This article covers a regulatory clearance for a clinical trial and is not medical or investment advice.

Sources

Norroy Bioscience Co., Ltd.: Norroy Bioscience Initiates Pivotal Phase III Clinical Trial of 177Lu-NYM032, a PSMA-Targeted Radioligand Therapy for mCRPC, PRNewswire, September 2, 2026.

Novartis: FDA Approves Novartis Radioligand Therapy Pluvicto for Earlier Use Before Chemotherapy in PSMA-Positive Metastatic Castration-Resistant Prostate Cancer, cited for background on the existing approved PSMA-targeted radioligand therapy market.

Editorial Disclosure

This article is based on a press release issued by Norroy Bioscience Co., Ltd. on September 2, 2026, distributed via PRNewswire, with market background on Novartis’ Pluvicto drawn from Novartis’ own published announcements, cited above. Norroy Bioscience is a privately held company and does not trade under a stock ticker; no securities are discussed in this article. BioTech Stocks Daily was not compensated for this coverage. Norroy’s Phase I/II results for 177Lu-NYM032 have not yet been publicly disclosed and are described by the company as forthcoming at a future scientific conference; statements regarding anti-tumor activity and safety are the company’s own unverified characterizations. This article is for informational and educational purposes only, does not constitute investment advice, and is not medical advice. Consult a qualified healthcare professional for medical guidance. See our full DISCLAIMER.